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
  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 Formulation A
Drug: AGN-195263 Formulation B
Drug: AGN-195263 Formulation C
Drug: AGN-195263 Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Meibum Quality Score Assessed by the Investigator on a 4-Point Scale [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Overall Ocular Discomfort on a 5-Point Scale [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: July 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AGN-195263 Formulation A
1 drop of AGN-195263 Formulation A will be instilled in each eye twice daily.
Drug: AGN-195263 Formulation A
1 drop of AGN-195263 Formulation A will be instilled in each eye twice daily.
Experimental: AGN-195263 Formulation B
1 drop of AGN-195263 Formulation B 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.
Experimental: AGN-195263 Formulation C
1 drop of AGN-195263 Formulation C 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.
Placebo Comparator: AGN-195263 Vehicle
1 drop of AGN-195263 vehicle (placebo) 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633788

Contacts
Contact: Allergan Inc. clinicaltrials@allergan.com

Locations
United States, California
Recruiting
Glendale, California, United States
Recruiting
Newport Beach, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Additional Information:
No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01633788     History of Changes
Other Study ID Numbers: 195263-006
Study First Received: July 2, 2012
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 22, 2014