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    EudraCT Number:2011-003816-21
    Sponsor's Protocol Code Number:RDG-10298_17Agosto2011
    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:2011-11-18
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2011-003816-21
    A.3Full title of the trial
    Multi-Center Study Assessing Efficacy and Tolerability of TRAVATAN® Solution without BAK, containing Polyquad® Preservative (0.004% travoprost) in Patients Previously on latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution Monotherapy
    Estudio Multicéntrico para evaluar la eficacia y la tolerabilidad de TRAVATAN® sin BAK (Cloruro de Benzalconio), con el conservante Polyquad (0,004% de travoprost) en pacientes previamente tratados con monoterapia consistente en solución oftálmica de latanoprost al 0,005% o bimatoprost al 0,01%.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to evaluate wether Travatan is effective and well tolerated by patients that were previously treated with latanoprost or bimatoprost
    Ensayo clínico para evaluar si Travatan es efectivo y bien tolerado por pacientes con tratamiento previo de latanoprost o bimatoprost.
    A.4.1Sponsor's protocol code numberRDG-10298_17Agosto2011
    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 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 organisationGenexion SA
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street Address15, rue des Alpes
    B.5.3.2Town/ cityGeneva
    B.5.3.3Post code1201
    B.5.4Telephone number410227043240
    B.5.5Fax number410227043242
    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. name TRAVATAN
    D. of the Marketing Authorisation holderAlcon Laboratories (UK) Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameTRAVATAN
    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 INNTravoprost
    D.3.9.1CAS number 157283-68-6
    D.3.9.2Current sponsor codeTravatan
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Ocular Hypertension
    Glaucoma de ángulo abierto
    Hipertensión ocular
    E.1.1.1Medical condition in easily understood language
    Ocular Hypertension
    Glaucoma de ángulo abierto
    Hipertensión ocular
    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 PT
    E.1.2Classification code 10030043
    E.1.2Term Ocular hypertension
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10030348
    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
    Change in IOP (on TRAVATAN® Solution without BAK, containing Polyquad® Preservative) at the 12 week visit from prior latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy (baseline).
    Cambio en la presión intraocular (con solución TRAVATAN® sin BAK, con el conservante Polyquad®) en la visita de 12 semanas desde el tratamiento previo con monoterapia de latanoprost al 0.005% o bimatoprost al 0.01% (estado basal)
    E.2.2Secondary objectives of the trial
    Percentage of patients who reach target IOP (≤ 18 mmHg).
    Porcentaje de pacientes que alcanzan la presión intraocular buscada (≤ 18 mmHg)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Must be at least 18 years of age.
    2.Must have a clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye.
    3.Must be on either latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy (including BAK containing generics) for at least 4 weeks prior the Screening Visit but, in the opinion of the investigator, would benefit from a switch to TRAVATAN® Solution without BAK, containing Polyquad® Preservative because of tolerability issues.
    4.IOP less than 30 mmHg in both eyes while on latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy.
    5.Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
    6.In the eye that is not included in the study, the IOP should be able to be controlled on no pharmacologic therapy or on the study medicine alone.
    7.Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
    8.Must be able to follow instructions and be willing and able to attend all study visits.
    9.Must have best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye.
    10.An Ethics Committee reviewed and approved (for use in this study) informed consent form must be read, signed, and dated by the participating patient, as well as signed and dated by the individual (Principal Investigator or other site personnel) obtaining the informed consent, before conducting the Screening Visit and prior to initiation of study procedures.
    1. Como mínimo 18 años de edad.
    2. Deberán estar clínicamente diagnosticados de hipertensión ocular o glaucoma de ángulo abierto al menos en un ojo.
    3. Deberán estar en monoterapia con solución oftálmica latanoprost 0,005% o bimatoprost 0,01% (incluidos los genéricos que contengan cloruro de benzalconio) durante al menos 4 semanas antes de la visita de selección y que, a juicio del investigador, puedan beneficiarse del cambio al colirio TRAVATAN® sin BAK, con el conservante Polyquad® porque tengan problemas de tolerabilidad.
    4. La presión intraocular deberá ser inferior a 30 mmHg en ambos ojos durante el tratamiento con latanoprost 0,005% o bimatoprost 0,01%.
    5. Deberán tener una presión intraocular que no represente riesgos (a juicio del investigador), en ambos ojos, de modo que pueda garantizarse una estabilidad clínica de la visión y del nervio óptico durante el período de estudio.
    6. En el ojo no incluido en el estudio, la presión intraocular debería poder controlarse sin ningún tratamiento farmacológico o solamente con el medicamento del estudio.
    7. Antes de recibir la medicación del estudio, deberán abandonar voluntariamente el uso de todos los demás medicamentos reductores de la presión ocular durante todo el período de duración del estudio.
    8. Deberán ser capaces de seguir todas las instrucciones y asistir voluntariamente a todas las visitas relacionadas con el estudio.
    9. Deberán tener una agudeza visual lo mejor corregida posible según el test de Snellen de 6/60 (20/200, 1.0 LogMAR) o mejor en cada ojo.
    10. El paciente participante deberá leer, firmar y datar un formulario de consentimiento informado revisado y aprobado por un comité ético (para su uso en este estudio), que deberá asimismo firmarse por el investigador principal u otro personal del centro que obtenga el consentimiento informado, antes de la visita de selección y antes de iniciarse los procedimientos del estudio.
    E.4Principal exclusion criteria
    1.Known medical history of allergy, hypersensitivity or poor tolerance to any components of the preparations to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
    2.Any abnormality preventing reliable applanation tonometry in either eye.
    3.Corneal dystrophies in either eye.
    4.Any opacity or patient uncooperativeness that restricts adequate examination of the anterior chamber of either eye.
    5.Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
    6.Severe dry eye, or Dry eye or keratoconjunctivitis sicca which has been, or is currently being, treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
    7.Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
    8.Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator?s best judgment.
    9.Progressive retinal or optic nerve disease from any cause.
    10.A history of, or at risk for uveitis or cystoid macular edema (CME).
    11.Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for at least 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
    12.Any clinically significant, serious, or severe medical condition.
    13.Women of childbearing potential not using reliable means of birth control. A reliable effective method of birth control must have been used for at least one month prior to Visit 1 and is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.
    14.Women who are pregnant or lactating
    15.A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient.
    16.Participation in any other investigational study within 30 days prior to the Screening Visit.
    1. Historial médico conocido de alergias, hipersensibilidad o poca tolerancia a cualquiera de los componentes de las preparaciones que vayan a utilizarse en este estudio y que puedan considerarse clínicamente significativas a juicio del investigador principal.
    2. Cualquier anormalidad que impida realizar una tonometría fiable en cualquier ojo.
    3. Distrofias de córnea en cualquier ojo.
    4. Cualquier opacidad o falta de colaboración por parte del paciente que limite un examen adecuado de la cámara anterior de cualquiera de los ojos.
    5. Conjuntivitis infecciosa o no infecciosa concurrente, queratitis o uveítis en cualquiera de los ojos.
    6. Ojo seco agudo, o bien ojo seco o queratoconjuntivitis sicca que ha sido o está siendo tratada actualmente con el uso de sellados puntuales, cauterización puntual, Restasis®, o mediante corticoesteroides oculares tópicos.
    7. Cirugía intraocular convencional o cirugía mediante láser en cualquiera de los ojos que haya tenido lugar menos de tres meses antes de la visita de selección.
    8. Riesgo de empeoramiento del campo visual o de la actividad visual como consecuencia de la participación en el estudio, a juicio del investigador.
    9. Enfermedad progresiva de la retina o del nervio óptico por cualquier motivo.
    10. Historial, o bien riesgo de uveítis o edema macular cistoide (EMC).
    11. Uso de cualquier medicamento sistémico que pueda afectar a la presión intraocular (por ejemplo, betabloqueantes adrenérgicos orales, alfa-agonistas y bloqueantes, inhibidores de enzimas conversores de la angiotensina y bloqueantes del calcio), que no hayan sido estabilizados al menos durante 7 días antes de la visita de selección o hayan tenido un cambio anticipado en la dosis durante el curso del estudio.
    12. Cualquier condición médica clínicamente significativa, grave o severa.
    13. Mujeres en edad fértil que no estén utilizando métodos fiables para el control de la natalidad. Deberán haber utilizado un método fiable para el control de la natalidad durante al menos un mes antes de la primera visita y éstos se definen como aquellos que tengan un bajo índice de error (es decir, menos de 1% por año) cuando se utilicen coherente y correctamente como implantes, inyectables, combinados con contraceptivos orales, algunos dispositivos intrauterinos (DIU), abstinencia sexual o pareja con vasectomía. Aquellas pacientes que utilicen un método contraceptivo hormonal, deberán ser informadas respecto al producto en evaluación y sus efectos potenciales sobre los contraceptivos.
    14. Mujeres embarazadas o lactantes
    15. Condición, que en opinión del investigador principal, podría interferir con una participación óptima en el estudio, o bien podría representar un riesgo especial para la paciente.
    16. La participación en cualquier otro estudio investigacional 30 días antes de la visita de selección.
    E.5 End points
    E.5.1Primary end point(s)
    Change in IOP (on TRAVATAN® Solution without BAK, containing Polyquad® Preservative) at the 12 week visit from prior latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy (baseline).
    Cambio en la presión intraocular (con solución TRAVATAN® sin BAK, con el conservante Polyquad®) en la visita de 12 semanas desde el tratamiento previo con monoterapia de latanoprost al 0.005% o bimatoprost al 0.01% (estado basal)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 semanas
    E.5.2Secondary end point(s)
    Percentage of patients who reach target IOP (≤ 18 mmHg).
    Porcentaje de pacientes que alcanzan la presión intraocular buscada (≤ 18 mmHg)
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 semanas
    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. 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Last visit Last subject
    Última visita del último paciente
    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 months12
    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 months12
    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: 120
    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 state53
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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 close out activities. Follow activities only in case of ongoing SAE or pregnancy
    Se realizarán las actividades estándar de finalización. Solo se hará seguimeinto en caso de Acontecimeintos Adversos graves abiertos y en caso de embarazo.
    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 Decision2011-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
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