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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36083   clinical trials with a EudraCT protocol, of which   5932   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).
     
    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

    Print Download

    Summary
    EudraCT Number:2016-000946-69
    Sponsor's Protocol Code Number:AZ07
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-01
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-000946-69
    A.3Full title of the trial
    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
    Wieloośrodkowe, randomizowane, zaślepione dla badacza, krzyżowe, porównawcze badanie kliniczne III fazy oceniające skuteczność i bezpieczeństwo generycznego produktu brinzolamide 10 mg/ml + timolol 5 mg/ml (Azad Pharma AG) w postaci zawiesiny kropli do oczu z brinzolamide 10 mg/ml + timolol 5 mg/ml w postaci zawiesiny kropli do oczu Azarga ® (Alcon Ltd ) u pacjentów z jaskrą z otwartym kątem przesączania i nadciśnieniem wewnątrzgałkowym.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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) and of Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops suspension Azarga® (Alcon Ltd) in open-angle glaucoma and ocular hypertension patients
    Wieloośrodkowe, randomizowane, zaślepione dla badacza, krzyżowe, porównawcze badanie kliniczne III fazy oceniające skuteczność i bezpieczeństwo generycznego produktu brinzolamide 10 mg/ml + timolol 5 mg/ml (Azad Pharma AG) w postaci zawiesiny kropli do oczu z brinzolamide 10 mg/ml + timolol 5 mg/ml w postaci zawiesiny kropli do oczu Azarga ® (Alcon Ltd ) u pacjentów z jaskrą z otwartym kątem przesączania i nadciśnieniem wewnątrzgałkowym.
    A.3.2Name or abbreviated title of the trial where available
    Azad Brinolamid/Timolol combination generic study
    A.4.1Sponsor's protocol code numberAZ07
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAZAD Pharma AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAzad AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzad AG
    B.5.2Functional name of contact pointVan Van Khov
    B.5.3 Address:
    B.5.3.1Street AddressBahnhofstrasse 9
    B.5.3.2Town/ cityToffen
    B.5.3.3Post codeCH-3125
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number004152632 09 2323
    B.5.5Fax number004152632 09 1111
    B.5.6E-mailvkhov@azad.ch
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBrinzolamide 10mg/ml + Timolol 5mg/ml
    D.3.2Product code Brinzolamide 10mg/ml + Timolol 5mg/ml
    D.3.4Pharmaceutical form Ear/eye drops, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBrinzolamide
    D.3.9.1CAS number 138890-62-7
    D.3.9.3Other descriptive nameBRINZOLAMIDE
    D.3.9.4EV Substance CodeSUB05892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTimolol maleate
    D.3.9.1CAS number 26921-17-5
    D.3.9.3Other descriptive nameTIMOLOL
    D.3.9.4EV Substance CodeSUB11069MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Azarga®
    D.2.1.1.2Name of the Marketing Authorisation holderAlcon Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Ear/eye drops, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBrinzolamide
    D.3.9.1CAS number 138890-62-7
    D.3.9.3Other descriptive nameBRINZOLAMIDE
    D.3.9.4EV Substance CodeSUB05892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTimolol maleate
    D.3.9.1CAS number 26921-17-5
    D.3.9.3Other descriptive nameTIMOLOL
    D.3.9.4EV Substance CodeSUB11069MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction
    E.1.1.1Medical condition in easily understood language
    Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level HLGT
    E.1.2Classification code 10018307
    E.1.2Term Glaucoma and ocular hypertension
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10030043
    E.1.2Term Ocular hypertension
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of the generic Brinzolamide 10
    mg/ml + Timolol 5 mg/ml eye drops suspension AZAD Pharma AG (test product) in lowering
    intra-ocular pressure (IOP) when compared to Brinzolamide 10 mg/ml + Timolol 5mg/ml eye
    drops suspension product Azarga® (reference product, Alcon Ltd).
    E.2.2Secondary objectives of the trial
    1. To compare the tolerance of the test and reference products using a ocular comfort level
    score.
    2. To compare the levels of conjunctival hyperaemia induced by test product and reference
    product.
    3. To evaluate the general safety of the test product compared to the reference product.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Elevated IOP / primary open angle glaucoma (irideocorneal angle > 30°) in at least one
    eye: IOP pre-treatment (measured at approx. 8 am, 10 am and 4 pm) must be equal or
    higher than 22 mmHg, and equal or lower to 35 mmHg (untreated, i.e. naïve or after
    washout).

    2. Not on any ophthalmic pressure-lowering medication, or in the condition not to suffer
    an untoward effects by withdrawal from current pressure-lowering medications for the
    washout period(s).

    3. No ocular trauma, surgery, inflammation or infection, no corneal foreign body in the
    previous 3 months.

    4. No clinically significant or progressive retinal disease as determined by dilated
    peripheral retinal examination done at screening.

    5. No concomitant use of any topical ophthalmic medication other than artificial tears.

    6. No ocular glucocorticoids in the previous 3 months.
    E.4Principal exclusion criteria
    1. Visual acuity of less than distance Snellen 20/100 corresponding to decimal 0.20 or 0.70
    logMAR in either eye.

    2. Evidence of acute ocular infection, corneal foreign body, or ocular inflammation.

    3. Previous significant ocular trauma, laser or incisional surgery within 3 months of the
    screening visit.

    4. Any corneal abnormalities preventing reliable applanation tonometry.

    5. Patients with risk of angle closure or evidence of acute, intermittent or chronic angle
    closure.

    6. Types of glaucoma other than POAG with glaucomatous optic disc morphology or
    glaucoma visual field defect such as pigmentary or pseudo-exfoliative glaucoma.

    7. Pupil with inadequate ability to dilate sufficiently for peripheral retinal examination.

    8. History or evidence of severe inflammatory eye disease (i.e. uveitis, retinitis, scleritis) in
    one or both eyes.

    9. Traumatic cataract surgery with an open posterior capsule or any patient with an anterior
    chamber intraocular lens implant or aphakia

    10. Pregnant or nursing women.

    11. History of drug or alcohol abuse within the last 6 months.

    12. A history of hypersensitivity to Brinzolamide, Timolol, sulphonamides or any component
    in the formulation of the products being tested.

    13. Patient with history of severe renal insufficiency (Creatinin Clearance <30ml/min) or
    hyperchloremic acidosis.

    14. Patients with reactive airway disease including bronchial asthma or a history of bronchial
    asthma, or severe chronic obstructive pulmonary disease.

    15. Patients with sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third
    degree atrioventricular block not controlled with pace-maker. Overt cardiac failure,
    cardiogenic shock.

    16. Patients with severe allergic rhinitis.

    17. Patients who have participated in another research study for an investigational drug within
    30 days of the screening visit.

    18. History of evidence of any medical condition that would, in the opinion of the investigator,
    make the patient unsuitable for the study.

    19. Systemic medication that may alter IOP in the previous 30 days (i.e. beta-blockers, Calcium
    channel blockers, angiotensin converting enzyme (ACE) inhibitors, prostaglandins etc.) or not expected to continue the current treatment with these medical products on a stable
    regimen for 30 days prior to the study and during the study.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is non-inferiority of test product when compared with reference product, with respect to the differences in the mean diurnal IOP measured at approximately 8 am, 10 am and 4 pm in the
    study eye between Day 1 (baseline, before treatment) and Day 22 (under treatment).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Diurnal IOP measured at approximately 8 am, 10 am and 4 pm in the
    study eye between Day 1 (baseline, before treatment) and Day 22 (under treatment).
    E.5.2Secondary end point(s)
    a) Ocular tolerance:
    - Difference between the investigational products with respect to ocular comfort score at baseline Day 1 and Day 22
    - Difference between investigational products with respect to conjunctival hyperaemia at baseline Day 1 and Day 22

    b) Safety:
    Difference between investigational products with respect to general safety as assessed by occurence of adverse events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 (baseline) and Day 22 (under treatment)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of trial is Las Visit of Last Subject LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    F.4.2.2In the whole clinical trial 66
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    treatment as per standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-18
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA