Trial Outcomes & Findings for Bimatoprost in the Treatment of Eyelash Hypotrichosis (NCT NCT01698554)
NCT ID: NCT01698554
Last Updated: 2015-02-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
464 participants
Primary outcome timeframe
Baseline, Month 4
Results posted on
2015-02-10
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
153
|
157
|
75
|
79
|
|
Overall Study
COMPLETED
|
147
|
147
|
73
|
77
|
|
Overall Study
NOT COMPLETED
|
6
|
10
|
2
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
5
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Overall Study
Personal Reasons
|
0
|
5
|
1
|
1
|
|
Overall Study
Protocol Violation
|
2
|
0
|
1
|
0
|
|
Overall Study
Other Miscellaneous Reasons
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Bimatoprost in the Treatment of Eyelash Hypotrichosis
Baseline characteristics by cohort
| Measure |
Bimatoprost Formulation A Solution
n=153 Participants
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 %
n=157 Participants
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
n=75 Participants
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 %
n=79 Participants
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.
|
Total
n=464 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<45 years
|
27 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
Age, Customized
45 to 65 years
|
104 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
312 Participants
n=21 Participants
|
|
Age, Customized
>65 years
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
457 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 4Population: Intent-to-treat (ITT) Population included all randomized participants.
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.
Outcome measures
| Measure |
Bimatoprost Formulation A Solution
n=153 Participants
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 %
n=157 Participants
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
n=75 Participants
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 %
n=79 Participants
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.
|
|---|---|---|---|---|
|
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
|
83.4 percentage of participants
|
24.0 percentage of participants
|
20.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 4Population: Participants from the ITT Population, all randomized participants, with data available for analysis.
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)
Outcome measures
| Measure |
Bimatoprost Formulation A Solution
n=152 Participants
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 %
n=157 Participants
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
n=75 Participants
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 %
n=79 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)
Baseline
|
6.09 mm
Standard Deviation 0.856
|
5.97 mm
Standard Deviation 0.789
|
5.90 mm
Standard Deviation 0.812
|
6.03 mm
Standard Deviation 0.852
|
|
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
|
1.62 mm
Standard Deviation 0.955
|
0.08 mm
Standard Deviation 0.442
|
0.05 mm
Standard Deviation 0.482
|
SECONDARY outcome
Timeframe: Baseline Month 4Population: Participants from the ITT Population, all randomized participants, with data available for analysis.
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).
Outcome measures
| Measure |
Bimatoprost Formulation A Solution
n=151 Participants
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 %
n=156 Participants
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
n=74 Participants
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 %
n=78 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA
Baseline
|
0.85 mm^2
Standard Deviation 0.400
|
0.82 mm^2
Standard Deviation 0.404
|
0.76 mm^2
Standard Deviation 0.333
|
0.81 mm^2
Standard Deviation 0.380
|
|
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
|
0.64 mm^2
Standard Deviation 0.392
|
0.02 mm^2
Standard Deviation 0.196
|
0.03 mm^2
Standard Deviation 0.237
|
SECONDARY outcome
Timeframe: Baseline, Month 4Population: Participants from the ITT Population, all randomized participants, with data available for analysis.
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).
Outcome measures
| Measure |
Bimatoprost Formulation A Solution
n=151 Participants
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 %
n=156 Participants
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
n=74 Participants
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 %
n=78 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA
Baseline
|
145.33 intensity units
Standard Deviation 24.024
|
147.39 intensity units
Standard Deviation 24.934
|
147.44 intensity units
Standard Deviation 22.323
|
145.79 intensity units
Standard Deviation 26.670
|
|
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
|
-24.78 intensity units
Standard Deviation 16.417
|
-2.78 intensity units
Standard Deviation 10.443
|
0.17 intensity units
Standard Deviation 10.065
|
SECONDARY outcome
Timeframe: Month 4Population: ITT Population included all randomized participants.
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.
Outcome measures
| Measure |
Bimatoprost Formulation A Solution
n=153 Participants
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 %
n=157 Participants
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
n=75 Participants
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 %
n=79 Participants
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.
|
|---|---|---|---|---|
|
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
|
65.0 percentage of participants
|
28.0 percentage of participants
|
20.3 percentage of participants
|
Adverse Events
Bimatoprost Formulation A Solution
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Bimatoprost Solution 0.03 %
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Vehicle of Bimatoprost Formulation A Solution
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Vehicle of Bimatoprost Solution 0.03 %
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bimatoprost Formulation A Solution
n=153 participants at risk
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 %
n=157 participants at risk
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
n=75 participants at risk
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 %
n=79 participants at risk
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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/153
|
0.64%
1/157
|
0.00%
0/75
|
0.00%
0/79
|
|
Infections and infestations
Cellulitis
|
0.00%
0/153
|
0.64%
1/157
|
0.00%
0/75
|
0.00%
0/79
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/153
|
0.64%
1/157
|
0.00%
0/75
|
0.00%
0/79
|
|
Infections and infestations
Pneumonia
|
0.00%
0/153
|
0.64%
1/157
|
0.00%
0/75
|
0.00%
0/79
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/153
|
0.00%
0/157
|
1.3%
1/75
|
0.00%
0/79
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/153
|
0.64%
1/157
|
0.00%
0/75
|
0.00%
0/79
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/150
|
0.00%
0/153
|
0.00%
0/75
|
1.3%
1/79
|
Other adverse events
| Measure |
Bimatoprost Formulation A Solution
n=153 participants at risk
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 %
n=157 participants at risk
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
n=75 participants at risk
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 %
n=79 participants at risk
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.
|
|---|---|---|---|---|
|
Investigations
Intraocular pressure decreased
|
4.6%
7/153
|
5.1%
8/157
|
4.0%
3/75
|
3.8%
3/79
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER