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Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome

This study is currently recruiting participants.
Verified October 2012 by Acucela Inc.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Acucela Inc.
ClinicalTrials.gov Identifier:
NCT01632137
First received: June 28, 2012
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome.


Condition Intervention Phase
Dry Eye Syndrome
 Drug: Rebamipide 2% ophthalmic suspension
Drug: Placebo (vehicle)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Study to Determine the Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Acucela Inc.:

Primary Outcome Measures:
  • Primary ocular sign: Fluorescein corneal staining total score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Primary ocular symptom: Worst ocular symptom severity score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fluorescein corneal staining total score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Worst ocular symptom severity score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 560
Study Start Date: June 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo (vehicle) Drug: Placebo (vehicle)
Instill one drop into each eye 4 times a day for 4 weeks.
Experimental: Rebamipide 2% ophthalmic suspension Drug: Rebamipide 2% ophthalmic suspension
Instill one drop into each eye 4 times a day for 4 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of dry eye-related ocular symptoms for at least 20 months.
  • Meet protocol-defined criteria for corneal and conjunctival staining.
  • Meet protocol-defined criteria for ocular discomfort.

Exclusion Criteria:

  • Active anterior segment ocular disease other than dry eye syndrome.
  • Inability to suspend the use of topical ophthalmic medications throughout the duration of the study.
  • Inability to suspend the use of contact lenses for the duration of the study.
  • Judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease, or safety concerns.
  • Received any other investigational product within 4 months before the screening visit.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632137

Contacts
Contact: Acucela Clinical Trials Helpdesk 206-805-8310 clinicaltrials@acucela.com

  Show 34 Study Locations
Sponsors and Collaborators
Acucela Inc.
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Acucela Medical Monitor Acucela Inc.
  More Information

No publications provided

Responsible Party: Acucela Inc.
ClinicalTrials.gov Identifier: NCT01632137     History of Changes
Other Study ID Numbers: ACU-RED-301
Study First Received: June 28, 2012
Last Updated: October 3, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal 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