Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence

This study has been completed.

Sponsor:

Information provided by:

Allergan

ClinicalTrials.gov Identifier:

NCT00693420

First received: June 5, 2008

Last updated: March 26, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

June 5, 2008

Last Updated Date

March 26, 2009

Start Date ^ICMJE

April 2007

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Overall eyelash prominence as measured by the Global Eyelash Assessment (GEA) score [ Time Frame: Month 4 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00693420 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 [ Time Frame: Week 16 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Upper eyelash length as measured by image analysis [ Time Frame: Day 1, Week 1, Month 1-5 ] [ Designated as safety issue: No ]
Upper eyelash thickness as measured by image analysis [ Time Frame: Day 1, Week 1, Month 1-5 ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence

Official Title ^ICMJE

Not Provided

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Eyelashes

Intervention ^ICMJE

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 Name: LUMIGAN®
Drug: vehicle sterile solution
Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily

Study Arm (s)

Experimental: 1
Bimatoprost 0.03% solution

Intervention: Drug: Bimatoprost 0.03% sterile solution
Placebo Comparator: 2
Vehicle solution

Intervention: Drug: vehicle sterile solution

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

278

Completion Date

December 2007

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00693420

Other Study ID Numbers ^ICMJE

192024-032

Has Data Monitoring Committee

Not Provided

Responsible Party

Therapeutic Area Head, Allergan, Inc.

Study Sponsor ^ICMJE

Allergan

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Director

Allergan

Information Provided By

Allergan

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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