Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence

This study evaluates the safety and effectiveness of topical bimatoprost solution for enhancing eyelash prominence.

Intervention(s) in this Clinical Trial

• Drug: Bimatoprost 0.03% sterile solution
  • Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily.
• Drug: vehicle sterile solution
  • Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Bimatoprost 0.03% solution
• Placebo Comparator: 2
  • Vehicle solution

Primary Measures

• Percentage of Participants Experiencing at Least a 1-Grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16
  • Time Frame: Week 16
    Safety Issue?: No
• Percentage of Participants Experiencing at Least a 1-Grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-Treatment)
  • Time Frame: Week 20
    Safety Issue?: No

Secondary Measures

• Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
  • Time Frame: Week 16
    Safety Issue?: No
• Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-Treatment)
  • Time Frame: Week 20
    Safety Issue?: No
• Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
  • Time Frame: Week 16
    Safety Issue?: No
• Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-Treatment)
  • Time Frame: Week 20
    Safety Issue?: No
• Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
  • Time Frame: Week 16
    Safety Issue?: No
• Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-Treatment)
  • Time Frame: Week 20
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Allergan Industry

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Allergan  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00693420

Study ID Number: 192024-032

ClinicalTrials.gov Identifier: NCT00693420

Health Authority: United States: Food and Drug Administration