Clinical trial

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

Name

IZ-4-001

Description

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.

Trial arms

Trial start

2023-07-15

Estimated PCD

2024-01-15

Trial end

2024-02-15

Status

Recruiting

Phase

Early phase I

Treatment

Chloroprocaine ophthalmic gel 3%

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

Arms:

Chloroprocaine ophthalmic gel 3%, Tetracaine ophthalmic solution 0.5%

Other names:

Iheezo

Size

Primary endpoint

Change in colony forming units

Baseline and 5 minutes after baseline.

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2023-09-21

1 organization

1 product

3 indications

Organization

Product

Indication

Indication

Indication