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

Not Applicable

Completed

• Conditions: Hypertrichosis
• Interventions: Drug: Bimatoprost Suspension

• Registration Number: NCT00773136
• Lead Sponsor: University of Miami

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 Timeline

• Study Start: 2008-02
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2008-10-15
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Results First Submitted: 2013-06-22
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-20
• Last Update Submitted: 2014-03-20
• Results First Posted: 2014-04-16
• Last Update Posted: 2014-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bimatoprost Suspension	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Miami, Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States