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    Clinical Trial Results:
    An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients

    Summary
    EudraCT number
    		 2017-002727-24
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    15 Apr 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    C-10-051
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01573910
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alcon Research
    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
    15 Apr 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate Moxifloxacin 0.5% relative to Ofloxacin 0.3% in the treatment of bacterial conjunctivitis in Chinese patients.
    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
    02 May 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 982
    Worldwide total number of subjects
    982
    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)
    17
    Adolescents (12-17 years)
    10
    Adults (18-64 years)
    897
    From 65 to 84 years
    54
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from 16 study centers located in China

    Pre-assignment
    Screening details
    		 Of the 985 subjects who signed an informed consent for this study, 3 subjects were exited as screen failures. This reporting group includes all enrolled and randomized subjects (982).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Moxifloxacin
    Arm description
    		 Moxifloxacin ophthalmic solution, 0.5%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9
    Arm type
    		 Experimental

    Investigational medicinal product name
    Moxifloxacin ophthalmic solution, 0.5%
    Investigational medicinal product code
    Other name
    VIGAMOX®
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    1 drop instilled 3 times per day (TID) in each eye for 7 days

    Arm title
    		 Ofloxacin
    Arm description
    		 Ofloxacin ophthalmic solution, 0.3%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ofloxacin ophthalmic solution, 0.3%
    Investigational medicinal product code
    Other name
    Tarivid® Eye Drops
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    1 drop instilled 3 times per day (TID) in each eye 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 Assessor was masked.
    Number of subjects in period 1
    		Moxifloxacin Ofloxacin
    Started
    489
    493
    Completed
    469
    476
    Not completed
    20
    17
         Adverse event, non-fatal
    4
    4
         Withdrawal by Subject
    -
    1
         Protocol Violation
    3
    -
         Patient decision unrelated to Advs Event
    11
    11
         Lost to follow-up
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Moxifloxacin
    Reporting group description
    		 Moxifloxacin ophthalmic solution, 0.5%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9

    Reporting group title
    Ofloxacin
    Reporting group description
    		 Ofloxacin ophthalmic solution, 0.3%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9

    Reporting group values
    		 Moxifloxacin Ofloxacin Total
    Number of subjects
    		 489 493 982
    Age categorical
    Units: Subjects
    Age continuous
    This analysis population includes all participants who were administered study medication or potentially used study medication.
    Units: years
        arithmetic mean (standard deviation)
    		 37.4 ( 15.54 ) 38.4 ( 15.83 ) -
    Gender categorical
    This analysis population includes all participants who were administered study medication or potentially used study medication.
    Units: Subjects
        Female
    		 254 265 519
        Male
    		 235 228 463

    End points

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    End points reporting groups
    Reporting group title
    Moxifloxacin
    Reporting group description
    		 Moxifloxacin ophthalmic solution, 0.5%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9

    Reporting group title
    Ofloxacin
    Reporting group description
    		 Ofloxacin ophthalmic solution, 0.3%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9

    Primary: Clinical Cure Rate

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    End point title
    		 Clinical Cure Rate
    End point description
    Ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) were rated by the investigator on a 4-point scale, with 0=normal/absent; 1=mild; 2=moderate, and 3=severe. Clinical cure rate is presented as the percentage of participants for which the sum of the numerical scores for the 2 cardinal ocular signs of bacterial conjunctivitis was 0 at Day 9 TOC/Exit Visit. This analysis population includes all patients who received study medication, had no major protocol deviations, had bacteria present at Day 1 visit, and had baseline and TOC/exit data or early exit data.
    End point type
    Primary
    End point timeframe
    Day 9
    End point values
    		 Moxifloxacin Ofloxacin
    Number of subjects analysed
    295
    291
    Units: percentage of participants
        number (not applicable)
    85.4
    81.4
    Statistical analysis title
    		 Clinical Cure Rate
    Comparison groups
    Moxifloxacin v Ofloxacin
    Number of subjects included in analysis
    586
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 11.1

    Primary: Microbiological Success Rate

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    End point title
    		 Microbiological Success Rate
    End point description
    Microbiological specimen(s) from the affected eye(s) were collected according to a protocol-defined process. Microbiological success rate is presented as the percentage of participants for which the pre-therapy pathogens at Visit 1 (Day 1) were eradicated at Day 9 TOC/Exit Visit. This analysis population includes all patients who received study medication, had no major protocol deviations, had bacteria present at Day 1 visit, and had baseline and TOC/exit data or early exit data.
    End point type
    Primary
    End point timeframe
    Day 9
    End point values
    		 Moxifloxacin Ofloxacin
    Number of subjects analysed
    295
    291
    Units: percentage of participants
        number (not applicable)
    95.3
    94.8
    Statistical analysis title
    		 Microbiological Success
    Comparison groups
    Moxifloxacin v Ofloxacin
    Number of subjects included in analysis
    586
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 7.7

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events (AEs) were collected for the duration of the study (May 2012 to April 2014). This analysis group includes all patients who were administered or potentially used study medication.
    Adverse event reporting additional description
    An adverse event was defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Moxifloxacin
    Reporting group description
    		 1 drop instilled TID in each eye for 7 days with a TOC at Day 9

    Reporting group title
    Ofloxacin
    Reporting group description
    		 1 drop instilled TID in each eye for 7 days with a TOC at Day 9

    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.
    Serious adverse events
    		 Moxifloxacin Ofloxacin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 489 (0.20%)
    0 / 493 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 489 (0.20%)
    0 / 493 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Moxifloxacin Ofloxacin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 489 (0.00%)
    0 / 493 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Aug 2013
    Added contents to the protocol in order to help better understand the efficacy of Moxifloxacin

    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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