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    Clinical Trial Results:
    Effect of topical antibiotics on duration of acute infective conjunctivitis in children: a randomized clinical trial

    Summary
    EudraCT number
    		 2013-005623-16
    Trial protocol
    		 FI  
    Global end of trial date
    07 Feb 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    14 Dec 2024
    First version publication date
    17 Nov 2021
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    Posting final results of the trial
    Summary report(s)
    		 EudraCT_2013-005623-16

    Trial information

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    Trial identification
    Sponsor protocol code
    OY122013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Oulu University Hospital
    Sponsor organisation address
    Kajaanintie 50, Oulu, Finland, 90220
    Public contact
    Minna Honkila, Minna Honkila, minna.honkila@gmail.com
    Scientific contact
    Minna Honkila, Minna Honkila, minna.honkila@gmail.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Feb 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the benefits of antibiotic therapy in the management of acute conjunctivitis in children
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Oct 2014
    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
    Finland: 95
    Worldwide total number of subjects
    95
    EEA total number of subjects
    95
    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)
    28
    Children (2-11 years)
    67
    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
    		 From October 15, 2014, to February 7, 2020

    Pre-assignment
    Screening details
    		 209 children with acute conjunctivitis were evaluated for eligibility; 114 children were excluded: 25 did not meet the inclusion criteria and 89 declined to participate

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer
    Blinding implementation details
    The eye drops and instructions were distributed in opaque cardboard boxes; the moxifloxacin eye drops were packed in plastic bottles and the placebo eye drops in single-dose vials; the bottles and the vials were transparent and did not have any labels

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active comparator
    Arm description
    		 Moxifloxacin eye drops (5 mg/mL)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vigamox
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Conjunctival use
    Dosage and administration details
    1 drop in each affected eye 3 times daily until conjunctival symptoms were absent for at least 24 hours; the maximum duration of treatment was 7 days

    Arm title
    		 Placebo
    Arm description
    		 Carboxymethylcellulose sodium (1.0%)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Celluvisc
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Conjunctival use
    Dosage and administration details
    1 drop in each affected eye 3 times daily until conjunctival symptoms were absent for at least 24 hours; the maximum duration of treatment was 7 days

    Arm title
    		 No intervention
    Arm description
    		 Removal of discharge from the child’s eyes at least 3 times a day
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Active comparator Placebo No intervention
    Started
    32
    31
    32
    Completed
    30
    27
    31
    Not completed
    2
    4
    1
         Lost to follow-up
    2
    3
    -
         Protocol deviation
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active comparator
    Reporting group description
    		 Moxifloxacin eye drops (5 mg/mL)

    Reporting group title
    Placebo
    Reporting group description
    		 Carboxymethylcellulose sodium (1.0%)

    Reporting group title
    No intervention
    Reporting group description
    		 Removal of discharge from the child’s eyes at least 3 times a day

    Reporting group values
    		 Active comparator Placebo No intervention Total
    Number of subjects
    		 32 31 32 95
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 14 4 10 28
        Children (2-11 years)
    		 18 27 22 67
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 2.8 ( 1.6 ) 3.0 ( 1.3 ) 3.2 ( 1.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 17 15 18 50
        Male
    		 15 16 14 45

    End points

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    End points reporting groups
    Reporting group title
    Active comparator
    Reporting group description
    		 Moxifloxacin eye drops (5 mg/mL)

    Reporting group title
    Placebo
    Reporting group description
    		 Carboxymethylcellulose sodium (1.0%)

    Reporting group title
    No intervention
    Reporting group description
    		 Removal of discharge from the child’s eyes at least 3 times a day

    Primary: Time to clinical cure

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    End point title
    		 Time to clinical cure
    End point description
    End point type
    Primary
    End point timeframe
    14 days
    End point values
    		 Active comparator Placebo No intervention
    Number of subjects analysed
    30
    27
    31
    Units: Days
    30
    27
    31
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Active comparator v Placebo v No intervention
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    14 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NA
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    Active comparator
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    No intervention
    Reporting group description
    		 -

    Serious adverse events
    		 Active comparator Placebo No intervention
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Active comparator Placebo No intervention
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 30 (16.67%)
    2 / 27 (7.41%)
    1 / 31 (3.23%)
    Eye disorders
    Relapse
         subjects affected / exposed
    5 / 30 (16.67%)
    2 / 27 (7.41%)
    1 / 31 (3.23%)
         occurrences all number
    5
    2
    1

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36194412
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