Clinical Trial: Safety and Efficacy Study of Bimatoprost to Treat Hypotrichosis of the Eyelashes After Application to the Eyelid Margin

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary: This one-year study evaluates the long-term safety and effectiveness of bimatoprost solution application to the eyelid margin (where the eyelashes meet the skin) to treat hypotrichosis of the eyelashes (inadequate or not enough eyelashes). There will be two different types of subjects participating in the study 1)those with inadequate eyelashes due to natural causes or 2) those with inadequate eyelashes following a complete course of chemotherapy treatment. There will be two treatment periods of six months each. Subjects will receive either the study medication or vehicle in either of the two treatment periods.

Detailed Summary:
Sponsor: Allergan

Current Primary Outcome: Percentage of Treatment Responders at Month 4 [ Time Frame: Month 4 ]

Percentage of Treatment Responders at Month 4 defined by: a) at least a 1-grade improvement from baseline in the Global Eyelash Assessment (GEA) score, AND b) at least a 3-point improvement from baseline in the total score for Domain 2 of the Eyelash Symptom Questionnaire (ESQ). The GEA 4-point scale assessed eyelash prominence from 1 (minimal) to 4 (very marked). Domain 2 of the ESQ assessed subjective attributes of confidence, attractiveness, and professionalism rated on a 5-point scale from 1 (very much disagree) to 5 (very much agree) for a total score between 3 and 15.


Original Primary Outcome: Proportion of subjects with an increase in eyelash prominence as well as an increase in subjective feelings about their eyelash appearance [ Time Frame: Change from baseline at month 4 ]

Current Secondary Outcome:

  • Change From Baseline in Upper Eyelash Length at Month 4 [ Time Frame: Baseline, Month 4 ]
    Change from Baseline to in upper eyelash length at Month 4, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length.
  • Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4 [ Time Frame: Baseline, Month 4 ]
    Change from baseline in average progressive upper eyelash thickness at Month 4 was measured within 3 preset areas. Eyelash thickness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2). Changes from baseline at Month 4 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness.
  • Change From Baseline in Upper Eyelash Darkness at Month 4 [ Time Frame: Baseline, Month 4 ]
    Change from baseline in upper eyelash darkness at Month 4 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. A negative number value change from baseline indicated increased eyelash darkening.


Original Secondary Outcome:

  • Change from baseline in upper eyelash length [ Time Frame: Baseline, Month 4, 6, 10, 12 ]
  • Change in eyelash thickness [ Time Frame: Baseline, Month 4, 6, 10, 12 ]
  • Change in eyelash darkness [ Time Frame: Baseline, Month 4, 6, 10, 12 ]


Information By: Allergan

Dates:
Date Received: May 20, 2009
Date Started: August 2009
Date Completion:
Last Updated: August 21, 2012
Last Verified: August 2012