Clinical trial NCT01057147: Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Subjects With Dry Eye - Effects on Central Cornea
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Keratoconjunctivitis Sicca
Dry Eye
Lead sponsor: Kubota Vision Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2010-01-27
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Central corneal clearing as measured by fluorescein staining
timeFrame: 12 weeks
Secondary outcomes:
measure: Ocular staining
timeFrame: 12 weeks
measure: Dry eye symptoms
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mesa
country: United States
facility: East Valley Ophthalmology
state: Arizona
city: Phoenix
country: United States
facility: Arizona Center for Clinical Trials, LLC
state: Arizona
city: Phoenix
country: United States
facility: Cornea Consultants of Arizona
state: Arizona
city: Los Angeles
country: United States
facility: Macy Eye Center
state: California
city: Littleton
country: United States
facility: Corneal Consultants of Colorado
state: Colorado
city: Parker
country: United States
facility: Specialty Eye Care
state: Colorado
city: Boca Raton
country: United States
facility: Cohen Laser and Vision Center
state: Florida
city: Boynton Beach
country: United States
facility: Florida Eye Microsurgical Institute, Inc.
state: Florida
city: Miami
country: United States
facility: Med Eye Associates
state: Florida
city: Louisville
country: United States
facility: George R. John, MD
state: Kentucky
city: Lewiston
country: United States
facility: Central Maine Eye Care
state: Maine
city: Andover
country: United States
facility: Ora, Inc.
state: Massachusetts
city: St. Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Las Vegas
country: United States
facility: Nevada Eye Care Professionals
state: Nevada
city: Las Vegas
country: United States
facility: Avista Eye Center
state: Nevada
city: Manhasset
country: United States
facility: New York Ophthalmology, PC
state: New York
city: Charlotte
country: United States
facility: Mundorf Eye Center
state: North Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: El Paso
country: United States
facility: The Cataract & Glaucoma Center
state: Texas
Study officials:
affiliation: Kubota Vision Inc.
name: Ryo Kubota, MD, PhD
role: STUDY_DIRECTOR
References: