Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence

Hypotrichosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448525
• Other study ID #: GMA-LTS-11-002
• Status: Completed
• Phase: Phase 4
• First received: October 6, 2011
• Last updated: April 5, 2013
• Start date: October 2011
• Est. completion date: April 2012

Study information

• Verified date: April 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypotrichosis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall	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.	Week 16	No
Secondary	Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score	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.	Baseline, Week 16	No