Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome

Phase 3

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: Placebo (vehicle); Drug: Rebamipide 2% ophthalmic suspension

• 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

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2012-06-29
• Study First Posted: 2012-07-02
• Primary Completion: 2013-06
• Status Verified: 2014-04
• Disposition First Submitted: 2014-04-17
• Disposition First Submitted QC: 2014-04-17
• Last Update Submitted: 2014-04-17
• Disposition First Posted: 2014-05-07
• Last Update Posted: 2014-05-07

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