Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence

Study Overview
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Brief Summary
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The purpose of this study is to determine patient satisfaction with LATISSE® treatment for increasing eyelash prominence.

Conditions
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Hypotrichosis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have inadequate eyelashes Never used prescription eyelash growth products Exclusion Criteria: No visible eyelashes Permanent eyeliner or eyelash implants Semi-permanent eyelash tint, dye, or extensions within 3 months Over-the-counter eyelash growth products within 6 months Any disease, infection or abnormality of the eye or area around the eye Eye surgery within 3 months, or the anticipated need for eye surgery during the study Unable or unwilling to keep contact lenses out during drug application and for 30 minutes after application

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bimatoprost ophthalmic solution 0.03%<br>One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. | Drug: bimatoprost ophthalmic solution 0.03%<br>* One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.<br>* Other names: LATISSE®;|
| Placebo Comparator: bimatoprost vehicle solution<br>One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. | Drug: bimatoprost vehicle solution<br>* One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall | 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: -2=very unsatisfied (worst), -1=unsatisfied, 0=neutral, 1=satisfied or 2=very satisfied (best). The percentage of participants who rated their satisfaction as 1=satisfied or 2=very satisfied at Week 16 is reported. | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score | The investigator evaluated the patient's overall eyelash prominence using the 4-point GEA scale: 1=minimal (worst), 2=moderate, 3=marked or 4=very marked (best). An at least a 1-grade increase in GEA score indicated improvement. | Baseline, Week 16 |