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    Summary
    EudraCT Number:2010-024512-34
    Sponsor's Protocol Code Number:C-10-040
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-04-19
    Trial results View 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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2010-024512-34
    A.3Full title of the trial
    Safety and IOP-Lowering Efficacy of Brinzolamide 10 mg/ml / Brimonidine 2 mg/ml Fixed Combination Eye Drops, Suspension compared to Brinzolamide 10 mg/ml Eye Drops, Suspension and Brimonidine 2 mg/ml Eye Drops, Solution in Patients with Open-Angle Glaucoma or Ocular Hypertension
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and eye pressure lowering effect of Brinz/Brim eye drops , compared to Brinzolamide and Brimonidine given separately in patients with increased eye pressure (ocular hypertension) or with associated changes to the nerve inside the eye (glaucoma).
    A.3.2Name or abbreviated title of the trial where available
    Brinz/Brim BID FC vs Brinzolamide BID and Brimonidine BID in Patients with OAG
    A.4.1Sponsor's protocol code numberC-10-040
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01310777
    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 SponsorAlcon Research, Ltd.
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 10 mg/ml/Brimonidine Tartrate 2 mg/ml Eye Drops, Suspension
    D.3.2Product code 115576
    D.3.4Pharmaceutical form Eye drops, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Ocular 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.3.10 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 INNBRIMONIDINE TARTRATE
    D.3.9.1CAS number 79570-19-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 AZOPT
    D.2.1.1.2Name of the Marketing Authorisation holderAlcon Laboratories (UK), 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.3.1Product nameBrinzolamide 10 mg/ml Eye Drops, Suspension
    D.3.2Product code 89984
    D.3.4Pharmaceutical form Eye drops, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Ocular 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.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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: 3
    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 Information not present in EudraCT
    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 nameBrimonidine Tartrate 2 mg/ml Eye Drops, Solution
    D.3.2Product code 101461
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Ocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBRIMONIDINE TARTRATE
    D.3.9.1CAS number 79570-19-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Open-angle glaucoma and ocular hypertension
    E.1.1.1Medical condition in easily understood language
    Elevated pressure in the eye with (glaucoma) or without optic nerve damages (ocular hypertension)
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Brinzolamide 10 mg/mL / brimonidine 2 mg/mL eye drops,
    suspension is superior to brinzolamide 10 mg/mL eye drops,
    suspension, with respect to IOP-lowering efficacy, and
    brinzolamide 10 mg/mL / brimonidine 2 mg/mL eye drops,
    suspension is superior to brimonidine 2 mg/mL eye drops,
    solution, with respect to IOP-lowering efficacy
    E.2.2Secondary objectives of the trial
    There are no secondary objectives.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients 18 years of age or older, of either gender, and any
    race/ethnicity, diagnosed with open angle glaucoma or ocular
    hypertension, who in the opinion of the Investigator are
    insufficiently controlled on monotherapy or are already on
    multiple IOP-lowering medications.
    2. Patients should be able to understand and sign an informed
    consent that has been approved by an Institutional Review
    Board/Independent Ethics Committee.
    3. Mean IOP measurements in at least 1 eye, the same eye(s),
    must be:
    • ≥ 24 mmHg and ≤ 36 mmHg at the 9 AM time point
    and,
    • ≥ 21 mmHg and ≤ 36 mmHg at the 11 AM time point at
    both E1 and E2 Visits.
    IOP must not be > 36 mmHg at any time point.
    E.4Principal exclusion criteria
    1. Females of childbearing potential (those who are not surgically
    sterilized or post-menopausal for at least 1 year) are excluded
    from participation in the studyif they meet any one of the
    following conditions:
    a. are currently pregnant or,
    b. have a positive result on the urine pregnancy test at the
    Screening Visit or,
    c. intend to become pregnant during the study period or,
    d. are breast-feeding or,
    e. they are not using highly effective birth control measures,
    such as:
    Hormonal –
    oral, implanted, transdermal, or injected
    contraceptives;
    Mechanical –
    spermicide in conjunction with a barrier such
    as a condom or diaphragm or IUD.
    Patients with Schaffer angle Grade < 2, as measured by
    gonioscopy (extreme narrow angle with complete or partial
    closure).
    3. Patients with a cup/disc ratio (C/D) greater than 0.80
    (horizontal or vertical measurement).
    4. Patients with severe central visual field loss. Severe central
    visual field loss is defined as a sensitivity of less than or equal
    to 10 dB in at least 2 of the 4 visual field test points closest to
    the point of fixation.
    5. Patients who cannot safely discontinue use of all IOPlowering
    ocular medication(s) for a minimum period of 5 days
    ± 1 day to 28 days ± 1 day prior to Eligibility 1 (E1) Visit.
    Chronic, recurrent or severe inflammatory eye disease
    (ie, scleritis, uveitis, herpes keratitis).
    7. Ocular trauma within the past 6 months.
    8. Ocular infection or ocular inflammation within the past 3
    months.
    9. Clinically significant or progressive retinal disease such as
    retinal degeneration, diabetic retinopathy, or retinal
    detachment.
    10. Best-corrected visual acuity (BCVA) score worse than 55
    ETDRS letters (equivalent to approximately 20/80 Snellen,
    0.60 logMAR, or 0.25 decimal).
    11. Other ocular pathology (including severe dry eye) that may, in
    the opinion of the Investigator, preclude the administration of
    alpha-adrenergic agonist and/or topical carbonic anhydrase
    inhibitor (CAI).
    12. Intraocular surgery within the past 6 months.
    13. Ocular laser surgery within the past 3 months.
    14. Any abnormality preventing reliable applanation tonometry.
    15. Any other conditions including severe illness which would
    make the patient, in the opinion of the Investigator, unsuitable
    for the study.
    16. History of active, severe, unstable or uncontrolled
    cardiovascular (eg, coronary insufficiency, hypertension,
    Raynaud’s phenomenon, orthostatic hypotension,
    thromboangiitis obliterans), cerebrovascular (eg, cerebral
    insufficiency), hepatic, or renal disease that would preclude
    the safe administration of a topical alpha-adrenergic agonist or
    CAI in the opinion of the investigator.
    17. Patients with recent (within 4 weeks of the Eligibility 1 Visit)
    use of high-dose (> 1 g daily) salicylate therapy.
    18. Current or anticipated treatment with any psychotropic drugs
    that augment adrenergic response (eg, desipramine,
    amitriptyline).
    19. Concurrent use of monoamine oxidase inhibitor.
    20. Therapy with another investigational agent within 30 days
    prior to the Screening Visit.
    21. Hypersensitivity to alpha-adrenergic agonist drugs, topical or
    oral CAIs, sulfonamide derivatives, or to any component of
    the study medications in the opinion of the Investigator.
    22. Less than 30 days stable dosing regimen before the Screening
    Visit of any medications or substances administered by any
    route and used on a chronic basis that may affect IOP,
    including but not limited to, β-adrenergic blocking agents.
    23. Use of any additional topical or systemic ocular hypotensive
    medication during the study.
    24. Concurrent use of glucocorticoids administered by any route.
    E.5 End points
    E.5.1Primary end point(s)
    Primary:
    • Mean diurnal IOP change from baseline (Month 3).
    Supportive Efficacy:
    • Diurnal IOP change from baseline (Week 2, Week 6)
    • IOP (Week 2, Week 6, Month 3)
    • IOP change from baseline (Week 2, Week 6, Month 3)
    • IOP % change from baseline (Week 2, Week 6, Month 3)
    • Percentage of patients with IOP < 18 mmHg at each ontherapy
    visit and time point (Week 2, Week 6, Month 3).)
    Safety: Pachymetry, fundus parameters, BCVA, slit-lamp exam,
    standard automated perimetry, pulse / blood pressure,
    Gonioscopy, adverse events.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Average other 9 AM + 2Hrs, + 7Hrs and + 10 Hrs (this last time point will be collected at only same selected sites.
    E.5.2Secondary end point(s)
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    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 trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Germany
    Hungary
    Italy
    Latvia
    Lithuania
    Mexico
    New Zealand
    Portugal
    Singapore
    Spain
    Taiwan
    Thailand
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    E.8.9.2In all countries concerned by the trial months8
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 275
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 525
    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)
    Post trial treatment or care will not be different from the expected normal treatment of that condition.
    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 Decision2011-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-01-18
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