Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced 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 following chemotherapy treatment.

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 to Treat Chemotherapy-induced Hypotrichosis of the Eyelashes in Japanese Subjects

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 due to chemotherapy treatment Treated for solid tumors such as breast or colorectal cancer in early stages where the cancer has not spread outside the primary organ (eg, stage 1, 2 or 3a for breast cancer) Have completed chemotherapy treatment for at least 4 weeks but not more than 24 weeks and all side effects related to chemotherapy are recovered, improved or maintained, with the exception of hair loss 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) within 6 months except for prior chemotherapy

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 |