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    Summary
    EudraCT Number:2019-004501-27
    Sponsor's Protocol Code Number:2183/2019
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-15
    Trial 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 ConcernedAustria - BASG
    A.2EudraCT number2019-004501-27
    A.3Full title of the trial
    Perioperative analgesia in children undergoing ophthalmic surgery
    Perioperatives Schmerzmanagement in der Augenchirurgie bei Kindern
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pain management in children undergoing eye surgery
    Management von Schmerzmitteln bei Kindern während Augenoperationen
    A.3.2Name or abbreviated title of the trial where available
    Perioperative analgesia in children
    A.4.1Sponsor's protocol code number2183/2019
    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 SponsorMedical University of Vienna
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedical University of Vienna
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Vienna
    B.5.2Functional name of contact pointMUW
    B.5.3 Address:
    B.5.3.1Street AddressSpitalgasse 23
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+43140400-79310
    B.5.5Fax number+43140400-79320
    B.5.6E-maileva.stifter@meduniwien.ac.at
    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 Novain 0.4%
    D.2.1.1.2Name of the Marketing Authorisation holderAgepha Pharma
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameNovain 0.4%
    D.3.4Pharmaceutical form Eye drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNovain 0.4%
    D.3.9.3Other descriptive nameOXYBUPROCAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03580MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    perioperative analgesia
    E.1.1.1Medical condition in easily understood language
    Pain during surgery
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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
    In this study we want to evaluate the role of additional topical Oxybuprocainhydrochlorid (Novain 0.4%) versus Placebo lubrication eye drops (Oculotect®) for perioperative analgesia in pediatric surgery with regard to intra- and postoperative pain management.
    E.2.2Secondary objectives of the trial
    • Anesthesia variables
    Durations
    Hemodynamic monitoring
    Oxygenation
    Intraoperative pain score
    Postoperative pain assessment

    • Ophthalmologic variables
    Surgical variables
    Intra- and postoperative complications
    Functional and morphologic results
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Written informed consent to participate in the study by the parental guardian
    • Zero to three years of age
    • Uni- and bilateral cataract
    • Strabismus convergens or divergens
    • Scheduled for ophthalmic surgery
    E.4Principal exclusion criteria
    • History of secondary cataract (inflammatory, uveitic)
    • History of connatal cataract associated with Rieger syndrome, Rieger-Axenfeld syndrome, Peters anomaly
    • History of ectoia lentis associated with Marfan syndrome, homocystinuria or Ehlers-Danlos syndrom
    • History of penetrating or perforating eye trauma
    • Previous surgery due to glaucoma, retinal detachment
    • Active intraocular inflammation (grade trace or above) in the study eye, like infectious conjunctivitis, scleritis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis
    E.5 End points
    E.5.1Primary end point(s)
    Amount of intraoperative analgesia with intravenous fentanyl (1 µg/kg; 0.2 mL/kg of 5 µg/kg) and the postoperative analgesia
    E.5.1.1Timepoint(s) of evaluation of this end point
    day of surgery
    E.5.2Secondary end point(s)
    • Anesthesia variables
    o Durations: total anesthesia time, time for intubation and extubation, time at the recovery room
    o Hemodynamic monitoring: heart rate, pulse, blood pressure (systolic and diastolic)
    o Oxygenation: intraoperative and postoperative in the recovery room
    o Intraoperative pain score: salivation, tearing, Bell phenomenon
    o Postoperative: nausea, vomiting, headache, sore throat; time to drink; time to eat; discharge same/next day

    • Ophthalmologic variables
    o Surgical variables: duration of surgery, type of surgery
    o Safety
    o Intraoperative complications: Iris bleeding, iris prolapse, hypotony, expulsive bleeding, posterior capsule rupture, vitreous loss, globe perforation
    o Postoperative complications: Retinal detachment, endophthalmitis, visual axis obscuration (VAO), nystagmus, strabismus, amblyopia
    o Functional and morphologic results

    • Demographic information
    o Age, gender
    E.5.2.1Timepoint(s) of evaluation of this end point
    surgery day and postoperative follow-up visits: one day, one week, one, three and six months after surgery
    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 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 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 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.8.2.4Number of treatment arms in the trial2
    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 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
    The trial ends one year after the initial treatment for the last enrolled patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 80
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 26
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 27
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 27
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    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)
    The patients will be further treated at the Department of Ophthalmology at the Medical University of Vienna.
    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 Decision2021-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-26
    P. End of Trial
    P.End of Trial StatusOngoing
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