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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

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    Trial identification
    Sponsor protocol code
    192024-046
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01698554
    WHO universal trial number (UTN)
    -
    Sponsors
    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
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    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?
    No
    General information about the trial
    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
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    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
    51
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    393
    From 65 to 84 years
    71
    85 years and over
    0

    Subject disposition

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    Recruitment
    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.

    Pre-assignment
    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
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    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.

    Arm title
    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.

    Arm title
    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.

    Arm title
    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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    Baseline characteristics reporting groups
    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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    End points reporting groups
    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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    Adverse events information
    Timeframe for reporting adverse events
    Up to 157 Days
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    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

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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