Study of Rebamipide Eye Drops to Treat Dry Eye

Phase 3

Completed

• Conditions: Keratoconjunctivitis Sicca
• Interventions: Drug: Rebamipide

• Registration Number: NCT00201981
• 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 symptom.

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: 2007-02
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-04
• Last Update Posted: 2008-01-07

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

Arm && Interventions

Group	Intervention	Description
2	Rebamipide	Rebamipide 2%
1	Rebamipide	rebamipide 1%

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	12 week and 26 week

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	12 week and 26 week

Trial Locations

Locations (63)

Alabama Research Center, LLC; 🇺🇸 Birmingham, Alabama, United States

Sun Valley Arthritis Center, Ltd.; 🇺🇸 Glendale, Arizona, United States

Pivotel Research Center; 🇺🇸 Peoria, Arizona, United States

Hope research Institute; 🇺🇸 Phoenix, Arizona, United States

Buena Vista Eye Care Center; 🇺🇸 Phoenix, Arizona, United States

Radiant Research; 🇺🇸 Scottsdale, Arizona, United States

Sall Eye Research Center; 🇺🇸 Artesia, California, United States

Radiant Research - Irvine; 🇺🇸 Irvine, California, United States

Scripps Clinic Medical Group, Inc.; 🇺🇸 La Jolla, California, United States

American Eye Institute; 🇺🇸 Los Angeles, California, United States

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