The Usefulness of Visuprime in Cataract Surgery

VISUfarma

Status: Completed

Conditions: Cataract

Treatments: Other: Placebo; Device: Visuprime

Study type: Interventional

Funder types: Industry

Identifiers

NCT06533995

VF-OS-005/2021

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years old patients, male and female
• Previous diagnosis of cataract requiring surgery
• Wishing to participate in the study and able to sign the ICF
• No topic ophthalmic medication, including lubricating eyedrops administration for at least 4 days before screening visit.

Exclusion criteria

• Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g.rheumatic disease)
• Previous participation on this study for the fellow eye
• Increased risk of complicated cataract surgery according to the investigator assessment (for example presence of dilation less than 6 mm, pupil decentration, pseudoexfoliation, areas of iris atrophy, sublussation or lussation of the lens, complete cataract, sac instability, iridodonesis, systemic disease limiting intraoperative patient cooperation)
• Coexisting corneal diseases
• Past or active conjunctivitis - any type
• Past ocular surface burns
• Keratinization of the eyelid margin
• Sjogren syndrome
• History of corneal trauma
• Pregnant and lactating women
• Inability to self-administer study medications
• Know allergic sensitivity to any of the devices ingredients, or any other type of allergy
• Participation in a clinical trial during the 3 months prior to the beginning of the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups, including a placebo group

VISUPRIME

Experimental group

Description:

Patients receiving Visuprime eyedrop BID from Visit 1 (day -3 from surgery) to Visit 3 (day 7 from surgery).

Treatment:

Device: Visuprime

Placebo

Placebo Comparator group

Description:

Patients receiving placebo eyedrop (the vehicle of Visuprime, ie isotonic buffered saline solution) BID from Visit 1 (day -3 from surgery) to Visit 3 (day 7 from surgery).

Treatment:

Other: Placebo