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New eye drops aim to soothe dry eye sufferers

NCT ID NCT00201955

Symptom relief Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tested rebamipide eye drops in 762 people with dry eye lasting at least 6 months. Participants received either rebamipide or placebo drops for 26 weeks. The goal was to see if the drops could reduce eye surface damage and discomfort better than placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rebamipide eye drops
What this could lead to
If it works, this could provide a new treatment option to ease dry eye symptoms and improve eye surface health.
What could go wrong
This is a completed Phase 3 trial, but results may not show a clear benefit over placebo. Dry eye is complex, and what works for some may not work for all.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

762 people

The number who actually took part.

Started

May 2004

Finished

Jul 2006

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

dry eye syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Keratoconjunctivitis sicca

Contacts and locations

Locations

  • Study site

    Houston, Texas, 77002, United States

  • Advanced Healthcare Clinical Research Center

    Milwaukee, Wisconsin, 21209, United States

  • Benchmark Research

    San Francisco, California, 94102, United States

  • Bend Medical Clinic

    Bend, Oregon, 97701, United States

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701, United States

  • Bossier Optical, Inc.

    Bossier City, Louisiana, 71111, United States

  • Carolina Eye Associates

    Southern Pines, North Carolina, 28387, United States

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242, United States

  • Clinical Research Laboratories

    Piscataway, New Jersey, 08854, United States

  • Colorado Eye Associates, PC

    Colorado Springs, Colorado, 80907, United States

  • Comprehensive Opthalmology & Optical Services

    Cleveland, Ohio, 44115, United States

  • Cornerstone Research Care

    High Point, North Carolina, 27262, United States

  • Corona Research Consultants, Inc.

    El Paso, Texas, 79904, United States

  • Danbury Eye Physicians and Surgeons, P.C.

    Danbury, Connecticut, 06810-4005, United States

  • Depremont Eye Specialists

    Gulfport, Mississippi, 39507, United States

  • Eye Care Associates

    Bethpage, New York, 11021, United States

  • Eye Clinic of South Texas

    San Antonio, Texas, 78209, United States

  • Family Eye Centers

    New Orleans, Louisiana, 70127, United States

  • Florida Ophthalmic Institute

    Gainesville, Florida, 32605-3192, United States

  • Florida Wellcare Alliance, L.C.

    Inverness, Florida, 34452, United States

  • Glaucome-Cataract Consultants

    Pittsburgh, Pennsylvania, 15243, United States

  • Harold Helms, MD

    Birmingham, Alabama, 35205, United States

  • Harvey and Bernice Jones Eye Institute

    Little Rock, Arkansas, 72205, United States

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207, United States

  • Horizon Eye Care - Clinical Research Dept.

    Charlotte, North Carolina, 28211, United States

  • Houston Eye Associates

    Houston, Texas, 77125, United States

  • I Care! Eye Care!

    Flagstaff, Arizona, 860001, United States

  • Magnolia Research Group, Inc.

    Ocala, Florida, 34471, United States

  • Medical Center Ophthalmology

    Houston, Texas, 77030, United States

  • Medical Eye Center

    Medford, Oregon, 97504, United States

  • Michael Bernstein, MD

    Birmingham, Alabama, 35216, United States

  • Minnesota Eye Associates

    Minneapolis, Minnesota, 55404, United States

  • Mt. Sinai Medical Center School of Medicine

    New York, New York, 10029, United States

  • Ophthalmic Consultants of Long Island

    New York, New York, 11570, United States

  • Ophthalmic Consultants of Long Island

    Valley Stream, New York, 11581, United States

  • Ophthalmic Research Associates, Inc.

    North Andover, Massachusetts, 01845, United States

  • Ophthalmology Associates

    Princeton, New Jersey, 08540, United States

  • Ophthmalmic Consultants of Long Island

    Lynbrook, New York, 11563, United States

  • Opthalmology Associates

    Creve Coeur, Missouri, 63141, United States

  • Philadelphia Eye Associates

    Philadelphia, Pennsylvania, 19148, United States

  • Physician Research Network

    Houston, Texas, 77002, United States

  • Radiant Research - West Palm Beach

    West Palm Beach, Florida, 33407, United States

  • Rochester Ophthalmological Group

    Rochester, New York, 14618, United States

  • Shettle Eye Center

    Largo, Florida, 33770, United States

  • Southeast Clinical Research Associates

    Charlotte, North Carolina, 28210, United States

  • Southern California Clinical Research, Inc.

    San Marino, California, 91108, United States

  • Stevenson Medical Surgical Eye Center

    New Orleans, Louisiana, 70119, United States

  • Sun Research Institute

    San Antonio, Texas, 78205, United States

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652, United States

  • Taustine Eye Center

    Louisville, Kentucky, 40217, United States

  • The University of Texas Medical Branch

    Galveston, Texas, 77555, United States

  • Total Eye Care, P.A.

    Memphis, Tennessee, 38119, United States

  • Tukio Institute for Clinical Research

    North Miami Beach, Florida, 33169, United States

  • United Medical Research Institute

    Inglewood, California, 90301, United States

  • University of Pittsburg Eye and Ear Institute

    Pittsburgh, Pennsylvania, 15233, United States

  • Valley Clinical Research Center

    Easton, Pennsylvania, 18045, United States

  • Vision Incorporated

    Savannah, Georgia, 31406, United States

  • Welborn Clinic

    Evansville, Indiana, 47714, United States

  • Western Wake Eye Center, P.A.

    Cary, North Carolina, 27511, United States

  • Wichita Clinic, PA

    Wichita, Kansas, 67208, United States

More trials for these conditions

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