Trial Outcomes & Findings for Study of Bimatoprost Solution in Increasing Eyelash Prominence in African Americans With Eyelash Hypotrichosis (NCT NCT00958035)

NCT ID: NCT00958035

Last Updated: 2012-01-05

Results Overview

Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 89 participants
• Primary outcome timeframe: Month 4
• Results posted on: 2012-01-05

Participant Flow

Participant milestones

Measure	LATISSE® bimatoprost ophthalmic 0.03% solution	Placebo vehicle sterile solution
Overall Study STARTED	46	43
Overall Study COMPLETED	43	39
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Bimatoprost Solution in Increasing Eyelash Prominence in African Americans With Eyelash Hypotrichosis

Baseline characteristics by cohort

Measure	LATISSE® n=46 Participants bimatoprost ophthalmic 0.03% solution	Placebo n=43 Participants vehicle sterile solution	Total n=89 Participants Total of all reporting groups
Age, Customized < 45 years	19 participants n=5 Participants	16 participants n=7 Participants	35 participants n=5 Participants
Age, Customized 45 - 65 years	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants
Age, Customized > 65 years	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	42 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 4

Population: Intent-to-Treat: All randomized subjects

Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence).

Outcome measures

Measure	LATISSE® n=46 Participants bimatoprost ophthalmic 0.03% solution	Placebo n=43 Participants vehicle sterile solution
Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4	69.6 Percentage of Patients	48.8 Percentage of Patients

Adverse Events

LATISSE®

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	LATISSE® n=46 participants at risk bimatoprost ophthalmic 0.03% solution	Placebo n=43 participants at risk vehicle sterile solution
Hepatobiliary disorders Hepatic Failure	2.2% 1/46	0.00% 0/43
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/46	2.3% 1/43

Other adverse events

Measure	LATISSE® n=46 participants at risk bimatoprost ophthalmic 0.03% solution	Placebo n=43 participants at risk vehicle sterile solution
Eye disorders Eyelids Pruritus	6.5% 3/46	7.0% 3/43
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	23.9% 11/46	2.3% 1/43

Additional Information

Therapeutic Area Head

Allergan, Inc.

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

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