Study of Rebamipide Eye Drops to Treat Dry Eye
Rebamipide Ophthalmic Suspension in the Treatment of Dry Eye: A Multicenter, Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, 26 Week Study
1 other identifier
interventional
740
1 country
60
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2004
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedNovember 2, 2006
October 1, 2006
September 12, 2005
October 31, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12
Secondary Outcomes (1)
fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26
Interventions
Eligibility Criteria
You may qualify if:
- must have symptoms of dry eye for a minimum of 6 months
- must be able to sign and date an informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Harold Helms, MD
Birmingham, Alabama, 35205, United States
Michael Bernstein, MD
Birmingham, Alabama, 35216, United States
I Care! Eye Care!
Flagstaff, Arizona, 860001, United States
Harvey and Bernice Jones Eye Institute
Little Rock, Arkansas, 72205, United States
United Medical Research Institute
Inglewood, California, 90301, United States
Benchmark Research
San Francisco, California, 94102, United States
Southern California Clinical Research, Inc.
San Marino, California, 91108, United States
Colorado Eye Associates, PC
Colorado Springs, Colorado, 80907, United States
Danbury Eye Physicians and Surgeons, P.C.
Danbury, Connecticut, 06810-4005, United States
Florida Ophthalmic Institute
Gainesville, Florida, 32605-3192, United States
Florida Wellcare Alliance, L.C.
Inverness, Florida, 34452, United States
Shettle Eye Center
Largo, Florida, 33770, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Tukio Institute for Clinical Research
North Miami Beach, Florida, 33169, United States
Magnolia Research Group, Inc.
Ocala, Florida, 34471, United States
Radiant Research - West Palm Beach
West Palm Beach, Florida, 33407, United States
Vision Incorporated
Savannah, Georgia, 31406, United States
Welborn Clinic
Evansville, Indiana, 47714, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Wichita Clinic, PA
Wichita, Kansas, 67208, United States
Taustine Eye Center
Louisville, Kentucky, 40217, United States
Bossier Optical, Inc.
Bossier City, Louisiana, 71111, United States
Stevenson Medical Surgical Eye Center
New Orleans, Louisiana, 70119, United States
Family Eye Centers
New Orleans, Louisiana, 70127, United States
Ophthalmic Research Associates, Inc.
North Andover, Massachusetts, 01845, United States
Minnesota Eye Associates
Minneapolis, Minnesota, 55404, United States
Depremont Eye Specialists
Gulfport, Mississippi, 39507, United States
Opthalmology Associates
Creve Coeur, Missouri, 63141, United States
Clinical Research Laboratories
Piscataway, New Jersey, 08854, United States
Ophthalmology Associates
Princeton, New Jersey, 08540, United States
Eye Care Associates
Bethpage, New York, 11021, United States
Ophthmalmic Consultants of Long Island
Lynbrook, New York, 11563, United States
Mt. Sinai Medical Center School of Medicine
New York, New York, 10029, United States
Rochester Ophthalmological Group
Rochester, New York, 14618, United States
Ophthalmic Consultants of Long Island
Rockville Centre, New York, 11570, United States
Ophthalmic Consultants of Long Island
Valley Stream, New York, 11581, United States
Western Wake Eye Center, P.A.
Cary, North Carolina, 27511, United States
Southeast Clinical Research Associates
Charlotte, North Carolina, 28210, United States
Horizon Eye Care - Clinical Research Dept.
Charlotte, North Carolina, 28211, United States
Cornerstone Research Care
High Point, North Carolina, 27262, United States
Carolina Eye Associates
Southern Pines, North Carolina, 28387, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
Comprehensive Opthalmology & Optical Services
Cleveland, Ohio, 44115, United States
Bend Medical Clinic
Bend, Oregon, 97701, United States
Medical Eye Center
Medford, Oregon, 97504, United States
Valley Clinical Research Center
Easton, Pennsylvania, 18045, United States
Philadelphia Eye Associates
Philadelphia, Pennsylvania, 19148, United States
University of Pittsburg Eye and Ear Institute
Pittsburgh, Pennsylvania, 15233, United States
Glaucome-Cataract Consultants
Pittsburgh, Pennsylvania, 15243, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Total Eye Care, P.A.
Memphis, Tennessee, 38119, United States
Corona Research Consultants, Inc.
El Paso, Texas, 79904, United States
The University of Texas Medical Branch
Galveston, Texas, 77555, United States
Physician Research Network
Houston, Texas, 77002, United States
Unknown Facility
Houston, Texas, 77002, United States
Medical Center Ophthalmology
Houston, Texas, 77030, United States
Houston Eye Associates
Houston, Texas, 77125, United States
Sun Research Institute
San Antonio, Texas, 78205, United States
Eye Clinic of South Texas
San Antonio, Texas, 78209, United States
Advanced Healthcare Clinical Research Center
Milwaukee, Wisconsin, 21209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
May 1, 2004
Study Completion
July 1, 2006
Last Updated
November 2, 2006
Record last verified: 2006-10