Clinical Trial: Bimatoprost in the Treatment of Eyelash Hypotrichosis

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

Official Title:

Brief Summary: This study will evaluate the safety and efficacy of bimatoprost solution formulation A compared with bimatoprost solution 0.03% (LATISSE®) and vehicle in the treatment of eyelash hypotrichosis (inadequate eyelashes).

Detailed Summary:
Sponsor: Allergan

Current Primary Outcome: Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA) [ Time Frame: Baseline, Month 4 ]

The investigator evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.


Original Primary Outcome: Investigator's Assessment of Overall Eyelash Prominence as Measured by the 4-point Global Eyelash Assessment (GEA) Scale [ Time Frame: Month 4 ]

Current Secondary Outcome:

  • Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA) [ Time Frame: Baseline, Month 4 ]
    Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement)
  • Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA [ Time Frame: Baseline Month 4 ]
    Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was measured in millimeters squared (mm^2). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated fuller eyelashes (improvement).
  • Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA [ Time Frame: Baseline, Month 4 ]
    Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).
  • Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9) [ Time Frame: Month 4 ]
    Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: "Overall, how satisfied are you with your eyelashes?" using a 5-point scale: 1= very unsatisfied (worst), 2= unsatisfied, 3= neutral, 4= satisfied or 5= very satisfied (best). The percentage of participants who rated their satisfaction as satisfied or very satisfied at Month 4 is reported.


Original Secondary Outcome:

  • Upper Eyelash Length as Measured Using Digital Image Analysis (DIA) [ Time Frame: Month 4 ]
  • Upper Eyelash Thickness/Fullness as Measured Using DIA [ Time Frame: Month 4 ]
  • Upper Eyelash Intensity (Darkness) as Measured Using DIA [ Time Frame: Month 4 ]
  • Patient's Assessment of Overall Eyelash Satisfaction as Measured by the 9-item Eyelash Satisfaction Questionnaire [ Time Frame: Month 4 ]


Information By: Allergan

Dates:
Date Received: October 1, 2012
Date Started: November 2012
Date Completion:
Last Updated: January 27, 2015
Last Verified: January 2015