Diabetic Macular Edema Clinical Trial
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
Verified date | April 2024 |
Source | VISUfarma SpA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | January 23, 2024 |
Est. primary completion date | January 23, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale Santa Maria della Misericordia | Perugia | PG |
Lead Sponsor | Collaborator |
---|---|
VISUfarma SpA | CROlife |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Antibiotic sensitivity | Identification of microorganism sensitivity or resistant to various antibiotics using antibiogram technique. | three days | |
Secondary | 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. | three days | |
Secondary | Adverse Events | Evaluation of the rate of related Adverse Events (AEs) that occur during the study treatment. | three days |
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