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    Clinical Trial Results:
    Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Peri-Operative Tube Otorrhea

    Summary
    EudraCT number
    2018-000642-19
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    11 Feb 2009

    Results information
    Results version number
    v1(current)
    This version publication date
    30 Jul 2018
    First version publication date
    30 Jul 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C-05-38
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00578773
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Alcon Research Ltd
    Sponsor organisation address
    6201 S. Freeway, Fort Worth, TX, United States, 76134
    Public contact
    Ophthalmology Unit, Novartis Pharmaceuticals, + 44 0127666733385, Linda.masson@novartis.com
    Scientific contact
    Ophthalmology Unit, Novartis Pharmaceuticals, + 44 0127666733385, Linda.masson@novartis.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Feb 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Feb 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Feb 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to evaluate the efficacy and safety of topical Moxidex plus tympanostomy tubes (TT) for the treatment of peri-surgical tube otorrhea.
    Protection of trial subjects
    Prior to the start of the study, the study protocol, the informed consent and assent documents, patient instruction sheets, the Investigator’s Brochure, as well as any advertising materials used to recruit patients were submitted to institutional review boards (IRBs) and independent ethics committees (IECs). The IRB/IECs reviewed all documents and approved required documents; copies of the approval letters were provided to Alcon. Consistent with both the IRB/IEC’s requirements and all applicable regulations, the Investigators periodically provided study updates to the IRB/IEC. A patient or parent/legal guardian (if necessary, a legally authorized representative) provided informed consent, and children signed an approved assent form when appropriate. This study was conducted in accordance with Good Clinical Practices (GCP) and the ethical principles that have their origins in the Declaration of Helsinki.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 Dec 2007
    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
    United States: 303
    Worldwide total number of subjects
    303
    EEA total number of subjects
    0
    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)
    217
    Children (2-11 years)
    86
    Adolescents (12-17 years)
    0
    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
    Subjects were recruited from 16 study centers located in the United States.

    Pre-assignment
    Screening details
    This reporting group includes all enrolled and treated subjects (303).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Investigator [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Moxidex plus TT
    Arm description
    Moxifloxacin 0.5%/dexamethasone phosphate 0.1% otic solution, 4 drops twice daily (BID) for 7 days, in ears with inserted tympanostomy tubes
    Arm type
    Experimental

    Investigational medicinal product name
    Moxifloxacin 0.5%/dexamethasone phosphate 0.1% otic solution
    Investigational medicinal product code
    Other name
    Moxidex
    Pharmaceutical forms
    Ear drops, solution
    Routes of administration
    Auricular use
    Dosage and administration details
    Dosed in the affected ear(s), 4 drops twice daily (BID) for 7 days

    Arm title
    Moxifloxacin plus TT
    Arm description
    Moxifloxacin hydrochloride 0.5% solution, 4 drops BID for 7 days, in ears with inserted tympanostomy tubes
    Arm type
    Active comparator

    Investigational medicinal product name
    Moxifloxacin hydrochloride 0.5% solution
    Investigational medicinal product code
    Other name
    Moxifloxacin
    Pharmaceutical forms
    Ear drops, solution
    Routes of administration
    Auricular use
    Dosage and administration details
    Dosed in the affected ear(s), 4 drops BID for 7 days

    Arm title
    TT only
    Arm description
    Tympanostomy tube surgically inserted through the ear drum for the treatment of recurrent otitis media; no test article
    Arm type
    Active comparator

    Investigational medicinal product name
    Tympanostomy tubes
    Investigational medicinal product code
    Other name
    TT
    Pharmaceutical forms
    Implant
    Routes of administration
    Auricular use
    Dosage and administration details
    Tubes surgically inserted through the ear drum

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This was a single-masked trial and only the investigator was masked.
    Number of subjects in period 1
    Moxidex plus TT Moxifloxacin plus TT TT only
    Started
    100
    100
    103
    Completed
    86
    85
    57
    Not completed
    14
    15
    46
         Tube obstruction
    -
    1
    3
         Subject's decision unrelated to an AE
    2
    1
    -
         Baseline culture results positive for Strep A
    -
    -
    1
         Noncompliance
    1
    -
    -
         Baseline culture results positive for yeast
    -
    -
    1
         Treatment failure
    8
    9
    34
         Adverse event, non-fatal
    2
    1
    5
         Lost to follow-up
    1
    3
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Moxidex plus TT
    Reporting group description
    Moxifloxacin 0.5%/dexamethasone phosphate 0.1% otic solution, 4 drops twice daily (BID) for 7 days, in ears with inserted tympanostomy tubes

    Reporting group title
    Moxifloxacin plus TT
    Reporting group description
    Moxifloxacin hydrochloride 0.5% solution, 4 drops BID for 7 days, in ears with inserted tympanostomy tubes

    Reporting group title
    TT only
    Reporting group description
    Tympanostomy tube surgically inserted through the ear drum for the treatment of recurrent otitis media; no test article

    Reporting group values
    Moxidex plus TT Moxifloxacin plus TT TT only Total
    Number of subjects
    100 100 103 303
    Age categorical
    This analysis population includes all subjects with successful bilateral myringotomy and TT insertion (Intent-to-Treat (ITT) Analysis Set).
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    82 60 75 217
        Children (2-11 years)
    18 40 28 86
    Gender categorical
    Units: Subjects
        Female
    36 37 49 122
        Male
    64 63 54 181

    End points

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    End points reporting groups
    Reporting group title
    Moxidex plus TT
    Reporting group description
    Moxifloxacin 0.5%/dexamethasone phosphate 0.1% otic solution, 4 drops twice daily (BID) for 7 days, in ears with inserted tympanostomy tubes

    Reporting group title
    Moxifloxacin plus TT
    Reporting group description
    Moxifloxacin hydrochloride 0.5% solution, 4 drops BID for 7 days, in ears with inserted tympanostomy tubes

    Reporting group title
    TT only
    Reporting group description
    Tympanostomy tube surgically inserted through the ear drum for the treatment of recurrent otitis media; no test article

    Primary: Time (in days) to cessation of otorrhea

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    End point title
    Time (in days) to cessation of otorrhea [1]
    End point description
    The time (in days) to the cessation of otorrhea (i.e. absence of otorrhea) was calculated as the number of days from surgery to the absence of otorrhea in both ears as recorded by the subject's parent/guardian via the phone-in diary. Otorrhea was defined as ending on the first day that otorrhea was absent from both ears and remaining absent for all subsequent diary entries. Pre-specified for Moxidex plus TT and TT only. ITT Analysis Set.
    End point type
    Primary
    End point timeframe
    Up to Day 14 (Test of Cure (TOC))
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was pre-specified for only 2 arms.
    End point values
    Moxidex plus TT TT only
    Number of subjects analysed
    100
    103
    Units: Days
        median (confidence interval 95%)
    1.0 (1.00 to 2.00)
    4.0 (1.00 to 11.00)
    Statistical analysis title
    Time to cessation of otorrhea
    Comparison groups
    Moxidex plus TT v TT only
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Logrank
    Confidence interval

    Secondary: Percentage of subjects with clinical cure at each visit

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    End point title
    Percentage of subjects with clinical cure at each visit [2]
    End point description
    Clinical cure was defined as resolved/cured (i.e. otorrhea absent) or improved/not changed or worsened (i.e. otorrhea present) as rated by the investigator at the EOT and TOC visits. Pre-specified for Moxidex plus TT and TT only. ITT Analysis Set.
    End point type
    Secondary
    End point timeframe
    Day 8 (End of therapy (EOT)), Day 14 (TOC)
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was pre-specified for only 2 arms.
    End point values
    Moxidex plus TT TT only
    Number of subjects analysed
    100
    103
    Units: percentage of subjects
    number (not applicable)
        EOT - Absent
    90.0
    56.3
        EOT - Present
    10.0
    43.7
        TOC - Absent
    84.0
    56.3
        TOC - Present
    16.0
    43.7
    Statistical analysis title
    Clinical Cure - EOT Absent
    Comparison groups
    Moxidex plus TT v TT only
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Chi-squared
    Confidence interval
    Statistical analysis title
    Clinical Cure - TOC Absent
    Comparison groups
    Moxidex plus TT v TT only
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Chi-squared
    Confidence interval

    Secondary: Percentage of subjects with microbiological outcome of success

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    End point title
    Percentage of subjects with microbiological outcome of success [3]
    End point description
    Microbiological success (i.e. eradication of pre-therapy pathogens) was reported as a percentage. This analysis population includes all subjects in the ITT population who met pre-randomization inclusion and exclusion criteria and were culture positive for bacteria on Day 1 (Modified ITT (MITT) Analysis Set). However, any ear with a baseline culture containing Group A Streptococci or yeast or fungi were excluded from the MITT population. Pre-specified for Moxidex plus TT and TT only.
    End point type
    Secondary
    End point timeframe
    Day 14 (TOC)
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was pre-specified for only 2 arms.
    End point values
    Moxidex plus TT TT only
    Number of subjects analysed
    54
    62
    Units: Percentage of subjects
    number (not applicable)
        Success
    74.1
    48.4
    No statistical analyses for this end point

    Secondary: Percentage of subjects discontinued due to treatment failure

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    End point title
    Percentage of subjects discontinued due to treatment failure [4]
    End point description
    A subject could be considered a treatment failure at the EOT, or after, if otorrhea was confirmed by an Investigator. Reported as a percentage of subjects who discontinued due to treatment failure at any point following surgery at each follow-up visit. Pre-specified for Moxidex plus TT and TT only. ITT Analysis Set.
    End point type
    Secondary
    End point timeframe
    Up to Day 14 (TOC)
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was pre-specified for only 2 arms.
    End point values
    Moxidex plus TT TT only
    Number of subjects analysed
    100
    103
    Units: percentage of subjects
        number (not applicable)
    8.0
    33.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Adverse event reporting additional description
    This analysis population includes all subjects with successful bilateral myringotomy and TT insertion (Safety Analysis Set). Only total subjects affected by non-serious AEs that occurred at >5% are reported.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Moxidex plus TT
    Reporting group description
    Moxifloxacin 0.5%/dexamethasone phosphate 0.1% otic solution, 4 drops twice daily (BID) for 7 days plus tympanostomy tube in affected ear(s)

    Reporting group title
    Moxifloxacin plus TT
    Reporting group description
    Moxifloxacin hydrochloride 0.5% solution, 4 drops BID for 7 days plus tympanostomy tube in affected ear(s)

    Reporting group title
    TT only
    Reporting group description
    Tympanostomy tube surgically inserted through the ear drum for the treatment of recurrent otitis media; no test article

    Serious adverse events
    Moxidex plus TT Moxifloxacin plus TT TT only
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 103 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Moxidex plus TT Moxifloxacin plus TT TT only
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 100 (4.00%)
    6 / 100 (6.00%)
    6 / 103 (5.83%)
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 100 (4.00%)
    6 / 100 (6.00%)
    6 / 103 (5.83%)
         occurrences all number
    4
    6
    6

    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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