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    Summary
    EudraCT Number:2020-005263-31
    Sponsor's Protocol Code Number:LEVOKETO_02-2020
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-005263-31
    A.3Full title of the trial
    Assessment of the effects and tolerability of RD03/2016 (Levofloxacin; Ketorolac Trometamol 0.5+0.5% w/v eye drops solution) for the treatment of bacterial conjunctivitis in adults: a multicentre, randomized, blinded-assessor, phase II non-inferiority study – MIRAKLE
    Valutazione dell’efficacia e della tollerabilità di RD03/2016 (soluzione oftalmica di Levofloxacina; Ketorolac Trometamolo 0.5+0.5% p/v) per il trattamento della congiuntivite batterica negli adulti: studio clinico di fase II di non inferiorità, multicentrico, randomizzato, con valutatore in cieco- MIRAKLE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of the effects and tolerability of RD03/2016 (Levofloxacin; Ketorolac Trometamol 0.5+0.5% w/v eye drops solution) for the treatment of bacterial conjunctivitis in adults: a multicentre, randomized, blinded-assessor, phase ii non-inferiority study – mirakle – MIRAKLE
    Valutazione dell’efficacia e della tollerabilità di RD03/2016 (soluzione oftalmica di Levofloxacina; Ketorolac Trometamolo 0.5+0.5% p/v) per il trattamento della congiuntivite batterica negli adulti: studio clinico di fase II di non inferiorità, multicentrico, randomizzato, con valutatore in cieco-MIRAKLE
    A.3.2Name or abbreviated title of the trial where available
    MIRAKLE
    MIRAKLE
    A.4.1Sponsor's protocol code numberLEVOKETO_02-2020
    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 SponsorNTC SRL
    B.1.3.4CountryItaly
    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 supportNTC SRL
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOPIS Srl
    B.5.2Functional name of contact pointDipartimento Medico
    B.5.3 Address:
    B.5.3.1Street AddressPalazzo Aliprandi - Via Matteotti, 10
    B.5.3.2Town/ cityDesio (MB)
    B.5.3.3Post code20832
    B.5.3.4CountryItaly
    B.5.4Telephone number003903626331
    B.5.5Fax number00390362633633
    B.5.6E-mailinfo.studiclinici@opis.it
    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 nameRD03/2016
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Eye drops, solution
    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 INNLEVOFLOXACINA
    D.3.9.1CAS number 100986-85-4
    D.3.9.2Current sponsor codeLEVOFLOXACINA
    D.3.9.4EV Substance CodeSUB08471MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKETOROLAC TROMETAMINA
    D.3.9.1CAS number 74103-07-4
    D.3.9.2Current sponsor codeKetorolac Trometamina
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 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.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 OFTAQUIX - 1 FLACONE DI COLLIRO 0.5% DA 5 ML
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameOftaquix
    D.3.2Product code [Oftaquix]
    D.3.4Pharmaceutical form Eye drops, solution
    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 INNLEVOFLOXACINA
    D.3.9.1CAS number 100986-85-4
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB08471MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 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
    Bacterial conjunctivitis
    Congiuntivite batterica
    E.1.1.1Medical condition in easily understood language
    Bacterial conjunctivitis
    Congiuntivite batterica
    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 PT
    E.1.2Classification code 10061784
    E.1.2Term Conjunctivitis bacterial
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061784
    E.1.2Term Conjunctivitis bacterial
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the non-inferiority of RD03/2016 eye drops vs. levofloxacin alone in microbiological eradication at final visit (Day 7-9)
    Dimostrare la non inferiorità di RD03/2016 collirio vs. la sola levofloxacina in forma di collirio nell’eradicazione microbiologica alla visita finale (Giorno 7-9).
    E.2.2Secondary objectives of the trial
    -To assess the efficacy of RD03/2016 eye drops vs. levofloxacin alone in the proportion of patients with clinical cure, i.e. resolution of cardinal signs of bacterial conjunctivitis, at On-Therapy (OT) visit (Day 3-4) and final visit (Day 7-9).
    -To assess the efficacy of RD03/2016 eye drops vs. levofloxacin alone in time to clinical cure, assessed through photographs taken every 12 ± 1 hours from Day 1 to Day 7-9, using eyePRO.net (photographs on Day 0 to be taken at the earliest feasible time point post-baseline visit)
    - To assess the efficacy of RD03/2016 eye drops vs. levofloxacin alone in time to resolution of symptoms of bacterial conjunctivitis.
    - To evaluate the safety and tolerability of RD03/2016 eye drops
    - To evaluate compliance with the prescribed treatment

    For other secondary objectives see the protocol.
    -Valutare l’efficacia di RD03/2016 collirio vs. la sola levofloxacina in forma di collirio sulla proporzione di pazienti con guarigione clinica (risoluzione dei segni cardinali) di congiuntivite batterica, alla visita in corso di terapia (On-Therapy - OT) (Giorno 3-4) e alla visita finale (Giorno 7-9).
    -Valutare l’efficacia di RD03/2016 collirio vs. la sola levofloxacina in forma di collirio sul tempo alla guarigione clinica, determinato tramite fotografie scattate ogni 12 ± 1 ore dal Giorno 1 al Giorno 7-9, usando eyePRO.net.(fotografie al Giorno 0 da scattare al primo tempo utile dopo la visita basale).
    -Valutare l’efficacia di RD03/2016 collirio vs. la sola levofloxacina in forma di collirio sul tempo alla risoluzione dei sintomi di congiuntivite batterica.
    - Valutare la sicurezza e la tollerabilità di RD03/2016 collirio.
    - Valutare l’aderenza al trattamento prescritto.

    Per altri obiettivi secondari si veda il protocollo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability of patient to consent and provide signed written informed consent
    2. Male or female aged major >= 18 year
    3. Clinical diagnosis of acute bacterial conjunctivitis with moderate/severe signs (score = 2 for each cardinal signs, i.e. bulbar conjunctival injection, palpebral conjunctival injection and conjunctival discharge, in at least one eye), not previously treated with antibiotics, steroids and nonsteroidal anti-inflammatory drugs (NSAIDs)
    4. Able and willing to follow study procedures
    5. Availability of a person (a relative or a caregiver) to be trained for the execution of the photographic documentation required by the study and for the use of eyePRO.net (see Study procedures)
    6. Willing to interrupt the use of contact lenses for the entire duration of the study
    1. Capacità del paziente di fornire il consenso e ottenimento del consenso informato scritto firmato
    2. Pazienti di sesso maschile o femminile, di età maggiore >= 18 anni
    3. Diagnosi clinica di congiuntivite batterica acuta con segni moderati/severi (punteggio = 2 per ciascun segno cardinale, ovvero iniezione della congiuntiva bulbare, iniezione della congiuntiva palpebrale e secrezione congiuntivale, in almeno un occhio), non trattati in precedenza con antibiotici, corticosteroidi e farmaci antiinfiammatori non steroidei (FANS)
    4. Pazienti disponibili e in grado di seguire le procedure di studio
    5. Disponibilità di una persona (un familiare, conoscente o un assistente) ad essere istruita in merito all’esecuzione della documentazione fotografica richiesta dallo studio e all’utilizzo di eyePRO.net (si vedano le procedure di studio)
    6. Pazienti disponibili ad interrompere l’uso di lenti a contatto per tutta la durata dello studio
    E.4Principal exclusion criteria
    1. Any acute ocular disease other than bacterial conjunctivitis
    2. Any ocular surgery (including laser treatment) in the study eye within 30 days prior to study entry
    3. Any ocular (in the study eye) or systemic antimicrobial agents administered concurrently or within 3 days prior to study entry
    4. Any ocular (in the study eye) or systemic steroids or NSAIDs administered concurrently
    5. Pathological conditions or treatments that in the opinion of the Investigator may interfere with the efficacy and/or safety evaluations of the study (e.g. chronic blepharitis, glaucoma, moderate-severe dry eye)
    6. Participation in previous clinical studies if less than 5 half-lives of the Investigational Medicinal Product (IMP) used have passed
    7. Hypersensitivity to the products, other quinolones, acetylsalicylic acid and other NSAIDs (due to potential for cross-sensitivity), or their excipients
    8. Contraindications to ocular treatment with levofloxacin and/or ketorolac
    9. Pregnancy or breastfeeding
    1. Qualsiasi patologia oculare acuta diversa da congiuntivite batterica
    2. Qualsiasi intervento chirurgico oculare nell’occhio in studio (inclusa la laserterapia) nei 30 giorni precedenti l’ingresso nello studio
    3. Qualsiasi antibiotico somministrato per via oculare (nell’occhio in studio) o sistemica in concomitanza o nei 3 giorni precedenti l’ingresso nello studio
    4. Qualsiasi steroide o FANS somministrato in concomitanza per via oculare (nell’occhio in studio) o sistemica
    5. Condizioni patologiche o trattamenti che, a giudizio dello Sperimentatore, possono interferire con le valutazioni di efficacia e/o di sicurezza dello studio (ad es. blefarite cronica, glaucoma, sindrome dell’occhio secco moderata-severa)
    6. Partecipazione a precedenti studi clinici se sono trascorse meno di 5 emivite del farmaco sperimentale (Investigational Medicinal Product - IMP)
    7. Ipersensibilità ai prodotti, altri chinoloni, acido acetilsalicilico e altri FANS (a causa del potenziale di sensibilità incrociata), o ad uno qualsiasi dei loro eccipienti
    8. Controindicazioni al trattamento oculare con levofloxacina e/o ketorolac
    9. Gravidanza o allattamento
    E.5 End points
    E.5.1Primary end point(s)
    - Proportion of patients with microbiological eradication i.e. absence/no growth of baseline pathogens assessed through bacteriological culture (calcium alginate swab of the lower conjunctiva) at final visit (Day 7-9);
    - Proporzione di pazienti con eradicazione microbiologica, ovvero assenza/nessuna crescita dei patogeni presenti al basale valutata per mezzo di coltura batteriologica (tampone di calcio alginato a livello della congiuntiva inferiore) alla visita finale (Giorno 7-9);
    E.5.1.1Timepoint(s) of evaluation of this end point
    Days 7-9
    Giorno 7-9
    E.5.2Secondary end point(s)
    -Proportion of patients with clinical cure, i.e. absence of cardinal signs of bacterial conjunctivitis (conjunctival discharge, bulbar conjunctival injectionand palpebral conjunctival injection) at OT visit (Day 3-4) and final visit (Day 7-9);
    -Time to clinical cure assessed through photographs taken every 12 ± 1 hours from Day 1 to Day 7-9, using the study smartphone and eyePRO.net;
    - Time to resolution (absence) of bacterial conjunctivitis symptoms (pain, burning/stinging, itching, tearing, foreign body sensation, photophobia and discomfort) recorded by the patient (0, absent; 1, present) every 12 ± 1 hours from Day 1 to Day 7-9 through an electronic patient diary;
    - Proporzione di pazienti con guarigione clinica, ovvero risoluzione dei segni cardinali di congiuntivite batterica (secrezione congiuntivale, iniezione o iperemia della congiuntiva bulbare ed iniezione della congiuntiva palpebrale), alla visita OT (Giorno 3-4) e alla visita finale (Giorno 7-9);
    - Tempo alla guarigione clinica determinato tramite fotografie scattate ogni 12 ± 1 ore dal Giorno 1 al Giorno 7-9, usando lo smartphone di studio fornito al paziente e eyePRO.net;
    - Tempo alla risoluzione (assenza) dei sintomi di congiuntivite batterica (dolore, bruciore/sensazione pungente, prurito, lacrimazione, sensazione di corpo estraneo, fotofobia e fastidio) registrati dal paziente (0, assente; 1, presente) ogni 12 ± 1 ore dal Giorno 1 al Giorno 7-9 tramite diario elettronico;
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 7-9
    Giorno 7-9
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Valutatore in cieco
    Blinded-assessor
    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.8.2.4Number of treatment arms in the trial2
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Russian Federation
    Germany
    Portugal
    Spain
    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
    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 months13
    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 months13
    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 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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 252
    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)
    standard therapy
    terapia standard
    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 Decision2021-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-01
    P. End of Trial
    P.End of Trial StatusOngoing
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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
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