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    Summary
    EudraCT Number:2011-002601-30
    Sponsor's Protocol Code Number:QTM/OMN0111
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-07-19
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2011-002601-30
    A.3Full title of the trial
    A COMPARISON OF LATANOPROST 50µg/ml EYE DROPS vs. XALATAN EYE DROPS IN THE TREATMENT OF OPEN ANGLE GLAUCOMA: AN OPEN, RANDOMIZED, CLINICAL TRIAL
    COMPARACION DE LATANOPROST 50μg/ml COLIRIO vs. XALATAN COLIRIO EN EL TRATAMIENTO GLAUCOMA DE ANGULO ABIERTO: UN ESTUDIO CLINICO ABIERTO, RANDOMIZADO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A COMPARISON OF LATANOPROST 50µg/ml EYE DROPS vs. XALATAN EYE DROPS IN THE TREATMENT OF OPEN ANGLE GLAUCOMA
    COMPARACION DE LATANOPROST 50μg/ml COLIRIO vs. XALATAN COLIRIO EN EL TRATAMIENTO DE GLAUCOMA DE ANGULO ABIERTO
    A.3.2Name or abbreviated title of the trial where available
    QTM/OMN0111
    A.4.1Sponsor's protocol code numberQTM/OMN0111
    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 SponsorOMNIVISION GmbH
    B.1.3.4CountryGermany
    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 supportOmnivision GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuantum Experimental S.L
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressAvd/ M40 Portal 17 1º69
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28925
    B.5.3.4CountrySpain
    B.5.4Telephone number3491485 53 47
    B.5.5Fax number3491485 54 09
    B.5.6E-mailaescacena@quantumexperimental.es
    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 nameLatanoprost
    D.3.4Pharmaceutical form Eye drops
    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 INNLATANOPROST
    D.3.9.1CAS number 130209-82-4
    D.3.9.3Other descriptive name13,14-dihydro-15(R)-17-phenyl-18,19,20-trinor-prostaglandina-2-alpha-isopropyl ester
    D.3.9.4EV Substance CodeSUB08409MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Xalatan
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameXALATAN
    D.3.4Pharmaceutical form Eye drops
    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 INNLATANOPROST
    D.3.9.1CAS number 130209-82-4
    D.3.9.4EV Substance CodeSUB08409MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Open angle glaucoma
    Glaucoma de ángulo abierto
    E.1.1.1Medical condition in easily understood language
    Glaucoma
    Glaucoma
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10030856
    E.1.2Term Open-angle glaucoma
    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
    To explore the clinical efficacy of the Latanoprost 50 µg/ml in comparison with marketed Latanoprost (Xalatan, Pfizer) in the relief open angle glaucoma
    Evaluar la eficacia clínica de Latanoprost 50 μg/ml colirio en comparación con Latanoprost comercializado (Xalatan, Pfizer) en el alivio de glaucoma de ángulo abierto
    E.2.2Secondary objectives of the trial
    To collect information on safety and tolerability of the product under investigation.
    Recoger información sobre la seguridad y tolerancia del producto en estudio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    >18 years of age
    Diagnosis of open angle glaucoma, ocular hypertension, pigmentary glaucoma or exfoliation glaucoma
    Expectation by the investigator that IOP would remain controlled with a single treatment without optic nerve damage or progression of visual field loss.
    Edad > 18 años
    Diagnóstico de glaucoma de ángulo abierto, hypertension ocular, glaucoma pigmentario y glaucoma pseudoexfoliativo
    Expectativa por el investigador que la PIO se mantendría controlada con un solo tratamiento, sin daño del nervio óptico o la progresión de la pérdida del campo visual.
    E.4Principal exclusion criteria
    Using topical ocular anti-glaucoma within 14 days prior to the study.
    Narrow angle glaucoma patients.
    Ocular surgery or lasser trabelulopalasty carried out within 6 months prior to the study.
    History of allergic hypersensitivity or poor tolerance to any component of the preparations used in this trial.
    Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
    No deben incluirse pacientes con glaucoma de ángulo cerrado
    Cirugía ocular o trabeculoplastia láser en los 6 meses previos al estudio.
    No tener antecedentes de hipersensibilidad o intolerancia a los componentes de los productos utilizados en estudio.
    Mujeres embarazadas o lactantes y mujeres en edad fértil que no utilizan métodos de control de embarazo fiables
    E.5 End points
    E.5.1Primary end point(s)
    Inter Ocular Pressure (IOP)
    Presion Intra Ocular (PIO)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1, day 7, day 14 and day 28
    Día 1, día 7, día 14 y día 28
    E.5.2Secondary end point(s)
    -Best-corrected log MAR visual acuity
    -Ophthalmoscopy
    -Ocular discomfort after instillation of the study drug
    - Agudeza visual bajo mejor corrección (log MAR)
    - Oftalmoscopia
    - Disconfort ocular tras la aplicación del colirio
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, day 7, day 14 and day 28
    Día 1, día 7, día 14 y día 28
    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) 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 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 Yes
    E.8.2.3.1Comparator description
    Xalatan
    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 end of the trial is expected to be in February 2012
    El final del estudio se prevé para Febrero de 2012
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state150
    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)
    FOLLOW UP
    SEGUIMIENTO
    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 Decision2011-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-04
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