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    Clinical Trial Results:
    The effect of hyperoxia and hypoxia on fluorescence lifetime imaging ophthalmoscopy in healthy subjects

    Summary
    EudraCT number
    		 2019-000804-14
    Trial protocol
    		 AT  
    Global end of trial date
    02 Jul 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Apr 2026
    First version publication date
    15 Apr 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OPHT-070119
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Department of Clinical Pharmacology, Medical University of Vienna, +43 14040029810, klin-pharmakologie@meduniwien.ac.at
    Scientific contact
    Department of Clinical Pharmacology, Medical University of Vienna, +43 14040029810, klin-pharmakologie@meduniwien.ac.at
    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
    02 Jul 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jul 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jul 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of 100% oxygen breathing on fluorescence lifetime imaging ophthalmoscopy (FLIO) in healthy subjects
    Protection of trial subjects
    not applicable- healthy volunteers
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Apr 2019
    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: 48
    Worldwide total number of subjects
    48
    EEA total number of subjects
    48
    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)
    48
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from the database of the Department of Clinical Pharmacology

    Pre-assignment
    Screening details
    		 A screening examination was carried out on each study participant, which included medical history, urine pregnancy test in women with childbearing potential, physical examination, 12-lead electrocardiogram, hemodynamic measurements and a complete ophthalmological examination.

    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
    Blinding implementation details
    Neither the subject nor the investigator where aware which gas mixture the subject was about to receive.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Hyperoxia
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxygen 100%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    SAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria. Dose: 100%, breathing for a maximum of 30 min.

    Arm title
    		 Hypoxia
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nitrogen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    STICKSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria. Dose: 88% nitrogen in 12% oxygen, breathing for a maximum of 30 min.

    Number of subjects in period 1
    		Hyperoxia Hypoxia
    Started
    47
    48
    Completed
    47
    47
    Not completed
    0
    1
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 48 48
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 48 48
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 24 24
        Male
    		 24 24

    End points

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

    Reporting group title
    Hypoxia
    Reporting group description
    		 -

    Primary: Change in retinal oxygen extraction from baseline

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    End point title
    		 Change in retinal oxygen extraction from baseline
    End point description
    End point type
    Primary
    End point timeframe
    Before and during gas breathing.
    End point values
    		 Hyperoxia Hypoxia
    Number of subjects analysed
    21
    22
    Units: percent
        arithmetic mean (standard deviation)
    -36 ( 17 )
    6 ( 13 )
    Statistical analysis title
    		 Difference between groups
    Comparison groups
    Hyperoxia v Hypoxia
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the whole study period.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26
    Reporting groups
    Reporting group title
    Study participants
    Reporting group description
    		 -

    Serious adverse events
    		 Study participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 48 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Study participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 48 (14.58%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 48 (4.17%)
         occurrences all number
    2
    Dizziness
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences all number
    1
    General disorders and administration site conditions
    Presyncope
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences all number
    1
    Eye disorders
    Eyelid swelling
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences all number
    1
    Infections and infestations
    Covid-19 infection
         subjects affected / exposed
    1 / 48 (2.08%)
         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? 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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