Clinical Trial: Safety and Efficacy of LATISSE® in the Augmentation of Eyelashes of Korean Subjects

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

Official Title:

Brief Summary: This study will evaluate the safety and efficacy of LATISSE® (bimatoprost 0.03%) in the augmentation of eyelashes in Korean women.

Detailed Summary:
Sponsor: Allergan

Current Primary Outcome: Change From Baseline in Eyelash Length at Week 20 [ Time Frame: Baseline, Week 20 ]

Change from baseline in eyelash length at Week 20. Measurements made were based on the mean length of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash length, and a negative change from baseline indicates a decrease in eyelash length.


Original Primary Outcome: Upper Eyelash Length [ Time Frame: Week 20 ]

Current Secondary Outcome:

  • Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20 [ Time Frame: Week 20 ]
    Percentage of subjects with an improvement of at least 1-point in GEA score at Week 20 from baseline. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence.
  • Change From Baseline in Eyelash Thickness at Week 20 [ Time Frame: Baseline, Week 20 ]
    Change from baseline in eyelash thickness at Week 20. Assessments made were based on the mean thickness of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash thickness, and a negative change from baseline indicates a decrease in eyelash thickness.
  • Change From Baseline in Eyelash Intensity (Darkness) at Week 20 [ Time Frame: Baseline, Week 20 ]
    Change from baseline in eyelash intensity (darkness) at Week 20. Assessments made were based on the mean eyelash intensity of the upper left and right eyelashes. Intensity was measured on a scale ranging from 0 (black) to 255 (white). A negative change from baseline indicates eyelash darkening in color, and a positive change from baseline indicates eyelash lightening in color.
  • Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20 [ Time Frame: Week 20 ]
    Percentage of subjects with an improvement in satisfaction with overall eyelash prominence at Week 20. Subject satisfaction with overall eyelash prominence was assessed by response to the question "Overall how satisfied are you with your eyelashes?" Responses were based on a 5-point scale ("very unsatisfied", "unsatisfied", "neutral", "satisfied", "very satisfied"). Improvement in subject satisfaction is defined as a 1-point increase from baseline.
  • Percentage of Subjects Satisfied With Treatment at Week 20 [ Time Frame: Week 20 ]
    Percentage of subjects satisfied with treatment at week 20 was assessed using the Treatment Satisfaction Scale response to the question "Which best describes your satisfaction with LATISSE®?" Responses were "very satisfied", "satisfied", "neutral", "unsatisfied", and "very unsatisfied." Satisfied is defined as responses of "very satisfied" and "satisfied."


Original Secondary Outcome:

  • Assessment of Overall Eyelash Prominence using the 4-point Global Eyelash Assessment (GEA) Scale [ Time Frame: Week 20 ]
  • Subject's Satisfaction using the Subject Assessment Questionnaire [ Time Frame: Week 20 ]


Information By: Allergan

Dates:
Date Received: October 25, 2010
Date Started: November 2009
Date Completion:
Last Updated: December 16, 2011
Last Verified: December 2011