Study of Rebamipide Eye Drops to Treat Dry Eye

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

Status

Completed

Intervention / Treatment

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%
  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
Active Comparator: 2
Rebamipide 2%
  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
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

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

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.

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