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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00773136
Recruitment Status : Completed
First Posted : October 16, 2008
Results First Posted : April 16, 2014
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
Sara T. Wester, University of Miami

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertrichosis Drug: Bimatoprost Suspension Not Applicable

Detailed Description:
Study completed
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Bimatoprost (Lumigan) in Gel Suspension Applied to the Eyelashes on Eyelash Growth
Study Start Date : February 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Bimatoprost

Arms and Interventions
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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 Name: Lumigan


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00773136


Locations
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United States, Florida
University of Miami, Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Wendy W Lee, MD University of Miami
More Information
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Responsible Party: Sara T. Wester, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00773136    
Other Study ID Numbers: 20070706
First Posted: October 16, 2008    Key Record Dates
Results First Posted: April 16, 2014
Last Update Posted: April 16, 2014
Last Verified: March 2014
Keywords provided by Sara T. Wester, University of Miami:
Bimatoprost
Eyelash lengthening
Prostaglandin Analogs
Cosmetics
Additional relevant MeSH terms:
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Hypertrichosis
Hair Diseases
Skin Diseases
Bimatoprost
Antihypertensive Agents