Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A PHASE III, MULTICENTRE, RANDOMISED, INVESTIGATOR-MASKED, CROSS- OVER, COMPARATIVE CLINICAL TRIAL EVALUATING THE EFFICACY AND SAFETY OF THE GENERIC BRINZOLAMIDE 10 MG/ML + TIMOLOL 5 MG/ML EYE DROPS SUSPENSION (AZAD PHARMA AG) WITH BRINZOLAMIDE 10 MG/ML + TIMOLOL 5 MG/ML EYE DROPS SUSPENSION AZARGA® (ALCON LTD) IN OPEN- ANGLE GLAUCOMA AND OCULAR HYPERTENSION PATIENTS

    Summary
    EudraCT number
    		 2016-000946-69
    Trial protocol
    		 HU   AT   PL  
    Global end of trial date
    22 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jun 2022
    First version publication date
    03 Jun 2022
    Other versions
    Summary report(s)
    		 2016-000946-69_summary of results

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AZ07
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AZAD Pharma AG
    Sponsor organisation address
    Durachweg 15 , Schaffhausen , Switzerland, CH-8200
    Public contact
    Van Van Khov, AZAD Pharma AG, +41 52 632, contact@azad.ch
    Scientific contact
    Van Van Khov, AZAD Pharma AG, +41 52 632, contact@azad.ch
    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
    17 Jul 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to show non-inferiority of the test product AZAD (BT) versus the reference product Azarga in accordance with the “Guideline on the Choice of the Noninferiority Margin”, section 3.2. “Two arm trials: test and reference” EMEA/CPMP/EWP/2158/99.
    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. Exclusion criteria based on the experience of the approved, well known reference drug prevent harm to test subjects, which are not suited for the treatment. The test product is a generic version to the reference product.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Aug 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: 31
    Country: Number of subjects enrolled
    Hungary: 22
    Country: Number of subjects enrolled
    Austria: 13
    Worldwide total number of subjects
    66
    EEA total number of subjects
    66
    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)
    42
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 79 patients were screened, thirteen (13) of them were screening failures. Sixty-six (N=66) patients were randomised and received at least one dose of the test or reference product, therefore 66 patients are defined as safety population (SAF).

    Pre-assignment
    Screening details
    		 The most common reason for screening failure was that one or more eligibility criteria were not met (N=8). Four (4) patients withdrew informed consent prior to starting treatment.

    Pre-assignment period milestones
    Number of subjects started
    		 66
    Number of subjects completed
    		 64

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Physician decision: 2
    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
    		 Investigator [1]
    Blinding implementation details
    The study is investigator-masked, since the commercially available Azarga® was used. Azarga® was relabelled according to GMP annex 13. The bottles were different. The investigators who were assigned to evaluate the efficacy and safety outcomes were masked (blinded), i.e. they did not know the identity of the product given to the patient, in order to avoid bias.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Period I, AZAD (BT) then AZARGA
    Arm description
    		 AZAD (BT) then AZARGA
    Arm type
    		 crossover

    Investigational medicinal product name
    AZAD (BT) then AZARGA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, suspension
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    1 drop per eye

    Arm title
    		 Period I, AZARGA then AZAD (BT)
    Arm description
    		 AZARGA then AZAD (BT)
    Arm type
    		 crossover

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The study is investigator-masked.
    Number of subjects in period 1 [2]
    		Period I, AZAD (BT) then AZARGA Period I, AZARGA then AZAD (BT)
    Started
    35
    29
    Completed
    30
    25
    Not completed
    5
    4
         Protocol deviation
    5
    4
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: From the Safety Analysis Set 2 patients were withdrawn to the ITT set due to deviations from the ITT definitions.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Period I, AZAD (BT) then AZARGA
    Reporting group description
    		 AZAD (BT) then AZARGA

    Reporting group title
    Period I, AZARGA then AZAD (BT)
    Reporting group description
    		 AZARGA then AZAD (BT)

    Reporting group values
    		 Period I, AZAD (BT) then AZARGA Period I, AZARGA then AZAD (BT) Total
    Number of subjects
    		 35 29 64
    Age categorical
    Units: Subjects
        18-75
    		 35 29 64
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.0 ( 11.18 ) 61.8 ( 11.76 ) -
    Gender categorical
    Units: Subjects
        Female
    		 22 16 38
        Male
    		 13 13 26

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Period I, AZAD (BT) then AZARGA
    Reporting group description
    		 AZAD (BT) then AZARGA

    Reporting group title
    Period I, AZARGA then AZAD (BT)
    Reporting group description
    		 AZARGA then AZAD (BT)

    Primary: Primary Endpoint

    		 Close Top of page
    End point title
    		 Primary Endpoint
    End point description
    End point type
    Primary
    End point timeframe
    42 days
    End point values
    		 Period I, AZAD (BT) then AZARGA Period I, AZARGA then AZAD (BT)
    Number of subjects analysed
    35
    29
    Units: Non Inferior
        Non Inferior
    35
    29
    Statistical analysis title
    		 Non-inferiority Margin mean IOP
    Comparison groups
    Period I, AZARGA then AZAD (BT) v Period I, AZAD (BT) then AZARGA
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.167 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Notes
    [1] - The difference in IOP lowering effect between the two treatments was not significant (p-value 0.167 > 0.05) and the lower limit of the confidence interval was within the non-inferiority margin (-0.162 > -1.5 mm Hg).

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    whole study timeframe
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    AZAD Test product
    Reporting group description
    		 -

    Reporting group title
    AZARGA Reference
    Reporting group description
    		 -

    Serious adverse events
    		 AZAD Test product AZARGA Reference
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 AZAD Test product AZARGA Reference
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 65 (60.00%)
    36 / 64 (56.25%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 65 (15.38%)
    7 / 64 (10.94%)
         occurrences all number
    10
    7
    Eye disorders
    blurred vision
         subjects affected / exposed
    39 / 65 (60.00%)
    36 / 64 (56.25%)
         occurrences all number
    39
    36
    Dysgeusia
         subjects affected / exposed
    19 / 65 (29.23%)
    14 / 64 (21.88%)
         occurrences all number
    19
    14
    eye itching
         subjects affected / exposed
    6 / 65 (9.23%)
    7 / 64 (10.94%)
         occurrences all number
    6
    7
    eyes stingeling
         subjects affected / exposed
    7 / 65 (10.77%)
    6 / 64 (9.38%)
         occurrences all number
    7
    6
    Eye pain
         subjects affected / exposed
    4 / 65 (6.15%)
    0 / 64 (0.00%)
         occurrences all number
    4
    0

    More information

    		 Close Top of page

    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.

    European Medicines Agency © 1995-Mon Apr 29 13:29:01 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA