Clinical trial NCT01633788: A Study of AGN-195263 for the Treatment of Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meibomian Gland Dysfunction
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-07-04
Enrollment: 232
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of AGN-195263 compared to vehicle in patients with meibomian gland dysfunction (MGD) in the eyelids.


Eligibility criteria: Inclusion Criteria:

* Meibomian gland dysfunction in both eyes
* Best-corrected visual acuity of 20/40 or better in each eye

Exclusion Criteria:

* Known or suspected prostate cancer
* History of breast cancer
* Using LATISSE® or any other eye lash growth-stimulating product at least 30 days prior to the screening visit, or anticipated use during the study
* Contact lens wear in either eye during any portion of the study
* Unable to instill eye drops correctly
* History of corneal refractive surgery in either eye within 1 year

Primary outcomes:
measure: Percentage of Meibum Quality Responders in the Study Eye
timeFrame: Month 6
Secondary outcomes:
measure: Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye
timeFrame: Month 6
measure: Percentage of Complete Overall Ocular Discomfort Responders
timeFrame: Month 6
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cornea Consultants of Arizona
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical
state: Arkansas
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Garden Grove
country: United States
facility: Orange County Ophthalmology Medical Group, Inc.
state: California
city: Glendale
country: United States
facility: Lugene Eye Institute
state: California
city: Irvine
country: United States
facility: Lakeside Vision Center
state: California
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group, Inc.
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates, Inc.
state: California
city: Centennial
country: United States
facility: Centennial Eye Associates
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Eye Associates, PC
state: Colorado
city: Danbury
country: United States
facility: Danbury Eye Physicians & Surgeons, PC
state: Connecticut
city: Bradenton
country: United States
facility: The Eye Associates of Manatee, LLP
state: Florida
city: Bloomingdale
country: United States
facility: Wohl Eye Center
state: Illinois
city: New Albany
country: United States
facility: John-Kenyon American Eye Institute
state: Indiana
city: Overland Park
country: United States
facility: Durrie Vision
state: Kansas
city: Louisville
country: United States
facility: Taustine Eye Center
state: Kentucky
city: Chesterfield
country: United States
facility: Lifelong Vision Foundation
state: Missouri
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care, Ltd.
state: Missouri
city: South Orange
country: United States
facility: Northern New Jersey Eye Institute, PA
state: New Jersey
city: Rochester
country: United States
facility: Rochester Ophthalmological Group, PC
state: New York
city: Rockville Centre
country: United States
facility: Ophthalmic Consultants Long Island
state: New York
city: Wantagh
country: United States
facility: South Shore Eye Care, LLP
state: New York
city: High Point
country: United States
facility: Cornerstone Eye Care
state: North Carolina
city: Eugene
country: United States
facility: Drs. Fine, Hoffman, and Packer, LLC
state: Oregon
city: Cedar Park
country: United States
facility: Vision Center of Texas, PA
state: Texas
city: Houston
country: United States
facility: University of Houston, College of Optometry
state: Texas
city: Salt Lake City
country: United States
facility: Focus Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Stacy Smith, MD, PC
state: Utah
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: