Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome
Phase 3
Completed
- Conditions
- Dry Eye Syndrome
- Interventions
- Drug: Placebo (vehicle)
- Registration Number
- NCT01632137
- Lead Sponsor
- Kubota Vision Inc.
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 564
Inclusion Criteria
- History of dry eye-related ocular symptoms for at least 20 months.
- Meet protocol-defined criteria for corneal and conjunctival staining.
- Meet protocol-defined criteria for ocular discomfort.
Exclusion Criteria
- Active anterior segment ocular disease other than dry eye syndrome.
- Inability to suspend the use of topical ophthalmic medications throughout the duration of the study.
- Inability to suspend the use of contact lenses for the duration of the study.
- Judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease, or safety concerns.
- Received any other investigational product within 4 months before the screening visit.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (vehicle) Placebo (vehicle) - Rebamipide 2% ophthalmic suspension Rebamipide 2% ophthalmic suspension -
- Primary Outcome Measures
Name Time Method Primary ocular sign: Fluorescein corneal staining total score 4 weeks Primary ocular symptom: Worst ocular symptom severity score 4 weeks
- Secondary Outcome Measures
Name Time Method Fluorescein corneal staining total score 2 weeks Worst ocular symptom severity score 2 weeks