Study of Rebamipide Eye Drops to Treat Dry Eye

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborator: Novartis
• Treatments: Rebamipide

Criteria

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