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IRX-101 for Glaucoma (CLEAN Trial)

Phase 3
Waitlist Available
Research Sponsored by iRenix Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stated willingness to comply with all study procedures and availability for the duration of the study
Capable of giving informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours post-injection
Awards & highlights

CLEAN Trial Summary

This study is evaluating whether a new treatment for eye infections is better than the current standard treatment.

Eligible Conditions
  • Diabetic Macular Edema
  • Branch Retinal Vein Occlusion
  • Glaucoma

CLEAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

CLEAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours post-injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours post-injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of infectious endophthalmitis after topical use of IRX-101 combined with IVT
Secondary outcome measures
Telephone questionnaire regarding patient-reported post-injection pain

CLEAN Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Test DrugExperimental Treatment1 Intervention
IRX-101 drops instilled prior to intravitreal injection
Group II: ControlActive Control1 Intervention
Povidone-Iodine/Betadine drops instilled prior to intravitreal injection

Find a Location

Who is running the clinical trial?

iRenix Medical, Inc.Lead Sponsor
2 Previous Clinical Trials
315 Total Patients Enrolled
Stephen Smith, MD, MSStudy ChairiRenix Medical

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
EffiCacy, Safety and ToLErability of a Novel Ocular ANtiseptic for Ocular Use (CLEAN)
2021. "EffiCacy, Safety and ToLErability of a Novel Ocular ANtiseptic for Ocular Use (CLEAN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05127525.
~1 spots leftby Apr 2025
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