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VISUPRIME® Eye Drops | Clinical Trials | Clareo Health

COMPLETEDNA

VISUPRIME® Eye Drops

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

NCT05677685•VISUfarma SpA

View on ClinicalTrials.gov

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.

Detailed Description

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (6)

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, BA, Italy

Ospedale Santa Maria della Misericordia

Perugia, PG, Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, RM, Italy

Azienda Sanitaria Universitaria Giuliano Isontina

Trieste, TS, Italy

Azienda Ospedaliera Universitaria Federico II

Naples, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, Italy

Key Dates

Start Date

June 22, 2023

Primary Completion Date

January 23, 2024

Completion Date

January 23, 2024

Last Updated

July 19, 2024

Enrollment

ACTUAL participants

Conditions

Macular Degeneration, Age RelatedMyopic Choroidal NeovascularisationProliferative Diabetic RetinopathyDiabetic Macular EdemaMacular Edema of Right Retina (Diagnosis)

Interventions

VISUPRIME

DEVICE

Placebo

DEVICE

UNITY VCS Vitreoretinal Surgery

NCT07054281

Epiretinal MembraneMacular Hole+6 more

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NOT_YET_RECRUITINGPHASE2

Efficacy and Safety of Ginkgo Biloba Extract EGb761® in Patients With Diabetic Retinopathy

NCT07236645

Non-proliferative Diabetic Retinopathy (NPDR)

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

VISUPRIME® Eye Drops

Inclusion Criteria

Exclusion Criteria

UNITY VCS Vitreoretinal Surgery

Efficacy and Safety of Ginkgo Biloba Extract EGb761® in Patients With Diabetic Retinopathy

To Evaluate the Efficacy and Safety of Combination Therapy With B55R1 and B55R2 Compared to B55R1 Monotherapy in Patients With NPDR

Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)

Gas Tamponade for Prevention of Postoperative Vitreous Hemorrhage in Diabetics

A Study on the Treatment Strategy of NVG Secondary to PDR