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Completed

NCT Number: NCT00693420

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.

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Key information

Conditions

Eyelashes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bimatoprost 0.03% sterile solution

Drug

Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily.

Other names: LUMIGAN®

vehicle sterile solution

Drug

Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily

Primary outcomes

  1. 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])

  2. 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 outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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)

  6. 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 outcomes

  1. 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:

    • - Very Satisfied
    • - Satisfied
    • - Neutral
    • - Unsatisfied
    • - Very Unsatisfied

  2. 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)

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jun 9, 2008
Registry last updated
Oct 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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