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    Summary
    EudraCT Number:2012-003664-41
    Sponsor's Protocol Code Number:PMS/LEVO-001-06-2012
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-16
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2012-003664-41
    A.3Full title of the trial
    Open-labeled, randomized, comparative clinical study of efficacy and safety of Levofloxan 0,5% eye drops in patients with Acute Bacterial Conjunctivitis.
    Открито, рандомизирано, сравнително клинично изпитване на ефективността и безопасността на Левофлоксан 0,5% очни капки при пациенти с остър бактериален конюнктивит.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of efficacy and safety of two drugs in patients with acute conjunctivitis caused by bacteria.
    Сравнение на ефективността и безопасността на два лекарствени продукта при пациенти с остър конюнктивит, предизвикан от бактерии.
    A.4.1Sponsor's protocol code numberPMS/LEVO-001-06-2012
    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 SponsorBalkanpharma-Razgrad AD
    B.1.3.4CountryBulgaria
    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 supportBalkanpharma-Razgrad AD
    B.4.2CountryBulgaria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBalkanpharma-Razgrad AD
    B.5.2Functional name of contact pointResearch and Development
    B.5.3 Address:
    B.5.3.1Street Address68 "Aprilsko Vastanie" blvd.
    B.5.3.2Town/ cityRazgrad
    B.5.3.3Post code7200
    B.5.3.4CountryBulgaria
    B.5.4Telephone number+35984613303
    B.5.5Fax number+35984615318
    B.5.6E-mailoffice@razgrad.bg
    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 LEVOFLOXAN eye drops, solution, 5 ml
    D.2.1.1.2Name of the Marketing Authorisation holderAntibiotic-Razgrad AD
    D.2.1.2Country which granted the Marketing AuthorisationBulgaria
    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 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 INNLEVOFLOXACIN
    D.3.9.1CAS number 100986-85-4
    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 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.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 5 mg/ml eye drops
    D.2.1.1.2Name of the Marketing Authorisation holderSanten Oy Finland
    D.2.1.2Country which granted the Marketing AuthorisationBulgaria
    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 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 INNLEVOFLOXACIN
    D.3.9.1CAS number 100986-85-4
    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 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
    Acute Bacterial Conjunctivitis
    Остър бактериален конюнктивит.
    E.1.1.1Medical condition in easily understood language
    Acute inflammation of conjunctiva caused by bacteria
    Остро възпаление на конюнктивата, причинено от бактерии
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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
    - Evaluation of therapeutically effect of Levofloxan 0,5% eye drops in patients with Acute Bacterial Conjunctivitis.
    - Comparative evaluation of efficacy of Levofloxan 0,5% eye drops with respect to the comparator
    - Оценка на терапевтичния ефект на Левофлоксан 0,5% очни капки при пациенти с остър бактериален конюнктивит
    - Сравнителна оценка на ефикасността на Левофлоксан 0,5% очни капки по отношение на сравнителния лекарствен продукт
    E.2.2Secondary objectives of the trial
    - Evaluation of tolerability and safety of Levofloxan 0,5% eye drops
    - Comparative evaluation of tolerability and safety of Levofloxan 0,5% eye drops with respect to the comparator
    - Оценка на поносимостта и безопасността на Левофлоксан 0,5% очни капки
    - Сравнителна оценка на поносимостта и безопасността на Левофлоксан 0,5% очни капки по отношение на сравнителния лекарствен продукт
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Men and women between 18 and 70 years
    - Acute Bacterial Conjunctivitis affecting one or both eyes, determined microbiologicaly and by biomicroscopy
    - Microbiologicaly proven cause sensitive to the action of Levofloxacin
    - Patient is willing to participate and sign an informed consent
    - Жени и мъже на възраст >18 и <70 г.
    - Остър бактериален конюнктивит засягащ едното или двете очи, установен биомикроскопски и микробиологично;
    - Микробиологично доказан причинител, чувствителен към действието на левофлоксацин
    - Желание на пациента да участва в изпитването и да подпише информирано съгласие
    E.4Principal exclusion criteria
    - Age <18 and > 70
    - Non bacterial Conjunctivitis
    - Bacterial Conjunctivitis lasting more than 3 days
    - Bacterial Conjunctivitis that excludes Levofloxacin monotherapy
    - Superficial infections of the eye, excl. of bacterial conjunctivitis and those due to trauma, presence of foreign body or from wearing contact lenses
    - Corneal inflammation – keratitis, corneal ulcers
    - Hypersensitivity to levofloxacin – other quinolones and/or any of excipients of investigational medicinal products
    - Treatment with systemic quinolones in 30 days before study and/or systemic corticosteroids in 14 days before or during the trial
    - Treatment with NSAIDs, corticosteroids or quinolones for ocular use 7 days before the trial
    - Participation in other clinical trial related to application of antibacterial drugs, NSAIDs and corticosteroids
    - Pregnancy and nursing
    - Result of microbiological examination showing insensitive to levofloxacin cause
    - Occurrence of hypersensitivity reactions
    - Lack of effect on the clinical condition after 3 - 4 days of treatment (visit 2)
    - Refuses to sign informed consent form
    - Non compliance with the protocol
    - Discretion of the principal investigator
    - Occurrence of circumstances unrelated to participation in the trial (eg change of residence
    - Възраст <18 и >70 г.
    - Небактериален конюнктивит
    - Бактериален конюнктивит с продължителност > 3 дни
    - Бактериален конюнктивит, чиято тежест изключва монотерапия с левофлоксацин
    - Повърхностни инфекции на окото, с изкл. на бактериален конюнктивит и такива дължащи се на травма, наличие на чуждо тяло или вследствие носене на контактни лещи
    - Роговични възпаления – кератит, язви на роговицата.
    - Свръхчувствителност към левофлоксацин, други хинолони и/или към някое от помощните вещества на изследваните лекарствени продукти
    - Лечение със системни хинолони в последните 30 дни и/или системни кортикостероиди през последните 14 дни или в хода на изпитването
    - Лечение с НСПВС, кортикостероиди или хинолони, предназначени за приложение в окото през последните 7 дни
    - Участие в друго клинично изпитване, свързано с приложение на антибактериални средства, кортикостериоди или НСПВС
    - Бременност и кърмене
    - Резултат от микробиологично изследване, показващ нечувствителен към левофлоксацин причинител.
    - Поява на реакции на свръхчувствителност
    - Неповлияване на клиничното състояние в рамките на 3-4 дни от началото на лечението (Визита 2).
    - Отказ от подписване на Информирано съгласие
    - Нежелание от страна на пациента за продължаване на участие
    - Неспазване условията на Протокола
    - Лична преценка на изследователя
    - Поява на обстоятелства, несвързани с участието в изпитването (напр. промяна на местоживеене)
    E.5 End points
    E.5.1Primary end point(s)
    Microbiological finding, eradication rate, biomicroscopy data
    Mикробиологична находка, степен на ерадикация на причинителя, данни от биомикроскопия
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1, Visit 3
    Визита 1, визита 3
    E.5.2Secondary end point(s)
    Clinical symptoms (redness, irritation, itching, feeling presence of foreign body, secretion, photosensitivity)
    Kлинични симптоми (зачервяване, дразнене, сърбеж, чувство за наличие на чуждо тяло, секреция, фоточувствителност)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Визита 1, визита 2, визита 3
    Visit 1, visit 2, visit 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 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 Yes
    E.8.1.3Single blind No
    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.8.2.4Number 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 concerned2
    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
    LVLS
    Последна визита последен пациент
    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 months8
    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 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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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)
    None.
    Няма.
    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 Decision2013-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-04
    P. End of Trial
    P.End of Trial StatusCompleted
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