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Completed Phase 3 Interventional

Study of Rebamipide Eye Drops to Treat Dry Eye

ClinicalTrials.gov ID: NCT00201955

Public ClinicalTrials.gov record NCT00201955. 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, 1:53 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, 26 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
NCT00201955
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
762 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
Jul 1, 2006 (Actual)
Completion
Jul 1, 2006 (Actual)
Last update posted
Jun 24, 2026

2004 – 2006

United States locations

U.S. sites
60
U.S. states
26
U.S. cities
50
Facility City State ZIP Site status
Harold Helms, MD Birmingham Alabama 35205 —
Michael Bernstein, MD Birmingham Alabama 35216 —
I Care! Eye Care! Flagstaff Arizona 860001 —
Harvey and Bernice Jones Eye Institute Little Rock Arkansas 72205 —
United Medical Research Institute Inglewood California 90301 —
Benchmark Research San Francisco California 94102 —
Southern California Clinical Research, Inc. San Marino California 91108 —
Colorado Eye Associates, PC Colorado Springs Colorado 80907 —
Danbury Eye Physicians and Surgeons, P.C. Danbury Connecticut 06810-4005 —
Florida Ophthalmic Institute Gainesville Florida 32605-3192 —
Florida Wellcare Alliance, L.C. Inverness Florida 34452 —
Shettle Eye Center Largo Florida 33770 —
Suncoast Clinical Research, Inc. New Port Richey Florida 34652 —
Tukio Institute for Clinical Research North Miami Beach Florida 33169 —
Magnolia Research Group, Inc. Ocala Florida 34471 —
Radiant Research - West Palm Beach West Palm Beach Florida 33407 —
Vision Incorporated Savannah Georgia 31406 —
Welborn Clinic Evansville Indiana 47714 —
Heartland Research Associates, LLC Wichita Kansas 67207 —
Wichita Clinic, PA Wichita Kansas 67208 —
Taustine Eye Center Louisville Kentucky 40217 —
Bossier Optical, Inc. Bossier City Louisiana 71111 —
Stevenson Medical Surgical Eye Center New Orleans Louisiana 70119 —
Family Eye Centers New Orleans Louisiana 70127 —
Ophthalmic Research Associates, Inc. North Andover Massachusetts 01845 —
Minnesota Eye Associates Minneapolis Minnesota 55404 —
Depremont Eye Specialists Gulfport Mississippi 39507 —
Opthalmology Associates Creve Coeur Missouri 63141 —
Clinical Research Laboratories Piscataway New Jersey 08854 —
Ophthalmology Associates Princeton New Jersey 08540 —
Eye Care Associates Bethpage New York 11021 —
Ophthmalmic Consultants of Long Island Lynbrook New York 11563 —
Mt. Sinai Medical Center School of Medicine New York New York 10029 —
Ophthalmic Consultants of Long Island New York New York 11570 —
Rochester Ophthalmological Group Rochester New York 14618 —
Ophthalmic Consultants of Long Island Valley Stream New York 11581 —
Western Wake Eye Center, P.A. Cary North Carolina 27511 —
Southeast Clinical Research Associates Charlotte North Carolina 28210 —
Horizon Eye Care - Clinical Research Dept. Charlotte North Carolina 28211 —
Cornerstone Research Care High Point North Carolina 27262 —
Carolina Eye Associates Southern Pines North Carolina 28387 —
Cincinnati Eye Institute Cincinnati Ohio 45242 —
Comprehensive Opthalmology & Optical Services Cleveland Ohio 44115 —
Bend Medical Clinic Bend Oregon 97701 —
Medical Eye Center Medford Oregon 97504 —
Valley Clinical Research Center Easton Pennsylvania 18045 —
Philadelphia Eye Associates Philadelphia Pennsylvania 19148 —
University of Pittsburg Eye and Ear Institute Pittsburgh Pennsylvania 15233 —
Glaucome-Cataract Consultants Pittsburgh Pennsylvania 15243 —
Black Hills Regional Eye Institute Rapid City South Dakota 57701 —
Total Eye Care, P.A. Memphis Tennessee 38119 —
Corona Research Consultants, Inc. El Paso Texas 79904 —
The University of Texas Medical Branch Galveston Texas 77555 —
Physician Research Network Houston Texas 77002 —
Not listed Houston Texas 77002 —
Medical Center Ophthalmology Houston Texas 77030 —
Houston Eye Associates Houston Texas 77125 —
Sun Research Institute San Antonio Texas 78205 —
Eye Clinic of South Texas San Antonio Texas 78209 —
Advanced Healthcare Clinical Research Center Milwaukee Wisconsin 21209 —

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 NCT00201955, 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 24, 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 NCT00201955 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →