Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome

Completed · Phase 3 · Has a placebo group

Conditions studied: Dry Eye Syndrome

In brief

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

Key facts

Study ID

NCT01632137

Run by

Kubota Vision Inc.

People needed

564

Starts

2012-06-01

Last updated by the study team

2014-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Artesia, California, United States
• Study site — Glendale, California, United States
• Study site — Inglewood, California, United States
• Study site — San Diego, California, United States
• Study site — Wheat Ridge, Colorado, United States
• Study site — Fort Myers, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Stuart, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Morrow, Georgia, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Lutherville, Maryland, United States
• Study site — Kansas City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Washington, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Princeton, New Jersey, United States
• Study site — Rochester, New York, United States
• Study site — Rockville Centre, New York, United States
• Study site — Valley Stream, New York, United States
• Study site — Wantagh, New York, United States
• Study site — Ashville, North Carolina, United States

Full record on ClinicalTrials.gov

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