Eyelash Growth From Application of Bimatoprost in Gel Suspension to the Base of the Eyelashes

March 20, 2014 updated by: Sara T. Wester, University of Miami

Effect of Bimatoprost (Lumigan) in Gel Suspension Applied to the Eyelashes on Eyelash Growth

Objective: To determine if Lumigan (bimatoprost) causes increased lash length when used in gel suspension applied to the base of the eyelashes. Methods: Subjects recruited from the Bascom Palmer Eye Institute were screened and those who met inclusion criteria were enrolled. Each participant received two vials of gel suspension, which contained bimatoprost and normal saline, respectively, each mixed 1:1 with GonakTM gel and labeled "right eye" and "left eye" according to randomization. The suspension was applied to the eyelashes every evening on the designated eye for 6 weeks. Lash length was measured with a caliper at enrollment, at weekly intervals during the study and at 1 and 3 months after study completion. Visual acuity, ocular symptoms, intraocular pressure and photographs were documented at these same intervals. Results: The average eyelash growth in the Lumigan group was 2.01mm (vs. control average of 1.13mm) which was a statistically significant difference (p=0.009). The average intraocular pressure decreased equally in both groups (2.14 mmHg). No change in visual acuity or iris discoloration was noted in any of the subjects. Discussion: Our data showed an increase in eyelash length with use of Lumigan in gel suspension, suggesting that it may have eyelash lengthening properties.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study completed

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

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

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami, Bascom Palmer Eye Institute

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

20 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age greater than 20 and less than 90 and patients who have previously used and are comfortable with applying mascara.

Exclusion Criteria:

  • History of glaucoma, uveitis, pregnancy, allergic reaction to prostaglandins or the gel suspension, alopecia, and previous usage of other eyelash growth enhancement.

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Bimatoprost Suspension
Intervention to be administered: Each subject was given two suspensions, one mixed with Bimatoprost and one mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The intervention was the one eye with the Bimatoprost.
Drug: Bimatoprost Suspension
see prior
Other Names:
  • Lumigan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Bimatoprost in Lengthening of Eyelashes
Time Frame: 4.5 months (6 weeks of drug application and 3 months after discontinuing)
Eyelash growth after application of bimatoprost vs control (split face study).
4.5 months (6 weeks of drug application and 3 months after discontinuing)

Collaborators and Investigators

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

Sponsor

University of Miami

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

February 1, 2008

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

October 15, 2008

First Submitted That Met QC Criteria

October 15, 2008

First Posted (ESTIMATE)

October 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 16, 2014

Last Update Submitted That Met QC Criteria

March 20, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20070706

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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