Clinical Trial: Safety and Efficacy Study of Bimatoprost in Japanese Patients With Eyelash Hypotrichosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter, Double-masked, Randomized, Parallel-group Study Assessing the Safety and Efficacy of Once-Daily Application of Bimatoprost Solution 0.03% Compared to Vehicle in Increasing Overall Eyela
Brief Summary: This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes.
Detailed Summary:
Sponsor: Allergan
Current Primary Outcome: Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA) [ Time Frame: Baseline, Month 4 ]
Original Primary Outcome: Change from Baseline in Overall Eyelash Prominence [ Time Frame: Baseline, Month 4 ]
Current Secondary Outcome:
- Change From Baseline in Eyelash Length as Measured by 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 Eyelash Thickness as Measured by DIA [ Time Frame: Baseline, Month 4 ]Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).
- Change From Baseline in Eyelash Darkness as Measured by DIA [ Time Frame: Baseline, Month 4 ]Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness 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).
Original Secondary Outcome:
- Change from Baseline in Eyelash Length [ Time Frame: Baseline, Month 4 ]
- Change from Baseline in Eyelash Fullness [ Time Frame: Baseline, Month 4 ]
- Change from Baseline in Eyelash Darkness [ Time Frame: Baseline, Month 4 ]
Information By: Allergan
Dates:
Date Received: July 8, 2011
Date Started: July 2011
Date Completion:
Last Updated: May 21, 2013
Last Verified: May 2013