Avenova vs Betadine for Bacterial Eye Infections

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Jorge Fortun, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Miami

Must not be taking: Glaucoma drops, Antibiotics, Steroids

Disqualifiers: Pregnancy, Minors, Prisoners, others

No Placebo Group

Prior Safety Data

Trial Summary

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.

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}

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.

Trial 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)

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Medical Center Ophthalmology Associates San Antonio, TX

Bascom Palmer Eye Institute Palm Beach Gardens, FL

Who Is Running the Clinical Trial?

University of Miami Lead Sponsor

References

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

Clinical trial of povidone-iodine (Betadine) versus placebo in the pretreatment of corneal ulcers. [2017] To investigate antimicrobial effectiveness of povidone-iodine (Betadine) in reducing bacterial load of corneal ulcers before patients were given antibiotics.

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] The aim of this monocentric, randomized, comparative, open study was to evaluate the safety of Amukine 0.06% solution (an isotonic hypochloride sodium solution) versus a 5% povidone iodine solution (Bétadine 5% solution for ocular irrigation) in antisepsis before cataract surgery.

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] A half-strength povidone-iodine (Betadine) solution was used topically as part of the preoperative chemical preparation of the eye. Aerobic and anaerobic bacterial cultures of the conjunctiva were taken before and after the chemical preparation in 30 consecutive patients; the second eye served as a control. In the control eyes, no significant change in the number of colonies or species of bacteria was found. In the povidone-iodine-treated eyes, the numbers of colonies decreased 91% and the number of species decreased 50% (statistically significant). We therefore recommend that a half-strength povidone-iodine solution be used as part of the chemical preparation of the eye for surgery.

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

Povidone Iodine 0.66% to Fight Pseudomonas aeruginosa in Contact Lens Wearer: A Case Report. [2022] Contact lens use is often associated with corneal infections. Pseudomonas aeruginosa is the most common cause of contact lens-associated infections. Its treatment is often challenging due to the ability of this opportunistic bacteria to be resistant to antibiotics that are, usually, prescribed empirically. Antiseptic could be an adjunctive therapy aiming to broaden the antimicrobial spectrum. Low concentration povidone iodine has rapid broad-spectrum activity against bacteria including P. aeruginosa, fungi, viruses, protozoa, and biofilms, lack of resistance and efficacy in wound healing process, along with an optimum safety and tolerability profile. The purpose of this case report was to show the effect of 0.66% povidone iodine added to the antimicrobial treatment of a corneal abscess caused by P. aeruginosa in a contact lens wearer. A 25-year-old female, with suspected microbial keratoconjunctivitis was empirically treated with topical antibiotics (gentamicin and moxifloxacin). After a worsening of the corneal abscess, subconjunctival injection of gentamicin was started and, with the aim of broadening the antimicrobial spectrum, 0.66% PVP-I (2 times a day) was added. Based on the antibiogram, registering abundant growth of P. aeruginosa, topical antibiotics were substituted with ciprofloxacin, while PVP-I was maintained until complete recovery. Combined treatment of antibiotics and PVP-I 0.66% was effective, safe, and well tolerated in treating ocular infection caused by P. aeruginosa. PVP-I could be a useful additional therapeutic tool for fighting P. aeruginosa infections, generally resistant to antibiotics, and to prevent clinical worsening pending the correct microbiological diagnosis.

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] Betadine (Povidone-Iodine) solution is a topically applied antiseptic, which has been used routinely used in wound care and general surgery to prevent skin and wound infections. However, several studies have documented the ineffectiveness of betadine. Other topical antimicrobial dressings, including those that contain silver, have been used in the management of infected wounds. The present study was undertaken to determine if the combination of 5% betadine solution and silver colloidal gel (Ag-gel) is more effective than either substance alone in inhibiting the growth gram-negative and gram-positive bacteria.

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

[The use of Betadine antiseptic in the treatment of oral surgical, parodontological and oral mucosal diseases]. [2017] The Betadine is an antiseptic PVP (polyvinil prrolidon)-iodine containing, water soluble solution, which has been in circulation in Hungary for years. Until now Betadine was not applied in the oral cavity for bacterial and fungal infections, although its effectiveness is unquery. The PVP-iodine is water solubilized that's why it does not sting the healthy or ill oral mucosa and has not side effects as discoloration of the teeth and tongue and trouble in the sensation of taste as does chlorhexidine. The only contraindication is iodine allergy. In the present study: in periodontal cases (abscesses, postoperative prevention) and in oral medicine cases alone or in combination with specific treatment schedule was Betadine applied. PVP-iodine as oral rinse was applied in 25 cases. According to our experience Betadine was excellent against bacterial and fungal infections in the oral cavity, which prevent or treat bacterial infections after surgical interventions. By this way the bacterial superinfections of exulcerant oral mucosal diseases avoidable.

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] Povidone-iodine is currently the agent of choice for pre-operative antisepsis in ophthalmology. Due to experimental and analytical constraints, iodine absorption into the anterior chamber (AC) has not yet been studied. However, knowledge of the details of iodine transfer into the aqueous humor (AH) is critical for risk assessment of local and/or systemic side effects

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

Chlorhexidine gluconate vs povidone-iodine vaginal antisepsis for urogynecologic surgery: a randomized controlled noninferiority trial. [2022] Although povidone-iodine (iodine) is the only Food and Drug Administration-approved vaginal antiseptic solution, there is a lack of comparative data evaluating alternatives. Chlorhexidine gluconate is readily accessible, recommended by multiple societies as an alternative for patients with iodine allergy, and preliminary data indicate that it may provide superior antisepsis.

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

[Iodized polyvidone (betadine) and prevention of postoperative infection. A multicenter study]. [2017] A multicentre study of a new preparation of povidone iodine (5% betadine) was carried out on 150 patients undergoing cataract surgery. Pre-operatively the eye was prepared by daubing the peri-ocular skin and a two-minute instillation into the conjunctival fornices. No other antiseptic was applied. Tolerance to the product was evaluated in all the patients: clinical evaluation postoperatively and during a 60-day follow-up period confirmed that the preparation was harmless to the eye. Microbiological investigations (comprising conjunctival swabbing, bacterial culture and count of the bacterial species isolated, before and after application of the product) performed on 60 patients showed a significant fall in the number of colonies after treatment.

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

Ocular applications of povidone-iodine. [2017] Ocular infections can have devastating consequences and may lead to blindness. Povidone-iodine (PVP-I) has many potential advantages over the currently used drugs, including a broader antibacterial spectrum, it turns the surface of the eye brown for a few minutes, bacterial resistance has not been seen and it is cheaper than other agents. PVP-I has made a significant contribution to pre- and postoperative ocular surgical prophylaxis, ophthalmia neonatorum prophylaxis and treatment of bacterial conjunctivitis. Scientific support for these applications includes studies conducted over the past 17 years, which are reviewed.