Phase 3
N=368
Safety and Efficacy Study of Bimatoprost to Treat Hypotrichosis of the Eyelashes After Application to the Eyelid Margin
Hypotrichosis
Bottom Line
View on ClinicalTrials.gov: NCT00907426 ↗Enrolled (actual)
368
Serious AEs
8.7%
Results posted
Sep 2012
Primary outcome: Primary: Percentage of Treatment Responders at Month 4 — 39.3; 10.9 Percentage of Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bimatoprost 0.03% solution (Drug); Vehicle solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Treatment Responders at Month 4 |
39.3; 10.9 | — |
| SECONDARY Change From Baseline in Upper Eyelash Length at Month 4 |
5.40; 5.42; 1.33; 0.07 | — |
| SECONDARY Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4 |
0.67; 0.82; 0.59; -0.07 | — |
| SECONDARY Change From Baseline in Upper Eyelash Darkness at Month 4 |
151.36; 148.82; -23.55; -2.60 | — |
Summary
This one-year study evaluates the long-term safety and effectiveness of bimatoprost solution application to the eyelid margin (where the eyelashes meet the skin) to treat hypotrichosis of the eyelashes (inadequate or not enough eyelashes). There will be two different types of subjects participating in the study 1)those with inadequate eyelashes due to natural causes or 2) those with inadequate eyelashes following a complete course of chemotherapy treatment. There will be two treatment periods of six months each. Subjects will receive either the study medication or vehicle in either of the two treatment periods.
Eligibility Criteria
Inclusion Criteria
- Subjects who have inadequate eyelashes due to natural causes and are not satisfied with their eyelash appearance.
- For the post-chemotherapy population: subjects who have inadequate eyelashes following a complete course of chemotherapy treatment and are not satisfied with their eyelash appearance, are considered free of cancer and are well enough to complete the study.
Exclusion Criteria
- Subjects with unequal right and left eyelashes, any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants, eyelash extension application.
- Any use of over the counter or prescription use eyelash growth products.
- Subjects requiring eye drop medications for glaucoma.
- Females who are pregnant, nursing or planning a pregnancy during the study or who are of childbearing potential and not using a reliable method of contraception.
Data sourced from ClinicalTrials.gov (NCT00907426). 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.