## Protocol Section
### Identification Module
**NCT ID:** NCT02120079

**Brief Title:** The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED

**Official Title:** The Utility of in Vivo Confocal Microscopy (IVCM) to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With Dry Eye Disease (DED)

**NCT ID Aliases:**
- NCT02106377
#### Organization Study ID Info
**ID:** 13-150H
#### Organization
**Class:** OTHER
**Full Name:** Tufts Medical Center
### Status Module
#### Completion Date
**Date:** 2018-01-28

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2018-05-08

**Type:** ACTUAL

**Disp First Submit Date:** 2018-05-02
**Disp First Submit QC Date:** 2018-05-02

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-03-23

**Type:** ACTUAL

**Last Update Submit Date:** 2022-02-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-04

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2022-03-23

**Type:** ACTUAL

**Results First Submit Date:** 2022-02-24

**Results First Submit QC Date:** 2022-02-24

#### Start Date
**Date:** 2014-02

**Status Verified Date:** 2022-02

#### Study First Post Date
**Date:** 2014-04-22
**Type:** ESTIMATED
**Study First Submit Date:** 2014-02-12
**Study First Submit QC Date:** 2014-04-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Tufts Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This research study is looking to see if in vivo confocal microscopy (IVCM) imaging can be used to confirm clinical findings (which are noted by the doctor during an eye exam) and measure the immune response to the inflammation in the subject's cornea (the front part of the eyeball).

Additionally, this study is trying to determine the effectiveness of two eye-drops, Lotemax and artificial tears, in treating the inflammation associated with DED by measuring changes in immune cells with IVCM imaging. The subject will be treated with either Lotemax (loteprednol) or artificial tears (a lubricating eye drop with no medication). Lotemax is an FDA-approved steroid eye-drop that is often used to treat inflammation associated with DED. Artificial tears are approved by the FDA for treatment of dryness associated with DED.

Thus, this study is designed to determine the effects of the administration of a topical steroid, Lotemax, over a treatment period of 6 weeks, using novel methods of detecting efficacy. In order to achieve the aforementioned goal, subjects will be prospectively randomized to one of two treatment arms - Lotemax or artificial tear. Both groups will follow the same study schedule.

**Detailed Description:** IVCM is a non-invasive imaging technique that images the cornea at a cellular level with 800x magnification, using a scanning laser. The laser is used to map the cornea, and will not damage or harm the subject's eye. Studies have shown that IVCM can be used to study cells and nerves within the cornea, providing a better understanding of how the cornea reacts to irritants. IVCM has recently been used by the investigator to assess the extent of eye inflammation in cases of dry eye patients.

Current steroid therapy in dry eye disease (DED) is comprised of a 2 week duration of pulse therapy, administered twice daily (to avoid adverse effects associated with long-term steroid use). This time frame is often too short to meaningfully resolve the inflammation associated with DED. DED often occurs when there is a decrease in the eye's tear production or if there is an increase in the evaporation of the tear film (a thin layer of tears that keep the eye moist). Eye irritation and inflammation (swelling) is often associated with DED because the surface of the eye is unable to maintain a normal level of moisture.

### Conditions Module

**Conditions:**

- Dry Eye Disease

**Keywords:**

- Dry Eye

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 38

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension supplied by Bausch \& Lomb, Inc. Lotemax (loteprednol etabonate) 0.5% has been approved by the FDA for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. The medication will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

**Intervention Names:**

- Drug: Lotemax

- Diagnostic Test: In Vivo Confocal Microscopy (IVCM)

**Label:** Lotemax

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

**Intervention Names:**

- Drug: Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)

- Diagnostic Test: In Vivo Confocal Microscopy (IVCM)

**Label:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Lotemax

**Description:** Lotemax (loteprednol etabonate) 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

**Name:** Lotemax

**Other Names:**

- Lotemax (loteprednol etabonate) 0.5%

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)

**Description:** Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

**Name:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)

**Other Names:**

- Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.)

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Lotemax

- Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)

**Description:** In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.

**Name:** In Vivo Confocal Microscopy (IVCM)

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Density (in cells/mm2) of Corneal Immune Dendritiform Cells

**Measure:** IVCM for Density of Corneal Immune Dendritiform Cells

**Time Frame:** 2 Weeks

**Description:** Density (in cells/mm2) of corneal immune dendritiform cells

**Measure:** IVCM for Density of Corneal Immune Dendritiform Cells

**Time Frame:** 6 Weeks

**Description:** Morphology (in cells/mm2) of Corneal Immune Dendritiform Cells

**Measure:** IVCM for Corneal Immune Dendritiform Cell (DC) Morphology

**Time Frame:** 2 Weeks

**Description:** Morphology (in cells.mm2) of Corneal Immune Dendritiform Cells

**Measure:** IVCM for Corneal Immune Dendritiform Cell (DC) Morphology

**Time Frame:** 6 Weeks

#### Secondary Outcomes

**Description:** Corneal Fluorescein Staining Using the National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-15 Higher score means worse outcome

**Measure:** Ocular Signs: Corneal Epitheliopathy

**Time Frame:** 2 Weeks

**Description:** Corneal Fluorescein Staining Using the National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-15 Higher score means worse outcome

**Measure:** Ocular Signs: Corneal Epitheliopathy

**Time Frame:** 6 Weeks

**Description:** Conjunctival Lissamine Green Staining Using National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-18 Higher score means worse outcome

**Measure:** Ocular Signs: Conjunctival Epitheliopathy

**Time Frame:** 2 Weeks

**Description:** Conjunctival Lissamine Green Staining Using National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-18 Higher score means worse outcome

**Measure:** Ocular Signs: Conjunctival Epitheliopathy

**Time Frame:** 6 Weeks

**Description:** Total Score of the Ocular Surface Disease Index (OSDI) Questionnaire Minimum score- 0 Maximum score-100 Higher score means worse outcome

**Measure:** Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire

**Time Frame:** 2 Weeks

**Description:** Total Score of the Ocular Surface Disease Index (OSDI) Questionnaire Minimum score- 0 Maximum score-100 Higher score means worse outcome

**Measure:** Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire

**Time Frame:** 6 Weeks

**Description:** Intraocular Pressure (IOP) will be measured via Applanation and the result will have these units: mmHg

**Measure:** Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry

**Time Frame:** 2 Weeks

**Description:** Intraocular Pressure (IOP) will be measured via Applanation and the result will have these units: mmHg

**Measure:** Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry

**Time Frame:** 6 Weeks

**Description:** Tear Break Up Time (TBUT) will be recorded in seconds

**Measure:** Ocular Signs: Tear Break Up Time (TBUT)

**Time Frame:** 2 Weeks

**Description:** Tear Break Up Time (TBUT) will be recorded in seconds

**Measure:** Ocular Signs: Tear Break Up Time (TBUT)

**Time Frame:** 6 Weeks

**Description:** The Schirmer's Test (performed using Anesthesia) will be measured in mm.

**Measure:** Ocular Signs: Schirmer's Test With Anesthesia

**Time Frame:** 2 Weeks

**Description:** The Schirmer's Test (performed using Anesthesia) will be measured in mm.

**Measure:** Ocular Signs: Schirmer's Test With Anesthesia

**Time Frame:** 6 Weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age 18-89 years.
* Willing and able to provide written informed consent.
* Willing and able to comply with study assessments for the full duration of the study.
* In good stable overall health.
* Corneal dendritiform cell count by confocal microscopy of \>=75/mm2 (13 immune cells per image)
* Diagnosis of dry eye disease based on the followings:
* Symptoms of dry eye disease such as foreign body sensation, burning, stinging, light sensitivity for at least 6 months.
* Two or more of the following objective signs:
* Schirmer test with anesthesia \<10 mm at 5 minutes \[mean Schirmer between eyes.
* Tear break-up time (TBUT) of \<10 seconds.
* Corneal fluorescein staining of 4 (NEI grading scheme, 0-15) in at least one eye
* Lissamine green staining of the nasal and temporal conjunctiva (NEI grading scheme, 0-18) in at least one eye

Exclusion Criteria:

* Central corneal subbasal dendritic cell count by in vivo confocal microscopy of \<75/mm2 in both eyes
* Active ocular allergies
* Active allergies to steroids, aminoglycosides, or benzalkonium chloride (BAK)
* History of contact lens wear within 3 months before enrollment.
* Intraocular surgery or ocular laser surgery within 3 months before enrollment.
* History of ocular infection within 3 months before enrollment.
* History of topical (for ophthalmic use) or systemic steroid treatment (Loteprednol (other than Lotemax suspension used in our study), Difluprednate, Fluorometholone, Prednisolone, Dexamethasone, Triamcinolone, Rimexolone, Medrysone) within 1 month before enrollment. In case of topical ophthalmic steroid use, a wash-out period of 1 month is required.
* History of increased intraocular pressure after using topical steroids (steroid responsive)
* Change in systemic immunosuppression medication in the past 3 months.
* History of any change in the frequency of topical cyclosporine or oral tetracycline compounds (tetracycline, doxycycline, and minocycline) within 1 month before enrollment.
* Any condition (including language barrier) that precludes subject's ability to comply with study requirements including completion of study.

**Maximum Age:** 89 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Boston

**Country:** United States

**Facility:** Tufts Medical Center

**State:** Massachusetts

**Zip:** 02111

#### Overall Officials

**Official 1:**

**Affiliation:** Tufts Medical Center

**Name:** Pedram Hamrah, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2017-01-13

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 1120235

- Type Abbrev: Prot_SAP

- Upload Date: 2017-12-07T14:48

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007766

- Term: Lacrimal Apparatus Diseases

- ID: D000007637

- Term: Keratoconjunctivitis

- ID: D000003231

- Term: Conjunctivitis

- ID: D000003229

- Term: Conjunctival Diseases

- ID: D000007634

- Term: Keratitis

- ID: D000003316

- Term: Corneal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M18040

- Name: Dry Eye Syndromes

- Relevance: HIGH

- As Found: Dry Eye Disease

- ID: M10664

- Name: Keratoconjunctivitis Sicca

- Relevance: HIGH

- As Found: Dry Eye Disease

- ID: M8271

- Name: Eye Diseases

- Relevance: HIGH

- As Found: Eye Disease

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10663

- Name: Keratoconjunctivitis

- Relevance: LOW

- As Found: Unknown

- ID: M10786

- Name: Lacrimal Apparatus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6455

- Name: Conjunctivitis

- Relevance: LOW

- As Found: Unknown

- ID: M6453

- Name: Conjunctival Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10660

- Name: Keratitis

- Relevance: LOW

- As Found: Unknown

- ID: M6539

- Name: Corneal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015352

- Term: Dry Eye Syndromes

- ID: D000007638

- Term: Keratoconjunctivitis Sicca

- ID: D000005128

- Term: Eye Diseases

### Intervention Browse Module - Ancestors

- ID: D000019999

- Term: Pharmaceutical Solutions

- ID: D000018926

- Term: Anti-Allergic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: AAll

- Name: Anti-Allergic Agents

### Intervention Browse Module - Browse Leaves

- ID: M12814

- Name: Ophthalmic Solutions

- Relevance: HIGH

- As Found: Cerebral

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M30506

- Name: Lubricant Eye Drops

- Relevance: HIGH

- As Found: Employment

- ID: M468

- Name: Loteprednol Etabonate

- Relevance: HIGH

- As Found: Autologous Transplantation

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M20962

- Name: Anti-Allergic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069559

- Term: Loteprednol Etabonate

- ID: D000009883

- Term: Ophthalmic Solutions

- ID: D000065346

- Term: Lubricant Eye Drops

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Lotemax

**Deaths Num At Risk:** 17

**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax (loteprednol etabonate) 0.5% has been approved by the FDA for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. The medication will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Lotemax: Lotemax (loteprednol etabonate) 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of

**ID:** EG000

**Other Num at Risk:** 17

**Serious Number At Risk:** 17

**Title:** Lotemax

**Group ID:** EG001

**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)

**Deaths Num At Risk:** 20

**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.

**ID:** EG001

**Other Num at Risk:** 20

**Serious Number At Risk:** 20

**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)

**Frequency Threshold:** 0

**Time Frame:** 6 Weeks

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 17

**Group ID:** BG001

**Value:** 20

**Group ID:** BG002

**Value:** 37

**Units:** Participants

**Group ID:** BG000

**Value:** 28

**Group ID:** BG001

**Value:** 34

**Group ID:** BG002

**Value:** 62

**Units:** Eyes

### Group

**ID:** BG000

**Title:** Lotemax

**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.

### Group

**ID:** BG001

**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)

**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 12.62

**Value:** 57.29

#### Measurement

**Group ID:** BG001

**Spread:** 15.78

**Value:** 55.35

#### Measurement

**Group ID:** BG002

**Spread:** 14.25

**Value:** 56.24

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Measurement

**Group ID:** BG001

**Value:** 17

#### Measurement

**Group ID:** BG002

**Value:** 29

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 8

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG002

**Value:** 0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 14.98

**Value:** 26.83

#### Measurement

**Group ID:** BG001

**Spread:** 29.15

**Value:** 34.59

#### Measurement

**Group ID:** BG002

**Spread:** 23.76

**Value:** 30.97

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 16.67

**Value:** 90.79

#### Measurement

**Group ID:** BG001

**Spread:** 23.82

**Value:** 92.29

#### Measurement

**Group ID:** BG002

**Spread:** 20.64

**Value:** 91.59

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 2.50

**Value:** 3.39

#### Measurement

**Group ID:** BG001

**Spread:** 3.27

**Value:** 4.06

#### Measurement

**Group ID:** BG002

**Spread:** 2.94

**Value:** 3.76

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 29.36

**Value:** 56.93

#### Measurement

**Group ID:** BG001

**Spread:** 20.34

**Value:** 38.46

#### Measurement

**Group ID:** BG002

**Spread:** 26.35

**Value:** 47.18

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 2.71

**Value:** 3.57

#### Measurement

**Group ID:** BG001

**Spread:** 4.26

**Value:** 5.74

#### Measurement

**Group ID:** BG002

**Spread:** 3.78

**Value:** 4.76

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 3.18

**Value:** 14.50

#### Measurement

**Group ID:** BG001

**Spread:** 2.46

**Value:** 14.97

#### Measurement

**Group ID:** BG002

**Spread:** 2.79

**Value:** 14.76

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 2.18

**Value:** 3.99

#### Measurement

**Group ID:** BG001

**Spread:** 3.30

**Value:** 4.17

#### Measurement

**Group ID:** BG002

**Spread:** 2.82

**Value:** 4.09

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 8.94

**Value:** 10.44

#### Measurement

**Group ID:** BG001

**Spread:** 9.35

**Value:** 10.57

#### Measurement

**Group ID:** BG002

**Spread:** 9.09

**Value:** 10.51

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
#### Denomination 1
##### Denomination Count 1
**Group ID:** BG000
**Value:** 17
##### Denomination Count 2
**Group ID:** BG001
**Value:** 20
##### Denomination Count 3
**Group ID:** BG002
**Value:** 37
**Units:** Participants
#### Denomination 2
##### Denomination Count 1
**Group ID:** BG000
**Value:** 28
##### Denomination Count 2
**Group ID:** BG001
**Value:** 34
##### Denomination Count 3
**Group ID:** BG002
**Value:** 62
**Units:** Eyes
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
#### Denomination 1
##### Denomination Count 1
**Group ID:** BG000
**Value:** 17
##### Denomination Count 2
**Group ID:** BG001
**Value:** 20
##### Denomination Count 3
**Group ID:** BG002
**Value:** 37
**Units:** Participants
#### Denomination 2
##### Denomination Count 1
**Group ID:** BG000
**Value:** 28
##### Denomination Count 2
**Group ID:** BG001
**Value:** 34
##### Denomination Count 3
**Group ID:** BG002
**Value:** 62
**Units:** Eyes
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Race and Ethnicity were not collected from any participant.
**Title:** Race and Ethnicity Not Collected
**Unit of Measure:** Participants
#### Denomination 1
##### Denomination Count 1
**Group ID:** BG000
**Value:** 0
##### Denomination Count 2
**Group ID:** BG001
**Value:** 0
##### Denomination Count 3
**Group ID:** BG002
**Value:** 0
**Units:** Participants
#### Denomination 2
##### Denomination Count 1
**Group ID:** BG000
**Value:** 28
##### Denomination Count 2
**Group ID:** BG001
**Value:** 34
##### Denomination Count 3
**Group ID:** BG002
**Value:** 62
**Units:** Eyes
### Measure 4
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Corneal immune dendritiform cell (DC) density at Baseline
**Unit of Measure:** cells/mm2
#### Denomination 1
##### Denomination Count 1
**Group ID:** BG000
**Value:** 17
##### Denomination Count 2
**Group ID:** BG001
**Value:** 20
##### Denomination Count 3
**Group ID:** BG002
**Value:** 37
**Units:** Participants
#### Denomination 2
##### Denomination Count 1
**Group ID:** BG000
**Value:** 28
##### Denomination Count 2
**Group ID:** BG001
**Value:** 34
##### Denomination Count 3
**Group ID:** BG002
**Value:** 62
**Units:** Eyes
### Measure 5
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Corneal immune dendritiform cell (DC) morphology at Baseline
**Unit of Measure:** cells/mm2
#### Denomination 1
##### Denomination Count 1
**Group ID:** BG000
**Value:** 17
##### Denomination Count 2
**Group ID:** BG001
**Value:** 20
##### Denomination Count 3
**Group ID:** BG002
**Value:** 37
**Units:** Participants
#### Denomination 2
##### Denomination Count 1
**Group ID:** BG000
**Value:** 28
##### Denomination Count 2
**Group ID:** BG001
**Value:** 34
##### Denomination Count 3
**Group ID:** BG002
**Value:** 62
**Units:** Eyes
### Measure 6
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Corneal fluorescein staining at Baseline
**Unit of Measure:** Score
#### Denomination 1
##### Denomination Count 1
**Group ID:** BG000
**Value:** 17
##### Denomination Count 2
**Group ID:** BG001
**Value:** 20
##### Denomination Count 3
**Group ID:** BG002
**Value:** 37
**Units:** Participants
#### Denomination 2
##### Denomination Count 1
**Group ID:** BG000
**Value:** 28
##### Denomination Count 2
**Group ID:** BG001
**Value:** 34
##### Denomination Count 3
**Group ID:** BG002
**Value:** 62
**Units:** Eyes
### Measure 7
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** OSDI at Baseline
**Unit of Measure:** Score
#### Denomination 1
##### Denomination Count 1
**Group ID:** BG000
**Value:** 17
##### Denomination Count 2
**Group ID:** BG001
**Value:** 20
##### Denomination Count 3
**Group ID:** BG002
**Value:** 37
**Units:** Participants
#### Denomination 2
##### Denomination Count 1
**Group ID:** BG000
**Value:** 28
##### Denomination Count 2
**Group ID:** BG001
**Value:** 34
##### Denomination Count 3
**Group ID:** BG002
**Value:** 62
**Units:** Eyes
### Measure 8
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Lissamine Green at Baseline
**Unit of Measure:** Score
#### Denomination 1
##### Denomination Count 1
**Group ID:** BG000
**Value:** 17
##### Denomination Count 2
**Group ID:** BG001
**Value:** 20
##### Denomination Count 3
**Group ID:** BG002
**Value:** 37
**Units:** Participants
#### Denomination 2
##### Denomination Count 1
**Group ID:** BG000
**Value:** 28
##### Denomination Count 2
**Group ID:** BG001
**Value:** 34
##### Denomination Count 3
**Group ID:** BG002
**Value:** 62
**Units:** Eyes
### Measure 9
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** IOP at Baseline
**Unit of Measure:** mmHG
#### Denomination 1
##### Denomination Count 1
**Group ID:** BG000
**Value:** 17
##### Denomination Count 2
**Group ID:** BG001
**Value:** 20
##### Denomination Count 3
**Group ID:** BG002
**Value:** 37
**Units:** Participants
#### Denomination 2
##### Denomination Count 1
**Group ID:** BG000
**Value:** 28
##### Denomination Count 2
**Group ID:** BG001
**Value:** 34
##### Denomination Count 3
**Group ID:** BG002
**Value:** 62
**Units:** Eyes
### Measure 10
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** TBUT at Baseline
**Unit of Measure:** Seconds
#### Denomination 1
##### Denomination Count 1
**Group ID:** BG000
**Value:** 17
##### Denomination Count 2
**Group ID:** BG001
**Value:** 20
##### Denomination Count 3
**Group ID:** BG002
**Value:** 37
**Units:** Participants
#### Denomination 2
##### Denomination Count 1
**Group ID:** BG000
**Value:** 28
##### Denomination Count 2
**Group ID:** BG001
**Value:** 34
##### Denomination Count 3
**Group ID:** BG002
**Value:** 62
**Units:** Eyes
### Measure 11
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Schirmer's at Baseline
**Unit of Measure:** mm in 10 min
#### Denomination 1
##### Denomination Count 1
**Group ID:** BG000
**Value:** 17
##### Denomination Count 2
**Group ID:** BG001
**Value:** 20
##### Denomination Count 3
**Group ID:** BG002
**Value:** 37
**Units:** Participants
#### Denomination 2
##### Denomination Count 1
**Group ID:** BG000
**Value:** 28
##### Denomination Count 2
**Group ID:** BG001
**Value:** 34
##### Denomination Count 3
**Group ID:** BG002
**Value:** 62
**Units:** Eyes
**Type Units Analyzed:** Eyes
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** phamrah@tuftsmedicalcenter.org
**Organization:** Tufts Medical Center
**Phone:** 617-636-5321
**Title:** Dr. Pedram Hamrah
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
### Outcome Measure 16
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.13
- **Upper Limit:** 
- **Value:** 9.47
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 26.09
- **Upper Limit:** 
- **Value:** 28.60
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.10
- **Upper Limit:** 
- **Value:** 9.80
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 31.92
- **Upper Limit:** 
- **Value:** 34.03
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 40.56
- **Upper Limit:** 
- **Value:** 109.50
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 30.92
- **Upper Limit:** 
- **Value:** 97.95
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 26.25
- **Upper Limit:** 
- **Value:** 102.31
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 24.73
- **Upper Limit:** 
- **Value:** 89.34
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.12
- **Upper Limit:** 
- **Value:** 1.86
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.55
- **Upper Limit:** 
- **Value:** 3.18
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.98
- **Upper Limit:** 
- **Value:** 2.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.75
- **Upper Limit:** 
- **Value:** 3.59
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.47
- **Upper Limit:** 
- **Value:** 3.79
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.13
- **Upper Limit:** 
- **Value:** 4.50
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.86
- **Upper Limit:** 
- **Value:** 2.46
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.55
- **Upper Limit:** 
- **Value:** 3.44
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 27.36
- **Upper Limit:** 
- **Value:** 47.25
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 23.55
- **Upper Limit:** 
- **Value:** 33.16
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 29.15
- **Upper Limit:** 
- **Value:** 46.63
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 23.30
- **Upper Limit:** 
- **Value:** 36.04
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.87
- **Upper Limit:** 
- **Value:** 15.52
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.32
- **Upper Limit:** 
- **Value:** 14.50
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.30
- **Upper Limit:** 
- **Value:** 16.88
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.32
- **Upper Limit:** 
- **Value:** 13.76
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.48
- **Upper Limit:** 
- **Value:** 5.20
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.91
- **Upper Limit:** 
- **Value:** 3.93
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.68
- **Upper Limit:** 
- **Value:** 4.83
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.04
- **Upper Limit:** 
- **Value:** 3.44
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.98
- **Upper Limit:** 
- **Value:** 7.98
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.92
- **Upper Limit:** 
- **Value:** 6.88
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.78
- **Upper Limit:** 
- **Value:** 8.16
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.06
- **Upper Limit:** 
- **Value:** 8.18
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Density (in cells/mm2) of Corneal Immune Dendritiform Cells
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 2 Weeks
**Title:** IVCM for Density of Corneal Immune Dendritiform Cells
**Type:** PRIMARY
**Type Units Analyzed:** eyes
**Unit of Measure:** cells/mm2
##### Group
**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG000
**Title:** Lotemax
##### Group
**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG001
**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
#### Outcome Measure 2
**Description:** Density (in cells/mm2) of corneal immune dendritiform cells
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 6 Weeks
**Title:** IVCM for Density of Corneal Immune Dendritiform Cells
**Type:** PRIMARY
**Type Units Analyzed:** eyes
**Unit of Measure:** cells/mm2
##### Group
**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG000
**Title:** Lotemax
##### Group
**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG001
**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
#### Outcome Measure 3
**Description:** Morphology (in cells/mm2) of Corneal Immune Dendritiform Cells
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 2 Weeks
**Title:** IVCM for Corneal Immune Dendritiform Cell (DC) Morphology
**Type:** PRIMARY
**Type Units Analyzed:** Eyes
**Unit of Measure:** cells/mm2
##### Group
**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG000
**Title:** Lotemax
##### Group
**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG001
**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
#### Outcome Measure 4
**Description:** Morphology (in cells.mm2) of Corneal Immune Dendritiform Cells
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 6 Weeks
**Title:** IVCM for Corneal Immune Dendritiform Cell (DC) Morphology
**Type:** PRIMARY
**Type Units Analyzed:** Eyes
**Unit of Measure:** Cells/mm2
##### Group
**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG000
**Title:** Lotemax
##### Group
**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG001
**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
#### Outcome Measure 5
**Description:** Corneal Fluorescein Staining Using the National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-15 Higher score means worse outcome
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 2 Weeks
**Title:** Ocular Signs: Corneal Epitheliopathy
**Type:** SECONDARY
**Type Units Analyzed:** Eyes
**Unit of Measure:** Score
##### Group
**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG000
**Title:** Lotemax
##### Group
**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG001
**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
#### Outcome Measure 6
**Description:** Corneal Fluorescein Staining Using the National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-15 Higher score means worse outcome
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 6 Weeks
**Title:** Ocular Signs: Corneal Epitheliopathy
**Type:** SECONDARY
**Type Units Analyzed:** Eyes
**Unit of Measure:** Score
##### Group
**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension supplied by Bausch \& Lomb, Inc. Lotemax (loteprednol etabonate) 0.5% has been approved by the FDA for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. The medication will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Lotemax: Lotemax (loteprednol etabonate) 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG000
**Title:** Lotemax
##### Group
**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG001
**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
#### Outcome Measure 7
**Description:** Conjunctival Lissamine Green Staining Using National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-18 Higher score means worse outcome
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 2 Weeks
**Title:** Ocular Signs: Conjunctival Epitheliopathy
**Type:** SECONDARY
**Type Units Analyzed:** Eyes
**Unit of Measure:** Score
##### Group
**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG000
**Title:** Lotemax
##### Group
**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG001
**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
#### Outcome Measure 8
**Description:** Conjunctival Lissamine Green Staining Using National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-18 Higher score means worse outcome
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 6 Weeks
**Title:** Ocular Signs: Conjunctival Epitheliopathy
**Type:** SECONDARY
**Type Units Analyzed:** Eyes
**Unit of Measure:** Score
##### Group
**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG000
**Title:** Lotemax
##### Group
**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG001
**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
#### Outcome Measure 9
**Description:** Total Score of the Ocular Surface Disease Index (OSDI) Questionnaire Minimum score- 0 Maximum score-100 Higher score means worse outcome
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 2 Weeks
**Title:** Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire
**Type:** SECONDARY
**Unit of Measure:** Score
##### Group
**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG000
**Title:** Lotemax
##### Group
**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG001
**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
#### Outcome Measure 10
**Description:** Total Score of the Ocular Surface Disease Index (OSDI) Questionnaire Minimum score- 0 Maximum score-100 Higher score means worse outcome
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 6 Weeks
**Title:** Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire
**Type:** SECONDARY
**Unit of Measure:** Score
##### Group
**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG000
**Title:** Lotemax
##### Group
**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG001
**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
#### Outcome Measure 11
**Description:** Intraocular Pressure (IOP) will be measured via Applanation and the result will have these units: mmHg
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 2 Weeks
**Title:** Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry
**Type:** SECONDARY
**Type Units Analyzed:** Eyes
**Unit of Measure:** mmHg
##### Group
**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG000
**Title:** Lotemax
##### Group
**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG001
**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
#### Outcome Measure 12
**Description:** Intraocular Pressure (IOP) will be measured via Applanation and the result will have these units: mmHg
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 6 Weeks
**Title:** Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry
**Type:** SECONDARY
**Type Units Analyzed:** Eyes
**Unit of Measure:** mmHg
##### Group
**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG000
**Title:** Lotemax
##### Group
**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG001
**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
#### Outcome Measure 13
**Description:** Tear Break Up Time (TBUT) will be recorded in seconds
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 2 Weeks
**Title:** Ocular Signs: Tear Break Up Time (TBUT)
**Type:** SECONDARY
**Type Units Analyzed:** Eyes
**Unit of Measure:** Seconds
##### Group
**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG000
**Title:** Lotemax
##### Group
**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG001
**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
#### Outcome Measure 14
**Description:** Tear Break Up Time (TBUT) will be recorded in seconds
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 6 Weeks
**Title:** Ocular Signs: Tear Break Up Time (TBUT)
**Type:** SECONDARY
**Type Units Analyzed:** Eyes
**Unit of Measure:** Seconds
##### Group
**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG000
**Title:** Lotemax
##### Group
**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG001
**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
#### Outcome Measure 15
**Description:** The Schirmer's Test (performed using Anesthesia) will be measured in mm.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 2 Weeks
**Title:** Ocular Signs: Schirmer's Test With Anesthesia
**Type:** SECONDARY
**Type Units Analyzed:** Eyes
**Unit of Measure:** mm
##### Group
**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG000
**Title:** Lotemax
##### Group
**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG001
**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
#### Outcome Measure 16
**Description:** The Schirmer's Test (performed using Anesthesia) will be measured in mm.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 6 Weeks
**Title:** Ocular Signs: Schirmer's Test With Anesthesia
**Type:** SECONDARY
**Type Units Analyzed:** Eyes
**Unit of Measure:** mm
##### Group
**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG000
**Title:** Lotemax
##### Group
**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** OG001
**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
### Participant Flow Module
#### Group
**Description:** Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** FG000
**Title:** Lotemax
#### Group
**Description:** Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.

In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
**ID:** FG001
**Title:** Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
#### Period
**Title:** Baseline
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 17
**Number of Units:** 28
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
**Number of Units:** 34
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 17
**Number of Units:** 28
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
**Number of Units:** 34
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Number of Units:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Number of Units:** 0
#### Period
**Title:** 2 Weeks
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 17
**Number of Units:** 28
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
**Number of Units:** 34
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 17
**Number of Units:** 28
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
**Number of Units:** 34
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Number of Units:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Number of Units:** 0
#### Period
**Title:** 6 Weeks
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 17
**Number of Units:** 28
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
**Number of Units:** 34
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 17
**Number of Units:** 28
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
**Number of Units:** 34
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Number of Units:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Number of Units:** 0
**Type Units Analyzed:** eyes
**Has Results:** True