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

Information source: Acucela Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Keratoconjunctivitis Sicca; Dry Eye

Intervention: rebamipide 2% ophthalmic suspension (Drug); placebo eye drops (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Acucela Inc.

Official(s) and/or principal investigator(s):
Ryo Kubota, MD, PhD, Study Director, Affiliation: Acucela Inc.

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.

Clinical Details

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)

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

Primary outcome: Central corneal clearing as measured by fluorescein staining

Secondary outcome:

Ocular staining

Dry eye symptoms

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

East Valley Ophthalmology, Mesa, Arizona 85206, United States

Arizona Center for Clinical Trials, LLC, Phoenix, Arizona 85003, United States

Cornea Consultants of Arizona, Phoenix, Arizona 85032, United States

Macy Eye Center, Los Angeles, California 90048, United States

Corneal Consultants of Colorado, Littleton, Colorado 80120, United States

Specialty Eye Care, Parker, Colorado 80134, United States

Cohen Laser and Vision Center, Boca Raton, Florida 33431, United States

Florida Eye Microsurgical Institute, Inc., Boynton Beach, Florida 33426, United States

Med Eye Associates, Miami, Florida 33143, United States

George R. John, MD, Louisville, Kentucky 40205, United States

Central Maine Eye Care, Lewiston, Maine 04240, United States

Ora, Inc., Andover, Massachusetts 01810, United States

Ophthalmology Associates, St. Louis, Missouri 63131, United States

Avista Eye Center, Las Vegas, Nevada 89131, United States

Nevada Eye Care Professionals, Las Vegas, Nevada 89119, United States

New York Ophthalmology, PC, Manhasset, New York 11030, United States

Mundorf Eye Center, Charlotte, North Carolina 28204, United States

Black Hills Regional Eye Institute, Rapid City, South Dakota 57701, United States

The Cataract & Glaucoma Center, El Paso, Texas 79902, United States

Additional Information

Starting date: February 2010
Last updated: January 9, 2012

Page last updated: August 20, 2015

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