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    Summary
    EudraCT Number:2013-004302-26
    Sponsor's Protocol Code Number:201350
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-06
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2013-004302-26
    A.3Full title of the trial
    A phase I study to evaluate the pharmacokinetics, safety and tolerability of preservative free tafluprost ophthalmic solution (0.0015%) in pediatric patients diagnosed with glaucoma or ocular hypertension.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of how tafluprost is distributed in blood circulation after ocular administration in children who have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general will also be assessed.
    A.3.2Name or abbreviated title of the trial where available
    Phase I Study to Evaluate Tafluprost Eye Drops in Paediatric Patients.
    A.4.1Sponsor's protocol code number201350
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/132/2012
    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 organisationINC Research
    B.5.2Functional name of contact pointSarah Johnstone
    B.5.3 Address:
    B.5.3.1Street Address3201 Beechleaf Court, Suite 600
    B.5.3.2Town/ cityRaleigh
    B.5.3.3Post codeNC 27604
    B.5.3.4CountryUnited States
    B.5.4Telephone number+19197452594
    B.5.6E-mailsarah.johnstone@incresearch.com
    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 Tafluprost
    D.2.1.1.2Name of the Marketing Authorisation holderSanten Oy
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 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 INNtafluprost
    D.3.9.1CAS number 209860-88-8
    D.3.9.2Current sponsor codeTAFLUPROST
    D.3.9.3Other descriptive nameTAFLUPROST
    D.3.9.4EV Substance CodeSUB30776
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.015
    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
    E.1.1.1Medical condition in easily understood language
    Glaucoma or elevated intraocular hypertension
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to evaluate the pharmacokinetics (PK) of preservativefree tafluprost 0.0015% eye drops in paediatric patients of at least 36 week gestation and 1 month postnatal to under 18 years of age diagnosed with paediatric glaucoma or ocular hypertension (OHT).
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate tolerability and safety of preservativefree tafluprost 0.0015% eye drops in pediatric patients of at least 36 week gestation and 1 month postnatal to under 18 years of age diagnosed with pediatric glaucoma or ocular hypertension (OHT).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is a non-smoking male or female ≤ 17 years of age on the day of signing the informed consent with the first day of study drug dosing to occur prior to the 18th birthday. Infants less than 12 months old must be of ≥ 36 weeks gestational age and at least 1 month of age.
    2. A diagnosis of primary or secondary paediatric glaucoma or ocular hypertension in one or both eyes.
    3. A history of intraocular pressure (IOP) greater than or equal to 22 mmHg in at least one eye. Newly diagnosed patients may have this criterion fulfilled at the prestudy visit.
    4. Patient is currently prescribed ocular hypotensive medication or patient is treatmentnaïve.
    5. Female patients of reproductive potential must demonstrate a negative pregnancy test at the prestudy visit.
    6. Patient is judged to be in good health, other than having glaucoma or ocular hypertension, based on medical history, physical examination, vital signs measurements, and laboratory safety tests .
    7. Patient has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy visit.
    8. Parent/legal guardian and/or patient have/has provided a written informed consent and patient assent has been given as applicable.
    9. The patient and parent/guardian should agree to comply with study restrictions, treatment plan, procedures and keep scheduled clinic visits.
    E.4Principal exclusion criteria
    1. Patient currently wears continuous wear contact lenses (use of daily wear contact lenses during the study is permitted).
    2. Onesighted or monocular patients, including patients who cannot be dosed in both eyes for any reason.
    3. History of goniotomy or trabeculotomy within 1 month of prestudy visit or history of cataract surgery, laser surgery, filtration surgery, implant surgery or cyclodestructive surgery within 3 months prior to prestudy visit in one or both eyes.
    4. Patient has a history or evidence of significant ocular trauma within 3 months of prestudy visit.
    5. Patient has a history or evidence of recent ocular inflammation and/or infection within 1 month of prestudy visit.
    6. Patient has chronic conjunctivitis, chronic keratitis or lacrimal deficiency.
    7. Patient is pregnant, breastfeeding, expecting to conceive within the projected duration of the study.
    8. Patient has had major (nonocular) surgery, loss of > 5 cc/kg of blood within 4 weeks of the prestudy visit.
    9. Any other ocular, systemic or psychiatric disease/condition or laboratory abnormality that may put the patient at a significant risk or may confound the study results or may interfere significantly with the patient’s participation in the study as judged by the investigator.
    10. History of febrile illness within 5 days prior to start of study treatment.
    11. Patient has a history of hypersensitivity to any component of tafluprost eye drops, or known severe or serious hypersensitivity to any prostaglandin analogue product (e.g. latanoprost).
    12. Patient has a history of multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription
    (overthecounter) drugs or food.
    13. There is any concern by the investigator regarding the safe participation of a patient in the study; or for any other reason the investigator considers the patient inappropriate for participation in the study.
    14. Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days from the prestudy visit.
    E.5 End points
    E.5.1Primary end point(s)
    Testing of tafluprost acid plasma concentrations that are drawn at Day 8 visit.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 8: before the administration and then 10, 30 and 60 minutes after the administration of tafluprost eye drops.
    E.5.2Secondary end point(s)
    Assessment of safety and tolerability at all visits. Will be followed with the following variables:
    1. Adverse events
    2. Bestcorrected visual acuity
    3. Intraocular pressure
    4. Biomicroscopy
    5. Ophthalmoscopy
    6. Vital signs: blood pressure and heart rate, respiratory rate, body temperature
    7. ECG
    8. Laboratory safety tests
    E.5.2.1Timepoint(s) of evaluation of this end point
    All visits (prestudy, day 1, day 8 and poststudy).
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmocokinetics in children
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 18
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 8
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 5
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children: parent/guardian will provide consent on behalf of the child. Written or verbal assent from the child will also be obtained as appropriate.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6
    F.4.2.2In the whole clinical trial 18
    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)
    None planned for this trial. Patients will receive their normal/standard of care treatment from their Doctor, in respect of their glaucoma or ocular hypertension once they have ended their participation in the study.
    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 Decision2016-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-05
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