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

Completed · Phase 2 · Has a placebo group

Conditions studied: Keratoconjunctivitis Sicca, Dry Eye

In brief

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.

Key facts

Study ID

NCT01057147

Run by

Kubota Vision Inc.

People needed

116

Starts

2010-02-01

Expected to finish

2011-02-01

Last updated by the study team

2012-01-11

Who can join

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

You may qualify if…

• Age 18 years and older
• Diagnosis of dry eye as defined by the protocol
• Central corneal staining

You may not qualify if…

• 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

Where it is running

• East Valley Ophthalmology — Mesa, Arizona, United States
• Arizona Center for Clinical Trials, LLC — Phoenix, Arizona, United States
• Cornea Consultants of Arizona — Phoenix, Arizona, United States
• Macy Eye Center — Los Angeles, California, United States
• Corneal Consultants of Colorado — Littleton, Colorado, United States
• Specialty Eye Care — Parker, Colorado, United States
• Cohen Laser and Vision Center — Boca Raton, Florida, United States
• Florida Eye Microsurgical Institute, Inc. — Boynton Beach, Florida, United States
• Med Eye Associates — Miami, Florida, United States
• George R. John, MD — Louisville, Kentucky, United States
• Central Maine Eye Care — Lewiston, Maine, United States
• Ora, Inc. — Andover, Massachusetts, United States
• Ophthalmology Associates — St Louis, Missouri, United States
• Nevada Eye Care Professionals — Las Vegas, Nevada, United States
• Avista Eye Center — Las Vegas, Nevada, United States
• New York Ophthalmology, PC — Manhasset, New York, United States
• Mundorf Eye Center — Charlotte, North Carolina, United States
• Black Hills Regional Eye Institute — Rapid City, South Dakota, United States
• The Cataract & Glaucoma Center — El Paso, Texas, United States

Full record on ClinicalTrials.gov

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