Comparing eye infection treatments with Avenova and Betadine
Comparison of Conjunctival Antimicrobial Activity and Patient Comfort Between Topical Hypochlorous Acid (Avenova) and Betadine
PHASE4 · University of Miami · NCT04981860
This study is testing if a new eye wash called Avenova works better than Betadine for treating eye infections and making patients more comfortable during eye procedures.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Miami (other) |
| Locations | 2 sites (Palm Beach Gardens, Florida and 1 other locations) |
| Trial ID | NCT04981860 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of 0.01% hypochlorous acid (Avenova) compared to Betadine (povidone iodine) in reducing bacterial presence and improving patient comfort during eye procedures. The study focuses on treatment-naïve patients and those currently receiving intravitreal injections, assessing their responses to both antiseptic agents. By analyzing bacterial reduction and patient-reported discomfort, the trial seeks to identify a safer and more effective alternative to the commonly used Betadine, particularly for individuals with iodine allergies.
Who should consider this trial
Good fit: Ideal candidates include adults who are treatment-naïve or currently receiving intravitreal injections and can provide informed consent.
Not a fit: Patients who have received intravitreal injections in the past six months or have used certain eye drops may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer antiseptic option for patients with eye infections, particularly those allergic to iodine.
How similar studies have performed: While there have been studies comparing chlorhexidine and povidone iodine, the use of hypochlorous acid as an alternative is relatively novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: Treatment Naïve patients: - Any patient who is able to give consent for the study and did not receive an intravitreal injection in the past 6 months Patients receiving injections: - Patient currently undergoing treatment for which he/she receives a intravitreal injection in one eye. Exclusion Criteria: Treatment Naïve patients: * Intravitreal injections in the past 6 months * Use of eye drops for treatment of glaucoma in the past 6 months * Use of eye drops with antibiotics or steroids in the past 6 months Patients receiving injections: * Patient receiving injections in both eyes * Use of eye drops for treatment of glaucoma in the past 6 months * Use of eye drops with antibiotics or steroids in the past 6 months * Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements. For both groups: * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners
Where this trial is running
Palm Beach Gardens, Florida and 1 other locations
- Bascom Palmer Eye Institute — Palm Beach Gardens, Florida, United States (RECRUITING)
- Medical Center Ophthalmology Associates — San Antonio, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Jorge Fortun, MD — University of Miami
- Study coordinator: Marilyn Marquez, MD
- Email: mam8757@med.miami.edu
- Phone: 919-943-2314
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Eye Infections, Bacterial