Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Subjects With Dry Eye - Effects on Central Cornea

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of 2% rebamipide compared to placebo in clearing of fluorescein staining of the central cornea in subjects with dry eye disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Age 18 years and older

• Diagnosis of dry eye as defined by the protocol

• Central corneal staining

Exclusion Criteria:

• Ongoing ocular disease that may interfere with study parameters

• Inability to stop using topical ophthalmic medications throughout the duration of the study

• Inability to stop the use of contact lenses for the duration of the study