A Study of AGN-195263 for the Treatment of Meibomian Gland Dysfunction
- Conditions
- Meibomian Gland Dysfunction
- Interventions
- Drug: AGN-195263 0.1%Drug: AGN-195263 0.03%Drug: AGN-195263 0.01%Drug: AGN-195263 Vehicle
- Registration Number
- NCT01633788
- Lead Sponsor
- Allergan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 232
- Meibomian gland dysfunction in both eyes
- Best-corrected visual acuity of 20/40 or better in each eye
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AGN-195263 0.1% AGN-195263 0.1% 1 drop of AGN-195263 0.1% instilled in each eye twice daily. AGN-195263 0.03% AGN-195263 0.03% 1 drop of AGN-195263 0.03% instilled in each eye twice daily. AGN-195263 0.01% AGN-195263 0.01% 1 drop of AGN-195263 0.01% instilled in each eye twice daily. AGN-195263 Vehicle AGN-195263 Vehicle 1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
- Primary Outcome Measures
Name Time Method Percentage of Meibum Quality Responders in the Study Eye Month 6 Meibum quality response is defined as a patient who experiences a reduction ≥ 50% in the number of meibomian glands with a Meibum Quality Score (MQS) of 2 or 3 in the study eye. The MQS is based on Mathers' meibum quality secretion grading 4-point scale where: 0 = Clear excreta or clear with small particles (normal viscosity), 1 = Opaque excreta with normal viscosity, 2 = Opaque excreta with increased viscosity (gel-like), and 3 = Secretions retain shape (or secretions do not express but a toothpaste-like substance can be seen at the opening of the orifice).
- Secondary Outcome Measures
Name Time Method Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye Month 6 The MQS is assessed based on Mathers' meibum quality secretion grading 4-point scale where: 0 = Clear excreta or clear with small particles (normal viscosity), 1 = Opaque excreta with normal viscosity, 2 = Opaque excreta with increased viscosity (gel-like), and 3 = Secretions retain shape (or secretions do not express but a toothpaste-like substance can be seen at the opening of the orifice). MMQS is calculated for each eye as the maximum of the meibum quality scores of the expressible glands within the 6 central glands of the lower eyelids. A patient is considered to be an MMQS responder at a postrandomization visit if the MMQS in the study eye is 0 or 1 (indicating normal viscosity) at that visit.
Percentage of Complete Overall Ocular Discomfort Responders Month 6 Ocular symptoms of blurred vision, burning, dryness, eye pain, light sensitivity, itching, and foreign body sensation are assessed by the patient on a 5-point scale ranging from 0 = none to 4 = very severe. A patient is considered a complete overall ocular discomfort responder if the overall ocular discomfort score is 0 (indicating no overall ocular discomfort) at that visit.
Trial Locations
- Locations (33)
Virginia Eye Consultants
🇺🇸Norfolk, Virginia, United States
Ophthalmic Consultants Long Island
🇺🇸Rockville Centre, New York, United States
Wohl Eye Center
🇺🇸Bloomingdale, Illinois, United States
John-Kenyon American Eye Institute
🇺🇸New Albany, Indiana, United States
Cornerstone Eye Care
🇺🇸High Point, North Carolina, United States
North Valley Eye Medical Group, Inc.
🇺🇸Mission Hills, California, United States
Drs. Fine, Hoffman, and Packer, LLC
🇺🇸Eugene, Oregon, United States
Eye Research Foundation
🇺🇸Newport Beach, California, United States
North Bay Eye Associates, Inc.
🇺🇸Petaluma, California, United States
Colorado Eye Associates, PC
🇺🇸Colorado Springs, Colorado, United States
Durrie Vision
🇺🇸Overland Park, Kansas, United States
Lakeside Vision Center
🇺🇸Irvine, California, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
University of Arkansas for Medical
🇺🇸Little Rock, Arkansas, United States
Orange County Ophthalmology Medical Group, Inc.
🇺🇸Garden Grove, California, United States
Lugene Eye Institute
🇺🇸Glendale, California, United States
Sall Research Medical Center
🇺🇸Artesia, California, United States
Centennial Eye Associates
🇺🇸Centennial, Colorado, United States
Danbury Eye Physicians & Surgeons, PC
🇺🇸Danbury, Connecticut, United States
The Eye Associates of Manatee, LLP
🇺🇸Bradenton, Florida, United States
Lifelong Vision Foundation
🇺🇸Chesterfield, Missouri, United States
Ophthalmology Associates
🇺🇸Saint Louis, Missouri, United States
Comprehensive Eye Care, Ltd.
🇺🇸Washington, Missouri, United States
Rochester Ophthalmological Group, PC
🇺🇸Rochester, New York, United States
South Shore Eye Care, LLP
🇺🇸Wantagh, New York, United States
Vision Center of Texas, PA
🇺🇸Cedar Park, Texas, United States
Cornea Consultants of Arizona
🇺🇸Phoenix, Arizona, United States
Taustine Eye Center
🇺🇸Louisville, Kentucky, United States
Tauber Eye Center
🇺🇸Kansas City, Missouri, United States
Stacy Smith, MD, PC
🇺🇸Salt Lake City, Utah, United States
University of Houston, College of Optometry
🇺🇸Houston, Texas, United States
Focus Clinical Research
🇺🇸Salt Lake City, Utah, United States
Northern New Jersey Eye Institute, PA
🇺🇸South Orange, New Jersey, United States