Trial Outcomes & Findings for Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence (NCT NCT01064882)
NCT ID: NCT01064882
Last Updated: 2011-12-09
Results Overview
Change from Baseline at Month 3 in eyelash length, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length.
COMPLETED
PHASE2
104 participants
Baseline, Month 3
2011-12-09
Participant Flow
Participant milestones
| Measure |
Bimatoprost Ophthalmic Solution 0.005%
bimatoprost ophthalmic sterile solution 0.005%
|
Bimatoprost Ophthalmic Solution 0.015%
bimatoprost ophthalmic sterile solution 0.015%
|
Bimatoprost Ophthalmic Solution 0.03%
bimatoprost ophthalmic solution 0.03%
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
34
|
|
Overall Study
COMPLETED
|
34
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence
Baseline characteristics by cohort
| Measure |
Bimatoprost Ophthalmic Solution 0.005%
n=36 Participants
bimatoprost ophthalmic sterile solution 0.005%
|
Bimatoprost Ophthalmic Solution 0.015%
n=34 Participants
bimatoprost ophthalmic sterile solution 0.015%
|
Bimatoprost Ophthalmic Solution 0.03%
n=34 Participants
bimatoprost ophthalmic solution 0.03%
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
46.9 years
n=5 Participants
|
45.4 years
n=7 Participants
|
46.7 years
n=5 Participants
|
46.3 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3Population: Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one-follow-up visit. (Note that one subject in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.)
Change from Baseline at Month 3 in eyelash length, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length.
Outcome measures
| Measure |
Bimatoprost Ophthalmic Solution 0.005%
n=36 Participants
bimatoprost ophthalmic sterile solution 0.005%
|
Bimatoprost Ophthalmic Solution 0.015%
n=33 Participants
bimatoprost ophthalmic sterile solution 0.015%
|
Bimatoprost Ophthalmic Solution 0.03%
n=34 Participants
bimatoprost ophthalmic solution 0.03%
|
|---|---|---|---|
|
Change From Baseline in Eyelash Length at Month 3
Change from Baseline at Month 3
|
0.74 millimeters (mm)
Standard Deviation 0.684
|
0.92 millimeters (mm)
Standard Deviation 0.668
|
1.36 millimeters (mm)
Standard Deviation 0.944
|
|
Change From Baseline in Eyelash Length at Month 3
Baseline
|
5.65 millimeters (mm)
Standard Deviation 0.763
|
5.68 millimeters (mm)
Standard Deviation 0.613
|
5.95 millimeters (mm)
Standard Deviation 0.744
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit. (Note that 2 subjects in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.)
Change from baseline in upper eyelash thickness/fullness at Month 3 was measured within 3 preset areas. Eyelash thickness/fullness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm\^2). Changes from baseline to Month 3 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness.
Outcome measures
| Measure |
Bimatoprost Ophthalmic Solution 0.005%
n=36 Participants
bimatoprost ophthalmic sterile solution 0.005%
|
Bimatoprost Ophthalmic Solution 0.015%
n=32 Participants
bimatoprost ophthalmic sterile solution 0.015%
|
Bimatoprost Ophthalmic Solution 0.03%
n=34 Participants
bimatoprost ophthalmic solution 0.03%
|
|---|---|---|---|
|
Change From Baseline in Upper Eyelash Thickness at Month 3
Baseline
|
12.75 Millimeters squared (mm^2)
Standard Deviation 5.502
|
14.67 Millimeters squared (mm^2)
Standard Deviation 7.540
|
13.69 Millimeters squared (mm^2)
Standard Deviation 6.753
|
|
Change From Baseline in Upper Eyelash Thickness at Month 3
Change from Baseline at Month 3
|
4.50 Millimeters squared (mm^2)
Standard Deviation 4.760
|
5.64 Millimeters squared (mm^2)
Standard Deviation 5.238
|
8.48 Millimeters squared (mm^2)
Standard Deviation 7.387
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit. (Note that 2 subjects in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.)
Change from baseline in upper eyelash darkness at Month 3 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. Therefore, a change from baseline to Month 3 represented by a negative value indicated increased eyelash darkening.
Outcome measures
| Measure |
Bimatoprost Ophthalmic Solution 0.005%
n=36 Participants
bimatoprost ophthalmic sterile solution 0.005%
|
Bimatoprost Ophthalmic Solution 0.015%
n=32 Participants
bimatoprost ophthalmic sterile solution 0.015%
|
Bimatoprost Ophthalmic Solution 0.03%
n=34 Participants
bimatoprost ophthalmic solution 0.03%
|
|---|---|---|---|
|
Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3
Change from Baseline at Month 3
|
-18.75 Units on a Scale
Standard Deviation 23.276
|
-26.55 Units on a Scale
Standard Deviation 22.505
|
-29.61 Units on a Scale
Standard Deviation 20.443
|
|
Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3
Baseline
|
157.14 Units on a Scale
Standard Deviation 22.814
|
154.41 Units on a Scale
Standard Deviation 21.065
|
162.41 Units on a Scale
Standard Deviation 17.321
|
SECONDARY outcome
Timeframe: Month 3Population: Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit.
Percentage of subjects with a clinical response in overall eyelash prominence at Month 3 was measured using a 4-point GEA scale with the aid of the photonumeric guide. The scale ranges from 1 (minimal = worst) prominence to 4 (very marked = best)prominence. Eyelash prominence was assessed and graded by the investigator over both eyes. A clinical response was defined as at least a 1-grade increase in GEA score from baseline to Month 3.
Outcome measures
| Measure |
Bimatoprost Ophthalmic Solution 0.005%
n=36 Participants
bimatoprost ophthalmic sterile solution 0.005%
|
Bimatoprost Ophthalmic Solution 0.015%
n=34 Participants
bimatoprost ophthalmic sterile solution 0.015%
|
Bimatoprost Ophthalmic Solution 0.03%
n=34 Participants
bimatoprost ophthalmic solution 0.03%
|
|---|---|---|---|
|
Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3
|
52.8 Percentage of Subjects
|
79.4 Percentage of Subjects
|
85.3 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit.
Change from baseline at Month 3 in question 3 "overall, how satisfied are you with your eyelashes?" Responses ranged from 1 (very unsatisfied = worst) to 5 (very satisfied = best). Individual responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline.
Outcome measures
| Measure |
Bimatoprost Ophthalmic Solution 0.005%
n=36 Participants
bimatoprost ophthalmic sterile solution 0.005%
|
Bimatoprost Ophthalmic Solution 0.015%
n=34 Participants
bimatoprost ophthalmic sterile solution 0.015%
|
Bimatoprost Ophthalmic Solution 0.03%
n=34 Participants
bimatoprost ophthalmic solution 0.03%
|
|---|---|---|---|
|
Change From Baseline in Overall Eyelash Satisfaction at Month 3
Baseline
|
1.47 Scores on a Scale
Standard Deviation 0.560
|
1.56 Scores on a Scale
Standard Deviation 0.613
|
1.71 Scores on a Scale
Standard Deviation 0.524
|
|
Change From Baseline in Overall Eyelash Satisfaction at Month 3
Change from Baseline at Month 3
|
1.35 Scores on a Scale
Standard Deviation 1.323
|
2.25 Scores on a Scale
Standard Deviation 1.368
|
2.06 Scores on a Scale
Standard Deviation 0.840
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit.
Change from baseline in the CAP domain at Month 3 included responses to questions 7, 8, and 9. Responses to each question ranged from 1 (very much disagree = worst) to 5 (very much agree = best) with the minimum sum of the scores for the domain equal to 3 and the maximum sum of the scores for the domain equal to 15. Domain responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline.
Outcome measures
| Measure |
Bimatoprost Ophthalmic Solution 0.005%
n=36 Participants
bimatoprost ophthalmic sterile solution 0.005%
|
Bimatoprost Ophthalmic Solution 0.015%
n=34 Participants
bimatoprost ophthalmic sterile solution 0.015%
|
Bimatoprost Ophthalmic Solution 0.03%
n=34 Participants
bimatoprost ophthalmic solution 0.03%
|
|---|---|---|---|
|
Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3
Change from Baseline at Month 3
|
2.79 Scores on a Scale
Standard Deviation 3.198
|
4.72 Scores on a Scale
Standard Deviation 3.752
|
3.06 Scores on a Scale
Standard Deviation 2.526
|
|
Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3
Baseline
|
4.33 Scores on a Scale
Standard Deviation 2.098
|
4.53 Scores on a Scale
Standard Deviation 1.830
|
4.94 Scores on a Scale
Standard Deviation 2.029
|
SECONDARY outcome
Timeframe: Month 3Population: Modified Intent-to-Treat: All randomized subjects who were treated with the intended study medication and completed at least one follow-up visit.(Note: 2 subjects in the Bim 0.015% treatment group, 1 subject in the Bim 0.005% treatment group, and 1 subject in the Bim 0.03% treatment group did not have Month 3 visit data for this outcome measure)
The Treatment Satisfaction Questionnaire at Month 3 consisted of 2 questions that collected information regarding subject satisfaction with the treatment overall. The questions assessed the likelihood that the subject would use the product, as well as the likelihood that the subject would recommend the product to family and/or friends, if it were available. The score was based on the responses to each question. Questions were answered on a 5-point scale ranging from 1 (very unlikely = worst) to 5 (very likely = best).
Outcome measures
| Measure |
Bimatoprost Ophthalmic Solution 0.005%
n=35 Participants
bimatoprost ophthalmic sterile solution 0.005%
|
Bimatoprost Ophthalmic Solution 0.015%
n=32 Participants
bimatoprost ophthalmic sterile solution 0.015%
|
Bimatoprost Ophthalmic Solution 0.03%
n=33 Participants
bimatoprost ophthalmic solution 0.03%
|
|---|---|---|---|
|
Treatment Satisfaction Questionnaire Score at Month 3
If Avail, How Likely Would You Continue to Use It?
|
4.1 Scores on a Scale
Standard Deviation 1.21
|
4.2 Scores on a Scale
Standard Deviation 1.14
|
4.1 Scores on a Scale
Standard Deviation 0.93
|
|
Treatment Satisfaction Questionnaire Score at Month 3
If Avail, How Likely Would You Recommend It?
|
4.1 Scores on a Scale
Standard Deviation 1.26
|
4.2 Scores on a Scale
Standard Deviation 1.07
|
4.4 Scores on a Scale
Standard Deviation 0.61
|
Adverse Events
Bimatoprost Ophthalmic Solution 0.005%
Bimatoprost Ophthalmic Solution 0.015%
Bimatoprost Ophthalmic Solution 0.03%
Serious adverse events
| Measure |
Bimatoprost Ophthalmic Solution 0.005%
n=36 participants at risk
bimatoprost ophthalmic sterile solution 0.005%
|
Bimatoprost Ophthalmic Solution 0.015%
n=34 participants at risk
bimatoprost ophthalmic sterile solution 0.015%
|
Bimatoprost Ophthalmic Solution 0.03%
n=34 participants at risk
bimatoprost ophthalmic solution 0.03%
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/36
|
2.9%
1/34
|
0.00%
0/34
|
Other adverse events
| Measure |
Bimatoprost Ophthalmic Solution 0.005%
n=36 participants at risk
bimatoprost ophthalmic sterile solution 0.005%
|
Bimatoprost Ophthalmic Solution 0.015%
n=34 participants at risk
bimatoprost ophthalmic sterile solution 0.015%
|
Bimatoprost Ophthalmic Solution 0.03%
n=34 participants at risk
bimatoprost ophthalmic solution 0.03%
|
|---|---|---|---|
|
Eye disorders
Eyelids Pruritus
|
0.00%
0/36
|
8.8%
3/34
|
5.9%
2/34
|
|
Eye disorders
Eyelid Pain
|
0.00%
0/36
|
5.9%
2/34
|
0.00%
0/34
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/36
|
5.9%
2/34
|
0.00%
0/34
|
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