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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01633788
First received: July 2, 2012
Last updated: April 22, 2014
Last verified: April 2014

July 2, 2012
April 22, 2014
July 2012
September 2015   (final data collection date for primary outcome measure)
Meibum Quality Score Assessed by the Investigator on a 4-Point Scale [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Meibum Quality Score Assessed by the Investigator [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01633788 on ClinicalTrials.gov Archive Site
Patient Overall Ocular Discomfort on a 5-Point Scale [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Patient Overall Ocular Discomfort [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Meibomian Gland Dysfunction
  • Drug: AGN-195263 Formulation A
    1 drop of AGN-195263 Formulation A will be instilled in each eye twice daily.
  • Drug: AGN-195263 Formulation B
    1 drop of AGN-195263 Formulation B will be instilled in each eye twice daily.
  • Drug: AGN-195263 Formulation C
    1 drop of AGN-195263 Formulation C will be instilled in each eye twice daily.
  • Drug: AGN-195263 Vehicle
    1 drop of AGN-195263 vehicle (placebo) will be instilled in each eye twice daily.
  • Experimental: AGN-195263 Formulation A
    1 drop of AGN-195263 Formulation A will be instilled in each eye twice daily.
    Intervention: Drug: AGN-195263 Formulation A
  • Experimental: AGN-195263 Formulation B
    1 drop of AGN-195263 Formulation B will be instilled in each eye twice daily.
    Intervention: Drug: AGN-195263 Formulation B
  • Experimental: AGN-195263 Formulation C
    1 drop of AGN-195263 Formulation C will be instilled in each eye twice daily.
    Intervention: Drug: AGN-195263 Formulation C
  • Placebo Comparator: AGN-195263 Vehicle
    1 drop of AGN-195263 vehicle (placebo) will be 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.
 
Recruiting
300
September 2015
September 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
Both
40 Years and older
No
Contact: Allergan Inc. clinicaltrials@allergan.com
United States
 
NCT01633788
195263-006
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
April 2014

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