Study of Rebamipide Eye Drops to Treat Dry Eye
- Registration Number
- NCT00201981
- 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 symptom.
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
- Arm && Interventions
Group Intervention Description 2 Rebamipide Rebamipide 2% 1 Rebamipide rebamipide 1%
- 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 12 week and 26 week
- 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 12 week and 26 week
Trial Locations
- Locations (63)
Montana Medical Research, LLC
🇺🇸Missoula, Montana, United States
Sall Eye Research Center
🇺🇸Artesia, California, United States
Western New York Eye Center
🇺🇸Orchard Park, New York, United States
Alabama Research Center, LLC
🇺🇸Birmingham, Alabama, United States
Buena Vista Eye Care Center
🇺🇸Phoenix, Arizona, United States
Kentucky Lions Eye Center
🇺🇸Louisville, Kentucky, United States
Lakeview Optical
🇺🇸New Orleans, Louisiana, United States
Northwest Corneal Services
🇺🇸Portland, Oregon, United States
Axia Research
🇺🇸Salt Lake City, Utah, United States
New England Eye Center
🇺🇸Boston, Massachusetts, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Comprehensive Opthalmology & Optical Services
🇺🇸Cleveland, Ohio, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Sun Valley Arthritis Center, Ltd.
🇺🇸Glendale, Arizona, United States
Western States Clinical Research, Inc.
🇺🇸Wheat Ridge, Colorado, United States
Radiant Research, Inc. - Lake Worth
🇺🇸Lake Worth, Florida, United States
Gulf Coast Research Associates, Inc.
🇺🇸Baton Rouge, Louisiana, United States
Krieger Eye Institute
🇺🇸Baltimore, Maryland, United States
Hope research Institute
🇺🇸Phoenix, Arizona, United States
Healthcare Partners Medical Group
🇺🇸Torrance, California, United States
Eye Center Northeast
🇺🇸Bangor, Maine, United States
Pivotel Research Center
🇺🇸Peoria, Arizona, United States
Marvin E. Greenberg, MD PA 7
🇺🇸Tamarac, Florida, United States
Glaucoma Consultants and Center for Eye Research
🇺🇸Mt. Pleasant, South Carolina, United States
American Eye Institute
🇺🇸Los Angeles, California, United States
Scripps Clinic Medical Group, Inc.
🇺🇸La Jolla, California, United States
Eye Associates International
🇺🇸Ormond Beach, Florida, United States
Ft. Lauderdale Eye Institute
🇺🇸Sunrise, Florida, United States
St. Luke's Eye Institute
🇺🇸Amarillo, Texas, United States
Brazosport Eye Institute
🇺🇸Lake Jackson, Texas, United States
Radiant Research - Irvine
🇺🇸Irvine, California, United States
The Eye Associates
🇺🇸Bradenton, Florida, United States
Clinical Research Institute of Southern Oregon
🇺🇸Medford, Oregon, United States
Omni Eye Services
🇺🇸Atlanta, Georgia, United States
Surgical Eye Associates, PA
🇺🇸Houston, Texas, United States
Pinellas Eye Center
🇺🇸Pinellas Park, Florida, United States
University Eye Surgeons
🇺🇸Maryville, Tennessee, United States
Physicians Research Options, LC
🇺🇸Sandy, Utah, United States
Eye Clinic of San Diego
🇺🇸San Diego, California, United States
Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Hernando Eye Institute
🇺🇸Brooksville, Florida, United States
Centennial Eye Associates
🇺🇸Centennial, Colorado, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Opticare Eye Health Center
🇺🇸Waterbury, Connecticut, United States
Danial Long, MD
🇺🇸Gretna, Louisiana, United States
The Eye Institute - Lahey Clinic North
🇺🇸Peabody, Massachusetts, United States
The Wilmer Eye Institute
🇺🇸Lutherville, Maryland, United States
Glaucoma Consultants of the Capital Region
🇺🇸Slingerlands, New York, United States
Orellana Retina Associates, PLLC
🇺🇸Raleigh, North Carolina, United States
Clinical Research Source, Inc.
🇺🇸Perryberg, Ohio, United States
West Hills Vision Center
🇺🇸Moon Township, Pennsylvania, United States
Peter C. Donshik, MDPC
🇺🇸Bloomfield, Connecticut, United States
Mississippi Eye Associates
🇺🇸Ocean Springs, Mississippi, United States
Vision Surgery and Laser Center
🇺🇸Roseburg, Oregon, United States
Corneal Consultants of Colorado
🇺🇸Littleton, Colorado, United States
University of Kentucky, Department of Ophthamology
🇺🇸Lexington, Kentucky, United States
Access Eye Research Center
🇺🇸Fredericksburg, Virginia, United States
Eye Associates of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
International Eye Center
🇺🇸Tampa, Florida, United States
Eye Clinic of Austin
🇺🇸Austin, Texas, United States
John Moran Eye Center, University of Utah
🇺🇸Salt Lake City, Utah, United States
Radiant Research
🇺🇸Scottsdale, Arizona, United States