VISUPRIME® Eye Drops

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-22

Study Completion Date

2024-01-23

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

This is a double-blind study and therefore participants and clinical staff are not aware of the treatment group assigned to each participant.

Study Groups

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Investigational Device

Group Type ACTIVE_COMPARATOR

VISUPRIME

Intervention Type DEVICE

twice daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

twice daily

Interventions

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VISUPRIME

twice daily

Intervention Type DEVICE

Placebo

twice daily

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No