VISUPRIME® Eye Drops

Study Overview
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Brief Summary
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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.

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

Official Title
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Multicentre Randomized Double-blind Trial of VISUPRIME® Eye Drops to be Evaluated in Preventing the Conjunctival Bacterial Load in Patients Undergoing to Anti-VEGF Injection

Conditions
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Diabetic Macular Edema, Macular Degeneration, Age Related, Myopic Choroidal Neovascularisation, Proliferative Diabetic Retinopathy, Macular Edema of Right Retina (Diagnosis)

Intervention / Treatment
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* Device: VISUPRIME
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible patients who meet the study inclusion criteria will be randomized in a 1:1 assignment ratio to the study group or control group in a double-blind manner.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Investigational Device<br> | Device: VISUPRIME<br>* twice daily<br>|
| Placebo Comparator: Placebo<br> | Device: Placebo<br>* twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic sensitivity | Identification of microorganism sensitivity or resistant to various antibiotics using antibiogram technique. | three days | 
| 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 | 
| Adverse Events | Evaluation of the rate of related Adverse Events (AEs) that occur during the study treatment. | three days |