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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00693420 |
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Date of registration:
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05/06/2008 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence
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Scientific title:
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Date of first enrolment:
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April 2007 |
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Target sample size:
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278 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00693420 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Allergan |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Eyelashes
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Intervention(s)
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Drug: Bimatoprost 0.03% sterile solution
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Drug: vehicle sterile solution
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Primary Outcome(s)
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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]
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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]
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Secondary Outcome(s)
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Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
[Time Frame: Week 16]
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Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-Treatment)
[Time Frame: Week 20]
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Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
[Time Frame: Week 16]
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Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-Treatment)
[Time Frame: Week 20]
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Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
[Time Frame: Week 16]
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Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-Treatment)
[Time Frame: Week 20]
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Secondary ID(s)
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192024-032
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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