Safety and Efficacy Study of Bimatoprost in Japanese Patients With 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 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes.

Official Title
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A Multicenter, Double-masked, Randomized, Parallel-group Study Assessing the Safety and Efficacy of Once-Daily Application of Bimatoprost Solution 0.03% Compared to Vehicle in Increasing Overall Eyelash Prominence in Japanese Subjects With Hypotrichosis of the Eyelashes

Conditions
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Eyelash Hypotrichosis

Intervention / Treatment
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* Drug: bimatoprost solution 0.03%
* Drug: bimatoprost vehicle solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have inadequate eyelashes Exclusion Criteria: Any disease/infection/abnormality of the eye or area around the eye Any ocular surgery within 3 months or anticipated need for ocular surgery during the study Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products Use of treatments which may affect hair growth (eg, minoxidil, chemotherapy) within 6 months

Ages Eligible for Study
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Minimum Age: 20 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bimatoprost solution 0.03%<br>One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months. | Drug: bimatoprost solution 0.03%<br>* One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.<br>* Other names: LATISSE®;|
| Placebo Comparator: bimatoprost vehicle solution<br>One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months. | Drug: bimatoprost vehicle solution<br>* One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.<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 in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA) | The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement. | Baseline, Month 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Eyelash Length as Measured by 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 Eyelash Thickness as Measured by DIA | 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). | Baseline, Month 4 | 
| Change From Baseline in Eyelash Darkness as Measured by DIA | Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness 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 |