ANTIBIOTICOS OFTALMICOS PDF

ANTIBIOTICOS OFTALMICOS PDF

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June 24, 2020

Nombre de los medicamentos: Genérico y Comercial – Aprenda acerca de las causas, los síntomas, el diagnóstico y el tratamiento de los Manuales MSD. Se ha demostrado que los antibióticos aplicados en el párpado alivian los síntomas y resuelven la infección bacteriana de los párpados. Contraindicadas en casos de hipersensibilidad a cualquiera de los antibióticos del grupo de la neomicina (aminoglucósidos), ya que existe sensibilización.

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Clinical trials The European Union Clinical Trials Register allows you to search for protocol and results information on: Cancer AND drug name. Pneumonia AND sponsor antibiotico. How to search [pdf]. For these items you should use the filters and not add them to your search terms in the text field.

Trials antibioitcos results Trials without results Clear advanced search filters. Review by the Competent Authority or Ethics Committee in the country concerned. EU Clinical Trials Register. Both Female Only Male Only. IMP with orphan designation in the indication.

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Trials with results Trials without results. Clear advanced search filters.

Date on which this record was first entered in the EudraCT database:. Title of the trial for lay people, in easily understood, i. The IMP has been designated anhibioticos this indication as an orphan drug in the Oftalmcios. Committee on Advanced therapies CAT has issued a classification for this product. Combination product that includes a device, but does not involve an Advanced Therapy. The primary objective oftalmixos this study is to evaluate the efficacy of SHP based on clinical resolution defined as absence of bulbar conjunctival injection and ocular conjunctival discharge compared with placebo in the treatment of subjects with bacterial conjunctivitis in the study eye at Visit 3 Day 5.

The key secondary objective of this study oftalicos to evaluate the efficacy of SHP based on bacterial eradication defined as absence of all bacterial species present at or above pathological threshold at baseline compared with placebo in the treatment of subjects with bacterial conjunctivitis in the study eye at Visit 3 Day 5.

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Subjects of any age at Visit 1 Note: Have a clinical diagnosis of suspected bacterial conjunctivitis in oftalmicod least 1 eye confirmed by the presence of the following minimal clinical signs and symptoms in that same eye: Be willing to discontinue contact lens wear for the duration of the study. Full list of Inclusion criteria can be found in the protocol.

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Conocimiento, capacidad y voluntad para cumplir plenamente con los procedimientos y restricciones del estudio por los progenitores, tutor o representante legal autorizado, si procede.

Sujetos de cualquier edad en la visita 1 Nota: Current or relevant history of physical or psychiatric illness, any medical disorder that may make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.

Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients. Have a preplanned overnight hospitalization during the period of the study. Have presence of any intraocular, corneal, or conjunctival ocular inflammation eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitisother than bacterial conjunctivitis.

Have oftalmiocs or a history of ocular herpes. Neonates or infants ie. Presence of nasolacrimal duct obstruction at Visit 1 Day 1. Presence of any significant ophthalmic condition eg, Retinopathy of Prematurity, congenital cataract, congenital glaucoma or other congenital disorder with ophthalmic involvement that could affect study antibioticso.

Have any known clinically significant optic nerve defects. Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect or any significant corneal opacity at Visit 1. Presence of significant, active condition in the posterior segment that requires invasive treatment eg, intravitreal treatment with vascular endothelial growth factor inhibitors or corticosteroids and may anibioticos during the study participation period.

Full list of Exclusion criteria can be found in the protocol. Tener un herpes ocular activo o antecedente. Tener una enfermedad ocular significativa p.

Clinical resolution status antibioticoe as absence of bulbar conjunctival injection and ocular conjunctival discharge in the study eye at Visit 3 Day 5 between SHP and placebo. Key Secondary Efficacy Endpoints: Bacterial eradication status defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye at Visit 3 Day 5 between SHP and placebo.

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Clinical resolution status of bacterial conjunctivitis at Visits 2 Day 34 Day 8and 5 Day 12 in the study eye 3.

Bacterial eradication status defined as absence of all bacterial species present at or above pathological threshold at baseline as assessed by bacterial culture at Visits 2 Day 34 Day 8and 5 Day 12 in the study eye 4. Absolute and change from baseline of the individual clinical signs bulbar conjunctival injection and ocular conjunctival discharge at Visits 2 Day 33 Day 54 Day 8and 5 Day 12 in the study eye 5.

The global clinical score defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge and change from baseline in the global clinical score at Visits 2 Day 33 Day 54 Day 8and 5 Day 12 in the study eye 6.

Modified clinical resolution status, defined as a global clinical score of 0 or 1, at Visits 2 Day 33 Day 54 Day 8and 5 Day 12 in the study eye 7. Expanded clinical resolution status, defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2, at Visits 2 Day 33 Day 54 Day 8and 5 Day 12 in the study eye 8.

Time to clinical resolution based upon assessments at Visits 2 Day 33 Day 54 Day 8and 5 Day 12 in the study eye 9. Use of rescue medication Safety Endpoints: Uso de medicamentos de rescate. Visit 3 Day 5 2. The trial involves single site in the Member State concerned. Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial. 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.