Clinical trial NCT00693420: Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Eyelashes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-06-09
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment)
timeFrame: Baseline to Week 20
Secondary outcomes:
measure: Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)
timeFrame: Baseline to Week 20
measure: Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)
timeFrame: Baseline to Week 20
measure: Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)
timeFrame: Baseline to Week 20
Other outcomes:
measure: Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment)
timeFrame: Baseline to Week 20
Locations:
city: San Diego
country: United States
state: California
city: Vancouver
country: Canada
state: British Columbia
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Fagien S, Walt JG, Carruthers J, Cox SE, Wirta D, Weng E, Beddingfield FC 3rd. Patient-reported outcomes of bimatoprost for eyelash growth: results from a randomized, double-masked, vehicle-controlled, parallel-group study. Aesthet Surg J. 2013 Aug 1;33(6):789-98. doi: 10.1177/1090820X13495887. Epub 2013 Jul 19.