Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Subjects With Dry Eye - Effects on Central Cornea
NCT ID: NCT01057147
Last Updated: 2012-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
116 participants
INTERVENTIONAL
2010-02-28
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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rebamipide 2% ophthalmic suspension
rebamipide 2% ophthalmic suspension
Instill one drop in each eye four times daily for 12 weeks.
placebo eye drops
placebo eye drops
Instill one drop in each eye four times daily for 12 weeks.
Interventions
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rebamipide 2% ophthalmic suspension
Instill one drop in each eye four times daily for 12 weeks.
placebo eye drops
Instill one drop in each eye four times daily for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of dry eye as defined by the protocol
* Central corneal staining
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Kubota Vision Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ryo Kubota, MD, PhD
Role: STUDY_DIRECTOR
Kubota Vision Inc.
Locations
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East Valley Ophthalmology
Mesa, Arizona, United States
Arizona Center for Clinical Trials, LLC
Phoenix, Arizona, United States
Cornea Consultants of Arizona
Phoenix, Arizona, United States
Macy Eye Center
Los Angeles, California, United States
Corneal Consultants of Colorado
Littleton, Colorado, United States
Specialty Eye Care
Parker, Colorado, United States
Cohen Laser and Vision Center
Boca Raton, Florida, United States
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, United States
Med Eye Associates
Miami, Florida, United States
George R. John, MD
Louisville, Kentucky, United States
Central Maine Eye Care
Lewiston, Maine, United States
Ora, Inc.
Andover, Massachusetts, United States
Ophthalmology Associates
St Louis, Missouri, United States
Nevada Eye Care Professionals
Las Vegas, Nevada, United States
Avista Eye Center
Las Vegas, Nevada, United States
New York Ophthalmology, PC
Manhasset, New York, United States
Mundorf Eye Center
Charlotte, North Carolina, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
The Cataract & Glaucoma Center
El Paso, Texas, United States
Countries
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Other Identifiers
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ACU-RED-204
Identifier Type: -
Identifier Source: org_study_id
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