Clinical Trial: Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children

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

Official Title:

Brief Summary: This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily application to the upper eyelid margins compared with vehicle in treating eyelash loss or hypotrichosis (inadequate or not enough eyelashes) in children.

Detailed Summary:
Sponsor: Allergan

Current Primary Outcome:

• Percentage of Participants With Adverse Events [ Time Frame: 5 Months ]
  An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
• Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score [ Time Frame: Baseline, Month 4 ]
  The physician 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: Overall Eyelash Prominence [ Time Frame: Month 4 ]

Current Secondary Outcome:

• Change From Baseline Upper 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 Upper 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 Upper Eyelash Darkness as Measured by 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).

Original Secondary Outcome:

• Upper Eyelash Length [ Time Frame: Month 4 ]
• Upper Eyelash Thickness [ Time Frame: Month 4 ]
• Upper Eyelash Darkness [ Time Frame: Month 4 ]

Information By: Allergan

Dates:
Date Received: November 30, 2009
Date Started: June 2010
Date Completion:
Last Updated: July 9, 2013
Last Verified: July 2013