Health TrialsbyHealthPanel

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

ConditionRetinal Disease
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsoriRenix Medical, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • IRX-101

    Drug

    IRX-101 is a novel ocular anti-septic

  • Providone-Iodine

    Drug

    5% Providone-Iodine

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: IRX-101Experimental treatment 1 intervention
Group B: 5% Povidone-iodineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
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)

Time frame
Immediately following intraviteral injection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

iRenix Medical, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: