Phase 2
N=104
Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence
Eyelash Hypotrichosis
Bottom Line
View on ClinicalTrials.gov: NCT01064882 ↗Enrolled (actual)
104
Serious AEs
1.0%
Results posted
Dec 2011
Primary outcome: Primary: Change From Baseline in Eyelash Length at Month 3 — 5.65; 5.68; 5.95; 0.74 millimeters (mm)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bimatoprost ophthalmic solution 0.005% (Drug); bimatoprost ophthalmic solution 0.015% (Drug); bimatoprost ophthalmic solution 0.03% (Drug)
- Age
- Adult · 30+ yrs
- Sex
- Female
- Sponsor
- Allergan
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Eyelash Length at Month 3 |
5.65; 5.68; 5.95; 0.74; 0.92; 1.36 | — |
| SECONDARY Change From Baseline in Upper Eyelash Thickness at Month 3 |
12.75; 14.67; 13.69; 4.50; 5.64; 8.48 | — |
| SECONDARY Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3 |
157.14; 154.41; 162.41; -18.75; -26.55; -29.61 | — |
| SECONDARY Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3 |
52.8; 79.4; 85.3 | — |
| SECONDARY Change From Baseline in Overall Eyelash Satisfaction at Month 3 |
1.47; 1.56; 1.71; 1.35; 2.25; 2.06 | — |
| SECONDARY Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3 |
4.33; 4.53; 4.94; 2.79; 4.72; 3.06 | — |
| SECONDARY Treatment Satisfaction Questionnaire Score at Month 3 |
4.1; 4.2; 4.1; 4.1; 4.2; 4.4 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01064882). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.