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

This study is currently recruiting participants.
Verified April 2013 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01633788
First received: July 2, 2012
Last updated: April 17, 2013
Last verified: April 2013
History of Changes
  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: 346
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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
  Contacts and Locations
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:
More information  This link exits the ClinicalTrials.gov site

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 17, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013