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EffiCacy, Safety and ToLErability of a Novel Ocular ANtiseptic for Ocular Use (CLEAN)

NCT05127525 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-05-24

No results posted yet for this study

Summary

This is a randomized, double-masked, multicenter, study to evaluate the efficacy, safety, and tolerability of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections. The study will be conducted in up to 30 centers in the United States (US).

Conditions

Interventions

DRUG

IRX-101

IRX-101 to prevent infectious endophthalmitis following intravitreal injection therapy (IVT)

DRUG

Control

Providone-Iodine Betadine to prevent infectious endophthalmitis following intravitreal injection therapy (IVT)

Sponsors & Collaborators

  • iRenix Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Stephen Smith, MD, MS · iRenix Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2022-01-31
Completion
2022-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05127525 on ClinicalTrials.gov