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    Clinical Trial Results:
    The post-cataract inflammatory reaction with combination therapy of topical steroid and NSAID.

    Summary
    EudraCT number
    		 2011-006066-40
    Trial protocol
    		 NL  
    Global end of trial date
    31 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2016
    First version publication date
    29 Apr 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OZR-2011-23
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    The Rotterdam Eye Hospital
    Sponsor organisation address
    PO Box 70030, Rotterdam, Netherlands, 3000LM
    Public contact
    Rotterdam Ophthalmic Institute, The Rotterdam Eye Hospital, 31 4023449, roi@oogziekenhuis.nl
    Scientific contact
    Rotterdam Ophthalmic Institute, The Rotterdam Eye Hospital, 31 4023449, roi@oogziekenhuis.nl
    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
    03 Apr 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of the inflammatory reaction with NSAID and steroid prophylaxis.
    Protection of trial subjects
    No specific measures.
    Background therapy
    		 After cataract extraction, ocular inflammation may be observed. A rapid decline of inflammation and minimal irritation of the eye during the early postoperative period may prevent cystoid macular edema and other postoperative complications. The inflammatory response has been frequently measured during the first 3 months after cataract extraction. Three types of prophylaxis were compared: 1) subconjunctival depot of betamethasone, 2) dexamethasone eye drops, and 3) combination of dexamethasone + nepafenac eye drops. [Arms 1) and 2) have been performed as an addendum to study OZR-2006-01 (EudraCT 2006-001486-41); arm 3) was submitted for ethical approval as a separate protocol OZR-2011-23 (EudraCT 2011-006066-40). Here, results are summarized for all three study arms.]
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2012
    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
    Netherlands: 29
    Worldwide total number of subjects
    29
    EEA total number of subjects
    29
    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)
    6
    From 65 to 84 years
    21
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients indicated for cataract surgery.

    Pre-assignment
    Screening details
    		 Subcapsular posterior cataract (very soft, short phaco time). Brunescens or mature cataract (hard, long phaco time).

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm 1
    Arm description
    		 Subconjunctival depot of betamethasone
    Arm type
    		 Experimental

    Investigational medicinal product name
    Betamehtasone
    Investigational medicinal product code
    RVG05399
    Other name
    Celestone chronodose
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subconjunctival use
    Dosage and administration details
    Single perioperative subconjunctival injection, 2.7 mg (1 ml).

    Arm title
    		 Arm 2
    Arm description
    		 Eye drops dexamethasone
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    RVG56003
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Topical use
    Dosage and administration details
    Dexamethasone eye drops (0,1%, 1mg/ml), 3 times a day: postop days 1-28.

    Arm title
    		 Arm 3
    Arm description
    		 Combination of dexamethasone and nepafenac drops.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nepafenac
    Investigational medicinal product code
    EU/1/07/433/001
    Other name
    Nevanac ophthalmic
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Topical use
    Dosage and administration details
    Nevanac eye drops (0,1%, 1mg/ml), 3 times a day: one day preop, day of surgery and postop days 1-28.

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    RVG56003
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Topical use
    Dosage and administration details
    Dexamethasone eye drops (0,1%, 1mg/ml), 3 times a day: postop days 1-28.

    Number of subjects in period 1
    		Arm 1 Arm 2 Arm 3
    Started
    9
    10
    10
    Completed
    9
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 Subconjunctival depot of betamethasone

    Reporting group title
    Arm 2
    Reporting group description
    		 Eye drops dexamethasone

    Reporting group title
    Arm 3
    Reporting group description
    		 Combination of dexamethasone and nepafenac drops.

    Reporting group values
    		 Arm 1 Arm 2 Arm 3 Total
    Number of subjects
    		 9 10 10 29
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 72.2 ( 7.7 ) 70.9 ( 7.7 ) 70.3 ( 10 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 5 6 15
        Male
    		 5 5 4 14
    Flare at baseline
    Units: Arbitrary
        arithmetic mean (standard deviation)
    		 1.54 ( 0.89 ) 1.7 ( 0.46 ) 1.8 ( 0.38 ) -

    End points

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    End points reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 Subconjunctival depot of betamethasone

    Reporting group title
    Arm 2
    Reporting group description
    		 Eye drops dexamethasone

    Reporting group title
    Arm 3
    Reporting group description
    		 Combination of dexamethasone and nepafenac drops.

    Subject analysis set title
    Repeated flare measurements
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Flare measurements comparison in three arms.

    Primary: Flare at day 1

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    End point title
    		 Flare at day 1
    End point description
    End point type
    Primary
    End point timeframe
    Postoperative
    End point values
    		 Arm 1 Arm 2 Arm 3
    Number of subjects analysed
    9
    10
    10
    Units: Arbitrary
        arithmetic mean (standard deviation)
    2.62 ( 0.72 )
    2.76 ( 0.69 )
    2.88 ( 0.46 )
    Statistical analysis title
    		 Repeated measurements analysis
    Comparison groups
    Arm 2 v Arm 3 v Arm 1
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Primary: Flare at day 3

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    End point title
    		 Flare at day 3 [1]
    End point description
    End point type
    Primary
    End point timeframe
    Postoperative
    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: Mixed model analysis (see end point 'Flare at day 1').
    End point values
    		 Arm 1 Arm 2 Arm 3
    Number of subjects analysed
    9
    10
    10
    Units: Arbitrayr
        arithmetic mean (standard deviation)
    2.97 ( 0.76 )
    3.06 ( 0.73 )
    2.77 ( 0.38 )
    No statistical analyses for this end point

    Primary: Flare at day 5

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    End point title
    		 Flare at day 5 [2]
    End point description
    End point type
    Primary
    End point timeframe
    Postoperative
    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: Mixed model analysis (see end point 'Flare at day 1').
    End point values
    		 Arm 1 Arm 2 Arm 3
    Number of subjects analysed
    9
    10
    10
    Units: Arbitrary
        arithmetic mean (standard deviation)
    3.04 ( 1 )
    2.91 ( 0.66 )
    2.53 ( 0.5 )
    No statistical analyses for this end point

    Primary: Flare at day 7

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    End point title
    		 Flare at day 7 [3]
    End point description
    End point type
    Primary
    End point timeframe
    Postoperativ
    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: Mixed model analysis (see end point 'Flare at day 1').
    End point values
    		 Arm 1 Arm 2 Arm 3
    Number of subjects analysed
    9
    10
    10
    Units: Arbitrary
        arithmetic mean (standard deviation)
    2.96 ( 1.09 )
    2.5 ( 0.37 )
    2.39 ( 0.6 )
    No statistical analyses for this end point

    Primary: Flare at day 10

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    End point title
    		 Flare at day 10 [4]
    End point description
    End point type
    Primary
    End point timeframe
    Postoperative
    Notes
    [4] - 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: Mixed model analysis (see end point 'Flare at day 1').
    End point values
    		 Arm 1 Arm 2 Arm 3
    Number of subjects analysed
    9
    10
    10
    Units: Arbitrary
        arithmetic mean (standard deviation)
    3.07 ( 0.76 )
    2.5 ( 0.41 )
    2.46 ( 0.34 )
    No statistical analyses for this end point

    Primary: Flare at day 14

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    End point title
    		 Flare at day 14 [5]
    End point description
    End point type
    Primary
    End point timeframe
    Postoperative
    Notes
    [5] - 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: Mixed model analysis (see end point 'Flare at day 1').
    End point values
    		 Arm 1 Arm 2 Arm 3
    Number of subjects analysed
    9
    10
    10
    Units: Arbitrary
        arithmetic mean (standard deviation)
    2.9 ( 0.84 )
    2.38 ( 0.35 )
    2.34 ( 0.31 )
    No statistical analyses for this end point

    Primary: Flare at day 21

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    End point title
    		 Flare at day 21 [6]
    End point description
    End point type
    Primary
    End point timeframe
    Postoperative
    Notes
    [6] - 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: Mixed model analysis (see end point 'Flare at day 1').
    End point values
    		 Arm 1 Arm 2 Arm 3
    Number of subjects analysed
    9
    10
    10
    Units: Arbitrary
        arithmetic mean (standard deviation)
    2.62 ( 0.76 )
    2.19 ( 0.47 )
    2.21 ( 0.48 )
    No statistical analyses for this end point

    Primary: Flare at day 30

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    End point title
    		 Flare at day 30 [7]
    End point description
    End point type
    Primary
    End point timeframe
    Postoperativ
    Notes
    [7] - 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: Mixed model analysis (see end point 'Flare at day 1').
    End point values
    		 Arm 1 Arm 2 Arm 3
    Number of subjects analysed
    9
    10
    10
    Units: Arbitrary
        arithmetic mean (standard deviation)
    2.48 ( 0.62 )
    2.29 ( 0.57 )
    2.2 ( 0.59 )
    No statistical analyses for this end point

    Primary: Flare at day 60

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    End point title
    		 Flare at day 60 [8]
    End point description
    End point type
    Primary
    End point timeframe
    Postoperative
    Notes
    [8] - 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: Mixed model analysis (see end point 'Flare at day 1').
    End point values
    		 Arm 1 Arm 2 Arm 3
    Number of subjects analysed
    9
    10
    10
    Units: Arbitrary
        arithmetic mean (standard deviation)
    2.28 ( 0.73 )
    1.99 ( 0.31 )
    2.19 ( 0.5 )
    No statistical analyses for this end point

    Primary: Flare at day 90

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    End point title
    		 Flare at day 90 [9]
    End point description
    End point type
    Primary
    End point timeframe
    Postoperative
    Notes
    [9] - 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: Mixed model analysis (see end point 'Flare at day 1').
    End point values
    		 Arm 1 Arm 2 Arm 3
    Number of subjects analysed
    9
    10
    10
    Units: Arbitrary
        arithmetic mean (standard deviation)
    2.19 ( 0.67 )
    1.95 ( 0.45 )
    2.13 ( 0.34 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Three months postoperative.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    All study patients
    Reporting group description
    		 -

    Serious adverse events
    		 All study patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 29 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All study patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 29 (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 adverse events were reported.

    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
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