Idiopathic Eyelash Hypotrichosis
Conditions
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).
Interventions
DRUGbimatoprost formulation A solution
Bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
DRUGbimatoprost solution 0.03 %
Bimatoprost solution 0.03 % (LATISSE®) applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
DRUGvehicle of bimatoprost formulation A solution
Vehicle of bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
DRUGvehicle of bimatoprost solution 0.03 %
Vehicle of bimatoprost solution 0.03 % applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA) | Baseline, Month 4 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA) | Baseline, Month 4 | 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 | Baseline Month 4 | 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 | Baseline, Month 4 | 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) | Month 4 | 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. |
Countries
Russia, Sweden, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost Formulation A Solution Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. | 153 |
| Bimatoprost Solution 0.03 % 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. | 157 |
| Vehicle of Bimatoprost Formulation A Solution 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. | 75 |
| Vehicle of Bimatoprost Solution 0.03 % 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. | 79 |
| Total | 464 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 5 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 |
| Overall Study | Other Miscellaneous Reasons | 1 | 0 | 0 | 0 |
| Overall Study | Personal Reasons | 0 | 5 | 1 | 1 |
| Overall Study | Protocol Violation | 2 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Bimatoprost Formulation A Solution | Bimatoprost Solution 0.03 % | Vehicle of Bimatoprost Formulation A Solution | Vehicle of Bimatoprost Solution 0.03 % |
|---|---|---|---|---|---|
| Age, Customized 45 to 65 years | 312 Participants | 104 Participants | 106 Participants | 47 Participants | 55 Participants |
| Age, Customized <45 years | 92 Participants | 27 Participants | 34 Participants | 16 Participants | 15 Participants |
| Age, Customized >65 years | 60 Participants | 22 Participants | 17 Participants | 12 Participants | 9 Participants |
| Sex: Female, Male Female | 457 Participants | 150 Participants | 153 Participants | 75 Participants | 79 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 4 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 153 | 8 / 157 | 3 / 75 | 3 / 79 |
| serious Total, serious adverse events | 0 / 153 | 5 / 157 | 1 / 75 | 1 / 79 |
Outcome results
Primary
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.
Time frame: Baseline, Month 4
Population: Intent-to-treat (ITT) Population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimatoprost Formulation A Solution | Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA) | 82.4 percentage of participants |
| Bimatoprost Solution 0.03 % | Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA) | 83.4 percentage of participants |
| Vehicle of Bimatoprost Formulation A Solution | Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA) | 24.0 percentage of participants |
| Vehicle of Bimatoprost Solution 0.03 % | Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA) | 20.3 percentage of participants |
Secondary
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).
Time frame: Baseline, Month 4
Population: Participants from the ITT Population, all randomized participants, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost Formulation A Solution | Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA | Baseline | 145.33 intensity units | Standard Deviation 24.024 |
| Bimatoprost Formulation A Solution | Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA | Change from Baseline at Month 4 | -23.98 intensity units | Standard Deviation 15.719 |
| Bimatoprost Solution 0.03 % | Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA | Change from Baseline at Month 4 | -24.78 intensity units | Standard Deviation 16.417 |
| Bimatoprost Solution 0.03 % | Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA | Baseline | 147.39 intensity units | Standard Deviation 24.934 |
| Vehicle of Bimatoprost Formulation A Solution | Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA | Baseline | 147.44 intensity units | Standard Deviation 22.323 |
| Vehicle of Bimatoprost Formulation A Solution | Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA | Change from Baseline at Month 4 | -2.78 intensity units | Standard Deviation 10.443 |
| Vehicle of Bimatoprost Solution 0.03 % | Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA | Baseline | 145.79 intensity units | Standard Deviation 26.67 |
| Vehicle of Bimatoprost Solution 0.03 % | Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA | Change from Baseline at Month 4 | 0.17 intensity units | Standard Deviation 10.065 |
Secondary
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)
Time frame: Baseline, Month 4
Population: Participants from the ITT Population, all randomized participants, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost Formulation A Solution | Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA) | Baseline | 6.09 mm | Standard Deviation 0.856 |
| Bimatoprost Formulation A Solution | Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA) | Change from Baseline at Month 4 | 1.61 mm | Standard Deviation 0.888 |
| Bimatoprost Solution 0.03 % | Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA) | Change from Baseline at Month 4 | 1.62 mm | Standard Deviation 0.955 |
| Bimatoprost Solution 0.03 % | Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA) | Baseline | 5.97 mm | Standard Deviation 0.789 |
| Vehicle of Bimatoprost Formulation A Solution | Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA) | Baseline | 5.90 mm | Standard Deviation 0.812 |
| Vehicle of Bimatoprost Formulation A Solution | Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA) | Change from Baseline at Month 4 | 0.08 mm | Standard Deviation 0.442 |
| Vehicle of Bimatoprost Solution 0.03 % | Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA) | Baseline | 6.03 mm | Standard Deviation 0.852 |
| Vehicle of Bimatoprost Solution 0.03 % | Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA) | Change from Baseline at Month 4 | 0.05 mm | Standard Deviation 0.482 |
Secondary
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).
Time frame: Baseline Month 4
Population: Participants from the ITT Population, all randomized participants, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost Formulation A Solution | Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA | Baseline | 0.85 mm^2 | Standard Deviation 0.4 |
| Bimatoprost Formulation A Solution | Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA | Change from Baseline At Month 4 | 0.58 mm^2 | Standard Deviation 0.359 |
| Bimatoprost Solution 0.03 % | Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA | Change from Baseline At Month 4 | 0.64 mm^2 | Standard Deviation 0.392 |
| Bimatoprost Solution 0.03 % | Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA | Baseline | 0.82 mm^2 | Standard Deviation 0.404 |
| Vehicle of Bimatoprost Formulation A Solution | Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA | Baseline | 0.76 mm^2 | Standard Deviation 0.333 |
| Vehicle of Bimatoprost Formulation A Solution | Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA | Change from Baseline At Month 4 | 0.02 mm^2 | Standard Deviation 0.196 |
| Vehicle of Bimatoprost Solution 0.03 % | Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA | Baseline | 0.81 mm^2 | Standard Deviation 0.38 |
| Vehicle of Bimatoprost Solution 0.03 % | Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA | Change from Baseline At Month 4 | 0.03 mm^2 | Standard Deviation 0.237 |
Secondary
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.
Time frame: Month 4
Population: ITT Population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimatoprost Formulation A Solution | 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) | 71.2 percentage of participants |
| Bimatoprost Solution 0.03 % | 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) | 65.0 percentage of participants |
| Vehicle of Bimatoprost Formulation A Solution | 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) | 28.0 percentage of participants |
| Vehicle of Bimatoprost Solution 0.03 % | 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) | 20.3 percentage of participants |