Clinical Trial: Study of Rebamipide Eye Drops to Treat Dry Eye

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Rebamipide Ophthalmic Suspension in the Treatment of Dry Eye: A Multicenter, Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, 52 Week Study

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 Summary: 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.
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Current Primary Outcome: fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12

Original Primary Outcome: fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12

Current Secondary Outcome: fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26

Original Secondary Outcome: fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26

Information By: Otsuka Pharmaceutical Development & Commercialization, Inc.

Dates:
Date Received: September 12, 2005
Date Started: May 2004
Date Completion: July 2006
Last Updated: October 31, 2006
Last Verified: October 2006