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    Clinical Trial Results:
    The effect of Tetrahydrocannabinol on ocular hemodynamics in patients with primary open angle glaucoma- A Phase II Study

    Summary
    EudraCT number
    		 2019-003089-42
    Trial protocol
    		 AT  
    Global end of trial date
    06 Aug 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-250719
    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 4040029810, klin-pharmakologie@meduniwien.ac.at
    Scientific contact
    Department of Clinical Pharmacology, Medical University of Vienna, +43 4040029810, 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
    06 Aug 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Aug 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Aug 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate the effect of single administration of Tetrahydrocannabinol (THC) on ocular blood flow and its regulation in patients with primary open angle glaucoma and healthy subjects.
    Protection of trial subjects
    No specific measures
    Background therapy
    		 Patients with glaucoma continued to take their prescribed intraocular pressure lowering medication during the study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Jul 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: 51
    Worldwide total number of subjects
    51
    EEA total number of subjects
    51
    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)
    14
    From 65 to 84 years
    37
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was done via the database of the Department of Clinical Pharmacology and co-operating private practices and hospitals.

    Pre-assignment
    Screening details
    		 The following examinations and tests were carried out in each patient and healthy subject in the 4 weeks up to 1 day before the first study day: Informed consent, medical history, urine and blood analysis, physical examination, psychiatric examination, complete opthalmic 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, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 5mg Dronabinol
    Arm description
    		 Patients were randomized to receive 5mg Dronabinol on one study day and Placebo on the other study day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dronabinol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    - Experimental Day: 1 capsule containing 5 mg Dronabinol and 1 capsule Placebo taken together with 15g butter, 2 pieces of bread and 250ml of water - Placebo Day: 2 capsules Placebo taken together with 15g butter, 2 pieces of bread and 250ml of water

    Arm title
    		 10mg Dronabinol
    Arm description
    		 Patients were randomized to receive 10mg Dronabinol on one study day and Placebo on the other study day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dronabinol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Experimental Day: 2 capsules containing 5 mg Dronabinol (total dose 10 mg) taken together with 15g butter, 2 pieces of bread and 250ml of water Placebo Day: 2 capsules Placebo taken together with 15g butter, 2 pieces of bread and 250ml of water

    Number of subjects in period 1
    		5mg Dronabinol 10mg Dronabinol
    Started
    24
    27
    Completed
    23
    23
    Not completed
    1
    4
         Consent withdrawn by subject
    1
    4

    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
    		 51 51
    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)
    		 14 14
        From 65-84 years
    		 37 37
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 31 31
        Male
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    5mg Dronabinol
    Reporting group description
    		 Patients were randomized to receive 5mg Dronabinol on one study day and Placebo on the other study day.

    Reporting group title
    10mg Dronabinol
    Reporting group description
    		 Patients were randomized to receive 10mg Dronabinol on one study day and Placebo on the other study day.

    Primary: Relative change in optic nerve head blood flow (MA) in glaucoma patients

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    End point title
    		 Relative change in optic nerve head blood flow (MA) in glaucoma patients
    End point description
    End point type
    Primary
    End point timeframe
    change from baseline after drug administration
    End point values
    		 5mg Dronabinol 10mg Dronabinol
    Number of subjects analysed
    11
    12
    Units: percent
        arithmetic mean (standard deviation)
    -2.2 ( 7.9 )
    10.8 ( 20.6 )
    Statistical analysis title
    		 Difference between groups
    Comparison groups
    5mg Dronabinol v 10mg Dronabinol
    Number of subjects included in analysis
    23
    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
    First Subject first visit - last Subject last visit
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26
    Reporting groups
    Reporting group title
    5mg Dronabinol
    Reporting group description
    		 Patients were randomized to receive 5mg Dronabinol on one study day and Placebo on the other study day.

    Reporting group title
    10mg Dronabinol
    Reporting group description
    		 Patients were randomized to receive 10mg Dronabinol on one study day and Placebo on the other study day.

    Serious adverse events
    		 5mg Dronabinol 10mg Dronabinol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 27 (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: 2%
    Non-serious adverse events
    		 5mg Dronabinol 10mg Dronabinol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 24 (50.00%)
    24 / 27 (88.89%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 24 (16.67%)
    8 / 27 (29.63%)
         occurrences all number
    4
    8
    Lightheadedness
         subjects affected / exposed
    2 / 24 (8.33%)
    4 / 27 (14.81%)
         occurrences all number
    2
    4
    Headache
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 27 (7.41%)
         occurrences all number
    1
    2
    Altered perception
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 27 (7.41%)
         occurrences all number
    1
    2
    General disorders and administration site conditions
    Tiredness
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 27 (7.41%)
         occurrences all number
    1
    2
    Syncope
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Feeling of weakness
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 27 (7.41%)
         occurrences all number
    1
    2
    Vomiting
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 27 (7.41%)
         occurrences all number
    1
    2
    Renal and urinary disorders
    Increased urge to urinate
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/40772417
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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
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