Phase 3
N=278
Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence
Eyelashes
Bottom Line
View on ClinicalTrials.gov: NCT00693420 ↗Enrolled (actual)
278
Serious AEs
—
Results posted
May 2009
Primary outcome: Primary: Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16 — 5.1; 2.1; 14.6; 7.8 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bimatoprost 0.03% sterile solution (Drug); vehicle sterile solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16 |
5.1; 2.1; 14.6; 7.8; 50.4; 14.9 | — |
| PRIMARY Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment) |
78.6; 21.4 | — |
| SECONDARY Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 |
5.79; 5.71; 0.05; 0.00; 0.22; 0.06 | — |
| SECONDARY Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) |
1.47; 0.06 | — |
| SECONDARY Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 |
16.16; 16.66; 0.94; 0.24; 1.62; 0.81 | — |
| SECONDARY Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) |
11.16; 1.88 | — |
| SECONDARY Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 |
105.67; 102.82; -2.97; -1.25; -5.10; -2.91 | — |
| SECONDARY Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) |
-20.12; -5.51 | — |
Summary
This study evaluates the safety and effectiveness of topical bimatoprost solution for enhancing eyelash prominence.
Eligibility Criteria
Inclusion Criteria
- Dissatisfaction with eyelash prominence,
- Eyelash prominence assessment of minimal or moderate,
- Ability to provide written informed consent
Exclusion Criteria
- Subjects without visible lashes,
- Asymmetrical (uneven lashes or longer on one side than the other) eyelashes,
- Any eye disease or abnormality,
- Eye surgery,
- Permanent eyeliner,
- Eyelash implants,
- Eyelash extension application,
- Any use of eyelash growth products within 6 months of study entry,
- Treatments that may effect hair growth,
- Subjects requiring eye drop medications for glaucoma,
- Subjects having a situation or condition, which the study doctor feels might put you at risk, may make the study results confusing, or may interfere with the study.
Data sourced from ClinicalTrials.gov (NCT00693420). 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.