E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with eye pain associated to dry eye |
Pacientes con dolor ocular asociado a ojo seco |
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E.1.1.1 | Medical condition in easily understood language |
Patients with eye pain associated to dry eye |
Pacientes con dolor ocular asociado a ojo seco |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
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 assess the analgesic effect of different doses of SYL1001 ophthalmic solution. - Ocular tolerance at the site of administration (cornea and conjunctiva) after 10 days of treatment. |
- Evaluación del efecto analgésico de las distintas dosis del colirio en solución de SYL1001. - Tolerancia ocular en el sitio de administración (cornea y conjuntiva) tras 10 días de tratamiento. |
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E.2.2 | Secondary objectives of the trial |
? Assessment of systemic tolerance. Impact of the treatment (change from the baseline) in blood and urine parameters, the physical examination and in vital signs after 10 days of treatment. ? Assessment of local tolerance. Impact of the treatment (change from the baseline) in ocular parameters (visual acuity, intraocular pressure (IOP), Schirmer?s test and tear break-up time) ? Assessment of Adverse Events (AEs) occurred |
? Evaluación de la tolerancia sistémica. Repercusión del tratamiento (cambio con respecto al basal) en los parámetros sanguíneos y urinarios, en el examen físico y en los signos vitales tras 10 días de tratamiento. ? Evaluación de la tolerancia local. Repercusión del tratamiento (cambio con respecto al basal) en los parámetros oculares (agudeza visual, presión intraocular (PIO), test de Schirmer y tiempo de rotura de la lágrima) ? Evaluación de los Acontecimientos Adversos (AA) ocurridos |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients aged ? 18 years - Men or women (individuals of either sex can participate in the study) - Have submitted their written consent to participate in the study, after having received all information relating to the design, aims and possible risks resulting therefrom. - Common symptoms of persistent, daily, mild to moderate dry eye lasting more than three months. o OSDI scale between 13-70 o VAS scale between 2 ? 7
- Eye tests in both eyes until 15 days before inclusion: o Corneal fluorescein staining. Oxford scale > 0 o Tear break-up time (TBUT) < 10 seconds o Schirmer?s test with anaesthesia < 10 mm/5min |
- Pacientes de ? 18 años de edad - Hombres o mujeres (individuos de cualquier sexo pueden participar en el estudio) - Haber otorgado por escrito su consentimiento para participar en el estudio, después de haber recibido toda la información relativa al diseño, objetivos y posibles riesgos que de él se deriven. - Síntomas habituales de ojo seco, de leve a moderados de forma persistente y diaria durante más de tres meses. o Escala OSDI entre 13-70 o Escala EVA entre 2 ? 7 - Pruebas oculares en los dos ojos hasta 15 días antes de la inclusión: o Tinción corneal con fluoresceína. Escala Oxford > 0 o Tiempo de rotura de la lágrima (BUT) < 10 segundos o Test de Schirmer con anestésico < 10 mm/5min |
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E.4 | Principal exclusion criteria |
- Women who are pregnant or breastfeeding or who have a positive urine pregnancy test. Women who do not commit to use a medically acceptable method of contraception from the time of selection and throughout the study. - Any current, relevant disease, including respiratory disease, cardiovascular disease, endocrine disease, neurological disease, haematological disease, kidney disease, oncological disease, liver disease, gastrointestinal dysfunction, hypertension or active acute infectious processes. - Previous chronic or recurrent processes which, according to the investigator, could affect the development of the study. - Concomitant use of other medications with analgesic activity by any route of administration at the time of entry into the study. - Change in any concomitant eye and/or systemic medication of the patient one month before the study and during the study. - Changes in the pre-established administration schedule of artificial tears during the 15 days before the study and during the 10 days of the study. - Initiation of treatment with cyclosporine or changes in the dosage or administration schedule of cyclosporine within the 6 months before inclusion in the study. - History of hypersensitivity to drugs. - Use of contact lenses during the treatment and previous 15 days. - History of drug abuse or drug or alcohol dependence. - Laboratory abnormalities which, in the investigator?s opinion, are clinically significant. - Previous refractive surgery. - Having participated in another clinical trial within the 2 months prior to inclusion. - Another eye disease that is significant in the investigator?s opinion. |
- Mujeres embarazadas o en período de lactancia o test de embarazo en orina positivo. Mujeres que no se comprometan a seguir un método anticonceptivo médicamente aceptable desde la selección y durante todo el estudio. - Cualquier enfermedad relevante actual, incluyendo enfermedad respiratoria, cardiovascular, endocrina, neurológica, hematológica, renal, oncológica, hepatopatía, disfunción gastrointestinal, hipertensión o procesos infecciosos agudos activos. - Procesos crónicos o recurrentes previos que a juicio del investigador pudieran influir en el desarrollo del estudio. - Utilización concomitante de otros medicamentos con actividad analgésica por cualquier vía de administración en el momento de entrada en el estudio. - Cambio en cualquier medicación concomitante ocular y/o sistémica del paciente un mes antes del estudio y durante el mismo. - Cambios en la pauta preestablecida de administración de lágrimas artificiales siempre durante los 15 días anteriores y los 10 días que dura el estudio. - Inicio de tratamiento con ciclosporina o cambios en la posología o pauta de administración de ciclosporina en los 6 meses anteriores a la inclusión en el estudio. - Antecedentes de hipersensibilidad a fármacos. - Uso de lentillas durante el tratamiento y los 15 días anteriores. - Antecedentes de abuso o dependencia a fármacos o alcohol. - Alteraciones analíticas clínicamente relevantes, en opinión del investigador. - Cirugía refractiva previa. - Haber participado en otro ensayo clínico en los 2 meses previos a la inclusión. - Otra patología ocular relevante a juicio del investigador. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Assessment of the analgesic effect - The change from the baseline scoring on the VAS scale after 10 days of treatment. - The change from the baseline in the scoring of the OSDI questionnaire after 10 days of treatment.
Assessment of local tolerance - The frequency of new abnormalities occurring at the site of administration (cornea and conjunctiva) |
Evaluación del efecto analgésico - El cambio con respecto al basal en la puntuación de la escala EVA tras 10 días de tratamiento. - El cambio con respecto al basal en la puntuación del cuestionario OSDI tras 10 días de tratamiento.
Evaluación de la tolerancia local - La frecuencia de aparición de nuevas alteraciones en el sitio de administración (córnea y conjuntiva) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 10 days of treatment |
Tras 10 días de tratamiento |
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E.5.2 | Secondary end point(s) |
Assessment of systemic tolerance. The impact of treatment (change from the baseline) in the blood and urine parameters, the physical examination and in vital signs after 10 days of treatment. The impact of treatment (change from the baseline) in the remaining local tolerance parameters (anterior eye examination, visual acuity and IOP) after 10 days of treatment.
Assessment of AEs. All AEs occurring during the study will be recorded. |
Evaluación de la tolerancia sistémica. La repercusión del tratamiento (cambio con respecto al basal) en los parámetros sanguíneos y urinarios, en el examen físico y en los signos vitales tras 10 días de tratamiento. La repercusión del tratamiento (cambio con respecto al basal) en el resto de parámetros de tolerancia local (exploración anterior del ojo, agudeza visual y PIO) tras 10 días de tratamiento.
Evaluación de AA. Todos los AA ocurridos durante el estudio serán registrados. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 10 days of treatment |
Tras 10 días de tratamiento |
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
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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Closing of the database |
Cierre de la Base de Datos |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |