VISUPRIME® Eye Drops

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05677685
• Other study ID #: VF-03-2022
• Status: Completed
• Phase: N/A
• Start date: June 22, 2023
• Est. completion date: January 23, 2024

Study information

• Verified date: April 2024
• Source: VISUfarma SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Multicentre, double-masked, placebo-controlled randomized 1:1 of the VISUPRIME® treatment in patients undergoing intravitreal anti-VEGF injection.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Macular Degeneration
• Macular Edema
• Myopic Choroidal Neovascularisation
• Neovascularization, Pathologic
• Proliferative Diabetic Retinopathy

Intervention

Device:
• VISUPRIME
twice daily
• Placebo
twice daily

Locations

Country	Name	City	State
Italy	Ospedale Santa Maria della Misericordia	Perugia	PG

Sponsors (2)

Lead Sponsor	Collaborator
VISUfarma SpA	CROlife

Country where clinical trial is conducted

Italy, 

Outcome

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