- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01064882
Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence
November 7, 2011 updated by: Allergan
This study will evaluate the safety and efficacy of bimatoprost ophthalmic solution 0.005% or 0.015% compared with bimatoprost ophthalmic solution 0.03% once-daily application to the upper eyelid margins in increasing eyelash prominence
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
104
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
-
San Diego, California, United States
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female Caucasians between 30 and 55 years of age, with hypotrichosis (inadequate or not enough) of the eyelashes
- Eyelash prominence assessment of minimal or moderate
Exclusion Criteria:
- Any eye disease or abnormality
- Any permanent eyeliner or eyelash implants of any kind
- Any ocular surgery, semi-permanent eyelash tint, or eyelash extension application during the 3 months prior to study entry
- Any use of prescription eyelash growth products
- Any use of over the counter eyelash growth products during the 6 months prior to baseline
- Any use of treatments that may affect hair growth during the 6 months prior to baseline
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: bimatoprost ophthalmic solution 0.005%
bimatoprost ophthalmic sterile solution 0.005%
|
One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)
|
Experimental: bimatoprost ophthalmic solution 0.015%
bimatoprost ophthalmic sterile solution 0.015%
|
One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)
|
Active Comparator: bimatoprost ophthalmic solution 0.03%
|
One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Eyelash Length at Month 3
Time Frame: Baseline, Month 3
|
Change from Baseline at Month 3 in eyelash length, measured in millimeters (mm).
Data from both eyes were averaged for each subject for analysis.
Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length.
|
Baseline, Month 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Upper Eyelash Thickness at Month 3
Time Frame: Baseline, Month 3
|
Change from baseline in upper eyelash thickness/fullness at Month 3 was measured within 3 preset areas.
Eyelash thickness/fullness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2).
Changes from baseline to Month 3 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness.
|
Baseline, Month 3
|
Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3
Time Frame: Baseline, Month 3
|
Change from baseline in upper eyelash darkness at Month 3 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest).
Upper eyelash darkness was measured in both eyes and averaged for analysis.
Colors ranged from black=0 to white=255.
Lower numbers on this continuum indicated darker colors.
Therefore, a change from baseline to Month 3 represented by a negative value indicated increased eyelash darkening.
|
Baseline, Month 3
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Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3
Time Frame: Month 3
|
Percentage of subjects with a clinical response in overall eyelash prominence at Month 3 was measured using a 4-point GEA scale with the aid of the photonumeric guide.
The scale ranges from 1 (minimal = worst) prominence to 4 (very marked = best)prominence.
Eyelash prominence was assessed and graded by the investigator over both eyes.
A clinical response was defined as at least a 1-grade increase in GEA score from baseline to Month 3.
|
Month 3
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Change From Baseline in Overall Eyelash Satisfaction at Month 3
Time Frame: Baseline, Month 3
|
Change from baseline at Month 3 in question 3 "overall, how satisfied are you with your eyelashes?"
Responses ranged from 1 (very unsatisfied = worst) to 5 (very satisfied = best).
Individual responses at Month 3 were compared to baseline.
Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline.
|
Baseline, Month 3
|
Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3
Time Frame: Baseline, Month 3
|
Change from baseline in the CAP domain at Month 3 included responses to questions 7, 8, and 9. Responses to each question ranged from 1 (very much disagree = worst) to 5 (very much agree = best) with the minimum sum of the scores for the domain equal to 3 and the maximum sum of the scores for the domain equal to 15. Domain responses at Month 3 were compared to baseline.
Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline.
|
Baseline, Month 3
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Treatment Satisfaction Questionnaire Score at Month 3
Time Frame: Month 3
|
The Treatment Satisfaction Questionnaire at Month 3 consisted of 2 questions that collected information regarding subject satisfaction with the treatment overall.
The questions assessed the likelihood that the subject would use the product, as well as the likelihood that the subject would recommend the product to family and/or friends, if it were available.
The score was based on the responses to each question.
Questions were answered on a 5-point scale ranging from 1 (very unlikely = worst) to 5 (very likely = best).
|
Month 3
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
February 5, 2010
First Submitted That Met QC Criteria
February 5, 2010
First Posted (Estimate)
February 9, 2010
Study Record Updates
Last Update Posted (Estimate)
December 9, 2011
Last Update Submitted That Met QC Criteria
November 7, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 192024-051
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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