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

NCT05127525 | Terminated Phase 3 FDA Drug

• 1 other identifier: IRX-2021-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Diabetic Macular Edema; Branch Retinal Vein Occlusion; Glaucoma/Closed Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Telephone questionnaire regarding patient-reported post-injection pain

  2 hours post-injection

Study Arms (2)

Test Drug

EXPERIMENTAL

IRX-101 drops instilled prior to intravitreal injection

Drug: IRX-101

Control

ACTIVE COMPARATOR

Povidone-Iodine/Betadine drops instilled prior to intravitreal injection

Drug: Control

Interventions

IRX-101 DRUG

IRX-101 to prevent infectious endophthalmitis following intravitreal injection therapy (IVT)

Also known as: Test Arm 1

Test Drug

Control DRUG

Providone-Iodine Betadine to prevent infectious endophthalmitis following intravitreal injection therapy (IVT)

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current or past diagnosis of endophthalmitis
• Current diagnosis of uveitis
• Current use of viscous lidocaine products for ocular anesthesia prior to IVT
• Currently receiving intravitreal steroid injections
• Concurrent participation in another clinical trial

Sponsors & Collaborators

• iRenix Medical, Inc.: lead

Study Sites (1)

Florida

Tampa, Florida, 33609-4614, United States

Location

MeSH Terms

Conditions

Retinal Vein Occlusion; Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Glaucoma; Ocular Hypertension

Study Officials

• Stephen Smith, MD, MS

  iRenix Medical

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 19, 2021
• Study Start: November 15, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)