Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:10/2/2013
Start Date:June 2012
End Date:November 2013
Contact:Acucela Clinical Trials Helpdesk
Email:clinicaltrials@acucela.com
Phone:206-805-8310

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A Phase 3 Study to Determine the Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome


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


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.
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