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    Clinical Trial Results:
    A Phase 3 Multicenter Randomized, Sham-Controlled Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia type 2

    Summary
    EudraCT number
    2017-003260-12
    Trial protocol
    DE  
    Global end of trial date
    07 Sep 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Aug 2024
    First version publication date
    04 Aug 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NTMT-03-B
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03319849
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Neurotech Pharmaceuticals Inc
    Sponsor organisation address
    900 Highland Corporate Drive, Suite 101, Cumberland, United States,
    Public contact
    Kevin Hibbert, Neurotech Pharmaceuticals Inc, k.hibbert@neurotechusa.com
    Scientific contact
    Kevin Hibbert, Neurotech Pharmaceuticals Inc, k.hibbert@neurotechusa.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
    Final
    Date of interim/final analysis
    30 Nov 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The overall objective of this study is to evaluate the efficacy and safety of NT-501 for the treatment of MacTel. Primary objective: • To determine the rate of change in the ellipsoid zone (EZ; inner segment/outer segment [IS/OS]) area loss over 24 months, as measured by study eye spectral-domain optical coherence tomography (SD-OCT) in participants with MacTel
    Protection of trial subjects
    Ethics committee approval
    Background therapy
    None
    Evidence for comparator
    A sham surgical procedure was performed to mimic the implant procedure; there was no comparator product,
    Actual start date of recruitment
    22 Jan 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 25
    Country: Number of subjects enrolled
    United States: 73
    Country: Number of subjects enrolled
    Germany: 21
    Worldwide total number of subjects
    119
    EEA total number of subjects
    21
    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)
    79
    From 65 to 84 years
    40
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Screening period for up to 30 days

    Pre-assignment
    Screening details
    NTMT-03-B: 119 subjects enrolled (6 participants withdrew after randomization) but prior to the implantation/sham surgery procedure; 59 subjects in NT-501 arm and 54 subjects in sham arm.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind [1]
    Roles blinded
    Subject, Data analyst, Carer, Assessor
    Blinding implementation details
    The subjects and all personnel at the image reading center remained masked to the treatment assignment throughout the study. In addition, the refractionist, VA examiner, and photographers/imagers were masked to treatment assignment (NT-501 implantation or sham procedure) at all follow-up visits. The ophthalmologist, surgeon, and clinic coordinator were instructed not to discuss the assigned treatment with the subject.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    NT-501
    Arm description
    Test product
    Arm type
    Experimental

    Investigational medicinal product name
    NT-501 Implant
    Investigational medicinal product code
    NT-501
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Each implant consisting of hCNTF-secreting NTC-201-6A.02 cells encapsulated within supportive matrices and surrounded by a semipermeable polymer membrane. The NTC-201-6A cells continuously secrete CNTF from the NT-501 implant into the vitreous cavity. Implanted by a qualified Health Care Professional.

    Arm title
    Sham Procedure
    Arm description
    A sham surgical procedure was performed to mimic the implant procedure; there was no comparator product.
    Arm type
    Sham surgical procedure

    Investigational medicinal product name
    Sham procedure
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intravitreal use
    Dosage and administration details
    The sham surgery involved a superficial conjunctival incision performed under local anesthetic and closure with a single suture.

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: The subjects and all personnel at the image reading center remained masked to the treatment assignment throughout the study. In addition, the refractionist, VA examiner, and photographers/imagers were masked to treatment assignment (NT-501 implantation or sham procedure) at all follow-up visits. The ophthalmologist, surgeon, and clinic coordinator were instructed not to discuss the assigned treatment with the subject.
    Number of subjects in period 1
    NT-501 Sham Procedure
    Started
    60
    59
    Completed
    57
    49
    Not completed
    3
    10
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    -
    1
         Physician decision
    -
    1
         COVID-19
    -
    1
         Other
    1
    2
         Eligible and did not enrol in amendment
    1
    3
         Lost to follow-up
    -
    2

    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
    119 119
    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)
    79 79
        From 65-84 years
    40 40
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    84 84
        Male
    35 35
    Subject analysis sets

    Subject analysis set title
    Safety population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety population included all randomized subjects who underwent either NT-501 implantation surgery or sham surgery and had at least 1 safety measurement.

    Subject analysis set title
    Modified Intention-to-Treat population
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    The mITT population comprised all randomized subjects who underwent either NT-501 implantation surgery or sham surgery

    Subject analysis set title
    Per Protocol Population
    Subject analysis set type
    Per protocol
    Subject analysis set description
    The PP population included all subjects in the mITT population who had no important protocol deviations (ie, deviations that may have had a substantial impact on the primary efficacy endpoint).

    Subject analysis sets values
    Safety population Modified Intention-to-Treat population Per Protocol Population
    Number of subjects
    113
    113
    105
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    78
    78
    74
        From 65-84 years
    35
    35
    31
        85 years and over
    0
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    82
    82
    76
        Male
    31
    31
    29

    End points

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    End points reporting groups
    Reporting group title
    NT-501
    Reporting group description
    Test product

    Reporting group title
    Sham Procedure
    Reporting group description
    A sham surgical procedure was performed to mimic the implant procedure; there was no comparator product.

    Subject analysis set title
    Safety population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety population included all randomized subjects who underwent either NT-501 implantation surgery or sham surgery and had at least 1 safety measurement.

    Subject analysis set title
    Modified Intention-to-Treat population
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    The mITT population comprised all randomized subjects who underwent either NT-501 implantation surgery or sham surgery

    Subject analysis set title
    Per Protocol Population
    Subject analysis set type
    Per protocol
    Subject analysis set description
    The PP population included all subjects in the mITT population who had no important protocol deviations (ie, deviations that may have had a substantial impact on the primary efficacy endpoint).

    Primary: Primary Efficacy Endpoint

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    End point title
    Primary Efficacy Endpoint
    End point description
    The rate of change in the area of EZ loss (IS/OS; macular photoreceptor loss) from baseline through month 24, as assessed using SD-OCT in the study eye of subjects with MacTel.
    End point type
    Primary
    End point timeframe
    End point timeframe is 2 years Baseline, Month 6, 12, 16, 20 and 24. Month 6 was collected but not included in the primary analyses.
    End point values
    NT-501 Sham Procedure
    Number of subjects analysed
    59
    54
    Units: mm2
        number (not applicable)
    0.111
    0.160
    Statistical analysis title
    Statistical Analysis - NT-501 vs Sham Procedure
    Statistical analysis description
    The efficacy and safety of the NT-501 implant that delivers a daily dose of CNTF in comparison to sham surgery with no implant, in participants with confirmed MacTel.
    Comparison groups
    Sham Procedure v NT-501
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0186
    Method
    longitudinal mixed model
    Parameter type
    Mean difference (net)
    Point estimate
    -0.049
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.089
         upper limit
    -0.0082
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0206

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the Clinical Trial
    Adverse event reporting additional description
    Please note that only non-ocular and ocular events in the study eye have been reported. The Adverse events reported are those that occurred through month 24.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    NT-501
    Reporting group description
    Test product

    Reporting group title
    Sham Procedure
    Reporting group description
    A sham surgical procedure was performed to mimic the implant procedure; there was no comparator product.

    Serious adverse events
    NT-501 Sham Procedure
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 59 (18.64%)
    10 / 54 (18.52%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Suture related complication
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Small intestinal obstruction
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Endometriosis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device extrusion
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    NT-501 Sham Procedure
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    56 / 59 (94.92%)
    48 / 54 (88.89%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Blepharal papilloma
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 54 (1.85%)
         occurrences all number
    1
    1
    Melanocytic naevus
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 59 (6.78%)
    1 / 54 (1.85%)
         occurrences all number
    4
    1
    Hot flush
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Prehypertension
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Adverse drug reaction
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Social circumstances
    Menopause
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Prostatomegaly
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 54 (1.85%)
         occurrences all number
    2
    1
    Cough
         subjects affected / exposed
    1 / 59 (1.69%)
    2 / 54 (3.70%)
         occurrences all number
    1
    2
    Respiratory tract congestion
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 54 (0.00%)
         occurrences all number
    3
    0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 54 (1.85%)
         occurrences all number
    1
    1
    Hypopnoea
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Sinus congestion
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Agitation
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Product issues
    Product deposit
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Intraocular pressure increased
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 54 (1.85%)
         occurrences all number
    2
    1
    Blood cholesterol increased
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Mammogram abnormal
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Suture related complication
         subjects affected / exposed
    14 / 59 (23.73%)
    2 / 54 (3.70%)
         occurrences all number
    14
    2
    Conjunctival scar
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Corneal abrasion
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Arthropod bite
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 54 (1.85%)
         occurrences all number
    1
    1
    Muscle strain
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 54 (1.85%)
         occurrences all number
    1
    1
    Ankle fracture
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Contusion
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Joint dislocation
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Limb injury
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Muscle rupture
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Scar
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Tooth fracture
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Congenital, familial and genetic disorders
    Macular dystrophy congenital
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 59 (1.69%)
    2 / 54 (3.70%)
         occurrences all number
    1
    2
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Nervous system disorders
    Aura
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Headache
         subjects affected / exposed
    7 / 59 (11.86%)
    6 / 54 (11.11%)
         occurrences all number
    7
    6
    Dizziness
         subjects affected / exposed
    2 / 59 (3.39%)
    2 / 54 (3.70%)
         occurrences all number
    2
    2
    Paraesthesia
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Transient ischaemic attack
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Ageusia
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Carotid artery stenosis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Essential tremor
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Hypoaesthesia
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Migraine
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Migraine with aura
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Sciatica
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Tremor
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Deafness unilateral
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Vertigo
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    19 / 59 (32.20%)
    10 / 54 (18.52%)
         occurrences all number
    19
    10
    Foreign body sensation in eyes
         subjects affected / exposed
    14 / 59 (23.73%)
    8 / 54 (14.81%)
         occurrences all number
    14
    8
    Conjunctival hyperaemia
         subjects affected / exposed
    12 / 59 (20.34%)
    7 / 54 (12.96%)
         occurrences all number
    12
    7
    Eye pain
         subjects affected / exposed
    12 / 59 (20.34%)
    6 / 54 (11.11%)
         occurrences all number
    12
    6
    Delayed dark adaptation
         subjects affected / exposed
    15 / 59 (25.42%)
    2 / 54 (3.70%)
         occurrences all number
    15
    2
    Conjunctival oedema
         subjects affected / exposed
    4 / 59 (6.78%)
    6 / 54 (11.11%)
         occurrences all number
    4
    6
    Vision blurred
         subjects affected / exposed
    6 / 59 (10.17%)
    3 / 54 (5.56%)
         occurrences all number
    6
    3
    Dry eye
         subjects affected / exposed
    6 / 59 (10.17%)
    2 / 54 (3.70%)
         occurrences all number
    6
    2
    Miosis
         subjects affected / exposed
    8 / 59 (13.56%)
    0 / 54 (0.00%)
         occurrences all number
    8
    0
    Conjunctival irritation
         subjects affected / exposed
    3 / 59 (5.08%)
    3 / 54 (5.56%)
         occurrences all number
    3
    3
    Swelling of eyelid
         subjects affected / exposed
    3 / 59 (5.08%)
    3 / 54 (5.56%)
         occurrences all number
    3
    3
    Visual impairment
         subjects affected / exposed
    3 / 59 (5.08%)
    3 / 54 (5.56%)
         occurrences all number
    3
    3
    Vitreous floaters
         subjects affected / exposed
    6 / 59 (10.17%)
    0 / 54 (0.00%)
         occurrences all number
    6
    0
    Vitreous haemorrhage
         subjects affected / exposed
    6 / 59 (10.17%)
    0 / 54 (0.00%)
         occurrences all number
    6
    0
    Choroidal neovascularisation
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 54 (1.85%)
         occurrences all number
    2
    1
    Eye irritation
         subjects affected / exposed
    2 / 59 (3.39%)
    3 / 54 (5.56%)
         occurrences all number
    2
    3
    Metamorphopsia
         subjects affected / exposed
    1 / 59 (1.69%)
    4 / 54 (7.41%)
         occurrences all number
    1
    4
    Ocular discomfort
         subjects affected / exposed
    4 / 59 (6.78%)
    1 / 54 (1.85%)
         occurrences all number
    4
    1
    Eye discharge
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 54 (1.85%)
         occurrences all number
    2
    1
    Eye pruritus
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 54 (1.85%)
         occurrences all number
    2
    1
    Lacrimation increased
         subjects affected / exposed
    0 / 59 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    0
    3
    Retinal haemorrhage
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Vitreous detachment
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Anterior chamber cell
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Anterior chamber flare
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Asthenopia
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Blepharitis
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 54 (1.85%)
         occurrences all number
    1
    1
    Cataract
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Cataract subcapsular
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Diplopia
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Meibomian gland dysfunction
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Photophobia
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Photopsia
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 54 (1.85%)
         occurrences all number
    1
    1
    Punctate keratitis
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 54 (1.85%)
         occurrences all number
    1
    1
    Visual field defect
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Amaurosis fugax
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Anterior chamber collapse
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Blepharospasm
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Cataract cortical
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Chorioretinal folds
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Conjunctival cyst
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Corneal deposits
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Corneal epithelium defect
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Corneal erosion
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Corneal opacity
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Delayed light adaptation
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Epiretinal membrane
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Eye swelling
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Eyelid margin crusting
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Eyelid pain
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Eyelids pruritus
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Hypotony of eye
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Lenticular opacities
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Mydriasis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Night blindness
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Periorbital pain
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Pinguecula
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Presbyopia
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Retinal artery embolism
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Retinal vasculitis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Scleral thinning
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Visual acuity reduced
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Vitreoretinal traction syndrome
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Vitreous haze
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Abdominal discomfort
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Colitis
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Intestinal obstruction
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Large intestine polyp
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Periodontal inflammation
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Tooth erosion
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Dermatitis contact
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Sebaceous gland disorder
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Stasis dermatitis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 54 (1.85%)
         occurrences all number
    1
    1
    Endocrine disorders
    Autoimmune thyroiditis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Hypothyroidism
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 59 (5.08%)
    3 / 54 (5.56%)
         occurrences all number
    3
    3
    Osteoarthritis
         subjects affected / exposed
    1 / 59 (1.69%)
    5 / 54 (9.26%)
         occurrences all number
    1
    5
    Back pain
         subjects affected / exposed
    1 / 59 (1.69%)
    3 / 54 (5.56%)
         occurrences all number
    1
    3
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 59 (1.69%)
    2 / 54 (3.70%)
         occurrences all number
    1
    2
    Rotator cuff syndrome
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 54 (1.85%)
         occurrences all number
    2
    1
    Arthritis
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Bursitis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Neck pain
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Spondylitis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Tendon disorder
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Trigger finger
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Infections and infestations
    Adenoviral conjunctivitis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis bacterial
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis viral
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Periorbital cellulitis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    5 / 59 (8.47%)
    3 / 54 (5.56%)
         occurrences all number
    5
    3
    COVID-19
         subjects affected / exposed
    1 / 59 (1.69%)
    3 / 54 (5.56%)
         occurrences all number
    1
    3
    Influenza
         subjects affected / exposed
    0 / 59 (0.00%)
    4 / 54 (7.41%)
         occurrences all number
    0
    4
    Urinary tract infection
         subjects affected / exposed
    1 / 59 (1.69%)
    3 / 54 (5.56%)
         occurrences all number
    1
    3
    Cellulitis
         subjects affected / exposed
    1 / 59 (1.69%)
    2 / 54 (3.70%)
         occurrences all number
    1
    2
    Ear infection
         subjects affected / exposed
    0 / 59 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    0
    3
    Sinusitis
         subjects affected / exposed
    1 / 59 (1.69%)
    2 / 54 (3.70%)
         occurrences all number
    1
    2
    Staphylococcal infection
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 54 (1.85%)
         occurrences all number
    1
    1
    Tooth abscess
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 54 (1.85%)
         occurrences all number
    1
    1
    Candida infection
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Croup infectious
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Diverticulitis
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Erysipelas
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Gingivitis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Localised infection
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Pilonidal disease
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Pulpitis dental
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Bronchitis
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 54 (1.85%)
         occurrences all number
    2
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Hypercalcaemia
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Magnesium deficiency
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 54 (0.00%)
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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jun 2019
    Version 4.0
    12 Apr 2021
    Version 6.1
    31 Aug 2021
    Version 7.0

    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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