The Effects of Low Viscosity Preservative-Free Chloroprocaine Ophthalmic Gel 3% versus BAK-Containing Tetracaine 0.5% on the Bactericidal Action of Povidone-Iodine

Abstract

Purpose

To evaluate if chloroprocaine ophthalmic gel 3% acts as a barrier to the bactericidal actions of povidone-iodine (PVI) which has been seen in other higher viscosity gel anesthetics.

Methods

This was a single site, prospective, randomized, patient-masked study evaluating the effects of preservative-free chloroprocaine ophthalmic gel 3% (IHEEZO^®, Harrow, Nashville, TN) compared with tetracaine ophthalmic solution 0.5% and their effects on the bactericidal action of povidone-iodine 5%. The study comprised 82 patients who had both eyes cultured before and after application of randomized treatment and povidone-iodine.

Results

In terms of mean percent reduction in colony forming units, chloroprocaine with povidone-iodine was non-inferior to tetracaine with povidone-iodine, with a higher mean percent reduction in colony forming units in the chloroprocaine group (change [∆] = −7.2; 90% CI, −13.56 to 3.28).

Conclusion

Data collected in this study suggest that preservative-free chloroprocaine ophthalmic gel 3% does not act as a barrier to the bactericidal actions of povidone-iodine 5% and that the reduction in CFU from PVI is similar when compared with tetracaine 0.5% ophthalmic solution with PVI.

Keywords:

• anesthetics
• cataract
• cornea
• infection
• drug formulation

Data Sharing Statement

Deidentified patient data not presented in this manuscript will not be shared with any parties. Requests for additional information may be made to the corresponding author. These data will be made available for a minimum of three years.

Disclosure

Haroon Ilyas served as the primary investigator for this study and was reimbursed by Harrow for his time and expertise. Richard Costine is an employee of Harrow.

Additional information

Funding

This study was funded by Harrow.