Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence

Phase 4

Completed

• Conditions: Hypotrichosis
• Interventions: Drug: bimatoprost ophthalmic solution 0.03%; Drug: bimatoprost vehicle solution

• Registration Number: NCT01448525
• Lead Sponsor: Allergan

Brief Summary

The purpose of this study is to determine patient satisfaction with LATISSE® treatment for increasing eyelash prominence.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-04
• Results First Submitted: 2013-04-05
• Results First Submitted QC: 2013-04-05
• Last Update Submitted: 2013-04-05
• Results First Posted: 2013-05-22
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

• Have inadequate eyelashes
• Never used prescription eyelash growth products

Exclusion Criteria

• No visible eyelashes
• Permanent eyeliner or eyelash implants
• Semi-permanent eyelash tint, dye, or extensions within 3 months
• Over-the-counter eyelash growth products within 6 months
• Any disease, infection or abnormality of the eye or area around the eye
• Eye surgery within 3 months, or the anticipated need for eye surgery during the study
• Unable or unwilling to keep contact lenses out during drug application and for 30 minutes after application

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bimatoprost ophthalmic solution 0.03%	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	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall	Week 16	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score	Baseline, Week 16	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.