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    Summary
    EudraCT Number:2009-013178-42
    Sponsor's Protocol Code Number:C-09-032
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-08-05
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-013178-42
    A.3Full title of the trial
    A Twelve-Month Open-Label Safety Study of Polyquaternium-Preserved DuoTrav APS
    Dosed Once Daily in Patients with Open-Angle Glaucoma or Ocular Hypertension
    A.3.2Name or abbreviated title of the trial where available
    Safety Study of DuoTrav APS
    A.4.1Sponsor's protocol code numberC-09-032
    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.3.9.3Other descriptive nameTRAVOPROST
    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.3.9.2Current 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.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 or Ocular Hypertension
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10030043
    E.1.2Term Ocular hypertension
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10030348
    E.1.2Term Open angle glaucoma
    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 describe the
    safety of polyquaternium-preserved DuoTrav APS
    dosed once daily for 12 months, 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
    1. Patients of either sex and any race, 18 years of age or older.
    2. 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.
    NOTE: Patients are eligible if they are insufficiently responsive to an intraocular
    pressure lowering monotherapy, as documented in the patients' medical records.
    NOTE: Patients may currently be treated with unfixed or fixed combination IOPlowering
    medications. Patients may be eligible if they are insufficiently responsive or
    intolerant to a combination therapy (fixed or unfixed), excluding combination therapies
    containing a prostaglandin analogue and a beta-blocker. Patients may be eligible if
    they are well controlled on a combination therapy (fixed or unfixed) containing a
    prostaglandin analogue and a beta-blocker.
    3. Patients currently on a stable treatment (i.e., at least 30 days) with an IOP-lowering
    medication.
    4. Only patients who satisfy all Informed Consent requirements may be included in the
    study. Section 18.4. lists the required elements of the Informed Consent, the origins of
    which are derived from the Declaration of Helsinki, amended in 2002 (see Section
    18.3.). The Informed Consent documents must be executed as follows: the patient must
    read, sign, and date the Informed Consent document before any study-related
    procedures are performed. The person who conducted the informed consent discussion
    must also sign and date the Informed Consent document.
    Only patients who are able to read, sign, and date the informed consent can be enrolled.
    The Informed Consent form signed by patients must have been approved by the
    IRB/IEC for the current study.
    E.4Principal exclusion criteria
    Exclusion Criteria
    Patients demonstrating any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of test article, safe participation in this study, or affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude patients from enrollment in this study:
    Pregnancy:
    1. Females of childbearing potential (those who are not surgically sterilized or at least two years post-menopausal) are excluded from participation in the study if they meet any one of the following conditions:
    • They are currently pregnant or,
    • They have a positive result on the urine pregnancy test at the Screen/Enrollment
    Visit or, they intend to become pregnant during the study period or,
    • They are breast-feeding or, they are not using highly effective birth control
    measures:
    o Hormonal – oral, implanted, topical, or injected contraceptives;
    o Mechanical – spermicide in conjunction with a barrier such as a condom or
    diaphragm or; IUD

    Exclusion Criteria related to the disease condition being investigated (open-angle
    glaucoma or ocular hypertension):

    2. Patients with any form of glaucoma other than open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or confirmed ocular
    hypertension.
    3. Patients with iridocorneal angle Shaffer grade < 2 (extreme narrow angle with
    complete or partial closure) in either eye, as measured by gonioscopy (see
    Section 18.1.3.).
    4. Patients with a cup/disc ratio greater than 0.80 (horizontal or vertical measurement) in either eye.
    5. Patients with severe central visual field loss in either eye (see Section 9.4.6. for
    details).

    Exclusion Criteria related to ocular/systemic patient history or current ocular condition in either eye:

    6. History of (i.e., within the last 3 months), or current chronic, recurrent, or severe ocular nfection, inflammation or 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 in the opinion of the Investigator.
    7. History of ocular trauma within the past 6 months.
    8. Intraocular laser surgery within the past 6 months.
    9. Ocular laser surgery within the past 3 months.
    10. Best-corrected visual acuity score worse than 55 ETDRS letters (equivalent to
    approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal). See Section 9.4.9. for
    details on the procedure.
    11. 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.
    12. Any abnormality preventing reliable applanation tonometry.
    13. 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.
    14. 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.
    15. History of spontaneous or current hypoglycemia or uncontrolled diabetes.
    16. History of or current severe allergic rhinitis and bronchial hyper reactivity.
    17. History of or current corneal dystrophies.

    Exclusion Criteria related to systemic or ocular medications:

    18. History of severe or serious hypersensitivity to prostaglandin drugs or their analogues, beta-adrenergic blocking agents, or to any components of the study medication. For listings of additional formulation components present in the study medication, see the Clinical Investigator’s Brochure for DuoTrav APS.
    19. Use of any additional topical or systemic ocular hypotensive medication during the study.

    Others:

    20. Patients who are currently on therapy or were on therapy with another investigational agent within 30 days prior to the Screening Visit.
    21. Patients not willing to complete all required study visits.
    22. 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.
    23. Additionally, in rare circumstances, a patient may be declared ineligible by the Alcon Medical Monitor for a valid medical reason [e.g., patients with a medical condition (systemic or ophthalmic) not specified above that may preclude the safe administration of test article or safe participation in this study, or that may affect the results of this study].
    E.5 End points
    E.5.1Primary end point(s)
    Long-term safety of polyquaternium-preserved DuoTrav APS dosed once daily for 12 months, in patients with open-angle glaucoma or ocular hypertension
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Information not present in EudraCT
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    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 EEA4
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 150
    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 Decision2009-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-11-01
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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