Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Does Hyaluronidase permit volume reduction in sub-Tenon anaestehesia?

    Summary
    EudraCT number
    		 2005-001203-19
    Trial protocol
    		 GB  
    Global end of trial date
    23 Feb 2006

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Sep 2022
    First version publication date
    09 Sep 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AN 05/6922
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Leeds Teaching Hosptials NHS Trust
    Sponsor organisation address
    Beckett Street, Leeds, United Kingdom, LS9 7TF
    Public contact
    LTHT R&I Manager, Leeds Teaching Hospitals NHS Trust Beckett Street Leeds LS9 7TF, 0113 2433144, daniel.skinner@nhs.net
    Scientific contact
    LTHT R&I Manager, Leeds Teaching Hospitals NHS Trust Beckett Street Leeds LS9 7TF, 0113 2433144, daniel.skinner@nhs.net
    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
    23 Feb 2006
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Feb 2006
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Feb 2006
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess and quantify if Hyaluronidase permits volume reduction of the local anaesthetic solution used for sub-Tenon's anaesthesia during cataract surgery. Sub-Tenon's local anaesthesia is a well recognized technique in ophthalmic surgery. By injecting local anaesthetic solution in the sub-Tenon's space the eye is numbed and prevented from moving during surgery. Large volumes of solution can cause chemosis which can complicate the surgical field.This can be avoided by reducing the volume of the injection, which then reduces the quality of the block. Addition of Hyaluronidase increases the spread of the block, but can cause allergic reactions. It is not clear whether the ideal block can be achieved by simply increasing the volume of local anaesthetic, which may worsen the surgical field, or adding hyaluronidase and taking the additional, if small, risk of an adverse event.
    Protection of trial subjects
    It is not the drug or the procedure that is being tested. Both the drugs and the procedure being used are part of standard protocols throughout the UK. What we are testing is the volume of drug that is needed to numb your eye without causing too many side effects and whether the addition of hyaluronidase permits a reduction in the volume.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jul 2005
    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 Kingdom: 66
    Worldwide total number of subjects
    66
    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)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    66
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 patients awaiting cataract surgery identified at SJUH and asked if they would like to join study

    Period 1
    Period 1 title
    Trial Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 treatment arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    hyaluronidase
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Injection
    Dosage and administration details
    15 IU ml−1

    Number of subjects in period 1
    		treatment arm
    Started
    66
    Completed
    66

    Baseline characteristics

    		 Close Top of page

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    treatment arm
    Reporting group description
    		 -

    Primary: verbal response scale from 0 (no pain) to 10 (worst imaginable pain).

    		 Close Top of page
    End point title
    		 verbal response scale from 0 (no pain) to 10 (worst imaginable pain). [1]
    End point description
    End point type
    Primary
    End point timeframe
    at time of injection
    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: trial was terminated early and no significant statistical analysis was performed
    End point values
    		 treatment arm
    Number of subjects analysed
    66 [2]
    Units: verbal response scale
        number (not applicable)
    66
    Notes
    [2] - VRS pain score of 0-4
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    reported to sponsor within 24 hours
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    treatment arm
    Reporting group description
    		 -

    Serious adverse events
    		 treatment arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 66 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 treatment arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 66 (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: trial was terminated early and no serious adverse event reports have been made available.

    More information

    		 Close Top of page

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon Apr 29 03:48:01 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA