Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 104
- Primary Endpoint
- Change From Baseline in Eyelash Length at Month 3
Overview
Brief Summary
This study will evaluate the safety and efficacy of bimatoprost ophthalmic solution 0.005% or 0.015% compared with bimatoprost ophthalmic solution 0.03% once-daily application to the upper eyelid margins in increasing eyelash prominence
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female Caucasians between 30 and 55 years of age, with hypotrichosis (inadequate or not enough) of the eyelashes
- •Eyelash prominence assessment of minimal or moderate
Exclusion Criteria
- •Any eye disease or abnormality
- •Any permanent eyeliner or eyelash implants of any kind
- •Any ocular surgery, semi-permanent eyelash tint, or eyelash extension application during the 3 months prior to study entry
- •Any use of prescription eyelash growth products
- •Any use of over the counter eyelash growth products during the 6 months prior to baseline
- •Any use of treatments that may affect hair growth during the 6 months prior to baseline
Arms & Interventions
bimatoprost ophthalmic solution 0.005%
bimatoprost ophthalmic sterile solution 0.005%
Intervention: bimatoprost ophthalmic solution 0.005% (Drug)
bimatoprost ophthalmic solution 0.015%
bimatoprost ophthalmic sterile solution 0.015%
Intervention: bimatoprost ophthalmic solution 0.015% (Drug)
bimatoprost ophthalmic solution 0.03%
bimatoprost ophthalmic solution 0.03%
Intervention: bimatoprost ophthalmic solution 0.03% (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Eyelash Length at Month 3
Time Frame: Baseline, Month 3
Change from Baseline at Month 3 in eyelash length, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length.
Secondary Outcomes
- Change From Baseline in Upper Eyelash Thickness at Month 3(Baseline, Month 3)
- Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3(Baseline, Month 3)
- Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3(Month 3)
- Change From Baseline in Overall Eyelash Satisfaction at Month 3(Baseline, Month 3)
- Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3(Baseline, Month 3)
- Treatment Satisfaction Questionnaire Score at Month 3(Month 3)