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    Clinical Trial Results:
    A Phase 3 Randomised, Double-Masked, Placebo-Controlled Study of the Effect of OMS302 on Intraoperative Pupil Diameter in Subjects at High Risk of Intraoperative Floppy Iris Syndrome Undergoing Intraocular Lens Replacement

    Summary
    EudraCT number
    		 2013-003885-15
    Trial protocol
    		 DE   AT  
    Global end of trial date
    11 Aug 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jan 2019
    First version publication date
    19 Jan 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OMS302-ILR-006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02093689
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Omeros Corporation
    Sponsor organisation address
    201 Elliott Avenue West, Seattle, United States, 98119
    Public contact
    Clinical Operations Coordinator, Iris Pharma, 33 (0)493 594 959, info@iris-pharma.com
    Scientific contact
    Clinical Operations Coordinator, Iris Pharma, 33 (0)493 594 959, info@iris-pharma.com
    Sponsor organisation name
    Omeros Corporation
    Sponsor organisation address
    201 Elliott Ave W, Seattle, United States, 98119
    Public contact
    Andrea Kessler, Omeros Corporation, 011 12066765000, akessler@omeros.com
    Scientific contact
    Soyoung Han, Omeros Corporation, 011 12066765000, shan@omeros.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
    Interim
    Date of interim/final analysis
    11 Aug 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Aug 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of Part 1 of the study is to evaluate whether intraoperative pupil diameter can be accurately measured in subjects at high risk for Intraoperative Floppy Iris Syndrome (IFIS). The primary objective of Part 2 of the study is to evaluate the effect of OMS302 compared to placebo when administered in irrigation solution during intraocular lens replacement in subjects at high risk for IFIS on: • Intraoperative pupil diameter.
    Protection of trial subjects
    None.
    Background therapy
    		 None.
    Evidence for comparator
    		 None.
    Actual start date of recruitment
    29 Nov 2013
    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
    Austria: 7
    Country: Number of subjects enrolled
    Germany: 7
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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
    11
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adult males 18 years or older.

    Pre-assignment
    Screening details
    		 None.

    Pre-assignment period milestones
    Number of subjects started
    		 14
    Number of subjects completed
    		 14

    Period 1
    Period 1 title
    Baseline Analysis Popluation
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 OMS302
    Arm description
    		 OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution.
    Arm type
    		 Experimental

    Investigational medicinal product name
    OMS302
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for intraocular irrigation
    Routes of administration
    Intraocular use
    Dosage and administration details
    4.4 mL added to BSS solution during cataract surgery.

    Number of subjects in period 1
    		OMS302
    Started
    14
    Completed
    14
    Period 2
    Period 2 title
    Overall Study
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 OMS302
    Arm description
    		 OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution.
    Arm type
    		 Experimental

    Investigational medicinal product name
    OMS302
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for intraocular irrigation
    Routes of administration
    Intraocular use
    Dosage and administration details
    4.4 mL added to BSS solution during cataract surgery.

    Number of subjects in period 2
    		OMS302
    Started
    14
    Completed
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline Analysis Popluation
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Analysis Popluation Total
    Number of subjects
    		 14 14
    Age categorical
    Units: Subjects
        Adults >= 65 years
    		 14 14
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 14 14

    End points

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    End points reporting groups
    Reporting group title
    OMS302
    Reporting group description
    		 OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution.
    Reporting group title
    OMS302
    Reporting group description
    		 OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution.

    Primary: Pupil diameter

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    End point title
    		 Pupil diameter [1]
    End point description
    The primary objective of Part 1 of the study is to evaluate whether intraoperative pupil diameter can feasibly be measured in subjects at high risk for Intraoperative Floppy Iris Syndrome (IFIS).
    End point type
    Primary
    End point timeframe
    After 15 patients enrolled.
    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: Pupil measurement methodology determined not to be appropriate in this population and data were not analyzed from any participant.
    End point values
    		 OMS302
    Number of subjects analysed
    0 [2]
    Units: pixels
        number (not applicable)
    Notes
    [2] - Pupil measurement methodology determined not to be appropriate in this population.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE's are collected from time of consent through the last visit of follow-up.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Part 1
    Reporting group description
    		 Part 1 will be an open-label study in which all subjects receive OMS302

    Serious adverse events
    		 Part 1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 Part 1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 14 (21.43%)
    Investigations
    Intraocular pressure increased
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Surgical and medical procedures
    Zonulolysis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Eye disorders
    Iridocele
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    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? Yes
    Date
    Interruption
    Restart date
    11 Aug 2014
    Pupil measurement methodology determined not to be appropriate in this population.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Pupil measurement methodology determined not to be appropriate in this population.
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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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