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

Phase 4

Recruiting

• Conditions: Antiseptic; Anesthesia, Local
• Interventions: Drug: Chloroprocaine ophthalmic gel 3%

• Registration Number: NCT05934253
• Lead Sponsor: Harrow Inc

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.

Study Timeline

• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-28
• Study First Posted: 2023-07-06
• Study Start: 2023-07-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-01-15
• Study Completion: 2024-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tetracaine ophthalmic solution 0.5%	Chloroprocaine ophthalmic gel 3%	FDA approved topical ophthalmic anesthetic applied 3 drops to the ocular surface before the planned procedure.
Chloroprocaine ophthalmic gel 3%	Chloroprocaine ophthalmic gel 3%	FDA approved topical ophthalmic anesthetic applied 3 drops to the ocular surface before the planned procedure.

Primary Outcome Measures

Name	Time	Method
Change in colony forming units	Baseline and 5 minutes after baseline.	Comparison of results from Bacterial Culture Swabs before and after application of drug and povidone-iodine. First bacterial culture at initiation. Study medication applied after culture. Povidone-iodine applied two minutes after. Second bacterial culture three minutes after.

Trial Locations

Locations (1)

Brandon Eye Associates; 🇺🇸 Brandon, Florida, United States