An Observational Study of Patients Treated With Bimatoprost 0.03% (Latisse®) for Hypotrichosis of the Eyelashes

April 3, 2019 updated by: Allergan
This is an observational study of patients treated with bimatoprost 0.03% (Latisse®) for at least 12 months for hypotrichosis of the eyelashes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

585

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with hypotrichosis of the eyelashes

Description

Inclusion Criteria:

  • Hypotrichosis of the eyelashes
  • Using bimatoprost ophthalmic solution 0.03% (Latisse®) for at least 12 months

Exclusion Criteria:

  • Use of any over-the-counter medication(s) for eyelash growth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hypotrichosis of the Eyelashes
Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
Drug: bimatoprost 0.03%
Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
Other Names:
  • Latisse®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Satisfied With Latisse®
Time Frame: Day 1
Overall subject satisfaction with Latisse® was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Applications of Latisse® Per Week
Time Frame: Day 1
Number of applications of Latisse® per week as reported by the subjects.
Day 1
Percentage of Subjects Satisfied Wtih Their Eyelashes
Time Frame: Day 1
Overall subject satisfaction with their eyelashes was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

June 18, 2012

First Submitted That Met QC Criteria

June 18, 2012

First Posted (Estimate)

June 20, 2012

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMA-LTS-10-001
  • CED2009 (Other Identifier: Allergan)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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