Study of Rebamipide Eye Drops to Treat Dry Eye

Study Overview
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Brief Summary
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The purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).

Detailed Description
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There is a need for effective therapy for dry eye that treats the underlying cause of the syndrome. The goal of this study is to assess the impact of rebamipide on dry eye symptom.

Official Title
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Rebamipide Ophthalmic Suspension in the Treatment of Dry Eye: A Multicenter, Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, 52 Week Study

Conditions
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Keratoconjunctivitis Sicca

Intervention / Treatment
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* Drug: Rebamipide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: must have symptoms of dry eye for a minimum of 6 months must be able to sign and date an informed consent Exclusion Criteria: presence of anterior segment disease glaucoma or ocular hypertension using Restasis use of topically instilled ocular medications during study use of contact lenses history of ocular surgery within 12 months females who are pregnant, breast feeding, or child-bearing potential and not willing to remain abstinent or use contraception presence of Stevens-Johnson syndrome any anticipated change in medication through-out study concurrent involvement in another study or previous receipt of this drug cannot be safely be weaned off of ocular medications

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>rebamipide 1% | Drug: Rebamipide<br>* OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks<br>|
| Active Comparator: 2<br>Rebamipide 2% | Drug: Rebamipide<br>* OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks<br>|
| No Intervention: 3<br>placebo | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12 |  | 12 week and 26 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26 |  | 12 week and 26 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry eye, keratoconjunctivitis sicca