VISUPRIME® Eye Drops

NCT05677685 | Completed

• 1 other identifier: VF-03-2022
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 6

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.

Conditions

Macular Degeneration, Age Related; Myopic Choroidal Neovascularisation; Proliferative Diabetic Retinopathy; Diabetic Macular Edema; Macular Edema of Right Retina (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• CFU (Colony Forming Units)

  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 Outcomes (3)

• Antibiotic sensitivity

  three days

• SANDE Symptom Assessment iN Dry Eye

  three days

• Adverse Events

  three days

Study Arms (2)

Investigational Device

ACTIVE COMPARATOR

Device: VISUPRIME

Placebo

PLACEBO COMPARATOR

Device: Placebo

Interventions

VISUPRIME DEVICE

twice daily

Investigational Device

Placebo DEVICE

twice daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• VISUfarma SpA: lead
• CROlife: collaborator

Study Sites (6)

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, BA, 70124, Italy

Location

Ospedale Santa Maria della Misericordia

Perugia, PG, 06156, Italy

Location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, RM, 00168, Italy

Location

Azienda Sanitaria Universitaria Giuliano Isontina

Trieste, TS, 34148, Italy

Location

Azienda Ospedaliera Universitaria Federico II

Napoli, 80131, Italy

Location

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, 28100, Italy

Location

MeSH Terms

Conditions

Macular Degeneration; Disease

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna Rita Bigioni, PhD

  CROlife

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study and therefore participants and clinical staff are not aware of the treatment group assigned to each participant.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible patients who meet the study inclusion criteria will be randomized in a 1:1 assignment ratio to the study group or control group in a double-blind manner.

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 10, 2023
• Study Start: June 22, 2023
• Primary Completion: January 23, 2024
• Study Completion: January 23, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)