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

NCT ID: NCT05934253

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-15
• Study Completion Date: 2024-02-15

Brief 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.

Detailed 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.

Conditions

Antiseptic; Anesthesia, Local

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Chloroprocaine ophthalmic gel 3%

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

Group Type: EXPERIMENTAL

Chloroprocaine ophthalmic gel 3%

Intervention Type: DRUG

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

Tetracaine ophthalmic solution 0.5%

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

Group Type: ACTIVE_COMPARATOR

Chloroprocaine ophthalmic gel 3%

Intervention Type: DRUG

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

Interventions

Chloroprocaine ophthalmic gel 3%

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

Intervention Type: DRUG

Other Intervention Names

Iheezo

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harrow Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Brandon Eye Associates

Brandon, Florida, United States

Countries

United States

Other Identifiers

IZ-4-001

Identifier Type: -

Identifier Source: org_study_id