Back to resultsSafety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence
Primary Purpose
Eyelash Hypotrichosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bimatoprost ophthalmic solution 0.005%
bimatoprost ophthalmic solution 0.015%
bimatoprost ophthalmic solution 0.03%
Sponsored by
About this trial
This is an interventional treatment trial for Eyelash Hypotrichosis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
bimatoprost ophthalmic solution 0.005%
bimatoprost ophthalmic solution 0.015%
bimatoprost ophthalmic solution 0.03%
Arm Description
bimatoprost ophthalmic sterile solution 0.005%
bimatoprost ophthalmic sterile solution 0.015%
bimatoprost ophthalmic solution 0.03%
Outcomes
Primary Outcome Measures
Change From Baseline in Eyelash Length at 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.
Secondary Outcome Measures
Change From Baseline in Upper Eyelash Thickness at 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.
Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at 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.
Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at 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.
Change From Baseline in Overall Eyelash Satisfaction at 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.
Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at 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.
Treatment Satisfaction Questionnaire Score at 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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01064882
Brief Title
Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelash Hypotrichosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bimatoprost ophthalmic solution 0.005%
Arm Type
Experimental
Arm Description
bimatoprost ophthalmic sterile solution 0.005%
Arm Title
bimatoprost ophthalmic solution 0.015%
Arm Type
Experimental
Arm Description
bimatoprost ophthalmic sterile solution 0.015%
Arm Title
bimatoprost ophthalmic solution 0.03%
Arm Type
Active Comparator
Arm Description
bimatoprost ophthalmic solution 0.03%
Intervention Type
Drug
Intervention Name(s)
bimatoprost ophthalmic solution 0.005%
Intervention Description
One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)
Intervention Type
Drug
Intervention Name(s)
bimatoprost ophthalmic solution 0.015%
Intervention Description
One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)
Intervention Type
Drug
Intervention Name(s)
bimatoprost ophthalmic solution 0.03%
Other Intervention Name(s)
LATISSE®
Intervention Description
One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)
Primary Outcome Measure Information:
Title
Change From Baseline in Eyelash Length at Month 3
Description
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.
Time Frame
Baseline, Month 3
Secondary Outcome Measure Information:
Title
Change From Baseline in Upper Eyelash Thickness at Month 3
Description
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.
Time Frame
Baseline, Month 3
Title
Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3
Description
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.
Time Frame
Baseline, Month 3
Title
Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3
Description
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.
Time Frame
Month 3
Title
Change From Baseline in Overall Eyelash Satisfaction at Month 3
Description
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.
Time Frame
Baseline, Month 3
Title
Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3
Description
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.
Time Frame
Baseline, Month 3
Title
Treatment Satisfaction Questionnaire Score at Month 3
Description
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).
Time Frame
Month 3
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
San Diego
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence
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