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Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence
This study has been completed.
Study NCT00693420   Information provided by Allergan
First Received: June 5, 2008   Last Updated: March 26, 2009   History of Changes

June 5, 2008
March 26, 2009
April 2007
October 2007   (final data collection date for primary outcome measure)
  • 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 ]
Overall eyelash prominence as measured by the Global Eyelash Assessment (GEA) score [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00693420 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
 
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.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Eyelashes
  • Drug: Bimatoprost 0.03% sterile solution
  • Drug: vehicle sterile solution
  • Experimental: Bimatoprost 0.03% solution
  • Placebo Comparator: Vehicle solution
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
278
December 2007
October 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00693420
Therapeutic Area Head, Allergan, Inc.
192024-032
Allergan
 
Study Director: Medical Director Allergan
Allergan
March 2009

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