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

Sponsor
iRenix Medical, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT05127525
Collaborator
(none)
5
Enrollment
1
Location
2
Arms
2.5
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Randomized, Double-Masked, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of IRX-101 Versus 5% Povidone-Iodine as an Ocular Surface Sterilizer
Actual Study Start Date :
Nov 15, 2021
Actual Primary Completion Date :
Jan 31, 2022
Actual Study Completion Date :
Jan 31, 2022

Arms and Interventions

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)

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of infectious endophthalmitis after topical use of IRX-101 combined with IVT [2 hours post-injection]

      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)

    Secondary Outcome Measures

    1. Telephone questionnaire regarding patient-reported post-injection pain [2 hours post-injection]

      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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Florida Tampa Florida United States 33609-4614

    Sponsors and Collaborators

    • iRenix Medical, Inc.

    Investigators

    • Study Chair: Stephen Smith, MD, MS, iRenix Medical

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    iRenix Medical, Inc.
    ClinicalTrials.gov Identifier:
    NCT05127525
    Other Study ID Numbers:
    • IRX-2021-001
    First Posted:
    Nov 19, 2021
    Last Update Posted:
    May 24, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Glaucoma
    Macular Edema
    Retinal Vein Occlusion
    Glaucoma, Angle-Closure

    Study Results

    No Results Posted as of May 24, 2022