Safety and Tolerability of IRX-101 in Patients Receiving Intravitreal Injections

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Controlled, Double-Masked Study to Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal Pain and Corneal Epitheliopathy

Conditions
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Retinal Disease

Intervention / Treatment
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* Drug: IRX-101
* Drug: Providone-Iodine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capable of giving informed consent Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes Exclusion Criteria: Current or past diagnosis of endophthalmitis Current diagnosis of uveitis Monocular patients (vision 20/100 or worse in one eye) who are receiving injections in the better seeing eye Current use of viscous lidocaine products for ocular anesthesia prior to IVT Currently receiving intravitreal steroid injections Concurrent participation in another clinical trial Females who are pregnant, planning to become pregnant or lactating

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized to IRX-101 or Providone-Iodine
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IRX-101<br>Subjects randomized to IRX-101 will receive the investigational product, IRX-101. | Drug: IRX-101<br>* IRX-101 is a novel ocular anti-septic<br>|
| Active Comparator: 5% Povidone-iodine<br>Subjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%. | Drug: Providone-Iodine<br>* 5% Providone-Iodine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |