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

Harrow Inc

Status and phase: Enrolling; Phase 4

Conditions: Anesthesia, Local; Antiseptic

Treatments: Drug: Chloroprocaine ophthalmic gel 3%

Study type: Interventional

Funder types: Industry

Identifiers

NCT05934253

IZ-4-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Ocular surgery (e.g., intraocular, oculoplastic, corneal, or refractive surgical procedure) performed within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this 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 fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including 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 pregnant during participation in the study.
• Monocular patients.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Chloroprocaine ophthalmic gel 3%

Experimental group

Description:

FDA approved topical ophthalmic anesthetic applied 3 drops to the ocular surface before the planned procedure.

Treatment:

Drug: Chloroprocaine ophthalmic gel 3%

Tetracaine ophthalmic solution 0.5%

Active Comparator group

Description:

FDA approved topical ophthalmic anesthetic applied 3 drops to the ocular surface before the planned procedure.

Treatment:

Drug: Chloroprocaine ophthalmic gel 3%