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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 Formulation of Travoprost 40μg/ml Eye Drops Free of Preservatives vs. TRAVATAN® 40μg/ml Eye Drops in Patients with Open Angle Glaucoma, or Ocular Hypertension, already on Treatment with IOP-lowering Drugs and Low Intraocular Pressure (IOP≤21 mmHg)

    Summary
    EudraCT number
    		 2014-002576-91
    Trial protocol
    		 GR  
    Global end of trial date
    18 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2021
    First version publication date
    29 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Becro/OV/Travoprost
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    OmniVision
    Sponsor organisation address
    Lindberghstraße 9, Puchheim, Germany, 82178
    Public contact
    CLINICAL TRIAL INFORMATION, BECRO, +30 210 6729037, trials@becro.gr
    Scientific contact
    CLINICAL TRIAL INFORMATION, BECRO, +30 210 6729037, trials@becro.gr
    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
    20 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this clinical trial is to demonstrate the non-inferiority of the generic investigational medicinal product containing preservative-free Travoprost 40μg/ml in comparison with the commercially available preservative-containing comparator TRAVATAN® 40μg/ml (Alcon Laboratories Ltd UK) in the treatment of open angle glaucoma or ocular hypertension by examining the average change of diurnal IOP measured between last visit and baseline.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Oct 2014
    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: 200
    Worldwide total number of subjects
    200
    EEA total number of subjects
    200
    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)
    66
    From 65 to 84 years
    124
    85 years and over
    10

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Potential patients are evaluated for eligibility at a pre-study screening visit (SV) seven to one days before starting the clinical trial.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    The clinical trial was performed as observer-blind because of the differences in the primary packaging of both drugs. The investigational medicinal product (test) is a preservative-free preparation (Polyquad is excluded), in single dose containers while the reference product Travatan® is in multiple dose containers. Consequently, the clinical trial site had to have blind and not-blind clinical trial personnel.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Travoprost
    Arm description
    		 A new preservative-free formulation of Travoprost 40μg/ml Eye Drops solution (Test product-T)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Preservative-free Travoprost
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Topical use
    Dosage and administration details
    Products will be self-administered by the patient, as indicated: One drop in the affected eye(s) once daily in the evening, approximately at 21:00.

    Arm title
    		 Travatan
    Arm description
    		 Marketed Travatan® including preservative (Reference).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Travatan® 40μg/ml eye drops solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Topical use
    Dosage and administration details
    Products will be self-administered by the patient, as indicated: One drop in the affected eye(s) once daily in the evening, approximately at 21:00.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The clinical trial was performed as observer-blind because of the differences in the primary packaging of both drugs. The investigational medicinal product (test) is a preservative-free preparation (Polyquad is excluded), in single dose containers while the reference product Travatan® is in multiple dose containers. Consequently, the clinical trial site had to have blind and not-blind clinical trial personnel.
    Number of subjects in period 1
    		Travoprost Travatan
    Started
    101
    99
    Completed
    77
    80
    Not completed
    24
    19
         Patients had incomplete IOP data
    9
    7
         Protocol deviation
    15
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Travoprost
    Reporting group description
    		 A new preservative-free formulation of Travoprost 40μg/ml Eye Drops solution (Test product-T)

    Reporting group title
    Travatan
    Reporting group description
    		 Marketed Travatan® including preservative (Reference).

    Reporting group values
    		 Travoprost Travatan Total
    Number of subjects
    		 101 99 200
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 29 37 66
        From 65-84 years
    		 70 54 124
        85 years and over
    		 2 8 10
    Gender categorical
    Units: Subjects
        Female
    		 51 47 98
        Male
    		 50 52 102

    End points

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    End points reporting groups
    Reporting group title
    Travoprost
    Reporting group description
    		 A new preservative-free formulation of Travoprost 40μg/ml Eye Drops solution (Test product-T)

    Reporting group title
    Travatan
    Reporting group description
    		 Marketed Travatan® including preservative (Reference).

    Subject analysis set title
    Per Protocol Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The non-inferiority of the Test was proven based on the per protocol population: 157 patients, 77 in Test and 80 in Reference.

    Subject analysis set title
    Intent-to-treat (ITT) Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized patients (N=200) were evaluated for safety as these subjects received at least one dose of the study medication.

    Primary: mean diurnal IOP change from baseline to last visit

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    End point title
    		 mean diurnal IOP change from baseline to last visit
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to last visit (week 4)
    End point values
    		 Travoprost Travatan
    Number of subjects analysed
    77
    80
    Units: mmHg
    arithmetic mean (standard deviation)
        mean IOP at baseline
    15.619 ( 2.531 )
    15.404 ( 2.410 )
        mean IOP at week 1
    15.322 ( 2.531 )
    15.638 ( 2.198 )
        mean IOP at week 2
    15.240 ( 2.513 )
    15.640 ( 2.150 )
        mean IOP at week 4
    15.194 ( 2.453 )
    15.785 ( 2.070 )
    Statistical analysis title
    		 Mean change in diurnal IOP
    Statistical analysis description
    The primary endpoint was the mean diurnal IOP change from baseline to last visit and the primary efficacy analysis was planned and carried out as a test of non-inferiority. Then, the analysis of covariance (ANCOVA) model was used to analyse the mean change in diurnal IOP with baseline IOP as the covariate, and treatment as factor. The treatment difference and a two-sided 95% confidence interval (CI) for the difference are calculated.
    Comparison groups
    Travoprost v Travatan
    Number of subjects included in analysis
    157
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.731
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.237
         upper limit
    		 0.225
    Variability estimate
    Standard deviation

    Secondary: mean change in IOP between baseline and week 1

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    End point title
    		 mean change in IOP between baseline and week 1
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to week 1
    End point values
    		 Travoprost Travatan
    Number of subjects analysed
    77
    80
    Units: mmHg
    arithmetic mean (standard deviation)
        mean IOP at baseline
    15.619 ( 2.531 )
    15.404 ( 2.410 )
        mean IOP at week 1
    15.322 ( 2.531 )
    15.638 ( 2.198 )
    Statistical analysis title
    		 Analysis of secondary end point, baseline to wk 1
    Comparison groups
    Travoprost v Travatan
    Number of subjects included in analysis
    157
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.483
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.921
         upper limit
    		 -0.045
    Variability estimate
    Standard deviation

    Secondary: mean change in IOP between baseline and week 2

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    End point title
    		 mean change in IOP between baseline and week 2
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to week 2
    End point values
    		 Travoprost Travatan
    Number of subjects analysed
    77
    80
    Units: mmHg
    arithmetic mean (standard deviation)
        mean IOP at baseline
    15.619 ( 2.531 )
    15.404 ( 2.410 )
        mean IOP at week 1
    15.322 ( 2.531 )
    15.638 ( 2.198 )
        mean IOP at week 2
    15.240 ( 2.513 )
    15.640 ( 2.150 )
    Statistical analysis title
    		 Analysis of secondary end point, baseline to wk 2
    Comparison groups
    Travoprost v Travatan
    Number of subjects included in analysis
    157
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.555
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.032
         upper limit
    		 -0.078
    Variability estimate
    Standard deviation

    Secondary: proportion of patients with measured IOP <21 mmHg at the end of study (week 4)

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    End point title
    		 proportion of patients with measured IOP <21 mmHg at the end of study (week 4)
    End point description
    End point type
    Secondary
    End point timeframe
    At week 4
    End point values
    		 Travoprost Travatan
    Number of subjects analysed
    77
    80
    Units: percent
    number (not applicable)
        Percent
    98.7
    100
    No statistical analyses for this end point

    Secondary: proportion of patients with measured IOP <21 mmHg during the study

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    End point title
    		 proportion of patients with measured IOP <21 mmHg during the study
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to week 4
    End point values
    		 Travoprost Travatan
    Number of subjects analysed
    77
    80
    Units: percent
    number (not applicable)
        Percent
    97.4
    100
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events (AEs) that occurred during the study were documented.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Travoprost
    Reporting group description
    		 Travoprost 40μg/ml Eye Drops Free of Preservatives

    Reporting group title
    Travatan
    Reporting group description
    		 Travatan® 40μg/ml Eye Drops

    Serious adverse events
    		 Travoprost Travatan
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 99 (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
    		 Travoprost Travatan
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 101 (14.85%)
    12 / 99 (12.12%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 99 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 99 (1.01%)
         occurrences all number
    0
    1
    Eye disorders
    Conjunctival hyperaemia
         subjects affected / exposed
    6 / 101 (5.94%)
    3 / 99 (3.03%)
         occurrences all number
    6
    3
    Stinging
         subjects affected / exposed
    0 / 101 (0.00%)
    3 / 99 (3.03%)
         occurrences all number
    0
    3
    Foreign body sensation
         subjects affected / exposed
    3 / 101 (2.97%)
    4 / 99 (4.04%)
         occurrences all number
    3
    4
    Eye dryness
         subjects affected / exposed
    1 / 101 (0.99%)
    3 / 99 (3.03%)
         occurrences all number
    1
    3
    Eye redness
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 99 (1.01%)
         occurrences all number
    0
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 99 (0.00%)
         occurrences all number
    1
    0
    Itching
         subjects affected / exposed
    0 / 101 (0.00%)
    2 / 99 (2.02%)
         occurrences all number
    0
    2
    Blepharitis
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 99 (1.01%)
         occurrences all number
    1
    1
    Blurred vision
         subjects affected / exposed
    2 / 101 (1.98%)
    0 / 99 (0.00%)
         occurrences all number
    2
    0
    Visual acuity reduction
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 99 (1.01%)
         occurrences all number
    0
    1
    Eye burning
         subjects affected / exposed
    3 / 101 (2.97%)
    0 / 99 (0.00%)
         occurrences all number
    3
    0
    Eye irritation
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 99 (0.00%)
         occurrences all number
    1
    0
    Photopsia
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 99 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 99 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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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