A Study of AGN-195263 for the Treatment of Meibomian Gland Dysfunction

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

Study Overview

• Status: Completed
• Conditions: Meibomian Gland Dysfunction
• Intervention / Treatment: Drug: AGN-195263 0.1%; Drug: AGN-195263 0.03%; Drug: AGN-195263 0.01%; Drug: AGN-195263 Vehicle

• Study Type: Interventional
• Enrollment (Actual): 232
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Cornea Consultants of Arizona
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical
  • California
    • Artesia, California, United States, 90701
      • Sall Research Medical Center
    • Garden Grove, California, United States, 92843
      • Orange County Ophthalmology Medical Group, Inc.
    • Glendale, California, United States, 91205
      • Lugene Eye Institute
    • Irvine, California, United States, 92604
      • Lakeside Vision Center
    • La Jolla, California, United States, 92037
      • Scripps Clinic
    • Mission Hills, California, United States, 91345
      • North Valley Eye Medical Group, Inc.
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates, Inc.
  • Colorado
    • Centennial, Colorado, United States, 80112
      • Centennial Eye Associates
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Eye Associates, PC
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Danbury Eye Physicians & Surgeons, PC
  • Florida
    • Bradenton, Florida, United States, 34209
      • The Eye Associates of Manatee, LLP
  • Illinois
    • Bloomingdale, Illinois, United States, 60108
      • Wohl Eye Center
  • Indiana
    • New Albany, Indiana, United States, 47150
      • John-Kenyon American Eye Institute
  • Kansas
    • Overland Park, Kansas, United States, 66061
      • Durrie Vision
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Taustine Eye Center
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Lifelong Vision Foundation
    • Kansas City, Missouri, United States, 64111
      • Tauber Eye Center
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Associates
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care, Ltd.
  • New Jersey
    • South Orange, New Jersey, United States, 07079
      • Northern New Jersey Eye Institute, PA
  • New York
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmological Group, PC
    • Rockville Centre, New York, United States, 11570
      • Ophthalmic Consultants Long Island
    • Wantagh, New York, United States, 11793
      • South Shore Eye Care, LLP
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Cornerstone Eye Care
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Drs. Fine, Hoffman, and Packer, LLC
  • Texas
    • Cedar Park, Texas, United States, 78613
      • Vision Center of Texas, PA
    • Houston, Texas, United States, 77204
      • University of Houston, College of Optometry
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Focus Clinical Research
    • Salt Lake City, Utah, United States, 84117
      • Stacy Smith, MD, PC
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Eye Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AGN-195263 0.1%; 1 drop of AGN-195263 0.1% instilled in each eye twice daily.	Drug: AGN-195263 0.1%; 1 drop of AGN-195263 0.1% instilled in each eye twice daily.
EXPERIMENTAL: AGN-195263 0.03%; 1 drop of AGN-195263 0.03% instilled in each eye twice daily.	Drug: AGN-195263 0.03%; 1 drop of AGN-195263 0.03% instilled in each eye twice daily.
EXPERIMENTAL: AGN-195263 0.01%; 1 drop of AGN-195263 0.01% instilled in each eye twice daily.	Drug: AGN-195263 0.01%; 1 drop of AGN-195263 0.01% instilled in each eye twice daily.
PLACEBO_COMPARATOR: AGN-195263 Vehicle; 1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.	Drug: AGN-195263 Vehicle; 1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye	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.	Month 6
Percentage of Complete Overall Ocular Discomfort Responders	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.	Month 6

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 22, 2012
• Primary Completion (ACTUAL): February 5, 2015
• Study Completion (ACTUAL): February 5, 2015

Study Registration Dates

• First Submitted: July 2, 2012
• First Submitted That Met QC Criteria: July 2, 2012
• First Posted (ESTIMATE): July 4, 2012

Study Record Updates

• Last Update Posted (ACTUAL): September 8, 2017
• Last Update Submitted That Met QC Criteria: August 10, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction
• Other Study ID Numbers: 195263-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No