Trial Outcomes & Findings for Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence (NCT NCT01448525)

Results Overview

Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: "Overall, how satisfied are you with your eyelashes?" using a 5-point scale: -2=very unsatisfied (worst), -1=unsatisfied, 0=neutral, 1=satisfied or 2=very satisfied (best). The percentage of participants who rated their satisfaction as 1=satisfied or 2=very satisfied at Week 16 is reported.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

88 participants

Primary outcome timeframe

Week 16

Results posted on

2013-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	Bimatoprost Ophthalmic Solution 0.03% One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.	Bimatoprost Vehicle Solution One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
Overall Study STARTED	44	44
Overall Study COMPLETED	43	42
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bimatoprost Ophthalmic Solution 0.03% n=44 Participants One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.	Bimatoprost Vehicle Solution n=44 Participants One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.	Total n=88 Participants Total of all reporting groups
Age Continuous	49.2 Years STANDARD_DEVIATION 12.6 • n=5 Participants	50.2 Years STANDARD_DEVIATION 10.5 • n=7 Participants	49.7 Years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	44 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Population: Intent to treat population included all randomized participants who had at least 1 post-baseline efficacy assessment.

Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: "Overall, how satisfied are you with your eyelashes?" using a 5-point scale: -2=very unsatisfied (worst), -1=unsatisfied, 0=neutral, 1=satisfied or 2=very satisfied (best). The percentage of participants who rated their satisfaction as 1=satisfied or 2=very satisfied at Week 16 is reported.

Outcome measures

Outcome measures
Measure	Bimatoprost Ophthalmic Solution 0.03% n=43 Participants One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.	Bimatoprost Vehicle Solution n=42 Participants One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall	67.4 Percentage of participants	7.1 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Intent to treat population included all randomized participants who had at least 1 post-baseline efficacy assessment.

The investigator evaluated the patient's overall eyelash prominence using the 4-point GEA scale: 1=minimal (worst), 2=moderate, 3=marked or 4=very marked (best). An at least a 1-grade increase in GEA score indicated improvement.

Outcome measures

Outcome measures
Measure	Bimatoprost Ophthalmic Solution 0.03% n=43 Participants One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.	Bimatoprost Vehicle Solution n=42 Participants One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score	72.1 Percentage of participants 0.37	19.0 Percentage of participants 0.43

Adverse Events

Bimatoprost Ophthalmic Solution 0.03%

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Bimatoprost Vehicle Solution

Serious events: 0 serious events

Other events: 3 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=44 participants at risk One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.	Bimatoprost Vehicle Solution n=44 participants at risk One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
Infections and infestations Nasopharyngitis	2.3% 1/44 Treatment-emergent adverse events are presented.	6.8% 3/44 Treatment-emergent adverse events are presented.

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