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    Summary
    EudraCT Number:2010-024512-34
    Sponsor's Protocol Code Number:C-10-040
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-15
    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 ConcernedItaly - Italian Medicines Agency
    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.
    Sicurezza ed efficacia della combinazione fissa Brinzolamide 10 mg/mL / Brimonidina 2 mg/mL collirio, sospensione in confronto a Brinzolamide 10 mg/mL collirio, sospensione e Brimonidina 2 mg/mL collirio, soluzione nella riduzione della pressione intraoculare in pazienti con Glaucoma ad angolo aperto o ipertensione oculare.
    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).
    Brinzolamide e Brimonidina utilizzati separatamente o in combinazione fissa in un unico collirio in pazienti con elevata pressione intraoculare (ipertensione oculare) o con danni al nervo ottico (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 supportAlcon Research, Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlcon Italia S.p.A
    B.5.2Functional name of contact pointUfficio Regolatorio
    B.5.3 Address:
    B.5.3.1Street AddressViale Giulio Richard, 1/b
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20143
    B.5.3.4CountryItaly
    B.5.4Telephone number02818031
    B.5.5Fax number028139499
    B.5.6E-mailmarcello.fornoni@alconlabs.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 10 mg/mL / Brimonidine 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 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.3.10 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 INNBrimonidina tartrato
    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 AuthorisationBelgium
    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 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.3.9.2Current sponsor code89984
    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 Yes
    D.2.1.1.1Trade name Brimonidine generic
    D.2.1.1.2Name of the Marketing Authorisation holderN.A.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Eye drops, solution
    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 INNBRIMONIDINE TARTRATE
    D.3.9.1CAS number 79570-19-7
    D.3.9.2Current sponsor code101461
    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
    Glaucoma ad angolo aperto e ipertensione oculare
    E.1.1.1Medical condition in easily understood language
    Elevated pressure in the eye with (glaucoma) or without optic nerve damages (ocular hypertension)
    Pressione elevata nell'occhio con (glaucoma) o senza danni al nervo ottico (ipertensione oculare
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that: Brinzolamide 10 mg / ml / brimonidine 2 mg / ml eyes drops suspension is superior to brinzolamide ophthalmic suspension, 10 mg / ml with respect to IOP-lowering efficacy; Brinzolamide 10mg / ml / brimonidine 2 mg / ml eyes drops suspension is superior to brimonidine ophthalmic solution, 2 mg / ml with respect to IOP-lowering efficacy
    Dimostrare che: Il collirio brinzolamide 10 mg/ml / brimonidina 2 mg/ml sospensione è superiore rispetto a brinzolamide 10 mg/ml collirio sospensione nel ridurre la pressione intraoculare; il collirio brinzolamide 10 mg/ml / brimonidina 2 mg/ml sospensione è superiore a brimonidina 2 mg/ml collirio soluzione nel ridurre la pressione intraoculare.
    E.2.2Secondary objectives of the trial
    There are no secondary objectives.
    Non ci sono obiettivi secondari.
    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.
    1) Pazienti di 18 anni o di età superiore, di entrambi i sessi e di qualsiasi razza/etnia, per i quali è stato diagnosticato un glaucoma ad angolo aperto o ipertensione oculare, che secondo l’opinione dello sperimentatore sono controllati in modo insufficiente in monoterapia o in trattamento con terapie multiple per la riduzione della pressione intraoculare. 2) I pazienti devono essere in grado di comprendere e firmare un consenso informato che sia stato approvato da un Comitato Etico indipendente. 3) La media delle misurazioni della pressione intraoculare in almeno un occhio, lo stesso occhio (gli stessi occhi) deve essere: ≥ 24 mmHg e ≤ 36 mmHg alle ore 9:00 del mattino alle visite di Idoneità 1 e Idoneità 2 e ≥ 21 mmHg e ≤ 36 mmHg alle ore 11:00 del mattino alle visite di Idoneità 1 e Idoneità 2. La pressione intraoculare media non deve essere superiore a 36 mmHg a qualsiasi ora.
    E.4Principal exclusion criteria
    1. Females of childbearing potential 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. 2. 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. 6. 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.
    1. Le donne in età fertile sono escluse dalla partecipazione allo studio se sono attualmente in gravidanza, se ottengono un risultato positivo dal test di gravidanza sulle urine in fase di screening o intendono programmare una gravidanza durante il periodo dello studio; se sono in fase di allattamento; se non accettano di servirsi di adeguati metodi contraccettivi per evitare il verificarsi della gravidanza durante il periodo dello studio. 2. Pazienti con angolo di Shaffer di grado &lt; 2 in entrambi gli occhi, come misurato dall’esame gonioscopico (angolo chiuso con chiusura completa o parziale). 3. Pazienti con un rapporto coppa/disco superiore a 0.80 (misurazione orizzontale o verticale). 4. Pazienti con grave perdita del campo visivo centrale in entrambi gli occhi. Una grave perdita del campo visivo centrale viene definita come sensibilità inferiore o uguale a 10dB in almeno due dei punti di test del campo visivo vicini al punto di fissazione. 5. I pazienti che non possono interrompere in modo sicuro l’assunzione di tutti i farmaci oculari per la riduzione della pressione intraoculare per un periodo minimo di 5 giorni ± 1 giorno fino a un massimo di 28 giorni ± 1 giorno prima della Visita di Eleggibilità 1. 6. Patologia oculare infiammatoria cronica, ricorrente o grave (ad es., sclerite, uveite, cheratite erpetica). 7. Trauma oculare negli ultimi 6 mesi. 8. Infezione oculare o infiammazione oculare nel corso degli ultimi 3 mesi. 9. Malattia retinica clinicamente significativa o progressiva come ad esempio degenerazione retinica, retinopatia diabetica o distacco della retina. 10. Punteggio di acuità visiva inferiore a 55 lettere ETDRS (equivalente a circa 20/80 Snellen, 0,60 logMAR o 0,25 decimali). 11. Altra patologia oculare (compreso sindrome dell’occhio secco grave) che potrebbe, secondo l’opinione dello sperimentatore, precludere la somministrazione di farmaci alfa-agonisti adrenergici e/o inibitori dell’anidrasi carbonica. 12. Chirurgia intraoculare entro gli ultimi 6 mesi. 13. Chirurgia oculare laser entro gli ultimi 3 mesi. 14. Qualsiasi anormalità che impedisca una tonometria ad applanazione affidabile. 15. Qualsiasi altro disturbo comprese gravi malattie che renderebbero il paziente, secondo l’opinione dello sperimentatore, non adatto per le partecipazione allo studio. 16. Anamnesi di malattie cardiovascolari (ad es., insufficienza coronarica, ipertensione, fenomeno di Raynaud, ipotensione ortostatica, tromboangite obliterante), cerebrovascolari (ad es., insufficienza cerebrale), epatiche o renali attive, gravi, non stabili o non controllate che precluderebbero una sicura somministrazione dell’alfa-agonista adrenergico topico o di inibitori dell’anidrasi carbonica (CAI, Carbonic anhydrase inhibitors) secondo l’opinione dello sperimentatore. 17. Pazienti con recente uso (entro 4 settimane della Visita di idoneità 1) di terapia salicilica ad alto dosaggio (&gt;1 g al giorno). 18. Terapia attuale o prevista con qualsiasi farmaco psicotropico che aumenta la risposta adrenergica (ad es., desipramina, amitriptilina). 19. Uso concomitante di un inibitore della monammina ossidasi. 20. Terapia con un altro farmaco sperimentale entro 30 giorni prima della visita di screening. 21. Ipersensibilità ai farmaci alfa-agonisti adrenergici, CAI topici o orali, derivati della sulfonamide o qualsiasi componente dei farmaci oggetto di studio secondo l’opinione dello sperimentatore. 22. Regime di dosaggio stabile inferiore a 30 giorni prima della visita di screening per qualsiasi farmaco o sostanza e per qualsiasi somministrazione usati su base cronica che potrebbero influire sulla pressione intraoculare, compresi, a titolo esemplificativo ma non esaustivo, gli agenti bloccanti beta-adrenergici. 23. Uso di qualsiasi farmaco ipotensivo oculare aggiuntivo topico o sistemico durante lo studio. 24. Uso concomitante di glucocorticoidi somministrati per qualsiasi via.
    E.5 End points
    E.5.1Primary end point(s)
    • 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.
    • Variazione diurna media PIO al mese 3 rispetto al basale. Efficacia di sostegno; • variazione diurna media della PIO rispetto al basale (variazione della PIO del paziente rispetto al basale mediata sui tempi di rilevamento 9:00 + 2, + 7 ore) per visite settimana 2, settimana 6 e mese 6 • PIO media (settimana 2, settimana 6, mese 3 e mese 6) per ciascun punto di rilevamento (9:00 + 2, + 7 ore); • variazione media della PIO rispetto al basale delle visite settimana 2, settimana 6, mese 3 e mese 6 per ciascun punto di rilevamento (9:00 + 2, + 7 ore); • variazione percentuale media della PIO rispetto al basale settimana 2, settimana 6, mese 3 e mese 6 per ciascun punto di rilevamento (9:00 + 2, + 7 ore); • percentuale di pazienti con PIO < 18 mmHg a ogni visita durante il trattamento (Settimana 2, Settimana 6, Mese 3, Mese 6) e ad ogni punto di rilevamento (9:00, +2 e +7 ore) Sicurezza: pachimetria, esame del fondo, BCVA, esame con lampada a fessura, perimetria automatica standard, frequenza cardiaca / pressione sanguigna, eventi avversi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patient IOP change from baseline averaged over the 9 AM, +2 hrs, and +7 hrs time points
    Variazione della PIO del paziente rispetto al basale mediata sui tempi di rilevamento alle ore 9:00, +2 ore e +7 ore.
    E.5.2Secondary end point(s)
    N.A.
    N.A.
    E.5.2.1Timepoint(s) of evaluation of this end point
    N.A.
    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 Yes
    E.8.2.3.1Comparator description
    Brinzolamide 10 mg /ml collirio sospensione
    Brinzolamide eyes drops suspension, 10 mg /ml
    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.8.4.1Number of sites anticipated in Member State concerned3
    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
    Mexico
    New Zealand
    Singapore
    Taiwan
    Thailand
    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
    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 months19
    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 months20
    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.1.1Number of subjects for this age range: 0
    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 state60
    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.
    Il trattamento o l’assistenza per i soggetti al termine della loro partecipazione allo studio non saranno diversi dal normale trattamento ricevuto per la patologia.
    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 Decision2011-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-09
    P. End of Trial
    P.End of Trial StatusCompleted
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