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    Clinical Trial Results:
    Continuation of platelet inhibiting drugs in eyelid surgery. A randomized, double-masked, placebo-controlled clinical trial.

    Summary
    EudraCT number
    		 2009-009986-32
    Trial protocol
    		 NL  
    Global end of trial date
    20 Jan 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2016
    First version publication date
    04 Dec 2014
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OZR-2008-12
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Nederlands Trial Register: NTR1932
    Sponsors
    Sponsor organisation name
    The Rotterdam Eye Hospital
    Sponsor organisation address
    PO Box 70030, Rotterdam, Netherlands, 3000-LM
    Public contact
    Rotterdam Ophthalmic Institute, The Rotterdam Eye Hospital, +31 10 4023449, roi@oogziekenhuis.nl
    Scientific contact
    Rotterdam Ophthalmic Institute, The Rotterdam Eye Hospital, +31 10 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
    20 Jan 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jan 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jan 2011
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To demonstrate non-inferiority of continuation of platelet inhibiting drugs in eyelid surgery regarding the risk of haemorrhagic complications.
    Protection of trial subjects
    In case of retrobulbar bleeding, the wound will be reopened to allow drainage of blood and/or cauterizing. If considered necessary, a lateral canthotomy will be performed. Visual acuity will be measured and the fundus will be viewed (in mydriasis).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Oct 2009
    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
    Netherlands: 7
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    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)
    1
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients using platelet inhibiting drugs (acetylsalicylic acid, carbasalate calcium), who are scheduled for surgical correction of involutional ectropion, entropion, or upper eyelid dermatochalasis without fat prolapse at The Rotterdam Eye Hospital.

    Pre-assignment
    Screening details
    		 Replacement of regular medication will start 7 days preop and will end at 3 days postop.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Acetylsalicylic acid
    Investigational medicinal product code
    RVG16466
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    As prescribed for individual patient.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    As prescribed for individual patient.

    Number of subjects in period 1
    		Active Placebo
    Started
    4
    3
    Completed
    4
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Active Placebo Total
    Number of subjects
    		 4 3 7
    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)
    		 68 ( 10 ) 69 ( 4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 1 1
        Male
    		 4 2 6

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Peroperative bleeding

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    End point title
    		 Peroperative bleeding
    End point description
    End point type
    Primary
    End point timeframe
    peroperative
    End point values
    		 Active Placebo
    Number of subjects analysed
    4
    3
    Units: bleeding events
    1
    0
    Statistical analysis title
    		 No statistics performed.
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    7
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 t-test, 1-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Seven days preop until six weeks postop.
    Adverse event reporting additional description
    No serious adverse events occurred. No postoperative bleeding occurred.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Placebo group.
    Reporting group description
    		 -

    Reporting group title
    Active group.
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo group. Active group.
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo group. Active group.
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (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: Peroperative bleeding is primary outcome; excessive bleeding occurred once (active group). Postoperative bleeding did not occur.

    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? Yes
    Date
    Interruption
    Restart date
    20 Jan 2011
    Shortly after the start of this study, it was decided that the Ocuoplastic Surgery Department of The Rotterdam Eye Hospital would be adopting the international guidelines with respect to the use of platelet inhibiting drugs in periods of surgical intervention. As an interruption of platelet inhibiting drugs for oculoplastic surgery was no longer recommended, this study was prematurely terminated.
    -

    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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