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Clinical trials The European Union Clinical Exueado Register allows you to search for protocol and results information on: Cancer AND drug name. Pneumonia AND sponsor name. 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 with results Trials without results Clear advanced toico filters. Review by the Competent Authority or Ethics Committee in the country concerned.
EU Clinical Trials Register. Both Female Only Male Only. Oticp with orphan designation in the indication. 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 in this indication as an orphan drug in the Community.
Committee on Advanced therapies CAT has issued a classification for this product. Combination product that includes a device, but does oticl involve an Advanced Therapy.
The primary objective of this study is to evaluate the efficacy of SHP based on clinical resolution defined as absence of bulbar conjunctival injection and watery conjunctival discharge compared with placebo in the treatment of subjects with adenoviral conjunctivitis in the study eye at Visit 3 Day 6.
Los objetivos secundarios clave de este estudio son los siguientes: La lista completa de objectivos secuandarios se puede encontrar en el protocolo. Subjects of any age at Visit 1 Note: Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye the same eye as the AdenoPlus positive 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 otio of the study.
Full list of Inclusion criteria can be found in the protocol. Conocimiento, capacidad y voluntad para cumplir plenamente con los procedimientos y restricciones del estudio por los progenitores, exudaod o representante legal autorizado, si procede. Pacientes 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 adenoviral conjunctivitis. Have presence of corneal subepithelial infiltrates at Visit 1.
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Have active or 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 variables.
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 which requires invasive treatment eg, intravitreal treatment with VEGF inhibitors or corticosteroids and may progress during the study participation period.
Full list of Exclusion criteria can be found in the protocol. Presencia de infiltrados subepiteliales corneales en la visita 1. Tener un herpes ocular activo o antecedente. Tener una enfermedad ocular significativa p.
Clinical resolution status defined as absence of bulbar conjunctival injection and watery conjunctival discharge in the study eye at Visit 3 Day 6 between SHP and placebo.
Key Secondary Efficacy Endpoint: Clinical resolution and 2. Adenoviral eradication status defined as negative cell culture-immunofluorescence assay [CC-IFA] in the study eye. Five hypotheses tests will be performed on the key secondary efficacy endpoints at Visit 3 Day 6 unless specified otherwise in following order: Comparison of proportion of subjects achieving adenoviral eradication between SHP and Placebo. Absolute and change from baseline in adenovirus viral titer as assessed by qPCR in the study eye 4.
The clinical resolution status of adenoviral conjunctivitis in the study eye 6. The individual clinical signs score bulbar conjunctival injection and watery conjunctival discharge and change from baseline in the study eye 7. The global clinical score as defined as the sum of bulbar conjunctival injection and watery conjunctival discharge and change from baseline in the global clinical score in the study eye 8.
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Modified clinical resolution status, defined as a global clinical score of 0 or 1, in the study eye 9. 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, in the study eye Time to clinical resolution based upon assessments in the study eye Safety Endpoints: Visit 3 Day 6 2.
Visits 2 Day 3 and 3 Day 6. Visit 3 Day 6 and 4 Day 8 4. Visits 4 Day 8 and 5 Day 12 5. Puntos finales de eficacia secundaria: 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.