Trial Outcomes & Findings for Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children (NCT NCT01023841)

Results Overview

An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

71 participants

Primary outcome timeframe

5 Months

Results posted on

2019-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	Bimatoprost Ophthalmic Solution 0.03% One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.	Vehicle Sterile Solution One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
Overall Study STARTED	48	23
Overall Study COMPLETED	47	23
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bimatoprost Ophthalmic Solution 0.03% n=48 Participants One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.	Vehicle Sterile Solution n=23 Participants One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.	Total n=71 Participants Total of all reporting groups
Age, Customized 5-11 years	6 participants n=5 Participants	3 participants n=7 Participants	9 participants n=5 Participants
Age, Customized 12-17 years	42 participants n=5 Participants	20 participants n=7 Participants	62 participants n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	16 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 Months

Population: Safety population included all randomized participants who received treatment.

An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.

Outcome measures

Outcome measures
Measure	Bimatoprost Ophthalmic Solution 0.03% n=48 Participants One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.	Vehicle Sterile Solution n=23 Participants One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
Percentage of Participants With Adverse Events	35.4 Percentage of participants	43.5 Percentage of participants

PRIMARY outcome

Timeframe: Baseline, Month 4

Population: Intent-to-treat population included all randomized participants.

The physician 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

Outcome measures
Measure	Bimatoprost Ophthalmic Solution 0.03% n=48 Participants One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.	Vehicle Sterile Solution n=23 Participants One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score	70.8 Percentage of participants	26.1 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: 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

Outcome measures
Measure	Bimatoprost Ophthalmic Solution 0.03% n=48 Participants One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.	Vehicle Sterile Solution n=23 Participants One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA) Baseline	6.83 mm Standard Deviation 2.568	6.04 mm Standard Deviation 2.915
Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA) Change from Baseline at Month 4	1.12 mm Standard Deviation 1.626	0.67 mm Standard Deviation 1.846

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: Participants from the Intent-to-treat population, that included all randomized participants, with data available at Baseline and Month 4.

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

Outcome measures
Measure	Bimatoprost Ophthalmic Solution 0.03% n=48 Participants One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.	Vehicle Sterile Solution n=22 Participants One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
Change From Baseline in Upper Eyelash Thickness as Measured by DIA Baseline	1.20 mm^2 Standard Deviation 0.738	1.18 mm^2 Standard Deviation 0.862
Change From Baseline in Upper Eyelash Thickness as Measured by DIA Change from Baseline at Month 4	0.41 mm^2 Standard Deviation 0.535	0.05 mm^2 Standard Deviation 0.449

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: Participants from the Intent-to-treat population, that included all randomized participants, with data available at Baseline and Month 4.

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

Outcome measures
Measure	Bimatoprost Ophthalmic Solution 0.03% n=43 Participants One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.	Vehicle Sterile Solution n=19 Participants One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
Change From Baseline in Upper Eyelash Darkness as Measured by DIA Baseline	143.78 Intensity units Standard Deviation 20.446	143.44 Intensity units Standard Deviation 25.844
Change From Baseline in Upper Eyelash Darkness as Measured by DIA Change from Baseline at Month 4	-15.34 Intensity units Standard Deviation 15.724	-5.47 Intensity units Standard Deviation 12.289

Adverse Events

Bimatoprost Ophthalmic Solution 0.03%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle Sterile Solution

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bimatoprost Ophthalmic Solution 0.03% n=48 participants at risk One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.	Vehicle Sterile Solution n=23 participants at risk One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/37	6.2% 1/16

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

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