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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
July 2, 2012
July 4, 2012
August 10, 2017
September 8, 2017
September 8, 2017
August 22, 2012
February 5, 2015   (Final data collection date for primary outcome measure)
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).
Meibum Quality Score Assessed by the Investigator [ Time Frame: Month 6 ]
Complete list of historical versions of study NCT01633788 on ClinicalTrials.gov Archive Site
  • 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.
Patient Overall Ocular Discomfort [ Time Frame: Month 6 ]
Not Provided
Not Provided
 
A Study of AGN-195263 for the Treatment of Meibomian Gland Dysfunction
Not Provided
This study will evaluate the safety and efficacy of AGN-195263 compared to vehicle in patients with meibomian gland dysfunction (MGD) in the eyelids.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Meibomian Gland Dysfunction
  • Drug: AGN-195263 0.1%
    1 drop of AGN-195263 0.1% instilled in each eye twice daily.
  • Drug: AGN-195263 0.03%
    1 drop of AGN-195263 0.03% instilled in each eye twice daily.
  • Drug: AGN-195263 0.01%
    1 drop of AGN-195263 0.01% instilled in each eye twice daily.
  • Drug: AGN-195263 Vehicle
    1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
  • Experimental: AGN-195263 0.1%
    1 drop of AGN-195263 0.1% instilled in each eye twice daily.
    Intervention: Drug: AGN-195263 0.1%
  • Experimental: AGN-195263 0.03%
    1 drop of AGN-195263 0.03% instilled in each eye twice daily.
    Intervention: Drug: AGN-195263 0.03%
  • Experimental: AGN-195263 0.01%
    1 drop of AGN-195263 0.01% instilled in each eye twice daily.
    Intervention: Drug: AGN-195263 0.01%
  • Placebo Comparator: AGN-195263 Vehicle
    1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
    Intervention: Drug: AGN-195263 Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
232
February 5, 2015
February 5, 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01633788
195263-006
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP