Trial Outcomes & Findings for An Observational Study of Patients Treated With Bimatoprost 0.03% (Latisse®) for Hypotrichosis of the Eyelashes (NCT NCT01623479)

Results Overview

Overall subject satisfaction with Latisse® was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported.

Recruitment status

COMPLETED

Target enrollment

585 participants

Primary outcome timeframe

Day 1

Results posted on

2019-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	Hypotrichosis of the Eyelashes Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
Overall Study STARTED	585
Overall Study COMPLETED	585
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Observational Study of Patients Treated With Bimatoprost 0.03% (Latisse®) for Hypotrichosis of the Eyelashes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hypotrichosis of the Eyelashes n=585 Participants Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
Age, Continuous	50.54 Years STANDARD_DEVIATION 9.68 • n=5 Participants
Sex: Female, Male Female	580 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Subjects with all study data

Overall subject satisfaction with Latisse® was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported.

Outcome measures

Outcome measures
Measure	Hypotrichosis of the Eyelashes n=585 Participants Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
Percentage of Subjects Satisfied With Latisse®	92.48 Percentage of Subjects

SECONDARY outcome

Timeframe: Day 1

Population: Subjects with all study data

Number of applications of Latisse® per week as reported by the subjects.

Outcome measures

Outcome measures
Measure	Hypotrichosis of the Eyelashes n=585 Participants Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
Number of Applications of Latisse® Per Week	6.69 Number of Applications Standard Deviation 1.13

SECONDARY outcome

Timeframe: Day 1

Population: Subjects with all study data

Overall subject satisfaction with their eyelashes was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported.

Outcome measures

Outcome measures
Measure	Hypotrichosis of the Eyelashes n=585 Participants Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
Percentage of Subjects Satisfied Wtih Their Eyelashes	79.81 Percentage of Subjects

Adverse Events

Hypotrichosis of the Eyelashes

Serious events: 0 serious events

Other events: 155 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Hypotrichosis of the Eyelashes n=585 participants at risk Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	8.7% 51/585
Eye disorders Erythema of the Eyelid	6.0% 35/585
Eye disorders Eye Pruritus	6.2% 36/585
Eye disorders Ocular Irritation	5.6% 33/585

Additional Information

Vice President Medical Affairs,

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