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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IRX-101 | Experimental | Subjects randomized to IRX-101 will receive the investigational product, IRX-101. |
|
| 5% Povidone-iodine | Active Comparator | Subjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRX-101 | Drug | IRX-101 is a novel ocular anti-septic |
| |
| Providone-Iodine |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephen Smith, MD | Contact | 650-785-1316 | stephen@irenix.com |
| Name | Affiliation | Role |
|---|---|---|
| Stephen Smith, MD | Founder | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| R. Gary Lane, II MD | San Antonio | Texas | 78240 | United States |
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| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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Subjects will be randomized to IRX-101 or Providone-Iodine
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Treatment assignment will be unknown (or masked) to the study subjects, the evaluating physician, the Sponsor and its agents (with the exception of personnel performing randomization, unmasked drug accountability study monitors, and corporate compliance staff). The treating physician will be unmasked.
| Drug |
5% Providone-Iodine |
|