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Study of Rebamipide Eye Drops to Treat Dry Eye | Clinical Trials | Clareo Health

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COMPLETEDPhase 3NCT00201981

Study of Rebamipide Eye Drops to Treat Dry Eye

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 (d...

Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.•63 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Novartis

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 7, 2008Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment740

Start dateMay 2004

Last updatedJan 7, 2008

Condition

Keratoconjunctivitis Sicca

Locations shown

Alabama Research Center, LLC

Birmingham, Alabama

Sun Valley Arthritis Center, Ltd.

Glendale, Arizona

Pivotel Research Center

Peoria, Arizona

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2008Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions