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    Clinical Trial Results:
    Safety and Efficacy with Twice Daily Brinzolamide 1% / Brimonidine 0.2% (SIMBRINZA®) as an Adjunctive Therapy to Travoprost 0.004% / Timolol 0.5% (DUOTRAV®)

    Summary
    EudraCT number
    		 2016-000176-20
    Trial protocol
    		 ES   BE   GB   DE   GR   FR   NL  
    Global end of trial date
    13 Jul 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 May 2019
    First version publication date
    09 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GLJ576-P001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02730871
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alcon Research
    Sponsor organisation address
    6201 S. Freeway, Fort Worth, TX, United States, 76134
    Public contact
    EMEA Regulatory Affairs, Alcon Eye Care UK Ltd, emea.ra@alcon.com
    Scientific contact
    EMEA Regulatory Affairs, Alcon Eye Care UK Ltd, emea.ra@alcon.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
    13 Jul 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jul 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this study was to evaluate the additive intraocular pressure (IOP) lowering effect of Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) dosed twice daily (BID) when added to Travoprost 0.004%/Timolol 0.5% (DUOTRAV®) in subjects with open-angle glaucoma or ocular hypertension.
    Protection of trial subjects
    Prior to the start of the study, the study protocol, the informed consent and assent documents, patient instruction sheets, the Investigator’s Brochure, as well as any advertising materials used to recruit patients were submitted to institutional review boards (IRBs) and independent ethics committees (IECs). The IRB/IECs reviewed all documents and approved required documents; copies of the approval letters were provided to Alcon. Consistent with both the IRB/IEC’s requirements and all applicable regulations, the Investigators periodically provided study updates to the IRB/IEC. This study was conducted in accordance with Good Clinical Practices (GCP) and the ethical principles that have their origins in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jun 2016
    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
    Poland: 11
    Country: Number of subjects enrolled
    Spain: 20
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Greece: 4
    Country: Number of subjects enrolled
    Argentina: 33
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Chile: 1
    Country: Number of subjects enrolled
    Colombia: 12
    Country: Number of subjects enrolled
    Malaysia: 6
    Country: Number of subjects enrolled
    Taiwan: 6
    Country: Number of subjects enrolled
    Italy: 23
    Worldwide total number of subjects
    134
    EEA total number of subjects
    74
    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)
    50
    From 65 to 84 years
    79
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from sites located in Argentina, Australia, Belgium, Chile, Columbia, Germany, Greece, Italy, Malaysia, Poland, Spain, Taiwan, and the United Kingdom.

    Pre-assignment
    Screening details
    		 Of the 173 enrolled, 39 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized and treated subjects (134).

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Simbrinza + Duotrav
    Arm description
    		 Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
    Investigational medicinal product code
    Other name
    SIMBRINZA® suspension
    Pharmaceutical forms
    Eye drops, suspension
    Routes of administration
    Ocular use
    Dosage and administration details
    One drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) for 42 days (Treatment Phase)

    Investigational medicinal product name
    Travoprost 0.004%/timolol 0.5% solution
    Investigational medicinal product code
    Other name
    DUOTRAV®
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ocular use
    Dosage and administration details
    One drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)

    Arm title
    		 Vehicle + Duotrav
    Arm description
    		 Brinzolamide/brimonidine vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Brinzolamide/brimonidine vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, suspension
    Routes of administration
    Ocular use
    Dosage and administration details
    One drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) for 42 days (Treatment Phase)

    Investigational medicinal product name
    Travoprost 0.004%/timolol 0.5% solution
    Investigational medicinal product code
    Other name
    DUOTRAV®
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ocular use
    Dosage and administration details
    One drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)

    Number of subjects in period 1
    		Simbrinza + Duotrav Vehicle + Duotrav
    Started
    67
    67
    Completed
    61
    67
    Not completed
    6
    0
         Adverse event, non-fatal
    6
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Simbrinza + Duotrav
    Reporting group description
    		 Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)

    Reporting group title
    Vehicle + Duotrav
    Reporting group description
    		 Brinzolamide/brimonidine vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)

    Reporting group values
    		 Simbrinza + Duotrav Vehicle + Duotrav Total
    Number of subjects
    		 67 67 134
    Age categorical
    Units: Subjects
    Age continuous
    This analysis population includes all randomized subjects with a baseline assessment who completed at least 1 scheduled on-therapy visit (Full Analysis Set).
    Units: years
        arithmetic mean (standard deviation)
    		 65.7 ± 13.47 65.7 ± 11.77 -
    Gender categorical
    Units: Subjects
        Female
    		 32 41 73
        Male
    		 35 26 61
    Intraocular Pressure (IOP)
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg).
    Units: mmHg
        arithmetic mean (standard deviation)
    		 21.6 ± 1.78 21.8 ± 1.90 -
    IOP at 9:00 Hr
    IOP (fluid pressure inside the eye) was assessed at 09:00 using Goldmann applanation tonometry and reported in millimeters mercury (mmHg).
    Units: mmHg
        arithmetic mean (standard deviation)
    		 22.2 ± 1.84 22.5 ± 1.80 -
    IOP at 11:00 Hr
    IOP (fluid pressure inside the eye) was assessed at 11:00 using Goldmann applanation tonometry and reported in millimeters mercury (mmHg).
    Units: mmHg
        arithmetic mean (standard deviation)
    		 21.4 ± 1.93 21.4 ± 2.26 -

    End points

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    End points reporting groups
    Reporting group title
    Simbrinza + Duotrav
    Reporting group description
    		 Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)

    Reporting group title
    Vehicle + Duotrav
    Reporting group description
    		 Brinzolamide/brimonidine vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)

    Primary: Mean Change From Baseline in Diurnal Intraocular Pressure (IOP) (Mean of Changes at 09:00 and 11:00 Time Points) at Week 6

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    End point title
    		 Mean Change From Baseline in Diurnal Intraocular Pressure (IOP) (Mean of Changes at 09:00 and 11:00 Time Points) at Week 6
    End point description
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP change was defined as the average of the two changes from baseline (timepoints 9 AM, 11 AM). A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses. Full Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included in the calculation of change.
    End point type
    Primary
    End point timeframe
    Baseline, Week 6
    End point values
    		 Simbrinza + Duotrav Vehicle + Duotrav
    Number of subjects analysed
    61
    67
    Units: mmHg
        arithmetic mean (standard deviation)
    -4.5 ± 2.69
    -2.4 ± 3.01
    Statistical analysis title
    		 Mean Change From Baseline in Diurnal IOP
    Comparison groups
    Simbrinza + Duotrav v Vehicle + Duotrav
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 -1.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.342

    Secondary: Mean Diurnal IOP at Week 6

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    End point title
    		 Mean Diurnal IOP at Week 6
    End point description
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP was defined as the average of the two time points measured (9 AM, 11 AM). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was used for the analyses. Full Analysis Set with non-missing values.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Simbrinza + Duotrav Vehicle + Duotrav
    Number of subjects analysed
    61
    67
    Units: mmHg
        arithmetic mean (standard deviation)
    17.1 ± 2.96
    19.4 ± 3.45
    Statistical analysis title
    		 Mean Diurnal IOP at Week 6
    Comparison groups
    Simbrinza + Duotrav v Vehicle + Duotrav
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 -1.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.342

    Secondary: Mean Percentage Change From Baseline (BL) in Diurnal IOP at Week 6

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    End point title
    		 Mean Percentage Change From Baseline (BL) in Diurnal IOP at Week 6
    End point description
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP percentage change was defined as the average of the two changes from baseline (timepoints 9 AM, 11 AM). A more negative percentage change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses. Full Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included in the calculation of change.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6
    End point values
    		 Simbrinza + Duotrav Vehicle + Duotrav
    Number of subjects analysed
    61
    67
    Units: percentage change
        arithmetic mean (standard deviation)
    -20.7 ± 12.00
    -11.1 ± 13.86
    Statistical analysis title
    		 Mean Percentage Change From BL in Diurnal IOP
    Statistical analysis description
    At Week 6
    Comparison groups
    Simbrinza + Duotrav v Vehicle + Duotrav
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.1
         upper limit
    		 -6.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.572

    Secondary: Mean Change From Baseline in IOP (09:00, 11:00) at Week 6

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    End point title
    		 Mean Change From Baseline in IOP (09:00, 11:00) at Week 6
    End point description
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses. Full Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included in the calculation of change.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6
    End point values
    		 Simbrinza + Duotrav Vehicle + Duotrav
    Number of subjects analysed
    61
    67
    Units: mmHg
    arithmetic mean (standard deviation)
        Change from Baseline 9:00 Hr
    -4.4 ± 3.07
    -3.2 ± 3.40
        Change from Baseline 11:00 Hr
    -5.4 ± 2.84
    -2.5 ± 2.98
    Statistical analysis title
    		 Change From Baseline in IOP at 09:00
    Statistical analysis description
    At Week 6
    Comparison groups
    Simbrinza + Duotrav v Vehicle + Duotrav
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.022
    Method
    		 Repeated measures model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.576
    Statistical analysis title
    		 Change From Baseline in IOP at 11:00
    Statistical analysis description
    At Week 6
    Comparison groups
    Simbrinza + Duotrav v Vehicle + Duotrav
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Repeated measures model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.9
         upper limit
    		 -1.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.506

    Secondary: Mean Percentage Change From Baseline in IOP (09:00, 11:00) at Week 6

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    End point title
    		 Mean Percentage Change From Baseline in IOP (09:00, 11:00) at Week 6
    End point description
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. A more negative percentage change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses. Full Analysis Set. At each time point, only subjects with a value at both Baseline and that time point are included in the calculation of change.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6
    End point values
    		 Simbrinza + Duotrav Vehicle + Duotrav
    Number of subjects analysed
    61
    67
    Units: percentage change
    arithmetic mean (standard deviation)
        Percent change at 9:00 Hr
    -20.2 ± 13.56
    -14.1 ± 15.10
        Percent change at 11:00 Hr
    -25.0 ± 12.73
    -11.7 ± 13.63
    Statistical analysis title
    		 Percentage Change From Baseline in IOP at 09:00
    Statistical analysis description
    At Week 6
    Comparison groups
    Simbrinza + Duotrav v Vehicle + Duotrav
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.018
    Method
    		 Repeated measures model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.2
         upper limit
    		 -1.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.567
    Statistical analysis title
    		 Percentage Change from Baseline in IOP at 11:00
    Comparison groups
    Simbrinza + Duotrav v Vehicle + Duotrav
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Repeated measures model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -13.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.8
         upper limit
    		 -8.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.34

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Baseline through study completion, an average of 42 days
    Adverse event reporting additional description
    Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Includes all subjects who received a dose of masked investigational product (Safety Analysis Set).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Simbrinza + Duotrav
    Reporting group description
    		 Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)

    Reporting group title
    Vehicle + Duotrav
    Reporting group description
    		 Brinzolamide/brimonidine vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events occurred greater than the 5% threshold.
    Serious adverse events
    		 Simbrinza + Duotrav Vehicle + Duotrav
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
         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: 5%
    Non-serious adverse events
    		 Simbrinza + Duotrav Vehicle + Duotrav
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 67 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Apr 2017
    In order to facilitate subject recruitment, the amendment lowered the qualifying IOP criteria at both the Eligibility 1 and Eligibility 2 visits, removed the late day (15:00) IOP measurement time point reducing subject commitment, and allowed subjects currently on treatment with DUOTRAV for at least 28 days prior to screening in the morning or evening to be eligible for the study. To minimize unnecessary patient enrollment in the trial, an interim analysis was added at 50% completion to test for statistical differences between treatments. If it was achieved, the study enrollment would have been stopped and subjects in the study completed their visits.

    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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