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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01633788
First Posted: July 4, 2012
Last Update Posted: September 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  Purpose
This study will evaluate the safety and efficacy of AGN-195263 compared to vehicle in patients with meibomian gland dysfunction (MGD) in the eyelids.

Condition Intervention Phase
Meibomian Gland Dysfunction Drug: AGN-195263 0.1% Drug: AGN-195263 0.03% Drug: AGN-195263 0.01% Drug: AGN-195263 Vehicle Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Meibum Quality Responders in the Study Eye [ Time Frame: 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:
  • Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 232
Actual Study Start Date: August 22, 2012
Study Completion Date: February 5, 2015
Primary Completion Date: February 5, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633788


  Show 33 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01633788     History of Changes
Other Study ID Numbers: 195263-006
First Submitted: July 2, 2012
First Posted: July 4, 2012
Results First Submitted: August 10, 2017
Results First Posted: September 8, 2017
Last Update Posted: September 8, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No