Study of Rebamipide Eye Drops to Treat Dry Eye

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00201955
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 2, 2006
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Keratoconjunctivitis Sicca Drug: Rebamipide Phase 3

Detailed Description:
There is a need for effective therapy for dry eye that treats the underlying cause of the syndrome. The goal of this study is to assess the impact of rebamipide on dry eye symptoms.

Study Type : Interventional  (Clinical Trial)
Enrollment : 740 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : May 2004
Study Completion Date : July 2006

Primary Outcome Measures :
  1. fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12

Secondary Outcome Measures :
  1. fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • must have symptoms of dry eye for a minimum of 6 months
  • must be able to sign and date an informed consent

Exclusion Criteria:

  • presence of anterior segment disease
  • glaucoma or ocular hypertension
  • using Restasis
  • use of topically instilled ocular medications during study
  • use of contact lenses
  • history of ocular surgery within 12 months
  • females who are pregnant, breast feeding, or child-bearing potential and not willing to remain abstinent or use contraception
  • presence of Stevens-Johnson syndrome
  • any anticipated change in medication through-out study
  • concurrent involvement in another study or previous receipt of this drug
  • cannot be safely be weaned off of ocular medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00201955

  Hide Study Locations
United States, Alabama
Harold Helms, MD
Birmingham, Alabama, United States, 35205
Michael Bernstein, MD
Birmingham, Alabama, United States, 35216
United States, Arizona
I Care! Eye Care!
Flagstaff, Arizona, United States, 860001
United States, Arkansas
Harvey and Bernice Jones Eye Institute
Little Rock, Arkansas, United States, 72205
United States, California
United Medical Research Institute
Inglewood, California, United States, 90301
Benchmark Research
San Francisco, California, United States, 94102
Southern California Clinical Research, Inc.
San Marino, California, United States, 91108
United States, Colorado
Colorado Eye Associates, PC
Colorado Springs, Colorado, United States, 80907
United States, Connecticut
Danbury Eye Physicians and Surgeons, P.C.
Danbury, Connecticut, United States, 06810-4005
United States, Florida
Florida Ophthalmic Institute
Gainesville, Florida, United States, 32605-3192
Florida Wellcare Alliance, L.C.
Inverness, Florida, United States, 34452
Shettle Eye Center
Largo, Florida, United States, 33770
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States, 34652
Tukio Institute for Clinical Research
North Miami Beach, Florida, United States, 33169
Magnolia Research Group, Inc.
Ocala, Florida, United States, 34471
Radiant Research - West Palm Beach
West Palm Beach, Florida, United States, 33407
United States, Georgia
Vision Incorporated
Savannah, Georgia, United States, 31406
United States, Indiana
Welborn Clinic
Evansville, Indiana, United States, 47714
United States, Kansas
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
Wichita Clinic, PA
Wichita, Kansas, United States, 67208
United States, Kentucky
Taustine Eye Center
Louisville, Kentucky, United States, 40217
United States, Louisiana
Bossier Optical, Inc.
Bossier, Louisiana, United States, 71111
Stevenson Medical Surgical Eye Center
New Orleans, Louisiana, United States, 70119
Family Eye Centers
New Orleans, Louisiana, United States, 70127
United States, Massachusetts
Ophthalmic Research Associates, Inc.
N. Andover, Massachusetts, United States, 01845
United States, Minnesota
Minnesota Eye Associates
Minneapolis, Minnesota, United States, 55404
United States, Mississippi
Depremont Eye Specialists
Gulfport, Mississippi, United States, 39507
United States, Missouri
Opthalmology Associates
Creve Coeur, Missouri, United States, 63141
United States, New Jersey
Clinical Research Laboratories
Piscataway, New Jersey, United States, 08854
Ophthalmology Associates
Princeton, New Jersey, United States, 08540
United States, New York
Eye Care Associates
Bethpage, New York, United States, 11021
Ophthmalmic Consultants of Long Island
Lynbrook, New York, United States, 11563
Mt. Sinai Medical Center School of Medicine
New York, New York, United States, 10029
Rochester Ophthalmological Group
Rochester, New York, United States, 14618
Ophthalmic Consultants of Long Island
Rockville Center, New York, United States, 11570
Ophthalmic Consultants of Long Island
Valley Stream, New York, United States, 11581
United States, North Carolina
Western Wake Eye Center, P.A.
Cary, North Carolina, United States, 27511
Southeast Clinical Research Associates
Charlotte, North Carolina, United States, 28210
Horizon Eye Care - Clinical Research Dept.
Charlotte, North Carolina, United States, 28211
Cornerstone Research Care
High Point, North Carolina, United States, 27262
Carolina Eye Associates
Southern Pines, North Carolina, United States, 28387
United States, Ohio
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
Comprehensive Opthalmology & Optical Services
Cleveland, Ohio, United States, 44115
United States, Oregon
Bend Medical Clinic
Bend, Oregon, United States, 97701
Medical Eye Center
Medford, Oregon, United States, 97504
United States, Pennsylvania
Valley Clinical Research Center
Easton, Pennsylvania, United States, 18045
Philadelphia Eye Associates
Philadelphia, Pennsylvania, United States, 19148
Glaucome-Cataract Consultants
Pittsburgh, Pennsylvania, United States, 15243
University of Pittsburg Eye and Ear Institute
Pittsburg, Pennsylvania, United States, 15233
United States, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Total Eye Care, P.A.
Memphis, Tennessee, United States, 38119
United States, Texas
Corona Research Consultants, Inc.
El Paso, Texas, United States, 79904
The University of Texas Medical Branch
Galveston, Texas, United States, 77555
Physician Research Network
Houston, Texas, United States, 77002
Houston, Texas, United States, 77002
Medical Center Ophthalmology
Houston, Texas, United States, 77030
Houston Eye Associates
Houston, Texas, United States, 77125
Sun Research Institute
San Antonio, Texas, United States, 78205
Eye Clinic of South Texas
San Antonio, Texas, United States, 78209
United States, Wisconsin
Advanced Healthcare Clinical Research Center
Milwaukee, Wisconsin, United States, 21209
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Novartis Identifier: NCT00201955     History of Changes
Other Study ID Numbers: 37E-03-201
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 2, 2006
Last Verified: October 2006

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
dry eye
keratoconjunctivitis sicca

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors