E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary open angle glaucoma or intraocular hypertension |
Glaucoma primario de ángulo abierto o hipertensión intraocular |
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E.1.1.1 | Medical condition in easily understood language |
Primary open angle glaucoma or intraocular hypertension |
Glaucoma primario de ángulo abierto o hipertensión intraocular |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030043 |
E.1.2 | Term | Ocular hypertension |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036719 |
E.1.2 | Term | Primary open angle glaucoma |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To confirm the clinical non-inferiority of the preservative-free fixed combination Latanoprost/ Timolol eye drops compared with the marketed preservative-containing Xalacom? eye drops by the average decrease of diurnal IOP measured between the first and last visit |
Confirmar la no inferioridad clínica de las gotas oftálmicas de latanoprost y timolol en combinación fija y sin conservantes en comparación con las gotas oftálmicas comercializadas Xalacom? que contienen conservantes, mediante la disminución media de la PIO diurna entre la primera y la última visita |
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E.2.2 | Secondary objectives of the trial |
The average decreases of diurnal IOP measured between baseline and days 7 and 14 and the proportion of patients with measured IOP <21 mmHg at the end of the clinical trial |
La disminución promedio de la presión intra ocular (PIO) diurna entre la visita basal y las visitas de los dias 7 y 14 y la proporción de pacientes con una PIO <21 mmHg al final del ensayo clínico |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- male or female, of any race and ?18 years of age; - diagnosed of unilateral or bilateral primary open angle glaucoma or ocular hypertension; - on treatment with an IOP-lowering prostaglandin analogue/beta blocker combination for at least 6 months; - on treatment with an IOP ?21 mmHg measured as the mean of both eyes at two measurements at least one hour apart; - best-corrected visual acuity ?20 of 100 corresponding to logMAR of 0.7 in both eyes; - in case of women, postmenopausal (>12 months without menstrual bleeding), surgically sterilized, or on use of effective birth control measures; - expected by the investigator that IOP would remain controlled with the new treatment without optic nerve damage or progression of visual field loss; - able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits; - willing to provide voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed. |
- hombres o mujeres, de cualquier raza y ?18 años; - que estén diagnosticados de glaucoma primario de ángulo abierto o hipertensión ocular; - que estén en tratamiento con una combinación de un reductor de la PIO análogo de prostaglandina y un bloqueante beta durante al menos 6 meses; - que estén en tratamiento y tengan una PIO ?21 mmHg, determinada como la media de ambos ojos en dos mediciones realizadas al menos con una hora de diferencia; - con mejor agudeza visual corregida ?20 de 100 que corresponde en logMAR a 0,7 en ambos ojos - en el caso de las mujeres, que sean posmenopáusicas (>12 meses sin periodo), estén esterilizadas quirúrgicamente o usen medidas anticonceptivas eficaces; - en los que el investigador prevea que la PIO permanecerá controlada con el nuevo tratamiento sin dañar el nervio óptico y sin que avance la pérdida del campo visual; - capaces de entender los requisitos del ensayo y que estén dispuestos a acudir a las visitas de control necesarias; - dispuestos a otorgar voluntariamente su consentimiento informado por escrito y firmar la declaración de protección de datos antes de realizar cualquier procedimiento relacionado con el ensayo. |
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E.4 | Principal exclusion criteria |
- pre-treatment for primary open angle glaucoma or intraocular hypertension other than prostaglandin analogue/beta blocker combinations; - a history of chronic or recurrent inflammatory eye disease, ocular trauma or infections; - narrow-angle/angle-closure glaucoma; - clinically significant or progressive retinal disease; - intraocular surgery within the past 6 months; - ocular laser surgery within the past 3 months; - a change in glaucoma therapy within 1 month before the screening visit; - best-corrected visual acuity worse than 0.7 logarithm of minimal angle of resolution (logMAR) score, extremely narrow or partially closed angle, cup/disk ratio >0.8; - history of bronchial asthma, or severe chronic obstructive pulmonary disease; reactive airway disease including bronchial asthma, - treatment with local or systemic corticosteroids; - inability to discontinue the use of glucocorticoid medications; - not receiving stable doses of any medication that could affect IOP for 30 days before the beginning of the clinical trial (e.g. clonidine); - a history of allergic hypersensitivity or poor tolerance to any component of the eye drop solution used in this clinical trial or a contraindication of ß-adrenergic receptor antagonists due to systemic disease; - sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure or cardiogenic shock; - pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control; - current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s); - unwillingness or inability to comply with the clinical trial procedures; - unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons; - who are legally incapacitated, - who are legally detained in an official institute. |
- tratamiento previo para el glaucoma primario de ángulo abierto o hipertensión intraocular que no sea con un análogo de prostaglandina y un bloqueante beta - antecedentes de enfermedad inflamatoria ocular crónica o recurrente, traumatismos o infecciones oculares; - glaucoma de ángulo estrecho o ángulo cerrado; - retinopatía clínicamente importante o progresiva; - cirugía intraocular en los 6 últimos meses; - cirugía ocular con láser en los 3 últimos meses; - cambio en el tratamiento del glaucoma en el mes anterior a la visita de selección; - mejor agudeza visual corregida inferior a 0,7 logaritmo del ángulo mínimo de resolución (logMAR), ángulo muy estrecho o parcialmente cerrado, relación copa/disco >0,8; - antecedentes de asma bronquial o enfermedad pulmonar obstructiva crónica grave; enfermedad reactiva de las vías respiratorias, incluido el asma bronquial - tratamiento con corticosteroides locales o sistémicos; - incapacidad para suspender el uso de glucocorticoides; - dosis inestables de algún medicamento que pudiera afectar a la PIO en los 30 días anteriores al inicio del ensayo clínico (p. ej., clonidina); - antecedentes de hipersensibilidad alérgica o mala tolerancia a cualquier componente de la solución en gotas oftálmicas usada en este ensayo clínico o contraindicación de los antagonistas de los receptores adrenérgicos ß por enfermedad sistémica; - bradicardia sinusal, bloqueo auriculoventricular de segundo o tercer grado, insuficiencia cardiaca franca o choque cardiogénico; - embarazo o lactancia o edad fértil sin protección mediante un método anticonceptivo eficaz; - participación actual o que no haya terminado todavía el periodo de al menos 30 días desde la finalización de la participación en otro(s) ensayo(s) clínico(s) de un fármaco o dispositivo en investigación - poca disposición o incapacidad para completar los procedimientos del ensayo clínico; - poca disposición a otorgar el consentimiento para la conservación, grabación y transmisión de los datos médicos bajo pseudónimo por razones del ensayo clínico; - incapacidad legal, - detenidos legalmente en una institución oficial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Diurnal IOP measured by ocular tonometry (Goldmann Applanation Tonometry) |
PIO diurna medida mediante tonometría ocular (tonometría por aplanamiento de Goldmann) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
?number of withdrawals for therapeutic failure (diurnal IOP ?21 mmHg at any time point during or at the end of the clinical trial will be analysed by using Fisher?s exact test. |
"número de abandonos por fracaso terapéutico" (PIO diurna ?21 mmHg en cualquier momento durante el ensayo clínico o al final del mismo) se analizará mediante la prueba exacta de Fisher |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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
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LVLS |
LVLS (última visita del último paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |