Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye
NCT ID: NCT01027013
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
220 participants
INTERVENTIONAL
2009-12-31
2010-11-30
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
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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Nancy Boman, MD, PhD
Role: STUDY_DIRECTOR
Kubota Vision Inc.
Locations
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The Eye Care Group, P.C.
Waterbury, Connecticut, United States
Richard Eiferman, MD
Louisville, Kentucky, United States
Central Maine Eye Care
Lewiston, Maine, United States
Ora, Inc
Andover, Massachusetts, United States
Total Eye Care, P.A.
Memphis, Tennessee, United States
Countries
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Other Identifiers
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ACU-RED-203
Identifier Type: -
Identifier Source: org_study_id
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