Retinal DiseasePhase 3COMFORTNCT05750589
Safety and Tolerability of IRX-101 in Patients Receiving Intravitreal Injections
A Phase 3 study testing IRX-101 and Providone-Iodine in people with Retinal Disease, run by iRenix Medical, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Disease
- What is being tested?
- IRX-101 and Providone-Iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
R. Gary Lane, II MD
San Antonio, Texas, 78240
Francisco Angueira, 800-833-5921
About this study
Official title: Randomized, Controlled, Double-Masked Study to Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal Pain and Corneal Epitheliopathy
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.
- Conditions
- Retinal Disease
- Being tested
- IRX-101, Providone-Iodine
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRX-101Drug
IRX-101 is a novel ocular anti-septic
Providone-IodineDrug
5% Providone-Iodine
| Study group | Role | What they receive |
|---|---|---|
| IRX-101 | Experimental | Subjects randomized to IRX-101 will receive the investigational product, IRX-101. Receives: Drug: 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%. Receives: Drug: Providone-Iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Demonstrate a reduction in mean 1-hr post-injection pain scores
Secondary outcomes (1)
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)
Measured: Immediately following intraviteral injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Sep 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to IRX-101 or Providone-Iodine
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iRenix Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Smith, MD, Study chair, Founder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750589
- Sponsor's protocol ID
- IRX-2022-001
- Acronym
- COMFORT
- Status last verified
- Mar 2026
- First submitted
- 17 Feb 2023
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Double-Masked Study to Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal Pain and Corneal Epitheliopathy
- ClinicalTrials.gov ID
- NCT05750589
- Acronym / sponsor ID
- COMFORT / IRX-2022-001
- Conditions
- Retinal Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- iRenix Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects will be randomized to IRX-101 or Providone-Iodine
| Arm | Type | Receives |
|---|---|---|
| IRX-101 | Experimental | Drug: IRX-101Subjects randomized to IRX-101 will receive the investigational product, IRX-101. |
| 5% Povidone-iodine | Active comparator | Drug: Providone-IodineSubjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRX-101IRX-101 is a novel ocular anti-septic | Drug | IRX-101 |
| Providone-Iodine5% Providone-Iodine | Drug | 5% Povidone-iodine |
Primary outcome
Assessment of post-intravitreal injection eye pain
Time frame: 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
1 secondary outcome
Change in post-IVT corneal epitheliopathy as evaluated by corneal fluorescein staining scores
Time frame: Immediately following intraviteral injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen Smith, MD study chair
Founder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IRX-101 and Providone-Iodine in people with Retinal Disease, run by iRenix Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Smith, MD (650-785-1316, stephen@irenix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of post-intravitreal injection eye pain (time frame: Demonstrate a reduction in mean 1-hr post-injection pain scores). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.