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    Clinical Trial Results:
    Therapeutic Equivalence (non-inferiority), Randomized, Observer-blind, two Parallel Group, Clinical Trial for Comparing the Efficacy and Tolerability of a new Generic Preservative-Free Formulation of Latanoprost 50μg/ml/Timolol 5mg/ml Eye Drops vs Xalacom® Eye Drops in Patients with Open Angle Glaucoma, or Ocular Hypertension.

    Summary
    EudraCT number
    2017-004524-29
    Trial protocol
    GR  
    Global end of trial date
    17 Dec 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    31 Mar 2019
    First version publication date
    31 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BECRO/PHN/LATIM
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pharmathen S.A.
    Sponsor organisation address
    6 Dervenakion Str, Pallini Attica, Greece, 15351
    Public contact
    Lida Kalantzi, PhD Head of Scientific Affairs, Pharmathen S.A. , +30 2106604300, lkalantzi@pharmathen.com
    Scientific contact
    Lida Kalantzi, PhD Head of Scientific Affairs, Pharmathen S.A. , +30 2106604300, 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
    24 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To confirm the clinical non-inferiority of a generic ophthalmic product of Latanoprost 50μg/ml/Timolol 5mg/ml fixed combination which is preservative-free (test) compared with the marketed preservative-containing Xalacom® (reference) eye drops in patients with open angle glaucoma or ocular hypertension by examining the change of IOP at 8:00am from end of study to baseline.
    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
    29 Jun 2018
    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: 210
    Worldwide total number of subjects
    210
    EEA total number of subjects
    210
    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)
    53
    From 65 to 84 years
    145
    85 years and over
    12

    Subject disposition

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    Recruitment
    Recruitment details
    Study sites: Ophthalmiatreio Athens, General Hospital of Larissa, General University Hospital of Athens Attikon, General University Hospital of Thessaloniki AXEPA, IASO Thessalias, General University Hospital of Patra, General Hospital of Thessaloniki Ippokrateio, NIMITS 417

    Pre-assignment
    Screening details
    This study was conducted in 8 clinical sites in Greece between June 29, 2018 and December 17,2018.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Investigator [1]
    Blinding implementation details
    Observer-blind

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Test
    Arm description
    Latanoprost 50 μg/ml + Timolol 5mg/ml eye drops solution Preservative free
    Arm type
    Test

    Investigational medicinal product name
    Latanoprost 50 μg/ml + Timolol 5mg/ml eye drops solution Preservative free
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    One drop of the Test product containing Latanoprost 50μg/ml and Timolol 5mg/ml fixed combination preservative-free in each eye once daily in the evening (approximately at 20:00 pm).

    Arm title
    Reference
    Arm description
    XALACOM®
    Arm type
    Active comparator

    Investigational medicinal product name
    Xalacom®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    One drop of XALACOM® containing Latanoprost 50μg/ml and Timolol 5mg/ml in each eye once daily in the evening (approximately at 20:00 pm).

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Due to differences in the packaging of the study medication, the investigator measuring IOP was masked to study medication.
    Number of subjects in period 1
    Test Reference
    Started
    106
    104
    Completed
    96
    100
    Not completed
    10
    4
         Protocol deviation
    5
    3
         Adverse event, non-fatal
    2
    -
         Consent withdrawn by subject
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Test
    Reporting group description
    Latanoprost 50 μg/ml + Timolol 5mg/ml eye drops solution Preservative free

    Reporting group title
    Reference
    Reporting group description
    XALACOM®

    Reporting group values
    Test Reference Total
    Number of subjects
    106 104 210
    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
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    69.88 ± 11.46 70.80 ± 11.12 -
    Gender categorical
    Units: Subjects
        Female
    57 51 108
        Male
    49 53 102
    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 ITT population who had no major protocol deviations, who completed IOP measurements within the allowed time frames, who completed at least 12 weeks of treatment with the last dose administered before the 12-week visit, and who did not take prohibited concurrent medication.

    Subject analysis sets values
    PP
    Number of subjects
    196
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    70.22 ± 11.34
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Test
    Reporting group description
    Latanoprost 50 μg/ml + Timolol 5mg/ml eye drops solution Preservative free

    Reporting group title
    Reference
    Reporting group description
    XALACOM®

    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 ITT population who had no major protocol deviations, who completed IOP measurements within the allowed time frames, who completed at least 12 weeks of treatment with the last dose administered before the 12-week visit, and who did not take prohibited concurrent medication.

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

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    End point title
    Change in IOP at 8:00am in study eye from end of treatment (week 12) to baseline (week 0)
    End point description
    The change in IOP at 8:00 am in study eye from end of treatment (week 12) to baseline (week 0)
    End point type
    Primary
    End point timeframe
    End of treatment (week 12) to baseline (week 0)
    End point values
    Test Reference
    Number of subjects analysed
    96
    100
    Units: mm Hg
        arithmetic mean (confidence interval 95%)
    -7.965 (-8.476 to -7.454)
    -8.589 (-9.089 to -8.088)
    Statistical analysis title
    IOP change
    Statistical analysis description
    The analysis of covariance (ANCOVA) model was used to analyse the change in IOP with baseline IOP as the covariate, and treatment as a factor. The treatment difference and a two-sided 95% confidence interval (CI) for the difference were calculated. The preservative-free latanoprost/timolol eye drops (Test) was considered to be non-inferior to the marketed Xalacom® including preservative (Reference), if the upper limit of the 95% CI of the difference was < 1.5 mmHg
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.624
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.094
         upper limit
    1.341
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.364
    Notes
    [1] - Non-inferiority

    Secondary: Change in IOP at 12:00 pm from 12 weeks to baseline

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    End point title
    Change in IOP at 12:00 pm from 12 weeks to baseline
    End point description
    The change in IOP at 12:00 am in study eye from end of treatment (week 12) to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product
    End point type
    Secondary
    End point timeframe
    End of treatment (week 12) to baseline (week 0)
    End point values
    Test Reference
    Number of subjects analysed
    96
    100
    Units: mm Hg
        arithmetic mean (confidence interval 95%)
    -8.13 (-8.597 to -7.663)
    -8.7 (-9.157 to -8.242)
    Statistical analysis title
    IOP change at 12:00 pm from 12 weeks to baseline
    Statistical analysis description
    The secondary endpoint "change in IOP at 12:00 pm from weeks 12 to baseline" was analysed using an ANCOVA model with the respective baseline IOP as the covariate, and treatment as a factor
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.569
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.086
         upper limit
    1.225
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.332

    Secondary: IOP change at 16:00 pm from 12 weeks to baseline

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    End point title
    IOP change at 16:00 pm from 12 weeks to baseline
    End point description
    The change in IOP at 16:00 pm in study eye from end of treatment (week 12) to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product
    End point type
    Secondary
    End point timeframe
    End of treatment (week 12) to baseline (week 0)
    End point values
    Test Reference
    Number of subjects analysed
    96
    100
    Units: mm Hg
        arithmetic mean (confidence interval 95%)
    -8.177 (-8.676 to -7.677)
    -8.482 (-8.969 to -7.996)
    Statistical analysis title
    IOP change at 16:00 pm from 12 weeks to baseline
    Statistical analysis description
    The scondary endpoint "change in IOP at 16:00 pm from weeks 12 to baseline" was analysed using an ANCOVA model with the respective baseline IOP as the covariate and treatment as a factor
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [2]
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.306
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.392
         upper limit
    1.003
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.354
    Notes
    [2] - Non-inferiority

    Secondary: Change in IOP at 8:00 am in study eye from 6 weeks to baseline

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    End point title
    Change in IOP at 8:00 am in study eye from 6 weeks to baseline
    End point description
    Change in IOP at 8:00 am in study eye from week 6 to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product
    End point type
    Secondary
    End point timeframe
    From week 6 to baseline (week 0)
    End point values
    Test Reference
    Number of subjects analysed
    96
    100
    Units: mm Hg
        arithmetic mean (confidence interval 95%)
    -7.732 (-8.230 to -7.233)
    -8.243 (-8.731 to -7.754)
    Statistical analysis title
    Change in IOP at 8:00 am from 6 weeks to baseline
    Statistical analysis description
    The secondary endpoint "change in IOP at 8:00 am from weeks 6 to baseline" was analysed using an ANCOVA model with the respective baseline IOP as the covariate and treatment as a factor
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.511
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.188
         upper limit
    1.21
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.355

    Secondary: Change in IOP at 12:00 pm in study eye from 6 weeks to baseline

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    End point title
    Change in IOP at 12:00 pm in study eye from 6 weeks to baseline
    End point description
    Change in IOP at 12:00 pm in study eye from week 6 to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product
    End point type
    Secondary
    End point timeframe
    From week 6 to baseline (week 0)
    End point values
    Test Reference
    Number of subjects analysed
    96
    100
    Units: mm Hg
        arithmetic mean (confidence interval 95%)
    -7.880 (-8.356 to -7.404)
    -8.351 (-8.817 to -7.884)
    Statistical analysis title
    Change in IOP at 12:00 pm from 6 weeks to baseline
    Statistical analysis description
    The secondary endpoint "change in IOP at 8:00 am from weeks 6 to baseline" was analysed using an ANCOVA model with the respective baseline IOP as the covariate and treatment as a factor
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.471
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.197
         upper limit
    1.139
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.339

    Secondary: Change in IOP at 16:00 pm in study eye from 6 weeks to baseline

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    End point title
    Change in IOP at 16:00 pm in study eye from 6 weeks to baseline
    End point description
    Change in IOP at 16:00 pm in study eye from week 6 to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product
    End point type
    Secondary
    End point timeframe
    From week 6 to baseline (week 0)
    End point values
    Test Reference
    Number of subjects analysed
    96
    100
    Units: mm Hg
        arithmetic mean (confidence interval 95%)
    -7.923 (-8.440 to -7.406)
    -8.074 (-8.581 to -7.568)
    Statistical analysis title
    Change in IOP at 16:00 pm from 6 weeks to baseline
    Statistical analysis description
    The secondary endpoint "change in IOP at 16:00 pm from 6 weeks to baseline" was analysed using an ANCOVA model with the respective baseline IOP as the covariate and treatment as a factor
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.152
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.572
         upper limit
    0.875
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.367

    Secondary: Change in IOP at 8:00 am in study eye from 2 weeks to baseline

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    End point title
    Change in IOP at 8:00 am in study eye from 2 weeks to baseline
    End point description
    Change in IOP at 8:00 am in study eye from week 2 to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product
    End point type
    Secondary
    End point timeframe
    From week 2 to baseline (week 0)
    End point values
    Test Reference
    Number of subjects analysed
    96
    100
    Units: mm Hg
        arithmetic mean (confidence interval 95%)
    -6.887 (-7.413 to -6.362)
    -7.008 (-7.523 to -6.493)
    Statistical analysis title
    Change in IOP at 8:00 am from 2 weeks to baseline
    Statistical analysis description
    The secondary endpoint "change in IOP at 8:00 am from 2 weeks to baseline" was analysed using an ANCOVA model with the respective baseline IOP as the covariate and treatment as a factor
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.121
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.617
         upper limit
    0.858
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.374

    Secondary: Change in IOP at 12:00 pm in study eye from 2 weeks to baseline

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    End point title
    Change in IOP at 12:00 pm in study eye from 2 weeks to baseline
    End point description
    Change in IOP at 12:00 pm in study eye from week 2 to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product
    End point type
    Secondary
    End point timeframe
    From week 2 to baseline (week 0)
    End point values
    Test Reference
    Number of subjects analysed
    96
    100
    Units: mm Hg
        arithmetic mean (confidence interval 95%)
    -7.033 (-7.555 to -6.511)
    -6.983 (-7.495 to -6.472)
    Statistical analysis title
    Change in IOP at 12:00 pm from weeks 2 to baseline
    Statistical analysis description
    The secondary endpoint "change in IOP at 12:00 pm from 2 weeks to baseline" was analysed using an ANCOVA model with the respective baseline IOP as the covariate and treatment as a factor
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.049
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.783
         upper limit
    0.684
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.372

    Secondary: Change in IOP at 16:00 pm in study eye from 2 weeks to baseline

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    End point title
    Change in IOP at 16:00 pm in study eye from 2 weeks to baseline
    End point description
    Change in IOP at 16:00 pm in study eye from week 2 to baseline (week 0) in subjects treated with the test product as compared to subjects treated with the reference product
    End point type
    Secondary
    End point timeframe
    From week 2 to baseline (week 0)
    End point values
    Test Reference
    Number of subjects analysed
    96
    100
    Units: mm Hg
        arithmetic mean (confidence interval 95%)
    -6.875 (-7.414 to -6.337)
    -6.920 (-7.447 to -6.392)
    Statistical analysis title
    Change in IOP at 16:00 pm from 2 weeks to baseline
    Statistical analysis description
    The secondary endpoint "change in IOP at 16:00 pm from 2 weeks to baseline" was analysed using an ANCOVA model with the respective baseline IOP as the covariate and treatment as a factor
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.044
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.71
         upper limit
    0.798
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.382

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline to end of treatment (12 weeks)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.1
    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 / 106 (0.00%)
    0 / 104 (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: 0%
    Non-serious adverse events
    Test Reference
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 106 (33.96%)
    42 / 104 (40.38%)
    Cardiac disorders
    Heart rate decreased
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 104 (0.00%)
         occurrences all number
    2
    0
    Eye disorders
    Blurred vision
         subjects affected / exposed
    4 / 106 (3.77%)
    4 / 104 (3.85%)
         occurrences all number
    4
    7
    Burning sensation
         subjects affected / exposed
    1 / 106 (0.94%)
    5 / 104 (4.81%)
         occurrences all number
    1
    5
    Conjuctival hyperaemia
         subjects affected / exposed
    7 / 106 (6.60%)
    13 / 104 (12.50%)
         occurrences all number
    7
    13
    Diplopia
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Abnormal sensation in eye
         subjects affected / exposed
    0 / 106 (0.00%)
    2 / 104 (1.92%)
         occurrences all number
    0
    2
    Eye irritation
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 104 (0.00%)
         occurrences all number
    2
    0
    Irritation during instillation
         subjects affected / exposed
    2 / 106 (1.89%)
    1 / 104 (0.96%)
         occurrences all number
    2
    1
    Ocular hyperaemia (upon waking up)
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Eye pain/Eyelid pain
         subjects affected / exposed
    4 / 106 (3.77%)
    10 / 104 (9.62%)
         occurrences all number
    4
    10
    Foreign body sensation
         subjects affected / exposed
    7 / 106 (6.60%)
    12 / 104 (11.54%)
         occurrences all number
    7
    12
    Instillation site burn
         subjects affected / exposed
    0 / 106 (0.00%)
    2 / 104 (1.92%)
         occurrences all number
    0
    2
    IOP increased
         subjects affected / exposed
    13 / 106 (12.26%)
    15 / 104 (14.42%)
         occurrences all number
    13
    15
    Eye Pruritus/Eyelid Pruritus
         subjects affected / exposed
    6 / 106 (5.66%)
    2 / 104 (1.92%)
         occurrences all number
    6
    2
    Lacrimation increased
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Visual impairment
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 104 (0.96%)
         occurrences all number
    1
    1
    Vitreous Floaters
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Erythema of Eyelid
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Oedema peripheral (ankle oedema)
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    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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