Study of Rebamipide Eye Drops to Treat Dry Eye

NCT ID: NCT00201955

Last Updated: 2006-11-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

740 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2006-07-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Keratoconjunctivitis Sicca

Keywords

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dry eye keratoconjunctivitis sicca

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Rebamipide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Locations

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Harold Helms, MD

Birmingham, Alabama, United States

Site Status

Michael Bernstein, MD

Birmingham, Alabama, United States

Site Status

I Care! Eye Care!

Flagstaff, Arizona, United States

Site Status

Harvey and Bernice Jones Eye Institute

Little Rock, Arkansas, United States

Site Status

United Medical Research Institute

Inglewood, California, United States

Site Status

Benchmark Research

San Francisco, California, United States

Site Status

Southern California Clinical Research, Inc.

San Marino, California, United States

Site Status

Colorado Eye Associates, PC

Colorado Springs, Colorado, United States

Site Status

Danbury Eye Physicians and Surgeons, P.C.

Danbury, Connecticut, United States

Site Status

Florida Ophthalmic Institute

Gainesville, Florida, United States

Site Status

Florida Wellcare Alliance, L.C.

Inverness, Florida, United States

Site Status

Shettle Eye Center

Largo, Florida, United States

Site Status

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Site Status

Tukio Institute for Clinical Research

North Miami Beach, Florida, United States

Site Status

Magnolia Research Group, Inc.

Ocala, Florida, United States

Site Status

Radiant Research - West Palm Beach

West Palm Beach, Florida, United States

Site Status

Vision Incorporated

Savannah, Georgia, United States

Site Status

Welborn Clinic

Evansville, Indiana, United States

Site Status

Heartland Research Associates, LLC

Wichita, Kansas, United States

Site Status

Wichita Clinic, PA

Wichita, Kansas, United States

Site Status

Taustine Eye Center

Louisville, Kentucky, United States

Site Status

Bossier Optical, Inc.

Bossier City, Louisiana, United States

Site Status

Stevenson Medical Surgical Eye Center

New Orleans, Louisiana, United States

Site Status

Family Eye Centers

New Orleans, Louisiana, United States

Site Status

Ophthalmic Research Associates, Inc.

North Andover, Massachusetts, United States

Site Status

Minnesota Eye Associates

Minneapolis, Minnesota, United States

Site Status

Depremont Eye Specialists

Gulfport, Mississippi, United States

Site Status

Opthalmology Associates

Creve Coeur, Missouri, United States

Site Status

Clinical Research Laboratories

Piscataway, New Jersey, United States

Site Status

Ophthalmology Associates

Princeton, New Jersey, United States

Site Status

Eye Care Associates

Bethpage, New York, United States

Site Status

Ophthmalmic Consultants of Long Island

Lynbrook, New York, United States

Site Status

Mt. Sinai Medical Center School of Medicine

New York, New York, United States

Site Status

Rochester Ophthalmological Group

Rochester, New York, United States

Site Status

Ophthalmic Consultants of Long Island

Rockville Centre, New York, United States

Site Status

Ophthalmic Consultants of Long Island

Valley Stream, New York, United States

Site Status

Western Wake Eye Center, P.A.

Cary, North Carolina, United States

Site Status

Southeast Clinical Research Associates

Charlotte, North Carolina, United States

Site Status

Horizon Eye Care - Clinical Research Dept.

Charlotte, North Carolina, United States

Site Status

Cornerstone Research Care

High Point, North Carolina, United States

Site Status

Carolina Eye Associates

Southern Pines, North Carolina, United States

Site Status

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Site Status

Comprehensive Opthalmology & Optical Services

Cleveland, Ohio, United States

Site Status

Bend Medical Clinic

Bend, Oregon, United States

Site Status

Medical Eye Center

Medford, Oregon, United States

Site Status

Valley Clinical Research Center

Easton, Pennsylvania, United States

Site Status

Philadelphia Eye Associates

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburg Eye and Ear Institute

Pittsburgh, Pennsylvania, United States

Site Status

Glaucome-Cataract Consultants

Pittsburgh, Pennsylvania, United States

Site Status

Black Hills Regional Eye Institute

Rapid City, South Dakota, United States

Site Status

Total Eye Care, P.A.

Memphis, Tennessee, United States

Site Status

Corona Research Consultants, Inc.

El Paso, Texas, United States

Site Status

The University of Texas Medical Branch

Galveston, Texas, United States

Site Status

Physician Research Network

Houston, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Medical Center Ophthalmology

Houston, Texas, United States

Site Status

Houston Eye Associates

Houston, Texas, United States

Site Status

Sun Research Institute

San Antonio, Texas, United States

Site Status

Eye Clinic of South Texas

San Antonio, Texas, United States

Site Status

Advanced Healthcare Clinical Research Center

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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37E-03-201

Identifier Type: -

Identifier Source: org_study_id