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    Clinical Trial Results:
    Safety and Efficacy Evaluation of Topical Moxidex Otic Solution Compared to Moxifloxacin Solution in the Treatment of Acute Otitis Media with Otorrhea through Tympanostomy Tubes (AOMT)

    Summary
    EudraCT number
    		 2018-000640-26
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    04 Feb 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Aug 2018
    First version publication date
    23 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C-05-36
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00579189
    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
    04 Feb 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Feb 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    04 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 otic solution for the treatment of subjects with acute otitis media with tympanostomy tubes (AOMT) and to compare Moxidex otic solution with Moxifloxacin solution for cessation of 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
    22 Feb 2006
    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: 776
    Worldwide total number of subjects
    776
    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)
    377
    Children (2-11 years)
    395
    Adolescents (12-17 years)
    4
    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 at 48 sites located in the United States.

    Pre-assignment
    Screening details
    		 This reporting group includes all randomized and treated subjects (776).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Moxidex Solution
    Arm description
    		 Moxifloxacin hydrochloride 0.5%/Dexamethasone phosphate 0.1%, 4 drops into the infected ear(s), twice daily (morning and evening), for 7 days
    Arm type
    		 Experimental

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

    Arm title
    		 Moxifloxacin Solution
    Arm description
    		 Moxifloxacin hydrochloride 0.5%, 4 drops into the infected ear(s), twice daily (morning and evening), for 7 days
    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
    4 drops BID for 7 days

    Number of subjects in period 1
    		Moxidex Solution Moxifloxacin Solution
    Started
    389
    387
    Completed
    302
    264
    Not completed
    87
    123
         Treatment failure
    30
    50
         Baseline culture results positive for Strep A
    7
    8
         Adverse event, non-fatal
    35
    40
         Inclusion/exclusion violation
    3
    4
         Baseline culture results positive for yeast
    1
    4
         Decision unrelated to an AE
    1
    3
         Lost to follow-up
    3
    1
         Noncompliance
    1
    4
         Other - Reason not given
    6
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Moxidex Solution
    Reporting group description
    		 Moxifloxacin hydrochloride 0.5%/Dexamethasone phosphate 0.1%, 4 drops into the infected ear(s), twice daily (morning and evening), for 7 days

    Reporting group title
    Moxifloxacin Solution
    Reporting group description
    		 Moxifloxacin hydrochloride 0.5%, 4 drops into the infected ear(s), twice daily (morning and evening), for 7 days

    Reporting group values
    		 Moxidex Solution Moxifloxacin Solution Total
    Number of subjects
    		 389 387 776
    Age categorical
    This analysis population includes all subjects who received drug. Subjects were analysed based on planned treatment group (Intent-to-Treat (ITT) Analysis Set).
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 201 176 377
        Children (2-11 years)
    		 184 211 395
        Adolescents (12-17 years)
    		 4 0 4
    Gender categorical
    ITT Analysis Set
    Units: Subjects
        Female
    		 166 159 325
        Male
    		 223 228 451

    End points

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    End points reporting groups
    Reporting group title
    Moxidex Solution
    Reporting group description
    		 Moxifloxacin hydrochloride 0.5%/Dexamethasone phosphate 0.1%, 4 drops into the infected ear(s), twice daily (morning and evening), for 7 days

    Reporting group title
    Moxifloxacin Solution
    Reporting group description
    		 Moxifloxacin hydrochloride 0.5%, 4 drops into the infected ear(s), twice daily (morning and evening), for 7 days

    Primary: Time to Cessation of Otorrhea

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    End point title
    		 Time to Cessation of Otorrhea
    End point description
    Time to cessation of otorrhea was defined as the time (in days) to the cessation of otorrhea (i.e. absence of otorrhea), calculated as the number of days from surgery to the absence of otorrhea in both ears, as recorded by the parent/guardian via the patient diary. This analysis set includes all subjects who received drug, met pre-randomization inclusion and exclusion criteria and were pathogen positive for bacteria on Day 1 (Modified ITT (MITT) Analysis Set).
    End point type
    Primary
    End point timeframe
    Up to Day 15 (Test of Cure (TOC))
    End point values
    		 Moxidex Solution Moxifloxacin Solution
    Number of subjects analysed
    298
    305
    Units: days
        median (confidence interval 95%)
    3.0 (2.5 to 3.5)
    5.0 (4.0 to 5.5)
    Statistical analysis title
    		 Time to cessation of otorrhea
    Comparison groups
    Moxidex Solution v Moxifloxacin Solution
    Number of subjects included in analysis
    603
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Logrank
    Confidence interval

    Secondary: Percentage of subjects with clinical cure at TOC

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    End point title
    		 Percentage of subjects with clinical cure at TOC
    End point description
    Clinical Cure was defined as a clinical response of resolved/cured (i.e. otorrhea absent) or improved/ not changed/ worsened (i.e. otorrhea present) as evaluated by the Investigator. Reported as a percentage. MITT Analysis Set.
    End point type
    Secondary
    End point timeframe
    Day 15 (TOC)
    End point values
    		 Moxidex Solution Moxifloxacin Solution
    Number of subjects analysed
    298
    305
    Units: percentage of subjects
    number (not applicable)
        Absent
    84.6
    71.5
        Present
    15.4
    28.5
    Statistical analysis title
    		 Clinical cure at TOC
    Comparison groups
    Moxidex Solution v Moxifloxacin Solution
    Number of subjects included in analysis
    603
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0001
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Percentage of subjects for microbiological outcome at TOC

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    End point title
    		 Percentage of subjects for microbiological outcome at TOC
    End point description
    Microbiological outcome (success or failure of eradication of pre-therapy pathogens ) was measured by bacterial response at the TOC visit. MITT Analysis Set.
    End point type
    Secondary
    End point timeframe
    Day 15 (TOC)
    End point values
    		 Moxidex Solution Moxifloxacin Solution
    Number of subjects analysed
    298
    305
    Units: percentage of subjects
    number (not applicable)
        Success
    84.6
    71.5
        Failure
    15.4
    28.5
    Statistical analysis title
    		 Microbiological success
    Comparison groups
    Moxidex Solution v Moxifloxacin Solution
    Number of subjects included in analysis
    603
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0001
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Percentage of subjects with treatment failure at TOC

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    End point title
    		 Percentage of subjects with treatment failure at TOC
    End point description
    Subjects who showed no clinically relevant response to the medication or who worsened in otorrhea after at least 2 full days of treatment with the study medication could be considered treatment failures. Reported as a percentage. MITT Analysis Set.
    End point type
    Secondary
    End point timeframe
    Day 15 (TOC)
    End point values
    		 Moxidex Solution Moxifloxacin Solution
    Number of subjects analysed
    298
    305
    Units: percentage of subjects
        number (not applicable)
    6.7
    14.8
    Statistical analysis title
    		 Treatment Failure
    Comparison groups
    Moxidex Solution v Moxifloxacin Solution
    Number of subjects included in analysis
    603
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0015
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs 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 who received drug (Safety Analysis Set). Subjects were analysed based on actual treatment group.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Moxidex Solution
    Reporting group description
    		 Subjects treated with Moxidex solution

    Reporting group title
    Moxifloxacin Solution
    Reporting group description
    		 Subjects treated with Moxifloxacin solution

    Serious adverse events
    		 Moxidex Solution Moxifloxacin Solution
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 389 (0.00%)
    1 / 387 (0.26%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 389 (0.00%)
    1 / 387 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Moxidex Solution Moxifloxacin Solution
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    153 / 389 (39.33%)
    147 / 387 (37.98%)
    Injury, poisoning and procedural complications
    Injury
         subjects affected / exposed
    4 / 389 (1.03%)
    7 / 387 (1.81%)
         occurrences all number
    5
    7
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    21 / 389 (5.40%)
    17 / 387 (4.39%)
         occurrences all number
    21
    17
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    10 / 389 (2.57%)
    12 / 387 (3.10%)
         occurrences all number
    10
    12
    Otorrhoea
         subjects affected / exposed
    8 / 389 (2.06%)
    6 / 387 (1.55%)
         occurrences all number
    8
    7
    Ear discomfort
         subjects affected / exposed
    5 / 389 (1.29%)
    7 / 387 (1.81%)
         occurrences all number
    5
    7
    Gastrointestinal disorders
    Teething
         subjects affected / exposed
    13 / 389 (3.34%)
    2 / 387 (0.52%)
         occurrences all number
    13
    2
    Diarrhoea
         subjects affected / exposed
    7 / 389 (1.80%)
    8 / 387 (2.07%)
         occurrences all number
    7
    8
    Vomiting
         subjects affected / exposed
    9 / 389 (2.31%)
    3 / 387 (0.78%)
         occurrences all number
    9
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    14 / 389 (3.60%)
    13 / 387 (3.36%)
         occurrences all number
    14
    13
    Rhinorrhoea
         subjects affected / exposed
    12 / 389 (3.08%)
    12 / 387 (3.10%)
         occurrences all number
    12
    12
    Nasal congestion
         subjects affected / exposed
    5 / 389 (1.29%)
    7 / 387 (1.81%)
         occurrences all number
    5
    7
    Rhinitis allergic
         subjects affected / exposed
    2 / 389 (0.51%)
    4 / 387 (1.03%)
         occurrences all number
    2
    4
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    6 / 389 (1.54%)
    0 / 387 (0.00%)
         occurrences all number
    6
    0
    Infections and infestations
    Otitis media
         subjects affected / exposed
    28 / 389 (7.20%)
    22 / 387 (5.68%)
         occurrences all number
    28
    22
    Upper respiratory tract infection
         subjects affected / exposed
    25 / 389 (6.43%)
    10 / 387 (2.58%)
         occurrences all number
    25
    10
    Conjunctivitis
         subjects affected / exposed
    7 / 389 (1.80%)
    2 / 387 (0.52%)
         occurrences all number
    7
    2
    Sinusitis
         subjects affected / exposed
    1 / 389 (0.26%)
    5 / 387 (1.29%)
         occurrences all number
    1
    5
    Product issues
    Device occlusion
         subjects affected / exposed
    3 / 389 (0.77%)
    8 / 387 (2.07%)
         occurrences all number
    3
    8

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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