Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children

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% once daily application to the upper eyelid margins compared with vehicle in treating eyelash loss or hypotrichosis (inadequate or not enough eyelashes) in children.

Conditions
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Eyelash Hypotrichosis, Alopecia Areata

Intervention / Treatment
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* Drug: bimatoprost ophthalmic solution 0.03%
* Drug: Vehicle Sterile Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children who have inadequate eyelashes or have lost their eyelashes as a result of chemotherapy treatment, who completed their chemotherapy (intensive treatment) at least 4 weeks before starting the study, are considered to be at low risk for relapse of their cancer, and are well enough to complete the study Children who have minimal to moderate inadequate eyelashes due to alopecia areata Adolescents between the ages of 15-17 years who have minimal to marked inadequate eyelashes Exclusion Criteria: Any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants. Semi-permanent eyelash tint, dye or eyelash extension application within 3 months Use of over the counter eyelash growth products within 6 months. Use of prescription eyelash growth products (eg, Latisse®) Any eye condition that would prevent required ophthalmology exams

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bimatoprost ophthalmic solution 0.03%<br>One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months. | Drug: bimatoprost ophthalmic solution 0.03%<br>* One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.<br>* Other names: LATISSE®;|
| Placebo Comparator: Vehicle Sterile Solution<br>One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months. | Drug: Vehicle Sterile Solution<br>* One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly 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 Adverse Events | An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. | 5 Months | 
| Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score | The physician 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 Upper 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 Upper 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 Upper Eyelash Darkness as Measured by 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 |