Safety and Efficacy Study of Bimatoprost in Japanese Patients With Eyelash Hypotrichosis

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

PHASE3

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-01

Study Completion Date

2012-05-19

Brief Summary

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This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes.

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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

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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bimatoprost solution 0.03%

One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.

Group Type EXPERIMENTAL

bimatoprost solution 0.03%

Intervention Type DRUG

One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.

bimatoprost vehicle solution

One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.

Group Type PLACEBO_COMPARATOR

bimatoprost vehicle solution

Intervention Type DRUG

One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.

Interventions

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bimatoprost solution 0.03%

One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.

Intervention Type DRUG

bimatoprost vehicle solution

One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.

Intervention Type DRUG

Other Intervention Names

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LATISSE®

Eligibility Criteria

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Inclusion Criteria

* Have inadequate eyelashes

Exclusion Criteria

* Any disease/infection/abnormality of the eye or area around the eye
* Any ocular surgery within 3 months or anticipated need for ocular surgery during the study
* Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes
* Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months
* Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products
* Use of treatments which may affect hair growth (eg, minoxidil, chemotherapy) within 6 months

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No