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

Primary Purpose

Hypertrichosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bimatoprost Suspension
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrichosis focused on measuring Bimatoprost, Eyelash lengthening, Prostaglandin Analogs, Cosmetics

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Miami, Bascom Palmer Eye Institute

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Bimatoprost Suspension

Arm Description

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.

Outcomes

Primary Outcome Measures

Efficacy of Bimatoprost in Lengthening of Eyelashes
Eyelash growth after application of bimatoprost vs control (split face study).

Secondary Outcome Measures

Full Information

First Posted
October 15, 2008
Last Updated
March 20, 2014
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT00773136
Brief Title
Eyelash Growth From Application of Bimatoprost in Gel Suspension to the Base of the Eyelashes
Official Title
Effect of Bimatoprost (Lumigan) in Gel Suspension Applied to the Eyelashes on Eyelash Growth
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Study completed

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrichosis
Keywords
Bimatoprost, Eyelash lengthening, Prostaglandin Analogs, Cosmetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bimatoprost Suspension
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost Suspension
Other Intervention Name(s)
Lumigan
Intervention Description
see prior
Primary Outcome Measure Information:
Title
Efficacy of Bimatoprost in Lengthening of Eyelashes
Description
Eyelash growth after application of bimatoprost vs control (split face study).
Time Frame
4.5 months (6 weeks of drug application and 3 months after discontinuing)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy W Lee, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami, Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

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

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