Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence

Study Overview
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Brief Summary
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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

Conditions
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Eyelash Hypotrichosis

Intervention / Treatment
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* Drug: bimatoprost ophthalmic solution 0.005%
* Drug: bimatoprost ophthalmic solution 0.015%
* Drug: bimatoprost ophthalmic solution 0.03%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bimatoprost ophthalmic solution 0.005%<br>bimatoprost ophthalmic sterile solution 0.005% | Drug: bimatoprost ophthalmic solution 0.005%<br>* One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)<br>|
| Experimental: bimatoprost ophthalmic solution 0.015%<br>bimatoprost ophthalmic sterile solution 0.015% | Drug: bimatoprost ophthalmic solution 0.015%<br>* One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)<br>|
| Active Comparator: bimatoprost ophthalmic solution 0.03%<br>bimatoprost ophthalmic solution 0.03% | Drug: bimatoprost ophthalmic solution 0.03%<br>* One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)<br>* Other names: LATISSE®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Eyelash Length at Month 3 | 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. | Baseline, Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Upper Eyelash Thickness at Month 3 | 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. | Baseline, Month 3 | 
| Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3 | 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. | Baseline, Month 3 | 
| Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3 | 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. | Month 3 | 
| Change From Baseline in Overall Eyelash Satisfaction at Month 3 | 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. | Baseline, Month 3 | 
| Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3 | 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. | Baseline, Month 3 | 
| Treatment Satisfaction Questionnaire Score at Month 3 | 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). | Month 3 |