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COMPLETED
NCT00201955
PHASE3

Study of Rebamipide Eye Drops to Treat Dry Eye

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, 26 Week Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

762

Start Date

2004-05-01

Completion Date

2006-07-01

Last Updated

2026-06-24

Healthy Volunteers

No

Interventions

DRUG

Rebamipide 1%

ophthalmic suspension

DRUG

Rebamipide 2%

ophthalmic suspension

DRUG

Placebo

Rebamipide-matching placebo ophthalmic suspension

Locations (60)

Harold Helms, MD

Birmingham, Alabama, United States

Michael Bernstein, MD

Birmingham, Alabama, United States

I Care! Eye Care!

Flagstaff, Arizona, United States

Harvey and Bernice Jones Eye Institute

Little Rock, Arkansas, United States

United Medical Research Institute

Inglewood, California, United States

Benchmark Research

San Francisco, California, United States

Southern California Clinical Research, Inc.

San Marino, California, United States

Colorado Eye Associates, PC

Colorado Springs, Colorado, United States

Danbury Eye Physicians and Surgeons, P.C.

Danbury, Connecticut, United States

Florida Ophthalmic Institute

Gainesville, Florida, United States

Florida Wellcare Alliance, L.C.

Inverness, Florida, United States

Shettle Eye Center

Largo, Florida, United States

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Tukio Institute for Clinical Research

North Miami Beach, Florida, United States

Magnolia Research Group, Inc.

Ocala, Florida, United States

Radiant Research - West Palm Beach

West Palm Beach, Florida, United States

Vision Incorporated

Savannah, Georgia, United States

Welborn Clinic

Evansville, Indiana, United States

Heartland Research Associates, LLC

Wichita, Kansas, United States

Wichita Clinic, PA

Wichita, Kansas, United States

Taustine Eye Center

Louisville, Kentucky, United States

Bossier Optical, Inc.

Bossier City, Louisiana, United States

Stevenson Medical Surgical Eye Center

New Orleans, Louisiana, United States

Family Eye Centers

New Orleans, Louisiana, United States

Ophthalmic Research Associates, Inc.

North Andover, Massachusetts, United States

Minnesota Eye Associates

Minneapolis, Minnesota, United States

Depremont Eye Specialists

Gulfport, Mississippi, United States

Opthalmology Associates

Creve Coeur, Missouri, United States

Clinical Research Laboratories

Piscataway, New Jersey, United States

Ophthalmology Associates

Princeton, New Jersey, United States

Eye Care Associates

Bethpage, New York, United States

Ophthmalmic Consultants of Long Island

Lynbrook, New York, United States

Mt. Sinai Medical Center School of Medicine

New York, New York, United States

Ophthalmic Consultants of Long Island

New York, New York, United States

Rochester Ophthalmological Group

Rochester, New York, United States

Ophthalmic Consultants of Long Island

Valley Stream, New York, United States

Western Wake Eye Center, P.A.

Cary, North Carolina, United States

Southeast Clinical Research Associates

Charlotte, North Carolina, United States

Horizon Eye Care - Clinical Research Dept.

Charlotte, North Carolina, United States

Cornerstone Research Care

High Point, North Carolina, United States

Carolina Eye Associates

Southern Pines, North Carolina, United States

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Comprehensive Opthalmology & Optical Services

Cleveland, Ohio, United States

Bend Medical Clinic

Bend, Oregon, United States

Medical Eye Center

Medford, Oregon, United States

Valley Clinical Research Center

Easton, Pennsylvania, United States

Philadelphia Eye Associates

Philadelphia, Pennsylvania, United States

University of Pittsburg Eye and Ear Institute

Pittsburgh, Pennsylvania, United States

Glaucome-Cataract Consultants

Pittsburgh, Pennsylvania, United States

Black Hills Regional Eye Institute

Rapid City, South Dakota, United States

Total Eye Care, P.A.

Memphis, Tennessee, United States

Corona Research Consultants, Inc.

El Paso, Texas, United States

The University of Texas Medical Branch

Galveston, Texas, United States

Physician Research Network

Houston, Texas, United States

Houston, Texas, United States

Medical Center Ophthalmology

Houston, Texas, United States

Houston Eye Associates

Houston, Texas, United States

Sun Research Institute

San Antonio, Texas, United States

Eye Clinic of South Texas

San Antonio, Texas, United States

Advanced Healthcare Clinical Research Center

Milwaukee, Wisconsin, United States