Trial Outcomes & Findings for Safety and Efficacy of LATISSE® in the Augmentation of Eyelashes of Korean Subjects (NCT NCT01229423)

NCT ID: NCT01229423

Last Updated: 2019-01-29

Results Overview

Change from baseline in eyelash length at Week 20. Measurements made were based on the mean length of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash length, and a negative change from baseline indicates a decrease in eyelash length.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 62 participants
• Primary outcome timeframe: Baseline, Week 20
• Results posted on: 2019-01-29

Participant Flow

Participant milestones

Measure	LATISSE® bimatoprost 0.03% (LATISSE®)
Overall Study STARTED	62
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of LATISSE® in the Augmentation of Eyelashes of Korean Subjects

Baseline characteristics by cohort

Measure	LATISSE® n=62 Participants bimatoprost 0.03% (LATISSE®)
Age, Continuous	37.3 years STANDARD_DEVIATION 6.69 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 20

Population: Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.

Change from baseline in eyelash length at Week 20. Measurements made were based on the mean length of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash length, and a negative change from baseline indicates a decrease in eyelash length.

Outcome measures

Measure	LATISSE® n=62 Participants bimatoprost 0.03% (LATISSE®)
Change From Baseline in Eyelash Length at Week 20 Baseline	5.92 Millimeter (mm) Standard Deviation 0.72
Change From Baseline in Eyelash Length at Week 20 Change from Baseline at Week 20	1.10 Millimeter (mm) Standard Deviation 0.8

SECONDARY outcome

Timeframe: Week 20

Population: Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.

Percentage of subjects with an improvement of at least 1-point in GEA score at Week 20 from baseline. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence.

Outcome measures

Measure	LATISSE® n=62 Participants bimatoprost 0.03% (LATISSE®)
Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20	81.4 Percentage of Subjects

SECONDARY outcome

Timeframe: Baseline, Week 20

Population: Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.

Change from baseline in eyelash thickness at Week 20. Assessments made were based on the mean thickness of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash thickness, and a negative change from baseline indicates a decrease in eyelash thickness.

Outcome measures

Measure	LATISSE® n=62 Participants bimatoprost 0.03% (LATISSE®)
Change From Baseline in Eyelash Thickness at Week 20 Baseline	1.39 Millimeters Squared (mm^2) Standard Deviation 0.395
Change From Baseline in Eyelash Thickness at Week 20 Change from Baseline at Week 20	0.25 Millimeters Squared (mm^2) Standard Deviation 0.269

SECONDARY outcome

Timeframe: Baseline, Week 20

Population: Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.

Change from baseline in eyelash intensity (darkness) at Week 20. Assessments made were based on the mean eyelash intensity of the upper left and right eyelashes. Intensity was measured on a scale ranging from 0 (black) to 255 (white). A negative change from baseline indicates eyelash darkening in color, and a positive change from baseline indicates eyelash lightening in color.

Outcome measures

Measure	LATISSE® n=62 Participants bimatoprost 0.03% (LATISSE®)
Change From Baseline in Eyelash Intensity (Darkness) at Week 20 Baseline	140.02 Units on a Scale Standard Deviation 15.788
Change From Baseline in Eyelash Intensity (Darkness) at Week 20 Change from Baseline at Week 20	-12.97 Units on a Scale Standard Deviation 13.115

SECONDARY outcome

Timeframe: Week 20

Population: Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.

Percentage of subjects with an improvement in satisfaction with overall eyelash prominence at Week 20. Subject satisfaction with overall eyelash prominence was assessed by response to the question "Overall how satisfied are you with your eyelashes?" Responses were based on a 5-point scale ("very unsatisfied", "unsatisfied", "neutral", "satisfied", "very satisfied"). Improvement in subject satisfaction is defined as a 1-point increase from baseline.

Outcome measures

Measure	LATISSE® n=62 Participants bimatoprost 0.03% (LATISSE®)
Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20	83.05 Percentage of Subjects

SECONDARY outcome

Timeframe: Week 20

Population: Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.

Percentage of subjects satisfied with treatment at week 20 was assessed using the Treatment Satisfaction Scale response to the question "Which best describes your satisfaction with LATISSE®?" Responses were "very satisfied", "satisfied", "neutral", "unsatisfied", and "very unsatisfied." Satisfied is defined as responses of "very satisfied" and "satisfied."

Outcome measures

Measure	LATISSE® n=62 Participants bimatoprost 0.03% (LATISSE®)
Percentage of Subjects Satisfied With Treatment at Week 20	83.1 Percentage of Subjects

Adverse Events

LATISSE®

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	LATISSE® n=62 participants at risk bimatoprost 0.03% (LATISSE®)
Eye disorders Conjunctival Hyperaemia	9.7% 6/62
Infections and infestations Nasopharyngitis	14.5% 9/62
Skin and subcutaneous tissue disorders Hypertrichosis	6.5% 4/62
Skin and subcutaneous tissue disorders Skin Hyperpigmentation (eyelid)	12.9% 8/62

Additional Information

Vice President, Medical Affairs

Allergan, Inc.

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place