Back to resultsSteRilizing Eye SoLution to ImprovE Patient ComFort (RELIEF) (RELIEF)
Primary Purpose
Retinal Disease
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IRX-101
Providone-Iodine
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Disease
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
Sites / Locations
- Edward Wood, 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
Safety of new drug
Safety will be measured via slit lamp and fundoscopic examinations
Secondary Outcome Measures
Mean corneal fluorescein staining scores
Compare mean corneal fluorescein staining scores obtained after IVT in the IRX-101 and standard of care groups; corneal staining will be obtained using the validated Oxford Corneal Staining scale of 0 (no staining) to 5 (maximal staining)
Patient-reported post-injection pain scores
Compare mean patient-reported post-injection pain scores 1-hour post-administration; 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05747430
Brief Title
SteRilizing Eye SoLution to ImprovE Patient ComFort (RELIEF)
Acronym
RELIEF
Official Title
Randomized, Controlled, Double-Masked Study to Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal Injection Pain and Corneal Epitheliopathy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
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. The study will be conducted in up to 15 centers in the United States (US).
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 2
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
75 (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
Safety of new drug
Description
Safety will be measured via slit lamp and fundoscopic examinations
Time Frame
1-hour and 1-week post-treatment
Secondary Outcome Measure Information:
Title
Mean corneal fluorescein staining scores
Description
Compare mean corneal fluorescein staining scores obtained after IVT in the IRX-101 and standard of care groups; corneal staining will be obtained using the validated Oxford Corneal Staining scale of 0 (no staining) to 5 (maximal staining)
Time Frame
Immediately following intraviteral injection
Title
Patient-reported post-injection pain scores
Description
Compare mean patient-reported post-injection pain scores 1-hour post-administration; 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
1-hour post-administration
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
Edward Wood, MD
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Dixon
Phone
512-451-0103
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
SteRilizing Eye SoLution to ImprovE Patient ComFort (RELIEF)
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