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New eye drops aim to soothe dry eye sufferers

NCT ID NCT00201981

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 755 people with dry eye for at least 6 months. Participants received either rebamipide or placebo drops for up to 52 weeks. The goal was to see if the drops could reduce eye surface damage and ease discomfort.

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 significant benefit over placebo. Dry eye is complex and individual responses vary.

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

755 people

The number who actually took part.

Started

May 2004

Finished

Feb 2007

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

  • Access Eye Research Center

    Fredericksburg, Virginia, 22405, United States

  • Alabama Research Center, LLC

    Birmingham, Alabama, 35209, United States

  • American Eye Institute

    Los Angeles, California, 90048, United States

  • Axia Research

    Salt Lake City, Utah, 84107, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Brazosport Eye Institute

    Lake Jackson, Texas, 77566, United States

  • Buena Vista Eye Care Center

    Phoenix, Arizona, 85012, United States

  • Centennial Eye Associates

    Centennial, Colorado, 80112, United States

  • Clinical Research Center of Nevada

    Las Vegas, Nevada, 89104, United States

  • Clinical Research Institute of Southern Oregon

    Medford, Oregon, 97504, United States

  • Clinical Research Source, Inc.

    Perrysburg, Ohio, 43551, United States

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33603, United States

  • Comprehensive Opthalmology & Optical Services

    Cleveland, Ohio, 44115, United States

  • Corneal Consultants of Colorado

    Littleton, Colorado, 80120, United States

  • Danial Long, MD

    Gretna, Louisiana, 70056, United States

  • Eye Associates International

    Ormond Beach, Florida, 32174, United States

  • Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109, United States

  • Eye Center Northeast

    Bangor, Maine, 04401, United States

  • Eye Clinic of Austin

    Austin, Texas, 78731, United States

  • Eye Clinic of San Diego

    San Diego, California, 92103, United States

  • Ft. Lauderdale Eye Institute

    Sunrise, Florida, 33351, United States

  • Glaucoma Consultants and Center for Eye Research

    Mt. Pleasant, South Carolina, 29464, United States

  • Glaucoma Consultants of the Capital Region

    Slingerlands, New York, 12159, United States

  • Gulf Coast Research Associates, Inc.

    Baton Rouge, Louisiana, 70808, United States

  • Healthcare Partners Medical Group

    Torrance, California, 90503, United States

  • Hernando Eye Institute

    Brooksville, Florida, 34613, United States

  • Hope research Institute

    Phoenix, Arizona, 85006, United States

  • International Eye Center

    Tampa, Florida, 33603, United States

  • John Moran Eye Center, University of Utah

    Salt Lake City, Utah, 84132, United States

  • Kentucky Lions Eye Center

    Louisville, Kentucky, 40222, United States

  • Krieger Eye Institute

    Baltimore, Maryland, 21215, United States

  • Lakeview Optical

    New Orleans, Louisiana, 70124, United States

  • Marvin E. Greenberg, MD PA 7

    Tamarac, Florida, 33321, United States

  • Mississippi Eye Associates

    Ocean Springs, Mississippi, 39564, United States

  • Montana Medical Research, LLC

    Missoula, Montana, 59804, United States

  • New England Eye Center

    Boston, Massachusetts, 02111, United States

  • Northwest Corneal Services

    Portland, Oregon, 97223, United States

  • Omni Eye Services

    Atlanta, Georgia, 30342, United States

  • Opticare Eye Health Center

    Waterbury, Connecticut, 06708, United States

  • Orellana Retina Associates, PLLC

    Raleigh, North Carolina, 27612, United States

  • Peter C. Donshik, MDPC

    Bloomfield, Connecticut, 06002, United States

  • Physicians Research Options, LC

    Sandy City, Utah, 84070, United States

  • Pinellas Eye Center

    Pinellas Park, Florida, 33781, United States

  • Pivotel Research Center

    Peoria, Arizona, 85381, United States

  • Radiant Research

    Scottsdale, Arizona, 85251, United States

  • Radiant Research - Irvine

    Irvine, California, 92618, United States

  • Radiant Research, Inc. - Lake Worth

    Lake Worth, Florida, 33461, United States

  • Sall Eye Research Center

    Artesia, California, 90701-5653, United States

  • Scripps Clinic Medical Group, Inc.

    La Jolla, California, 92037, United States

  • St. Luke's Eye Institute

    Amarillo, Texas, 79106, United States

  • Sun Valley Arthritis Center, Ltd.

    Glendale, Arizona, 85308, United States

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652, United States

  • Surgical Eye Associates, PA

    Houston, Texas, 77055, United States

  • The Eye Associates

    Bradenton, Florida, 34209, United States

  • The Eye Institute - Lahey Clinic North

    Peabody, Massachusetts, 01960, United States

  • The Wilmer Eye Institute

    Lutherville, Maryland, 21093, United States

  • University Eye Surgeons

    Maryville, Tennessee, 37803, United States

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106-5068, United States

  • University of Kentucky, Department of Ophthamology

    Lexington, Kentucky, 40536-0293, United States

  • Vision Surgery and Laser Center

    Roseburg, Oregon, 97470, United States

  • West Hills Vision Center

    Moon Township, Pennsylvania, 15108, United States

  • Western New York Eye Center

    Orchard Park, New York, 14127, United States

  • Western States Clinical Research, Inc.

    Wheat Ridge, Colorado, 80033, United States

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Other studies related to the condition(s) this trial covers.