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

NCT00773136 | Completed Results

• 1 other identifier: 20070706
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrichosis

Keywords

Bimatoprost; Eyelash lengthening; Prostaglandin Analogs; Cosmetics

Outcome Measures

Primary Outcomes (1)

• Efficacy of Bimatoprost in Lengthening of Eyelashes

  Eyelash growth after application of bimatoprost vs control (split face study).

  4.5 months (6 weeks of drug application and 3 months after discontinuing)

Study Arms (1)

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.

Drug: Bimatoprost Suspension

Interventions

Bimatoprost Suspension DRUG

see prior

Also known as: Lumigan

Bimatoprost Suspension

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 20 and less than 90 and patients who have previously used and are comfortable with applying mascara.

You may not qualify if:

• History of glaucoma, uveitis, pregnancy, allergic reaction to prostaglandins or the gel suspension, alopecia, and previous usage of other eyelash growth enhancement.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami, Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Hypertrichosis

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Limitations and Caveats

A larger and longer term study would help assess the incidence of ocular side effects related to the Bimatoprost. This randomized controlled study evaluated patients after only 6 weeks of application of the drug.

Results Point of Contact

• Title: Dr. Sara Wester
• Organization: University of Miami

swester2@med.miami.edu

305-326-6132

Study Officials

• Wendy W Lee, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: April 16, 2014
• Results First Posted: April 16, 2014

Record last verified: 2014-03

Locations

US (1)