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, 52 Week Study
1 other identifier
interventional
740
1 country
63
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
Typical duration for phase_3
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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
February 1, 2007
CompletedJanuary 7, 2008
January 1, 2008
September 12, 2005
January 4, 2008
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
12 week and 26 week
Secondary Outcomes (1)
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
Study Arms (3)
1
ACTIVE COMPARATORrebamipide 1%
2
ACTIVE COMPARATORRebamipide 2%
3
NO INTERVENTIONplacebo
Interventions
1. OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks 2. OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks
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 (63)
Alabama Research Center, LLC
Birmingham, Alabama, 35209, United States
Sun Valley Arthritis Center, Ltd.
Glendale, Arizona, 85308, United States
Pivotel Research Center
Peoria, Arizona, 85381, United States
Hope research Institute
Phoenix, Arizona, 85006, United States
Buena Vista Eye Care Center
Phoenix, Arizona, 85012, United States
Radiant Research
Scottsdale, Arizona, 85251, United States
Sall Eye Research Center
Artesia, California, 90701-5653, United States
Radiant Research - Irvine
Irvine, California, 92618, United States
Scripps Clinic Medical Group, Inc.
La Jolla, California, 92037, United States
American Eye Institute
Los Angeles, California, 90048, United States
Eye Clinic of San Diego
San Diego, California, 92103, United States
Healthcare Partners Medical Group
Torrance, California, 90503, United States
Centennial Eye Associates
Centennial, Colorado, 80112, United States
Corneal Consultants of Colorado
Littleton, Colorado, 80120, United States
Western States Clinical Research, Inc.
Wheat Ridge, Colorado, 80033, United States
Peter C. Donshik, MDPC
Bloomfield, Connecticut, 06002, United States
Opticare Eye Health Center
Waterbury, Connecticut, 06708, United States
The Eye Associates
Bradenton, Florida, 34209, United States
Hernando Eye Institute
Brooksville, Florida, 34613, United States
Radiant Research, Inc. - Lake Worth
Lake Worth, Florida, 33461, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Eye Associates International
Ormond Beach, Florida, 32174, United States
Pinellas Eye Center
Pinellas Park, Florida, 33781, United States
Ft. Lauderdale Eye Institute
Sunrise, Florida, 33351, United States
Marvin E. Greenberg, MD PA 7
Tamarac, Florida, 33321, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603, United States
International Eye Center
Tampa, Florida, 33603, United States
Omni Eye Services
Atlanta, Georgia, 30342, United States
University of Kentucky, Department of Ophthamology
Lexington, Kentucky, 40536-0293, United States
Kentucky Lions Eye Center
Louisville, Kentucky, 40222, United States
Gulf Coast Research Associates, Inc.
Baton Rouge, Louisiana, 70808, United States
Danial Long, MD
Gretna, Louisiana, 70056, United States
Lakeview Optical
New Orleans, Louisiana, 70124, United States
Eye Center Northeast
Bangor, Maine, 04401, United States
Krieger Eye Institute
Baltimore, Maryland, 21215, United States
The Wilmer Eye Institute
Lutherville, Maryland, 21093, United States
New England Eye Center
Boston, Massachusetts, 02111, United States
The Eye Institute - Lahey Clinic North
Peabody, Massachusetts, 01960, United States
Mississippi Eye Associates
Ocean Springs, Mississippi, 39564, United States
Montana Medical Research, LLC
Missoula, Montana, 59804, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104, United States
Eye Associates of New Mexico
Albuquerque, New Mexico, 87109, United States
Western New York Eye Center
Orchard Park, New York, 14127, United States
Glaucoma Consultants of the Capital Region
Slingerlands, New York, 12159, United States
Orellana Retina Associates, PLLC
Raleigh, North Carolina, 27612, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106-5068, United States
Comprehensive Opthalmology & Optical Services
Cleveland, Ohio, 44115, United States
Clinical Research Source, Inc.
Perryberg, Ohio, 43551, United States
Clinical Research Institute of Southern Oregon
Medford, Oregon, 97504, United States
Northwest Corneal Services
Portland, Oregon, 97223, United States
Vision Surgery and Laser Center
Roseburg, Oregon, 97470, United States
West Hills Vision Center
Moon Township, Pennsylvania, 15108, United States
Glaucoma Consultants and Center for Eye Research
Mt. Pleasant, South Carolina, 29464, United States
University Eye Surgeons
Maryville, Tennessee, 37803, United States
St. Luke's Eye Institute
Amarillo, Texas, 79106, United States
Eye Clinic of Austin
Austin, Texas, 78731, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Surgical Eye Associates, PA
Houston, Texas, 77055, United States
Brazosport Eye Institute
Lake Jackson, Texas, 77566, United States
Axia Research
Salt Lake City, Utah, 84107, United States
John Moran Eye Center, University of Utah
Salt Lake City, Utah, 84132, United States
Physicians Research Options, LC
Sandy City, Utah, 84070, United States
Access Eye Research Center
Fredericksburg, Virginia, 22405, United States
Related Publications (17)
Yamasaki K, Ishiyama H, Imaizumi T, Kanbe T, Yabuuchi Y. Effect of OPC-12759, a novel antiulcer agent, on chronic and acute experimental gastric ulcer, and gastric secretion in rats. Jpn J Pharmacol. 1989 Apr;49(4):441-8. doi: 10.1254/jjp.49.441.
PMID: 2542684BACKGROUNDYamasaki K, Kanbe T, Chijiwa T, Ishiyama H, Morita S. Gastric mucosal protection by OPC-12759, a novel antiulcer compound, in the rat. Eur J Pharmacol. 1987 Oct 6;142(1):23-9. doi: 10.1016/0014-2999(87)90649-2.
PMID: 3480223BACKGROUNDYoshikawa T, Naito Y, Tanigawa T, Kondo M. Free radical scavenging activity of the novel anti-ulcer agent rebamipide studied by electron spin resonance. Arzneimittelforschung. 1993 Mar;43(3):363-6.
PMID: 8387788BACKGROUNDYoshikawa T, Naito Y, Nakamura S, Nishimura S, Kaneko T, Iinuma S, Takahashi S, Kondo M, Yamasaki K. Effect of rebamipide on lipid peroxidation and gastric mucosal injury induced by indometacin in rats. Arzneimittelforschung. 1993 Dec;43(12):1327-30.
PMID: 8141822BACKGROUNDYamasaki K, et al. Effect of OPC 12759 on the production of oxygen-derived free radical from human polymorphonuclear leukocytes. In-house Report No. 004272.
BACKGROUNDYamasaki K, et al. Effect of OPC 12759 on gastric mucosal blood flow in rats-determination by the hydrogen gas clearance method. In-house Report No. 003915.
BACKGROUNDImaizumi, T, et al. Effect of OPC 12759 and cetraxate on gastric mucosal hemodynamics and oxygen sufficiency in rats-analysis by reflectance spectrophotometry. In-house Report No. 004101.
BACKGROUNDGarcher C, Bron A, Baudouin C, Bildstein L, Bara J. CA 19-9 ELISA test: a new method for studying mucus changes in tears. Br J Ophthalmol. 1998 Jan;82(1):88-90. doi: 10.1136/bjo.82.1.88.
PMID: 9536889BACKGROUNDDanjo Y, Watanabe H, Tisdale AS, George M, Tsumura T, Abelson MB, Gipson IK. Alteration of mucin in human conjunctival epithelia in dry eye. Invest Ophthalmol Vis Sci. 1998 Dec;39(13):2602-9.
PMID: 9856770BACKGROUNDPflugfelder SC, Tseng SC, Yoshino K, Monroy D, Felix C, Reis BL. Correlation of goblet cell density and mucosal epithelial membrane mucin expression with rose bengal staining in patients with ocular irritation. Ophthalmology. 1997 Feb;104(2):223-35. doi: 10.1016/s0161-6420(97)30330-3.
PMID: 9052626BACKGROUNDKinoshita S, Kiorpes TC, Friend J, Thoft RA. Goblet cell density in ocular surface disease. A better indicator than tear mucin. Arch Ophthalmol. 1983 Aug;101(8):1284-7. doi: 10.1001/archopht.1983.01040020286025.
PMID: 6882259BACKGROUNDRivas L, Oroza MA, Perez-Esteban A, Murube-del-Castillo J. Morphological changes in ocular surface in dry eyes and other disorders by impression cytology. Graefes Arch Clin Exp Ophthalmol. 1992;230(4):329-34. doi: 10.1007/BF00165940.
PMID: 1505763BACKGROUNDNelson JD, Wright JC. Conjunctival goblet cell densities in ocular surface disease. Arch Ophthalmol. 1984 Jul;102(7):1049-51. doi: 10.1001/archopht.1984.01040030851031.
PMID: 6378156BACKGROUNDFerris FL 3rd, Kassoff A, Bresnick GH, Bailey I. New visual acuity charts for clinical research. Am J Ophthalmol. 1982 Jul;94(1):91-6.
PMID: 7091289BACKGROUNDLemp MA. Report of the National Eye Institute/Industry workshop on Clinical Trials in Dry Eyes. CLAO J. 1995 Oct;21(4):221-32. No abstract available.
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PMID: 4027319BACKGROUNDDavis CS, Chung Y. Randomization model methods for evaluating treatment efficacy in multicenter clinical trials. Biometrics. 1995 Sep;51(3):1163-74.
PMID: 7548700BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gary Foulks, MD
University of Louisville
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- 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
February 1, 2007
Last Updated
January 7, 2008
Record last verified: 2008-01