Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acucela Inc.; Kubota Vision Inc.
• Collaborator: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Rebamipide

Criteria

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.