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Keratoconjunctivitis SiccaPhase 3NCT00201981

A 1-Year Study in Multiple Clinics Testing Rebamipide Eye Drops for Dry Eye Compared With a Placebo

A Phase 3 study testing Rebamipide 1% and Rebamipide 2% in people with Keratoconjunctivitis Sicca, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 63 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Keratoconjunctivitis Sicca
What is being tested?
Rebamipide 1% and Rebamipide 2%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
755 participants
Where
63 sitesUnited States
Study dates
1 May 2004to 1 Feb 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • must have symptoms of dry eye for a minimum of 6 months
  • must be able to sign and date an informed consent

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

63 sites in 1 country.

63 sites in 1 country

United States63 sites

  • Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109

  • St. Luke's Eye Institute

    Amarillo, Texas, 79106

  • Sall Eye Research Center

    Artesia, California, 90701-5653

  • Omni Eye Services

    Atlanta, Georgia, 30342

  • Eye Clinic of Austin

    Austin, Texas, 78731

  • Krieger Eye Institute

    Baltimore, Maryland, 21215

  • Eye Center Northeast

    Bangor, Maine, 04401

  • Gulf Coast Research Associates, Inc.

    Baton Rouge, Louisiana, 70808

  • Alabama Research Center, LLC

    Birmingham, Alabama, 35209

  • Peter C. Donshik, MDPC

    Bloomfield, Connecticut, 06002

  • New England Eye Center

    Boston, Massachusetts, 02111

  • The Eye Associates

    Bradenton, Florida, 34209

  • Hernando Eye Institute

    Brooksville, Florida, 34613

  • Centennial Eye Associates

    Centennial, Colorado, 80112

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106-5068

  • Comprehensive Opthalmology & Optical Services

    Cleveland, Ohio, 44115

  • Access Eye Research Center

    Fredericksburg, Virginia, 22405

  • Sun Valley Arthritis Center, Ltd.

    Glendale, Arizona, 85308

  • Danial Long, MD

    Gretna, Louisiana, 70056

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Surgical Eye Associates, PA

    Houston, Texas, 77055

  • Radiant Research - Irvine

    Irvine, California, 92618

  • Scripps Clinic Medical Group, Inc.

    La Jolla, California, 92037

  • Brazosport Eye Institute

    Lake Jackson, Texas, 77566

  • Radiant Research, Inc. - Lake Worth

    Lake Worth, Florida, 33461

  • Clinical Research Center of Nevada

    Las Vegas, Nevada, 89104

  • University of Kentucky, Department of Ophthamology

    Lexington, Kentucky, 40536-0293

  • Corneal Consultants of Colorado

    Littleton, Colorado, 80120

  • American Eye Institute

    Los Angeles, California, 90048

  • Kentucky Lions Eye Center

    Louisville, Kentucky, 40222

  • The Wilmer Eye Institute

    Lutherville, Maryland, 21093

  • University Eye Surgeons

    Maryville, Tennessee, 37803

  • Clinical Research Institute of Southern Oregon

    Medford, Oregon, 97504

  • Montana Medical Research, LLC

    Missoula, Montana, 59804

  • West Hills Vision Center

    Moon Township, Pennsylvania, 15108

  • Glaucoma Consultants and Center for Eye Research

    Mt. Pleasant, South Carolina, 29464

  • Lakeview Optical

    New Orleans, Louisiana, 70124

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Mississippi Eye Associates

    Ocean Springs, Mississippi, 39564

  • Western New York Eye Center

    Orchard Park, New York, 14127

  • Eye Associates International

    Ormond Beach, Florida, 32174

  • The Eye Institute - Lahey Clinic North

    Peabody, Massachusetts, 01960

  • Pivotel Research Center

    Peoria, Arizona, 85381

  • Clinical Research Source, Inc.

    Perrysburg, Ohio, 43551

  • Hope research Institute

    Phoenix, Arizona, 85006

  • Buena Vista Eye Care Center

    Phoenix, Arizona, 85012

  • Pinellas Eye Center

    Pinellas Park, Florida, 33781

  • Northwest Corneal Services

    Portland, Oregon, 97223

  • Orellana Retina Associates, PLLC

    Raleigh, North Carolina, 27612

  • Vision Surgery and Laser Center

    Roseburg, Oregon, 97470

  • Axia Research

    Salt Lake City, Utah, 84107

  • John Moran Eye Center, University of Utah

    Salt Lake City, Utah, 84132

  • Eye Clinic of San Diego

    San Diego, California, 92103

  • Physicians Research Options, LC

    Sandy City, Utah, 84070

  • Radiant Research

    Scottsdale, Arizona, 85251

  • Glaucoma Consultants of the Capital Region

    Slingerlands, New York, 12159

  • Ft. Lauderdale Eye Institute

    Sunrise, Florida, 33351

  • Marvin E. Greenberg, MD PA 7

    Tamarac, Florida, 33321

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33603

  • International Eye Center

    Tampa, Florida, 33603

  • Healthcare Partners Medical Group

    Torrance, California, 90503

  • Opticare Eye Health Center

    Waterbury, Connecticut, 06708

  • Western States Clinical Research, Inc.

    Wheat Ridge, Colorado, 80033

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
Rebamipide 1%, Rebamipide 2%, Placebo
Keywords
dry eye, keratoconjunctivitis sicca
Medical subject headings
Keratoconjunctivitis Sicca, Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rebamipide 1%Drug

    ophthalmic suspension

  • Rebamipide 2%Drug

    ophthalmic suspension

  • PlaceboDrug

    Rebamipide-matching placebo ophthalmic suspension

Study groups in NCT00201981
Study groupRoleWhat they receive
Rebamipide 1%Active comparatorParticipants will receive rebamipide 1% ophthalmic suspension four times daily (QID) for 52 weeks
Receives: Drug: Rebamipide 1%
Rebamipide 2%Active comparatorParticipants will receive rebamipide 2% ophthalmic suspension four times daily (QID) for 52 weeks
Receives: Drug: Rebamipide 2%
PlaceboPlacebo comparatorParticipants will receive a rebamipide-matching placebo ophthalmically four times daily (QID) for 52 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12

    Measured: 12 week and 26 week

Secondary outcomes (1)

  1. fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26

    Measured: 12 week and 26 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study start1 May 2004
  3. Primary completion1 Feb 2007
  4. Study completion1 Feb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
755 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00201981
Sponsor's protocol ID
37E-03-202
Status last verified
Jun 2026
First submitted
12 Sep 2005
Last updated
15 Jun 2026
Results posted
No

Publications

  • Yamasaki K, Ishiyama H, Imaizumi T, Kanbe T, Yabuuchi Y. Effect of OPC-12759, a novel antiulcer agent, on chronic and acute experimental gastric ulcer, and gastric secretion in rats. Jpn J Pharmacol. 1989 Apr;49(4):441-8. doi: 10.1254/jjp.49.441.

    PubMed 2542684

  • Yamasaki K, Kanbe T, Chijiwa T, Ishiyama H, Morita S. Gastric mucosal protection by OPC-12759, a novel antiulcer compound, in the rat. Eur J Pharmacol. 1987 Oct 6;142(1):23-9. doi: 10.1016/0014-2999(87)90649-2.

    PubMed 3480223

  • Yoshikawa T, Naito Y, Tanigawa T, Kondo M. Free radical scavenging activity of the novel anti-ulcer agent rebamipide studied by electron spin resonance. Arzneimittelforschung. 1993 Mar;43(3):363-6.

    PubMed 8387788

  • Yoshikawa T, Naito Y, Nakamura S, Nishimura S, Kaneko T, Iinuma S, Takahashi S, Kondo M, Yamasaki K. Effect of rebamipide on lipid peroxidation and gastric mucosal injury induced by indometacin in rats. Arzneimittelforschung. 1993 Dec;43(12):1327-30.

    PubMed 8141822

  • Yamasaki K, et al. Effect of OPC 12759 on the production of oxygen-derived free radical from human polymorphonuclear leukocytes. In-house Report No. 004272.

  • Yamasaki K, et al. Effect of OPC 12759 on gastric mucosal blood flow in rats-determination by the hydrogen gas clearance method. In-house Report No. 003915.

  • Imaizumi, T, et al. Effect of OPC 12759 and cetraxate on gastric mucosal hemodynamics and oxygen sufficiency in rats-analysis by reflectance spectrophotometry. In-house Report No. 004101.

  • Garcher C, Bron A, Baudouin C, Bildstein L, Bara J. CA 19-9 ELISA test: a new method for studying mucus changes in tears. Br J Ophthalmol. 1998 Jan;82(1):88-90. doi: 10.1136/bjo.82.1.88.

    PubMed 9536889

  • Danjo Y, Watanabe H, Tisdale AS, George M, Tsumura T, Abelson MB, Gipson IK. Alteration of mucin in human conjunctival epithelia in dry eye. Invest Ophthalmol Vis Sci. 1998 Dec;39(13):2602-9.

    PubMed 9856770

  • Pflugfelder SC, Tseng SC, Yoshino K, Monroy D, Felix C, Reis BL. Correlation of goblet cell density and mucosal epithelial membrane mucin expression with rose bengal staining in patients with ocular irritation. Ophthalmology. 1997 Feb;104(2):223-35. doi: 10.1016/s0161-6420(97)30330-3.

    PubMed 9052626

  • Kinoshita S, Kiorpes TC, Friend J, Thoft RA. Goblet cell density in ocular surface disease. A better indicator than tear mucin. Arch Ophthalmol. 1983 Aug;101(8):1284-7. doi: 10.1001/archopht.1983.01040020286025.

    PubMed 6882259

  • Rivas L, Oroza MA, Perez-Esteban A, Murube-del-Castillo J. Morphological changes in ocular surface in dry eyes and other disorders by impression cytology. Graefes Arch Clin Exp Ophthalmol. 1992;230(4):329-34. doi: 10.1007/BF00165940.

    PubMed 1505763

  • Nelson JD, Wright JC. Conjunctival goblet cell densities in ocular surface disease. Arch Ophthalmol. 1984 Jul;102(7):1049-51. doi: 10.1001/archopht.1984.01040030851031.

    PubMed 6378156

  • Ferris FL 3rd, Kassoff A, Bresnick GH, Bailey I. New visual acuity charts for clinical research. Am J Ophthalmol. 1982 Jul;94(1):91-6.

    PubMed 7091289

  • Lemp MA. Report of the National Eye Institute/Industry workshop on Clinical Trials in Dry Eyes. CLAO J. 1995 Oct;21(4):221-32. No abstract available.

    PubMed 8565190

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rebamipide 1% and Rebamipide 2% in people with Keratoconjunctivitis Sicca, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 63 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00201981, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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