Bimatoprost in the Treatment of Eyelash Hypotrichosis

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of bimatoprost solution formulation A compared with bimatoprost solution 0.03% (LATISSE®) and vehicle in the treatment of eyelash hypotrichosis (inadequate eyelashes).

Conditions
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Idiopathic Eyelash Hypotrichosis

Intervention / Treatment
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* Drug: bimatoprost formulation A solution
* Drug: bimatoprost solution 0.03 %
* Drug: vehicle of bimatoprost formulation A solution
* Drug: vehicle of bimatoprost solution 0.03 %


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth). Exclusion Criteria: Damage to eyelid area (scarring) that may prevent growth of eyelashes Active eye diseases (glaucoma, uveitis, eye infections, chronic blepharitis or severe dry eye) Eye or eyelid surgery (including laser, refractive, intraocular filtering surgery, blepharoplasty) during the 3 months prior to screening Current eyelash implants of any kind Eyelash tint or dye application within 2 months of baseline Eyelash extensions application within 3 months of baseline Use of eyelash growth products within 6 months of baseline Treatments that may affect hair growth (minoxidil, cancer chemotherapeutic agents, etc) within 6 months prior to baseline.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bimatoprost formulation A solution<br>Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. | Drug: bimatoprost formulation A solution<br>* Bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.<br>|
| Active Comparator: bimatoprost solution 0.03 %<br>Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. | Drug: bimatoprost solution 0.03 %<br>* Bimatoprost solution 0.03 % (LATISSE®) applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.<br>* Other names: LATISSE®;|
| Placebo Comparator: vehicle of bimatoprost formulation A solution<br>Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. | Drug: vehicle of bimatoprost formulation A solution<br>* Vehicle of bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.<br>|
| Placebo Comparator: vehicle of bimatoprost solution 0.03 %<br>Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. | Drug: vehicle of bimatoprost solution 0.03 %<br>* Vehicle of bimatoprost solution 0.03 % applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA) | The investigator 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. | Baseline, Month 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA) | 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) | Baseline, Month 4 | 
| Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA | Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was measured in millimeters squared (mm^2). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated fuller eyelashes (improvement). | Baseline Month 4 | 
| Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA | 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). | Baseline, Month 4 | 
| Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9) | Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: Overall, how satisfied are you with your eyelashes? using a 5-point scale: 1= very unsatisfied (worst), 2= unsatisfied, 3= neutral, 4= satisfied or 5= very satisfied (best). The percentage of participants who rated their satisfaction as satisfied or very satisfied at Month 4 is reported. | Month 4 |