## Protocol Section
### Identification Module
**NCT ID:** NCT02511379

**Brief Title:** Clinical Evaluation of Systane® Balance in Dry Eye Subjects

**Official Title:** Clinical Evaluation of Systane® Balance on Corneal Staining in Indian Subjects With Dry Eye

#### Organization Study ID Info
**ID:** EXJ821-P001 (C-13-039)
#### Organization
**Class:** INDUSTRY
**Full Name:** Alcon Research
#### Secondary ID Infos
**Domain:** CTRI
**ID:** CTRI/2015/10/006320
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2016-06-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-10-31

**Type:** ACTUAL

**Last Update Submit Date:** 2018-10-03

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2016-06-20

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2018-09-05

**Type:** ACTUAL

**Results First Submit Date:** 2017-12-15

**Results First Submit QC Date:** 2017-12-15

#### Start Date
**Date:** 2015-11-26

**Type:** ACTUAL

**Status Verified Date:** 2018-10

#### Study First Post Date
**Date:** 2015-07-30
**Type:** ESTIMATED
**Study First Submit Date:** 2015-07-28
**Study First Submit QC Date:** 2015-07-28
**Why Stopped:** Discontinuation of product development
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Alcon Research

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to evaluate the efficacy and safety of Systane® Balance following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye.

**Detailed Description:** This study was conducted in India.

### Conditions Module

**Conditions:**

- Dry Eye

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 14

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days

**Intervention Names:**

- Other: Propylene Glycol 0.6% eye drops

**Label:** Systane Balance

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Systane Balance

**Name:** Propylene Glycol 0.6% eye drops

**Other Names:**

- Systane® Balance

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15).

**Measure:** Change From Baseline in Corneal Staining Total Score

**Time Frame:** Baseline (Day 0), Day 45, Day 90

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Sign informed consent and willing and able to attend all study visits;
* Dry eye in both eyes diagnosed by an ophthalmologist;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential who are pregnant or breastfeeding;
* Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study;
* Ocular surgery or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening;
* Use of topical ocular prescription or non-prescription medications, RESTASIS or topical ocular steroids within 14 days of Screening;
* Use of any artificial tears/gels/lubricants/rewetting drops within 4 hours of Screening;
* Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study;
* Other protocol-specified exclusion criteria may apply.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Alcon Research

**Name:** Alcon Research, Ltd

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007766

- Term: Lacrimal Apparatus Diseases

- ID: D000005128

- Term: Eye 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

- ID: M10664

- Name: Keratoconjunctivitis Sicca

- Relevance: HIGH

- As Found: Dry Eye

- 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: M8271

- Name: Eye 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

### Intervention Browse Module - Ancestors

- ID: D000019999

- Term: Pharmaceutical Solutions

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M12814

- Name: Ophthalmic Solutions

- Relevance: HIGH

- As Found: Cerebral

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000009883

- Term: Ophthalmic Solutions

### Misc Info Module

#### Removed Countries

- Country: India

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Systane Balance

**Deaths Num At Risk:** 14

**Description:** Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days

**ID:** EG000

**Other Num at Risk:** 14

**Serious Number At Risk:** 14

**Title:** Systane Balance

**Frequency Threshold:** 0

**Time Frame:** Adverse events were collected for the duration of participation, an average of 90 days.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 14

**Units:** Participants

### Group

**ID:** BG000

**Title:** Systane Balance

**Description:** Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 14

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 6

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Restrictive Agreement:** True
### Point of Contact
**Email:** alcon.medinfo@alcon.com
**Organization:** Alcon, A Novartis Division
**Phone:** 1-888-451-3937
**Title:** Study Director Med Affairs
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -8
- **Spread:** 
- **Upper Limit:** 1
- **Value:** -3.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 14
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -11
- **Spread:** 
- **Upper Limit:** -1
- **Value:** -4.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 13
**Units:** Participants
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15).
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Population Description:** Analysis includes all participants with data present. Analysis was based on the eye with the higher corneal staining total score at screening or the right eye when both eyes have same corneal staining total score at screening, as observed.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0), Day 45, Day 90
**Title:** Change From Baseline in Corneal Staining Total Score
**Type:** PRIMARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days
**ID:** OG000
**Title:** Systane Balance
### Participant Flow Module
#### Group
**Description:** Propylene Glycol 0.6% eye drops, 1 drop QID (4 times/day) (with the last dose of each day at bedtime) in each eye for 90 days
**ID:** FG000
**Title:** Systane Balance
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Recruitment Details:** Participants were enrolled from 4 study sites located in India.
**Has Results:** True