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    Clinical Trial Results:
    A Multicenter, Double-masked, Randomized, Active-controlled, Parallel Study of the Safety and Efficacy of Once-daily Bimatoprost Preservative-free Ophthalmic Solution Compared to Twice-daily Timolol Ophthalmic Solution in Paediatric Patients with Glaucoma

    Summary
    EudraCT number
    2011-003278-10
    Trial protocol
    FR   GB   DE  
    Global end of trial date
    30 Oct 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    192024-056
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01426113
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Allergan Limited
    Sponsor organisation address
    Allergan Limited Marlow International The Parkway, Marlow, Buckinghamshire, 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)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000917-PIP01-10
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Oct 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Oct 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the safety and IOP-lowering efficacy of once-daily bimatoprost ophthalmic solution compared with twice-daily timolol ophthalmic solution for 12 weeks in pediatric patients with glaucoma.
    Protection of trial subjects
    Parent(s) or legal guardian(s) were required to read and sign an Informed Consent Form. Subjects may have signed an assent, if applicable, prior to any study procedures being performed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Sep 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    Long term follow-up duration
    9 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 3
    Country: Number of subjects enrolled
    Italy: 1
    Worldwide total number of subjects
    6
    EEA total number of subjects
    2
    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)
    6
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was discontinued prematurely after enrollment of 6 patients.

    Pre-assignment
    Screening details
    The Screening period was from Day -28 to Day -2. All randomized patients are noted in the overall study period.

    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, Carer, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    bimatoprost ophthalmic solution formulation A and vehicle
    Arm description
    1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    bimatoprost
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.

    Arm title
    timolol ophthalmic solution
    Arm description
    1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
    Arm type
    Active comparator

    Investigational medicinal product name
    timolol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.

    Number of subjects in period 1
    bimatoprost ophthalmic solution formulation A and vehicle timolol ophthalmic solution
    Started
    3
    3
    Completed
    2
    1
    Not completed
    1
    2
         Study Discontinued
    1
    1
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    bimatoprost ophthalmic solution formulation A and vehicle
    Reporting group description
    1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.

    Reporting group title
    timolol ophthalmic solution
    Reporting group description
    1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.

    Reporting group values
    bimatoprost ophthalmic solution formulation A and vehicle timolol ophthalmic solution Total
    Number of subjects
    3 3 6
    Age categorical
    Units: Subjects
        Adolescents (12-15 years)
    3 3 6
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    14.7 ± 0.58 12.7 ± 0.58 -
    Gender, Male/Female
    Units: Participants
        Female
    3 0 3
        Male
    0 3 3

    End points

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    End points reporting groups
    Reporting group title
    bimatoprost ophthalmic solution formulation A and vehicle
    Reporting group description
    1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.

    Reporting group title
    timolol ophthalmic solution
    Reporting group description
    1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.

    Primary: Change from Baseline in Intraocular Pressure (IOP) in the Study Eye

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    End point title
    Change from Baseline in Intraocular Pressure (IOP) in the Study Eye [1]
    End point description
    IOP is a measure of the fluid pressure inside the study eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive change from baseline indicates an increase in IOP (worsening). Due to lack of enrollment, analysis was not performed for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Week 6
    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: This study was discontinued after the enrollment of 6 patients; therefore, statistical analyses were not performed.
    End point values
    bimatoprost ophthalmic solution formulation A and vehicle timolol ophthalmic solution
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Millimeters of Mercury (mmHg)
        number (not applicable)
    Notes
    [2] - Due to lack of enrollment, analysis was not performed for this outcome measure.
    [3] - Due to lack of enrollment, analysis was not performed for this outcome measure.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from signing consent through Month 12/Exit.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    bimatoprost ophthalmic solution formulation A and vehicle
    Reporting group description
    1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.

    Reporting group title
    timolol ophthalmic solution
    Reporting group description
    1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.

    Serious adverse events
    bimatoprost ophthalmic solution formulation A and vehicle timolol ophthalmic solution
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    bimatoprost ophthalmic solution formulation A and vehicle timolol ophthalmic solution
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    1 / 3 (33.33%)
    Investigations
    Intraocular Pressure Increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    Eye disorders
    Eyelash Hyperpigmentation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Growth of Eyelashes
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 3 (33.33%)
         occurrences all number
    1
    1
    Eyelid Oedema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Conjunctival Hyperaemia
         subjects affected / exposed
    2 / 3 (66.67%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    Blepharal Pigmentation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jul 2012
    1) allow the use of Icare and Perkins tonometers; 2) remove PK sampling at baseline; and 3) change the noninferiority margin for analysis of the primary efficacy variable and update sample size calculations accordingly.
    19 Apr 2013
    1) remove evening office visits; 2) change the primary efficacy endpoint to week 6 (hour 2); 3) in the bimatoprost group, change the dosing of bimatoprost to the morning and vehicle to the evening from week 6 to week 12; 4) add a week 8 visit and move pharmacokinetic measurements from week 6 to week 8; 5) change the IOP measurement in weeks 8 and 12 to occur at time 0 (for trough effect); and 6) increase the study sample size to ensure that at least 80 patients were evaluable at weeks 6 and 12 (previous discontinuation rates predicted that approximately 90 patients would be needed to be randomized at baseline, but up to 120 patients could be enrolled if needed).

    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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