VISUPRIME® Eye Drops

April 22, 2024 updated by: VISUfarma SpA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • PG
      • Perugia, PG, Italy, 06156
        • Ospedale Santa Maria della Misericordia
        • Contact:
          • Carlo Cagini, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Device: Placebo
twice daily
Active Comparator: Investigational Device
Device: VISUPRIME
twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CFU (Colony Forming Units)
Time Frame: three days
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
Time Frame: three days
Identification of microorganism sensitivity or resistant to various antibiotics using antibiogram technique.
three days
SANDE Symptom Assessment iN Dry Eye
Time Frame: three days
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
Time Frame: three days
Evaluation of the rate of related Adverse Events (AEs) that occur during the study treatment.
three days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VISUfarma SpA

Collaborators

CROlife

Investigators

  • Study Chair: Anna Rita Bigioni, PhD, CROlife

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2023

Primary Completion (Actual)

January 23, 2024

Study Completion (Actual)

January 23, 2024

Study Registration Dates

First Submitted

December 12, 2022

First Submitted That Met QC Criteria

December 22, 2022

First Posted (Actual)

January 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VF-03-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Macular Edema

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe