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NCT05677685
VISUPRIME® Eye Drops
Conditions: Macular Degeneration, Age Related, Myopic Choroidal Neovascularisation, Proliferative Diabetic Retinopathy, Diabetic Macular Edema, Macular Edema of Right Retina (Diagnosis)
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 76
Sponsor: VISUfarma SpA
Location: Italy
Summary
The study purpose is to assess the efficacy of VISUPRIME® eye drops in preventing the conjunctival bacterial load in patients undergoing to anti-VEGF injection.
Eligibility Criteria
Inclusion Criteria:Adult patients (age ≥ 18)Naïve and pre-treated patients scheduled for IVIDiagnosis of one of the following:ARMDmCNVProliferative diabetic retinopathyDiabetic macular oedemaMacular oedema secondary to retinal vein occlusionThe subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the local Ethics Committee (EC).Exclusion Criteria:Use of systemic antibiotics, corticosteroids within 3 monthsUse of topical antibiotics and or corticosteroids within 15 days from study enrolmentUse of topical Artificial Tears within 15 days from the enrolmentUse of topical antiseptic agents within 1 month from study enrolmentsPresence of topical ocular therapies that cannot be suspended for the entire duration of the studyOngoing ocular or systemic inflammatory or infectious processesKnown hypersensitivity to the constituents of the study productDiagnosis of Open-Angle GlaucomaUveitisAcute and Chronic Conjunctival DiseaseAny intraocular surgery within 6 months from study enrolment, excluded IVISevere and Moderate Dry EyePregnancy or breast-feedingParticipation in other clinical studiesPatients with cognitive impairment and unable to manage home-assigned treatment.
Source: ClinicalTrials.gov (NCT05677685). StuddyBuddy aggregates publicly available trial information.