Study of Rebamipide Eye Drops to Treat Dry Eye

Phase 3

Completed

• Conditions: Keratoconjunctivitis Sicca

• Registration Number: NCT00201955
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

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 (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 Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Study Completion: 2006-07
• Status Verified: 2006-10
• Last Update Submitted: 2006-10-31
• Last Update Posted: 2006-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 740

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12

Secondary Outcome Measures

Name	Time	Method
fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26

Trial Locations

Locations (58)

Harold Helms, MD; 🇺🇸 Birmingham, Alabama, United States

Michael Bernstein, MD; 🇺🇸 Birmingham, Alabama, United States

I Care! Eye Care!; 🇺🇸 Flagstaff, Arizona, United States

Harvey and Bernice Jones Eye Institute; 🇺🇸 Little Rock, Arkansas, United States

United Medical Research Institute; 🇺🇸 Inglewood, California, United States

Benchmark Research; 🇺🇸 San Francisco, California, United States

Southern California Clinical Research, Inc.; 🇺🇸 San Marino, California, United States

Colorado Eye Associates, PC; 🇺🇸 Colorado Springs, Colorado, United States

Danbury Eye Physicians and Surgeons, P.C.; 🇺🇸 Danbury, Connecticut, United States

Florida Ophthalmic Institute; 🇺🇸 Gainesville, Florida, United States

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