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Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence

NCT ID: NCT01064882

Last Updated: 2011-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-07-31

Brief Summary

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This study will evaluate the safety and efficacy of bimatoprost ophthalmic solution 0.005% or 0.015% compared with bimatoprost ophthalmic solution 0.03% once-daily application to the upper eyelid margins in increasing eyelash prominence

Detailed Description

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Conditions

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Eyelash Hypotrichosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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bimatoprost ophthalmic solution 0.005%

bimatoprost ophthalmic sterile solution 0.005%

Group Type EXPERIMENTAL

bimatoprost ophthalmic solution 0.005%

Intervention Type DRUG

One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)

bimatoprost ophthalmic solution 0.015%

bimatoprost ophthalmic sterile solution 0.015%

Group Type EXPERIMENTAL

bimatoprost ophthalmic solution 0.015%

Intervention Type DRUG

One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)

bimatoprost ophthalmic solution 0.03%

bimatoprost ophthalmic solution 0.03%

Group Type ACTIVE_COMPARATOR

bimatoprost ophthalmic solution 0.03%

Intervention Type DRUG

One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)

Interventions

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bimatoprost ophthalmic solution 0.005%

One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)

Intervention Type DRUG

bimatoprost ophthalmic solution 0.015%

One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)

Intervention Type DRUG

bimatoprost ophthalmic solution 0.03%

One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)

Intervention Type DRUG

Other Intervention Names

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LATISSE®

Eligibility Criteria

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Inclusion Criteria

* Female Caucasians between 30 and 55 years of age, with hypotrichosis (inadequate or not enough) of the eyelashes
* Eyelash prominence assessment of minimal or moderate

Exclusion Criteria

* Any eye disease or abnormality
* Any permanent eyeliner or eyelash implants of any kind
* Any ocular surgery, semi-permanent eyelash tint, or eyelash extension application during the 3 months prior to study entry
* Any use of prescription eyelash growth products
* Any use of over the counter eyelash growth products during the 6 months prior to baseline
* Any use of treatments that may affect hair growth during the 6 months prior to baseline
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 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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San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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192024-051

Identifier Type: -

Identifier Source: org_study_id