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VISUPRIME® Eye Drops

Primary Purpose

Macular Degeneration, Age Related, Myopic Choroidal Neovascularisation, Proliferative Diabetic Retinopathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
VISUPRIME
Placebo
Sponsored by
VISUfarma SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Macular Degeneration, Age Related

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ospedale Santa Maria della Misericordia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Investigational Device

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Antibiotic sensitivity
Identification of microorganism sensitivity or resistant to various antibiotics using antibiogram technique.
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.
Adverse Events
Evaluation of the rate of related Adverse Events (AEs) that occur during the study treatment.

Full Information

First Posted
December 12, 2022
Last Updated
December 22, 2022
Sponsor
VISUfarma SpA
Collaborators
CROlife
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1. Study Identification

Unique Protocol Identification Number
NCT05677685
Brief Title
VISUPRIME® Eye Drops
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 30, 2023 (Anticipated)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VISUfarma SpA
Collaborators
CROlife

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed Description
Multicentre, double-masked, placebo-controlled randomized 1:1 of the VISUPRIME® treatment in patients undergoing intravitreal anti-VEGF injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Age Related, Myopic Choroidal Neovascularisation, Proliferative Diabetic Retinopathy, Diabetic Macular Edema, Macular Edema of Right Retina (Diagnosis)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational Device
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
VISUPRIME
Intervention Description
twice daily
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
twice daily
Primary Outcome Measure Information:
Title
CFU (Colony Forming Units)
Description
Primary endpoint is to evaluate the change in bacterial loads in terms of CFU/ sample in the two groups at V0 compared to V1.
Time Frame
three days
Secondary Outcome Measure Information:
Title
Antibiotic sensitivity
Description
Identification of microorganism sensitivity or resistant to various antibiotics using antibiogram technique.
Time Frame
three days
Title
SANDE Symptom Assessment iN Dry Eye
Description
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.
Time Frame
three days
Title
Adverse Events
Description
Evaluation of the rate of related Adverse Events (AEs) that occur during the study treatment.
Time Frame
three days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Rita Bigioni, PhD
Phone
00393492862271
Email
a.bigioni@crolife.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Rita Bigioni, PhD
Organizational Affiliation
CROlife
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale Santa Maria della Misericordia
City
Perugia
State/Province
PG
ZIP/Postal Code
06156
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo Cagini, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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