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

Meibomian Gland Dysfunction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01633788
• Other study ID #: 195263-006
• Status: Completed
• Phase: Phase 2
• First received: July 2, 2012
• Last updated: April 15, 2015
• Start date: July 2012
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of AGN-195263 compared to vehicle in patients with meibomian gland dysfunction (MGD) in the eyelids.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Drug:
• AGN-195263 Formulation A
1 drop of AGN-195263 Formulation A will be instilled in each eye twice daily.
• AGN-195263 Formulation B
1 drop of AGN-195263 Formulation B will be instilled in each eye twice daily.
• AGN-195263 Formulation C
1 drop of AGN-195263 Formulation C will be instilled in each eye twice daily.
• AGN-195263 Vehicle
1 drop of AGN-195263 vehicle (placebo) will be instilled in each eye twice daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meibum Quality Score Assessed by the Investigator on a 4-Point Scale		Month 6	No
Secondary	Patient Overall Ocular Discomfort on a 5-Point Scale		Month 6	No