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

Primary Purpose

Retinal Disease

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
IRX-101
Providone-Iodine
Sponsored by
iRenix Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • R. Gary Lane, II MDRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IRX-101

5% Povidone-iodine

Arm Description

Subjects randomized to IRX-101 will receive the investigational product, IRX-101.

Subjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
February 17, 2023
Last Updated
March 1, 2023
Sponsor
iRenix Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05750589
Brief Title
Safety and Tolerability of IRX-101 in Patients Receiving Intravitreal Injections
Acronym
COMFORT
Official Title
Randomized, Controlled, Double-Masked Study to Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal Pain and Corneal Epitheliopathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
iRenix Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized to IRX-101 or Providone-Iodine
Masking
ParticipantInvestigator
Masking Description
Treatment assignment will be unknown (or masked) to the study subjects, the evaluating physician, the Sponsor and its agents (with the exception of personnel performing randomization, unmasked drug accountability study monitors, and corporate compliance staff). The treating physician will be unmasked.
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IRX-101
Arm Type
Experimental
Arm Description
Subjects randomized to IRX-101 will receive the investigational product, IRX-101.
Arm Title
5% Povidone-iodine
Arm Type
Active Comparator
Arm Description
Subjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%.
Intervention Type
Drug
Intervention Name(s)
IRX-101
Intervention Description
IRX-101 is a novel ocular anti-septic
Intervention Type
Drug
Intervention Name(s)
Providone-Iodine
Intervention Description
5% Providone-Iodine
Primary Outcome Measure Information:
Title
Assessment of post-intravitreal injection eye pain
Description
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 Outcome Measure Information:
Title
Change in post-IVT corneal epitheliopathy as evaluated by corneal fluorescein staining scores
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Smith, MD
Phone
650-785-1316
Email
stephen@irenix.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Smith, MD
Organizational Affiliation
Founder
Official's Role
Study Chair
Facility Information:
Facility Name
R. Gary Lane, II MD
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Angueira
Phone
800-833-5921

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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