A Multicenter, Double-masked, Randomized, Parallel-group Study Assessing the Safety and Efficacy of Once-Daily Application of Bimatoprost Solution 0.03% Compared to Vehicle in Increasing Overall Eyelash Prominence in Japanese Subjects With Hypotrichosis of the Eyelashes
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 173
- Primary Endpoint
- Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)
Study Overview
Brief Summary
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have inadequate eyelashes
Exclusion Criteria
- •Any disease/infection/abnormality of the eye or area around the eye
- •Any ocular surgery within 3 months or anticipated need for ocular surgery during the study
- •Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes
- •Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months
- •Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products
- •Use of treatments which may affect hair growth (eg, minoxidil, chemotherapy) within 6 months
Arms & Interventions
bimatoprost solution 0.03%
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
Intervention: bimatoprost solution 0.03% (Drug)
bimatoprost vehicle solution
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
Intervention: bimatoprost vehicle solution (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)
Time Frame: Baseline, Month 4
The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.
Secondary Outcomes
- Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)(Baseline, Month 4)
- Change From Baseline in Eyelash Thickness as Measured by DIA(Baseline, Month 4)
- Change From Baseline in Eyelash Darkness as Measured by DIA(Baseline, Month 4)