COMFORT: Safety and Tolerability of IRX-101 in Patients Receiving Intravitreal Injections
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: IRX-101 Subjects randomized to IRX-101 will receive the investigational product, IRX-101. |
Drug: IRX-101
IRX-101 is a novel ocular anti-septic
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Active Comparator: 5% Povidone-iodine Subjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%. |
Drug: Providone-Iodine
5% Providone-Iodine
|
Outcome Measures
Primary Outcome Measures
- Assessment of post-intravitreal injection eye pain [Demonstrate a reduction in mean 1-hr post-injection pain scores]
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
Secondary Outcome Measures
- Change in post-IVT corneal epitheliopathy as evaluated by corneal fluorescein staining scores [Immediately following intraviteral injection]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Capable of giving informed consent
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Stated willingness to comply with all study procedures and availability for the duration of the study
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Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes
Exclusion Criteria:
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Current or past diagnosis of endophthalmitis
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Current diagnosis of uveitis
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Monocular patients (vision 20/100 or worse in one eye) who are receiving injections in the better seeing eye
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Current use of viscous lidocaine products for ocular anesthesia prior to IVT
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Currently receiving intravitreal steroid injections
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Concurrent participation in another clinical trial
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Females who are pregnant, planning to become pregnant or lactating
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | R. Gary Lane, II MD | San Antonio | Texas | United States | 78240 |
Sponsors and Collaborators
- iRenix Medical, Inc.
Investigators
- Study Chair: Stephen Smith, MD, Founder
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRX-2022-001