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

Primary Purpose

Meibomian Gland Dysfunction

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AGN-195263 0.1%
AGN-195263 0.03%
AGN-195263 0.01%
AGN-195263 Vehicle
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cornea Consultants of Arizona
  • University of Arkansas for Medical
  • Sall Research Medical Center
  • Orange County Ophthalmology Medical Group, Inc.
  • Lugene Eye Institute
  • Lakeside Vision Center
  • Scripps Clinic
  • North Valley Eye Medical Group, Inc.
  • Eye Research Foundation
  • North Bay Eye Associates, Inc.
  • Centennial Eye Associates
  • Colorado Eye Associates, PC
  • Danbury Eye Physicians & Surgeons, PC
  • The Eye Associates of Manatee, LLP
  • Wohl Eye Center
  • John-Kenyon American Eye Institute
  • Durrie Vision
  • Taustine Eye Center
  • Lifelong Vision Foundation
  • Tauber Eye Center
  • Ophthalmology Associates
  • Comprehensive Eye Care, Ltd.
  • Northern New Jersey Eye Institute, PA
  • Rochester Ophthalmological Group, PC
  • Ophthalmic Consultants Long Island
  • South Shore Eye Care, LLP
  • Cornerstone Eye Care
  • Drs. Fine, Hoffman, and Packer, LLC
  • Vision Center of Texas, PA
  • University of Houston, College of Optometry
  • Focus Clinical Research
  • Stacy Smith, MD, PC
  • Virginia Eye Consultants

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

AGN-195263 0.1%

AGN-195263 0.03%

AGN-195263 0.01%

AGN-195263 Vehicle

Arm Description

1 drop of AGN-195263 0.1% instilled in each eye twice daily.

1 drop of AGN-195263 0.03% instilled in each eye twice daily.

1 drop of AGN-195263 0.01% instilled in each eye twice daily.

1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 2, 2012
Last Updated
August 10, 2017
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01633788
Brief Title
A Study of AGN-195263 for the Treatment of Meibomian Gland Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 22, 2012 (Actual)
Primary Completion Date
February 5, 2015 (Actual)
Study Completion Date
February 5, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AGN-195263 0.1%
Arm Type
Experimental
Arm Description
1 drop of AGN-195263 0.1% instilled in each eye twice daily.
Arm Title
AGN-195263 0.03%
Arm Type
Experimental
Arm Description
1 drop of AGN-195263 0.03% instilled in each eye twice daily.
Arm Title
AGN-195263 0.01%
Arm Type
Experimental
Arm Description
1 drop of AGN-195263 0.01% instilled in each eye twice daily.
Arm Title
AGN-195263 Vehicle
Arm Type
Placebo Comparator
Arm Description
1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
Intervention Type
Drug
Intervention Name(s)
AGN-195263 0.1%
Intervention Description
1 drop of AGN-195263 0.1% instilled in each eye twice daily.
Intervention Type
Drug
Intervention Name(s)
AGN-195263 0.03%
Intervention Description
1 drop of AGN-195263 0.03% instilled in each eye twice daily.
Intervention Type
Drug
Intervention Name(s)
AGN-195263 0.01%
Intervention Description
1 drop of AGN-195263 0.01% instilled in each eye twice daily.
Intervention Type
Drug
Intervention Name(s)
AGN-195263 Vehicle
Intervention Description
1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
Primary Outcome Measure Information:
Title
Percentage of Meibum Quality Responders in the Study Eye
Description
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).
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye
Description
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.
Time Frame
Month 6
Title
Percentage of Complete Overall Ocular Discomfort Responders
Description
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.
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Cornea Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
University of Arkansas for Medical
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Sall Research Medical Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Orange County Ophthalmology Medical Group, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Lugene Eye Institute
City
Glendale
State/Province
California
ZIP/Postal Code
91205
Country
United States
Facility Name
Lakeside Vision Center
City
Irvine
State/Province
California
ZIP/Postal Code
92604
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
North Valley Eye Medical Group, Inc.
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
North Bay Eye Associates, Inc.
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Centennial Eye Associates
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Colorado Eye Associates, PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Danbury Eye Physicians & Surgeons, PC
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
The Eye Associates of Manatee, LLP
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Wohl Eye Center
City
Bloomingdale
State/Province
Illinois
ZIP/Postal Code
60108
Country
United States
Facility Name
John-Kenyon American Eye Institute
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Durrie Vision
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Facility Name
Taustine Eye Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Lifelong Vision Foundation
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Tauber Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Comprehensive Eye Care, Ltd.
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Northern New Jersey Eye Institute, PA
City
South Orange
State/Province
New Jersey
ZIP/Postal Code
07079
Country
United States
Facility Name
Rochester Ophthalmological Group, PC
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Ophthalmic Consultants Long Island
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
South Shore Eye Care, LLP
City
Wantagh
State/Province
New York
ZIP/Postal Code
11793
Country
United States
Facility Name
Cornerstone Eye Care
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Drs. Fine, Hoffman, and Packer, LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Vision Center of Texas, PA
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
University of Houston, College of Optometry
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
Facility Name
Focus Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Stacy Smith, MD, PC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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