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: September 26, 2013
Last verified: September 2013
  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:


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: Baseline to Week 16 ] [ Designated as safety issue: No ]
    The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])

  • 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: Baseline to Week 20 ] [ Designated as safety issue: No ]
    The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])


Secondary Outcome Measures:
  • Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
    Upper eyelash length technologically measured in millimeters

  • Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) [ Time Frame: Baseline to Week 20 ] [ Designated as safety issue: No ]
    Upper eyelash length technologically measured in millimeters

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

  • Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) [ Time Frame: Baseline to Week 20 ] [ Designated as safety issue: No ]
    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.

  • Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
    Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)

  • Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) [ Time Frame: Baseline to Week 20 ] [ Designated as safety issue: No ]
    Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)


Other Outcome Measures:
  • Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16 [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]

    "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

  • Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment) [ Time Frame: Baseline to Week 20 ] [ Designated as safety issue: No ]
    "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)


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Allergan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: September 26, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014