E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Functional Epifora |
Epífora funcional |
|
E.1.1.1 | Medical condition in easily understood language |
Continuous tearing |
Lagrimeo continuo |
|
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 |
Compare through the Munk Scale the efficacy of Botulinum Toxin A (IncobotulinuntoxinA) versus lateral tarsal strip, which is the usual surgery technique to treat the functional epifora, after 6 weeks of treatment. |
Comparar la eficacia de la Toxina Botulinica tipo A (TBA) IncobotulinuntoxinA frente a la técnica habitual quirúrgica de tensado horizontal con tira tarsal lateral en la epífora funcional mediante la Escala de Munk a las 6 semanas del tratamiento |
|
E.2.2 | Secondary objectives of the trial |
*Compare through the Schirmer Test the efficacy of treatment with Botulinum Toxin A VS lateral tarsal strip, the usual surgery technique, to treat the functional epifora after 2, 6, 12, 18, 24 and 30 weeks and through the Munk Scale after 2, 12, 18, 24 and 30 weeks . *Evaluate the effect duration of Botulinum Toxin A in functional epifora. *Describe the adverse events of Botulinum Toxin A. *Assess the relationship between the Munk Scale and the Shirmer Test in functional epífora. *Evaluate the successful rate in both treatments according to the laxity palpebral grade through the palpebral traction technique. |
*Comparar la eficacia de la TBA frente a la técnica habitual quirúrgica en la epífora funcional mediante el test de Schirmer a las 2, 6, 12, 18, 24 y 30 semanas del tratamiento y mediante la Escala de Munk a las 2, 12, 18, 24 y 30 semanas del tratamiento. *Evaluar la calidad de vida con el cuestionario específico de Shin et al. de los pacientes con epífora funcional después de los tratamientos a estudio. *Evaluar duración del efecto de TBA en epífora funcional. *Describir los efectos adversos de la toxina botulínica tipo A. *Valorar la tasa de éxito en ambos tratamientos según el grado de laxitud palpebral mediante la técnica de tracción palpebral o resorte palpebral. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
*Patients older than 18 years *Epifora with permeable tear duct with at least grade 3 in the Munk Scale. |
*Pacientes mayores de 18 años. *Epífora con vía lagrimal permeable con un valor mínimo de grado 3 en la escala de Munk. |
|
E.4 | Principal exclusion criteria |
*Pregnancy and Breastfeeding. *Patients with blepharoconjunctivitis with or without keratitis. *Palpebral malposition. *Background of previous palpebral surgery. *Tear Dysfunction Syndrome. *History of eye trauma or the tear duct. *Previous dacryocystorhinostomy. *Background of previous refractive surgery. *Coagulopathy. *Ptosis. *Disfunction of eye motility. *Hypersensitivity to Botulinum Toxin A or to any of the product excipients. |
*Embarazo y Lactancia *Pacientes con blefaroconjuntivitis acompañado o no de queratitis. *Malposiciones palpebrales. *Antecedentes de cirugía palpebral previa. *Síndrome de disfunción lagrimal. *Historia de trauma ocular o de la vía lagrimal. *Dacriocistorrinostomía previa. *Antecedentes de cirugía refractiva previa. *Coagulopatía. *Ptosis. *Disfunción de la motilidad ocular. *Hipersensibilidad a neurotoxina botulínica de tipo A o alguno de los excipientes del producto comercial. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Munk Scale |
Escala de Munk |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 weeks after treatment |
A las 6 semanas de tratamiento. |
|
E.5.2 | Secondary end point(s) |
*Schimer Test. *Munk Scale *Shin et al. questionnaire. *Palpebral traction technique. |
*Test de Schimer. *Escala de Munk. *Cuestionario de Shin et al. *Técnica de tracción palpebral. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
*Schimer Test: 2, 6, 12, 18, 24 and 30 weeks after treatment. *Munk Scale: 2, 12, 18, 24 and 30 weeks after treatment. *Shin et al. questionnaire: before and after both treatments. *Palpebral traction technique: not defined. |
*Test de Schimer: 2, 6, 12, 18, 24 y 30 semanas después del tratamiento. *Escala de Munk: 2, 12, 18, 24 y 30 semanas después del tratamiento. *Cuestionario de Shin et al: antes y después de ambos tratamientos. *Técnica de tracción palpebral: sin definir. |
|
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 | Yes |
E.8.1.7.1 | Other trial design description |
Unicéntrico |
Single center |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Cirugía de tira tarsal lateral. |
Lateral tarsal strip surgery |
|
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
|
LVLS. |
Última visita último paciente. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |