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Confronto tra attività antimicrobica congiuntivale e comfort del paziente tra acido ipocloroso topico (Avenova) e betadina

15 ottobre 2026 aggiornato da: Jorge Fortun, University of Miami

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.

Panoramica dello studio

Stato

Terminato

Descrizione dettagliata

About two percent of the population have an iodine allergy 1. A percentage of this population will also have a reaction to iodine-containing agents, including povidone iodine (PI) (Betadine®), which is the current standard of care for anti-septic preparation for conjunctival procedures. Despite being known to have a toxic effect on the cornea 2 and causing allergic reactions in some individuals, povidone Iodine (PI) (Betadine®) is still the most commonly used antiseptic agent for surgical scrub. Currently, there are no equivalent alternative prep agents available, although chlorhexidine has occasionally served as an alternative to povidone iodine (PI) (Betadine®) with variable results 2. Some studies have reported significantly less pain in patients prepped with chlorhexidine compared to povidone iodine (PI) (Betadine®) 2, and other studies have demonstrated that chlorhexidine has equal efficacy to povidone iodine (PI)(Betadine®) in decreasing the colony forming units of microbes both in vitro and in vivo 3. Although there have been no known reported allergies to chlorhexidine, it is known to be toxic to the cornea (leading to severe keratitis) and has proven to be less effective against methicillin-resistant Staphylococcus aureus(MRSA) 4.

The use of 0.01% hypochlorous acid (HOCl) in saline solution as an antiseptic agent has been gaining popularity as a possible alternative to povidone iodine (PI) (Betadine®). Hypochlorous acid (HOCl) is produced in vivo by neutrophils and causes oxidation of microbial nucleotides and inactivation of microbial enzymes, leading to cell death. Hypochlorous acid (HOCl) has a faster optimal kill-time for flora common to the eye 4, and has proven to be non-cytotoxic and well tolerated for continuous use 4,5,6. In vitro studies of 0.01% hypochlorous acid (HOCl) were found to have equal or more efficacious antiseptic properties compared with povidone iodine (PI) (Betadine®) and other potential antiseptic agents including chlorohexidine and isopropyl alcohol 4.

Currently, two concentrations of HOCl are available for commercial use: AvenovaTM with Neutrox™ (0.01% HOCl) and an over the counter product (0.02% HOCl). Both concentrations are used to treat blepharitis. Debabov et al5 presented toxicity data concluding that 0.01% hypochlorous acid (HOCl) (Avenova™ with Neutrox™) proved to be non-cytotoxic in comparison to the 0.02% hypochlorous acid (HOCl) product which was cytotoxic thus supporting the potential benefit of HOCl.

Stroman et al6 2017 concludes that hypochlorous acid (HOCl)in saline solution reduced bacterial colony load significantly without altering the variation of remaining bacterial species. Additionally, hypochlorous acid (HOCl) has been shown to reduce the population of bacterial and fungal species common to the lids and lashes by ≥ 99.9% 7. Despite the use of hypochlorous acid (HOCl) as a topical antiseptic on the eyelid, there have been no reports of its use as an antiseptic agent for conjunctival procedures. Many studies have confirmed that flora of the eyelid and eyelash only differ in their concentrations 8. Since hypochlorous acid (HOCl) has been found to be effective in reducing colony forming units and since the flora species of the conjunctiva, eyelid and eyelashes are equivalent, we propose that hypochlorous acid (HOCl) may serve as an alternative to povidone iodine (PI) (Betadine®) as a conjunctival procedure prep agent. Considering there were no reported negative side effects of hypochlorous acid (HOCl) contact with the eye, hypochlorous acid (HOCl) may prove to be a non-inferior alternative to povidone iodine (PI) (Betadine®). This may result in lower irritation and toxicity compared to povidone iodine (PI) (Betadine®)

Tipo di studio

Interventistico

Iscrizione (Effettivo)

20

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Florida
      • Palm Beach Gardens, Florida, Stati Uniti, 33418
        • Bascom Palmer Eye Institute
    • Texas
      • San Antonio, Texas, Stati Uniti, 78240
        • Medical Center Ophthalmology Associates

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Treatment naïve participants First Group L

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

One drop of 5% povidone-iodine (Betadine) administered to the inferior conjunctiva of one eye. In the intravitreal injection groups, Betadine was given to the eye receiving the injection, as standard of care.

Altri nomi:
  • Iodio povidone

One drop of 0.01% hypochlorous acid (Avenova) administered to the inferior conjunctiva of one eye. In the intravitreal injection groups, Avenova was given to the fellow (non-injected) eye. In the treatment-naive groups, the eye was assigned by randomization (Group L or Group R).

Altri nomi:
  • Acido Ipocloroso
Sperimentale: Treatment naïve participants Second Group R

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

One drop of 5% povidone-iodine (Betadine) administered to the inferior conjunctiva of one eye. In the intravitreal injection groups, Betadine was given to the eye receiving the injection, as standard of care.

Altri nomi:
  • Iodio povidone

One drop of 0.01% hypochlorous acid (Avenova) administered to the inferior conjunctiva of one eye. In the intravitreal injection groups, Avenova was given to the fellow (non-injected) eye. In the treatment-naive groups, the eye was assigned by randomization (Group L or Group R).

Altri nomi:
  • Acido Ipocloroso
Sperimentale: Participants undergoing intravitreal injection First Group L

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.

One drop of 5% povidone-iodine (Betadine) administered to the inferior conjunctiva of one eye. In the intravitreal injection groups, Betadine was given to the eye receiving the injection, as standard of care.

Altri nomi:
  • Iodio povidone

One drop of 0.01% hypochlorous acid (Avenova) administered to the inferior conjunctiva of one eye. In the intravitreal injection groups, Avenova was given to the fellow (non-injected) eye. In the treatment-naive groups, the eye was assigned by randomization (Group L or Group R).

Altri nomi:
  • Acido Ipocloroso
Sperimentale: Participants undergoing intravitreal injection Second Group R

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.

One drop of 5% povidone-iodine (Betadine) administered to the inferior conjunctiva of one eye. In the intravitreal injection groups, Betadine was given to the eye receiving the injection, as standard of care.

Altri nomi:
  • Iodio povidone

One drop of 0.01% hypochlorous acid (Avenova) administered to the inferior conjunctiva of one eye. In the intravitreal injection groups, Avenova was given to the fellow (non-injected) eye. In the treatment-naive groups, the eye was assigned by randomization (Group L or Group R).

Altri nomi:
  • Acido Ipocloroso

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Bacterial Colony Forming Units (CFU)
Lasso di tempo: Day 1

As assessed from sterile culture swab applied to the eye

Day 1

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Post-Exposure Pain Score on Day 2 in the Avenova-Treated and Betadine-Treated Eyes
Lasso di tempo: Day 2 (morning after instillation)

Pain in each eye was self-rated on the post-exposure questionnaire the morning after drug instillation (Day 2), on a numeric scale from 0 to 10, with higher scores indicating greater pain. The protocol described the scale as 1 to 10; scores of 0 were recorded and are reported as entered. No questionnaire was administered before instillation, so change from baseline could not be calculated; Day 2 scores are reported as absolute values. Scores are reported separately for the Avenova-treated eye and the Betadine-treated eye of each participant.

Day 2 (morning after instillation)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Jorge Fortun, MD, University of Miami

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

6 agosto 2021

Completamento primario (Effettivo)

27 giugno 2022

Completamento dello studio (Effettivo)

27 giugno 2022

Date di iscrizione allo studio

Primo inviato

27 luglio 2021

Primo inviato che soddisfa i criteri di controllo qualità

27 luglio 2021

Primo Inserito (Effettivo)

29 luglio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 ottobre 2026

Ultimo verificato

1 luglio 2025

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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