Study of Rebamipide Eye Drops to Treat Dry Eye
This study has been completed.
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborator:
Novartis
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00201955
First received: September 12, 2005
Last updated: October 31, 2006
Last verified: October 2006
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Keratoconjunctivitis Sicca |
Drug: Rebamipide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Rebamipide Ophthalmic Suspension in the Treatment of Dry Eye: A Multicenter, Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, 26 Week Study |
Resource links provided by NLM:
Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Primary Outcome Measures:
- fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12
Secondary Outcome Measures:
- fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26
| Estimated Enrollment: | 740 |
| Study Start Date: | May 2004 |
| Estimated Study Completion Date: | July 2006 |
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 symptoms.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00201955
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| United States, Alabama | |
| Michael Bernstein, MD | |
| Birmingham, Alabama, United States, 35216 | |
| Harold Helms, MD | |
| Birmingham, Alabama, United States, 35205 | |
| United States, Arizona | |
| I Care! Eye Care! | |
| Flagstaff, Arizona, United States, 860001 | |
| United States, Arkansas | |
| Harvey and Bernice Jones Eye Institute | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| United Medical Research Institute | |
| Inglewood, California, United States, 90301 | |
| Benchmark Research | |
| San Francisco, California, United States, 94102 | |
| Southern California Clinical Research, Inc. | |
| San Marino, California, United States, 91108 | |
| United States, Colorado | |
| Colorado Eye Associates, PC | |
| Colorado Springs, Colorado, United States, 80907 | |
| United States, Connecticut | |
| Danbury Eye Physicians and Surgeons, P.C. | |
| Danbury, Connecticut, United States, 06810-4005 | |
| United States, Florida | |
| Florida Ophthalmic Institute | |
| Gainesville, Florida, United States, 32605-3192 | |
| Florida Wellcare Alliance, L.C. | |
| Inverness, Florida, United States, 34452 | |
| Shettle Eye Center | |
| Largo, Florida, United States, 33770 | |
| Suncoast Clinical Research, Inc. | |
| New Port Richey, Florida, United States, 34652 | |
| Tukio Institute for Clinical Research | |
| North Miami Beach, Florida, United States, 33169 | |
| Magnolia Research Group, Inc. | |
| Ocala, Florida, United States, 34471 | |
| Radiant Research - West Palm Beach | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Georgia | |
| Vision Incorporated | |
| Savannah, Georgia, United States, 31406 | |
| United States, Indiana | |
| Welborn Clinic | |
| Evansville, Indiana, United States, 47714 | |
| United States, Kansas | |
| Wichita Clinic, PA | |
| Wichita, Kansas, United States, 67208 | |
| Heartland Research Associates, LLC | |
| Wichita, Kansas, United States, 67207 | |
| United States, Kentucky | |
| Taustine Eye Center | |
| Louisville, Kentucky, United States, 40217 | |
| United States, Louisiana | |
| Bossier Optical, Inc. | |
| Bossier, Louisiana, United States, 71111 | |
| Family Eye Centers | |
| New Orleans, Louisiana, United States, 70127 | |
| Stevenson Medical Surgical Eye Center | |
| New Orleans, Louisiana, United States, 70119 | |
| United States, Massachusetts | |
| Ophthalmic Research Associates, Inc. | |
| N. Andover, Massachusetts, United States, 01845 | |
| United States, Minnesota | |
| Minnesota Eye Associates | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, Mississippi | |
| Depremont Eye Specialists | |
| Gulfport, Mississippi, United States, 39507 | |
| United States, Missouri | |
| Opthalmology Associates | |
| Creve Coeur, Missouri, United States, 63141 | |
| United States, New Jersey | |
| Clinical Research Laboratories | |
| Piscataway, New Jersey, United States, 08854 | |
| Ophthalmology Associates | |
| Princeton, New Jersey, United States, 08540 | |
| United States, New York | |
| Eye Care Associates | |
| Bethpage, New York, United States, 11021 | |
| Ophthmalmic Consultants of Long Island | |
| Lynbrook, New York, United States, 11563 | |
| Mt. Sinai Medical Center School of Medicine | |
| New York, New York, United States, 10029 | |
| Rochester Ophthalmological Group | |
| Rochester, New York, United States, 14618 | |
| Ophthalmic Consultants of Long Island | |
| Rockville Center, New York, United States, 11570 | |
| Ophthalmic Consultants of Long Island | |
| Valley Stream, New York, United States, 11581 | |
| United States, North Carolina | |
| Western Wake Eye Center, P.A. | |
| Cary, North Carolina, United States, 27511 | |
| Horizon Eye Care - Clinical Research Dept. | |
| Charlotte, North Carolina, United States, 28211 | |
| Southeast Clinical Research Associates | |
| Charlotte, North Carolina, United States, 28210 | |
| Cornerstone Research Care | |
| High Point, North Carolina, United States, 27262 | |
| Carolina Eye Associates | |
| Southern Pines, North Carolina, United States, 28387 | |
| United States, Ohio | |
| Cincinnati Eye Institute | |
| Cincinnati, Ohio, United States, 45242 | |
| Comprehensive Opthalmology & Optical Services | |
| Cleveland, Ohio, United States, 44115 | |
| United States, Oregon | |
| Bend Medical Clinic | |
| Bend, Oregon, United States, 97701 | |
| Medical Eye Center | |
| Medford, Oregon, United States, 97504 | |
| United States, Pennsylvania | |
| Valley Clinical Research Center | |
| Easton, Pennsylvania, United States, 18045 | |
| Philadelphia Eye Associates | |
| Philadelphia, Pennsylvania, United States, 19148 | |
| University of Pittsburg Eye and Ear Institute | |
| Pittsburg, Pennsylvania, United States, 15233 | |
| Glaucome-Cataract Consultants | |
| Pittsburgh, Pennsylvania, United States, 15243 | |
| United States, South Dakota | |
| Black Hills Regional Eye Institute | |
| Rapid City, South Dakota, United States, 57701 | |
| United States, Tennessee | |
| Total Eye Care, P.A. | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Corona Research Consultants, Inc. | |
| El Paso, Texas, United States, 79904 | |
| The University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555 | |
| Houston, Texas, United States, 77002 | |
| Medical Center Ophthalmology | |
| Houston, Texas, United States, 77030 | |
| Physician Research Network | |
| Houston, Texas, United States, 77002 | |
| Houston Eye Associates | |
| Houston, Texas, United States, 77125 | |
| Eye Clinic of South Texas | |
| San Antonio, Texas, United States, 78209 | |
| Sun Research Institute | |
| San Antonio, Texas, United States, 78205 | |
| United States, Wisconsin | |
| Advanced Healthcare Clinical Research Center | |
| Milwaukee, Wisconsin, United States, 21209 | |
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Novartis
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00201955 History of Changes |
| Other Study ID Numbers: | 37E-03-201 |
| Study First Received: | September 12, 2005 |
| Last Updated: | October 31, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
|
dry eye keratoconjunctivitis sicca |
Additional relevant MeSH terms:
|
Keratoconjunctivitis Sicca Dry Eye Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases Rebamipide |
Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013