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Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00693420
First Posted: June 9, 2008
Last Update Posted: October 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Allergan
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]

    "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 ]
    "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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: June 5, 2008
First Posted: June 9, 2008
Results First Submitted: January 14, 2009
Results First Posted: May 12, 2009
Last Update Posted: October 30, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Pharmaceutical Solutions
Bimatoprost
Antihypertensive Agents