## Protocol Section
### Identification Module
**NCT ID:** NCT04886479

**Brief Title:** Comparing Silicone Hydrogel Contact Lens Wearers to Hydrogel Contact Lens Wearers and Non-lens Wearers

**Official Title:** Comparing Habitual Daily Disposable Silicone Hydrogel (DDSH) Contact Lens Wearers to Habitual Daily Disposable Hydrogel (DDH) Contact Lens Wearers and Non-lens Wearers

#### Organization Study ID Info
**ID:** EX-MKTG-89
#### Organization
**Class:** INDUSTRY
**Full Name:** Coopervision, Inc.
### Status Module
#### Completion Date
**Date:** 2022-10-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-10-07

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2024-01-30

**Type:** ACTUAL

**Results First Submit Date:** 2023-10-05

**Results First Submit QC Date:** 2024-01-03

#### Start Date
**Date:** 2019-03-06

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2021-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2021-05-10
**Study First Submit QC Date:** 2021-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Coopervision, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study was a multi-site, prospective, randomized, non-masked, unilateral, non-dispensing study.

**Detailed Description:** The purpose of this study was to to compare physiological response baseline data between 3 groups - habitual wearers of Daily Disposable Silicone Hydrogel (DDSH) contact lenses, habitual wearers of Daily Disposable Hydrogel (DDH) contact lenses, and non-lens wearers. The study then compared physiological response data following wear of a low Dk HEMA contact lens between habitual wearers of DDSH and habitual wearers of DDH.

### Conditions Module

**Conditions:**

- Myopia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 22

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants wore Test Lens for 3 hours

**Intervention Names:**

- Device: Test Lens

**Label:** Daily Disposable Silicone Hydrogel Contact Lens Wearers

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants wore Test Lens for 3 hours

**Intervention Names:**

- Device: Test Lens

**Label:** Daily Disposable Hydrogel Contact Lens Wearers

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Participants did not receive Test Lens

**Intervention Names:**

- Other: Control

**Label:** Non-lens Wearers

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Non-lens Wearers

**Description:** No lens

**Name:** Control

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Daily Disposable Hydrogel Contact Lens Wearers

- Daily Disposable Silicone Hydrogel Contact Lens Wearers

**Description:** Low Dk HEMA contact lens worn for 3 hours

**Name:** Test Lens

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of limbal redness after 6-8 hours of habitual device wear. For each participant, measurements were taken for both eyes (OD - right eye, OS - left eye) at two locations (T - temporal, N - nasal).

**Measure:** Limbal Redness - DDSH, DDH, Non-lens Groups

**Time Frame:** 6-8 hours of habitual wear

**Description:** Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of bulbar redness after 6-8 hours of habitual device wear. For each participant, measurements were taken for both eyes (OD - right eye, OS - left eye) at two locations (T - temporal, N - nasal).

**Measure:** Bulbar Redness DDSH, DDH, Non-lens Groups

**Time Frame:** 6-8 hours of habitual wear

**Description:** Number of participants with limbal vessel ingrowth longer than 0.50 mm at any of the 4 corneal quadrants (superior, inferior, nasal, temporal) after 6-8 hours of device wear.

**Measure:** Limbal Vessel Ingrowth - DDSH, DDH, Non-lens Groups

**Time Frame:** 6-8 hours of habitual wear

**Description:** Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of limbal redness by location (T - temporal, N - nasal) and time (t). Measurements were taken at baseline and over a 3 hour period of closed-eye Test Lens wear.

**Measure:** Limbal Redness - DDSH, DDH Groups

**Time Frame:** Immediately upon eye opening (t=baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal

**Description:** Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of bulbar redness by location (T - temporal, N - nasal) and time (t). Measurements were taken at baseline and over a 3 hour period of closed-eye Test Lens wear.

**Measure:** Bulbar Redness - DDSH, DDH Groups

**Time Frame:** Immediately upon eye opening (baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal

#### Secondary Outcomes

**Description:** Difference in central corneal swelling (μm, Visante OCT) at baseline (before lens insertion) vs. measurements taken over a 3 hour period following Test Lens removal. Derived by the formula: corneal swelling % = (measured corneal thickness - baseline corneal thickness) x 100 /baseline corneal thickness.

**Measure:** Central Corneal Swelling (%) - DDSH, DDH Groups

**Time Frame:** Immediately upon eye opening and lens removal (t=0), 0.5 hours (t=0.5), 1 hour (t=1), 2 hours (t=2), and 3 hours (t=3) post lens removal

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Is between 17 and 60 years of age inclusive (age matching required between all 3 study groups), and has full legal capacity to volunteer;
2. Has had a self-reported oculo-visual examination in the last two years.
3. Has read and signed an information consent letter;
4. Is willing and able to follow instructions and maintain the appointment schedule;
5. No previous history of overnight contact lens wear or PMMA (polymethylmethacrylate) lens wear.
6. Auto-refraction vertexed spherical equivalent between +4.00 and -8.00 (prescription matching required between groups 1 \& 2). This criterion is non-applicable to participants in group 3.
7. Is found to be in one of the study groups matched by age (±5 years), ethnicity (Asian vs. non-Asian) and CL Rx (±2.00 D) according using the following criteria.

   GROUP 1: For the past (minimum) 6 months has ONLY worn spherical DDSH lenses AND prior to wearing this lens they only wore SH material lenses in the past (minimum) 3 total years.

   GROUP 2: For the past (minimum) 6 months has ONLY worn spherical DDH lenses AND prior to wearing this lens they only wore H material lenses in the past (minimum) 3 total years.
8. For groups 1 \& 2, currently and for at least the previous 6 months has had habitual daily disposable wear schedule of at least 8 hrs a day, 5 days a week in only one material category - either silicone hydrogel or hydrogel material. This criterion is not-applicable to participants in group 3.
9. Is willing to wear the study contact lens in the randomized eye for 3 hours of eye closure on the second study day. This criterion is not-applicable to participants in group 3.
10. Has clear and healthy corneas and anterior eye and no active ocular disease;
11. Can achieve monocular HCVA of logMAR 0.10 or better in each eye with subjective refraction or pinhole.
12. Can achieve acceptable fit and comfort in the randomized eye with the study lens. This criterion will be confirmed at the baseline visit (V1). This criterion is not-applicable to participants in group 3.
13. Has a wearable pair of spectacles.

Exclusion Criteria:

1. Is participating in any concurrent clinical trial;
2. Is unable/unwilling to provide permission for the study site to seek CL history from their eye care practitioner
3. Has any known active ocular disease and/or infection;
4. Has a systemic condition that in the opinion of the investigator may affect a study measure or interfere with contact lens wear; this may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes, and systemic connective tissue disorders e.g. rheumatoid arthritis.
5. Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
6. Has known sensitivity to fluorescein dye, topical anesthetic, or products to be used in the study;
7. Appears to have any active ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
8. Appears to have any signs of corneal inflammation or previous infection or corneal opacity/scar;
9. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit), due to potential ocular physiological changes, such as changes in the corneal shape and cell types;
10. Is aphakic;
11. Has undergone refractive error surgery, or has a history of any ocular surgery or injury.
12. Is a toric or multifocal contact lens wearer.

**Healthy Volunteers:** True

**Maximum Age:** 60 Years

**Minimum Age:** 17 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Waterloo

**Country:** Canada

**Facility:** CORE, University of Waterloo

**Location 2:**

**City:** Manchester

**Country:** United Kingdom

**Facility:** Eurolens Research

#### Overall Officials

**Official 1:**

**Affiliation:** Centre for Ocular Research & Education

**Name:** Lyndon Jones, PhD FCOptom

**Role:** PRINCIPAL_INVESTIGATOR

## Document Section

### Large Document Module

#### Large Docs

- Date: 2020-11-28

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 445821

- Type Abbrev: Prot_SAP

- Upload Date: 2023-10-05T16:56

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012030

- Term: Refractive Errors

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12168

- Name: Myopia

- Relevance: HIGH

- As Found: Myopia

- ID: M14872

- Name: Refractive Errors

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009216

- Term: Myopia

### Misc Info Module

#### Submission Tracking

##### First MCP Info

###### Post Date

- Date: 2023-11-01

- Type: ACTUAL

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** DDSH Lens Wearers

**Deaths Num At Risk:** 10

**Description:** Participants that wore DDSH Lens in Period 1 and Test Lens in Period 2

**ID:** EG000

**Other Num at Risk:** 10

**Serious Number At Risk:** 10

**Title:** DDSH Lens Wearers

**Group ID:** EG001

**Title:** DDH Lens Wearers

**Deaths Num At Risk:** 3

**Description:** Participants that wore DDH Lens in Period 1 and Test Lens in Period 2

**ID:** EG001

**Other Num at Risk:** 3

**Serious Number At Risk:** 3

**Title:** DDH Lens Wearers

**Group ID:** EG002

**Title:** Non-lens Wearers

**Deaths Num At Risk:** 9

**Description:** Participants that did not wear DDSH or DDH Lenses in Period 1

**ID:** EG002

**Other Num Affected:** 1

**Other Num at Risk:** 9

**Serious Number At Risk:** 9

**Title:** Non-lens Wearers

**Frequency Threshold:** 0

#### Other Events

**Term:** Lightheadedness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Transitional feeling of light-headedness during confocal microscopy. Unrelated to study, as neither DDH Lens nor DDSH Lens were worn at time of event.

**Organ System:** Eye disorders

**Source Vocabulary:** 

**Time Frame:** Through study exit, up to 30 days from the first visit.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 10

**Group ID:** BG001

**Value:** 3

**Group ID:** BG002

**Value:** 9

**Group ID:** BG003

**Value:** 22

**Units:** Participants

### Group

**ID:** BG000

**Title:** DDSH Lens Wearers

**Description:** Participants who habitually wear DDSH lenses

### Group

**ID:** BG001

**Title:** DDH Lens Wearers

**Description:** Participants who habitually wear DDH lenses

### Group

**ID:** BG002

**Title:** Non-lens Wearers

**Description:** Participants that do not wear either DDSH or DDH Lens.

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 13.2

**Value:** 32.7

#### Measurement

**Group ID:** BG001

**Spread:** 7.5

**Value:** 30.0

#### Measurement

**Group ID:** BG002

**Spread:** 13.2

**Value:** 31.7

#### Measurement

**Group ID:** BG003

**Spread:** 12.2

**Value:** 31.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 6

#### Measurement

**Group ID:** BG003

**Value:** 13

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 3

#### Measurement

**Group ID:** BG003

**Value:** 9

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 9

#### Measurement

**Group ID:** BG003

**Value:** 22

**Class Title:** Non-Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Class Title:** Asian

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Description:** Ethnicity was measured due to possible differences in physiological response to corneal hypoxia in Asian and non-Asian participants. All subjects in this study were of non-Asian ethnicity, due to difficulty in finding and recruiting Asian candidates at the study site.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Restrictive Agreement:** True
### Point of Contact
**Email:** jvega2@coopervision.com
**Organization:** CooperVision Inc.
**Phone:** +19256213761
**Title:** Director Global Clinical Affairs
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.24
- **Spread:** 
- **Upper Limit:** 0.58
- **Value:** 0.41
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.05
- **Spread:** 
- **Upper Limit:** 0.68
- **Value:** 0.37
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 0.26
- **Spread:** 
- **Upper Limit:** 0.63
- **Value:** 0.44
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.25
- **Spread:** 
- **Upper Limit:** 0.73
- **Value:** 0.49
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.04
- **Spread:** 
- **Upper Limit:** 0.84
- **Value:** 0.40
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 0.19
- **Spread:** 
- **Upper Limit:** 0.70
- **Value:** 0.44
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.35
- **Spread:** 
- **Upper Limit:** 0.73
- **Value:** 0.54
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.05
- **Spread:** 
- **Upper Limit:** 0.65
- **Value:** 0.30
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 0.25
- **Spread:** 
- **Upper Limit:** 0.66
- **Value:** 0.46
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.18
- **Spread:** 
- **Upper Limit:** 0.46
- **Value:** 0.32
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.12
- **Spread:** 
- **Upper Limit:** 0.62
- **Value:** 0.37
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 0.27
- **Spread:** 
- **Upper Limit:** 0.56
- **Value:** 0.41
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.55
- **Spread:** 
- **Upper Limit:** 0.97
- **Value:** 0.76
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.28
- **Spread:** 
- **Upper Limit:** 1.05
- **Value:** 0.67
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 0.56
- **Spread:** 
- **Upper Limit:** 1.01
- **Value:** 0.79
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.59
- **Spread:** 
- **Upper Limit:** 1.13
- **Value:** 0.86
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.33
- **Spread:** 
- **Upper Limit:** 1.33
- **Value:** 0.83
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 0.42
- **Spread:** 
- **Upper Limit:** 1.00
- **Value:** 0.71
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.63
- **Spread:** 
- **Upper Limit:** 1.23
- **Value:** 0.93
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.18
- **Spread:** 
- **Upper Limit:** 1.28
- **Value:** 0.73
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 0.48
- **Spread:** 
- **Upper Limit:** 1.12
- **Value:** 0.80
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.60
- **Spread:** 
- **Upper Limit:** 1.12
- **Value:** 0.86
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.13
- **Spread:** 
- **Upper Limit:** 1.07
- **Value:** 0.60
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 0.40
- **Spread:** 
- **Upper Limit:** 0.94
- **Value:** 0.67
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.28
- **Spread:** 
- **Upper Limit:** 0.68
- **Value:** 0.48
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.04
- **Spread:** 
- **Upper Limit:** 0.71
- **Value:** 0.33
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.50
- **Spread:** 
- **Upper Limit:** 0.90
- **Value:** 0.70
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.07
- **Spread:** 
- **Upper Limit:** 0.79
- **Value:** 0.43
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.36
- **Spread:** 
- **Upper Limit:** 0.86
- **Value:** 0.61
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.03
- **Spread:** 
- **Upper Limit:** 0.90
- **Value:** 0.43
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.45
- **Spread:** 
- **Upper Limit:** 0.97
- **Value:** 0.71
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.17
- **Spread:** 
- **Upper Limit:** 0.77
- **Value:** 0.30
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.16
- **Spread:** 
- **Upper Limit:** 0.56
- **Value:** 0.36
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.13
- **Spread:** 
- **Upper Limit:** 0.87
- **Value:** 0.50
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.44
- **Spread:** 
- **Upper Limit:** 1.00
- **Value:** 0.72
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.11
- **Spread:** 
- **Upper Limit:** 1.15
- **Value:** 0.63
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.33
- **Spread:** 
- **Upper Limit:** 0.81
- **Value:** 0.57
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.13
- **Spread:** 
- **Upper Limit:** 1.01
- **Value:** 0.57
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.34
- **Spread:** 
- **Upper Limit:** 0.92
- **Value:** 0.63
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.10
- **Spread:** 
- **Upper Limit:** 0.97
- **Value:** 0.43
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.55
- **Spread:** 
- **Upper Limit:** 1.19
- **Value:** 0.87
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.02
- **Spread:** 
- **Upper Limit:** 1.18
- **Value:** 0.60
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.73
- **Spread:** 
- **Upper Limit:** 1.27
- **Value:** 1.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.14
- **Spread:** 
- **Upper Limit:** 1.12
- **Value:** 0.63
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.51
- **Spread:** 
- **Upper Limit:** 1.27
- **Value:** 0.89
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.12
- **Spread:** 
- **Upper Limit:** 1.25
- **Value:** 0.57
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.69
- **Spread:** 
- **Upper Limit:** 1.37
- **Value:** 1.03
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.03
- **Spread:** 
- **Upper Limit:** 1.23
- **Value:** 0.60
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.47
- **Spread:** 
- **Upper Limit:** 1.09
- **Value:** 0.78
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.23
- **Spread:** 
- **Upper Limit:** 1.37
- **Value:** 0.80
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.87
- **Spread:** 
- **Upper Limit:** 1.41
- **Value:** 1.14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.37
- **Spread:** 
- **Upper Limit:** 1.36
- **Value:** 0.87
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.73
- **Spread:** 
- **Upper Limit:** 1.27
- **Value:** 1.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.24
- **Spread:** 
- **Upper Limit:** 1.23
- **Value:** 0.73
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.81
- **Spread:** 
- **Upper Limit:** 1.61
- **Value:** 1.21
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.03
- **Spread:** 
- **Upper Limit:** 1.50
- **Value:** 0.77
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 7.28
- **Spread:** 
- **Upper Limit:** 12.07
- **Value:** 9.67
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.97
- **Spread:** 
- **Upper Limit:** 13.71
- **Value:** 9.34
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5.61
- **Spread:** 
- **Upper Limit:** 9.75
- **Value:** 7.68
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.03
- **Spread:** 
- **Upper Limit:** 10.60
- **Value:** 6.82
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.57
- **Spread:** 
- **Upper Limit:** 6.76
- **Value:** 5.17
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.35
- **Spread:** 
- **Upper Limit:** 7.17
- **Value:** 4.26
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.20
- **Spread:** 
- **Upper Limit:** 1.77
- **Value:** 0.98
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.99
- **Spread:** 
- **Upper Limit:** 1.88
- **Value:** 0.45
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.15
- **Spread:** 
- **Upper Limit:** 0.32
- **Value:** -0.41
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.80
- **Spread:** 
- **Upper Limit:** 0.89
- **Value:** -0.45
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of limbal redness after 6-8 hours of habitual device wear. For each participant, measurements were taken for both eyes (OD - right eye, OS - left eye) at two locations (T - temporal, N - nasal).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 6-8 hours of habitual wear
**Title:** Limbal Redness - DDSH, DDH, Non-lens Groups
**Type:** PRIMARY
**Type Units Analyzed:** Eyes (single)
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants wore habitual DDSH Lens in both eyes
**ID:** OG000
**Title:** DDSH Lens Wearers
##### Group
**Description:** Participants wore habitual DDH Lens in both eyes
**ID:** OG001
**Title:** DDH Lens Wearers
##### Group
**Description:** Participants did not wear either DDSH or DDH Lens
**ID:** OG002
**Title:** Non-lens Wearers
#### Outcome Measure 2
**Description:** Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of bulbar redness after 6-8 hours of habitual device wear. For each participant, measurements were taken for both eyes (OD - right eye, OS - left eye) at two locations (T - temporal, N - nasal).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 6-8 hours of habitual wear
**Title:** Bulbar Redness DDSH, DDH, Non-lens Groups
**Type:** PRIMARY
**Type Units Analyzed:** Eyes (single)
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants wore habitual DDSH Lens in both eyes
**ID:** OG000
**Title:** DDSH Lens Wearers
##### Group
**Description:** Participants wore habitual DDH Lens in both eyes
**ID:** OG001
**Title:** DDH Lens Wearers
##### Group
**Description:** Participants did not wear DDSH or DDH Lens
**ID:** OG002
**Title:** Non-lens Wearers
#### Outcome Measure 3
**Description:** Number of participants with limbal vessel ingrowth longer than 0.50 mm at any of the 4 corneal quadrants (superior, inferior, nasal, temporal) after 6-8 hours of device wear.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 6-8 hours of habitual wear
**Title:** Limbal Vessel Ingrowth - DDSH, DDH, Non-lens Groups
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants wore habitual DDSH Lens in both eyes
**ID:** OG000
**Title:** DDSH Lens Wearers
##### Group
**Description:** Participants wore habitual DDH Lens in both eyes
**ID:** OG001
**Title:** DDH Lens Wearers
##### Group
**Description:** Participants did not wear either DDSH or DDH Lens
**ID:** OG002
**Title:** Non-lens Wearers
#### Outcome Measure 4
**Description:** Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of limbal redness by location (T - temporal, N - nasal) and time (t). Measurements were taken at baseline and over a 3 hour period of closed-eye Test Lens wear.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Immediately upon eye opening (t=baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal
**Title:** Limbal Redness - DDSH, DDH Groups
**Type:** PRIMARY
**Type Units Analyzed:** Eyes (single)
**Unit of Measure:** score on a scale
##### Group
**Description:** Habitual DDSH lens wearers wore the Test Lens in one randomized eye that was kept closed and patched for 3 hours. The contralateral eye remained open.
**ID:** OG000
**Title:** DDSH Lens Wearers
##### Group
**Description:** Habitual DDH lens wearers wore the Test Lens in one randomized eye that was kept closed and patched for 3 hours. The contralateral eye remained open.
**ID:** OG001
**Title:** DDH Lens Wearers
#### Outcome Measure 5
**Description:** Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of bulbar redness by location (T - temporal, N - nasal) and time (t). Measurements were taken at baseline and over a 3 hour period of closed-eye Test Lens wear.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Immediately upon eye opening (baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal
**Title:** Bulbar Redness - DDSH, DDH Groups
**Type:** PRIMARY
**Type Units Analyzed:** Eyes (single)
**Unit of Measure:** score on a scale
##### Group
**Description:** Habitual DDSH lens wearers wore the Test Lens in one randomized eye that was kept closed and patched for 3 hours. The contralateral eye remained open.
**ID:** OG000
**Title:** DDSH Lens Wearers
##### Group
**Description:** Habitual DDH lens wearers wore the Test Lens in one randomized eye that was kept closed and patched for 3 hours. The contralateral eye remained open.
**ID:** OG001
**Title:** DDH Lens Wearers
#### Outcome Measure 6
**Description:** Difference in central corneal swelling (μm, Visante OCT) at baseline (before lens insertion) vs. measurements taken over a 3 hour period following Test Lens removal. Derived by the formula: corneal swelling % = (measured corneal thickness - baseline corneal thickness) x 100 /baseline corneal thickness.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Immediately upon eye opening and lens removal (t=0), 0.5 hours (t=0.5), 1 hour (t=1), 2 hours (t=2), and 3 hours (t=3) post lens removal
**Title:** Central Corneal Swelling (%) - DDSH, DDH Groups
**Type:** SECONDARY
**Type Units Analyzed:** Eyes (single)
**Unit of Measure:** Percent change in corneal swelling (%)
##### Group
**Description:** Habitual DDSH lens wearers wore the Test Lens in one randomized eye that was kept closed and patched for 3 hours. The contralateral eye remained open.
**ID:** OG000
**Title:** DDSH Lens Wearers
##### Group
**Description:** Habitual DDH lens wearers wore the Test Lens in one randomized eye that was kept closed and patched for 3 hours. The contralateral eye remained open.
**ID:** OG001
**Title:** DDH Lens Wearers
### Participant Flow Module
#### Group
**Description:** Participants wore habitual DDSH Lens in both eyes for 6-8 hours (Period 1, observational). Afterwards, participants wore the Test Lens in one randomized eye that was kept closed and patched for 3 hours (Period 2, interventional).
**ID:** FG000
**Title:** DDSH Lens Wearers
#### Group
**Description:** Participants wore habitual DDH Lens in both eyes for 6-8 hours (Period 1, observational). Afterwards, participants wore the Test Lens in one randomized eye that was kept closed and patched for 3 hours (Period 2, interventional).
**ID:** FG001
**Title:** DDH Lens Wearers
#### Group
**Description:** Participants had no previous history of contact lens wear. Participants wore habitual spectacles, if any, for 6-8 hours (Period 1, observational). They did not receive the Test Lens and were not involved in Period 2.
**ID:** FG002
**Title:** Non-lens Wearers
#### Period
**Title:** Period 1: Habitual Device, 6-8 Hours
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
**Number of Units:** 20
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
**Number of Units:** 6
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 9
**Number of Units:** 18
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
**Number of Units:** 20
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
**Number of Units:** 6
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 9
**Number of Units:** 18
##### 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
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
**Number of Units:** 0
#### Period
**Title:** Period 2: Test Lens, 3 Hours
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
**Number of Units:** 10
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
**Number of Units:** 3
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
**Number of Units:** 0
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
**Number of Units:** 10
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
**Number of Units:** 3
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
**Number of Units:** 0
##### 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
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
**Number of Units:** 0
**Pre-Assignment Details:** Twenty-six participants were screened, with 3 of these not meeting all eligibility criteria and were considered screen failures. One participant withdrew for reasons unrelated to the study. These participants were not included in the total number of participants enrolled.
**Type Units Analyzed:** Eyes [single]
**Has Results:** True