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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05750589
Other study ID # IRX-2022-001
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 22, 2023
Est. completion date August 30, 2024

Study information

Verified date March 2023
Source iRenix Medical, Inc.
Contact Stephen Smith, MD
Phone 650-785-1316
Email stephen@irenix.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, double-masked study to evaluate the tolerability and safety of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date August 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Capable of giving informed consent 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, = 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes Exclusion Criteria: 1. Current or past diagnosis of endophthalmitis 2. Current diagnosis of uveitis 3. Monocular patients (vision 20/100 or worse in one eye) who are receiving injections in the better seeing eye 4. Current use of viscous lidocaine products for ocular anesthesia prior to IVT 5. Currently receiving intravitreal steroid injections 6. Concurrent participation in another clinical trial 7. Females who are pregnant, planning to become pregnant or lactating

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IRX-101
IRX-101 is a novel ocular anti-septic
Providone-Iodine
5% Providone-Iodine

Locations

Country Name City State
United States R. Gary Lane, II MD San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
iRenix Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of post-intravitreal injection eye pain Demonstrate the superiority of IRX-101 compared to PI in terms of reducing patient-reported post-intravitreal injection eye pain; pain will be assessed using the visual analog pain scale, a validated patient-reported outcome measure (questionnaire) for assessing patient's subjective pain and discomfort Demonstrate a reduction in mean 1-hr post-injection pain scores
Secondary Change in post-IVT corneal epitheliopathy as evaluated by corneal fluorescein staining scores Demonstrate the superiority of IRX-101 compared to PI in terms of reducing corneal epitheliopathy / corneal fluorescein staining post-intravitreal injection; corneal staining will be obtained using validated Oxford Corneal Staining scale of 0 (no staining) to 5 (maximal corneal staining) Immediately following intraviteral injection
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