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    Clinical Trial Results:
    Assessing the Efficacy and Tolerability of TRAVATAN® Solution without BAK, containing Polyquad® Preservative (travoprost 0.004%) versus LUMIGAN® 0.01% Solution with BAK (bimatoprost 0.01%) in Treatment Naïve patients with Ocular Hypertension or Open Angle Glaucoma

    Summary
    EudraCT number
    		 2012-002078-30
    Trial protocol
    		 SI  
    Global end of trial date
    18 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2016
    First version publication date
    05 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RDG-11-244
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01664039
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Not available: Not available
    Sponsors
    Sponsor organisation name
    Alcon Research, Ltd.
    Sponsor organisation address
    6201 South Freeway, Fort Worth, United States, 76134
    Public contact
    Global Brand Lead, Medical Affairs, Glaucoma, Alcon Research, Ltd., 1 888-451-3937, alcon.medinfo@alcon.com
    Scientific contact
    Global Brand Lead, Medical Affairs, Glaucoma, Alcon Research, Ltd., 1 888-451-3937, alcon.medinfo@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
    18 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to assess the efficacy and tolerability of TRAVATAN® Solution without BAK, containing Polyquad® Preservative versus LUMIGAN® 0.01% Solution with BAK in treatment naïve patients with ocular hypertension or open angle glaucoma.
    Protection of trial subjects
    This study was performed in compliance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice (GCP). An Ethics Committee reviewed and approved (for use in this study) informed consent form was read, signed, and dated by the participating patient, as well as signed and dated by the individual (Principal Investigator or other site personnel) obtaining the informed consent, before conducting the Screening Visit and prior to initiation of study procedures.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2012
    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
    Slovenia: 104
    Worldwide total number of subjects
    104
    EEA total number of subjects
    104
    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)
    69
    From 65 to 84 years
    34
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled at 2 study centers in Slovenia

    Pre-assignment
    Screening details
    		 The study population included males and females of any race/ethnicity who were older than 18 years of age and who had newly diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and were treatment naïve to any glaucoma treatment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TRAVATAN
    Arm description
    		 Travoprost 0.004% ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative
    Arm type
    		 Experimental

    Investigational medicinal product name
    TRAVATAN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ear drops, solution
    Routes of administration
    Ocular use
    Dosage and administration details
    One drop to the study eye(s), once a day in the evening, for 6 months

    Arm title
    		 LUMIGAN
    Arm description
    		 Bimatoprost 0.01% ophthalmic solution containing benzalkonium chloride (BAK)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    LUMIGAN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ocular use
    Dosage and administration details
    One drop to the study eye(s), once a day in the evening, for 6 months

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The observer was masked in this study.
    Number of subjects in period 1
    		TRAVATAN LUMIGAN
    Started
    52
    52
    Completed
    46
    43
    Not completed
    6
    9
         Consent withdrawn by subject
    1
    3
         Adverse event, non-fatal
    3
    4
         Lost to follow-up
    1
    1
         Noncompliance
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TRAVATAN
    Reporting group description
    		 Travoprost 0.004% ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative

    Reporting group title
    LUMIGAN
    Reporting group description
    		 Bimatoprost 0.01% ophthalmic solution containing benzalkonium chloride (BAK)

    Reporting group values
    		 TRAVATAN LUMIGAN Total
    Number of subjects
    		 52 52 104
    Age categorical
    This analysis population includes all randomized participants
    Units: Subjects
        Adults (18-64 years)
    		 40 40 80
        From 65-84 years
    		 12 12 24
        85 years and over
    		 0 0 0
    Age continuous
    This analysis population includes all randomized participants.
    Units: years
        arithmetic mean (standard deviation)
    		 60 ( 10.8 ) 58 ( 12.8 ) -
    Gender categorical
    This analysis population includes all randomized participants.
    Units: Subjects
        Female
    		 35 16 51
        Male
    		 17 36 53

    End points

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    End points reporting groups
    Reporting group title
    TRAVATAN
    Reporting group description
    		 Travoprost 0.004% ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative

    Reporting group title
    LUMIGAN
    Reporting group description
    		 Bimatoprost 0.01% ophthalmic solution containing benzalkonium chloride (BAK)

    Primary: Mean Change from Baseline in Intraocular Pressure (IOP) at Month 6

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    End point title
    		 Mean Change from Baseline in Intraocular Pressure (IOP) at Month 6
    End point description
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters mercury (mmHg). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. This analysis population includes all randomized subjects who received at least one dose of either study treatment and had at least one post-baseline on-therapy study visit. Here, n=the number of subjects with non-missing values at the specific timepoint for each arm group respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Month 6
    End point values
    		 TRAVATAN LUMIGAN
    Number of subjects analysed
    50
    49
    Units: millimeters mercury (mmHg)
    arithmetic mean (standard deviation)
        Baseline (Day 0)
    24.66 ( 3.65 )
    24.59 ( 4.14 )
        Change from baseline at Month 6 (n=46,43)
    -7.61 ( 4.32 )
    -7.35 ( 3.84 )
    Statistical analysis title
    		 Analysis of Change from Baseline in IOP at Month 6
    Comparison groups
    TRAVATAN v LUMIGAN
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.544
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.419
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.789
         upper limit
    		 0.951
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.689

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events were collected for the duration of the study (September 2012 to June 2014). This analysis population includes all subjects who received at least one dose of either study treatment.
    Adverse event reporting additional description
    An Adverse Event (AE) was defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as both volunteered and elicited comments from the study subjects.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    TRAVATAN
    Reporting group description
    		 Travoprost 0.004% ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative,

    Reporting group title
    LUMIGAN
    Reporting group description
    		 Bimatoprost 0.01% ophthalmic solution containing benzalkonium chloride (BAK)

    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: There were no non-serious adverse events occurring above a threshold of 5% in either arm in this study.
    Serious adverse events
    		 TRAVATAN LUMIGAN
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Surgical and medical procedures
    Thromboendarterectomy
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
         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
    		 TRAVATAN LUMIGAN
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)

    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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