Back to resultsBimatoprost in the Treatment of Eyelash Hypotrichosis
Primary Purpose
Idiopathic Eyelash Hypotrichosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bimatoprost formulation A solution
bimatoprost solution 0.03 %
vehicle of bimatoprost formulation A solution
vehicle of bimatoprost solution 0.03 %
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Eyelash Hypotrichosis
Eligibility Criteria
Inclusion Criteria:
-Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth).
Exclusion Criteria:
- Damage to eyelid area (scarring) that may prevent growth of eyelashes
- Active eye diseases (glaucoma, uveitis, eye infections, chronic blepharitis or severe dry eye)
- Eye or eyelid surgery (including laser, refractive, intraocular filtering surgery, blepharoplasty) during the 3 months prior to screening
- Current eyelash implants of any kind
- Eyelash tint or dye application within 2 months of baseline
- Eyelash extensions application within 3 months of baseline
- Use of eyelash growth products within 6 months of baseline
- Treatments that may affect hair growth (minoxidil, cancer chemotherapeutic agents, etc) within 6 months prior to baseline.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Placebo Comparator
Placebo Comparator
Arm Label
bimatoprost formulation A solution
bimatoprost solution 0.03 %
vehicle of bimatoprost formulation A solution
vehicle of bimatoprost solution 0.03 %
Arm Description
Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Outcomes
Primary Outcome Measures
Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)
The investigator evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.
Secondary Outcome Measures
Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)
Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement)
Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA
Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was measured in millimeters squared (mm^2). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated fuller eyelashes (improvement).
Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA
Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).
Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)
Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: "Overall, how satisfied are you with your eyelashes?" using a 5-point scale: 1= very unsatisfied (worst), 2= unsatisfied, 3= neutral, 4= satisfied or 5= very satisfied (best). The percentage of participants who rated their satisfaction as satisfied or very satisfied at Month 4 is reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01698554
Brief Title
Bimatoprost in the Treatment of Eyelash Hypotrichosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of bimatoprost solution formulation A compared with bimatoprost solution 0.03% (LATISSE®) and vehicle in the treatment of eyelash hypotrichosis (inadequate eyelashes).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Eyelash Hypotrichosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
464 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bimatoprost formulation A solution
Arm Type
Experimental
Arm Description
Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Arm Title
bimatoprost solution 0.03 %
Arm Type
Active Comparator
Arm Description
Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Arm Title
vehicle of bimatoprost formulation A solution
Arm Type
Placebo Comparator
Arm Description
Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Arm Title
vehicle of bimatoprost solution 0.03 %
Arm Type
Placebo Comparator
Arm Description
Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Intervention Type
Drug
Intervention Name(s)
bimatoprost formulation A solution
Intervention Description
Bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Intervention Type
Drug
Intervention Name(s)
bimatoprost solution 0.03 %
Other Intervention Name(s)
LATISSE®
Intervention Description
Bimatoprost solution 0.03 % (LATISSE®) applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Intervention Type
Drug
Intervention Name(s)
vehicle of bimatoprost formulation A solution
Intervention Description
Vehicle of bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Intervention Type
Drug
Intervention Name(s)
vehicle of bimatoprost solution 0.03 %
Intervention Description
Vehicle of bimatoprost solution 0.03 % applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Primary Outcome Measure Information:
Title
Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)
Description
The investigator evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.
Time Frame
Baseline, Month 4
Secondary Outcome Measure Information:
Title
Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)
Description
Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement)
Time Frame
Baseline, Month 4
Title
Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA
Description
Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was measured in millimeters squared (mm^2). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated fuller eyelashes (improvement).
Time Frame
Baseline Month 4
Title
Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA
Description
Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).
Time Frame
Baseline, Month 4
Title
Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)
Description
Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: "Overall, how satisfied are you with your eyelashes?" using a 5-point scale: 1= very unsatisfied (worst), 2= unsatisfied, 3= neutral, 4= satisfied or 5= very satisfied (best). The percentage of participants who rated their satisfaction as satisfied or very satisfied at Month 4 is reported.
Time Frame
Month 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth).
Exclusion Criteria:
Damage to eyelid area (scarring) that may prevent growth of eyelashes
Active eye diseases (glaucoma, uveitis, eye infections, chronic blepharitis or severe dry eye)
Eye or eyelid surgery (including laser, refractive, intraocular filtering surgery, blepharoplasty) during the 3 months prior to screening
Current eyelash implants of any kind
Eyelash tint or dye application within 2 months of baseline
Eyelash extensions application within 3 months of baseline
Use of eyelash growth products within 6 months of baseline
Treatments that may affect hair growth (minoxidil, cancer chemotherapeutic agents, etc) within 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
Newport Beach
State/Province
California
Country
United States
City
St. Petersburg
Country
Russian Federation
City
Stockholm
Country
Sweden
City
Norfolk
State/Province
England
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Bimatoprost in the Treatment of Eyelash Hypotrichosis
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