Trial Outcomes & Findings for Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence (NCT NCT00693420)
NCT ID: NCT00693420
Last Updated: 2013-10-30
Results Overview
The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 \[minimal\], 2 \[moderate\], 3 \[marked\], 4 \[very marked\])
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
278 participants
Primary outcome timeframe
Baseline to Week 16
Results posted on
2013-10-30
Participant Flow
Participant milestones
| Measure |
Bimatoprost 0.03% Solution
|
Vehicle Solution
|
|---|---|---|
|
Overall Study
STARTED
|
137
|
141
|
|
Overall Study
COMPLETED
|
131
|
126
|
|
Overall Study
NOT COMPLETED
|
6
|
15
|
Reasons for withdrawal
| Measure |
Bimatoprost 0.03% Solution
|
Vehicle Solution
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Sponsor Request - Conflict of Interest
|
0
|
2
|
|
Overall Study
Personal Reasons
|
1
|
4
|
Baseline Characteristics
Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence
Baseline characteristics by cohort
| Measure |
Bimatoprost 0.03% Solution
n=137 Participants
|
Vehicle Solution
n=141 Participants
|
Total
n=278 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<45 years
|
44 participants
n=5 Participants
|
43 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Age, Customized
Between 45 and 65 years
|
82 participants
n=5 Participants
|
88 participants
n=7 Participants
|
170 participants
n=5 Participants
|
|
Age, Customized
>65 years
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
134 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
270 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16Population: Intent to Treat Population
The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 \[minimal\], 2 \[moderate\], 3 \[marked\], 4 \[very marked\])
Outcome measures
| Measure |
Bimatoprost 0.03% Solution
n=137 Participants
|
Vehicle Solution
n=141 Participants
|
|---|---|---|
|
Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16
Week 1
|
5.1 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16
Week 4
|
14.6 Percentage of participants
|
7.8 Percentage of participants
|
|
Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16
Week 8
|
50.4 Percentage of participants
|
14.9 Percentage of participants
|
|
Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16
Week 12
|
69.3 Percentage of participants
|
19.9 Percentage of participants
|
|
Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16
Week 16 (Primary Endpoint)
|
78.1 Percentage of participants
|
18.4 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline to Week 20Population: Intent to Treat Population
The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 \[minimal\], 2 \[moderate\], 3 \[marked\], 4 \[very marked\])
Outcome measures
| Measure |
Bimatoprost 0.03% Solution
n=137 Participants
|
Vehicle Solution
n=141 Participants
|
|---|---|---|
|
Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment)
|
78.6 Percentage of participants
|
21.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Intent to Treat Population
Upper eyelash length technologically measured in millimeters
Outcome measures
| Measure |
Bimatoprost 0.03% Solution
n=137 Participants
|
Vehicle Solution
n=141 Participants
|
|---|---|---|
|
Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Week 16 (Primary Endpoint)
|
1.39 millimeters
Standard Deviation 0.908
|
0.11 millimeters
Standard Deviation 0.425
|
|
Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Day 1 (Baseline)
|
5.79 millimeters
Standard Deviation 0.815
|
5.71 millimeters
Standard Deviation 0.814
|
|
Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Week 1
|
0.05 millimeters
Standard Deviation 0.327
|
0.00 millimeters
Standard Deviation 0.327
|
|
Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Week 4
|
0.22 millimeters
Standard Deviation 0.371
|
0.06 millimeters
Standard Deviation 0.382
|
|
Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Week 8
|
0.64 millimeters
Standard Deviation 0.559
|
0.07 millimeters
Standard Deviation 0.396
|
|
Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Week 12
|
1.16 millimeters
Standard Deviation 0.722
|
0.05 millimeters
Standard Deviation 0.425
|
SECONDARY outcome
Timeframe: Baseline to Week 20Population: Intent to Treat Population
Upper eyelash length technologically measured in millimeters
Outcome measures
| Measure |
Bimatoprost 0.03% Solution
n=137 Participants
|
Vehicle Solution
n=141 Participants
|
|---|---|---|
|
Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)
|
1.47 millimeters
Standard Deviation 0.831
|
0.06 millimeters
Standard Deviation 0.431
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Intent to Treat Population
Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.
Outcome measures
| Measure |
Bimatoprost 0.03% Solution
n=137 Participants
|
Vehicle Solution
n=141 Participants
|
|---|---|---|
|
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Day 1 (Baseline)
|
16.16 percentage of AOI (in pixels)
Standard Deviation 8.089
|
16.66 percentage of AOI (in pixels)
Standard Deviation 7.787
|
|
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Week 1
|
0.94 percentage of AOI (in pixels)
Standard Deviation 3.651
|
0.24 percentage of AOI (in pixels)
Standard Deviation 3.161
|
|
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Week 4
|
1.62 percentage of AOI (in pixels)
Standard Deviation 4.031
|
0.81 percentage of AOI (in pixels)
Standard Deviation 3.639
|
|
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Week 8
|
3.48 percentage of AOI (in pixels)
Standard Deviation 5.148
|
0.75 percentage of AOI (in pixels)
Standard Deviation 4.189
|
|
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Week 12
|
9.30 percentage of AOI (in pixels)
Standard Deviation 7.328
|
0.95 percentage of AOI (in pixels)
Standard Deviation 4.398
|
|
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Week 16 (Primary Endpoint)
|
12.21 percentage of AOI (in pixels)
Standard Deviation 8.381
|
1.10 percentage of AOI (in pixels)
Standard Deviation 3.984
|
SECONDARY outcome
Timeframe: Baseline to Week 20Population: Intent to Treat Population
Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.
Outcome measures
| Measure |
Bimatoprost 0.03% Solution
n=137 Participants
|
Vehicle Solution
n=141 Participants
|
|---|---|---|
|
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)
|
11.16 percentage of AOI (in pixels)
Standard Deviation 7.051
|
1.88 percentage of AOI (in pixels)
Standard Deviation 4.470
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Intent to Treat Population
Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)
Outcome measures
| Measure |
Bimatoprost 0.03% Solution
n=137 Participants
|
Vehicle Solution
n=141 Participants
|
|---|---|---|
|
Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Day 1 (Baseline)
|
105.67 intensity unit
Standard Deviation 20.349
|
102.82 intensity unit
Standard Deviation 18.161
|
|
Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Week 1
|
-2.97 intensity unit
Standard Deviation 8.102
|
-1.25 intensity unit
Standard Deviation 8.233
|
|
Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Week 4
|
-5.10 intensity unit
Standard Deviation 10.327
|
-2.91 intensity unit
Standard Deviation 9.363
|
|
Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Week 8
|
-9.11 intensity unit
Standard Deviation 11.824
|
-2.46 intensity unit
Standard Deviation 11.249
|
|
Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Week 12
|
-16.68 intensity unit
Standard Deviation 13.585
|
-4.22 intensity unit
Standard Deviation 11.073
|
|
Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Week 16 (Primary Endpoint)
|
-20.15 intensity unit
Standard Deviation 16.051
|
-3.57 intensity unit
Standard Deviation 10.491
|
SECONDARY outcome
Timeframe: Baseline to Week 20Population: Intent to Treat Population
Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)
Outcome measures
| Measure |
Bimatoprost 0.03% Solution
n=137 Participants
|
Vehicle Solution
n=141 Participants
|
|---|---|---|
|
Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)
|
-20.12 intensity unit
Standard Deviation 14.943
|
-5.51 intensity unit
Standard Deviation 10.789
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 16Population: Intent to Treat Population
"Overall, how satisfied are you with your eyelashes?" Possible Answers on a 5 point scale as follows: 1. \- Very Satisfied 2. \- Satisfied 3. \- Neutral 4. \- Unsatisfied 5. \- Very Unsatisfied
Outcome measures
| Measure |
Bimatoprost 0.03% Solution
n=137 Participants
|
Vehicle Solution
n=141 Participants
|
|---|---|---|
|
Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16
Day 1 (Baseline)
|
4.18 score on a scale
Standard Deviation 0.788
|
4.16 score on a scale
Standard Deviation 0.789
|
|
Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16
Week 1
|
0.06 score on a scale
Standard Deviation 0.466
|
-0.06 score on a scale
Standard Deviation 0.550
|
|
Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16
Week 4
|
-0.25 score on a scale
Standard Deviation 0.829
|
-0.35 score on a scale
Standard Deviation 0.728
|
|
Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16
Week 8
|
-0.90 score on a scale
Standard Deviation 1.107
|
-0.57 score on a scale
Standard Deviation 0.943
|
|
Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16
Week 12
|
-1.48 score on a scale
Standard Deviation 1.207
|
-0.67 score on a scale
Standard Deviation 0.939
|
|
Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16
Week 16 (Primary Endpoint)
|
-1.89 score on a scale
Standard Deviation 1.253
|
-0.70 score on a scale
Standard Deviation 1.074
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 20Population: Intent to Treat Population
"Overall, how satisfied are you with your eyelashes?" Possible Answers on a 5 point scale as follows: (1 - Very Satisfied; 2 - Satisfied; 3 - Neutral; 4 - Unsatisfied; 5 - Very Unsatisfied)
Outcome measures
| Measure |
Bimatoprost 0.03% Solution
n=137 Participants
|
Vehicle Solution
n=141 Participants
|
|---|---|---|
|
Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment)
|
-2.06 score on a scale
Standard Deviation 1.345
|
-0.61 score on a scale
Standard Deviation 1.128
|
Adverse Events
Bimatoprost 0.03% Solution
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Vehicle Solution
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bimatoprost 0.03% Solution
|
Vehicle Solution
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the skin (back)
|
0.73%
1/137
|
0.00%
0/141
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/137
|
0.71%
1/141
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Metastatic
|
0.00%
0/137
|
0.71%
1/141
|
Other adverse events
| Measure |
Bimatoprost 0.03% Solution
|
Vehicle Solution
|
|---|---|---|
|
Eye disorders
Eye pruritus
|
3.6%
5/137
|
0.71%
1/141
|
|
Eye disorders
Conjunctival hyperaemia
|
3.6%
5/137
|
0.00%
0/141
|
|
Eye disorders
Pinguecula
|
2.2%
3/137
|
2.1%
3/141
|
|
Eye disorders
Eye Irritation
|
2.2%
3/137
|
1.4%
2/141
|
|
Eye disorders
Dry Eye
|
2.2%
3/137
|
0.71%
1/141
|
|
Eye disorders
Erythema of eyelid
|
2.2%
3/137
|
0.71%
1/141
|
|
Eye disorders
Eyelids pruritus
|
0.73%
1/137
|
1.4%
2/141
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/137
|
1.4%
2/141
|
|
Immune system disorders
Seasonal allergy
|
1.5%
2/137
|
0.00%
0/141
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
2/137
|
3.5%
5/141
|
|
Infections and infestations
Sinusitis
|
1.5%
2/137
|
1.4%
2/141
|
|
Infections and infestations
Influenza
|
1.5%
2/137
|
0.00%
0/141
|
|
Infections and infestations
Urinary Tract Infection
|
0.73%
1/137
|
1.4%
2/141
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blepharal Papilloma
|
1.5%
2/137
|
0.00%
0/141
|
|
Skin and subcutaneous tissue disorders
Skin Hyper pigmentation
|
2.9%
4/137
|
0.71%
1/141
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
1.5%
2/137
|
0.00%
0/141
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At least ninety (90) days prior to any proposed submission for publication or presentation of Study data or other findings related to the Study, the Institution will provide the Sponsor with a manuscript of such submission(s) for review and comment.
- Publication restrictions are in place
Restriction type: OTHER