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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2014-005273-37
    Sponsor's Protocol Code Number:201450
    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:2015-04-22
    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 number2014-005273-37
    A.3Full title of the trial
    A phase IV study on the changes in ocular signs and symptoms in patients
    with ocular hypertension or open-angle glaucoma switched from Ganfort® eye drops (bimatoprost 0.03%/timolol 0.5%) to Taptiqom® eye drops (tafluprost 0.0015%/timolol 0.5%)
    Eine Phase IV-Studie zu den Veränderungen der okulären Zeichen und Symptome bei Patienten mit erhöhtem Augeninnendruck oder einem Offenwinkelglaukom, die von Ganfort®-Augentropfen (Bimatoprost 0,03 %/Timolol 0,5 %) auf Taptiqom®-Augentropfen (Tafluprost 0,0015 %/Timolol 0,5 %) umgestellt wurden
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial on the changes in ocular signs and symptoms in patients
    with ocular hypertension or open-angle glaucoma switched from Ganfort® eye drops to Taptiqom® eye drops.
    Eine klinische Studie zu den Veränderungen der okulären Zeichen und Symptome bei Patienten mit erhöhtem Augeninnendruck oder einem Offenwinkelglaukom, die von Ganfort®-Augentropfen auf Taptiqom®-Augentropfen umgestellt wurden
    A.4.1Sponsor's protocol code number201450
    A.7Trial is part of a Paediatric Investigation Plan No
    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 supportSanten Oy
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanten Oy
    B.5.2Functional name of contact pointManager, Clinical Research
    B.5.3 Address:
    B.5.3.1Street AddressNiittyhaankatu 20
    B.5.3.2Town/ cityTampere
    B.5.3.3Post code33720
    B.5.3.4CountryFinland
    B.5.4Telephone number358503502765
    B.5.6E-mailanne.pielismaa@santen.fi
    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 Taptiqom
    D.2.1.1.2Name of the Marketing Authorisation holderSanten Oy
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameTaptiqom
    D.3.4Pharmaceutical form Eye drops, solution in single-dose container
    D.3.4.1Specific paediatric formulation No
    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 INNTIMOLOL MALEATE, R-ENANTIOMER
    D.3.9.1CAS number 26921-17-5
    D.3.9.4EV Substance CodeSUB04876MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtafluprost
    D.3.9.1CAS number 209860-87-7
    D.3.9.2Current sponsor codeAFP-168
    D.3.9.3Other descriptive nameTAFLUPROST
    D.3.9.4EV Substance CodeSUB30776
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.0015
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Glaucoma or Ocular Hypertension
    Glaukom oder erhöhter Augeninnendruck
    E.1.1.1Medical condition in easily understood language
    Glaucoma or Ocular Hypertension
    Glaukom oder erhöhter Augeninnendruck
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLGT
    E.1.2Classification code 10018307
    E.1.2Term Glaucoma and ocular hypertension
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10030348
    E.1.2Term Open angle glaucoma
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10074026
    E.1.2Term Exfoliation glaucoma
    E.1.2System Organ Class 10015919 - Eye disorders
    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 whether changes in ocular signs or symptoms occur when patients with OHT or OAG (POAG or PEX) are switched from Ganfort® eye drops (FDC of bimatoprost 0.03% and timolol 0.5%) to Taptiqom® eye drops (FDC of tafluprost 0.0015% and timolol 0.5%).
    Ziel dieser Studie ist die Untersuchung, ob bei einer Umstellung von Ganfort®-Augentropfen (feste Dosiskombination [FDK] aus Bimatoprost 0,03 % und Timolol 0,5 %) auf Taptiqom®-Augentropfen (FDK aus Tafluprost 0,0015 % und Timolol 0,5 %) bei Patienten eine Änderung von Krankheitsbild und Symptomatik des Auges auftritt.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged 18 years or more
    2. A diagnosis of ocular hypertension or open-angle glaucoma (either POAG or PEX) in one or both eyes, for which the patient has been regularly using Ganfort® in the evening for at least 4 weeks before Screening.
    3. In the Screening visit evaluation, the presence of:
    - conjunctival redness/hyperemia at least in one treated eye
    AND
    - at least one ocular symptom considered for the two eyes together
    (irritation/burning/stinging, foreign body sensation, tearing, itching or dry eye
    sensation)
    4. A best corrected ETDRS visual acuity score of +0.6 logMAR or better in both eyes
    5. Have provided a written informed consent and are willing to follow instructions
    E.4Principal exclusion criteria
    1. Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
    2. Use of more than two active medicinal agents to treat glaucoma/OH during the past six months prior to Screening
    3. Anterior chamber angle in either eye to be treated less than grade 2 according to Schaffer classification as measured by gonioscopy
    4. Any corneal abnormality or other condition preventing reliable applanation tonometry,including prior refractive eye surgery
    5. IOP greater than 21 mmHg in treated eye(s) at Screening/Baseline visit
    6. Use of preserved eye drops (other than Ganfort®) including artificial tears at screening or within two weeks prior to screening visit
    7. Diagnosis of angle-closure glaucoma or secondary glaucoma other than PEX in either eye
    8. Suspected contraindication to tafluprost or timolol therapy (low heart rate or clinically relevant low blood pressure for age, chronic obstructive pulmonary disease, bronchial asthma, strong tendency to bronchospasm, certain cardiac arrhythmias or uncontrolled congestive heart failure)
    9. Glaucoma filtration surgery or any other ocular surgery (including ocular laser
    procedures) within 6 months prior to Screening in eye(s) to be treated with study
    medication
    10. Use of contact lenses at Screening or during the study
    11. Any ocular, systemic or psychiatric disease/conditio that may put the patient at a significant risk or may confound the study results as judged by the investigator
    12. Current alcohol or drug abuse
    13. Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days prior to Screening
    E.5 End points
    E.5.1Primary end point(s)
    Change from screening in conjunctival redness/hyperemia at week 12

    Change from screening in worst ocular symptom upon non-instillation at week 12
    Änderung bei der Rötung der Bindehaut/Hyperämie in Woche 12 gegenüber dem Screeningtermin

    Änderung beim schlimmsten okulären Symptom bei Nicht-Instillation in Woche 12 gegenüber dem Screeningtermin
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 12 weeks
    Woche 12
    E.5.2Secondary end point(s)
    Change from screening in ocular signs at week 12 (other than conjunctival redness/hyperemia)

    Change from screening in ocular symptoms upon non-instillation at week 12

    Quality of Life
    Änderung beim okulären Krankheitsbild in Woche 12 gegenüber dem Screeningtermin (außer Rötung der Bindehaut/Hyperämie)

    Änderung bei okulären Symptomen bei Nicht-Instillation in Woche 12 gegenüber dem Screeningtermin

    Lebensqualität
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 12 weeks
    Woche 12
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 No
    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
    Last patient last visit
    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 months4
    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 months4
    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.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state69
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    All subjects who end their participation in the trial will continue to be monitored by their respective physicians, using standard medical care. No special procedures or extra medical care is needed after the trial that would not be otherwise used in patients who have participated in the trial.
    Alle Studienteilnehmer werden nach Beendigung der Studienteilnahme von ihrem Arzt im Rahmen der normalen medizinischen Versorgung überwacht. Es sind nach der Studie keine speziellen Prozeduren oder zusätzliche medizinische Behandlungen notwendig, die nicht auch Patienten, die nicht an der Studie teilgenommen haben, erhalten.
    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 Decision2015-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-25
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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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