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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05677685
Other study ID # VF-03-2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 22, 2023
Est. completion date January 23, 2024

Study information

Verified date April 2024
Source VISUfarma SpA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Multicentre, double-masked, placebo-controlled randomized 1:1 of the VISUPRIME® treatment in patients undergoing intravitreal anti-VEGF injection.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date January 23, 2024
Est. primary completion date January 23, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients (age = 18) - Naïve and pre-treated patients scheduled for IVI - Diagnosis of one of the following: - ARMD - mCNV - Proliferative diabetic retinopathy - Diabetic macular oedema - Macular oedema secondary to retinal vein occlusion - The 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 months - Use of topical antibiotics and or corticosteroids within 15 days from study enrolment - Use of topical Artificial Tears within 15 days from the enrolment - Use of topical antiseptic agents within 1 month from study enrolments - Presence of topical ocular therapies that cannot be suspended for the entire duration of the study - Ongoing ocular or systemic inflammatory or infectious processes - Known hypersensitivity to the constituents of the study product - Diagnosis of Open-Angle Glaucoma - Uveitis - Acute and Chronic Conjunctival Disease - Any intraocular surgery within 6 months from study enrolment, excluded IVI - Severe and Moderate Dry Eye - Pregnancy or breast-feeding - Participation in other clinical studies - Patients with cognitive impairment and unable to manage home-assigned treatment.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
VISUPRIME
twice daily
Placebo
twice daily

Locations

Country Name City State
Italy Ospedale Santa Maria della Misericordia Perugia PG

Sponsors (2)

Lead Sponsor Collaborator
VISUfarma SpA CROlife

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary CFU (Colony Forming Units) Primary endpoint is to evaluate the change in bacterial loads in terms of CFU/ sample in the two groups at V0 compared to V1. three days
Secondary Antibiotic sensitivity Identification of microorganism sensitivity or resistant to various antibiotics using antibiogram technique. three days
Secondary SANDE Symptom Assessment iN Dry Eye The assessment of ocular irritation symptoms at V0 and V1, using a 2-item Symptom Assessment iN Dry Eye (SANDE) questionnaire consistent with all ocular diseases that may impact vision-related functioning. three days
Secondary Adverse Events Evaluation of the rate of related Adverse Events (AEs) that occur during the study treatment. three days
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