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:
NCT00201981
First received: September 12, 2005
Last updated: January 4, 2008
Last verified: January 2008
  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 (Subject, Caregiver, Investigator)
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, 52 Week Study

Resource links provided by NLM:


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 [ Time Frame: 12 week and 26 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26 [ Time Frame: 12 week and 26 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 740
Study Start Date: May 2004
Study Completion Date: February 2007
Arms Assigned Interventions
Active Comparator: 1
rebamipide 1%
Drug: Rebamipide
  1. OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks
  2. OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks
Active Comparator: 2
Rebamipide 2%
Drug: Rebamipide
  1. OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks
  2. OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks
No Intervention: 3
placebo

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201981

  Show 63 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Novartis
Investigators
Study Chair: Gary Foulks, MD University of Louisville
  More Information

Publications:

Responsible Party: Juan Guzman, MD/ Sr. Director, Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization
ClinicalTrials.gov Identifier: NCT00201981     History of Changes
Other Study ID Numbers: 37E-03-202
Study First Received: September 12, 2005
Last Updated: January 4, 2008
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
Keratoconjunctivitis Sicca
Dry Eye Syndromes
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 September 16, 2014