Status:
COMPLETED
Study of Rebamipide Eye Drops to Treat Dry Eye
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
Novartis
Conditions:
Keratoconjunctivitis Sicca
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 (d...
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.
Eligibility Criteria
Inclusion
- must have symptoms of dry eye for a minimum of 6 months
- must be able to sign and date an informed consent
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
740 Patients enrolled
Trial Details
Trial ID
NCT00201955
Start Date
May 1 2004
End Date
July 1 2006
Last Update
November 2 2006
Active Locations (60)
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1
Harold Helms, MD
Birmingham, Alabama, United States, 35205
2
Michael Bernstein, MD
Birmingham, Alabama, United States, 35216
3
I Care! Eye Care!
Flagstaff, Arizona, United States, 860001
4
Harvey and Bernice Jones Eye Institute
Little Rock, Arkansas, United States, 72205