Keratoconjunctivitis SiccaPhase 3NCT00201955
Study of Rebamipide Eye Drops to Treat Dry Eye
A Phase 3 study testing Rebamipide 1% and Rebamipide 2% in people with Keratoconjunctivitis Sicca, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 60 sites in United States.
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
- 762 participants
- Where
- 60 sitesUnited States
- Study dates
- 1 May 2004to 1 Jul 2006
- 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
60 sites in 1 country.
60 sites in 1 country
United States60 sites
Bend Medical Clinic
Bend, Oregon, 97701
Eye Care Associates
Bethpage, New York, 11021
Harold Helms, MD
Birmingham, Alabama, 35205
Michael Bernstein, MD
Birmingham, Alabama, 35216
Bossier Optical, Inc.
Bossier City, Louisiana, 71111
Western Wake Eye Center, P.A.
Cary, North Carolina, 27511
Southeast Clinical Research Associates
Charlotte, North Carolina, 28210
Horizon Eye Care - Clinical Research Dept.
Charlotte, North Carolina, 28211
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Comprehensive Opthalmology & Optical Services
Cleveland, Ohio, 44115
Colorado Eye Associates, PC
Colorado Springs, Colorado, 80907
Opthalmology Associates
Creve Coeur, Missouri, 63141
Danbury Eye Physicians and Surgeons, P.C.
Danbury, Connecticut, 06810-4005
Valley Clinical Research Center
Easton, Pennsylvania, 18045
Corona Research Consultants, Inc.
El Paso, Texas, 79904
Welborn Clinic
Evansville, Indiana, 47714
I Care! Eye Care!
Flagstaff, Arizona, 860001
Florida Ophthalmic Institute
Gainesville, Florida, 32605-3192
The University of Texas Medical Branch
Galveston, Texas, 77555
Depremont Eye Specialists
Gulfport, Mississippi, 39507
Cornerstone Research Care
High Point, North Carolina, 27262
Physician Research Network
Houston, Texas, 77002
Study site
Houston, Texas, 77002
Medical Center Ophthalmology
Houston, Texas, 77030
Houston Eye Associates
Houston, Texas, 77125
United Medical Research Institute
Inglewood, California, 90301
Florida Wellcare Alliance, L.C.
Inverness, Florida, 34452
Shettle Eye Center
Largo, Florida, 33770
Harvey and Bernice Jones Eye Institute
Little Rock, Arkansas, 72205
Taustine Eye Center
Louisville, Kentucky, 40217
Ophthmalmic Consultants of Long Island
Lynbrook, New York, 11563
Medical Eye Center
Medford, Oregon, 97504
Total Eye Care, P.A.
Memphis, Tennessee, 38119
Advanced Healthcare Clinical Research Center
Milwaukee, Wisconsin, 21209
Minnesota Eye Associates
Minneapolis, Minnesota, 55404
Stevenson Medical Surgical Eye Center
New Orleans, Louisiana, 70119
Family Eye Centers
New Orleans, Louisiana, 70127
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
Mt. Sinai Medical Center School of Medicine
New York, New York, 10029
Ophthalmic Consultants of Long Island
New York, New York, 11570
Ophthalmic Research Associates, Inc.
North Andover, Massachusetts, 01845
Tukio Institute for Clinical Research
North Miami Beach, Florida, 33169
Magnolia Research Group, Inc.
Ocala, Florida, 34471
Philadelphia Eye Associates
Philadelphia, Pennsylvania, 19148
Clinical Research Laboratories
Piscataway, New Jersey, 08854
University of Pittsburg Eye and Ear Institute
Pittsburgh, Pennsylvania, 15233
Glaucome-Cataract Consultants
Pittsburgh, Pennsylvania, 15243
Ophthalmology Associates
Princeton, New Jersey, 08540
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Rochester Ophthalmological Group
Rochester, New York, 14618
Sun Research Institute
San Antonio, Texas, 78205
Eye Clinic of South Texas
San Antonio, Texas, 78209
Benchmark Research
San Francisco, California, 94102
Southern California Clinical Research, Inc.
San Marino, California, 91108
Vision Incorporated
Savannah, Georgia, 31406
Carolina Eye Associates
Southern Pines, North Carolina, 28387
Ophthalmic Consultants of Long Island
Valley Stream, New York, 11581
Radiant Research - West Palm Beach
West Palm Beach, Florida, 33407
Heartland Research Associates, LLC
Wichita, Kansas, 67207
Wichita Clinic, PA
Wichita, Kansas, 67208
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, 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).
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 symptoms.
- Conditions
- Keratoconjunctivitis Sicca
- 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 group | Role | What they receive |
|---|---|---|
| Rebamipide 1% | Active comparator | Participants will receive rebamipide 1% ophthalmic suspension four times daily (QID) for 26 weeks Receives: Drug: Rebamipide 1% |
| Rebamipide 2% | Active comparator | Participants will receive rebamipide 2% ophthalmic suspension four times daily (QID) for 26 weeks Receives: Drug: Rebamipide 2% |
| Placebo | Placebo comparator | Participants will receive a rebamipide-matching placebo ophthalmically four times daily (QID) for 26 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12
Measured: 12 week
Secondary outcomes (1)
fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26
Measured: 26 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study start1 May 2004
- Primary completion1 Jul 2006
- Study completion1 Jul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratoconjunctivitis SiccaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 762 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201955
- Sponsor's protocol ID
- 37E-03-201
- Status last verified
- Jun 2026
- First submitted
- 12 Sep 2005
- Last updated
- 24 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rebamipide Ophthalmic Suspension in the Treatment of Dry Eye: A Multicenter, Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, 26 Week Study
- ClinicalTrials.gov ID
- NCT00201955
- Acronym / sponsor ID
- 37E-03-201
- Conditions
- Keratoconjunctivitis Sicca
- Keywords
- dry eye, keratoconjunctivitis sicca
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 762 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- 1 May 2004 (actual)
- Primary completion
- 1 Jul 2006 (actual)
- Study completion
- 1 Jul 2006 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rebamipide 1% | Active comparator | Drug: Rebamipide 1%Participants will receive rebamipide 1% ophthalmic suspension four times daily (QID) for 26 weeks |
| Rebamipide 2% | Active comparator | Drug: Rebamipide 2%Participants will receive rebamipide 2% ophthalmic suspension four times daily (QID) for 26 weeks |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a rebamipide-matching placebo ophthalmically four times daily (QID) for 26 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- must have symptoms of dry eye for a minimum of 6 months
- must be able to sign and date an informed consent
Key exclusion criteria (11 listed)
- presence of anterior segment disease
- glaucoma or ocular hypertension
- using Restasis
- use of topically instilled ocular medications during study
- use of contact lenses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rebamipide 1%ophthalmic suspension | Drug | Rebamipide 1% |
| Rebamipide 2%ophthalmic suspension | Drug | Rebamipide 2% |
| PlaceboRebamipide-matching placebo ophthalmic suspension | Drug | Placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Otsuka Clinical Trial Website:Link provided by the sponsor.
- Otsuka Clinical Trial Transparency:Link provided by the sponsor.
Related trials for Keratoconjunctivitis Sicca
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
60 sites in 1 country: see every site and its status.
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 60 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 24 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 60 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2026.