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Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome

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.
 
ClinicalTrials.gov Identifier: NCT01632137
Recruitment Status : Completed
First Posted : July 2, 2012
Last Update Posted : May 7, 2014
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Acucela Inc.

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2012
Actual Primary Completion Date : June 2013

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Primary ocular sign: Fluorescein corneal staining total score [ Time Frame: 4 weeks ]
  2. Primary ocular symptom: Worst ocular symptom severity score [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Fluorescein corneal staining total score [ Time Frame: 2 weeks ]
  2. Worst ocular symptom severity score [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): NCT01632137


Locations
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United States, Arizona
Phoenix, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Artesia, California, United States
Glendale, California, United States
Inglewood, California, United States
San Diego, California, United States
United States, Colorado
Wheat Ridge, Colorado, United States
United States, Florida
Fort Myers, Florida, United States
Miami, Florida, United States
Plantation, Florida, United States
Stuart, Florida, United States
Tampa, Florida, United States
United States, Georgia
Morrow, Georgia, United States
United States, Louisiana
Baton Rouge, Louisiana, United States
United States, Maryland
Lutherville, Maryland, United States
United States, Missouri
Kansas City, Missouri, United States
Saint Louis, Missouri, United States
Washington, Missouri, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Princeton, New Jersey, United States
United States, New York
Rochester, New York, United States
Rockville Centre, New York, United States
Valley Stream, New York, United States
Wantagh, New York, United States
United States, North Carolina
Ashville, North Carolina, United States
Charlotte, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
Mason, Ohio, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Chattanooga, Tennessee, United States
Memphis, Tennessee, United States
United States, Texas
Houston, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Norfolk, Virginia, United States
Sponsors and Collaborators
Acucela Inc.
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Acucela Medical Monitor Acucela Inc.
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Responsible Party: Acucela Inc.
ClinicalTrials.gov Identifier: NCT01632137    
Other Study ID Numbers: ACU-RED-301
First Posted: July 2, 2012    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Syndrome
Disease
Pathologic Processes
Keratoconjunctivitis
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