Study of Rebamipide Eye Drops to Treat Dry Eye

June 18, 2026 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, 26 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

Conditions

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 symptoms.

Study Type

Interventional

Enrollment (Actual)

762

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Harold Helms, MD
      • Birmingham, Alabama, United States, 35216
        • Michael Bernstein, MD
    • Arizona
      • Flagstaff, Arizona, United States, 860001
        • I Care! Eye Care!
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Harvey and Bernice Jones Eye Institute
    • California
      • Inglewood, California, United States, 90301
        • United Medical Research Institute
      • San Francisco, California, United States, 94102
        • Benchmark Research
      • San Marino, California, United States, 91108
        • Southern California Clinical Research, Inc.
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Colorado Eye Associates, PC
    • Connecticut
      • Danbury, Connecticut, United States, 06810-4005
        • Danbury Eye Physicians and Surgeons, P.C.
    • Florida
      • Gainesville, Florida, United States, 32605-3192
        • Florida Ophthalmic Institute
      • Inverness, Florida, United States, 34452
        • Florida Wellcare Alliance, L.C.
      • Largo, Florida, United States, 33770
        • Shettle Eye Center
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research, Inc.
      • North Miami Beach, Florida, United States, 33169
        • Tukio Institute for Clinical Research
      • Ocala, Florida, United States, 34471
        • Magnolia Research Group, Inc.
      • West Palm Beach, Florida, United States, 33407
        • Radiant Research - West Palm Beach
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Vision Incorporated
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Welborn Clinic
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates, LLC
      • Wichita, Kansas, United States, 67208
        • Wichita Clinic, PA
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Taustine Eye Center
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • Bossier Optical, Inc.
      • New Orleans, Louisiana, United States, 70119
        • Stevenson Medical Surgical Eye Center
      • New Orleans, Louisiana, United States, 70127
        • Family Eye Centers
    • Massachusetts
      • North Andover, Massachusetts, United States, 01845
        • Ophthalmic Research Associates, Inc.
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Eye Associates
    • Mississippi
      • Gulfport, Mississippi, United States, 39507
        • Depremont Eye Specialists
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Opthalmology Associates
    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Clinical Research Laboratories
      • Princeton, New Jersey, United States, 08540
        • Ophthalmology Associates
    • New York
      • Bethpage, New York, United States, 11021
        • Eye Care Associates
      • Lynbrook, New York, United States, 11563
        • Ophthmalmic Consultants of Long Island
      • New York, New York, United States, 10029
        • Mt. Sinai Medical Center School of Medicine
      • New York, New York, United States, 11570
        • Ophthalmic Consultants of Long Island
      • Rochester, New York, United States, 14618
        • Rochester Ophthalmological Group
      • Valley Stream, New York, United States, 11581
        • Ophthalmic Consultants of Long Island
    • North Carolina
      • Cary, North Carolina, United States, 27511
        • Western Wake Eye Center, P.A.
      • Charlotte, North Carolina, United States, 28210
        • Southeast Clinical Research Associates
      • Charlotte, North Carolina, United States, 28211
        • Horizon Eye Care - Clinical Research Dept.
      • High Point, North Carolina, United States, 27262
        • Cornerstone Research Care
      • Southern Pines, North Carolina, United States, 28387
        • Carolina Eye Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Eye Institute
      • Cleveland, Ohio, United States, 44115
        • Comprehensive Opthalmology & Optical Services
    • Oregon
      • Bend, Oregon, United States, 97701
        • Bend Medical Clinic
      • Medford, Oregon, United States, 97504
        • Medical Eye Center
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18045
        • Valley Clinical Research Center
      • Philadelphia, Pennsylvania, United States, 19148
        • Philadelphia Eye Associates
      • Pittsburgh, Pennsylvania, United States, 15243
        • Glaucome-Cataract Consultants
      • Pittsburgh, Pennsylvania, United States, 15233
        • University of Pittsburg Eye and Ear Institute
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Total Eye Care, P.A.
    • Texas
      • El Paso, Texas, United States, 79904
        • Corona Research Consultants, Inc.
      • Galveston, Texas, United States, 77555
        • The University of Texas Medical Branch
      • Houston, Texas, United States, 77002
        • Physician Research Network
      • Houston, Texas, United States, 77002
      • Houston, Texas, United States, 77030
        • Medical Center Ophthalmology
      • Houston, Texas, United States, 77125
        • Houston Eye Associates
      • San Antonio, Texas, United States, 78205
        • Sun Research Institute
      • San Antonio, Texas, United States, 78209
        • Eye Clinic of South Texas
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 21209
        • Advanced Healthcare Clinical 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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: Rebamipide 1%
Participants will receive rebamipide 1% ophthalmic suspension four times daily (QID) for 26 weeks
Drug: Rebamipide 1%
ophthalmic suspension
Active Comparator: Rebamipide 2%
Participants will receive rebamipide 2% ophthalmic suspension four times daily (QID) for 26 weeks
Drug: Rebamipide 2%
ophthalmic suspension
Placebo Comparator: Placebo
Participants will receive a rebamipide-matching placebo ophthalmically four times daily (QID) for 26 weeks.
Drug: Placebo
Rebamipide-matching placebo ophthalmic suspension

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
12 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: 26 week
26 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Novartis

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.

Helpful Links

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 (Actual)

May 1, 2004

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimated)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 37E-03-201

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.

Subscribe