EffiCacy, Safety and ToLErability of a Novel Ocular ANtiseptic for Ocular Use (CLEAN) (CLEAN)

Randomized, Double-Masked, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of IRX-101 Versus 5% Povidone-Iodine as an Ocular Surface Sterilizer

This is a randomized, double-masked, multicenter, study to evaluate the efficacy, safety, and tolerability of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections. The study will be conducted in up to 30 centers in the United States (US).

Study Overview

• Status: Terminated
• Conditions: Diabetic Macular Edema; Branch Retinal Vein Occlusion; Glaucoma/Closed Angle Glaucoma
• Intervention / Treatment: Drug: IRX-101; Drug: Control

Detailed Description

Intravitreal injection therapy (IVT) of anti-vascular endothelial growth factor (VEGF) agents has transformed the treatment landscape of several retinal diseases, including exudative (wet) macular degeneration, retinal vein occlusion, diabetic macular edema, and choroidal neovascularization. The most common adverse effects of IVT occur due to the side effects of Povidone-Iodine 5% (PI; brand name: Betadine® 5%; Alcon, Fort Worth, TX), the antiseptic placed on the ocular surface prior to each injection. PI is nearly universally used to prevent ocular infection (endophthalmitis). PI leads to marked corneal epithelial toxicity in humans,6, 7 resulting in debilitating side effects including decreased visual acuity and pain that can last more than 3 days post-IVT. Post-IVT pain is severe enough to require oral analgesics in up to 30% of patients and is a frequent cause of treatment discontinuation. Therefore, there is an unmet need in ophthalmology for a potent ocular antiseptic with a superior safety profile.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33609-4614
      • Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. Current use of viscous lidocaine products for ocular anesthesia prior to IVT
4. Currently receiving intravitreal steroid injections
5. Concurrent participation in another clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Drug; IRX-101 drops instilled prior to intravitreal injection	Drug: IRX-101; IRX-101 to prevent infectious endophthalmitis following intravitreal injection therapy (IVT); Other Names: Test Arm 1
Active Comparator: Control; Povidone-Iodine/Betadine drops instilled prior to intravitreal injection	Drug: Control; Providone-Iodine Betadine to prevent infectious endophthalmitis following intravitreal injection therapy (IVT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of infectious endophthalmitis after topical use of IRX-101 combined with IVT	To evaluate the rate of infectious endophthalmitis after topical use of IRX-101 following intravitreal injection therapy (IVT) (% occurrence or rate of population randomized to IRX-101 test arm)	2 hours post-injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Telephone questionnaire regarding patient-reported post-injection pain	Telephone questionnaire with questions asked of patients regarding patient-reported post-injection pain compared to Providone-Iodine Betadine control group (three questions asked scale of 0 to 10, 0 being no pain to 10 being worst pain)	2 hours post-injection

Collaborators and Investigators

• Sponsor: iRenix Medical, Inc.
• Investigators: Study Chair: Stephen Smith, MD, MS, iRenix Medical

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Ocular Hypertension; Retinal Degeneration; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Glaucoma; Macular Edema; Retinal Vein Occlusion; Glaucoma, Angle-Closure
• Other Study ID Numbers: IRX-2021-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No