Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01023841
• Collaborator: (none)
• Enrollment: 71
• Locations: 2
• Arms: 2
• Actual Duration (Months): 30
• Patients Per Site: 35.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily application to the upper eyelid margins compared with vehicle in treating eyelash loss or hypotrichosis (inadequate or not enough eyelashes) in children.

Condition or Disease	Intervention/Treatment	Phase
Eyelash Hypotrichosis; Alopecia Areata	Drug: bimatoprost ophthalmic solution 0.03%; Drug: Vehicle Sterile Solution	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Actual Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Nov 2, 2012
• Actual Study Completion Date: Nov 30, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: bimatoprost ophthalmic solution 0.03% One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.	Drug: bimatoprost ophthalmic solution 0.03%; One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.; Other Names: LATISSE®
Placebo Comparator: Vehicle Sterile Solution One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.	Drug: Vehicle Sterile Solution; One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Adverse Events [5 Months]

   An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.

2. Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score [Baseline, Month 4]

   The physician evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.

Secondary Outcome Measures

1. Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA) [Baseline, Month 4]

   Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).

2. Change From Baseline in Upper Eyelash Thickness as Measured by DIA [Baseline, Month 4]

   Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).

3. Change From Baseline in Upper Eyelash Darkness as Measured by DIA [Baseline, Month 4]

   Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Children who have inadequate eyelashes or have lost their eyelashes as a result of chemotherapy treatment, who completed their chemotherapy (intensive treatment) at least 4 weeks before starting the study, are considered to be at low risk for relapse of their cancer, and are well enough to complete the study

• Children who have minimal to moderate inadequate eyelashes due to alopecia areata

• Adolescents between the ages of 15-17 years who have minimal to marked inadequate eyelashes

Exclusion Criteria:

• Any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants.

• Semi-permanent eyelash tint, dye or eyelash extension application within 3 months

• Use of over the counter eyelash growth products within 6 months.

• Use of prescription eyelash growth products (eg, Latisse®)

• Any eye condition that would prevent required ophthalmology exams

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Newport Beach	California	United States
2		São Paulo		Brazil

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

• Borchert M, Bruce S, Wirta D, Yoelin SG, Lee S, Mao C, VanDenburgh A. An evaluation of the safety and efficacy of bimatoprost for eyelash growth in pediatric subjects. Clin Ophthalmol. 2016 Mar 10;10:419-29. doi: 10.2147/OPTH.S89561. eCollection 2016.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01023841
• Other Study ID Numbers: 192024-040
• First Posted: Dec 2, 2009
• Last Update Posted: Apr 17, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Alopecia; Alopecia Areata; Hypotrichosis; Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	Bimatoprost Ophthalmic Solution 0.03%	Vehicle Sterile Solution
Arm/Group Description	One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.	One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
Period Title: Overall Study
STARTED	48	23
COMPLETED	47	23
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Bimatoprost Ophthalmic Solution 0.03%	Vehicle Sterile Solution	Total
Arm/Group Description	One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.	One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.	Total of all reporting groups
Overall Participants	48	23	71
Age, Customized (participants) [Number]
5-11 years	6 12.5%	3 13%	9 12.7%
12-17 years	42 87.5%	20 87%	62 87.3%
Sex: Female, Male (Count of Participants)
Female	37 77.1%	16 69.6%	53 74.6%
Male	11 22.9%	7 30.4%	18 25.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Adverse Events
Description	An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Time Frame	5 Months

Outcome Measure Data

Analysis Population Description

Safety population included all randomized participants who received treatment.

Arm/Group Title	Bimatoprost Ophthalmic Solution 0.03%	Vehicle Sterile Solution
Arm/Group Description	One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.	One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
Measure Participants	48	23
Number [Percentage of participants]	35.4 73.8%	43.5 189.1%

2. Secondary Outcome

Title	Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA)
Description	Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).
Time Frame	Baseline, Month 4

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all randomized participants.

Arm/Group Title	Bimatoprost Ophthalmic Solution 0.03%	Vehicle Sterile Solution
Arm/Group Description	One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.	One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
Measure Participants	48	23
Baseline	6.83 (2.568)	6.04 (2.915)
Change from Baseline at Month 4	1.12 (1.626)	0.67 (1.846)

3. Secondary Outcome

Title	Change From Baseline in Upper Eyelash Thickness as Measured by DIA
Description	Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).
Time Frame	Baseline, Month 4

Outcome Measure Data

Analysis Population Description

Participants from the Intent-to-treat population, that included all randomized participants, with data available at Baseline and Month 4.

Arm/Group Title	Bimatoprost Ophthalmic Solution 0.03%	Vehicle Sterile Solution
Arm/Group Description	One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.	One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
Measure Participants	48	22
Baseline	1.20 (0.738)	1.18 (0.862)
Change from Baseline at Month 4	0.41 (0.535)	0.05 (0.449)

4. Secondary Outcome

Title	Change From Baseline in Upper Eyelash Darkness as Measured by DIA
Description	Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).
Time Frame	Baseline, Month 4

Outcome Measure Data

Analysis Population Description

Participants from the Intent-to-treat population, that included all randomized participants, with data available at Baseline and Month 4.

Arm/Group Title	Bimatoprost Ophthalmic Solution 0.03%	Vehicle Sterile Solution
Arm/Group Description	One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.	One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
Measure Participants	43	19
Baseline	143.78 (20.446)	143.44 (25.844)
Change from Baseline at Month 4	-15.34 (15.724)	-5.47 (12.289)

5. Primary Outcome

Title	Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score
Description	The physician evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.
Time Frame	Baseline, Month 4

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all randomized participants.

Arm/Group Title	Bimatoprost Ophthalmic Solution 0.03%	Vehicle Sterile Solution
Arm/Group Description	One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.	One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
Measure Participants	48	23
Number [Percentage of participants]	70.8 147.5%	26.1 113.5%

Adverse Events

Arm/Group Title	Bimatoprost Ophthalmic Solution 0.03%		Vehicle Sterile Solution
Arm/Group Description	One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.		One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
All Cause Mortality
	Bimatoprost Ophthalmic Solution 0.03%		Vehicle Sterile Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bimatoprost Ophthalmic Solution 0.03%		Vehicle Sterile Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Bimatoprost Ophthalmic Solution 0.03%		Vehicle Sterile Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		1/23 (4.3%)
Reproductive system and breast disorders
Ovarian cyst ruptured	0/37 (0%)		1/16 (6.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.