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

NCT ID: NCT01633788

Last Updated: 2017-09-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-22

Study Completion Date

2015-02-05

Brief Summary

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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

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Conditions

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Meibomian Gland Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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AGN-195263 0.1%

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

Group Type EXPERIMENTAL

AGN-195263 0.1%

Intervention Type DRUG

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

AGN-195263 0.03%

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

Group Type EXPERIMENTAL

AGN-195263 0.03%

Intervention Type DRUG

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

AGN-195263 0.01%

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

Group Type EXPERIMENTAL

AGN-195263 0.01%

Intervention Type DRUG

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

AGN-195263 Vehicle

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

Group Type PLACEBO_COMPARATOR

AGN-195263 Vehicle

Intervention Type DRUG

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

Interventions

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AGN-195263 0.1%

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

Intervention Type DRUG

AGN-195263 0.03%

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

Intervention Type DRUG

AGN-195263 0.01%

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

Intervention Type DRUG

AGN-195263 Vehicle

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Cornea Consultants of Arizona

Phoenix, Arizona, United States

Site Status

University of Arkansas for Medical

Little Rock, Arkansas, United States

Site Status

Sall Research Medical Center

Artesia, California, United States

Site Status

Orange County Ophthalmology Medical Group, Inc.

Garden Grove, California, United States

Site Status

Lugene Eye Institute

Glendale, California, United States

Site Status

Lakeside Vision Center

Irvine, California, United States

Site Status

Scripps Clinic

La Jolla, California, United States

Site Status

North Valley Eye Medical Group, Inc.

Mission Hills, California, United States

Site Status

Eye Research Foundation

Newport Beach, California, United States

Site Status

North Bay Eye Associates, Inc.

Petaluma, California, United States

Site Status

Centennial Eye Associates

Centennial, Colorado, United States

Site Status

Colorado Eye Associates, PC

Colorado Springs, Colorado, United States

Site Status

Danbury Eye Physicians & Surgeons, PC

Danbury, Connecticut, United States

Site Status

The Eye Associates of Manatee, LLP

Bradenton, Florida, United States

Site Status

Wohl Eye Center

Bloomingdale, Illinois, United States

Site Status

John-Kenyon American Eye Institute

New Albany, Indiana, United States

Site Status

Durrie Vision

Overland Park, Kansas, United States

Site Status

Taustine Eye Center

Louisville, Kentucky, United States

Site Status

Lifelong Vision Foundation

Chesterfield, Missouri, United States

Site Status

Tauber Eye Center

Kansas City, Missouri, United States

Site Status

Ophthalmology Associates

St Louis, Missouri, United States

Site Status

Comprehensive Eye Care, Ltd.

Washington, Missouri, United States

Site Status

Northern New Jersey Eye Institute, PA

South Orange, New Jersey, United States

Site Status

Rochester Ophthalmological Group, PC

Rochester, New York, United States

Site Status

Ophthalmic Consultants Long Island

Rockville Centre, New York, United States

Site Status

South Shore Eye Care, LLP

Wantagh, New York, United States

Site Status

Cornerstone Eye Care

High Point, North Carolina, United States

Site Status

Drs. Fine, Hoffman, and Packer, LLC

Eugene, Oregon, United States

Site Status

Vision Center of Texas, PA

Cedar Park, Texas, United States

Site Status

University of Houston, College of Optometry

Houston, Texas, United States

Site Status

Focus Clinical Research

Salt Lake City, Utah, United States

Site Status

Stacy Smith, MD, PC

Salt Lake City, Utah, United States

Site Status

Virginia Eye Consultants

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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195263-006

Identifier Type: -

Identifier Source: org_study_id

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