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

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05750589

Acronym

COMFORT

Enrollment

240

Registered

2023-03-01

Start date

2026-09-01

Completion date

2027-12-31

Last updated

2026-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Disease

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.

Interventions

DRUGIRX-101

IRX-101 is a novel ocular anti-septic

DRUGProvidone-Iodine

5% Providone-Iodine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

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.

Intervention model description

Subjects will be randomized to IRX-101 or Providone-Iodine

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

United States

Contacts

CONTACTStephen Smith, MD

stephen@irenix.com650-785-1316

STUDY_CHAIRStephen Smith, MD

Founder

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026