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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
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotrichosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
October 6, 2011
Last Updated
April 5, 2013
Sponsor
Allergan
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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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