Trial Outcomes & Findings for Safety and Efficacy Study of Bimatoprost in Japanese Patients With Eyelash Hypotrichosis (NCT NCT01391273)
NCT ID: NCT01391273
Last Updated: 2019-07-08
Results Overview
The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
173 participants
Primary outcome timeframe
Baseline, Month 4
Results posted on
2019-07-08
Participant Flow
Participant milestones
| Measure |
Bimatoprost Solution 0.03%
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
|
Bimatoprost Vehicle Solution
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
85
|
|
Overall Study
COMPLETED
|
84
|
83
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of Bimatoprost in Japanese Patients With Eyelash Hypotrichosis
Baseline characteristics by cohort
| Measure |
Bimatoprost Solution 0.03%
n=88 Participants
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
|
Bimatoprost Vehicle Solution
n=85 Participants
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 45 Years
|
58 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Age, Customized
45 to 65 Years
|
29 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Age, Customized
>65 Years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
155 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 4Population: Intent to treat population included all randomized participants.
The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.
Outcome measures
| Measure |
Bimatoprost Solution 0.03%
n=88 Participants
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
|
Bimatoprost Vehicle Solution
n=85 Participants
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
|
|---|---|---|
|
Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)
|
77.3 Percentage of participants
|
17.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 4Population: Intent to treat population included all randomized participants.
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 Solution 0.03%
n=88 Participants
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
|
Bimatoprost Vehicle Solution
n=85 Participants
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
|
|---|---|---|
|
Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)
Baseline
|
6.92 mm
Standard Deviation 0.810
|
7.00 mm
Standard Deviation 0.825
|
|
Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)
Change from Baseline at Month 4
|
1.62 mm
Standard Deviation 1.114
|
-0.04 mm
Standard Deviation 0.362
|
SECONDARY outcome
Timeframe: Baseline, Month 4Population: Participants from the Intent to treat population with data available for analysis.
Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm\^2). A positive change from Baseline indicated fuller eyelashes (improvement).
Outcome measures
| Measure |
Bimatoprost Solution 0.03%
n=88 Participants
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
|
Bimatoprost Vehicle Solution
n=84 Participants
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
|
|---|---|---|
|
Change From Baseline in Eyelash Thickness as Measured by DIA
Baseline
|
0.98 mm^2
Standard Deviation 0.318
|
1.01 mm^2
Standard Deviation 0.327
|
|
Change From Baseline in Eyelash Thickness as Measured by DIA
Change from Baseline at Month 4
|
0.35 mm^2
Standard Deviation 0.306
|
-0.03 mm^2
Standard Deviation 0.195
|
SECONDARY outcome
Timeframe: Baseline, Month 4Population: Participants from the Intent to treat population with data available for analysis.
Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness 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 Solution 0.03%
n=88 Participants
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
|
Bimatoprost Vehicle Solution
n=84 Participants
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
|
|---|---|---|
|
Change From Baseline in Eyelash Darkness as Measured by DIA
Baseline
|
147.57 Units on a scale
Standard Deviation 20.340
|
145.27 Units on a scale
Standard Deviation 18.069
|
|
Change From Baseline in Eyelash Darkness as Measured by DIA
Change from Baseline at Month 4
|
-12.02 Units on a scale
Standard Deviation 10.967
|
1.38 Units on a scale
Standard Deviation 10.854
|
Adverse Events
Bimatoprost Solution 0.03%
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Bimatoprost Vehicle Solution
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bimatoprost Solution 0.03%
n=87 participants at risk
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
|
Bimatoprost Vehicle Solution
n=85 participants at risk
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
1.1%
1/87
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/85
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Pyelonephritis
|
1.1%
1/87
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/85
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/87
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.2%
1/85
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/87
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.2%
1/85
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
Other adverse events
| Measure |
Bimatoprost Solution 0.03%
n=87 participants at risk
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
|
Bimatoprost Vehicle Solution
n=85 participants at risk
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
13.8%
12/87
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
7.1%
6/85
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
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