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Study of Rebamipide Eye Drops to Treat Dry Eye

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00201955
First received: September 12, 2005
Last updated: October 31, 2006
Last verified: October 2006
History of Changes
  Purpose

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).


Condition Intervention Phase
Keratoconjunctivitis Sicca
 Drug: Rebamipide
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Rebamipide Ophthalmic Suspension in the Treatment of Dry Eye: A Multicenter, Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, 26 Week Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

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

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

Estimated Enrollment: 740
Study Start Date: May 2004
Estimated Study Completion Date: July 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00201955

  Show 60 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Novartis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00201955     History of Changes
Other Study ID Numbers: 37E-03-201
Study First Received: September 12, 2005
Last Updated: October 31, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
dry eye
keratoconjunctivitis sicca

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Rebamipide
 Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013