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Clinical Trial Results:
Bimatoprost in the Treatment of Eyelash Hypotrichosis

Summary
EudraCT number	2012-003007-35
Trial protocol	GB SE
Global end of trial date	17 Mar 2014

Results information
Results version number	v1(current)
This version publication date	26 Mar 2016
First version publication date	26 Mar 2016
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

192024-046

ISRCTN number

US NCT number

NCT01698554

WHO universal trial number (UTN)

Sponsor organisation name

Allergan Limited

Sponsor organisation address

Allergan Limited Marlow International the Parkway, Marlow, United Kingdom, SL7 1YL

Public contact

Allergan Limited EU Regulatory Dept, Allergan Limited, +44 1628 494444, ml-eu_reg_affairs@allergan.com

Scientific contact

Allergan Limited EU Regulatory Dept, Allergan Limited, +44 1628 494444, ml-eu_reg_affairs@allergan.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

20 Aug 2014

Is this the analysis of the primary completion data?

Yes

Primary completion date

17 Mar 2014

Global end of trial reached?

Yes

Global end of trial date

17 Mar 2014

Was the trial ended prematurely?

Main objective of the trial

This study evaluated the safety and efficacy of bimatoprost solution formulation A compared with bimatoprost solution 0.03% (LATISSE®) and vehicle in the treatment of eyelash hypotrichosis (inadequate eyelashes).

Protection of trial subjects

All study participants were required to read and sign an Informed Consent Form.

Background therapy

Evidence for comparator

Actual start date of recruitment

15 Nov 2012

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Russian Federation: 20

Country: Number of subjects enrolled

Sweden: 20

Country: Number of subjects enrolled

United Kingdom: 31

Country: Number of subjects enrolled

United States: 393

Worldwide total number of subjects

464

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

393

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study took place at 26 centers in the United States (US), United Kingdom and Sweden (members of the European Union [EU]) and the Russia Federation from 15 November 2012 to 17 March 2014.

Screening details

Participants with eyelash hypotrichosis were enrolled in one of 4 treatment groups (2:2:1:1): bimatoprost formulation A solution, bimatoprost solution 0.03 %, vehicle of bimatoprost formulation A solution or vehicle of bimatoprost solution 0.03 %

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

bimatoprost formulation A solution

Arm description

Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Arm type

Experimental

Investigational medicinal product name

bimatoprost formulation A solution

Investigational medicinal product code

Other name

Pharmaceutical forms

Cutaneous solution

Routes of administration

Cutaneous use

Dosage and administration details

Solution applied to the upper eyelid of both eyes.

bimatoprost solution 0.03 %

Arm description

Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Arm type

Active comparator

Investigational medicinal product name

bimatoprost solution 0.03 %

Investigational medicinal product code

Other name

LATISSE®

Pharmaceutical forms

Cutaneous solution

Routes of administration

Cutaneous use

Dosage and administration details

Solution applied to the upper eyelid of each eye.

vehicle of bimatoprost formulation A solution

Arm description

Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Arm type

Placebo

Investigational medicinal product name

vehicle of bimatoprost formulation A solution

Investigational medicinal product code

Other name

Pharmaceutical forms

Cutaneous solution

Routes of administration

Cutaneous use

Dosage and administration details

Solution applied to the upper eyelid of both eyes.

vehicle of bimatoprost solution 0.03 %

Arm description

Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Arm type

Placebo

Investigational medicinal product name

vehicle of bimatoprost solution 0.03 %

Investigational medicinal product code

Other name

Pharmaceutical forms

Cutaneous solution

Routes of administration

Cutaneous use

Dosage and administration details

Solution applied to the upper eyelid of both eyes.

Number of subjects in period 1	bimatoprost formulation A solution	bimatoprost solution 0.03 %	vehicle of bimatoprost formulation A solution	vehicle of bimatoprost solution 0.03 %
Started	153	157	75	79
Completed	147	147	73	77
Not completed	6	10	2	2
Adverse event, non-fatal	2	5	-	1
Personal Reasons	-	5	1	1
Lost to follow-up	1	-	-	-
Other Miscellaneous Reasons	1	-	-	-
Protocol deviation	2	-	1	-

Baseline characteristics

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Reporting group title

bimatoprost formulation A solution

Reporting group description

Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Reporting group title

bimatoprost solution 0.03 %

Reporting group description

Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Reporting group title

vehicle of bimatoprost formulation A solution

Reporting group description

Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Reporting group title

vehicle of bimatoprost solution 0.03 %

Reporting group description

Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Reporting group values	bimatoprost formulation A solution	bimatoprost solution 0.03 %	vehicle of bimatoprost formulation A solution	vehicle of bimatoprost solution 0.03 %	Total
Number of subjects	153	157	75	79	464
Age categorical
Units: Subjects
<45 years	27	34	16	15	92
45 to 65 years	104	106	47	55	312
>65 years	22	17	12	9	60
Age continuous
Units: years
arithmetic mean (standard deviation)	53.9 ± 11.8	52.5 ± 11.01	54.1 ± 12.86	52.6 ± 12.22	-
Gender, Male/Female
Units: Participants
Female	150	153	75	79	457
Male	3	4	0	0	7

End points

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Reporting group title

bimatoprost formulation A solution

Reporting group description

Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Reporting group title

bimatoprost solution 0.03 %

Reporting group description

Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Reporting group title

vehicle of bimatoprost formulation A solution

Reporting group description

Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Reporting group title

vehicle of bimatoprost solution 0.03 %

Reporting group description

Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Primary: Percentage of Participants with at Least a 1-Grade Increase (Improvement) from Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)

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End point title

Percentage of Participants with at Least a 1-Grade Increase (Improvement) from Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA) ^[1]

End point description

The investigator 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.

End point type

Primary

End point timeframe

Baseline, Month 4

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No Statistical Analysis is reported for this outcome measure

End point values	bimatoprost formulation A solution	bimatoprost solution 0.03 %	vehicle of bimatoprost formulation A solution	vehicle of bimatoprost solution 0.03 %
Number of subjects analysed	153	157	75	79
Units: percentage of participants
number (not applicable)	82.4	83.4	24	20.3

No statistical analyses for this end point

Secondary: Change from Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)

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End point title

Change from Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)

End point 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)

End point type

Secondary

End point timeframe

Baseline, Month 4

End point values	bimatoprost formulation A solution	bimatoprost solution 0.03 %	vehicle of bimatoprost formulation A solution	vehicle of bimatoprost solution 0.03 %
Number of subjects analysed	152	157	75	79
Units: mm
arithmetic mean (standard deviation)
Baseline	6.09 ± 0.856	5.97 ± 0.789	5.9 ± 0.812	6.03 ± 0.852
Change from Baseline at Month 4	1.61 ± 0.888	1.62 ± 0.955	0.08 ± 0.442	0.05 ± 0.482

No statistical analyses for this end point

Secondary: Change from Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA

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End point title

Change from Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA

End point description

Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was measured in millimeters squared (mm^2). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated fuller eyelashes (improvement).

End point type

Secondary

End point timeframe

Baseline, Month 4

End point values	bimatoprost formulation A solution	bimatoprost solution 0.03 %	vehicle of bimatoprost formulation A solution	vehicle of bimatoprost solution 0.03 %
Number of subjects analysed	151	156	74	78
Units: mm^2
arithmetic mean (standard deviation)
Baseline	0.85 ± 0.4	0.82 ± 0.404	0.76 ± 0.333	0.81 ± 0.38
Change from Baseline At Month 4	0.58 ± 0.359	0.64 ± 0.392	0.02 ± 0.196	0.03 ± 0.237

No statistical analyses for this end point

Secondary: Change from Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA

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End point title

Change from Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA

End point 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).

End point type

Secondary

End point timeframe

Baseline, Month 4

End point values	bimatoprost formulation A solution	bimatoprost solution 0.03 %	vehicle of bimatoprost formulation A solution	vehicle of bimatoprost solution 0.03 %
Number of subjects analysed	151	156	74	78
Units: intensity units
arithmetic mean (standard deviation)
Baseline	145.33 ± 24.024	147.39 ± 24.934	147.44 ± 22.323	145.79 ± 26.67
Change from Baseline at Month 4	-23.98 ± 15.719	-24.78 ± 16.417	-2.78 ± 10.443	0.17 ± 10.065

No statistical analyses for this end point

Secondary: Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)

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End point title

Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)

End point description

Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: "Overall, how satisfied are you with your eyelashes?" using a 5-point scale: 1= very unsatisfied (worst), 2= unsatisfied, 3= neutral, 4= satisfied or 5= very satisfied (best). The percentage of participants who rated their satisfaction as satisfied or very satisfied at Month 4 is reported.

End point type

Secondary

End point timeframe

Month 4

End point values	bimatoprost formulation A solution	bimatoprost solution 0.03 %	vehicle of bimatoprost formulation A solution	vehicle of bimatoprost solution 0.03 %
Number of subjects analysed	153	157	75	79
Units: percentage of participants
number (not applicable)	71.2	65	28	20.3

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Up to 157 Days

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

16.1

Reporting group title

bimatoprost formulation A solution

Reporting group description

Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Reporting group title

vehicle of bimatoprost formulation A solution

Reporting group description

Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Reporting group title

vehicle of bimatoprost solution 0.03 %

Reporting group description

Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Reporting group title

bimatoprost solution 0.03 %

Reporting group description

Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Serious adverse events	bimatoprost formulation A solution	vehicle of bimatoprost formulation A solution	vehicle of bimatoprost solution 0.03 %	bimatoprost solution 0.03 %
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 153 (0.00%)	1 / 75 (1.33%)	1 / 79 (1.27%)	5 / 157 (3.18%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
subjects affected / exposed	0 / 153 (0.00%)	0 / 75 (0.00%)	0 / 79 (0.00%)	1 / 157 (0.64%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Hiatus hernia
subjects affected / exposed	0 / 153 (0.00%)	0 / 75 (0.00%)	0 / 79 (0.00%)	1 / 157 (0.64%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Menorrhagia
Additional description: female population
subjects affected / exposed	0 / 153 (0.00%)	0 / 75 (0.00%)	1 / 79 (1.27%)	0 / 157 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
subjects affected / exposed	0 / 153 (0.00%)	1 / 75 (1.33%)	0 / 79 (0.00%)	0 / 157 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Cellulitis
subjects affected / exposed	0 / 153 (0.00%)	0 / 75 (0.00%)	0 / 79 (0.00%)	1 / 157 (0.64%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis viral
subjects affected / exposed	0 / 153 (0.00%)	0 / 75 (0.00%)	0 / 79 (0.00%)	1 / 157 (0.64%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 153 (0.00%)	0 / 75 (0.00%)	0 / 79 (0.00%)	1 / 157 (0.64%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	bimatoprost formulation A solution	vehicle of bimatoprost formulation A solution	vehicle of bimatoprost solution 0.03 %	bimatoprost solution 0.03 %
Total subjects affected by non serious adverse events
subjects affected / exposed	7 / 153 (4.58%)	3 / 75 (4.00%)	3 / 79 (3.80%)	8 / 157 (5.10%)
Investigations
Intraocular pressure decreased
subjects affected / exposed	7 / 153 (4.58%)	3 / 75 (4.00%)	3 / 79 (3.80%)	8 / 157 (5.10%)
occurrences all number	9	3	3	10

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
Bimatoprost in the Treatment of Eyelash Hypotrichosis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants with at Least a 1-Grade Increase (Improvement) from Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)

Primary: Percentage of Participants with at Least a 1-Grade Increase (Improvement) from Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)

Secondary: Change from Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)

Secondary: Change from Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)

Secondary: Change from Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA

Secondary: Change from Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA

Secondary: Change from Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA

Secondary: Change from Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA

Secondary: Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)

Secondary: Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
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Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
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Slovenia
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Outside EU/EEA

Clinical trials

Clinical Trial Results: Bimatoprost in the Treatment of Eyelash Hypotrichosis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants with at Least a 1-Grade Increase (Improvement) from Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)

Primary: Percentage of Participants with at Least a 1-Grade Increase (Improvement) from Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)

Secondary: Change from Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)

Secondary: Change from Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)

Secondary: Change from Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA

Secondary: Change from Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA

Secondary: Change from Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA

Secondary: Change from Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA

Secondary: Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)

Secondary: Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Bimatoprost in the Treatment of Eyelash Hypotrichosis