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

Condition(s) targeted: Keratoconjunctivitis Sicca; Dry Eye

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

Phase: Phase 2

Status: Recruiting

Sponsored by: Acucela Inc.

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

Overall contact:
Nancy Boman, MD, PhD, Phone: 425.527.3268, Email: nboman@acucela.com

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.

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, Control: Placebo Control, 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

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

Nancy Boman, MD, PhD, Phone: 425.527.3268, Email: nboman@acucela.com

Cornea Consultants of Arizona, Phoenix, Arizona 85032, United States; Recruiting
Jung T Dao, MD, Principal Investigator

Macy Eye Center, Los Angeles, California 90048, United States; Recruiting
Jonathon Macy, M.D., Principal Investigator

Med Eye Associates, Miami, Florida 33143, United States; Recruiting
Zachary Segal, MD, Principal Investigator

Ora, Inc., Andover, Massachusetts 01810, United States; Recruiting
Gail Torkildsen, MD, Principal Investigator

Avista Eye Center, Las Vegas, Nevada 89131, United States; Recruiting
Tapan R Shah, MD, Principal Investigator

Black Hills Regional Eye Institute, Rapid City, South Dakota 57701, United States; Recruiting
Stephen S Khachikian, MD, Principal Investigator

The Cataract & Glaucoma Center, El Paso, Texas 79902, United States; Recruiting
Louis M Alpern, MD, Principal Investigator

Starting date: February 2010
Last updated: July 26, 2010