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    Clinical Trial Results:
    Aqueous humour concentrations after topical apPlication of combinEd levofloxacin dexamethasone eye dRops and of its single components: a randoMized, assEssor-blinded, parallel-group study in patients undergoing cataract surgery - iPERME

    Summary
    EudraCT number
    		 2018-001149-15
    Trial protocol
    		 IT  
    Global end of trial date
    06 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Aug 2020
    First version publication date
    16 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LevoDesa_05-2017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    NTC SRL
    Sponsor organisation address
    Via dei Gracchi, 35, Milano, Italy, 20146
    Public contact
    Dr. Federico Bertocchi , NTC SRL, 0039 0243850436, federico.bertocchi@ntcpharma.com
    Scientific contact
    Dr. Federico Bertocchi , NTC SRL, 0039 0243850436, federico.bertocchi@ntcpharma.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
    25 Mar 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the penetration of levofloxacin/dexamethasone 21-phosphate into the aqueous humour after ocular administration in combination or as single active ingredients.
    Protection of trial subjects
    The trial will be conducted in accordance with International Conference on Harmonisation Good Clinical Practice (ICH GCP) and all applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Sep 2018
    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
    Italy: 125
    Worldwide total number of subjects
    125
    EEA total number of subjects
    125
    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)
    0
    Adults (18-64 years)
    17
    From 65 to 84 years
    96
    85 years and over
    12

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study Period: • Date of first enrolment: 4 September 2018 • Date study finalized (last patient last visit): 6 December 2018 Study centres: • U.O. Oculistica Universitaria, Azienda Ospedaliera Universitaria Pisana, Presidio Ospedaliero di Cisanello, Pisa; • Clinica Oculistica, Presidio Ospedale San Paolo, Milan.

    Pre-assignment
    Screening details
    		 Planned sample size n.120; randomized patients n.125; screened patients n.133 (1 patient screened for both eyes).

    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
    		 Assessor [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Levofloxacin + Dexamethasone
    Arm description
    		 Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone; Administration route: ocular instillation; Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Levofloxacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ocular use
    Dosage and administration details
    Administration route: ocular instillation; Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP).

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ocular use
    Dosage and administration details
    Administration route: ocular instillation Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP).

    Arm title
    		 Levofloxacin
    Arm description
    		 Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin; Administration route: ocular instillation; Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Levofloxacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ocular use
    Dosage and administration details
    Administration route: ocular instillation; Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin).

    Arm title
    		 Dexamethasone
    Arm description
    		 Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone; Administration route: ocular instillation; Dose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ocular use
    Dosage and administration details
    Administration route: ocular instillation; Dose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP).

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This is a randomized, assessor-blinded, parallel-group study.
    Number of subjects in period 1
    		Levofloxacin + Dexamethasone Levofloxacin Dexamethasone
    Started
    42
    42
    41
    Completed
    42
    42
    41

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Levofloxacin + Dexamethasone
    Reporting group description
    		 Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone; Administration route: ocular instillation; Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP).

    Reporting group title
    Levofloxacin
    Reporting group description
    		 Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin; Administration route: ocular instillation; Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin).

    Reporting group title
    Dexamethasone
    Reporting group description
    		 Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone; Administration route: ocular instillation; Dose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP).

    Reporting group values
    		 Levofloxacin + Dexamethasone Levofloxacin Dexamethasone Total
    Number of subjects
    		 42 42 41 125
    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)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 7 4 6 17
        From 65-84 years
    		 33 31 32 96
        85 years and over
    		 2 7 3 12
    Age continuous
    Units: years
        median (standard deviation)
    		 72.45 ( 7.60 ) 75.38 ( 8.38 ) 74.59 ( 8.00 ) -
    Gender categorical
    Units: Subjects
        Female
    		 27 21 21 69
        Male
    		 15 21 20 56
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 0 1 1 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 0 1 0 1
        White
    		 42 40 40 122
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Levofloxacin + Dexamethasone
    Reporting group description
    		 Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone; Administration route: ocular instillation; Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP).

    Reporting group title
    Levofloxacin
    Reporting group description
    		 Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin; Administration route: ocular instillation; Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin).

    Reporting group title
    Dexamethasone
    Reporting group description
    		 Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone; Administration route: ocular instillation; Dose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP).

    Primary: Aqueous Humour Concentration of Levofloxacin

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    End point title
    		 Aqueous Humour Concentration of Levofloxacin [1]
    End point description
    Defined as the concentration of levofloxacin into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin. The concentration of levofloxacin has been measured by LC tandem mass spectrometry.
    End point type
    Primary
    End point timeframe
    90±15 min after the first administration of the study treatments
    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: No formal statistical hypothesis had been formulated. All analyses were descriptive in nature and no inferential statistical analyses were planned.
    End point values
    		 Levofloxacin + Dexamethasone Levofloxacin Dexamethasone
    Number of subjects analysed
    42
    42
    41
    Units: nmol/mL
        median (confidence interval 95%)
    1.970 (1.648 to 2.292)
    2.151 (1.708 to 2.594)
    0 (0 to 0)
    No statistical analyses for this end point

    Primary: Aqueous Humour Concentration of Dexamethasone 21-phosphate

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    End point title
    		 Aqueous Humour Concentration of Dexamethasone 21-phosphate [2]
    End point description
    Defined as the concentration of dexamethasone 21-phosphate into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin. The concentration of dexamethasone 21- phosphate has been measured by LC tandem mass spectrometry.
    End point type
    Primary
    End point timeframe
    90±15 min after the first administration of the study treatments
    Notes
    [2] - 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: No formal statistical hypothesis had been formulated. All analyses were descriptive in nature and no inferential statistical analyses were planned.
    End point values
    		 Levofloxacin + Dexamethasone Levofloxacin Dexamethasone
    Number of subjects analysed
    42
    42
    41
    Units: nmol/mL
        median (confidence interval 95%)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Primary: Aqueous Humour Concentration of Dexamethasone

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    End point title
    		 Aqueous Humour Concentration of Dexamethasone [3]
    End point description
    Defined as the concentration of dexamethasone into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin.The concentration of dexamethasone has been measured by LC tandem mass spectrometry.
    End point type
    Primary
    End point timeframe
    90±15 min after the first administration of the study treatments
    Notes
    [3] - 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: No formal statistical hypothesis had been formulated. All analyses were descriptive in nature and no inferential statistical analyses were planned.
    End point values
    		 Levofloxacin + Dexamethasone Levofloxacin Dexamethasone
    Number of subjects analysed
    42
    42
    41
    Units: nmol/mL
        median (confidence interval 95%)
    0.030 (0.025 to 0.035)
    0 (0 to 0)
    0.042 (0.035 to 0.048)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline to the study completion, approximately 2 hours
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Levofloxacin + Dexamethasone
    Reporting group description
    		 Levofloxacin 0.5% + DSP 0.132% (w/v) eye drops (TEST product). One ml contains levofloxacin hemihydrate 5.12 mg, corresponding to 5 mg of levofloxacin, and DSP 1.32 mg, corresponding to 1 mg of dexamethasone; Administration route: ocular instillation; Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin and 39.6 μg DSP).

    Reporting group title
    Levofloxacin
    Reporting group description
    		 Levofloxacin 0.5% eye drops (Oftaquix®). One ml contains 5,12 mg of levofloxacin hemihydrate equal to 5 mg of levofloxacin; Administration route: ocular instillation; Dose and regimen: two 30 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose contains 150 μg anhydrous levofloxacin).

    Reporting group title
    Dexamethasone
    Reporting group description
    		 Dexamethasone sodium phosphate 0.15% eye drops (Tamesad®). One ml contains 1.5 mg of DSP corresponding to 1.14 mg/ml of dexamethasone; Administration route: ocular instillation; Dose and regimen: two 26 μl doses 30 minutes apart, one 90 ± 15 minutes prior to surgery and the other 60 ± 15 minutes prior to surgery (each dose containing 39 μg DSP).

    Serious adverse events
    		 Levofloxacin + Dexamethasone Levofloxacin Dexamethasone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (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
    		 Levofloxacin + Dexamethasone Levofloxacin Dexamethasone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    Eye disorders
    Mild Mydriasis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    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
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