Avenova vs Betadine for Bacterial Eye Infections

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

230 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Avenova, Hypochlorous Acid, Betadine, Povidone iodine, Polyvidone iodine, Iodopovidone, Wokadine, Pyodine for bacterial eye infections?

Research shows that Betadine (povidone-iodine) is effective in reducing bacterial load in eye infections, as it significantly decreases the number of bacteria on the eye's surface. Additionally, Betadine has been shown to be effective against a wide range of bacteria, including those resistant to antibiotics, making it a useful tool in treating bacterial eye infections. ^{1 2 3 4 5}

Is it safe to use Avenova and Betadine for eye infections?

Studies show that Betadine (povidone-iodine) is generally safe for use in eye surgeries, with no harmful effects observed in patients. Avenova (hypochlorous acid) has not been specifically mentioned in these studies, but similar solutions have been used safely for eye antisepsis. ^{2 6 7 8 9}

How does the drug Avenova differ from Betadine for bacterial eye infections?

Betadine (povidone-iodine) is unique because it has a broad antibacterial spectrum, is cost-effective, and bacteria do not develop resistance to it. It is often used in eye surgeries and infections due to its rapid action and safety profile, making it a valuable option for treating bacterial eye infections. ^{1 3 4 9 10}

What is the purpose of this trial?

The purpose of this research study is to find out how Avenova (0.01 % hypochlorous acid) works compared to Betadine (Povidone iodide) for reducing bacteria and patient discomfort in the eyes.

Research Team

Jorge Fortun, MD

Principal Investigator

University of Miami

Eligibility Criteria

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 not had any eye injections 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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical trial of povidone-iodine (Betadine) versus placebo in the pretreatment of corneal ulcers. [2017]

2. France 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]. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Chemical preparation of the eye in ophthalmic surgery. III. Effect of povidone-iodine on the conjunctiva. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2023]

6. Hungary pubmed.ncbi.nlm.nih.gov

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

7. Germany 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Chlorhexidine gluconate vs povidone-iodine vaginal antisepsis for urogynecologic surgery: a randomized controlled noninferiority trial. [2022]

9. France pubmed.ncbi.nlm.nih.gov

[Iodized polyvidone (betadine) and prevention of postoperative infection. A multicenter study]. [2017]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Ocular applications of povidone-iodine. [2017]