Clinical trial NCT05677685: VISUPRIME® Eye Drops
Official title: Multicentre Randomized Double-blind Trial of VISUPRIME® Eye Drops to be Evaluated in Preventing the Conjunctival Bacterial Load in Patients Undergoing to Anti-VEGF Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Degeneration, Age Related
Myopic Choroidal Neovascularisation
Proliferative Diabetic Retinopathy
Diabetic Macular Edema
Macular Edema of Right Retina (Diagnosis)
Lead sponsor: VISUfarma SpA
Sponsor class: INDUSTRY
Collaborators: name: CROlife
First posted: 2023-01-10
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: CFU (Colony Forming Units)
timeFrame: three days
Secondary outcomes:
measure: Antibiotic sensitivity
timeFrame: three days
measure: SANDE Symptom Assessment iN Dry Eye
timeFrame: three days
measure: Adverse Events
timeFrame: three days
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
state: BA
city: Perugia
country: Italy
facility: Ospedale Santa Maria della Misericordia
state: PG
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Giuliano Isontina
state: TS
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carità
Study officials:
affiliation: CROlife
name: Anna Rita Bigioni, PhD
role: STUDY_CHAIR
References: