Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00693420
• Collaborator: (none)
• Enrollment: 278
• Locations: 2
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 139
• Patients Per Site Per Month: 17.3

Study Details

Study Description

Brief Summary

This study evaluates the safety and effectiveness of topical bimatoprost solution for enhancing eyelash prominence.

Condition or Disease	Intervention/Treatment	Phase
Eyelashes	Drug: Bimatoprost 0.03% sterile solution; Drug: vehicle sterile solution	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 278 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Bimatoprost 0.03% solution	Drug: Bimatoprost 0.03% sterile solution; Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily.; Other Names: LUMIGAN®
Placebo Comparator: 2 Vehicle solution	Drug: vehicle sterile solution; Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16 [Baseline to Week 16]

   The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])

2. Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment) [Baseline to Week 20]

   The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])

Secondary Outcome Measures

1. Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 [Baseline to Week 16]

   Upper eyelash length technologically measured in millimeters

2. Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) [Baseline to Week 20]

   Upper eyelash length technologically measured in millimeters

3. Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 [Baseline to Week 16]

   Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.

4. Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) [Baseline to Week 20]

   Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.

5. Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 [Baseline to Week 16]

   Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)

6. Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) [Baseline to Week 20]

   Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)

Other Outcome Measures

1. Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16 [Baseline to Week 16]

   "Overall, how satisfied are you with your eyelashes?" Possible Answers on a 5 point scale as follows: - Very Satisfied - Satisfied - Neutral - Unsatisfied - Very Unsatisfied

2. Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment) [Baseline to Week 20]

   "Overall, how satisfied are you with your eyelashes?" Possible Answers on a 5 point scale as follows: (1 - Very Satisfied; 2 - Satisfied; 3 - Neutral; 4 - Unsatisfied; 5 - Very Unsatisfied)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Dissatisfaction with eyelash prominence,

• Eyelash prominence assessment of minimal or moderate,

• Ability to provide written informed consent

Exclusion Criteria:

• Subjects without visible lashes,

• Asymmetrical (uneven lashes or longer on one side than the other) eyelashes,

• Any eye disease or abnormality,

• Eye surgery,

• Permanent eyeliner,

• Eyelash implants,

• Eyelash extension application,

• Any use of eyelash growth products within 6 months of study entry,

• Treatments that may effect hair growth,

• Subjects requiring eye drop medications for glaucoma,

• Subjects having a situation or condition, which the study doctor feels might put you at risk, may make the study results confusing, or may interfere with the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		San Diego	California	United States
2		Vancouver	British Columbia	Canada

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00693420
• Other Study ID Numbers: 192024-032
• First Posted: Jun 9, 2008
• Last Update Posted: Oct 30, 2013
• Last Verified: Sep 1, 2013

• Additional relevant MeSH terms: Bimatoprost; Pharmaceutical Solutions

Study Results

Participant Flow

Arm/Group Title	Bimatoprost 0.03% Solution	Vehicle Solution
Arm/Group Description
Period Title: Overall Study
STARTED	137	141
COMPLETED	131	126
NOT COMPLETED	6	15

Baseline Characteristics

Arm/Group Title	Bimatoprost 0.03% Solution	Vehicle Solution	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	137	141	278
Age, Customized (participants) [Number]
<45 years	44 32.1%	43 30.5%	87 31.3%
Between 45 and 65 years	82 59.9%	88 62.4%	170 61.2%
>65 years	11 8%	10 7.1%	21 7.6%
Sex: Female, Male (Count of Participants)
Female	134 97.8%	136 96.5%	270 97.1%
Male	3 2.2%	5 3.5%	8 2.9%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16
Description	The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])
Time Frame	Baseline to Week 16

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Bimatoprost 0.03% Solution	Vehicle Solution
Arm/Group Description
Measure Participants	137	141
Week 1	5.1 3.7%	2.1 1.5%
Week 4	14.6 10.7%	7.8 5.5%
Week 8	50.4 36.8%	14.9 10.6%
Week 12	69.3 50.6%	19.9 14.1%
Week 16 (Primary Endpoint)	78.1 57%	18.4 13%

2. Secondary Outcome

Title	Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Description	Upper eyelash length technologically measured in millimeters
Time Frame	Baseline to Week 16

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Bimatoprost 0.03% Solution	Vehicle Solution
Arm/Group Description
Measure Participants	137	141
Day 1 (Baseline)	5.79 (0.815)	5.71 (0.814)
Week 1	0.05 (0.327)	0.00 (0.327)
Week 4	0.22 (0.371)	0.06 (0.382)
Week 8	0.64 (0.559)	0.07 (0.396)
Week 12	1.16 (0.722)	0.05 (0.425)
Week 16 (Primary Endpoint)	1.39 (0.908)	0.11 (0.425)

3. Secondary Outcome

Title	Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)
Description	Upper eyelash length technologically measured in millimeters
Time Frame	Baseline to Week 20

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Bimatoprost 0.03% Solution	Vehicle Solution
Arm/Group Description
Measure Participants	137	141
Mean (Standard Deviation) [millimeters]	1.47 (0.831)	0.06 (0.431)

4. Secondary Outcome

Title	Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Description	Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.
Time Frame	Baseline to Week 16

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Bimatoprost 0.03% Solution	Vehicle Solution
Arm/Group Description
Measure Participants	137	141
Day 1 (Baseline)	16.16 (8.089)	16.66 (7.787)
Week 1	0.94 (3.651)	0.24 (3.161)
Week 4	1.62 (4.031)	0.81 (3.639)
Week 8	3.48 (5.148)	0.75 (4.189)
Week 12	9.30 (7.328)	0.95 (4.398)
Week 16 (Primary Endpoint)	12.21 (8.381)	1.10 (3.984)

5. Other Pre-specified Outcome

Title	Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16
Description	"Overall, how satisfied are you with your eyelashes?" Possible Answers on a 5 point scale as follows: - Very Satisfied - Satisfied - Neutral - Unsatisfied - Very Unsatisfied
Time Frame	Baseline to Week 16

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Bimatoprost 0.03% Solution	Vehicle Solution
Arm/Group Description
Measure Participants	137	141
Day 1 (Baseline)	4.18 (0.788)	4.16 (0.789)
Week 1	0.06 (0.466)	-0.06 (0.550)
Week 4	-0.25 (0.829)	-0.35 (0.728)
Week 8	-0.90 (1.107)	-0.57 (0.943)
Week 12	-1.48 (1.207)	-0.67 (0.939)
Week 16 (Primary Endpoint)	-1.89 (1.253)	-0.70 (1.074)

6. Primary Outcome

Title	Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment)
Description	The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])
Time Frame	Baseline to Week 20

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Bimatoprost 0.03% Solution	Vehicle Solution
Arm/Group Description
Measure Participants	137	141
Number [Percentage of participants]	78.6 57.4%	21.4 15.2%

7. Secondary Outcome

Title	Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)
Description	Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.
Time Frame	Baseline to Week 20

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Bimatoprost 0.03% Solution	Vehicle Solution
Arm/Group Description
Measure Participants	137	141
Mean (Standard Deviation) [percentage of AOI (in pixels)]	11.16 (7.051)	1.88 (4.470)

8. Secondary Outcome

Title	Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Description	Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)
Time Frame	Baseline to Week 16

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Bimatoprost 0.03% Solution	Vehicle Solution
Arm/Group Description
Measure Participants	137	141
Day 1 (Baseline)	105.67 (20.349)	102.82 (18.161)
Week 1	-2.97 (8.102)	-1.25 (8.233)
Week 4	-5.10 (10.327)	-2.91 (9.363)
Week 8	-9.11 (11.824)	-2.46 (11.249)
Week 12	-16.68 (13.585)	-4.22 (11.073)
Week 16 (Primary Endpoint)	-20.15 (16.051)	-3.57 (10.491)

9. Secondary Outcome

Title	Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)
Description	Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)
Time Frame	Baseline to Week 20

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Bimatoprost 0.03% Solution	Vehicle Solution
Arm/Group Description
Measure Participants	137	141
Mean (Standard Deviation) [intensity unit]	-20.12 (14.943)	-5.51 (10.789)

10. Other Pre-specified Outcome

Title	Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment)
Description	"Overall, how satisfied are you with your eyelashes?" Possible Answers on a 5 point scale as follows: (1 - Very Satisfied; 2 - Satisfied; 3 - Neutral; 4 - Unsatisfied; 5 - Very Unsatisfied)
Time Frame	Baseline to Week 20

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Bimatoprost 0.03% Solution	Vehicle Solution
Arm/Group Description
Measure Participants	137	141
Mean (Standard Deviation) [score on a scale]	-2.06 (1.345)	-0.61 (1.128)

Adverse Events

Arm/Group Title	Bimatoprost 0.03% Solution		Vehicle Solution
Arm/Group Description
All Cause Mortality
	Bimatoprost 0.03% Solution		Vehicle Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bimatoprost 0.03% Solution		Vehicle Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/ (NaN)		2/ (NaN)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the skin (back)	1/137 (0.7%)		0/141 (0%)
Lymphoma	0/137 (0%)		1/141 (0.7%)
Breast Cancer Metastatic	0/137 (0%)		1/141 (0.7%)
Other (Not Including Serious) Adverse Events
	Bimatoprost 0.03% Solution		Vehicle Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	40/ (NaN)		22/ (NaN)
Eye disorders
Eye pruritus	5/137 (3.6%)		1/141 (0.7%)
Conjunctival hyperaemia	5/137 (3.6%)		0/141 (0%)
Pinguecula	3/137 (2.2%)		3/141 (2.1%)
Eye Irritation	3/137 (2.2%)		2/141 (1.4%)
Dry Eye	3/137 (2.2%)		1/141 (0.7%)
Erythema of eyelid	3/137 (2.2%)		1/141 (0.7%)
Eyelids pruritus	1/137 (0.7%)		2/141 (1.4%)
Conjunctival haemorrhage	0/137 (0%)		2/141 (1.4%)
Immune system disorders
Seasonal allergy	2/137 (1.5%)		0/141 (0%)
Infections and infestations
Upper respiratory tract infection	2/137 (1.5%)		5/141 (3.5%)
Sinusitis	2/137 (1.5%)		2/141 (1.4%)
Influenza	2/137 (1.5%)		0/141 (0%)
Urinary Tract Infection	1/137 (0.7%)		2/141 (1.4%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blepharal Papilloma	2/137 (1.5%)		0/141 (0%)
Skin and subcutaneous tissue disorders
Skin Hyper pigmentation	4/137 (2.9%)		1/141 (0.7%)
Dermatitis Contact	2/137 (1.5%)		0/141 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

At least ninety (90) days prior to any proposed submission for publication or presentation of Study data or other findings related to the Study, the Institution will provide the Sponsor with a manuscript of such submission(s) for review and comment.