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    Clinical Trial Results:
    Proof of Concept of Single Application of AL-60371/AL-817 Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes Compared to CIPRODEX® (BID for 7 Days)

    Summary
    EudraCT number
    		 2017-002689-30
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    19 Aug 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jan 2018
    First version publication date
    04 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C-13-026
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01908803
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alcon Research Ltd
    Sponsor organisation address
    6201 S. Freeway, Fort Worth, Texas, United States, 76134
    Public contact
    Ophthalmology Unit, Novartis Pharmaceuticals , +44 0127666733391, dennis.wong@novartis.com
    Scientific contact
    Ophthalmology Unit, Novartis Pharmaceuticals , +44 0127666733391, dennis.wong@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
    19 Aug 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Aug 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Aug 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to 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
    26 Dec 2013
    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: 68
    Worldwide total number of subjects
    68
    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)
    33
    Children (2-11 years)
    35
    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 12 study centers located in the US.

    Pre-assignment
    Screening details
    		 Of the 84 enrolled, 14 subjects were exited as screen failures prior to randomization. Two randomized subjects discontinued prior to receiving investigational product.

    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
    		 AL-60371/AL-817
    Arm description
    		 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
    Arm type
    		 Experimental

    Investigational medicinal product name
    AL-60371/AL-817 otic suspension
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ear drops, suspension
    Routes of administration
    Auricular use
    Dosage and administration details
    200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)

    Arm title
    		 CIPRODEX
    Arm description
    		 Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension
    Investigational medicinal product code
    Other name
    CIPRODEX®
    Pharmaceutical forms
    Ear drops, suspension, Ear drops, suspension
    Routes of administration
    Auricular use, Auricular use
    Dosage and administration details
    Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This was a single-blind trial and only the investigator was masked.
    Number of subjects in period 1
    		AL-60371/AL-817 CIPRODEX
    Started
    44
    24
    Completed
    42
    23
    Not completed
    2
    1
         Physician decision
    -
    1
         Adverse Event
    1
    -
         Withdrawal by Subject
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AL-60371/AL-817
    Reporting group description
    		 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)

    Reporting group title
    CIPRODEX
    Reporting group description
    		 Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days

    Reporting group values
    		 AL-60371/AL-817 CIPRODEX Total
    Number of subjects
    		 44 24 68
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 2.9 ± 2.6 2.4 ± 1.54 -
    Gender categorical
    Units: Subjects
        Female
    		 21 9 30
        Male
    		 23 15 38

    End points

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    End points reporting groups
    Reporting group title
    AL-60371/AL-817
    Reporting group description
    		 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)

    Reporting group title
    CIPRODEX
    Reporting group description
    		 Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days

    Primary: Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit

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    End point title
    		 Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit
    End point description
    A sustained clinical cure at Day 3 was attained if otorrhea was absent at the Day 3 visit and continued to be absent through the last study visit (Day 8 or Early Exit). Proportion of subjects is reported as a percentage. This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.
    End point type
    Primary
    End point timeframe
    Day 3 post-treatment up to Day 8 or Early Exit
    End point values
    		 AL-60371/AL-817 CIPRODEX
    Number of subjects analysed
    39
    22
    Units: Percentage of subjects
        number (not applicable)
    38.5
    31.8
    Statistical analysis title
    		 Sustained Clinical Cure at Day 3
    Statistical analysis description
    Descriptive statistics for the difference of the group proportions are provided including the 95% CI.
    Comparison groups
    CIPRODEX v AL-60371/AL-817
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    6.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.1
         upper limit
    		 31.4

    Secondary: Proportion of Subjects With Microbiological Success at the Day 8 Visit

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    End point title
    		 Proportion of Subjects With Microbiological Success at the Day 8 Visit
    End point description
    Microbiological success was attained if all pre-therapy bacteria were absent in the Day 8 specimen. In a subject with no otorrhea at Day 8, eradication of pre-therapy bacteria was presumed and the subject was considered a microbiological success. This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.
    End point type
    Secondary
    End point timeframe
    Day 8
    End point values
    		 AL-60371/AL-817 CIPRODEX
    Number of subjects analysed
    0 [1]
    0 [2]
    Units: Percentage of subjects
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [1] - This outcome measure was not analyzed as a consequence of the study’s early termination.
    [2] - This outcome measure was not analyzed as a consequence of the study’s early termination.
    No statistical analyses for this end point

    Secondary: Median Time (in Days) to Cessation of Otorrhea

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    End point title
    		 Median Time (in Days) to Cessation of Otorrhea
    End point description
    Median time (in days) to the cessation of otorrhea (ie, otorrhea was absent) was calculated as the number of days from the Day 1 (Visit 1) to the absence of otorrhea in the affected ear(s) as recorded by the parent/guardian via the twice-daily diary. Cessation of otorrhea was defined as ending on the first day that otorrhea was absent from the affected ear(s) and remained absent for any/all subsequent diary entries. This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.
    End point type
    Secondary
    End point timeframe
    Time to event, up to Day 8
    End point values
    		 AL-60371/AL-817 CIPRODEX
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: Days
        median (standard error)
    ±
    ±
    Notes
    [3] - This outcome measure was not analyzed as a consequence of the study’s early termination.
    [4] - This outcome measure was not analyzed as a consequence of the study’s early termination.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were collected for the duration of subject participation in the study (8-10 days).
    Adverse event reporting additional description
    Only total subjects affected by non-serious AEs that occur at >5% are reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    AL-60371/AL-817
    Reporting group description
    		 Includes all subjects administered a dose of AL-60371/AL-817

    Reporting group title
    CIPRODEX
    Reporting group description
    		 Includes all subjects administered a dose of CIPRODEX®

    Serious adverse events
    		 AL-60371/AL-817 CIPRODEX
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 AL-60371/AL-817 CIPRODEX
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 44 (6.82%)
    1 / 24 (4.17%)
    Infections and infestations
    Otitis media acute
         subjects affected / exposed
    3 / 44 (6.82%)
    1 / 24 (4.17%)
         occurrences all number
    3
    2

    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.
    Terminated due to management decision.
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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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