Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence

NCT00693420 | Completed Phase 3 Results

• 1 other identifier: 192024-032
• Study Type: interventional
• Target: 278
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Eyelashes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16

  Baseline to Week 16

• Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)

  Baseline to Week 20

• Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16

  Baseline to Week 16

• Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)

  Baseline to Week 20

• Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16

  Baseline to Week 16

Other Outcomes (2)

• Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16

  Baseline to Week 16

• Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment)

  Baseline to Week 20

Study Arms (2)

1

EXPERIMENTAL

Bimatoprost 0.03% solution

Drug: Bimatoprost 0.03% sterile solution

2

PLACEBO COMPARATOR

Vehicle solution

Drug: vehicle sterile solution

Interventions

Bimatoprost 0.03% sterile solution DRUG

Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily.

Also known as: LUMIGAN®

1

vehicle sterile solution DRUG

Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dissatisfaction with eyelash prominence,
• Eyelash prominence assessment of minimal or moderate,
• Ability to provide written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Related Publications (1)

• 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.

  PMID: 23873891 DERIVED

MeSH Terms

Interventions

Bimatoprost

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

(714)246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 9, 2008
• Study Start: April 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: December 1, 2007
• Last Updated: October 30, 2013
• Results First Posted: May 12, 2009

Record last verified: 2013-09

Locations

US (1); CA (1)