Back to resultsEfficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome
Primary Purpose
Dry Eye Syndrome
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rebamipide 2% ophthalmic suspension
Placebo (vehicle)
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo (vehicle)
Rebamipide 2% ophthalmic suspension
Arm Description
Outcomes
Primary Outcome Measures
Primary ocular sign: Fluorescein corneal staining total score
Primary ocular symptom: Worst ocular symptom severity score
Secondary Outcome Measures
Fluorescein corneal staining total score
Worst ocular symptom severity score
Full Information
NCT ID
NCT01632137
First Posted
June 28, 2012
Last Updated
April 17, 2014
Sponsor
Kubota Vision Inc.
Collaborators
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01632137
Brief Title
Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome
Official Title
A Phase 3 Study to Determine the Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kubota Vision Inc.
Collaborators
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
564 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo (vehicle)
Arm Type
Placebo Comparator
Arm Title
Rebamipide 2% ophthalmic suspension
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rebamipide 2% ophthalmic suspension
Intervention Description
Instill one drop into each eye 4 times a day for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo (vehicle)
Intervention Description
Instill one drop into each eye 4 times a day for 4 weeks.
Primary Outcome Measure Information:
Title
Primary ocular sign: Fluorescein corneal staining total score
Time Frame
4 weeks
Title
Primary ocular symptom: Worst ocular symptom severity score
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Fluorescein corneal staining total score
Time Frame
2 weeks
Title
Worst ocular symptom severity score
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Acucela Medical Monitor
Organizational Affiliation
Kubota Vision Inc.
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Artesia
State/Province
California
Country
United States
City
Glendale
State/Province
California
Country
United States
City
Inglewood
State/Province
California
Country
United States
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San Diego
State/Province
California
Country
United States
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Wheat Ridge
State/Province
Colorado
Country
United States
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Fort Myers
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Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Plantation
State/Province
Florida
Country
United States
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Stuart
State/Province
Florida
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United States
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Tampa
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Florida
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United States
City
Morrow
State/Province
Georgia
Country
United States
City
Baton Rouge
State/Province
Louisiana
Country
United States
City
Lutherville
State/Province
Maryland
Country
United States
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Kansas City
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Missouri
Country
United States
City
Saint Louis
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Missouri
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United States
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Washington
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Missouri
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United States
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Las Vegas
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Nevada
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United States
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Princeton
State/Province
New Jersey
Country
United States
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Rochester
State/Province
New York
Country
United States
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Rockville Centre
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New York
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United States
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Valley Stream
State/Province
New York
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United States
City
Wantagh
State/Province
New York
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United States
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Ashville
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North Carolina
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
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Cleveland
State/Province
Ohio
Country
United States
City
Mason
State/Province
Ohio
Country
United States
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Pittsburgh
State/Province
Pennsylvania
Country
United States
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Chattanooga
State/Province
Tennessee
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United States
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Memphis
State/Province
Tennessee
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United States
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Houston
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome
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