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COMPLETED
NCT00201981
PHASE3

A 1-Year Study in Multiple Clinics Testing Rebamipide Eye Drops for Dry Eye Compared With a Placebo

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).

Official title: Rebamipide Ophthalmic Suspension in the Treatment of Dry Eye: A Multicenter, Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, 52 Week Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

755

Start Date

2004-05-01

Completion Date

2007-02-01

Last Updated

2026-06-15

Healthy Volunteers

No

Interventions

DRUG

Rebamipide 1%

ophthalmic suspension

DRUG

Rebamipide 2%

ophthalmic suspension

DRUG

Placebo

Rebamipide-matching placebo ophthalmic suspension

Locations (63)

Alabama Research Center, LLC

Birmingham, Alabama, United States

Sun Valley Arthritis Center, Ltd.

Glendale, Arizona, United States

Pivotel Research Center

Peoria, Arizona, United States

Hope research Institute

Phoenix, Arizona, United States

Buena Vista Eye Care Center

Phoenix, Arizona, United States

Radiant Research

Scottsdale, Arizona, United States

Sall Eye Research Center

Artesia, California, United States

Radiant Research - Irvine

Irvine, California, United States

Scripps Clinic Medical Group, Inc.

La Jolla, California, United States

American Eye Institute

Los Angeles, California, United States

Eye Clinic of San Diego

San Diego, California, United States

Healthcare Partners Medical Group

Torrance, California, United States

Centennial Eye Associates

Centennial, Colorado, United States

Corneal Consultants of Colorado

Littleton, Colorado, United States

Western States Clinical Research, Inc.

Wheat Ridge, Colorado, United States

Peter C. Donshik, MDPC

Bloomfield, Connecticut, United States

Opticare Eye Health Center

Waterbury, Connecticut, United States

The Eye Associates

Bradenton, Florida, United States

Hernando Eye Institute

Brooksville, Florida, United States

Radiant Research, Inc. - Lake Worth

Lake Worth, Florida, United States

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Eye Associates International

Ormond Beach, Florida, United States

Pinellas Eye Center

Pinellas Park, Florida, United States

Ft. Lauderdale Eye Institute

Sunrise, Florida, United States

Marvin E. Greenberg, MD PA 7

Tamarac, Florida, United States

Clinical Research of West Florida, Inc.

Tampa, Florida, United States

International Eye Center

Tampa, Florida, United States

Omni Eye Services

Atlanta, Georgia, United States

University of Kentucky, Department of Ophthamology

Lexington, Kentucky, United States

Kentucky Lions Eye Center

Louisville, Kentucky, United States

Gulf Coast Research Associates, Inc.

Baton Rouge, Louisiana, United States

Danial Long, MD

Gretna, Louisiana, United States

Lakeview Optical

New Orleans, Louisiana, United States

Eye Center Northeast

Bangor, Maine, United States

Krieger Eye Institute

Baltimore, Maryland, United States

The Wilmer Eye Institute

Lutherville, Maryland, United States

New England Eye Center

Boston, Massachusetts, United States

The Eye Institute - Lahey Clinic North

Peabody, Massachusetts, United States

Mississippi Eye Associates

Ocean Springs, Mississippi, United States

Montana Medical Research, LLC

Missoula, Montana, United States

Clinical Research Center of Nevada

Las Vegas, Nevada, United States

Eye Associates of New Mexico

Albuquerque, New Mexico, United States

Western New York Eye Center

Orchard Park, New York, United States

Glaucoma Consultants of the Capital Region

Slingerlands, New York, United States

Orellana Retina Associates, PLLC

Raleigh, North Carolina, United States

University Hospitals of Cleveland

Cleveland, Ohio, United States

Comprehensive Opthalmology & Optical Services

Cleveland, Ohio, United States

Clinical Research Source, Inc.

Perrysburg, Ohio, United States

Clinical Research Institute of Southern Oregon

Medford, Oregon, United States

Northwest Corneal Services

Portland, Oregon, United States

Vision Surgery and Laser Center

Roseburg, Oregon, United States

West Hills Vision Center

Moon Township, Pennsylvania, United States

Glaucoma Consultants and Center for Eye Research

Mt. Pleasant, South Carolina, United States

University Eye Surgeons

Maryville, Tennessee, United States

St. Luke's Eye Institute

Amarillo, Texas, United States

Eye Clinic of Austin

Austin, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Surgical Eye Associates, PA

Houston, Texas, United States

Brazosport Eye Institute

Lake Jackson, Texas, United States

Axia Research

Salt Lake City, Utah, United States

John Moran Eye Center, University of Utah

Salt Lake City, Utah, United States

Physicians Research Options, LC

Sandy City, Utah, United States

Access Eye Research Center

Fredericksburg, Virginia, United States