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

• Study Type: Interventional
• 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
• Enrollment: 21

Participant Flow

Recruitment Details	Through study advertisement with IRB approved flyers at the Bascom Palmer Eye Institute, 23 subjects were recruited for initial evaluation. Study recruitment and enrollment began in February 2008 and the study was completed in July of 2008, including 3 month post suspension use evaluations.
Pre-assignment Details

Arm/Group Title	Bimatoprost Mixed With Gonak Into a Gel Suspension
Arm/Group Description	Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak 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 solution vials were labeled right or left eye.
Period Title: Overall Study
Started	21
Completed	19
Not Completed	2
Reason Not Completed
Physician Decision	2

Baseline Characteristics

Arm/Group Title		Bimatoprost Mixed With Gonak Into a Gel Suspension
Arm/Group Description		Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak 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 solution vials were labeled right or left eye.
Overall Number of Baseline Participants		21
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Full Range); Unit of measure: Participants
	Number Analyzed	21 participants
		46; (23 to 69)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	21 participants
	Female	21 100.0%
	Male	0 0.0%
Region of Enrollment [1]; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	21 participants
		21
		[1] Measure Description: Patients were enrolled in the Bascom Palmer Eye Institute in Miami, FL.
Eyelash length [1]; Measure Type: Number; Unit of measure: Mm	Number Analyzed	21 participants
<=18 years		0
Between 23 and 69 years		21
>69 years		0
		[1] Measure Description: Lash length was measured using calipers and photos during the study, and the longest measured eyelashes were plucked from the upper eyelid of 13 of the 14 total enrolled patients at the end of the six weeks for comparison. Throughout the study, we used the same measuring technique, always measuring the length of the longest lash uncurled using a surgical caliper. Visual acuity, ocular symptoms, intraocular pressure and slit lamp exam were recorded at these same intervals.

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bimatoprost Mixed With Gonak Into a Gel Suspension	Control Group
Arm/Group Description:	Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak 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 solution vials were labeled right or left eye.	Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak 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 solution vials were labeled right or left eye.
Overall Number of Participants Analyzed	19	19
Mean (Standard Deviation); Unit of Measure: mm
	2 (0.001)	1.1 (0.001)

Adverse Events

Time Frame	4.5 months
Adverse Event Reporting Description	Serious adverse events = 0 Minor adverse events (irritation) = 2 subjects, discontinued from the study. It was not documented if the adverse events were only seen in the eye with the treatment arm and thus it was documented by subjects.
Arm/Group Title	Bimatoprost Mixed With Gonak Into a Gel Suspension
Arm/Group Description	Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak 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 solution vials were labeled right or left eye.
All-Cause Mortality
	Bimatoprost Mixed With Gonak Into a Gel Suspension
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Bimatoprost Mixed With Gonak Into a Gel Suspension
	Affected / at Risk (%)	# Events
Total	0/21 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Bimatoprost Mixed With Gonak Into a Gel Suspension
	Affected / at Risk (%)	# Events
Total	2/21 (9.52%)
Eye disorders
Minor Irritation † [1]	2/21 (9.52%)	2
† Indicates events were collected by systematic assessment; [1] Minor irritation, conjunctival injection

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Sara Wester
• Organization: University of Miami
• Phone: 305-326-6132
• EMail: swester2@med.miami.edu

• Responsible Party: Sara T. Wester, University of Miami
• ClinicalTrials.gov Identifier: NCT00773136
• Other Study ID Numbers: 20070706
• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Results First Submitted: June 22, 2013
• Results First Posted: April 16, 2014
• Last Update Posted: April 16, 2014