A Study of AGN-195263 for the Treatment of Meibomian Gland Dysfunction
1 other identifier
interventional
232
1 country
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2012
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2012
CompletedFirst Posted
Study publicly available on registry
July 4, 2012
CompletedStudy Start
First participant enrolled
August 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2015
CompletedResults Posted
Study results publicly available
September 8, 2017
CompletedSeptember 8, 2017
August 1, 2017
2.5 years
July 2, 2012
August 10, 2017
August 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Meibum Quality Responders in the Study Eye
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).
Month 6
Secondary Outcomes (2)
Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye
Month 6
Percentage of Complete Overall Ocular Discomfort Responders
Month 6
Study Arms (4)
AGN-195263 0.1%
EXPERIMENTAL1 drop of AGN-195263 0.1% instilled in each eye twice daily.
AGN-195263 0.03%
EXPERIMENTAL1 drop of AGN-195263 0.03% instilled in each eye twice daily.
AGN-195263 0.01%
EXPERIMENTAL1 drop of AGN-195263 0.01% instilled in each eye twice daily.
AGN-195263 Vehicle
PLACEBO COMPARATOR1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
Interventions
1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
Eligibility Criteria
You may qualify if:
- Meibomian gland dysfunction in both eyes
- Best-corrected visual acuity of 20/40 or better in each eye
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (33)
Cornea Consultants of Arizona
Phoenix, Arizona, 85032, United States
University of Arkansas for Medical
Little Rock, Arkansas, 72205, United States
Sall Research Medical Center
Artesia, California, 90701, United States
Orange County Ophthalmology Medical Group, Inc.
Garden Grove, California, 92843, United States
Lugene Eye Institute
Glendale, California, 91205, United States
Lakeside Vision Center
Irvine, California, 92604, United States
Scripps Clinic
La Jolla, California, 92037, United States
North Valley Eye Medical Group, Inc.
Mission Hills, California, 91345, United States
Eye Research Foundation
Newport Beach, California, 92663, United States
North Bay Eye Associates, Inc.
Petaluma, California, 94954, United States
Centennial Eye Associates
Centennial, Colorado, 80112, United States
Colorado Eye Associates, PC
Colorado Springs, Colorado, 80907, United States
Danbury Eye Physicians & Surgeons, PC
Danbury, Connecticut, 06810, United States
The Eye Associates of Manatee, LLP
Bradenton, Florida, 34209, United States
Wohl Eye Center
Bloomingdale, Illinois, 60108, United States
John-Kenyon American Eye Institute
New Albany, Indiana, 47150, United States
Durrie Vision
Overland Park, Kansas, 66061, United States
Taustine Eye Center
Louisville, Kentucky, 40217, United States
Lifelong Vision Foundation
Chesterfield, Missouri, 63017, United States
Tauber Eye Center
Kansas City, Missouri, 64111, United States
Ophthalmology Associates
St Louis, Missouri, 63131, United States
Comprehensive Eye Care, Ltd.
Washington, Missouri, 63090, United States
Northern New Jersey Eye Institute, PA
South Orange, New Jersey, 07079, United States
Rochester Ophthalmological Group, PC
Rochester, New York, 14618, United States
Ophthalmic Consultants Long Island
Rockville Centre, New York, 11570, United States
South Shore Eye Care, LLP
Wantagh, New York, 11793, United States
Cornerstone Eye Care
High Point, North Carolina, 27262, United States
Drs. Fine, Hoffman, and Packer, LLC
Eugene, Oregon, 97401, United States
Vision Center of Texas, PA
Cedar Park, Texas, 78613, United States
University of Houston, College of Optometry
Houston, Texas, 77204, United States
Focus Clinical Research
Salt Lake City, Utah, 84107, United States
Stacy Smith, MD, PC
Salt Lake City, Utah, 84117, United States
Virginia Eye Consultants
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ronald Bradford
- Organization
- Allergan plc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2012
First Posted
July 4, 2012
Study Start
August 22, 2012
Primary Completion
February 5, 2015
Study Completion
February 5, 2015
Last Updated
September 8, 2017
Results First Posted
September 8, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share