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

NCT05934253 | Completed Phase 4 FDA Drug

• 1 other identifier: IZ-4-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Antiseptic; Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Chloroprocaine ophthalmic gel 3%

EXPERIMENTAL

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

Drug: Chloroprocaine ophthalmic gel 3%

Tetracaine ophthalmic solution 0.5%

ACTIVE COMPARATOR

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

Drug: Chloroprocaine ophthalmic gel 3%

Interventions

Chloroprocaine ophthalmic gel 3% DRUG

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

Also known as: Iheezo

Chloroprocaine ophthalmic gel 3%; Tetracaine ophthalmic solution 0.5%

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harrow Inc: lead

Study Sites (1)

Brandon Eye Associates

Brandon, Florida, 33511, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: July 6, 2023
• Study Start: July 15, 2023
• Primary Completion: January 15, 2024
• Study Completion: February 15, 2024
• Last Updated: September 16, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)