Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of Systane® Gel Drops in dry eye subjects following 90 days of QID (4 times/day) dosing.

Official Title
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Clinical Evaluation of Systane® Gel Drops on Corneal Staining in Indian Subjects With Dry Eye

Conditions
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Dry Eye

Intervention / Treatment
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* Other: Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must give informed consent, and be willing and able to attend all study visits. Best-corrected visual acuity (BCVA) of ≥ 55 letters in each eye as measured by ETDRS (letters read method). 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, test positive on a pregnancy test, or breast-feeding. Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of test article or safe participation in the study. Any contraindications or hypersensitivities to the study medications or their components. Ocular surgery (of any type, including PRK, LASIK, Epilasik, etc.) 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. Chronic medications (over the counter, prescription, or vitamins) that have not been on a stable dose for at least 30 days prior to Screening. Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study. Participation in any other clinical trial within 30 days prior to Screening. Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane<br>Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID in each eye for 90 days | Other: Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops<br> <br> * Other names: Systane® Gel Drops;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Corneal Staining at All Study Time Points | Corneal staining was assessed by the Investigator through slit-lamp examination and reported on a scale of 0-3, where 0=normal (no staining) and 3=severe (numerous coalescent macropunctate areas and/or patches), for the 5 quadrants of each eye. The scores at each visit were summed by eye for each subject. The overall corneal staining score for the subject at each visit was then computed as the average of the sum from both eyes. Thus, the overall scores ranged between 0-15 with higher scores reflecting more damage to the corneal surface. | Baseline (Day 0), Day 45, Day 90 |