Completed

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

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What is being tested

Chloroprocaine ophthalmic gel 3%

Drug
Who is being recruted

From 18 to 99 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 4
Interventional
Study Start: July 2023
See protocol details

Summary

Principal SponsorHarrow Inc
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 15, 2023

Actual date on which the first participant was enrolled.

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.

Official TitleThe Effects of Low Viscosity Chloroprocaine Ophthalmic Gel 3% on the Bactericidal Action of Povidone-Iodine: A Comparison vs Tetracaine 0.5% Solution.
NCT05934253
Principal SponsorHarrow Inc
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Patients over age 18.

Able to comprehend and sign a statement of informed consent.

9 exclusion criteria prevent from participating
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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Brandon Eye Associates

Brandon, United StatesOpen Brandon Eye Associates in Google Maps
CompletedOne Study Center