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    Clinical Trial Results:
    Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Externa (AOE)

    Summary
    EudraCT number
    		 2018-000641-39
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    25 Jul 2007

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

    Trial information

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    Trial identification
    Sponsor protocol code
    C-05-37
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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
    25 Jul 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jul 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jul 2007
    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 solution for the treatment of acute otitis externa (AOE).
    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
    26 Jun 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: 268
    Worldwide total number of subjects
    268
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    74
    Adults (18-64 years)
    181
    From 65 to 84 years
    12
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 40 study centers located in the United States.

    Pre-assignment
    Screening details
    		 This reporting group includes all subjects who received drug (Intent-to-Treat (ITT) Analysis Set).

    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 0.5%/dexamethasone phosphate 0.1% solution, 4 drops 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 BID for 7 days

    Arm title
    		 Moxifloxacin Solution
    Arm description
    		 Moxifloxacin hydrochloride 0.5% solution, 4 drops 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
    131
    137
    Completed
    115
    121
    Not completed
    16
    16
         Treatment failure
    5
    7
         Adverse event, non-fatal
    6
    5
         Inclusion/exclusion violation
    2
    -
         Other
    1
    -
         Decision unrelated to an AE
    1
    2
         Lost to follow-up
    -
    2
         Noncompliance
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Moxidex solution
    Reporting group description
    		 Moxifloxacin 0.5%/dexamethasone phosphate 0.1% solution, 4 drops twice daily (morning and evening), for 7 days

    Reporting group title
    Moxifloxacin Solution
    Reporting group description
    		 Moxifloxacin hydrochloride 0.5% solution, 4 drops twice daily (morning and evening), for 7 days

    Reporting group values
    		 Moxidex solution Moxifloxacin Solution Total
    Number of subjects
    		 131 137 268
    Age categorical
    ITT Analysis Set.
    Units: Subjects
        Adolescents (12-17 years)
    		 35 39 74
        Adults (18-64 years)
    		 88 93 181
        From 65-84 years
    		 8 4 12
        85 years and over
    		 0 1 1
    Gender categorical
    Units: Subjects
        Female
    		 66 73 139
        Male
    		 65 64 129

    End points

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    End points reporting groups
    Reporting group title
    Moxidex solution
    Reporting group description
    		 Moxifloxacin 0.5%/dexamethasone phosphate 0.1% solution, 4 drops twice daily (morning and evening), for 7 days

    Reporting group title
    Moxifloxacin Solution
    Reporting group description
    		 Moxifloxacin hydrochloride 0.5% solution, 4 drops twice daily (morning and evening), for 7 days

    Primary: Time to complete relief of ear pain

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    End point title
    		 Time to complete relief of ear pain
    End point description
    Complete relief of ear pain was defined as occurring on the first day that ear pain was completely relieved and remained completely relieved for all subsequent diary entries. Subject reported ear pain relief was assessed twice daily using an interactive voice recognition phone-in diary system (IVRS) and graded on a scale of 0 (complete relief of ear pain) to 6 (very much worsening of ear pain). This analysis set included 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 11 (Test of Cure (TOC))
    End point values
    		 Moxidex solution Moxifloxacin Solution
    Number of subjects analysed
    127
    129
    Units: units on a scale
        median (confidence interval 95%)
    7.0 (6.50 to 8.00)
    7.0 (6.00 to 9.00)
    Statistical analysis title
    		 Time to complete relief of ear pain
    Comparison groups
    Moxifloxacin Solution v Moxidex solution
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5511
    Method
    		 Logrank
    Confidence interval

    Secondary: Percentage of subjects with clinical cure

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    End point title
    		 Percentage of subjects with clinical cure
    End point description
    A clinical response of resolved/cured as evaluated by the Investigator at Visit 4 was considered a clinical cure. MITT Analysis Set.
    End point type
    Secondary
    End point timeframe
    Day 11 (TOC)
    End point values
    		 Moxidex solution Moxifloxacin Solution
    Number of subjects analysed
    127
    129
    Units: percentage of subjects
        number (not applicable)
    85.0
    82.2
    Statistical analysis title
    		 Clinical Cure
    Comparison groups
    Moxidex solution v Moxifloxacin Solution
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5354
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Percentage of subjects for microbiological outcome

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    End point title
    		 Percentage of subjects for microbiological outcome
    End point description
    The eradication of pre-therapy pathogens was assessed at the TOC visit. Bacterial response (success or failure) was calculated. MITT Analysis Set.
    End point type
    Secondary
    End point timeframe
    Day 11 (TOC)
    End point values
    		 Moxidex solution Moxifloxacin Solution
    Number of subjects analysed
    127
    129
    Units: percentage of subjects
    number (not applicable)
        Success
    85.0
    82.2
        Failure
    15.0
    17.8
    Statistical analysis title
    		 Microbiological outcome - Treatment Failure
    Comparison groups
    Moxidex solution v Moxifloxacin Solution
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5354
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Percentage of subjects with treatment failure

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    End point title
    		 Percentage of subjects with treatment failure
    End point description
    Subjects who had no clinically relevant response to the medication or whose symptoms worsened after at least 2 full days of treatment with the study medication could be considered “treatment failures.” MITT Analysis Set.
    End point type
    Secondary
    End point timeframe
    Day 11 (TOC)
    End point values
    		 Moxidex solution Moxifloxacin Solution
    Number of subjects analysed
    127
    129
    Units: percentage of subjects
        number (not applicable)
    15.0
    17.8
    Statistical analysis title
    		 Treatment failure
    Comparison groups
    Moxidex solution v Moxifloxacin Solution
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5354
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events (AEs) 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 who received study drug (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 solution
    Reporting group description
    		 Moxifloxacin 0.5%/dexamethasone phosphate 0.1% solution, 4 drops twice daily (morning and evening), for 7 days

    Reporting group title
    Moxifloxacin Solution
    Reporting group description
    		 Moxifloxacin hydrochloride 0.5% solution, 4 drops twice daily (morning and evening), for 7 days

    Serious adverse events
    		 Moxidex solution Moxifloxacin Solution
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 137 (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
    		 Moxidex solution Moxifloxacin Solution
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 137 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events occurred above the 5% threshold.

    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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    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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