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    Clinical Trial Results:
    RANDOMIZED CONTROLLED CLINICAL STUDY ON THE EFFICACY AND TOLERABILITY OF 0.4% HYALURONIC ACID HYPOTONIC EYE DROPS (IALUREX) VS. HYDROXYPROPYL-GUAR EYE DROPS (SYSTANE) IN THE TREATMENT OF DRY EYE SYNDROME

    Summary
    EudraCT number
    		 2007-005882-37
    Trial protocol
    		 IT  
    Global end of trial date
    05 Jan 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jan 2020
    First version publication date
    03 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    524
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bausch & Lomb Group
    Sponsor organisation address
    Via Pasubio 34, Macherio, Italy, 20050
    Public contact
    Clinical Science Manager, Bausch & Lomb, + 39 03920731,
    Scientific contact
    Clinical Science Manager, Bausch & Lomb, + 39 03920731,
    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
    05 Jan 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Jan 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jan 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy of Ialurex vs. Systane Eye Drops on the basis of the improvement of corneal fluorescein staining
    Protection of trial subjects
    This clinical investigation was conducted in accordance with the protocol, ICH guidelines (CPMP/ICH/135/95), GCPs, applicable local regulations of Italian Legislative Decrees 211/2003 and 219/2006, and the Declaration of Helsinki (2004).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 May 2008
    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: 43
    Worldwide total number of subjects
    43
    EEA total number of subjects
    43
    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)
    30
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Informed consent, eligibility determination, medical history, recording of concomitant medication, demographic data, external eye examination, slit lamp examination, natural and best-corrected visual acuity (BCVA).

    Period 1
    Period 1 title
    Randomized (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ialurex
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    hypotonic 0.4% hyaluronic acid eye drop
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    1 drop/eye four times a day (4 hours interval)

    Arm title
    		 Systane
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hydroxypropyl-Guar Eye
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Ocular use
    Dosage and administration details
    1 drop/eye four times a day (4 hours interval)

    Number of subjects in period 1 [1]
    		Ialurex Systane
    Started
    20
    18
    Completed
    20
    18
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 43 subjects enrolled in this study. Three subjects were screened but not randomized.

    Baseline characteristics

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

    Reporting group title
    Systane
    Reporting group description
    		 -

    Reporting group values
    		 Ialurex Systane Total
    Number of subjects
    		 20 18 38
    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)
    		 57.6 ± 16.7 53.2 ± 18.2 -
    Gender categorical
    Units: Subjects
        Female
    		 15 14 29
        Male
    		 5 4 9
    Fluorescein Staining
    Units: total score for degree of corneal stain
        arithmetic mean (standard deviation)
    		 4.5 ± 1.5 5.4 ± 2.7 -

    End points

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

    Reporting group title
    Systane
    Reporting group description
    		 -

    Primary: Fluorescein Staining at Visit 4 (Month 2)

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    End point title
    		 Fluorescein Staining at Visit 4 (Month 2)
    End point description
    End point type
    Primary
    End point timeframe
    2 months
    End point values
    		 Ialurex Systane
    Number of subjects analysed
    20
    18
    Units: score
        arithmetic mean (standard deviation)
    4.5 ± 1.5
    5.4 ± 2.7
    Statistical analysis title
    		 Difference in Fluorescein Staining change
    Comparison groups
    Ialurex v Systane
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.547
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The period of observation for collection of AEs extended from the time the subject gave informed consent until the last study visit.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9
    Reporting groups
    Reporting group title
    Ialurex
    Reporting group description
    		 -

    Reporting group title
    Systane
    Reporting group description
    		 -

    Serious adverse events
    		 Ialurex Systane
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 18 (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: 0%
    Non-serious adverse events
    		 Ialurex Systane
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 20 (15.00%)
    4 / 18 (22.22%)
    Investigations
    Intra-ocular pressure increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctival disorder
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 18 (16.67%)
         occurrences all number
    1
    4
    Conjunctival hyperaemia
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    2

    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
    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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