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    Clinical Trial Results:
    A prospective, phase III, multicenter, randomized, investigator-masked, parallel groups, non-inferiority clinical trial for the comparison of efficacy and safety and of a generic fixed combination of Brinzolamide 10mg/ml / Timolol 5 mg/ml eye drops suspension versus Azarga®/ALCON 10mg/ml – 5mg/ml eye drops suspension in subjects with open angle glaucoma or ocular hypertension.

    Summary
    EudraCT number
    		 2019-000921-39
    Trial protocol
    		 GR   CY  
    Global end of trial date
    12 Apr 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Jun 2022
    First version publication date
    17 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PH-BRINLOL-01
    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, Attica, Greece, 15351
    Public contact
    Lida Kalantzi, PhD Director of Scientific Affairs Pharmaceutical Research Operations / Finished F, PHARMATHEN SA, 0030 2106604300, lkalantzi@pharmathen.com
    Scientific contact
    Lida Kalantzi, PhD Director of Scientific Affairs Pharmaceutical Research Operations / Finished F, PHARMATHEN SA, 0030 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
    05 Jul 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Apr 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to confirm the non-inferiority of the generic fixed combination of Brinzolamide 10mg/ml / Timolol 5mg/ml eye drops suspension (test product of Pharmathen S.A) in lowering the intra-ocular pressure (IOP) when compared to Brinzolamide 10mg/ml / Timolol 5mg/ml eye drops suspension marketed product Azarga® (reference product, ALCON) in subjects with open-angle glaucoma or ocular hypertension, by examining the mean diurnal IOP change from baseline to week 12 visit. The mean diurnal IOP change will be calculated as the average of the 08:00 a.m. and 10:00 a.m. time point measurements.
    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
    28 Aug 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Cyprus: 1
    Country: Number of subjects enrolled
    Greece: 214
    Worldwide total number of subjects
    215
    EEA total number of subjects
    215
    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)
    63
    From 65 to 84 years
    146
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 Greece : 13 Sites : Hospitals : G.Gennimatas Hospital, Agios Panteleimon, Papageorgiou, PAGNH Crete, 251 Air Force General Hospital, Evaggelismos, University General Hospital of Ioannina, General Hospital of Lamia, Tzaneio, AHEPA University General Hospital, Konstantopouleio, Hospital of Kerkyra Agia Eirini Cyprus : 1 site : Pantheo Eye Center

    Pre-assignment
    Screening details
    		 Study was conducted in clinical sites in Greece and Cyprus from 22 August 2019 to 12 April 2021

    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
    This was an investigator-masked study. The investigator (PI) at each site designated an independent site staff member to handle, store, dispense & collect the investigational products(IPs). He/she has been instructed NOT to disclose any details on the identity of the dispensed IP to other study staff including the investigator(s). The same instructions have been given to the patients.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Test
    Arm description
    		 Brinzolamide 10mg/ml /Timolol 5mg/ml eye drops, suspension (Pharmathen S.A.)
    Arm type
    		 Test

    Investigational medicinal product name
    Brinzolamide 10mg/ml / Timolol 5 mg/ml eye drops suspension, Pharmathen S.A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, suspension
    Routes of administration
    Ocular use
    Dosage and administration details
    One drop in the conjunctival sac of the affected eye(s) BID

    Arm title
    		 Reference
    Arm description
    		 Azarga®, Brinzolamide 10 mg/ml / Timolol 5 mg/ml eye drops suspension (Alcon)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Azarga®, Brinzolamide 10 mg/ml / Timolol 5 mg/ml eye drops suspension, Alcon
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, suspension
    Routes of administration
    Ocular use
    Dosage and administration details
    One drop in the conjunctival sac of the affected eye(s) BID

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Due to differences in the packaging of study medication, the investigator measuring IOP was masked to study medication.
    Number of subjects in period 1
    		Test Reference
    Started
    107
    108
    Completed
    91
    80
    Not completed
    16
    28
         Consent withdrawn by subject
    1
    4
         Physician decision
    -
    1
         Adverse event, non-fatal
    1
    4
         Circumstances defined as exclusion criterion
    -
    1
         Lost to follow-up
    1
    2
         Due to COVID-19 pandemic
    8
    12
         Protocol deviation
    5
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Test
    Reporting group description
    		 Brinzolamide 10mg/ml /Timolol 5mg/ml eye drops, suspension (Pharmathen S.A.)

    Reporting group title
    Reference
    Reporting group description
    		 Azarga®, Brinzolamide 10 mg/ml / Timolol 5 mg/ml eye drops suspension (Alcon)

    Reporting group values
    		 Test Reference Total
    Number of subjects
    		 107 108 215
    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 28 63
        From 65-84 years
    		 71 75 146
        85 years and over
    		 1 5 6
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67.7 ( 11.0 ) 70.3 ( 8.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 59 48 107
        Male
    		 48 60 108
    Subject analysis sets

    Subject analysis set title
    Test_ITT_Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Test_ ITT (Intention To Treat) population set is defined as all randomized patients, who have received the test product : Brinzolamide 10mg/ml /Timolol 5mg/ml eye drops, suspension (Pharmathen S.A.) and have at least one pre and post baseline efficacy measurement based on the protocol.

    Subject analysis set title
    Reference_ITT Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Reference_ ITT (Intention To Treat) population set is defined as all randomized patients, who have received the reference Azarga®, Brinzolamide 10 mg/ml / Timolol 5 mg/ml eye drops suspension (Alcon) and have at least one pre and post baseline efficacy measurement based on the protocol.

    Subject analysis set title
    Test_Per_Protocol_Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Test Per Protocol Population (PP) set consists of all randomized patients who received Brinzolamide 10mg/ml /Timolol 5mg/ml eye drops, suspension (Pharmathen S.A.) and completed all study primary efficacy endpoint assessments, without any major protocol deviation.

    Subject analysis set title
    Reference_Per_Protocol_Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Reference Per Protocol (PP) Population set consists of all randomized patients who received Azarga®, Brinzolamide 10 mg/ml / Timolol 5 mg/ml eye drops suspension (Alcon) and completed all study primary efficacy endpoint assessments, without any major protocol deviation.

    Subject analysis sets values
    		 Test_ITT_Population Reference_ITT Population Test_Per_Protocol_Population Reference_Per_Protocol_Population
    Number of subjects
    96
    84
    91
    80
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    32
    24
    30
    22
        From 65-84 years
    63
    56
    60
    54
        85 years and over
    1
    4
    1
    4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    79.14 ( 11.01 )
    67.31 ( 8.97 )
    67.5 ( 11.1 )
    70.4 ( 9.0 )
    Gender categorical
    Units: Subjects
        Female
    52
    35
    41
    33
        Male
    44
    49
    50
    47

    End points

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    End points reporting groups
    Reporting group title
    Test
    Reporting group description
    		 Brinzolamide 10mg/ml /Timolol 5mg/ml eye drops, suspension (Pharmathen S.A.)

    Reporting group title
    Reference
    Reporting group description
    		 Azarga®, Brinzolamide 10 mg/ml / Timolol 5 mg/ml eye drops suspension (Alcon)

    Subject analysis set title
    Test_ITT_Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Test_ ITT (Intention To Treat) population set is defined as all randomized patients, who have received the test product : Brinzolamide 10mg/ml /Timolol 5mg/ml eye drops, suspension (Pharmathen S.A.) and have at least one pre and post baseline efficacy measurement based on the protocol.

    Subject analysis set title
    Reference_ITT Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Reference_ ITT (Intention To Treat) population set is defined as all randomized patients, who have received the reference Azarga®, Brinzolamide 10 mg/ml / Timolol 5 mg/ml eye drops suspension (Alcon) and have at least one pre and post baseline efficacy measurement based on the protocol.

    Subject analysis set title
    Test_Per_Protocol_Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Test Per Protocol Population (PP) set consists of all randomized patients who received Brinzolamide 10mg/ml /Timolol 5mg/ml eye drops, suspension (Pharmathen S.A.) and completed all study primary efficacy endpoint assessments, without any major protocol deviation.

    Subject analysis set title
    Reference_Per_Protocol_Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Reference Per Protocol (PP) Population set consists of all randomized patients who received Azarga®, Brinzolamide 10 mg/ml / Timolol 5 mg/ml eye drops suspension (Alcon) and completed all study primary efficacy endpoint assessments, without any major protocol deviation.

    Primary: Change in IOP in study eye from baseline (Week 0) to Week 12 (End of treatment) (Main Analysis)

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    End point title
    		 Change in IOP in study eye from baseline (Week 0) to Week 12 (End of treatment) (Main Analysis)
    End point description
    The primary efficacy endpoint is the difference between test and reference product of the mean diurnal IOP change from baseline (week 0) to week 12 (End of treatment) visit, in study eye. The mean diurnal IOP change was calculated as the average of the 08:00 a.m. and 10:00 time point measurements at each visit (baseline, week 12).
    End point type
    Primary
    End point timeframe
    From baseline (Week 0) to week 12 (End of treatment)
    End point values
    		 Test_Per_Protocol_Population Reference_Per_Protocol_Population
    Number of subjects analysed
    91
    80
    Units: mmHg
        least squares mean (confidence interval 95%)
    8.57 (8.11 to 9.03)
    8.41 (7.92 to 8.90)
    Statistical analysis title
    		 IOP change from W0 to W12 (Main analysis)
    Statistical analysis description
    The analysis was performed using the average IOP measurements at 8:00am and 10:00am. Generalized Linear ANCOVA Model was employed with IOP reduction from W0 to W12 as dependent variable, treatment as fixed factor and baseline IOP as model covariate. The treatment difference and a two-sided 95% confidence interval (CI) for the difference were calculated. The non-inferiority was declared if the lower limit of the between-group difference in mean change from W0 to W12 in diurnal IOP was > -1.5mmHg
    Comparison groups
    Test_Per_Protocol_Population v Reference_Per_Protocol_Population
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.52
         upper limit
    		 0.83
    Notes
    [1] - The prespecified noninferiority margin is δ=-1.5 mmHg is the commonly used and accepted tolerance criterion in non-inferiority glaucoma studies

    Other pre-specified: Change in IOP in study eye from Week 0 (baseline) to Week 12 (End of treatment) (Sensitivity Analysis)

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    End point title
    		 Change in IOP in study eye from Week 0 (baseline) to Week 12 (End of treatment) (Sensitivity Analysis)
    End point description
    The supportive endpoint is the difference between test and reference product of the mean diurnal IOP change from baseline (week 0) to week 12 (End of treatment) visit, in study eye. The mean diurnal IOP change was calculated as the average of the 08:00 a.m. and 10:00 a.m and 16:00 time point measurements at each visit (baseline, week 12).
    End point type
    Other pre-specified
    End point timeframe
    Week 0 to Week 12
    End point values
    		 Test_ITT_Population Reference_ITT Population Test_Per_Protocol_Population Reference_Per_Protocol_Population
    Number of subjects analysed
    96
    84
    91
    80
    Units: mmHg
        least squares mean (confidence interval 95%)
    8.42 (8.00 to 8.86)
    8.33 (7.86 to 8.80)
    8.36 (7.90 to 8.81)
    8.31 (7.83 to 8.79)
    Statistical analysis title
    		 IOP change from W0 to W12 (Sensitivity analysis)PP
    Statistical analysis description
    The analysis was performed using the average IOP measurements at 8:00am,10:00am and 16:00. Generalized Linear ANCOVA Model was employed with IOP reduction from W0 to W12 as dependent variable, treatment as fixed factor and baseline IOP as model covariate. The treatment difference and a two-sided 95% confidence interval for the difference were calculated. The non-inferiority was declared if the lower limit of the between-group difference in mean change from W0 to W12 in diurnal IOP is >-1.5mmHg
    Comparison groups
    Reference_Per_Protocol_Population v Test_Per_Protocol_Population
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.61
         upper limit
    		 0.71
    Statistical analysis title
    		 IOP change from W0to W12 (Sensitivity analysis)ITT
    Statistical analysis description
    The analysis was performed using the average IOP measurements at 8:00am,10:00am and 16:00. Generalized Linear ANCOVA Model was employed with IOP reduction from W0 to W12 as dependent variable, treatment as fixed factor and baseline IOP as model covariate. The treatment difference and a two-sided 95% confidence interval for the difference were calculated. The non-inferiority was declared if the lower limit of the between-group difference in mean change from W0 to W12 in diurnal IOP is > -1.5mmHg
    Comparison groups
    Test_ITT_Population v Reference_ITT Population
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 0.72

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Week 0 to week 12
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    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 / 107 (0.00%)
    0 / 108 (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
    25 / 107 (23.36%)
    19 / 108 (17.59%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Heart rate decreased
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    2
    Injury, poisoning and procedural complications
    Muscle strain
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Respiratory therapy
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Therapeutic product ineffective
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    2
    Eye disorders
    Eye irritation
         subjects affected / exposed
    6 / 107 (5.61%)
    0 / 108 (0.00%)
         occurrences all number
    8
    0
    Eye pain
         subjects affected / exposed
    6 / 107 (5.61%)
    6 / 108 (5.56%)
         occurrences all number
    6
    6
    Foreign body sensation in eyes
         subjects affected / exposed
    4 / 107 (3.74%)
    1 / 108 (0.93%)
         occurrences all number
    5
    1
    Vision blurred
         subjects affected / exposed
    4 / 107 (3.74%)
    5 / 108 (4.63%)
         occurrences all number
    4
    6
    Chalazion
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Corneal epithelium defect
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Eye discharge
         subjects affected / exposed
    1 / 107 (0.93%)
    2 / 108 (1.85%)
         occurrences all number
    1
    2
    Eye pruritus
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 108 (0.93%)
         occurrences all number
    2
    1
    Lacrimation increased
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 108 (0.93%)
         occurrences all number
    2
    1
    Ocular hyperaemia
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Photopsia
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Ocular discomfort
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Keratopathy
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Dry eye
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Dysgeusia
         subjects affected / exposed
    4 / 107 (3.74%)
    1 / 108 (0.93%)
         occurrences all number
    5
    1
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Neurosis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Infections and infestations
    Eyelid infection
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Herpes simplex
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Hordeolum
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Viral infection
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 108 (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? Yes
    Date
    Amendment
    30 May 2019
    Addition of investigational sites : University General Hospital of Ioannina, University Ophthalmology Clinic, Piraeus General Hospital "TZANEIO", Ophthalmology Clinic, University General Hospital of Thessaloniki AHEPA, Ophthalmology Clinic
    08 Jan 2020
    Addition of 2 clinical sites : Nea Ionia General Hospital Konstantopouleio -Patision, Ophthalmology Clinic and General Hospital Pammakaristos, Ophthalmology Clinic
    25 Feb 2020
    Additional of investigational site : Ophthalmology Clinic, Corfu General Hospital
    03 Aug 2020
    The amendment included : 1) Protocol revision , Infromation Form and Patient Consent Form (Main study) : Greek Version 2.0, dated 26 March 2020, 3) Extension of the duration of the clinical trial . The overall rationale of the amendment of the protocol aims to protect study patients of the study from COVID-19 by reducing risk of potential exposure to COVID-19.Visits that are not essential to the health and/or well-being of the participants have been changed from in-person visits to telephone visits. Duration of in-person visits at sites has been reduced by modifying required assessments. The mean diurnal IOP change will be calculated as the average of the 08:00 a.m. and 10:00 a.m. time point measurements at each visit. 16:00 p.m. time point measurement was removed as at trough (08:00 a.m.) and peak (+2h, 10:00 a.m.), IOP is expected to be at the highest and lowest points respectively, on the diurnal curve for most patients. In-Person Visits at Week2 and Week6 have been changed to telephone visits. Study medication compliance and subjects’ well-being will be assessed during these visits. During the interview with the patients, if investigator deems necessary patient to procced to an in-person visit, an unscheduled visit should be arranged and the appropriate assessments to take place. Secondary evaluation criterion of difference between test and reference of the mean diurnal IOP change from baseline to week 2 and week 6 has been removed. Secondary Efficacy Analysis of IOP timepoints at Week2 and Week6 has been removed. Additionally, pigmentary & pseudo-exfoliating open angle glaucoma were removed from exclusion criteria and added in inclusion criteria.
    05 Aug 2020
    Cyprus was added in participating countries

    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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