VISUPRIME® Eye Drops

VISUfarma

Status: Completed

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

Treatments: Device: VISUPRIME; Device: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05677685

VF-03-2022

Details and patient eligibility

About

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.

Full description

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

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups, including a placebo group

Investigational Device

Active Comparator group

Treatment:

Device: VISUPRIME

Placebo

Placebo Comparator group

Treatment:

Device: Placebo