Trial Outcomes & Findings for Eyelash Growth From Application of Bimatoprost in Gel Suspension to the Base of the Eyelashes (NCT NCT00773136)
NCT ID: NCT00773136
Last Updated: 2014-04-16
Results Overview
Eyelash growth after application of bimatoprost vs control (split face study).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
4.5 months (6 weeks of drug application and 3 months after discontinuing)
Results posted on
2014-04-16
Participant Flow
Through study advertisement with IRB approved flyers at the Bascom Palmer Eye Institute, 23 subjects were recruited for initial evaluation. Study recruitment and enrollment began in February 2008 and the study was completed in July of 2008, including 3 month post suspension use evaluations.
Participant milestones
| Measure |
Bimatoprost Mixed With Gonak Into a Gel Suspension
Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Bimatoprost Mixed With Gonak Into a Gel Suspension
Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Eyelash Growth From Application of Bimatoprost in Gel Suspension to the Base of the Eyelashes
Baseline characteristics by cohort
| Measure |
Bimatoprost Mixed With Gonak Into a Gel Suspension
n=21 Participants
Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
|
|---|---|
|
Age, Continuous
|
46 participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=93 Participants
|
|
Eyelash length
<=18 years
|
0 mm
n=93 Participants
|
|
Eyelash length
Between 23 and 69 years
|
21 mm
n=93 Participants
|
|
Eyelash length
>69 years
|
0 mm
n=93 Participants
|
PRIMARY outcome
Timeframe: 4.5 months (6 weeks of drug application and 3 months after discontinuing)Eyelash growth after application of bimatoprost vs control (split face study).
Outcome measures
| Measure |
Bimatoprost Mixed With Gonak Into a Gel Suspension
n=19 Participants
Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
|
Control Group
n=19 Participants
Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
|
|---|---|---|
|
Efficacy of Bimatoprost in Lengthening of Eyelashes
|
2 mm
Standard Deviation 0.001
|
1.1 mm
Standard Deviation 0.001
|
Adverse Events
Bimatoprost Mixed With Gonak Into a Gel Suspension
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bimatoprost Mixed With Gonak Into a Gel Suspension
n=21 participants at risk
Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
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|---|---|
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Eye disorders
Minor Irritation
|
9.5%
2/21 • Number of events 2 • 4.5 months
Serious adverse events = 0 Minor adverse events (irritation) = 2 subjects, discontinued from the study. It was not documented if the adverse events were only seen in the eye with the treatment arm and thus it was documented by subjects.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place