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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-005936-99
    Sponsor's Protocol Code Number:C-07-16
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-03-28
    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 ConcernedGreece - EOF
    A.2EudraCT number2007-005936-99
    A.3Full title of the trial
    Effects of Topical Hypotensive Drugs on Circadian Ocular Perfusion Pressure and Ocular Blood Flow in Patients with Open-Angle Glaucoma
    A.3.2Name or abbreviated title of the trial where available
    Circadian Ocular Perfusion Pressure
    A.4.1Sponsor's protocol code numberC-07-16
    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 nameBrinzolamide/Timolol
    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 IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBRINZOLAMIDE
    D.3.9.1CAS number 138890627
    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 MALEATE
    D.3.9.1CAS number 26921175
    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
    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 COMBIGAN
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    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.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 79570197
    D.3.9.3Other descriptive nameBRIMONIDINE TARTRATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10030856
    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 statistical objective of this study is to demonstrate superior effect on diastolic ocular perfusion pressure of AZARGA (Brinzolamide 10 mg/ml/Timolol 5 mg/ml) Eye Drops Suspension relative to that of COMBIGAN (Brimonidine 20 mg/ml/Timolol 5 mg/ml) Eye Drops Solution
    E.2.2Secondary objectives of the trial
    The objectives of this study are to compare the short-term effects of AZARGA (Brinzolamide 10 mg/ml/Timolol 5 mg/ml) Eye Drops Suspension, and COMBIGAN (Brimonidine 20 mg/ml/Timolol 5 mg/ml) Eye Drops Solution on circadian ocular perfusion pressure, ocular blood flow, IOP and blood pressure in open-angle glaucoma patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients 18 years of age or older diagnosed with open-angle glaucoma (with or without pseudoexfoliative component) in at least one eye and requiring more than one IOP-lowering medication.
    2. Patients must meet the following IOP entry criteria in at least one eye:
    • For the qualifying eye(s), the mean IOP must be ≥ 23 mmHg at least at one time
    point and ≤ 32 mmHg at all time points at the Eligibility/Period 1 Baseline (24-hour
    assessment) Visit
    • The mean IOP in either eye at any time point during Screening, Safety and
    Eligibility/Period 1 Baseline Visits must not be greater than 32 mmHg
    3. Only patients who satisfy all informed consent requirements may be included in the study. Only patients who are able to read, sign and date the Informed Consent Form can be enrolled. The Informed Consent form signed by the patients MUST have been approved by the independent Ethics Committee (IEC) for this study.
    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. An original of the signed and dated Informed Consent document must be provided to the patient and one original signed document placed in the patient’s chart.
    4. Patients must be able to discontinue use of all IOP-lowering medication(s) for a
    minimum period of 3 days to 28 days prior to the Eligibility/Period 1 Baseline (24-hour
    assessment) Visit and for 4 weeks between the treatment periods during the study. The investigator shall assess the minimum initial washout period based on the class of the patient’s current IOP-lowering medication.
    5. Patients using topical ophthalmic and/or systemic non- IOP-lowering medications
    (except for those listed in the Exclusion Criteria n°15) may be included in the study.
    6. Patients must be willing to complete all required study visits.
    E.4Principal exclusion criteria
    1. Female of childbearing potential (those who are not surgically sterilized at least 3
    months prior to study start or who are at least two years post-menopausal) are excluded
    from participation in the study if they meet any one of the following.
    • They are currently pregnant, or
    • They have a positive results on the urine pregnancy test at the Screening 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:
    − Hormonal – oral, implanted, topical, or injected contraceptives;
    − Mechanical – spermicide in conjunction with a barrier such as a condom or
    diaphragm or IUD
    Note: All females of childbearing potential must consent to a urine pregnancy test upon entering and exiting the study.
    Note: Instruct females of childbearing potential to immediately inform the investigator if they become pregnant during the study. Should this occur, the investigator shall immediately contact the sponsor.
    Note: For non-sexually active females, abstinence may be regarded as an adequate
    method of birth control; however if the patient becomes sexually active during the study, she must agree to use adequate birth control methods as defined above for the remainder of the study.
    2. Patients with any form of glaucoma other than open-angle glaucoma (with or without pseudoexfoliative component).
    3. Patients with severe central visual loss in either eye defined as sensitivity ≤ 10dB in at least 2 of the 4 visual field test points closest to the point of fixation.
    4. Patients with angle grade less than Grade III, as measured by gonioscopy. See
    5. Patients with a cup/disc ratio greater than 0.8 in either eye.
    6. Patients who wear contact lenses.
    7. Patients who had previous intraocular surgery in the study eye(s) within 3 months
    prior to the Screening Visit.
    8. Patients who had previous glaucoma surgery in the study eye(s).
    9. Patients with best corrected visual acuity worse than 0.6 logMAR score in either eye.
    10. Patients who are currently on therapy or were on therapy with another investigational product within 30 days prior to the Screening Visit
    11. Patients with diabetic retinopathy of any stage.
    12. Patients who cannot safely discontinue the use of all glucocorticoid medication
    administered by any route. Patients must have washed out of chronic glucocorticoids
    for at least 4 weeks prior to the Screening Visit (period can be reduced to 2 weeks in
    case of intermittent glucocorticoid therapy) and must be able to remain off these
    medications for the duration of the study.
    13. History of allergy or severe hypersensitivity to timolol maleate, carbonic anhydrase inhibitors, sulfonamide derivative, or to any components of the study medications in the opinion of the investigator. For listing of additional components present in the study medications, see the Clinical Investigator’s Brochure for AZARGA and the SPC for COMBIGAN
    14. Cardiovascular diseases or uncontrolled hepatic or renal diseases that would require the use of medication as listed under exclusion criteria n°15 or would preclude the safe administration of a topical beta-blocker.
    15. Concomitant systemic treatments with medications that could effect IOP, blood pressure or blood flow (e.g., beta-blockers, angiotensin converting enzyme inhibitors, calcium antagonists, alpha blockers, platelet inhibitors, anti-coagulant)
    16. Recent (within 4 weeks of the Screening Visit) use of high–dose (> 1 gram daily)
    salicylate therapy. Rare instances of drug interactions have occurred with high-dose
    salicylate therapy and patients treated with oral carbonic anhydrase inhibitors.
    17. Bronchial asthma or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
    18. Any abnormality preventing reliable tonometry of either eye.
    19 Any severe illness or condition which would make the patient, in the opinion of the
    investigator, unsuitable for the study.
    20. The Alcon Medical monitor may declare any patient ineligible for a valid medical
    reason.
    E.5 End points
    E.5.1Primary end point(s)
    Diastolic Ocular Perfusion Pressure
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.6Cross over Yes
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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 state36
    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 Decision2008-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-31
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