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

• ClinicalTrials.gov Identifier: NCT00773136
• Recruitment Status: Completed
• First Posted: October 16, 2008
• Results First Posted: April 16, 2014
• Last Update Posted: April 16, 2014
• Sponsor: University of Miami
• Information provided by (Responsible Party): Sara T. Wester, University of Miami

Tracking Information

• First Submitted Date: October 15, 2008
• First Posted Date: October 16, 2008
• Results First Submitted Date: June 22, 2013
• Results First Posted Date: April 16, 2014
• Last Update Posted Date: April 16, 2014
• Study Start Date: February 2008
• Actual Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 20, 2014)

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).

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hypertrichosis

Intervention

Drug: Bimatoprost Suspension

see prior

Other Name: Lumigan

Study Arms

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.

Intervention: Drug: Bimatoprost Suspension

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 20, 2014): 21
• Original Enrollment: Not Provided
• Actual Study Completion Date: July 2008
• Actual Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00773136
• Other Study ID Numbers: 20070706
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sara T. Wester, University of Miami
• Original Responsible Party: Wendy W. Lee, University of Miami, Bascom Palmer Eye Institute
• Current Study Sponsor: University of Miami
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Wendy W Lee, MD; University of Miami

• PRS Account: University of Miami
• Verification Date: March 2014