Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye

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. Identifier: NCT01027013
Recruitment Status : Completed
First Posted : December 7, 2009
Last Update Posted : January 11, 2012
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Acucela Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of rebamipide 2% suspension for the treatment of patients with dry-eye.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Keratoconjunctivitis Sicca Drug: rebamipide 2% ophthalmic suspension Drug: placebo eye drops Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Prospective, Randomized, Double-masked, Parallel Group, Multi-center Study Assessing the Safety and Efficacy of 2% Rebamipide (OPC-12759) Compared to Placebo for the Treatment of Keratoconjunctivitis Sicca (Dry Eye)
Study Start Date : December 2009
Primary Completion Date : October 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arm Intervention/treatment
Experimental: rebamipide 2% ophthalmic suspension Drug: rebamipide 2% ophthalmic suspension
Instill one drop in each eye four times daily for 12 weeks.
Placebo Comparator: Placebo eye drops Drug: placebo eye drops
Instill one drop in each eye four times daily for 12 weeks.

Primary Outcome Measures :
  1. Total fluorescein corneal staining score [ Time Frame: 4 weeks ]
  2. Primary ocular discomfort [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Dry eye symptoms [ Time Frame: 12 weeks ]
  2. Ocular staining [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 years and older
  • Diagnosis of dry eye as defined by the protocol

Exclusion Criteria:

  • Ongoing ocular disease that may interfere with study parameters.
  • Inability to stop using topical ophthalmic medications throughout the duration of the study
  • Inability to stop the use of contact lenses for the duration of the study.

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 identifier (NCT number): NCT01027013

United States, Connecticut
The Eye Care Group, P.C.
Waterbury, Connecticut, United States, 06708
United States, Kentucky
Richard Eiferman, MD
Louisville, Kentucky, United States, 40205
United States, Maine
Central Maine Eye Care
Lewiston, Maine, United States, 04240
United States, Massachusetts
Ora, Inc
Andover, Massachusetts, United States, 01810
United States, Tennessee
Total Eye Care, P.A.
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Acucela Inc.
Otsuka Pharmaceutical Co., Ltd.
Study Director: Nancy Boman, MD, PhD Acucela Inc.

Responsible Party: Acucela Inc. Identifier: NCT01027013     History of Changes
Other Study ID Numbers: ACU-RED-203
First Posted: December 7, 2009    Key Record Dates
Last Update Posted: January 11, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors