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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 symptom.

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

Allocation :

ESTIMATED

End Date :

February 1 2007

Estimated Enrollment :

740 Patients enrolled

Trial Details

Trial ID

NCT00201981

Start Date

May 1 2004

End Date

February 1 2007

Last Update

January 7 2008

Active Locations (63)

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Page 1 of 16 (63 locations)

1

Alabama Research Center, LLC

Birmingham, Alabama, United States, 35209

2

Sun Valley Arthritis Center, Ltd.

Glendale, Arizona, United States, 85308

3

Pivotel Research Center

Peoria, Arizona, United States, 85381

4

Hope research Institute

Phoenix, Arizona, United States, 85006