NCT05677685Completed
VISUPRIME® Eye Drops
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
Source: ClinicalTrials.gov · Last updated 19 Jul 2024
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 78 (actual)
- First submitted
- 12 Dec 2022
- Start date
- 22 Jun 2023
- Primary completion date
- 23 Jan 2024
- Lead sponsor
- VISUfarma SpA
- Diseases
- Macular degeneration, Diabetic eye disease
- NCT number
- NCT05677685
What you commit to
- Study type: Interventional
- Participants enrolled: 78
- From 22 Jun 2023 to the primary completion date, 23 Jan 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of systemic antibiotics, corticosteroids within 3 months
- Use of topical antibiotics and or corticosteroids within 15 days from study enrolment
- Presence of topical ocular therapies that cannot be suspended for the entire duration of the study
- Any intraocular surgery within 6 months from study enrolment, excluded IVI
Other illness
- Known hypersensitivity to the constituents of the study product
- Acute and Chronic Conjunctival Disease
- Patients with cognitive impairment and unable to manage home-assigned treatment.
Other
- Use of topical Artificial Tears within 15 days from the enrolment
- Use of topical antiseptic agents within 1 month from study enrolments
- Ongoing ocular or systemic inflammatory or infectious processes
- Diagnosis of Open-Angle Glaucoma
- Uveitis
- Severe and Moderate Dry Eye
- Pregnancy or breast-feeding
- Participation in other clinical studies
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| Ospedale Santa Maria della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Unknown status |
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Azienda Sanitaria Universitaria Giuliano Isontina Coordinator of this site? Confirm its status | Trieste | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.