Phase 3
N=173
Safety and Efficacy Study of Bimatoprost in Japanese Patients With Eyelash Hypotrichosis
Eyelash Hypotrichosis
Bottom Line
View on ClinicalTrials.gov: NCT01391273 ↗Enrolled (actual)
173
Serious AEs
2.3%
Results posted
Jul 2013
Primary outcome: Primary: Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA) — 77.3; 17.6 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- bimatoprost solution 0.03% (Drug); bimatoprost vehicle solution (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA) |
77.3; 17.6 | — |
| SECONDARY Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA) |
6.92; 7.00; 1.62; -0.04 | — |
| SECONDARY Change From Baseline in Eyelash Thickness as Measured by DIA |
0.98; 1.01; 0.35; -0.03 | — |
| SECONDARY Change From Baseline in Eyelash Darkness as Measured by DIA |
147.57; 145.27; -12.02; 1.38 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01391273). 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.