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    Summary
    EudraCT Number:2009-010834-23
    Sponsor's Protocol Code Number:C-09-006
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-04-27
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-010834-23
    A.3Full title of the trial
    A multi-center, double-masked study of the safety and efficacy of DuoTrav APS compared to DuoTrav in patients with open-angle glaucoma or ocular hypertension
    A.3.2Name or abbreviated title of the trial where available
    Safety and Efficacy of DuoTrav APS versus DuoTrav
    A.4.1Sponsor's protocol code numberC-09-006
    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 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 nameDuoTrav APS
    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 IMPOcular use
    Topical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRAVOPROST
    D.3.9.1CAS number 157283-68-6
    D.3.9.2Current sponsor codeAL-6221
    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 26921175
    D.3.9.2Current sponsor codeAL-1239
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.8 to (5 mg/ml timolol)
    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.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 DuoTrav
    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.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOcular use
    Topical use (Noncurrent)
    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
    Open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level HLGT
    E.1.2Classification code 10018307
    E.1.2Term Glaucoma and ocular hypertension
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the
    efficacy and safety of DuoTrav APS to DuoTrav, both
    dosed once-daily in the morning, in patients with open angle
    glaucoma or ocular hypertension.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients of either sex and any race ,of 18 years of age or older.
    - Patients diagnosed with open-angle glaucoma (with or without pseudoexfoliation or
    pigment dispersion component) or confirmed ocular hypertension who would benefit
    from a fixed combination medication, in the opinion of the Investigator.
    - Patients currently on a stable treatment (i.e., at least 30 days) with an IOP-lowering medication.
    - Patients must meet the following IOP entry criteria in at least one eye at Eligibility
    Visits 1 & 2:
    • Mean IOP ≥ 24 mmHg at the 09:00 time point, and
    • Mean IOP ≥ 21 mmHg at the 11:00 and 16:00 time points.
    • The mean IOP in either eye at Screening or Eligibility must not be greater than 36 mmHg at any time point.
    The mean IOP is the average of IOP measurements in the same eye, as described in Section 9.4.7.
    The same eye(s) must qualify at all qualifying time points.
    - Only patients who satisfy all Informed Consent requirements may be included in the
    study.
    E.4Principal exclusion criteria
    - Pregnancy or females of childbearing potential not taking adeqaute birth control measures
    - Any form of glaucoma other than open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or confirmed ocular hypertension
    - Iridocorneal angle Shaffer grade < 2 (extreme narrow angle with complete or partial closure) in either eye, as measured by gonioscoy
    - Cup/Disc ratio greater than 0.80 (horizontal or vertical) in either eye
    - Severe central visual field loss in either eye
    - History of, or current chronic, recurrent, or severe inflammatory eye disease (e.g.,
    scleritis, uveitis, herpes keratitis), or current other severe ocular pathology (including
    severe dry eye) that would affect the conduct of the study.
    - History of ocular trauma within the past 6 months.
    - Intraocular surgery within the past 6 months.
    - Ocular laser surgery within the past 3 months.
    - Best-corrected visual acuity score worse than 55 ETDRS letters (equivalent to
    approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal)
    - Current ocular infection or inflammation, or history of ocular infection or inflammation within the past 3 months as determined by patient history and/or eye examination.
    - History of, or current clinically relevant (in the opinion of the Investigator) or
    progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
    - Any abnormality preventing reliable applanation tonometry.
    - History of, or current evidence of severe illness or any other conditions which would
    make the patient, in the opinion of the Investigator, unsuitable for the study.
    - History of or current bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-adrenergic blocking agent.
    - History of or current severe, unstable or uncontrolled cardiovascular, hepatic, or renal disease (e.g., sinus bradycardia, overt cardiac failure, greater than first degree
    atrioventricular block, cardiogenic shock, clinically relevant angina or uncontrolled
    hypertension) that would preclude the safe administration of a topical beta-adrenergic blocking agent.
    - History of spontaneous or current hypoglycemia or uncontrolled diabetes.
    - History of or current severe allergic rhinitis and bronchial hyper reactivity.
    - History of or current corneal dystrophies.
    - History of severe or serious hypersensitivity to prostaglandin drugs or their analogues, beta-adrenergic blocking agents, or to any components of the study medications.
    - Patients who are unable, in the opinion of the Investigator, to safely discontinue use of all IOP-lowering medication(s) during the washout period.
    - 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, beta-adrenergic blocking agents.
    Note: Patients must be on a stable dosing regimen of these medications for at least 30 days prior to the Screening Visit and must not change the dosing regimen during the eligibility period with the exception of a substitution of the patient’s current ocular hypotensive medication for one requiring a shorter washout period.
    Note: Patients using non-prescription and/or prescription topical ophthalmic
    medications that do not affect IOP may be included in the study.
    - Use of any additional topical or systemic ocular hypotensive medication during the
    study.
    - Patients who cannot safely discontinue all glucocorticoid medications administered by any route. Patients must have washed out of chronic glucocorticoid medications for at least 4 weeks, or of intermittent glucocorticoid medications for at least 2 weeks before the Eligibility 1 Visit, and must be able to remain off these medications for the duration of the study.
    - Patients who are currently on therapy or were on therapy with another investigational agent within 30 days prior to the Screening Visit.
    - Patients not willing to complete all required study visits.
    - Patients who are unwilling to remove their contact lenses prior to instillation of the
    study medication and to leave them out for a minimum of 15 minutes following
    instillation before reinserting the lenses.
    - The Medical Monitor may declare any patient ineligible for a valid medical reason.
    E.5 End points
    E.5.1Primary end point(s)
    Mean IOP at 9.00, 11.00 and 16.00 time points 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 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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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.1.3Elderly (>=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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 330
    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 Decision2009-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-05-01
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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