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    Summary
    EudraCT Number:2013-001793-21
    Sponsor's Protocol Code Number:CPA12001
    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:2013-05-15
    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 number2013-001793-21
    A.3Full title of the trial
    Efficacy and tolerability of brinzolamide in patients with elevated intraocular pressure: a double-blind, randomized, parallel, verum-controlled trial.
    A brinzolamid hatásossága és tolerálhatósága emelkedett szembelnyomásban szenvedő
    betegeknél: kettős-vak, randomizált, párhuzamos csoportos, aktív kontrollos vizsgálat
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and tolerability of brinzolamide in patients with elevated intraocular pressure
    A brinzolamid hatásossága és tolerálhatósága emelkedett szembelnyomásban szenvedő
    betegeknél
    A.4.1Sponsor's protocol code numberCPA12001
    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 SponsorPHARMATHEN S.A.
    B.1.3.4CountryGreece
    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 supportPHARMATHEN S.A.
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPHARMATHEN S.A.
    B.5.2Functional name of contact pointResearch and Scientific Operations
    B.5.3 Address:
    B.5.3.1Street Address6 Dervenakion Street
    B.5.3.2Town/ cityPallini, Athens
    B.5.3.3Post code15351
    B.5.3.4CountryGreece
    B.5.4Telephone number+3021066043001354
    B.5.5Fax number+302106604583
    B.5.6E-mailMKalovidouri@pharmathen.com
    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
    D.3.4Pharmaceutical form Eye drops, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBRINZOLAMIDE
    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.3.11 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 AuthorisationUnited Kingdom
    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 nameAZOPT
    D.3.4Pharmaceutical form 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.3.9.3Other 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.3.11 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
    intraocular pressure increased
    E.1.1.1Medical condition in easily understood language
    elevated intraocular pressure
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10022806
    E.1.2Term Intraocular pressure increased
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the non-inferiority of eye drops containing brinzolamide 10 mg/ml (Brinzolamide Ophthalmic Suspension) as compared to a reference product (AZOPT® 10 mg/ml eye drops suspension) for the treatment of elevated intraocular pressure or open angle glaucoma.
    E.2.2Secondary objectives of the trial
    To compare the overall efficacy and safety of the two brinzolamide products (test and reference) in subjects with open angle glaucoma or ocular hypertension in at least one eye.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Elevated IOP and open angles (irideocorneal angle >30 grad) in at least one eye: mean diurnal IOP measured at -12, -8, –4, -0 hours pre-treatment (Day 1) must be > 22 mmHg, and ≤ 35 mmHg (untreated, i.e. after washout) in the target eye. If both eyes have the same IOP, the investigator will select the target eye, using a right, left assignment. Otherwise, the eye with higher IOP will be used for analysis.
    [2] 18 years and older
    [3] Patients with open angle glaucoma or ocular hypertension in at least one eye
    [4] Patients who are both pre-treated or not pre-treated (patients in whom beta blockers are contraindicated or patients to whom it is used as adjunctive therapy to beta-blockers or prostaglandin analogues) with locally administered drugs for open angle glaucoma or ocular hypertension
    [5] Patients with IOP between 22 and 35 mm Hg in both eyes at 8:00 a.m., 12:00 noon, and 4:00 p.m.
    [6] Patients unresponsive to beta blockers or patients in whom beta blockers are contraindicated
    [7] Patients with best corrected visual acuity of ≥20/100 (Snellen) or 2/10 (Monoyer)
    [8] Patients with controlled arterial blood pressure according to the investigator’s opinion
    [9] No systemic medication that may alter IOP in the previous 30 days (e.g. beta-blockers, Ca-channel-blockers, ACE-inhibitors, prostaglandins, etc.), or expected to continue the current treatment with these medicinal products on a stable regimen for 30 days prior to the study and during the study.
    [10] Female subjects of childbearing age who are using a medically accepted form of birth control and have a negative urine pregnancy test at screening
    [11] Subjects with ability to follow study instructions and likely to attend and complete all required visits
    [12] Signed and dated informed consent
    E.4Principal exclusion criteria
    [1] Monophthalmia or legal blindness in either eye.
    [2] Pseudoexfoliative glaucoma or pigmentary glaucoma
    [3] Congenital or secondary glaucoma
    [4] History of angle closure
    [5] Ocular inflammation or infection (apart of completely cured blepharoconjunctivitis) within the last 3 months before randomization and/or noninfectious conjunctivitis, keratitis, scleritis or uveitis in either eye at the screening visit
    [6] Severe ocular trauma or surgery within the last 3 months before randomization
    [7] Laser therapy for glaucoma or ocular hypertension within the last 3 months before randomization
    [8] Xerophthalmia
    [9] Damage or failure of the corneal endothelium
    [10] Use of contact lenses for more than 2 hours per day
    [11] Hypersensitivity to the active substance or any of the excipients of both study drugs
    [12] Known hypersensitivity to sulphonamides
    [13] Administration of any concomitant alternative topical or systemic treatment for glaucoma or ocular hypertension
    [14] Administration of concomitant ocular corticosteroids or antibiotics
    [15] Administration of concomitant oral carbonic anhydrase inhibitors (e.g. acetazolamide, methazolamide, topiramate, sultiame, zonisamide)
    [16] Any of the following washout periods (time period between end of treatment with respective medication and randomization in the present trial) for previous treatments of glaucoma or ocular hypertension not fulfilled: 28 days for beta blockers or prostaglandins or carbonic anhydrase inhibitors,14 days for alpha or alpha/beta agonists, 5 days for miotics
    [17] Patients on dialysis or with severe renal failure: glomerular filtration rate of less than 30 ml/min or serum creatinine above 240 μmol/l
    [18] Hyperchloraemic acidosis
    [19] Hepatic impairment (ALT, AST or total bilirubin more than 3 times above the upper limit of the reference range)
    [20] Pregnancy or lactation
    [21] Simultaneous participation in another clinical study or participation in any clinical study involving an investigational drug within 3 months prior to start of the present study
    [22] Severe physical or mental concomitant diseases that might hamper the realization of the trial according to protocol
    [23] Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
    [24] Unreliability or lack of cooperation
    [25] History of severe, unstable or uncontrolled cardiovascular (e.g., sinus bradycardia, overt cardiac failure, greater than first degree atrioventricular block, cardiogenic shock, clinically relevant angina or uncontrolled hypertension) or severe renal impairment
    [26] Bronchial asthma or severe chronic obstructive pulmonary disease
    [27] Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye
    [28] Any corneal or retinal abnormality preventing reliable measurements by tonometry
    E.5 End points
    E.5.1Primary end point(s)
    • Comparison of reductions in intraocular pressure at 8:00 a.m. in subjects treated with the test or reference product, characterized as an intra-individual difference in the target eye from baseline to the end of the treatment period (12 weeks).

    Target eye is defined as the eye with the higher IOP. If both eyes have the same IOP, the investigator will select the target eye, using a right/left assignment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of the treatment period (12 weeks)
    E.5.2Secondary end point(s)
    • Comparison of reductions in intraocular pressure at 12:00 noon and 4:00 p.m. in subjects treated with the test or reference product, characterized as an intra-individual difference in the target eye from baseline to the end of the treatment period (12 weeks).
    • Comparison of reductions in intraocular pressure at 8:00 a.m., 12:00 noon and 4:00 p.m. in subjects treated with the test or reference product, characterized as an intra-individual difference in the target eye after 2 (Visit 3) and 6 (Visit 4) weeks of treatment.
    • Comparison of the reduction in intraocular pressure at 8:00 a.m., 12:00 noon and 4:00 p.m. between the target and the contralateral eye after 2 (Visit 3), 6 (Visit 4), and 12 weeks of treatment (end of the treatment period).
    • Ratings of overall efficacy of the test or reference product as per investigator’s opinion, according to the following scale:
    1. major improvement

    2. minor improvement

    3. no change

    4. minor deterioration

    5. major deterioration
    • Adverse Events (nature, incidence, severity, seriousness and relation to study medication).
    • Clinically significant findings in the ophthalmological examination.
    • Clinically significant abnormalities in vital signs, hematology and biochemistry analysis values.
    • Clinically significant findings in physical examination and general state.
    • Blood levels of brinzolamide at the end of treatment period (12 weeks).
    To evaluate the local tolerability based on ratings of burning, itching, stinging, foreign body sensation, eye pain, dry eye, and blurred vision upon instillation of the study medication
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of the treatment period (12 weeks)
    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 Yes
    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 trial2
    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.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    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 months6
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days15
    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: 168
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 168
    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 state115
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 168
    F.4.2.2In the whole clinical trial 168
    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)
    Usual treatment of the 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 Decision2013-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-04-16
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