Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence

Study Overview
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Brief Summary
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This study evaluates the safety and effectiveness of topical bimatoprost solution for enhancing eyelash prominence.

Conditions
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Eyelashes

Intervention / Treatment
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* Drug: Bimatoprost 0.03% sterile solution
* Drug: vehicle sterile solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dissatisfaction with eyelash prominence, Eyelash prominence assessment of minimal or moderate, Ability to provide written informed consent Exclusion Criteria: Subjects without visible lashes, Asymmetrical (uneven lashes or longer on one side than the other) eyelashes, Any eye disease or abnormality, Eye surgery, Permanent eyeliner, Eyelash implants, Eyelash extension application, Any use of eyelash growth products within 6 months of study entry, Treatments that may effect hair growth, Subjects requiring eye drop medications for glaucoma, Subjects having a situation or condition, which the study doctor feels might put you at risk, may make the study results confusing, or may interfere with the study.

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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Accepts Healthy Volunteers

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: 1<br>Bimatoprost 0.03% solution | Drug: Bimatoprost 0.03% sterile solution<br>* Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily.<br>* Other names: LUMIGAN®;|
| Placebo Comparator: 2<br>Vehicle solution | Drug: vehicle sterile solution<br>* Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16 | The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked]) | Baseline to Week 16 | 
| Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment) | The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked]) | Baseline to Week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 | Upper eyelash length technologically measured in millimeters | Baseline to Week 16 | 
| Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) | Upper eyelash length technologically measured in millimeters | Baseline to Week 20 | 
| Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 | Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm. | Baseline to Week 16 | 
| Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) | Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm. | Baseline to Week 20 | 
| Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 | Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white) | Baseline to Week 16 | 
| Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) | Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white) | Baseline to Week 20 |