Study of Rebamipide Eye Drops to Treat Dry Eye

Keratoconjunctivitis Sicca Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00201955
• Other study ID #: 37E-03-201
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: October 31, 2006
• Start date: May 2004
• Est. completion date: July 2006

Study information

• Verified date: October 2006
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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 symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 740
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Rebamipide

Locations

Country	Name	City	State
United States	Bend Medical Clinic	Bend	Oregon
United States	Eye Care Associates	Bethpage	New York
United States	Harold Helms, MD	Birmingham	Alabama
United States	Michael Bernstein, MD	Birmingham	Alabama
United States	Bossier Optical, Inc.	Bossier	Louisiana
United States	Western Wake Eye Center, P.A.	Cary	North Carolina
United States	Horizon Eye Care - Clinical Research Dept.	Charlotte	North Carolina
United States	Southeast Clinical Research Associates	Charlotte	North Carolina
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Comprehensive Opthalmology & Optical Services	Cleveland	Ohio
United States	Colorado Eye Associates, PC	Colorado Springs	Colorado
United States	Opthalmology Associates	Creve Coeur	Missouri
United States	Danbury Eye Physicians and Surgeons, P.C.	Danbury	Connecticut
United States	Valley Clinical Research Center	Easton	Pennsylvania
United States	Corona Research Consultants, Inc.	El Paso	Texas
United States	Welborn Clinic	Evansville	Indiana
United States	I Care! Eye Care!	Flagstaff	Arizona
United States	Florida Ophthalmic Institute	Gainesville	Florida
United States	The University of Texas Medical Branch	Galveston	Texas
United States	Depremont Eye Specialists	Gulfport	Mississippi
United States	Cornerstone Research Care	High Point	North Carolina
United States	Houston Eye Associates	Houston	Texas
United States	Medical Center Ophthalmology	Houston	Texas
United States	Physician Research Network	Houston	Texas
United States	United Medical Research Institute	Inglewood	California
United States	Florida Wellcare Alliance, L.C.	Inverness	Florida
United States	Shettle Eye Center	Largo	Florida
United States	Harvey and Bernice Jones Eye Institute	Little Rock	Arkansas
United States	Taustine Eye Center	Louisville	Kentucky
United States	Ophthmalmic Consultants of Long Island	Lynbrook	New York
United States	Medical Eye Center	Medford	Oregon
United States	Total Eye Care, P.A.	Memphis	Tennessee
United States	Advanced Healthcare Clinical Research Center	Milwaukee	Wisconsin
United States	Minnesota Eye Associates	Minneapolis	Minnesota
United States	Ophthalmic Research Associates, Inc.	N. Andover	Massachusetts
United States	Family Eye Centers	New Orleans	Louisiana
United States	Stevenson Medical Surgical Eye Center	New Orleans	Louisiana
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	Mt. Sinai Medical Center School of Medicine	New York	New York
United States	Tukio Institute for Clinical Research	North Miami Beach	Florida
United States	Magnolia Research Group, Inc.	Ocala	Florida
United States	Philadelphia Eye Associates	Philadelphia	Pennsylvania
United States	Clinical Research Laboratories	Piscataway	New Jersey
United States	University of Pittsburg Eye and Ear Institute	Pittsburg	Pennsylvania
United States	Glaucome-Cataract Consultants	Pittsburgh	Pennsylvania
United States	Ophthalmology Associates	Princeton	New Jersey
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Rochester Ophthalmological Group	Rochester	New York
United States	Ophthalmic Consultants of Long Island	Rockville Center	New York
United States	Eye Clinic of South Texas	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	Benchmark Research	San Francisco	California
United States	Southern California Clinical Research, Inc.	San Marino	California
United States	Vision Incorporated	Savannah	Georgia
United States	Carolina Eye Associates	Southern Pines	North Carolina
United States	Ophthalmic Consultants of Long Island	Valley Stream	New York
United States	Radiant Research - West Palm Beach	West Palm Beach	Florida
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	Wichita Clinic, PA	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12
Secondary	fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26