VISUPRIME® Eye Drops

Not Applicable

Completed

• Conditions: Proliferative Diabetic Retinopathy; Diabetic Macular Edema; Macular Edema of Right Retina (Diagnosis); Macular Degeneration, Age Related; Myopic Choroidal Neovascularisation
• Interventions: Device: VISUPRIME; Device: Placebo

• Registration Number: NCT05677685
• Lead Sponsor: VISUfarma SpA

Brief 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.

Study Timeline

• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2023-01-10
• Study Start: 2023-06-22
• Primary Completion: 2024-01-23
• Study Completion: 2024-01-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational Device	VISUPRIME	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
CFU (Colony Forming Units)	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.

Secondary Outcome Measures

Name	Time	Method
SANDE Symptom Assessment iN Dry Eye	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.
Adverse Events	three days	Evaluation of the rate of related Adverse Events (AEs) that occur during the study treatment.
Antibiotic sensitivity	three days	Identification of microorganism sensitivity or resistant to various antibiotics using antibiogram technique.

Trial Locations

Locations (6)

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari; 🇮🇹 Bari, BA, Italy

Azienda Sanitaria Universitaria Giuliano Isontina; 🇮🇹 Trieste, TS, Italy

Ospedale Santa Maria della Misericordia; 🇮🇹 Perugia, PG, Italy

Azienda Ospedaliera Universitaria Federico II; 🇮🇹 Napoli, Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Rome, RM, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità; 🇮🇹 Novara, Italy