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NCT01057147 Clinical Trial

Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Subjects With Dry Eye - Effects on Central Cornea

Dry Eye Clinical Trial

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 in Clearing of Fluorescein Staining of the Central Cornea in Subjects With Keratoconjunctivitis Sicca (Dry Eye)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01057147
Other study ID # ACU-RED-204
Secondary ID
Status Completed
Phase Phase 2
First received January 25, 2010
Last updated January 9, 2012
Start date February 2010
Est. completion date February 2011

Study information
Verified date January 2012
Source Acucela Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of 2% rebamipide compared to placebo in clearing of fluorescein staining of the central cornea in subjects with dry eye disease.

Recruitment information / eligibility
Status Completed
Enrollment 116
Est. completion date February 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 years and older

- Diagnosis of dry eye as defined by the protocol

- Central corneal staining

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 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.

Locations
Country Name City State
United States Ora, Inc. Andover Massachusetts
United States Cohen Laser and Vision Center Boca Raton Florida
United States Florida Eye Microsurgical Institute, Inc. Boynton Beach Florida
United States Mundorf Eye Center Charlotte North Carolina
United States The Cataract & Glaucoma Center El Paso Texas
United States Avista Eye Center Las Vegas Nevada
United States Nevada Eye Care Professionals Las Vegas Nevada
United States Central Maine Eye Care Lewiston Maine
United States Corneal Consultants of Colorado Littleton Colorado
United States Macy Eye Center Los Angeles California
United States George R. John, MD Louisville Kentucky
United States New York Ophthalmology, PC Manhasset New York
United States East Valley Ophthalmology Mesa Arizona
United States Med Eye Associates Miami Florida
United States Specialty Eye Care Parker Colorado
United States Arizona Center for Clinical Trials, LLC Phoenix Arizona
United States Cornea Consultants of Arizona Phoenix Arizona
United States Black Hills Regional Eye Institute Rapid City South Dakota
United States Ophthalmology Associates St. Louis Missouri

Sponsors (2)
Lead Sponsor Collaborator
Acucela Inc. Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Central corneal clearing as measured by fluorescein staining 12 weeks No
Secondary Ocular staining 12 weeks No
Secondary Dry eye symptoms 12 weeks No
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