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    Clinical Trial Results:
    Efficacy and tolerability of brinzolamide in patients with elevated intraocular pressure: a double-blind, randomized, parallel, verum-controlled trial.

    Summary
    EudraCT number
    		 2013-001793-21
    Trial protocol
    		 HU   GR  
    Global end of trial date
    16 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Apr 2022
    First version publication date
    25 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CPA12001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pharmathen S.A
    Sponsor organisation address
    Dervenakion 6 , Pallini, Athens , Greece, 15351
    Public contact
    Lida Kalantzi, PhD Director of Scientific Affairs Pharmaceutical Research Operations / Finished Fo, PHARMATHEN S.A., +30 210 66 04 300, lkalantzi@pharmathen.com
    Scientific contact
    Lida Kalantzi, PhD Director of Scientific Affairs Pharmaceutical Research Operations / Finished Fo, PHARMATHEN S.A., +30 210 66 04 300, lkalantzi@pharmathen.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
    21 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the non-inferiority of eye drops containing brinzolamide 10 mg/ml (Brinzolamide Ophthalmic Suspension) as compared to a reference product (AZOPT® 10 mg/ml eye drops suspension) for the treatment of elevated intraocular pressure or open angle glaucoma.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Sep 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
    Greece: 9
    Country: Number of subjects enrolled
    Hungary: 160
    Worldwide total number of subjects
    169
    EEA total number of subjects
    169
    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)
    67
    From 65 to 84 years
    102
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Greece : 2 Sites Hungary : 10 sites

    Pre-assignment
    Screening details
    		 Study has been conducted in sites in Greece and Hungary. For both countries : Number of subjects screened: 177 Number of screening failures: 8

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer
    Blinding implementation details
    The study was double blind. The subjects, the investigator(s) (the study team, monitors and CRO), and the central bioanalytical laboratory were held blind during the study. CROs personnel, including the trial biostatistician, were blind with respect to treatment allocation. Biostatisticians were informed on the unblinded treatment allocation following the database lock and statistical analysis. To achieve blinding, both products were identical in their appearance.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Test
    Arm description
    		 Brinzolamide Ophthalmic Suspension10 mg/ml, PHARMATHEN S.A., Greece
    Arm type
    		 Test

    Investigational medicinal product name
    Brinzolamide Ophthalmic Suspension
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, suspension
    Routes of administration
    Intraocular use
    Dosage and administration details
    One drop into the conjunctival sac: once in the morning and once in the evening, approximately 12 hours (between 8 and 14 hours) apart

    Arm title
    		 Reference
    Arm description
    		 AZOPT 10 mg/ml eye drops suspension, Alcon Laboratories (UK) Ltd
    Arm type
    		 Reference

    Investigational medicinal product name
    AZOPT
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, suspension
    Routes of administration
    Intraocular use
    Dosage and administration details
    One drop into the conjunctival sac: once in the morning and once in the evening, approximately 12 hours (between 8 and 14 hours) apart

    Number of subjects in period 1
    		Test Reference
    Started
    88
    81
    Completed
    80
    58
    Not completed
    8
    23
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    4
    7
         Adverse event, non-fatal
    -
    1
         Protocol deviation
    4
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Test
    Reporting group description
    		 Brinzolamide Ophthalmic Suspension10 mg/ml, PHARMATHEN S.A., Greece

    Reporting group title
    Reference
    Reporting group description
    		 AZOPT 10 mg/ml eye drops suspension, Alcon Laboratories (UK) Ltd

    Reporting group values
    		 Test Reference Total
    Number of subjects
    		 88 81 169
    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)
    		 35 32 67
        From 65-84 years
    		 53 49 102
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.1 ± 11.3 63.2 ± 13 -
    Gender categorical
    Units: Subjects
        Female
    		 53 51 104
        Male
    		 35 30 65
    Subject analysis sets

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per protocol (PP) population includes all those of the patients who had no major protocol violations, who completed IOP measurements within the allowed time frames, who completed 12 weeks of treatment and who did not take prohibited concurrent medication.

    Subject analysis sets values
    		 PP
    Number of subjects
    138
    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
    58
        85 years and over
    80
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    62.58 ± 12.25
    Gender categorical
    Units: Subjects
        Female
    82
        Male
    56

    End points

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    End points reporting groups
    Reporting group title
    Test
    Reporting group description
    		 Brinzolamide Ophthalmic Suspension10 mg/ml, PHARMATHEN S.A., Greece

    Reporting group title
    Reference
    Reporting group description
    		 AZOPT 10 mg/ml eye drops suspension, Alcon Laboratories (UK) Ltd

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per protocol (PP) population includes all those of the patients who had no major protocol violations, who completed IOP measurements within the allowed time frames, who completed 12 weeks of treatment and who did not take prohibited concurrent medication.

    Primary: Primary : Change in IOP at 8:00am in study eye from baseline (week 0) to end of treatment (week 12)

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    End point title
    		 Primary : Change in IOP at 8:00am in study eye from baseline (week 0) to end of treatment (week 12)
    End point description
    Comparison of reductions in IOP at 8:00 a.m. in subjects treated with the test or reference product, characterised as an intra-individual difference in the target eye from baseline (week 0) to the end of the treatment period (12 weeks).
    End point type
    Primary
    End point timeframe
    Week 0 (baseline) to end of treatment (week 12)
    End point values
    		 Test Reference PP
    Number of subjects analysed
    80
    58
    138
    Units: mmHg
        arithmetic mean (confidence interval 95%)
    7.8 (7.011 to 8.59)
    7.3 (6.27 to 8.33)
    0.54 (-0.75 to 1.83)
    Statistical analysis title
    		 IOP change
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.75
         upper limit
    		 1.83
    Notes
    [1] - Δ0 is the non–inferiority margin, which was set to 1.5 mmHg.

    Secondary: Secondary: Change in IOP at 8:00am in study eye from baseline (week 0) to week 2

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    End point title
    		 Secondary: Change in IOP at 8:00am in study eye from baseline (week 0) to week 2
    End point description
    Comparison of reductions in IOP at 8:00 a.m. in subjects treated with the test or reference product, characterised as an intra-individual difference in the target eye from baseline (week 0) to week 2 of treatment period.
    End point type
    Secondary
    End point timeframe
    Week 0 (baseline) to Week 2
    End point values
    		 Test Reference
    Number of subjects analysed
    80
    58
    Units: mmHg
        arithmetic mean (confidence interval 98.3%)
    6.7 (5.84 to 7.56)
    6.0 (4.8 to 7.19)
    Statistical analysis title
    		 change in IOP at 8.00a.m from week 0 to week 2
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.71
    Confidence interval
         level
    		 98.3%
         sides
    2-sided
         lower limit
    		 -0.79
         upper limit
    		 2.2

    Secondary: Secondary : Change in IOP at 12.00 noon in study eye from baseline (week 0) to week 2

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    End point title
    		 Secondary : Change in IOP at 12.00 noon in study eye from baseline (week 0) to week 2
    End point description
    Comparison of reductions in IOP at 12.00 noon in subjects treated with the test or reference product, characterized as an intra-individual difference in the target eye from baseline (week 0) to week 2 of treatment period.
    End point type
    Secondary
    End point timeframe
    Week 0 (baseline) to week 2
    End point values
    		 Test Reference
    Number of subjects analysed
    80
    58
    Units: mmHg
        arithmetic mean (confidence interval 98.3%)
    7.3 (6.49 to 8.11)
    7.1 (6.12 to 8.08)
    Statistical analysis title
    		 change in IOP at 12:00pm from week 0 to week 2
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.21
    Confidence interval
         level
    		 98.3%
         sides
    2-sided
         lower limit
    		 -1.12
         upper limit
    		 1.52

    Secondary: Secondary : Change in IOP at 4.00pm in study eye from baseline (week 0) to week 2

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    End point title
    		 Secondary : Change in IOP at 4.00pm in study eye from baseline (week 0) to week 2
    End point description
    Comparison of reductions in IOP at 4.00 pm. in subjects treated with the test or reference product, characterized as an intra-individual difference in the target eye from baseline (week 0) to week 2 of treatment period.
    End point type
    Secondary
    End point timeframe
    Week 0 (baseline) to Week 2
    End point values
    		 Test Reference
    Number of subjects analysed
    80
    58
    Units: mmHg
        arithmetic mean (confidence interval 98.3%)
    7.0 (6.17 to 7.83)
    6.9 (5.7 to 8.09)
    Statistical analysis title
    		 change in IOP at 4.00 pm from week 0 to week 2
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.13
    Confidence interval
         level
    		 98.3%
         sides
    2-sided
         lower limit
    		 -1.33
         upper limit
    		 1.59

    Secondary: Secondary : Change in IOP at 8:00am in study eye from baseline (week 0) to week 6

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    End point title
    		 Secondary : Change in IOP at 8:00am in study eye from baseline (week 0) to week 6
    End point description
    Comparison of reductions in IOP at 8:00 a.m. in subjects treated with the test or reference product, characterized as an intra-individual difference in the target eye from baseline (week 0) to week 6 of treatment period.
    End point type
    Secondary
    End point timeframe
    Week 0 (baseline) to week 6
    End point values
    		 Test Reference
    Number of subjects analysed
    80
    58
    Units: mmHg
        arithmetic mean (confidence interval 98.3%)
    7.5 (6.53 to 8.46)
    7.1 (5.81 to 8.39)
    Statistical analysis title
    		 change in IOP at 8.00 a.m from week 0 to week 6
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.46
    Confidence interval
         level
    		 98.3%
         sides
    2-sided
         lower limit
    		 -1.17
         upper limit
    		 2.09

    Secondary: Secondary : Change in IOP at 12.00 noon in study eye from baseline (week 0) to week 6

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    End point title
    		 Secondary : Change in IOP at 12.00 noon in study eye from baseline (week 0) to week 6
    End point description
    Comparison of reductions in IOP at 12.00 noon . in subjects treated with the test or reference product, characterized as an intra-individual difference in the target eye from baseline (week 0) to week 6 of treatment period.
    End point type
    Secondary
    End point timeframe
    Week 0 (baseline) to Week 6
    End point values
    		 Test Reference
    Number of subjects analysed
    80
    58
    Units: mmHg
        arithmetic mean (confidence interval 98.3%)
    8.1 (7.32 to 8.88)
    8 (6.99 to 9)
    Statistical analysis title
    		 change in IOP at 12:00pm from week 0 to week 6
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.05
    Confidence interval
         level
    		 98.3%
         sides
    2-sided
         lower limit
    		 -1.25
         upper limit
    		 1.34

    Secondary: Secondary : Change in IOP at 4.00 p.m in study eye from baseline (week 0) to week 6

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    End point title
    		 Secondary : Change in IOP at 4.00 p.m in study eye from baseline (week 0) to week 6
    End point description
    Comparison of reductions in IOP at 8:00 a.m. in subjects treated with the test or reference product, characterized as an intra-individual difference in the target eye from baseline to week 6 of treatment period.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) to Week 6
    End point values
    		 Test Reference
    Number of subjects analysed
    80
    58
    Units: mmHg
        arithmetic mean (confidence interval 98.3%)
    7.8 (6.94 to 8.66)
    8.1 (7.09 to 9.1)
    Statistical analysis title
    		 Change in IOP at 4.00p.m from week0 to week 6
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.31
    Confidence interval
         level
    		 98.3%
         sides
    2-sided
         lower limit
    		 -1.68
         upper limit
    		 1.07

    Secondary: Secondary : Change in IOP at 12.00 noon in study eye from baseline (week 0) to end of treatment (week 12)

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    End point title
    		 Secondary : Change in IOP at 12.00 noon in study eye from baseline (week 0) to end of treatment (week 12)
    End point description
    Comparison of reductions in IOP at 12.00 noon in subjects treated with the test or reference product, characterized as an intra-individual difference in the target eye from baseline (week 0) to the end of the treatment period (12 weeks).
    End point type
    Secondary
    End point timeframe
    Week 0 (baseline) to Week 12
    End point values
    		 Test Reference
    Number of subjects analysed
    80
    58
    Units: mmHg
        arithmetic mean (confidence interval 98.3%)
    8.2 (7.41 to 8.98)
    7.8 (6.76 to 8.84)
    Statistical analysis title
    		 change in IOP at 12:00pm from week 0 to week 12
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.32
    Confidence interval
         level
    		 98.3%
         sides
    2-sided
         lower limit
    		 -1.01
         upper limit
    		 1.66

    Secondary: Secondary : Change in IOP at 4.00 p.m in study eye from baseline (week 0) to the end of the treatment (week 12)

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    End point title
    		 Secondary : Change in IOP at 4.00 p.m in study eye from baseline (week 0) to the end of the treatment (week 12)
    End point description
    Comparison of reductions in IOP at 8:00 a.m. in subjects treated with the test or reference product, characterized as an intra-individual difference in the target eye from baseline (week 0) to the end of the treatment period (12 weeks).
    End point type
    Secondary
    End point timeframe
    Week 0 (Baseline) to week 12
    End point values
    		 Test Reference
    Number of subjects analysed
    80
    58
    Units: mmHg
        arithmetic mean (confidence interval 98.3%)
    8.1 (7.24 to 8.95)
    8.1 (6.99 to 9.2)
    Statistical analysis title
    		 change in IOP at 4.00 p.m from week 0 to week 12
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.01
    Confidence interval
         level
    		 98.3%
         sides
    2-sided
         lower limit
    		 -1.41
         upper limit
    		 1.43

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Week 0 to end of treatment (12 weeks)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Test
    Reporting group description
    		 -

    Reporting group title
    Reference
    Reporting group description
    		 -

    Serious adverse events
    		 Test Reference
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 81 (2.47%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastasis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Surgical and medical procedures
    Carpal tunnel decompression
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Test Reference
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 88 (28.41%)
    11 / 81 (13.58%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 81 (2.47%)
         occurrences all number
    0
    2
    Surgical and medical procedures
    Maxillofacial operation
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Drug intolerance
         subjects affected / exposed
    2 / 88 (2.27%)
    3 / 81 (3.70%)
         occurrences all number
    2
    4
    Product taste abnormal
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Asthenia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Bartholin's cyst
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Cough
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Blood glucose increased
         subjects affected / exposed
    3 / 88 (3.41%)
    1 / 81 (1.23%)
         occurrences all number
    3
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    3 / 88 (3.41%)
    1 / 81 (1.23%)
         occurrences all number
    3
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Blood pressure increased
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 81 (1.23%)
         occurrences all number
    1
    1
    Blood uric acid increased
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    2
    Injury
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Bradycardia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Palpitations
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Dysgeusia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Visual field defect
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Thrombocytopenia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Eye disorders
    Foreign body sensation in eyes
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 81 (0.00%)
         occurrences all number
    3
    0
    Eye pain
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 81 (2.47%)
         occurrences all number
    2
    2
    Ocular hyperaemia
         subjects affected / exposed
    2 / 88 (2.27%)
    1 / 81 (1.23%)
         occurrences all number
    2
    1
    Eye swelling
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Keratitis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Ocular discomfort
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    3
    Eye discharge
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 81 (2.47%)
         occurrences all number
    0
    2
    Eye irritation
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 81 (2.47%)
         occurrences all number
    0
    2
    Conjunctival hyperaemia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Corneal thickening
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Hypoaesthesia eye
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Laryngitis
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    Hordeolum
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 81 (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
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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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