NCT06533995

The Usefulness of Visuprime in Cataract Surgery

The Performance of Visuprime in Improving Ocular Surface Homeostasis and Reducing Conjunctival Bacterial Load in Patients Receiving Cataract Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: VISUfarma SpA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentre, post-market, open label, randomized, placebo-controlled prospective study exploring the performance of Visuprime in improving ocular surface homeostasis and reducing conjunctival bacterial load in patients receiving cataract surgery, as an addon treatment to postoperative standard terapy. The study will consist on 3 visits: Visit 1 (day -3 from surgery), Visit 2 (day 0, surgery), and Visit 3 (day 7 from surgery). Patients will be enrolled after having signed the informed consent form prior to any other study procedure and after inclusion/exclusion criteria check. At each visit all study procedures will be performed according to the clinical investigation plan requirements. Patients will be enrolled at Visit 1 and randomized with a 1:1 ratio to 2 groups: GROUP A: patients receiving Visuprime eyedrop BID from day -3 to week 1. After surgery, patients will be also given standard postoperative treatment consisting on unitdose desametasone eyedrop + levofloxacin eyedrop, both given four times daily (QID) from day 0 (after surgery) to the end of the study. GROUP B: patients receiving placebo eyedrop (the vehicle of Visuprime, i.e. isotonic buffered saline solution) BID from day -3 to week 1. After surgery, patients will be also given standard postoperative treatment consisting on unitdose desametasone eyedrop QID + levofloxacin eyedrop QID from day 0 to the end of the study.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Visuprime	Visuprime is a medical device (class IIa sterile) with ophtalmic indication, consisting on a 10 ml multidose bottle
OTHER	Placebo	placebo eyedrop isotonic buffered saline solution

Timeline

• Start date: 2021-10-25
• Primary completion: 2022-02-22
• Completion: 2022-02-22
• First posted: 2024-08-01
• Last updated: 2024-08-01

Locations

2 sites across 1 country: Italy