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    The EU Clinical Trials Register currently displays   35474   clinical trials with a EudraCT protocol, of which   5826   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2004-004974-94
    Sponsor's Protocol Code Number:74460
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-28
    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 ConcernedLatvia - SAM
    A.2EudraCT number2004-004974-94
    A.3Full title of the trial
    Efficacy and safety of tafluprost 0.0015% eye drops as adjunctive therapy with timolol 0.5% eye drops. A randomised, placebo-controlled, phase III study in patients with open-angle glaucoma or ocular hypertension.
    A.4.1Sponsor's protocol code number74460
    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 SponsorSanten Oy
    B.1.3.4CountryFinland
    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 Information not present in EudraCT
    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 nameTafluprost 0.0015 mg/ml, multidose
    D.3.2Product code AFP-168
    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)
    Ophthalmic 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    D.IMP: 2
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Oftan Timolol 5 mg/ml multidose
    D.2.1.1.2Name of the Marketing Authorisation holderSanten Oy
    D.2.1.2Country which granted the Marketing AuthorisationLatvia
    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 nameOftan Timolol 5 mg/ml multidose
    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)
    Ophthalmic use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops, solution
    D.8.4Route of administration of the placeboOphthalmic use (Noncurrent)
    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.1.3Condition 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 investigate the efficacy and safety of tafluprost 0.0015% eye drops when used as adjunctive therapy to timolol 0.5% eye drops in open-angle glaucoma or ocular hypertension patients who are only partially controlled with timolol treatment.
    Primary efficacy variable
    A repeated measurements analysis of covariance (RM ANCOVA) model will be used to analyse the changes from baseline in the diurnal IOP at 2, 4 and 6 weeks. The model will include fixed effects for center, baseline, treatment, visit and time, and all interactions among treatment, visit and time. The difference (tafluprost vs. vehicle) at 6 weeks and a 95% confidence interval for the difference will be estimated from the RM ANCOVA model using a contrast (over all three time points). The model will be fitted using the Mixed procedure in SAS.
    E.2.2Secondary objectives of the trial
    Analysis of safety
    Secondary efficacy variables
    The overall IOP comparisons at 2 and 4 weeks and the time-wise (i.e. 8:00, 10:00 and 16:00) IOP comparisons at 2, 4 and 6 weeks will be done using contrasts in the RM ANCOVA model described above.

    The (cumulative) distribution of responders at 6 weeks will be characterized descriptively and graphically. Statistical tests, e.g. a Cochran-Mantel-Haenszel test stratified by center (CMH), may be used to illustrate the comparability of the two treatment groups.

    In addition, absolute IOP values will be summarised descriptively.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    • Aged 18 years or more
    • A diagnosis of open-angle glaucoma (primary open-angle glaucoma, capsular glaucoma or pigmentary glaucoma) or ocular hypertension
    • An IOP of 22-30 mmHg at the screening visit with monotherapy other than prostaglandins
    • An IOP of 22-30 mmHg in at least one eye in at least one measurement of the diurnal IOP curve (at 8:00, 10:00 and 16:00) at the baseline visit (Visit 2) while having used timolol 0.5% eye drops twice daily as the only glaucoma medication for at least 4 weeks.
    • A best corrected ETDRS visual acuity score of +0.6 logMAR (Snellen equivalent of 20/80) or better in each eye
    • Are willing to follow instructions
    • Have provided a written informed consent
    E.4Principal exclusion criteria
    • Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
    • Previous participation in any clinical trial in which tafluprost was an investigational drug
    • Any uncontrolled systemic disease (e.g., hypertension, diabetes)
    • Filtration surgery without time limit or any other ocular (including ocular laser procedures) surgery within 6 months prior to Visit 1 in the treated eye(s)
    • Clinically relevant low or high heart rate or blood pressure for age, or contraindications to beta-blocker therapy such as chronic obstructive pulmonary disease, bronchial asthma, greater than first degree heart block, and uncontrolled congestive heart failure
    • Change of an existing chronic therapy that could substantially effect the IOP or the study outcomes within 30 days prior to Visit 1, or anticipated change in such therapy during the study
    • IOP greater than 30 mmHg at any time point in any eye at Visit 2 (baseline)
    • Known allergy or hypersensitivity to the study medications or their components, including benzalkonium chloride (BAK)
    • Use of contact lenses at Visit 1 or during the study
    • Any active external ocular disease, inflammation, or infection of the eye and/or eyelids within 3 months from study start
    • Any ocular disease/condition that in the opinion of the investigator may put the patient at a significant risk or may confound the study results or may interefere significantly with the patient’s participation in the study
    • Any corneal abnormality or other condition preventing reliable applanation tonometry
    • Anterior chamber angle less than grade 2 according to Schaffer classification as measured by gonioscopy
    • Advanced visual field defect or a visual field defect that is anticipated to progress during the study period
    • Use of any other antiglaucoma medications than the study medications during the study
    • Current alcohol or drug abuse
    • Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days
    E.5 End points
    E.5.1Primary end point(s)
    Changes from baseline in the diurnal IOP at 2, 4 and 6 weeks
    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 Information not present in EudraCT
    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) No
    E.8.2.2Placebo Yes
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    Defined in the protocol
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 45
    F.4.2.2In the whole clinical trial 200
    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)
    Normal treatment determined by the treating doctor
    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 Decision2005-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-02-18
    P. End of Trial
    P.End of Trial StatusCompleted
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