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Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence

NCT ID: NCT00693420

Last Updated: 2013-10-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-12-31

Brief Summary

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This study evaluates the safety and effectiveness of topical bimatoprost solution for enhancing eyelash prominence.

Detailed Description

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Conditions

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Eyelashes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Bimatoprost 0.03% solution

Group Type EXPERIMENTAL

Bimatoprost 0.03% sterile solution

Intervention Type DRUG

Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily.

2

Vehicle solution

Group Type PLACEBO_COMPARATOR

vehicle sterile solution

Intervention Type DRUG

Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily

Interventions

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Bimatoprost 0.03% sterile solution

Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily.

Intervention Type DRUG

vehicle sterile solution

Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily

Intervention Type DRUG

Other Intervention Names

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LUMIGAN®

Eligibility Criteria

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Inclusion Criteria

* Dissatisfaction with eyelash prominence,
* Eyelash prominence assessment of minimal or moderate,
* Ability to provide written informed consent

Exclusion Criteria

* Subjects without visible lashes,
* Asymmetrical (uneven lashes or longer on one side than the other) eyelashes,
* Any eye disease or abnormality,
* Eye surgery,
* Permanent eyeliner,
* Eyelash implants,
* Eyelash extension application,
* Any use of eyelash growth products within 6 months of study entry,
* Treatments that may effect hair growth,
* Subjects requiring eye drop medications for glaucoma,
* Subjects having a situation or condition, which the study doctor feels might put you at risk, may make the study results confusing, or may interfere with the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Allergan, Inc.

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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San Diego, California, United States

Site Status

Vancouver, British Columbia, Canada

Site Status

Countries

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United States Canada

References

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Fagien S, Walt JG, Carruthers J, Cox SE, Wirta D, Weng E, Beddingfield FC 3rd. Patient-reported outcomes of bimatoprost for eyelash growth: results from a randomized, double-masked, vehicle-controlled, parallel-group study. Aesthet Surg J. 2013 Aug 1;33(6):789-98. doi: 10.1177/1090820X13495887. Epub 2013 Jul 19.

Reference Type DERIVED
PMID: 23873891 (View on PubMed)

Other Identifiers

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192024-032

Identifier Type: -

Identifier Source: org_study_id