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    Summary
    EudraCT Number:2010-022948-21
    Sponsor's Protocol Code Number:RDG-10-246
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-12-28
    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 ConcernedAustria - BASG
    A.2EudraCT number2010-022948-21
    A.3Full title of the trial
    Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (Azarga®) in Ocular Hypertensive or Glaucoma Patients Uncontrolled on Prostaglandin Monotherapy
    A.4.1Sponsor's protocol code numberRDG-10-246
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name Azarga
    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 nameAzarga
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    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 µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.3.10 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    ocular hypertension or glaucoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10030043
    E.1.2Term Ocular hypertension
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10030856
    E.1.2Term Open-angle glaucoma
    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 objective of this study is to evaluate the safety and efficacy of adding AZARGA® as a single agent to prostaglandin monotherapy in patients with either ocular hypertension or primary open-angle glaucoma.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must be at least 18 years of age.
    2. Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
    3. Must have IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
    4. Must have been treated with, and in the Investigator’s judgment have demonstrated an adequate response to, prostaglandin monotherapy for a minimum of 4 weeks at Visit 1. Also, the last dose of their prostaglandin must have been instilled correctly so the patient is within the dosing cycle at Visit 1.
    5. At Visit 1, must have an intraocular pressure of ≥ 20 mm Hg in at least one eye and ≤ 35 mm Hg in both eyes treated with prostaglandin monotherapy.
    6. Must have best corrected visual acuity of 6/60 (6/60 Snellen, 1.0 LogMAR) or better in each eye.
    7. In any eye not qualifying as a study eye, the intraocular pressure should be able to be controlled on no pharmacologic therapy or on prostaglandin monotherapy alone.
    8. Patients who wear contact lenses must be able to remove them for study medication administration and wait at least 15 minutes after administration before reinserting them.
    9. An Ethics Committee reviewed and approved (for use in this study) informed consent form must be read, signed, and dated by the participating patient, as well as signed and dated by the individual (Principal Investigator or other site personnel) obtaining the informed consent, before conducting the Screening Visit and prior to initiation of study procedures.
    10. Must be able to follow instructions and be willing and able to attend required study visits.
    E.4Principal exclusion criteria
    1. Known medical history of allergy, hypersensitivity or poor tolerance to any components of the preparations to be used in this study that is deemed clinically significant in the opinion of the Investigator.
    2. Presence of other primary or secondary glaucoma not listed in inclusion criterion #2.
    3. Presence of extreme narrow angle with complete or partial closure in either eye, as measured by gonioscopy (occludable angles treated with a patent iridectomy are acceptable).
    4. A history of, or at risk for uveitis or cystoid macular edema (CME).
    5. History of ocular herpes simplex.
    6. Any abnormality preventing reliable applanation tonometry in study eye(s).
    7. Corneal dystrophies in either eye.
    8. Any opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of either eye.
    9. Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival hyperemia is allowed.
    10. Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to the Screening/Baseline Visit.
    11. Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator’s best judgment.
    12. Progressive retinal or optic nerve disease from any cause apart from glaucoma.
    13. Use of systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Screening/Baseline Visit or an anticipated change in the dosage during the course of the study.
    14. Use of corticosteroids (oral, topical ocular or nasal) within 30 days of the Screening/Baseline Visit and during the course of the study.
    15. Use of any systemic carbonic anhydrase inhibitors (e.g., methazolamide [Neptazane], acetazolamide [Diamox])
    16. Severely impaired renal function
    17. Hyperchloremic acidosis
    18. History of myasthenia gravis.
    19. History of an allergy to sulphonamides
    20. Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, Severe allergic rhinitis or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
    21. Sinus bradycardia (< 50 beats per minute), second- or third-degree atrioventricular block, sino-atrial block, overt cardiac failure, or cardiogenic shock that would preclude the safe administration of a topical beta-blocker.
    22. Women of childbearing potential not using a reliable method of birth control
    23. Women who are pregnant or lactating
    24. Any clinically significant, serious, or severe medical condition.
    25. A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient.
    26. Participation in any other investigational study within 30 days prior to Visit 1.
    E.5 End points
    E.5.1Primary end point(s)
    Mean IOP change from baseline at Month 3
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    historical control
    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 EEA6
    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 Information not present in EudraCT
    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
    Not Applicable
    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 months12
    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 Information not present in EudraCT
    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.1.3Elderly (>=65 years) Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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 Decision2011-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-08
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