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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
  Purpose

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


Condition Intervention Phase
Eyelashes
 Drug: Bimatoprost 0.03% sterile solution
Drug: vehicle sterile solution
 Phase 3

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

Resource links provided by NLM:

Drug Information available for: Bimatoprost
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 278
Study Start Date: April 2007
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693420

Locations
United States, California
San Diego, California, United States
Canada, British Columbia
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00693420     History of Changes
Other Study ID Numbers: 192024-032
Study First Received: June 5, 2008
Results First Received: January 14, 2009
Last Updated: March 26, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bimatoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013