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Study of Rebamipide Eye Drops to Treat Dry Eye

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00201981
First Posted: September 20, 2005
Last Update Posted: January 7, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Yamasaki K, et al. Effect of OPC 12759 on the production of oxygen-derived free radical from human polymorphonuclear leukocytes. In-house Report No. 004272.
Yamasaki K, et al. Effect of OPC 12759 on gastric mucosal blood flow in rats-determination by the hydrogen gas clearance method. In-house Report No. 003915.
Imaizumi, T, et al. Effect of OPC 12759 and cetraxate on gastric mucosal hemodynamics and oxygen sufficiency in rats-analysis by reflectance spectrophotometry. In-house Report No. 004101.

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
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: January 7, 2008
Last Verified: January 2008

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
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors