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OpenTrials
Completed

NCT Number: NCT05677685

VISUPRIME® Eye Drops

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari, Bari, BA, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VISUPRIME

Device

twice daily

PLACEBO

Device

twice daily

Primary outcomes

  1. CFU (Colony Forming Units)

    Time frame: 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 outcomes

  1. Antibiotic sensitivity

    Time frame: three days

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

  2. SANDE Symptom Assessment iN Dry Eye

    Time frame: 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

    Time frame: three days

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

Sponsors and collaborators

Lead sponsor

VISUfarma SpA

Industry

Collaborators

  • CROlife

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 10, 2023
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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