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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sara T. Wester, University of Miami
ClinicalTrials.gov Identifier:
NCT00773136
First received: October 15, 2008
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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 Intervention
Hypertrichosis
Drug: Bimatoprost Suspension

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Bimatoprost (Lumigan) in Gel Suspension Applied to the Eyelashes on Eyelash Growth

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Efficacy of Bimatoprost in Lengthening of Eyelashes [ Time Frame: 4.5 months (6 weeks of drug application and 3 months after discontinuing) ] [ Designated as safety issue: No ]
    Eyelash growth after application of bimatoprost vs control (split face study).


Enrollment: 21
Study Start Date: February 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Study completed

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773136

Locations
United States, Florida
University of Miami, Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Wendy W Lee, MD University of Miami
  More Information

No publications provided

Responsible Party: Sara T. Wester, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00773136     History of Changes
Other Study ID Numbers: 20070706
Study First Received: October 15, 2008
Results First Received: June 22, 2013
Last Updated: March 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Bimatoprost
Eyelash lengthening
Prostaglandin Analogs
Cosmetics

Additional relevant MeSH terms:
Hypertrichosis
Hirsutism
Hair Diseases
Skin Diseases
Virilism
Signs and Symptoms
Bimatoprost
Cloprostenol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014