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    Summary
    EudraCT Number:2008-003567-39
    Sponsor's Protocol Code Number:LT1225-PIIIB-02/08
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-06-27
    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 ConcernedFrance - ANSM
    A.2EudraCT number2008-003567-39
    A.3Full title of the trial
    clinical efficacy and safety of azyter (azythromycin 1,5%) versus tobramycin 0,3% eye drops in the treatment of purulent bacterial conjonctivitis of children.
    multicenter, international, investigator-masked, randomised, phase IIIB study, parallel comparaison versus reference product, 2 X 111 evaluable patients.
    A.4.1Sponsor's protocol code numberLT1225-PIIIB-02/08
    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 SponsorLaboratoires Thea
    B.1.3.4CountryFrance
    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 Yes
    D.2.1.1.1Trade name AZYTER
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires Théa
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOcular use
    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) Yes
    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 No
    D.3.11.8Extractive medicinal product Yes
    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 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 Tobrex 0,3%
    D.2.1.1.2Name of the Marketing Authorisation holderALCON
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameTobramycine
    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
    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) Yes
    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 No
    D.3.11.8Extractive medicinal product Yes
    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 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
    This trial will be performed on children aged from one day of life to 18 years old. The medical conditions that will be observed is the purulent bacterial conjonctivitis.
    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
    To demonstrate the efficacy of Azyter, in comparaison to tobramycine eye drops, for the treatment of purulent bacterial conjunctivitis of children aged from one day of life to 18 years old, and to assess the safety.
    The primary efficacy variable is the CLINICAL CURE on Day 3, in the "worse eye" for patients with Day-0 positive cultures.
    The clinical outcome will be evaluated on the basis of the two cardinal ocular signs:
    -a score 0 for bulbar conjunctival injection,
    -AND a score 0 for conjunctival discharge
    E.2.2Secondary objectives of the trial
    Clinical efficacy criteria
    - At Day 3:
    1. Clinical improvement with residual conjunctival injection / other at Day 3 for the “worse eye”
    2. Clinical status at Day 3
    for the “other eye”
    for “both eye”

    - At Day 7 ± 1:
    Clinical status for the “worse eye”
    Clinical status for the “other eye”
    Clinical status for “both eyes”.

    - Ocular signs and symptoms:

    - Judgement on the global efficacy by the investigator

    Bacteriological efficacy:
    - Bacterial outcome (resolved/not resolved)

    Ocular and systemic safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    patients will be eligible for inclusion in this study if all these criteria are respected:
    - Age superior than one day life (newborn, infant, child, adult)* and less than 18 years
    *(definition of new born's age= 0-2 months old)
    -Ability to provide written informed consent by the patient and his/her legally acceptable representatives (mother and father, or tutor or witness)
    -Ability to comply with the study-specified visit schedule and procedures
    -PURULENT BACTERIAL CONJUNCTIVITIS (unilateral or bilateral) defined by the following both cardinal signs in at least one eye:
    - a rating of at least 1 (grade 1,2 or 3) for conjunctival purulent discharge.
    AND - a rating of at least 1 (grades 1,2 or 3) for bulbar conjunctival injection
    E.4Principal exclusion criteria
    Ophthalmic non-inclusion criteria (in either eye)
    - Risk factors of complication:
    . Diagnosis of bacterial conjunctivitis of more than 7 days at Day 0.
    . Bacterial infection after trauma or presence of foreign body.
    . Dacryocystitis.
    . Corneal ulceration or keratitis.
    - Other aetiologies of red eyes:
    . Suspicion of viral conjunctivitis:
    - Viral epidemic context.
    - Clinical feature suggestive of viral ocular infection.
    . Suspicion of closed angle glaucoma crisis.
    . Suspicion of acute allergy conjunctivitis.
    -Ocular criteria for ethics purpose:
    . Presence of clinically significant abnormality in the cornea, iris or anterior/ posterior segment.
    . Organic amblyopia, monophthalmia.
    . Vision not correctable to at least 20/100 with the Snellen Chart or the equivalent with another optotype adapted to the age of the child (and usually used by the ophthalmologist department)
    . Contact lens wearer

    Systemic/non ophthalmic non-inclusion criteria
    - Known or suspected hypersensitivity to one of the components of the study medications, or to any other macrolide antibiotic or to test products
    - Any medical or surgical history, disorder or disease (such as acute or chronic severe organic disease: hepatic, endocrine, neoplasic, haematological; immunosuppressive, infectious diseases [like malaria, AIDS,…], severe psychiatric illness, relevant cardiovascular abnormalities, etc.) and/or any complicating factor or structural abnormality, judged by the investigator to be incompatible with the study.
    - Newborn not born at term (< 37 weeks of amenorrhea)

    Specific non-inclusion criteria for women
    - childbearing potential girl (menstruated girl) who is not using oral contraceptive method

    Non-inclusion criteria related to general conditions
    - Inability of patient and/or relatives to understand the study procedures.
    - Non compliant patient and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compliance).
    - Participation in another clinical study within the last 3 months.
    - Already included once in this study.
    - Patient not covered by the French Social Security scheme (for French patients only).

    Non-inclusion criteria related to previous and concomitant medications / non-product therapies
    Patient using any of the following previous and concomitant medication / treatment (according to the described periods) will not be included in the study:
    -Ocular surgery (12months before inclusion)
    -Systemic macrolide antibiotic medications (one month before inclusion)
    -Systemic steriods (2 weeks before inclusion)
    -Topical ocular macrolide antibiotics, when available in the country (1 week before inclusion)
    -Topical ocular steroids and /or nonteroidal anti inflammatories (1 week before inclusion)
    -Topical (ocular, nasal, bronchial, ...) treatment except nasal 0,9% eye drops (1 day before inclusion)
    -Systemic NSAIDs (1 day before inclusion)
    -Immunosupressive treatment (till inclusion)
    -Systemic antibiotic medication (till inclusion)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the clinical cure on Day 3.
    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 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) 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 Yes
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    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 months15
    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 months15
    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.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-06-27. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Babies
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 444
    F.4.2.2In the whole clinical trial 444
    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)
    an optional visit on day 15+/- 2 will be planned for cases of improvement of bacterial conjunctivitis with residual conjunctival injection (with at least one unit improvement from baseline), and without conjunctival discharge (score=0), observed at the Day 7 visit.
    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 Decision2008-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-02-28
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