Avenova vs Betadine for Bacterial Eye Infections

Not currently recruiting at 1 trial location

Overseen By Marilyn Marquez, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Miami

Must not be taking: Glaucoma drops, Antibiotics, Steroids

Disqualifiers: Pregnancy, Minors, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effectiveness of Avenova and Betadine in reducing bacteria and discomfort in the eyes. Avenova contains hypochlorous acid, while Betadine contains povidone iodide. The trial will involve two groups: one with patients new to treatment and another already receiving eye injections. Individuals who have not had eye injections in the past six months or those currently receiving injections in one eye might be suitable candidates. As a Phase 4 trial, this research seeks to understand how these FDA-approved treatments can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used eye drops for glaucoma, antibiotics, or steroids in the past 6 months.

What is the safety track record for Avenova and Betadine?

Research has shown that Avenova, containing a small amount (0.01%) of hypochlorous acid, is generally safe for use in the eyes. Studies report no harmful effects during treatment, and most people tolerate it well. However, using it in higher amounts might cause mild irritation for some.

For Betadine, which contains povidone-iodine, studies indicate it effectively fights eye infections. It is also considered safe, though some people might experience slight irritation when used. Overall, both treatments have been shown to be safe for many users, with only minor side effects reported. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Avenova and Betadine because they offer unique approaches to treating bacterial eye infections. Avenova stands out due to its active ingredient, hypochlorous acid, which is known for its strong antimicrobial properties and ability to reduce inflammation without causing irritation—unlike traditional antibiotics that may lead to resistance. Meanwhile, Betadine, commonly used as a pre-surgical antiseptic, is being explored for its effectiveness in eye infections due to its broad-spectrum antimicrobial action. Together, these treatments could provide more effective and rapid relief for patients compared to standard antibiotics and antiseptics, potentially reducing reliance on antibiotics and minimizing side effects.

What evidence suggests that this trial's treatments could be effective for bacterial eye infections?

This trial will compare Avenova and Betadine for bacterial eye infections. Studies have shown that Avenova, which contains a small amount of hypochlorous acid, effectively kills bacteria in the eye and quickly eases symptoms of eye infections. Research indicates that it reduces bacteria without harming the eye's natural structures.

Betadine, a povidone-iodine solution, has been found effective for treating both bacterial and viral eye infections. It works as well as some antibiotics for conditions like conjunctivitis (pink eye) and can also reduce the virus in viral eye infections, leading to symptom improvement.

Participants in this trial will receive either Avenova or Betadine in different eyes, allowing for a direct comparison of their effectiveness in reducing bacteria and managing symptoms in eye infections. ^{1 6 7 8 9}

Who Is on the Research Team?

Jorge Fortun, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for patients who can consent and haven't had an eye injection in the last 6 months. It's suitable for those currently getting treatment that involves an eye injection.

Inclusion Criteria

I have not had an eye injection in the last 6 months and can consent to the study.

I am getting eye injections for treatment in one eye.

Exclusion Criteria

For both groups: Pregnant women

I have used eye drops for glaucoma in the last 6 months.

Patients receiving injections: 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Avenova or Betadine in their eyes, depending on randomization

1 day

1 visit (in-person)

Follow-up

Participants are monitored for bacterial colony forming units and symptom severity

2 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Avenova
• Betadine

Trial Overview The study compares Avenova (0.01% hypochlorous acid) with Betadine (Povidone iodide) to see which is better at reducing bacteria and discomfort in patients with bacterial eye infections.

How Is the Trial Designed?

Group I: Treatment naïve participants Second Group R Experimental Treatment 2 Interventions

Treatment naïve participants randomized to receive Avenova on the left eye and Betadine on the right Eye

Group II: Treatment naïve participants First Group L Experimental Treatment 2 Interventions

Treatment naïve participants randomized to receive Betadine on the left eye and Avenova on the right Eye

Group III: Participants undergoing intravitreal injection Second Group R Experimental Treatment 2 Interventions

Participants undergoing intravitreal injection will receive betadine in the eye that is receiving injections and Avenova in the other eye. Group R are patients that are having intravitreal injections and will receive betadine in the right eye and Avenova in the left eye.

Group IV: Participants undergoing intravitreal injection First Group L Experimental Treatment 2 Interventions

Participants undergoing intravitreal injection will receive betadine in the eye that is receiving injections and Avenova in the other eye. Group L are patients that are having intravitreal injections and will receive betadine in the left eye and Avenova in the right eye.

Avenova is already approved in United States for the following indications:

Approved in United States as Avenova for:

• Dry Eye
• Blepharitis
• Meibomian Gland Dysfunction
• Contact Lens Intolerance
• Inflammation

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

Povidone-iodine (PVP-I) is an effective treatment for ocular infections, offering advantages such as a broader antibacterial spectrum, no observed bacterial resistance, and lower cost compared to other treatments.

PVP-I has been successfully used in various applications, including pre- and postoperative surgical prophylaxis and treatment of bacterial conjunctivitis, supported by studies conducted over the past 17 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocular applications of povidone-iodine. Isenberg, SJ., Apt, L., Campeas, D.[2017]

In a study involving 113 patients undergoing cataract surgery, Amukine 0.06% solution demonstrated similar ocular safety to the traditional 5% povidone iodine solution, with no significant differences in corneal superficial punctate keratitis or conjunctival hyperemia after surgery.

Amukine 0.06% could serve as a valuable alternative for surgical antisepsis in ophthalmology, especially for patients with iodine allergies, as it maintains safety standards comparable to established antiseptics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical evaluation of the ocular safety of Amukine 0.06% solution for local application versus povidone iodine (Bétadine) 5% solution for ocular irrigation) in preoperative antisepsis]. Auclin, F., Rat, P., Tuil, E., et al.[2017]

A study involving cataract patients showed that after using 1.25% povidone-iodine for antisepsis, the amount of iodine absorbed into the anterior chamber (AC) was similar to that remaining in the syringe, indicating effective antisepsis without significant absorption.

The research suggests that a healthy ocular surface acts as a barrier to iodine penetration, meaning that any detectable iodide in the aqueous humor after antisepsis is likely harmless, which is important for assessing safety in ophthalmic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study to determine the penetration of iodide into the anterior chamber following preoperative application of topical 1.25% povidone-iodine. Hansmann, F., Below, H., Kramer, A., et al.[2022]

In a study involving 35 patients with corneal ulcers, a single application of 5% Betadine did not significantly reduce bacterial load compared to a placebo, indicating limited efficacy in this context.

Only 17% of patients in the Betadine group showed improvement in bacterial load, compared to 41% in the placebo group, suggesting that Betadine may not be more effective than standard rinsing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trial of povidone-iodine (Betadine) versus placebo in the pretreatment of corneal ulcers. Gregori, NZ., Schiffman, JC., Miller, DM., et al.[2017]

In a study involving 30 patients, the use of a half-strength povidone-iodine solution for preoperative eye preparation significantly reduced bacterial colonies by 91% and the number of bacterial species by 50%.

The control eyes showed no significant changes in bacterial counts, highlighting the effectiveness of povidone-iodine in reducing the risk of infection during eye surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemical preparation of the eye in ophthalmic surgery. III. Effect of povidone-iodine on the conjunctiva. Apt, L., Isenberg, S., Yoshimori, R., et al.[2022]

Betadine, a PVP-iodine antiseptic solution, has been effectively used in 25 cases for treating bacterial and fungal infections in the oral cavity, showing excellent results in preventing infections after surgical procedures.

Unlike chlorhexidine, Betadine does not cause side effects like tooth and tongue discoloration or altered taste sensation, making it a safer alternative for oral use, with the only contraindication being iodine allergy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Betadine antiseptic in the treatment of oral surgical, parodontological and oral mucosal diseases]. Kövesi, G.[2017]

In a study involving 150 patients undergoing cataract surgery, a new 5% povidone iodine preparation was found to be safe for the eye, with no harmful effects observed during a 60-day follow-up.

Microbiological tests on 60 patients showed a significant reduction in bacterial colonies in the eye after using the povidone iodine, indicating its effectiveness as an antiseptic before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Iodized polyvidone (betadine) and prevention of postoperative infection. A multicenter study]. Lagoutte, F., Fosse, T., Jasinski, M., et al.[2017]

A case report demonstrated that adding 0.66% povidone iodine (PVP-I) to the treatment regimen of a corneal abscess caused by Pseudomonas aeruginosa in a contact lens wearer was effective and well tolerated, especially after initial antibiotic treatment failed.

PVP-I offers a broad-spectrum antimicrobial action against resistant bacteria like P. aeruginosa, making it a valuable adjunctive therapy to enhance treatment outcomes in ocular infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Povidone Iodine 0.66% to Fight Pseudomonas aeruginosa in Contact Lens Wearer: A Case Report. Castelnuovo, S.[2022]

In a study involving 119 women undergoing urogynecologic surgery, chlorhexidine was found to be as effective as povidone-iodine in preventing symptomatic urinary tract infections within 2 weeks post-surgery, with rates of 10% for chlorhexidine compared to 17% for iodine.

Chlorhexidine also showed similar safety profiles to iodine, with no significant differences in rates of surgical site infections or vaginal irritation, suggesting it is a safe alternative for vaginal antisepsis before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chlorhexidine gluconate vs povidone-iodine vaginal antisepsis for urogynecologic surgery: a randomized controlled noninferiority trial. Rockefeller, NF., Petersen, TR., Komesu, YM., et al.[2022]

The combination of 5% betadine solution and silver colloidal gel (Ag-gel) was found to be more effective at eliminating bacteria, including the difficult-to-treat Klebsiella pneumoniae, compared to using either treatment alone.

While Ag-gel effectively inhibited all tested bacteria except for one strain, 5% betadine alone did not completely kill any of the bacteria, highlighting the enhanced antimicrobial efficacy of their combination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The in vitro efficacy of betadine antiseptic solution and colloidal silver gel combination in inhibiting the growth of bacterial biofilms. Tran, P., Kopel, J., Luth, K., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9267159/

The role of hypochlorous acid in the management of eye ... This case series presents and discusses real-life experiences with using an HOCl ophthalmic spray to manage eye infections.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04981860/comparison-of-conjunctival-antimicrobial-activity-and-patient-comfort-between-topical-hypochlorous-acid-avenova-and-betadine

Comparison of Conjunctival Antimicrobial Activity and ... The purpose of this research study is to find out how Avenova (0.01 % hypochlorous acid) works compared to Betadine (Povidone iodide) for ...

3. ctv.veeva.com ctv.veeva.com/study/viral-conjunctivitis-treatment-study

Viral Conjunctivitis Treatment Study - ClinicalTrials.Veeva The objective of this study is to determine the efficacy Avenova® (0.01% hypochlorous acid) in the treatment of viral conjunctivitis.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/28/NCT03861728/Prot_SAP_001.pdf

Viral Conjunctivitis Treatment Study We hypothesize that patients treated with Avenova® will have a quicker resolution of their ocular signs and symptoms of Viral Conjunctivitis. 3) Background.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6046278/

In Vitro Evaluation of a Hypochlorous Acid Hygiene ... Hypochlorous acid (0.01%) hygiene solution was able to achieve bactericidal levels of killing of bacteria in biofilms, but did not disrupt biofilm structures.

6. bmjophth.bmj.com bmjophth.bmj.com/content/8/1/e001209

Hypochlorous acid hygiene solution in patients affected by ... According to our findings, wipes containing hypochlorous acid can be safely used in blepharitis considering the satisfying clinical and ...

7. webmd.com webmd.com/beauty/hypochlorous-acid-spray

Hypochlorous Acid Spray: What to Know It fights off bacteria and reduces inflammation. It's generally safe to use at low concentrations, but it may cause irritation if you use it ...

8. biomiq.health biomiq.health/blogs/blog/how-hypochlorous-acid-is-changing-eye-infection-treatment?srsltid=AfmBOor4iFGqiyerKkLdHyNP74KWjRxnSQgT2rmVx2shLBjf1iD1Booa

How HOCl is Changing Eye Infection Treatment - Biomiq The study further highlights the safety profile of HOCl, as no adverse effects were reported throughout the treatment period⁶.

9. biomedres.us biomedres.us/pdfs/BJSTR.MS.ID.009220.pdf

Antimicrobial Efficacy of a 200 ppm Hypochlorous Acid ... Results demonstrate that the 200 ppm HOCl solution achieves significant microbial reduction, with a 99.9% decrease in bacterial CFU within 10 ...