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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00201981

Public ClinicalTrials.gov record NCT00201981. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 4:09 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT00201981
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
755 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 1, 2004 (Actual)
Primary completion
Feb 1, 2007 (Actual)
Completion
Feb 1, 2007 (Actual)
Last update posted
Jun 15, 2026

2004 – 2007

United States locations

U.S. sites
63
U.S. states
26
U.S. cities
58
Facility City State ZIP Site status
Alabama Research Center, LLC Birmingham Alabama 35209 —
Sun Valley Arthritis Center, Ltd. Glendale Arizona 85308 —
Pivotel Research Center Peoria Arizona 85381 —
Hope research Institute Phoenix Arizona 85006 —
Buena Vista Eye Care Center Phoenix Arizona 85012 —
Radiant Research Scottsdale Arizona 85251 —
Sall Eye Research Center Artesia California 90701-5653 —
Radiant Research - Irvine Irvine California 92618 —
Scripps Clinic Medical Group, Inc. La Jolla California 92037 —
American Eye Institute Los Angeles California 90048 —
Eye Clinic of San Diego San Diego California 92103 —
Healthcare Partners Medical Group Torrance California 90503 —
Centennial Eye Associates Centennial Colorado 80112 —
Corneal Consultants of Colorado Littleton Colorado 80120 —
Western States Clinical Research, Inc. Wheat Ridge Colorado 80033 —
Peter C. Donshik, MDPC Bloomfield Connecticut 06002 —
Opticare Eye Health Center Waterbury Connecticut 06708 —
The Eye Associates Bradenton Florida 34209 —
Hernando Eye Institute Brooksville Florida 34613 —
Radiant Research, Inc. - Lake Worth Lake Worth Florida 33461 —
Suncoast Clinical Research, Inc. New Port Richey Florida 34652 —
Eye Associates International Ormond Beach Florida 32174 —
Pinellas Eye Center Pinellas Park Florida 33781 —
Ft. Lauderdale Eye Institute Sunrise Florida 33351 —
Marvin E. Greenberg, MD PA 7 Tamarac Florida 33321 —
Clinical Research of West Florida, Inc. Tampa Florida 33603 —
International Eye Center Tampa Florida 33603 —
Omni Eye Services Atlanta Georgia 30342 —
University of Kentucky, Department of Ophthamology Lexington Kentucky 40536-0293 —
Kentucky Lions Eye Center Louisville Kentucky 40222 —
Gulf Coast Research Associates, Inc. Baton Rouge Louisiana 70808 —
Danial Long, MD Gretna Louisiana 70056 —
Lakeview Optical New Orleans Louisiana 70124 —
Eye Center Northeast Bangor Maine 04401 —
Krieger Eye Institute Baltimore Maryland 21215 —
The Wilmer Eye Institute Lutherville Maryland 21093 —
New England Eye Center Boston Massachusetts 02111 —
The Eye Institute - Lahey Clinic North Peabody Massachusetts 01960 —
Mississippi Eye Associates Ocean Springs Mississippi 39564 —
Montana Medical Research, LLC Missoula Montana 59804 —
Clinical Research Center of Nevada Las Vegas Nevada 89104 —
Eye Associates of New Mexico Albuquerque New Mexico 87109 —
Western New York Eye Center Orchard Park New York 14127 —
Glaucoma Consultants of the Capital Region Slingerlands New York 12159 —
Orellana Retina Associates, PLLC Raleigh North Carolina 27612 —
University Hospitals of Cleveland Cleveland Ohio 44106-5068 —
Comprehensive Opthalmology & Optical Services Cleveland Ohio 44115 —
Clinical Research Source, Inc. Perrysburg Ohio 43551 —
Clinical Research Institute of Southern Oregon Medford Oregon 97504 —
Northwest Corneal Services Portland Oregon 97223 —
Vision Surgery and Laser Center Roseburg Oregon 97470 —
West Hills Vision Center Moon Township Pennsylvania 15108 —
Glaucoma Consultants and Center for Eye Research Mt. Pleasant South Carolina 29464 —
University Eye Surgeons Maryville Tennessee 37803 —
St. Luke's Eye Institute Amarillo Texas 79106 —
Eye Clinic of Austin Austin Texas 78731 —
Baylor College of Medicine Houston Texas 77030 —
Surgical Eye Associates, PA Houston Texas 77055 —
Brazosport Eye Institute Lake Jackson Texas 77566 —
Axia Research Salt Lake City Utah 84107 —
John Moran Eye Center, University of Utah Salt Lake City Utah 84132 —
Physicians Research Options, LC Sandy City Utah 84070 —
Access Eye Research Center Fredericksburg Virginia 22405 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00201981, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 15, 2026 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00201981 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →