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VISUPRIME® Eye Drops

Sponsor
VISUfarma SpA (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05677685
Collaborator
CROlife (Other)
76
Enrollment
1
Location
2
Arms
5.9
Anticipated Duration (Months)
12.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: VISUPRIME
  • Device: Placebo
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
This is a double-blind study and therefore participants and clinical staff are not aware of the treatment group assigned to each participant.
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Jan 30, 2023
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Jul 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Investigational Device

Device: VISUPRIME
twice daily
Placebo Comparator: Placebo

Device: Placebo
twice daily

Outcome Measures

Primary Outcome Measures

  1. CFU (Colony Forming Units) [three days]

    Primary endpoint is to evaluate the change in bacterial loads in terms of CFU/ sample in the two groups at V0 compared to V1.

Secondary Outcome Measures

  1. Antibiotic sensitivity [three days]

    Identification of microorganism sensitivity or resistant to various antibiotics using antibiogram technique.

  2. SANDE Symptom Assessment iN Dry Eye [three days]

    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.

  3. Adverse Events [three days]

    Evaluation of the rate of related Adverse Events (AEs) that occur during the study treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ospedale Santa Maria della Misericordia Perugia PG Italy 06156

Sponsors and Collaborators

  • VISUfarma SpA
  • CROlife

Investigators

  • Study Chair: Anna Rita Bigioni, PhD, CROlife

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VISUfarma SpA
ClinicalTrials.gov Identifier:
NCT05677685
Other Study ID Numbers:
  • VF-03-2022
First Posted:
Jan 10, 2023
Last Update Posted:
Jan 10, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Macular Degeneration
Macular Edema
Diabetic Retinopathy
Choroidal Neovascularization
Edema
Neovascularization, Pathologic

Study Results

No Results Posted as of Jan 10, 2023