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    Clinical Trial Results:
    An Evaluation of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates

    Summary
    EudraCT number
    2017-002732-17
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    09 Feb 2009

    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-05-04
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00579020
    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
    09 Feb 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Feb 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Feb 2009
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this study was to evaluate the efficacy and safety of Moxidex Ophthalmic Solution for the treatment of marginal corneal infiltrates.
    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
    10 Dec 2007
    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: 144
    Worldwide total number of subjects
    144
    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)
    14
    Adults (18-64 years)
    118
    From 65 to 84 years
    11
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were recruited from 26 study centers located in US.

    Pre-assignment
    Screening details
    This reporting group includes all enrolled and randomized subjects (144).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Moxidex
    Arm description
    Moxidex Ophthalmic Solution, administered in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids for 7 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Moxifloxacin Ophthalmic Solution 0.5%/dexamethasone phosphate 0.1%
    Investigational medicinal product code
    FID 107535
    Other name
    Moxidex
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Topical use , Ocular use
    Dosage and administration details
    Dosed in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids

    Arm title
    Moxifloxacin
    Arm description
    Moxifloxacin Ophthalmic Solution 0.5%, administered in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids for 7 days.
    Arm type
    Reference Comparator

    Investigational medicinal product name
    Moxifloxacin Ophthalmic Solution 0.5%
    Investigational medicinal product code
    FID 106489
    Other name
    Moxifloxacin
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ocular use, Topical use
    Dosage and administration details
    Dosed in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids

    Arm title
    Dexamethasone
    Arm description
    Dexamethasone Phosphate Solution 0.1%, administered in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids for 7 days.
    Arm type
    Reference Comparator

    Investigational medicinal product name
    Dexamethasone Phosphate Solution 0.1%
    Investigational medicinal product code
    FID 107595
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ocular use, Topical use
    Dosage and administration details
    Dosed in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: In this study, treatments were double-masked, unknown to the subject and the clinical assessor.
    Number of subjects in period 1
    Moxidex Moxifloxacin Dexamethasone
    Started
    50
    46
    48
    Completed
    48
    40
    43
    Not completed
    2
    6
    5
         Other
    -
    1
    -
         Treatment Failure
    -
    3
    1
         Adverse event, non-fatal
    -
    -
    1
         Lost to follow-up
    1
    -
    2
         Patient's Decision Unrelated to an Adverse Event
    1
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Moxidex
    Reporting group description
    Moxidex Ophthalmic Solution, administered in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids for 7 days.

    Reporting group title
    Moxifloxacin
    Reporting group description
    Moxifloxacin Ophthalmic Solution 0.5%, administered in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids for 7 days.

    Reporting group title
    Dexamethasone
    Reporting group description
    Dexamethasone Phosphate Solution 0.1%, administered in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids for 7 days.

    Reporting group values
    Moxidex Moxifloxacin Dexamethasone Total
    Number of subjects
    50 46 48 144
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    2 6 6 14
        Adults (18-64 years)
    44 37 37 118
        ≥ 65 Years
    4 3 5 12
    Gender categorical
    Units: Subjects
        Female
    28 31 36 95
        Male
    22 15 12 49

    End points

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    End points reporting groups
    Reporting group title
    Moxidex
    Reporting group description
    Moxidex Ophthalmic Solution, administered in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids for 7 days.

    Reporting group title
    Moxifloxacin
    Reporting group description
    Moxifloxacin Ophthalmic Solution 0.5%, administered in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids for 7 days.

    Reporting group title
    Dexamethasone
    Reporting group description
    Dexamethasone Phosphate Solution 0.1%, administered in the affected eye 4 times daily; 1 drop in cul-de-sac, 4 drops on closed lids for 7 days.

    Primary: Resolution of Corneal Stromal Infiltrates at Day 10 (Test of Cure [TOC])

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    End point title
    Resolution of Corneal Stromal Infiltrates at Day 10 (Test of Cure [TOC]) [1]
    End point description
    Resolution (complete clearing) of corneal stromal infiltrate(s)) was defined by its absence in the study eye at Day 10, regardless of the presence of scarring or haze. Reported as a percentage of total subjects with resolution.
    End point type
    Primary
    End point timeframe
    Day 10 (TOC)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Due to cancellation of the study, no inferential statistical analyses were performed. Descriptive statistics only were presented for the primary efficacy variable.
    End point values
    Moxidex Moxifloxacin Dexamethasone
    Number of subjects analysed
    47 [2]
    43 [3]
    44 [4]
    Units: Percentage of subjects
        number (not applicable)
    91.5
    79.1
    90.9
    Notes
    [2] - All subjects who received treatment (Safety Analysis Set) with non-missing data at TOC
    [3] - Safety Analysis Set with non-missing data at TOC
    [4] - Safety Analysis Set with non-missing data at TOC
    No statistical analyses for this end point

    Secondary: Microbiological Success at Day 10 (TOC)

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    End point title
    Microbiological Success at Day 10 (TOC)
    End point description
    Microbiological success was defined as eradication of all pre-therapy bacteria from the lid of the study eye at the Day 10 (TOC) visit. Reported as a percentage of total subjects with success. This analysis population, a culture positive subset of the safety analysis set, includes all subjects who were culture positive (ie, any bacteria recovered) in the study eye at baseline.
    End point type
    Secondary
    End point timeframe
    Day 10 (TOC)
    End point values
    Moxidex Moxifloxacin Dexamethasone
    Number of subjects analysed
    20 [5]
    17 [6]
    15 [7]
    Units: Percentage of subjects
        number (not applicable)
    85
    94.1
    80
    Notes
    [5] - All subjects who were culture positive (ie, any bacteria recovered) in the study eye at baseline.
    [6] - All subjects who were culture positive (ie, any bacteria recovered) in the study eye at baseline.
    [7] - All subjects who were culture positive (ie, any bacteria recovered) in the study eye at baseline.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    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.
    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
    11.0
    Reporting groups
    Reporting group title
    Moxidex
    Reporting group description
    -

    Reporting group title
    Moxifloxacin
    Reporting group description
    -

    Reporting group title
    Dexamethasone
    Reporting group description
    -

    Serious adverse events
    Moxidex Moxifloxacin Dexamethasone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 46 (0.00%)
    0 / 48 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Moxidex Moxifloxacin Dexamethasone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    3 / 46 (6.52%)
    0 / 48 (0.00%)
    Eye disorders
    Corneal Infiltrates
         subjects affected / exposed
    0 / 50 (0.00%)
    3 / 46 (6.52%)
    0 / 48 (0.00%)
         occurrences all number
    0
    4
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Nov 2007
    To change the primary efficacy variable based on recommendation from Health Authority

    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.
    Study was terminated due to lack of sufficient efficacy and not related to safety. Subjects currently enrolled at the time of termination were allowed to complete their remaining study visits.
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