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Clinical Trials/NCT00773136
NCT00773136CompletedNot Applicable

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

University of Miami1 site in 1 country21 target enrollmentStarted: February 2008Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Efficacy of Bimatoprost in Lengthening of Eyelashes

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Bimatoprost Suspension

Active Comparator

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: Bimatoprost Suspension (Drug)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sara T. Wester

Assistant Professor

University of Miami

Study Sites (1)

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