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    Clinical Trial Results:
    An Evaluation of the Safety and Efficacy of Moxifloxacin AF Ophthalmic Solution 0.5% for the Treatment of Bacterial Conjunctivitis in the USA

    Summary
    EudraCT number
    		 2017-002730-23
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    17 May 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Dec 2017
    First version publication date
    22 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C-04-38
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00331916
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alcon Research, Ltd.
    Sponsor organisation address
    6201 S. Freeway, Fort Worth, United States, 76134
    Public contact
    Ophthalmology Unit, Novartis Pharmaceuticals, +44 01276 6673 3391, dennis.wong@novartis.com
    Scientific contact
    Ophthalmology Unit, Novartis Pharmaceuticals, +44 01276 6673 3391, 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
    17 May 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 May 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    17 May 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 safety and efficacy of Moxifloxacin AF Ophthalmic Solution 0.5% compared to Moxifloxacin AF Vehicle in the treatment of bacterial conjunctivitis in patients one month of age or older.
    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
    03 Nov 2005
    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: 661
    Worldwide total number of subjects
    661
    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)
    113
    Children (2-11 years)
    241
    Adolescents (12-17 years)
    66
    Adults (18-64 years)
    226
    From 65 to 84 years
    14
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 32 study centers located in the USA.

    Pre-assignment
    Screening details
    		 This reporting group includes all randomized and treated subjects (661).

    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
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Moxifloxacin AF
    Arm description
    		 Moxifloxacin AF Ophthalmic Solution, one drop into the conjunctival sac of both eyes two times a day for three days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use , Ocular use, Topical use
    Dosage and administration details
    One drop into the conjunctival sac of both eyes two times a day for three days. The total assessment period was 7 days.

    Arm title
    		 Moxifloxacin AF Vehicle
    Arm description
    		 Moxifloxacin AF Vehicle, one drop into the conjunctival sac of both eyes two times a day for three days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Moxifloxacin Alternative Formulation (AF) Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ocular use, Ophthalmic use , Topical use
    Dosage and administration details
    One drop into the conjunctival sac of both eyes two times a day for three days. The total assessment period was 7 days.

    Number of subjects in period 1
    		Moxifloxacin AF Moxifloxacin AF Vehicle
    Started
    331
    330
    Completed
    309
    270
    Not completed
    22
    60
         Adverse event, non-fatal
    5
    5
         Treatment Failure
    7
    32
         Other
    1
    4
         Decision Unrelated to an Adverse Event
    5
    5
         Lost to follow-up
    3
    6
         Noncompliance
    1
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Moxifloxacin AF
    Reporting group description
    		 Moxifloxacin AF Ophthalmic Solution, one drop into the conjunctival sac of both eyes two times a day for three days.

    Reporting group title
    Moxifloxacin AF Vehicle
    Reporting group description
    		 Moxifloxacin AF Vehicle, one drop into the conjunctival sac of both eyes two times a day for three days.

    Reporting group values
    		 Moxifloxacin AF Moxifloxacin AF Vehicle Total
    Number of subjects
    		 331 330 661
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 62 51 113
        Children (2-11 years)
    		 117 124 241
        Adolescents (12-17 years)
    		 31 35 66
        Adults (18-64 years)
    		 114 112 226
        From 65-84 years
    		 7 7 14
        85 years and over
    		 0 1 1
    Gender categorical
    Units: Subjects
        Female
    		 184 189 373
        Male
    		 147 141 288

    End points

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    End points reporting groups
    Reporting group title
    Moxifloxacin AF
    Reporting group description
    		 Moxifloxacin AF Ophthalmic Solution, one drop into the conjunctival sac of both eyes two times a day for three days.

    Reporting group title
    Moxifloxacin AF Vehicle
    Reporting group description
    		 Moxifloxacin AF Vehicle, one drop into the conjunctival sac of both eyes two times a day for three days.

    Primary: Clinical cure rate at the Day 7 Exit/Test-of-cure (TOC) Visit

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    End point title
    		 Clinical cure rate at the Day 7 Exit/Test-of-cure (TOC) Visit
    End point description
    Clinical cure was attained when the sum of the two cardinal ocular signs of bacterial infections (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent). Only one eye (study eye) contributed to the analysis. This analysis population includes all subjects who received drug, had at least one on-therapy visit, met pre-randomization inclusion and exclusion criteria and were pathogen positive for bacteria on Day 1 (Modified Intent-to-Treat (MITT) Analysis Set).
    End point type
    Primary
    End point timeframe
    Day 7
    End point values
    		 Moxifloxacin AF Moxifloxacin AF Vehicle
    Number of subjects analysed
    177
    165
    Units: Percentage
        number (not applicable)
    72.3
    67.3
    Statistical analysis title
    		 Clinical Cure at Day 7
    Comparison groups
    Moxifloxacin AF v Moxifloxacin AF Vehicle
    Number of subjects included in analysis
    342
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3097
    Method
    		 Chi-squared
    Confidence interval

    Primary: Microbiological success rate at the Day 7 Exit/TOC Visit

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    End point title
    		 Microbiological success rate at the Day 7 Exit/TOC Visit
    End point description
    Microbiological success was defined as the eradication of pre-therapy pathogens. Only one eye (study eye) contributed to the analysis. MITT Analysis Set.
    End point type
    Primary
    End point timeframe
    Day 7
    End point values
    		 Moxifloxacin AF Moxifloxacin AF Vehicle
    Number of subjects analysed
    177
    165
    Units: Percentage
        number (not applicable)
    84.2
    66.1
    Statistical analysis title
    		 Microbiological success rate at Day 7
    Comparison groups
    Moxifloxacin AF v Moxifloxacin AF Vehicle
    Number of subjects included in analysis
    342
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0001
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information [1]
    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.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    8.0
    Reporting groups
    Reporting group title
    Moxifloxacin AF
    Reporting group description
    		 Moxifloxacin AF Ophthalmic Solution, one drop into the conjunctival sac of both eyes two times a day for three days.

    Reporting group title
    Moxifloxacin AF Vehicle
    Reporting group description
    		 Moxifloxacin AF Vehicle, one drop into the conjunctival sac of both eyes two times a day for three days.

    Serious adverse events
    		 Moxifloxacin AF Moxifloxacin AF Vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 331 (0.00%)
    0 / 330 (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
    		 Moxifloxacin AF Moxifloxacin AF Vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 331 (0.00%)
    0 / 330 (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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