Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence

NCT ID: NCT01448525

Last Updated: 2013-05-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-04-30

Brief Summary

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

Detailed Description

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Conditions

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Hypotrichosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

bimatoprost ophthalmic solution 0.03%

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

bimatoprost vehicle solution

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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LATISSE®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Coral Gables, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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GMA-LTS-11-002

Identifier Type: -

Identifier Source: org_study_id

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