Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence

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

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Key information

Conditions

Hypotrichosis Hair Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Coral Gables, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bimatoprost ophthalmic solution 0.03%

Drug

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.

Other names: LATISSE®

bimatoprost vehicle solution

Drug

One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.

Primary outcomes

Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall

Time frame: 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 outcomes

Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Oct 7, 2011
Registry last updated: May 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed