The Effects of Low Viscosity Chloroprocaine Ophthalmic Gel 3% on the Bactericidal Action of Povidone-Iodine

Last updated: September 20, 2023
Sponsor: Harrow Inc
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Chloroprocaine ophthalmic gel 3%

Clinical Study ID

NCT05934253
IZ-4-001
  • Ages 18-99
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To evaluate if Iheezo's (chloroprocaine 3%) gel vehicle acts as a barrier on the ocular surface, potentially blocking the bactericidal action of povidone-iodine.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients over age 18.
  • Able to comprehend and sign a statement of informed consent.

Exclusion

Exclusion Criteria:

  • Ocular surgery (e.g., intraocular, oculoplastic, corneal, or refractive surgicalprocedure) performed within the last 3 months or at any time that in theinvestigator's clinical judgment if it would interfere with the outcome measures ofthis study.
  • Clinically significant ocular trauma.
  • Diagnosis of lagophthalmos, or other severe eyelid abnormalities (entropion,ectropion, tumor, edema, blepharospasm, severe trichiasis, severe ptosis.)
  • Active ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis,conjunctivitis) at the discretion of the investigator.
  • Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungalinfection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelidsincluding hordeolum/stye).
  • Ocular infection within the last 3 months.
  • Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis.
  • Patients who are under age 18, pregnant or breastfeeding, or who may become pregnantduring participation in the study.
  • Monocular patients.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Chloroprocaine ophthalmic gel 3%
Phase: 4
Study Start date:
July 15, 2023
Estimated Completion Date:
February 15, 2024

Study Description

Choice in vehicle plays a large role in drug delivery with topical ophthalmic medications. One strategy to increase efficacy is by increasing the ocular surface contact time of a drug on the eye, primarily by increasing the viscosity of the vehicle. However, studies have demonstrated that high viscosity topical medications act as a barrier to subsequent drops. This poses a serious issue in pre-operative prophylaxis, as high viscosity vehicles may block the bactericidal action of povidone-iodine. This has been supported by in vitro studies of Akten (lidocaine 3.5%) gel.

Akten gel has a viscosity between 4000-9000 cps. Iheezo has a viscosity between 1200-2000 cps. Generic tetracaine 0.5% has a viscosity between 15-25cps. Healthy human tears have a viscosity of around 8 cps. For a vehicle to not act as a barrier to subsequent drops, it is believed that the viscosity should be close to human tears.

This study theorizes that Iheezo's lower viscosity will not act as a barrier to the bactericidal action of Povidone-iodine 5%.

This is a single site, prospective, randomized, patient masked, open-label study evaluating the effects of Iheezo (chloroprocaine HCl ophthalmic gel 3%) and how it may interact with povidone-iodine compared to tetracaine 0.5% ophthalmic solution. Consented patients will have their eyes randomized, one receiving Iheezo and the other tetracaine 0.5% ophthalmic solution.

Connect with a study center

  • Brandon Eye Associates

    Brandon, Florida 33511
    United States

    Active - Recruiting

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