Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence
- Conditions
- Eyelashes
- Interventions
- Drug: vehicle sterile solution
- Registration Number
- NCT00693420
- Lead Sponsor
- Allergan
- Brief Summary
This study evaluates the safety and effectiveness of topical bimatoprost solution for enhancing eyelash prominence.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 278
- Dissatisfaction with eyelash prominence,
- Eyelash prominence assessment of minimal or moderate,
- Ability to provide written informed consent
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Bimatoprost 0.03% sterile solution Bimatoprost 0.03% solution 2 vehicle sterile solution Vehicle solution
- Primary Outcome Measures
Name Time Method Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment) Baseline to Week 20 The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 \[minimal\], 2 \[moderate\], 3 \[marked\], 4 \[very marked\])
Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16 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 \[very marked\])
- Secondary Outcome Measures
Name Time Method Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 Baseline to Week 16 Upper eyelash length technologically measured in millimeters
Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) Baseline to Week 20 Upper eyelash length technologically measured in millimeters
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 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.
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) Baseline to Week 20 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.
Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 Baseline to Week 16 Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)
Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) Baseline to Week 20 Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)