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.

Study Overview

• Status: Completed
• Conditions: Eyelashes
• Intervention / Treatment: Drug: Bimatoprost 0.03% sterile solution; Drug: vehicle sterile solution

• Study Type: Interventional
• Enrollment (Actual): 278
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
• United States
  • California
    • San Diego, California, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Bimatoprost 0.03% solution	Drug: Bimatoprost 0.03% sterile solution; Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily.; Other Names: LUMIGAN®
Placebo Comparator: 2; Vehicle solution	Drug: vehicle sterile solution; Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16	The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])	Baseline to Week 16
Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment)	The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])	Baseline to Week 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16	Upper eyelash length technologically measured in millimeters	Baseline to Week 16
Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)	Upper eyelash length technologically measured in millimeters	Baseline to Week 20
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16	Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.	Baseline to Week 16
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)	Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.	Baseline to Week 20
Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16	Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)	Baseline to Week 16
Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)	Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)	Baseline to Week 20

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16	"Overall, how satisfied are you with your eyelashes?" Possible Answers on a 5 point scale as follows: - Very Satisfied; - Satisfied; - Neutral; - Unsatisfied; - Very Unsatisfied	Baseline to Week 16
Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment)	"Overall, how satisfied are you with your eyelashes?" Possible Answers on a 5 point scale as follows: (1 - Very Satisfied; 2 - Satisfied; 3 - Neutral; 4 - Unsatisfied; 5 - Very Unsatisfied)	Baseline to Week 20

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: June 5, 2008
• First Submitted That Met QC Criteria: June 6, 2008
• First Posted (Estimate): June 9, 2008

Study Record Updates

• Last Update Posted (Estimate): October 30, 2013
• Last Update Submitted That Met QC Criteria: September 26, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antihypertensive Agents; Pharmaceutical Solutions; Bimatoprost
• Other Study ID Numbers: 192024-032