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.
Multicentre, double-masked, placebo-controlled randomized 1:1 of the VISUPRIME® treatment in patients undergoing intravitreal anti-VEGF injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
78
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, BA, Italy
Ospedale Santa Maria della Misericordia
Perugia, PG, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, RM, Italy
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, TS, Italy
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.
Time frame: three days
Antibiotic sensitivity
Identification of microorganism sensitivity or resistant to various antibiotics using antibiogram technique.
Time frame: three days
SANDE Symptom Assessment iN Dry Eye
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.
Time frame: three days
Adverse Events
Evaluation of the rate of related Adverse Events (AEs) that occur during the study treatment.
Time frame: three days
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Azienda Ospedaliera Universitaria Federico II
Napoli, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, Italy