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| Name | Class |
|---|---|
| CROlife | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Device | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VISUPRIME | Device | twice daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic sensitivity | Identification of microorganism sensitivity or resistant to various antibiotics using antibiogram technique. | 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. |
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Inclusion Criteria:
Adult patients (age ≥ 18)
Naïve and pre-treated patients scheduled for IVI
Diagnosis of one of the following:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Rita Bigioni, PhD | CROlife | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari | Bari | BA | 70124 | Italy | ||
| Ospedale Santa Maria della Misericordia |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D004194 | Disease |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D010335 | Pathologic Processes |
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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.
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This is a double-blind study and therefore participants and clinical staff are not aware of the treatment group assigned to each participant.
| Device |
twice daily |
|
| three days |
| Adverse Events | Evaluation of the rate of related Adverse Events (AEs) that occur during the study treatment. | three days |
| Perugia |
| PG |
| 06156 |
| Italy |
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Rome | RM | 00168 | Italy |
| Azienda Sanitaria Universitaria Giuliano Isontina | Trieste | TS | 34148 | Italy |
| Azienda Ospedaliera Universitaria Federico II | Naples | 80131 | Italy |
| Azienda Ospedaliero Universitaria Maggiore della Carità | Novara | 28100 | Italy |
| D013568 |
| Pathological Conditions, Signs and Symptoms |