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

Anesthesia, Local Clinical Trial

Official title:

The Effects of Low Viscosity Chloroprocaine Ophthalmic Gel 3% on the Bactericidal Action of Povidone-Iodine: A Comparison vs Tetracaine 0.5% Solution.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05934253
• Other study ID #: IZ-4-001
• Status: Recruiting
• Phase: Phase 4
• Start date: July 15, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: September 2023
• Source: Harrow Inc
• Contact: Richard Costine, PharmD
• Phone: 8505097474
• Email: rcostine[@]harrowinc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local
• Antiseptic

Intervention

Drug:
• Chloroprocaine ophthalmic gel 3%
FDA approved topical ophthalmic anesthetic applied 3 drops to the ocular surface before the planned procedure.

Locations

Country	Name	City	State
United States	Brandon Eye Associates	Brandon	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Harrow Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in colony forming units	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.	Baseline and 5 minutes after baseline.