Study of Rebamipide Eye Drops to Treat Dry Eye
- Conditions
- Keratoconjunctivitis Sicca
- Registration Number
- NCT00201955
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 740
- must have symptoms of dry eye for a minimum of 6 months
- must be able to sign and date an informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12
- Secondary Outcome Measures
Name Time Method fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26
Trial Locations
- Locations (58)
Vision Incorporated
🇺🇸Savannah, Georgia, United States
Philadelphia Eye Associates
🇺🇸Philadelphia, Pennsylvania, United States
Western Wake Eye Center, P.A.
🇺🇸Cary, North Carolina, United States
Medical Eye Center
🇺🇸Medford, Oregon, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Physician Research Network
🇺🇸Houston, Texas, United States
Eye Clinic of South Texas
🇺🇸San Antonio, Texas, United States
Eye Care Associates
🇺🇸Bethpage, New York, United States
Southeast Clinical Research Associates
🇺🇸Charlotte, North Carolina, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, 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
Southern California Clinical Research, Inc.
🇺🇸San Marino, California, United States
Danbury Eye Physicians and Surgeons, P.C.
🇺🇸Danbury, Connecticut, 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
Welborn Clinic
🇺🇸Evansville, Indiana, United States
Bossier Optical, Inc.
🇺🇸Bossier, Louisiana, United States
Ophthalmic Research Associates, Inc.
🇺🇸N. Andover, Massachusetts, 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
Mt. Sinai Medical Center School of Medicine
🇺🇸New York, New York, United States
Ophthmalmic Consultants of Long Island
🇺🇸Lynbrook, New York, United States
Ophthalmic Consultants of Long Island
🇺🇸Valley Stream, New York, United States
Rochester Ophthalmological Group
🇺🇸Rochester, New York, 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
Comprehensive Opthalmology & Optical Services
🇺🇸Cleveland, Ohio, United States
Bend Medical Clinic
🇺🇸Bend, Oregon, United States
Valley Clinical Research Center
🇺🇸Easton, Pennsylvania, United States
Glaucome-Cataract Consultants
🇺🇸Pittsburgh, Pennsylvania, United States
Total Eye Care, P.A.
🇺🇸Memphis, Tennessee, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Corona Research Consultants, Inc.
🇺🇸El Paso, Texas, United States
The University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Medical Center Ophthalmology
🇺🇸Houston, Texas, United States
Colorado Eye Associates, PC
🇺🇸Colorado Springs, Colorado, United States
Wichita Clinic, PA
🇺🇸Wichita, Kansas, United States
Minnesota Eye Associates
🇺🇸Minneapolis, Minnesota, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Harold Helms, MD
🇺🇸Birmingham, Alabama, United States
Michael Bernstein, MD
🇺🇸Birmingham, Alabama, United States
Benchmark Research
🇺🇸San Francisco, California, United States
University of Pittsburg Eye and Ear Institute
🇺🇸Pittsburg, Pennsylvania, United States
Florida Ophthalmic Institute
🇺🇸Gainesville, Florida, United States
Taustine Eye Center
🇺🇸Louisville, Kentucky, United States
Family Eye Centers
🇺🇸New Orleans, Louisiana, United States
Advanced Healthcare Clinical Research Center
🇺🇸Milwaukee, Wisconsin, United States
Stevenson Medical Surgical Eye Center
🇺🇸New Orleans, Louisiana, United States