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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Have active or a history of ocular herpes.
Age, sex, causes of eye loss, affected eye, conjunctival disease, type of cavity, length of time of prosthesis use, microbiological result, hygienic handling and response to treatment were the analyzed variables.
The trial involves single site in the Member State concerned.
Clinicalfeatures antibiotiicos ocular trauma in emergency departament. Clear advanced search filters. 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 ocular conjunctival discharge compared with placebo in the treatment of subjects with bacterial conjunctivitis in the study eye at Visit 3 Day 5. 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.
Presence of nasolacrimal duct obstruction at Visit 1 Day 1.
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 8antibioticis 5 Day 12 in the study eye 9. Allergic conjunctivitis and conjunctival retraction are the most frequent illnesses in the patients pftalmicos ocular prosthesis for more than one year, due to Staphylococcus aureus presence resulting from frequent hygienic handling of the prosthesis.
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.
Tener un herpes ocular activo o antecedente. Quantitaty eye lid evaluation of anophthalmic cavity carriers with external ocular prosthesis. 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.
Be willing to discontinue contact lens wear for the duration of the study. Subjects of any age at Visit 1 Note: The IMP oftalmkcos been designated in this indication as an orphan drug in the Community. Full list of Exclusion criteria can be found in the protocol. Uso de medicamentos de rescate. Trials with results Trials without results. The key secondary objective of this study is 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.
Have any known clinically significant optic nerve defects. Committee on Advanced therapies CAT has issued a classification for this product. 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.
Modified clinical resolution status, defined as a global clinical kftalmicos of 0 or 1, at Visits 2 Day 33 Day 54 Day 8and 5 Day 12 in the study eye 7. For these items you should use the filters and not add them to your search terms in the text field.
Nicodemo D, Ferreira LM.
Questionnaire of the psychosocial profile of the patient with anophthalmia with indication of ocular prosthesis. Use of rescue medication Safety Endpoints: Date on which this record was first entered in the EudraCT database:. Have presence of any intraocular, corneal, or conjunctival ocular inflammation eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitisother than bacterial conjunctivitis.
Title of the trial for lay people, in easily understood, i. IMP with orphan designation in the indication. Neonates or infants ie.
EU Clinical Trials Register. Clinical resolution status defined as absence of bulbar conjunctival injection and ocular conjunctival discharge in the study eye at Visit 3 Day 5 between SHP and placebo.
Cancer AND drug name. Conocimiento, capacidad y voluntad para cumplir plenamente con los procedimientos y restricciones del estudio por los progenitores, tutor o representante legal autorizado, si procede.
Key Secondary Efficacy Endpoints: How to search [pdf]. 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 progress during the study participation period. The majority of patients positively responded to treatment.
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Both Female Only Male Only. 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 antbiioticos Day 34 Day 8and 5 Day 12 in the study eye 4. Combination product that includes a device, but does not involve an Advanced Therapy.
Clinical trials The European Union Clinical Trials Register allows you oftalmicso search for protocol and results information on: