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
• 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

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

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