Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence
Primary Purpose
Hypotrichosis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bimatoprost ophthalmic solution 0.03%
bimatoprost vehicle solution
Sponsored by
About this trial
This is an interventional treatment trial for Hypotrichosis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
bimatoprost ophthalmic solution 0.03%
bimatoprost vehicle solution
Arm Description
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.
One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01448525
Brief Title
Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine patient satisfaction with LATISSE® treatment for increasing eyelash prominence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotrichosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bimatoprost ophthalmic solution 0.03%
Arm Type
Active Comparator
Arm Description
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.
Arm Title
bimatoprost vehicle solution
Arm Type
Placebo Comparator
Arm Description
One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
bimatoprost ophthalmic solution 0.03%
Other Intervention Name(s)
LATISSE®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
bimatoprost vehicle solution
Intervention Description
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 Measure Information:
Title
Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score
Description
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.
Time Frame
Baseline, Week 16
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Coral Gables
State/Province
Florida
Country
United States
12. IPD Sharing Statement
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Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence
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