Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
740 participants
INTERVENTIONAL
2004-05-31
2007-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
rebamipide 1%
Rebamipide
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
2
Rebamipide 2%
Rebamipide
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
3
placebo
No interventions assigned to this group
Interventions
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Rebamipide
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
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Inclusion Criteria
* must be able to sign and date an informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Otsuka Pharmaceutical Development & Commercialization
Principal Investigators
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Gary Foulks, MD
Role: STUDY_CHAIR
University of Louisville
Locations
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Alabama Research Center, LLC
Birmingham, Alabama, United States
Sun Valley Arthritis Center, Ltd.
Glendale, Arizona, United States
Pivotel Research Center
Peoria, Arizona, United States
Hope research Institute
Phoenix, Arizona, United States
Buena Vista Eye Care Center
Phoenix, Arizona, United States
Radiant Research
Scottsdale, Arizona, United States
Sall Eye Research Center
Artesia, California, United States
Radiant Research - Irvine
Irvine, California, United States
Scripps Clinic Medical Group, Inc.
La Jolla, California, United States
American Eye Institute
Los Angeles, California, United States
Eye Clinic of San Diego
San Diego, California, United States
Healthcare Partners Medical Group
Torrance, California, United States
Centennial Eye Associates
Centennial, Colorado, United States
Corneal Consultants of Colorado
Littleton, Colorado, United States
Western States Clinical Research, Inc.
Wheat Ridge, Colorado, United States
Peter C. Donshik, MDPC
Bloomfield, Connecticut, United States
Opticare Eye Health Center
Waterbury, Connecticut, United States
The Eye Associates
Bradenton, Florida, United States
Hernando Eye Institute
Brooksville, Florida, United States
Radiant Research, Inc. - Lake Worth
Lake Worth, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Eye Associates International
Ormond Beach, Florida, United States
Pinellas Eye Center
Pinellas Park, Florida, United States
Ft. Lauderdale Eye Institute
Sunrise, Florida, United States
Marvin E. Greenberg, MD PA 7
Tamarac, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
International Eye Center
Tampa, Florida, United States
Omni Eye Services
Atlanta, Georgia, United States
University of Kentucky, Department of Ophthamology
Lexington, Kentucky, United States
Kentucky Lions Eye Center
Louisville, Kentucky, United States
Gulf Coast Research Associates, Inc.
Baton Rouge, Louisiana, United States
Danial Long, MD
Gretna, Louisiana, United States
Lakeview Optical
New Orleans, Louisiana, United States
Eye Center Northeast
Bangor, Maine, United States
Krieger Eye Institute
Baltimore, Maryland, United States
The Wilmer Eye Institute
Lutherville, Maryland, United States
New England Eye Center
Boston, Massachusetts, United States
The Eye Institute - Lahey Clinic North
Peabody, Massachusetts, United States
Mississippi Eye Associates
Ocean Springs, Mississippi, United States
Montana Medical Research, LLC
Missoula, Montana, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, United States
Eye Associates of New Mexico
Albuquerque, New Mexico, United States
Western New York Eye Center
Orchard Park, New York, United States
Glaucoma Consultants of the Capital Region
Slingerlands, New York, United States
Orellana Retina Associates, PLLC
Raleigh, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Comprehensive Opthalmology & Optical Services
Cleveland, Ohio, United States
Clinical Research Source, Inc.
Perryberg, Ohio, United States
Clinical Research Institute of Southern Oregon
Medford, Oregon, United States
Northwest Corneal Services
Portland, Oregon, United States
Vision Surgery and Laser Center
Roseburg, Oregon, United States
West Hills Vision Center
Moon Township, Pennsylvania, United States
Glaucoma Consultants and Center for Eye Research
Mt. Pleasant, South Carolina, United States
University Eye Surgeons
Maryville, Tennessee, United States
St. Luke's Eye Institute
Amarillo, Texas, United States
Eye Clinic of Austin
Austin, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Surgical Eye Associates, PA
Houston, Texas, United States
Brazosport Eye Institute
Lake Jackson, Texas, United States
Axia Research
Salt Lake City, Utah, United States
John Moran Eye Center, University of Utah
Salt Lake City, Utah, United States
Physicians Research Options, LC
Sandy City, Utah, United States
Access Eye Research Center
Fredericksburg, Virginia, United States
Countries
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References
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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.
Yamasaki 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.
Yoshikawa 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.
Yoshikawa 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.
Yamasaki K, et al. Effect of OPC 12759 on the production of oxygen-derived free radical from human polymorphonuclear leukocytes. In-house Report No. 004272.
Yamasaki 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.
Imaizumi, 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.
Garcher 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.
Danjo 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.
Pflugfelder 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.
Kinoshita 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.
Rivas 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.
Nelson 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.
Ferris FL 3rd, Kassoff A, Bresnick GH, Bailey I. New visual acuity charts for clinical research. Am J Ophthalmol. 1982 Jul;94(1):91-6.
Lemp 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.
Gail M, Simon R. Testing for qualitative interactions between treatment effects and patient subsets. Biometrics. 1985 Jun;41(2):361-72.
Davis CS, Chung Y. Randomization model methods for evaluating treatment efficacy in multicenter clinical trials. Biometrics. 1995 Sep;51(3):1163-74.
Other Identifiers
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37E-03-202
Identifier Type: -
Identifier Source: org_study_id
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