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    Summary
    EudraCT Number:2010-022791-31
    Sponsor's Protocol Code Number:D01092010AZNTG
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-10-12
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-022791-31
    A.3Full title of the trial
    Contrast sensitivity of patients with normal tension glaucoma by application of Azarga®
    A.4.1Sponsor's protocol code numberD01092010AZNTG
    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 SponsorUniversity Erlangen-Nuremberg
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 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 Eye drops, suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPConjunctival 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 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
    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 Yes
    D.3.11.13.1Other medicinal product typechemical product
    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
    The effect of AZARGA(R) on the central and spacial-temporal contrast sensitivity of patients with normal tension glaucoma will be examined. Healthy controls are required to prove the disease specific effect of the trial drug.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10019279
    E.1.2Term Heart failure
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10003555
    E.1.2Term Asthma bronchial
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10021005
    E.1.2Term Hypoglycemia
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10000456
    E.1.2Term Acid base balance
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10054844
    E.1.2Term Anaphylactic reaction to drug
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to examine if lowering of the intraocular pressure by combined local application of timolol/ brinzolamide improves the spacial-temporal contrast sensitivity of patients with normal tension glaucoma.
    E.2.2Secondary objectives of the trial
    By testing the retinal sensitivity to distinguish light stimuli and the subjective contrast sensitivity with and without photostress, it is possible to determine, whether in glaucoma predominantly the magno-cellular or the parvo-cellular sytem of the retinal ganglion cells is sensitive to the treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    OVERALL
    ● Patients from the clinic and outpatient clinic of Ophthalmology, Erlangen
    ● Age 18 to 75 years
    ● Both sexes (10 ± 1 male or female subjects, respectively, each per group)
    ● Ability to sign an informed consent

    GROUP OF GLAUCOMA
    ● 20 patients with normal tension glaucoma (untreated intraocular pressur <21 mmHg) and no systemic neurological diseases
    ● At least one eye with stage 1 -4 according to Jonas scale
    ● Glaucoma specific surgery is allowed
    ● Visual field defect > 2 dB
    and/or
    ● Spatial-temporal contrast sensitivity ≥ 5 (Score according to Patel)
    and/or
    ● Reduced peripapillary mean retinal nerve fiber layer thickness (Heidelberg Retinatomography, < 0.180 mm)

    CONTROL GROUP
    ● 20 patients without systemic neurological disease and without eye diseases, which comprise the visual pathway (e.g. eye lid tumor, pterygium, stenosis of te lacrimal duct)
    ● intraocular pressur <21 mmHg
    ● normal morphology of the papilla (stage 0 according to Jonas)
    ● Visual field defect ≤ 2dB
    and
    ● Score of the spatial-temporal contrast sensitivity < 5
    and
    ● Peripapillary mean retinal nerve fiber layer thickness ≥ 0.180 mm)
    E.4Principal exclusion criteria
    ● Glaucoma of other origin (e.g. angle closure glaucoma, pseudoexfoliative glaucoma, pigmentary glaucoma)
    ● Other eye diseases involving the retina and visual pathway
    ● Functional monophthalmia
    ● Preexisting damage of the cornea
    ● Use of contact lenses
    ● Ametropia > ±4,0 dpt sph and > ±2,0 dpt cyl
    ● History of heart failure, cardiogenic shock, , Prinzmetal angina, arterial hypotension, sinus bradycardia, av block II° and III°
    ● Asthma bronchiale, severe COPD, bronchial hyperreactivity
    ● Severe hepatic or renal impairment (creatinine clearance <30 ml/min)
    ● Diabetes mellitus, affinity to spontanous hypoglycemia
    ● Severe anaphylactic reaction in history
    ● Hyperchloremic acidosis, hyperthyreosis
    ● Hypersensitivity to beta-adrenergic blocking agents or sulfonamides
    ● Pregnancy, lactation period
    ● Application of oral calcium channel blocker, guanethidine, antarrhythmic agents, digitalis glycosides, parasympathicomimetics, clonidine, CYP2D6 inhibitors [quinidine, cimetidine], antidiabetics, beta-adrenergic blockers or inhibitors of carbonic anhydrase
    ● Participation in another clinical trial within the last 4 weeks
    E.5 End points
    E.5.1Primary end point(s)
    The Freiburger Vision Test "FrACT" will be implemented for examination.
    The therapy will be considered effective, if in the glaucoma group the time of readaption after photo stress and the threshold of contrast sensitivity changes significantly (p ≤ 0,05) after treatment.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    efficacy
    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 No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Control subjects
    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 No
    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
    The end of the trial is defined by the limited application of the trial drug (8 weeks).
    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 months3
    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 months0
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-10-12. Yes
    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 state40
    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)
    The treatment or care after the subject has ended his/her participation in the trial will be according to the normal treatment of glaucoma disease. Those patients, who benefit from the trial drug without serious adverse events, may continue the drug application.
    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 Decision2011-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusOngoing
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