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    The EU Clinical Trials Register currently displays   43976   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-001640-22
    Sponsor's Protocol Code Number:C-12-009
    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:2013-02-07
    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 number2012-001640-22
    A.3Full title of the trial
    An Open-Label, Pharmacokinetic and Safety Study of Travoprost Ophthalmic Solution, 0.004% in Pediatric Glaucoma or Ocular Hypertension Patients
    Estudio abierto, de farmacocinética y de seguridad de la solución oftálmica de Travoprost al 0,004% en pacientes pediátricos con glaucoma o hipertensión ocular.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients
    Estudio de farmacocinética y de seguridad de Travoprost al 0,004% en pacientes pediátricos con glaucoma
    A.3.2Name or abbreviated title of the trial where available
    Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients
    Estudio de farmacocinética y de seguridad de Travoprost al 0,004% en pacientes pediátricos con glauc
    A.4.1Sponsor's protocol code numberC-12-009
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlcon Research Ltd
    B.1.3.4CountryUnited States
    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 supportAlcon Research Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlcon Eye Care UK Ltd
    B.5.2Functional name of contact pointHead of EURMEA Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressFrimley Business Park, Frimley
    B.5.3.2Town/ cityCamberley, Surrey
    B.5.3.3Post codeGU16 7SR
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4401276673389
    B.5.6E-mailzubair.hussain@alconlabs.com
    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 Travatan
    D.2.1.1.2Name of the Marketing Authorisation holderAlcon Laboratories UK, Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOphthalmic use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtravoprost
    D.3.9.1CAS number 157283-68-6
    D.3.9.3Other descriptive nameTRAVATAN
    D.3.9.4EV Substance CodeSUB12613MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.004
    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
    Paediatric glaucoma
    Glaucoma pediátrico
    E.1.1.1Medical condition in easily understood language
    Glaucoma, elevated intraocular pressure
    Glaucoma, presión intraocular elevada
    E.1.1.2Therapeutic area Body processes [G] - Ocular Physiological Phenomena [G14]
    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 evaluate the steady-state plasma concentrations of Travoprost
    free acid (AL-5848) following once daily administration of
    Travoprost Ophthalmic Solution, 0.004% (preserved with
    POLYQUAD) in pediatric patients with glaucoma or ocular
    hypertension. To assess the safety of Travoprost Ophthalmic
    Solution, 0.004% in pediatric patients with glaucoma or ocular
    hypertension.
    Determinar las concentraciones plasmáticas en estado de equilibrio del ácido libre de Travoprost (AL-5848) tras administrar una dosis diaria de la solución oftálmica de Travoprost al 0,004 % (conservada con POLYQUAD) en niños con glaucoma o hipertensión ocular. Analizar la seguridad de la solución oftálmica de Travoprost al 0,004 % en pacientes pediátricos con glaucoma o hipertensión ocular.
    E.2.2Secondary objectives of the trial
    Not Applicable
    No procede.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients 2 mo to < 18 years of age at the time of screening.
    2. Diagnosis of glaucoma or ocular hypertension in at least 1 eye.
    NOTE: Patients with conditions requiring chronic treatment
    with glucocorticoids resulting in steroid induced glaucoma may
    be enrolled.
    3. A parent/legal guardian (if necessary, a legally authorized
    representative) must provide informed consent that has been
    approved by the Institutional Review Board/ Independent Ethics
    Committee (IRB/IEC), and children must agree to sign an
    approved assent form when applicable.
    4. Must agree to comply with the requirements of the study and
    must be accompanied by a parent/guardian.
    5. Aphakic patients with contact lenses may be enrolled.
    1. Pacientes de 2 meses a < 18 años en el momento de la selección.
    2. Pacientes a los que se les ha diagnosticado glaucoma o hipertensión ocular en al menos 1 ojo.
    NOTA: pueden incluirse pacientes que requieran un tratamiento crónico con glucocorticoides producto del glaucoma esteroideo.
    3. Un padre/tutor legal (si es necesario, un representante legal autorizado) deberá aportar el consentimiento informado que ha autorizado la Junta de Revisión Institucional/ Comité Independiente de Ética (IRB/IEC) y, si corresponde, los niños deben aceptar firmar un formulario de conformidad.
    4. Debe cumplir los requisitos del estudio y debe estar acompañado por un padre/tutor.
    5. Pueden incluirse pacientes afáquicos que utilicen lentes de contacto.
    E.4Principal exclusion criteria
    1. Females of childbearing potential are excluded from participation in the study, if they meet any of the conditions outlined in the protocol.
    2. Patients with only 1 sighted eye or monocular patients (including patients who cannot be dosed in both eyes for any reason).
    3. History of chronic, recurrent or severe inflammatory eye disease (ie, scleritis, uveitis, herpes keratitis).
    4. Ocular trauma requiring medical attention within the past 3 months prior to the Screening Visit.
    5. Ocular infection or ocular inflammation within the past 30 days prior to the Screening Visit.
    6. Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
    7. Other severe ocular pathology (including severe dry eye), that in the opinion of the Investigator, would preclude the administration of a topical prostaglandin analogue.
    8. Intraocular surgery within the past 30 days prior to the Screening Visit.
    9. Any abnormality preventing reliable tonometry including history of penetrating keratoplasty.
    10. Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
    11. Hypersensitivity to prostaglandin analogues or to any component of the study medications, including medication administered during study exams, in the opinion of the Investigator.
    12. Less than 30 days before the Screening Visit of stable dosing regimen of any medications (excluding the IOPlowering treatments) or substances administered by any route and used on a chronic basis. The dosing regimen of these medications should not change during the study.
    13. Therapy with another investigational agent or device within 30 days prior to the Screening Visit.
    14. Concurrent use of topical prostaglandin analogues during investigational product treatment period.
    15. Children less than 5kg of body weight.
    1. Se excluyen de este estudio todas las mujeres en edad fértil si se dan alguna de las siguientes condiciones descritas en el protocolo.
    2. Pacientes con vista en 1 ojo o pacientes monoculares (incluidos aquellos pacientes a los que no se les puede administrar la dosis en los dos ojos por cualquier motivo).
    3. Antecedentes de retinopatía inflamatoria crónica, recurrente o grave (es decir, escleritis, uveítis, queratitis por herpes).
    4. Traumatismo ocular que precisó asistencia médica en el plazo de los 3 meses anteriores a la visita de selección.
    5. Infección o inflamación ocular en el plazo de los 30 días anteriores a la visita de selección.
    6. Retinopatía clínicamente apreciable o progresiva, como degeneración retinal, retinopatía diabética o desprendimiento de la retina.
    7. Otras patologías oculares graves (entre las que se incluyen la xeroftalmia grave) que, según el investigador, imposibilitarían la administración de un análogo de la prostaglandina por vía tópica.
    8. Cirugía intraocular en el plazo de los 30 días anteriores a la visita de selección.
    9. Cualquier anomalía que impida una tonometría fiable, entre las que se incluyen los antecedentes de queratoplastia relevante.
    10. Cualquier otro estado, incluso enfermedades graves que, a criterio del investigador, harían que el paciente no fuera apto para el estudio.
    11. Hipersensibilidad, en opinión del investigador, a los análogos de la prostaglandina o a los componentes de los medicamentos del estudio según el investigador, incluidos los medicamentos administrados durante las exploraciones del estudio.
    12. Pauta terapéutica estable de cualquier medicamento que se haya llevado a cabo en un periodo inferior a 30 días antes de la visita de selección (no se incluyen los tratamientos para reducir la PIO), o bien sustancias administradas por cualquier tipo de vía o empleadas de manera crónica. La pauta terapéutica de estos medicamentos no debe variar durante el estudio.
    13. Tratamiento con otro elemento o dispositivo de investigación en el plazo de los 30 días anteriores a la visita de selección.
    14. Uso simultáneo de análogos de prostaglandina por vía tópica en la fase de tratamiento del producto en investigación.
    15. Niños de menos de 5 kg de peso corporal.
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    ? Extent of exposure
    ? Adverse events
    ? Best-corrected Visual Acuity (BCVA)
    ? Slit-lamp examination (eyelids/conjunctiva, cornea, lens, and
    iris/anterior chamber including aqueous flare and inflammatory
    cells)
    ? Dilated fundus parameters (vitreous, retina, macula, choroid, optic
    nerve and cup/disc ratio)
    ? Ocular Hyperemia
    ? Alertness
    ? Vitals signs (pulse, blood pressure, respiration rate and body
    temperature)
    ? 12 lead ECG
    Pharmacokinetic:
    ? Cmax
    ? Tmax
    ? Tlast (for each patient with at least 1 quantifiable time point)
    ? AUC0-last (provided sufficient quantifiable data exist)
    ? AUC 0-? (provided sufficient quantifiable data exist)
    ? t1/2 (provided sufficient quantifiable data exist)
    Seguridad:
    ? Alcance de la exposición
    ? Acontecimientos adversos
    ? Agudeza visual con la mejor corrección (BCVA)
    ? Examen con lámpara de hendidura (párpados/conjuntiva, córnea, lentes e iris/cámara anterior, incluida la turbidez en el humor acuoso y las células inflamatorias)
    ? Parámetros del fondo de ojo dilatado (vítreo, retina, mácula, coroide, nervio óptico y relación copa/disco)
    ? Hiperemia ocular
    ? Estado de alerta
    ? Constantes vitales (pulso, tensión arterial, frecuencia respiratoria y temperatura)
    ? ECG de 12 derivaciones
    Farmacocinética:
    ? Cmáx
    ? Tmáx
    ? Túltima (para los pacientes con al menos 1 momento cuantificable)
    ? ABC0-última (si existen datos cuantificables suficientes)
    ? ABC 0-? (si existen datos cuantificables suficientes)
    ? t1/2 (si existen datos cuantificables suficientes)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 7: pre-dose (trough) 0 min, 0.17 hr (10 min), 0.33 hr (20 min), 0.67 hr (40 min), and 1.33 hr (80 min)
    Día 7: dosis previa (mínimo) 0 min, 0,17 h (10 min), 0,33 h (20 min), 0,67 h (40 min) y 1,33 h (80 min)
    E.5.2Secondary end point(s)
    Not Applicable
    No procede.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    No procede.
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Paediatric PK study
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Brazil
    Colombia
    France
    Germany
    India
    Philippines
    Poland
    Portugal
    Saudi Arabia
    Singapore
    Spain
    Taiwan
    United Kingdom
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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: 24
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 8
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Paediatric patients who will need a caregiver to provide consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 24
    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)
    Not different from the expected normal treatment for the condition.
    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 Decision2013-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-09
    P. End of Trial
    P.End of Trial StatusCompleted
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