Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence

Phase 3CompletedNCT00693420

Allergan278 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

278

Conditions

Eyelashes

Interventions

Bimatoprost 0.03% sterile solutionDRUG

Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily.

vehicle sterile solutionDRUG

Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Unnamed facility

San Diego, California, United States

Unnamed facility

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

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 \[very marked\])

Time frame: 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 \[very marked\])

Time frame: Baseline to Week 20

Secondary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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