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Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01064882
First received: February 5, 2010
Last updated: November 7, 2011
Last verified: November 2011

February 5, 2010
November 7, 2011
March 2010
July 2010   (final data collection date for primary outcome measure)
Change From Baseline in Eyelash Length at Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
Change from Baseline at Month 3 in eyelash length, 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.
Eyelash Length [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01064882 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Upper Eyelash Thickness at Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    Change from baseline in upper eyelash thickness/fullness at Month 3 was measured within 3 preset areas. Eyelash thickness/fullness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2). Changes from baseline to Month 3 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 (in Intensity Units) at Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    Change from baseline in upper eyelash darkness at Month 3 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. Therefore, a change from baseline to Month 3 represented by a negative value indicated increased eyelash darkening.
  • Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Percentage of subjects with a clinical response in overall eyelash prominence at Month 3 was measured using a 4-point GEA scale with the aid of the photonumeric guide. The scale ranges from 1 (minimal = worst) prominence to 4 (very marked = best)prominence. Eyelash prominence was assessed and graded by the investigator over both eyes. A clinical response was defined as at least a 1-grade increase in GEA score from baseline to Month 3.
  • Change From Baseline in Overall Eyelash Satisfaction at Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    Change from baseline at Month 3 in question 3 "overall, how satisfied are you with your eyelashes?" Responses ranged from 1 (very unsatisfied = worst) to 5 (very satisfied = best). Individual responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline.
  • Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    Change from baseline in the CAP domain at Month 3 included responses to questions 7, 8, and 9. Responses to each question ranged from 1 (very much disagree = worst) to 5 (very much agree = best) with the minimum sum of the scores for the domain equal to 3 and the maximum sum of the scores for the domain equal to 15. Domain responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline.
  • Treatment Satisfaction Questionnaire Score at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    The Treatment Satisfaction Questionnaire at Month 3 consisted of 2 questions that collected information regarding subject satisfaction with the treatment overall. The questions assessed the likelihood that the subject would use the product, as well as the likelihood that the subject would recommend the product to family and/or friends, if it were available. The score was based on the responses to each question. Questions were answered on a 5-point scale ranging from 1 (very unlikely = worst) to 5 (very likely = best).
  • Upper Eyelash Thickness [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • Upper Eyelash Darkness [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • Overall Eyelash Prominence [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • Eyelash Satisfaction Questionnaire [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • Treatment Satisfaction Questionnaire [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence
Not Provided

This study will evaluate the safety and efficacy of bimatoprost ophthalmic solution 0.005% or 0.015% compared with bimatoprost ophthalmic solution 0.03% once-daily application to the upper eyelid margins in increasing eyelash prominence

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Eyelash Hypotrichosis
  • Drug: bimatoprost ophthalmic solution 0.005%
    One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)
  • Drug: bimatoprost ophthalmic solution 0.015%
    One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)
  • Drug: bimatoprost ophthalmic solution 0.03%
    One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)
    Other Name: LATISSE®
  • Experimental: bimatoprost ophthalmic solution 0.005%
    bimatoprost ophthalmic sterile solution 0.005%
    Intervention: Drug: bimatoprost ophthalmic solution 0.005%
  • Experimental: bimatoprost ophthalmic solution 0.015%
    bimatoprost ophthalmic sterile solution 0.015%
    Intervention: Drug: bimatoprost ophthalmic solution 0.015%
  • Active Comparator: bimatoprost ophthalmic solution 0.03%
    bimatoprost ophthalmic solution 0.03%
    Intervention: Drug: bimatoprost ophthalmic solution 0.03%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female Caucasians between 30 and 55 years of age, with hypotrichosis (inadequate or not enough) of the eyelashes
  • Eyelash prominence assessment of minimal or moderate

Exclusion Criteria:

  • Any eye disease or abnormality
  • Any permanent eyeliner or eyelash implants of any kind
  • Any ocular surgery, semi-permanent eyelash tint, or eyelash extension application during the 3 months prior to study entry
  • Any use of prescription eyelash growth products
  • Any use of over the counter eyelash growth products during the 6 months prior to baseline
  • Any use of treatments that may affect hair growth during the 6 months prior to baseline
Female
30 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01064882
192024-051
Not Provided
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP