- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00201981
Study of Rebamipide Eye Drops to Treat Dry Eye
January 4, 2008 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.
Rebamipide Ophthalmic Suspension in the Treatment of Dry Eye: A Multicenter, Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, 52 Week Study
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).
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
740
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35209
- Alabama Research Center, LLC
-
-
Arizona
-
Glendale, Arizona, United States, 85308
- Sun Valley Arthritis Center, Ltd.
-
Peoria, Arizona, United States, 85381
- Pivotel Research Center
-
Phoenix, Arizona, United States, 85006
- Hope Research Institute
-
Phoenix, Arizona, United States, 85012
- Buena Vista Eye Care Center
-
Scottsdale, Arizona, United States, 85251
- Radiant Research
-
-
California
-
Artesia, California, United States, 90701-5653
- Sall Eye Research Center
-
Irvine, California, United States, 92618
- Radiant Research - Irvine
-
La Jolla, California, United States, 92037
- Scripps Clinic Medical Group, Inc.
-
Los Angeles, California, United States, 90048
- American Eye Institute
-
San Diego, California, United States, 92103
- Eye Clinic of San Diego
-
Torrance, California, United States, 90503
- HealthCare Partners Medical Group
-
-
Colorado
-
Centennial, Colorado, United States, 80112
- Centennial Eye Associates
-
Littleton, Colorado, United States, 80120
- Corneal Consultants of Colorado
-
Wheat Ridge, Colorado, United States, 80033
- Western States Clinical Research, Inc.
-
-
Connecticut
-
Bloomfield, Connecticut, United States, 06002
- Peter C. Donshik, MDPC
-
Waterbury, Connecticut, United States, 06708
- Opticare Eye Health Center
-
-
Florida
-
Bradenton, Florida, United States, 34209
- The Eye Associates
-
Brooksville, Florida, United States, 34613
- Hernando Eye Institute
-
Lake Worth, Florida, United States, 33461
- Radiant Research, Inc. - Lake Worth
-
New Port Richey, Florida, United States, 34652
- Suncoast Clinical Research, Inc.
-
Ormond Beach, Florida, United States, 32174
- Eye Associates International
-
Pinellas Park, Florida, United States, 33781
- Pinellas Eye Center
-
Sunrise, Florida, United States, 33351
- Ft. Lauderdale Eye Institute
-
Tamarac, Florida, United States, 33321
- Marvin E. Greenberg, MD PA 7
-
Tampa, Florida, United States, 33603
- International Eye Center
-
Tampa, Florida, United States, 33603
- Clinical Research of West Florida, Inc.
-
-
Georgia
-
Atlanta, Georgia, United States, 30342
- Omni Eye Services
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536-0293
- University of Kentucky, Department of Ophthamology
-
Louisville, Kentucky, United States, 40222
- Kentucky Lions Eye Center
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Gulf Coast Research Associates, Inc.
-
Gretna, Louisiana, United States, 70056
- Danial Long, MD
-
New Orleans, Louisiana, United States, 70124
- Lakeview Optical
-
-
Maine
-
Bangor, Maine, United States, 04401
- Eye Center Northeast
-
-
Maryland
-
Baltimore, Maryland, United States, 21215
- Krieger Eye Institute
-
Lutherville, Maryland, United States, 21093
- The Wilmer Eye Institute
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- New England Eye Center
-
Peabody, Massachusetts, United States, 01960
- The Eye Institute - Lahey Clinic North
-
-
Mississippi
-
Ocean Springs, Mississippi, United States, 39564
- Mississippi Eye Associates
-
-
Montana
-
Missoula, Montana, United States, 59804
- Montana Medical Research, LLC
-
-
Nevada
-
Las Vegas, Nevada, United States, 89104
- Clinical Research Center of Nevada
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87109
- Eye Associates of New Mexico
-
-
New York
-
Orchard Park, New York, United States, 14127
- Western New York Eye Center
-
Slingerlands, New York, United States, 12159
- Glaucoma Consultants of the Capital Region
-
-
North Carolina
-
Raleigh, North Carolina, United States, 27612
- Orellana Retina Associates, PLLC
-
-
Ohio
-
Cleveland, Ohio, United States, 44115
- Comprehensive Opthalmology & Optical Services
-
Cleveland, Ohio, United States, 44106-5068
- University Hospitals of Cleveland
-
Perryberg, Ohio, United States, 43551
- Clinical Research Source, Inc.
-
-
Oregon
-
Medford, Oregon, United States, 97504
- Clinical Research Institute of Southern Oregon
-
Portland, Oregon, United States, 97223
- Northwest Corneal Services
-
Roseburg, Oregon, United States, 97470
- Vision Surgery and Laser Center
-
-
Pennsylvania
-
Moon Township, Pennsylvania, United States, 15108
- West Hills Vision Center
-
-
South Carolina
-
Mt. Pleasant, South Carolina, United States, 29464
- Glaucoma Consultants and Center for Eye Research
-
-
Tennessee
-
Maryville, Tennessee, United States, 37803
- University Eye Surgeons
-
-
Texas
-
Amarillo, Texas, United States, 79106
- St. Luke's Eye Institute
-
Austin, Texas, United States, 78731
- Eye Clinic of Austin
-
Houston, Texas, United States, 77030
- Baylor College of Medicine
-
Houston, Texas, United States, 77055
- Surgical Eye Associates, PA
-
Lake Jackson, Texas, United States, 77566
- Brazosport Eye Institute
-
-
Utah
-
Salt Lake City, Utah, United States, 84107
- Axia Research
-
Salt Lake City, Utah, United States, 84132
- John Moran Eye Center, University of Utah
-
Sandy, Utah, United States, 84070
- Physicians Research Options, LC
-
-
Virginia
-
Fredericksburg, Virginia, United States, 22405
- Access Eye Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- must have symptoms of dry eye for a minimum of 6 months
- must be able to sign and date an informed consent
Exclusion Criteria:
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
rebamipide 1%
|
|
Active Comparator: 2
Rebamipide 2%
|
|
No Intervention: 3
placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12
Time Frame: 12 week and 26 week
|
12 week and 26 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26
Time Frame: 12 week and 26 week
|
12 week and 26 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Gary Foulks, MD, University of Louisville
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- Davis CS, Chung Y. Randomization model methods for evaluating treatment efficacy in multicenter clinical trials. Biometrics. 1995 Sep;51(3):1163-74.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2004
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
January 7, 2008
Last Update Submitted That Met QC Criteria
January 4, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Lacrimal Apparatus Diseases
- Conjunctivitis
- Conjunctival Diseases
- Keratitis
- Corneal Diseases
- Dry Eye Syndromes
- Keratoconjunctivitis Sicca
- Keratoconjunctivitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Protective Agents
- Anti-Ulcer Agents
- Antioxidants
- Rebamipide
Other Study ID Numbers
- 37E-03-202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Keratoconjunctivitis Sicca
-
Karolinska InstitutetKällmark ClinicCompletedKeratoconjunctivitis Sicca (KCS)Sweden
-
Kala Pharmaceuticals, Inc.CompletedKerato Conjunctivitis SiccaUnited States
-
Oyster Point Pharma, Inc.Active, not recruitingDry Eye | Kerato Conjunctivitis SiccaUnited States
-
Meir Medical CenterUnknownHealthy Subjects | Moderate to Severe Keratoconjunctivitis Sicca (KCS) | Dry Eye Syndrome (DES)
-
Glaukos CorporationCompletedDry Eye Disease | Kerato Conjunctivitis SiccaUnited States
-
C.O.C. Farmaceutici S.r.l.CompletedDry Eye | Dry Eye Disease | Kerato Conjunctivitis SiccaItaly
-
C.O.C. Farmaceutici S.r.l.CompletedDry Eye | Dry Eye Disease | Kerato Conjunctivitis SiccaItaly
-
Mimetogen Pharmaceuticals USA, Inc.Active, not recruitingDry Eye Syndromes | Dry Eye Disease | Kerato Conjunctivitis SiccaUnited States
-
C.O.C. Farmaceutici S.r.l.CompletedDry Eye | Dry Eye Disease | Kerato Conjunctivitis SiccaItaly
-
C.O.C. Farmaceutici S.r.l.CompletedDry Eye | Dry Eye Disease | Kerato Conjunctivitis SiccaItaly
Clinical Trials on Rebamipide
-
Korea Otsuka Pharmaceutical Co., Ltd.CompletedHealthy VolunteersKorea, Republic of
-
Otsuka Pharmaceutical Co., Ltd.Completed
-
Korea Otsuka Pharmaceutical Co., Ltd.CompletedHealthy VolunteersKorea, Republic of
-
Dong-A Pharmaceutical Co., Ltd.UnknownAcute Gastritis | Chronic GastritisKorea, Republic of
-
Otsuka Pharmaceutical Co., Ltd.CompletedColitis, UlcerativeJapan
-
Otsuka Pharmaceutical Co., Ltd.Completed
-
Kubota Vision Inc.Otsuka Pharmaceutical Co., Ltd.Completed
-
Korea Otsuka Pharmaceutical Co., Ltd.RecruitingAcute Gastritis | Chronic GastritisKorea, Republic of
-
Samjin Pharmaceutical Co., Ltd.Completed
-
Otsuka Pharmaceutical, Inc., PhilippinesCompletedNSAID Induced GastropathyPhilippines