A Prospective Study of Cyclosporine A 0.1% Combined with Loteprednol 0.2% vs Cyclosporine A 0.05% Alone in the Treatment of Dry Eye

Abstract

Purpose

To examine the efficacy and tolerability of a combination of cyclosporine 0.1% and loteprednol 0.2% (CsA–LE; Klarity CL) in comparison to commercially available cyclosporine 0.05% (CsA; Restasis) in improving signs and symptoms of dry eye.

Methods

This multicenter, prospective, randomized, controlled, open-label study evaluated 60 patients randomized to a single treatment for 4 weeks and evaluated at day 0, day 14, and day 28. Comparison was made of corneal higher-order aberrations (HOAs), dry-eye symptoms (SPEED score), tear-breakup time (TBUT), corneal staining, and ocular hyperemia, as well as tolerability of each medication with the validated COMTOL instrument.

Results

A total of 56 patients completed enrollment. Corneal HOAs improved significantly with CsA–LE, but not CsA alone. Both groups showed significant improvement (with no significant differences between groups) in SPEED scores, corneal staining, TBUT, and conjunctival hyperemia. Tolerability was similar between the drugs, and no significant safety issues were identified.

Conclusion

The combination of CsA 0.1%–LE 0.2% provided significant improvement in corneal HOAs, while CsA 0.05% did not. For all other measures of ocular surface improvement, both medications showed similar benefits. Tolerability was comparable between the formulations. When rapid rehabilitation of the ocular surface is needed to reduce aberrations, CsA–LE is an appropriate choice.

Keywords:

• dry eye
• higher-order aberrations
• loteprednol
• cyclosporine

Data Sharing

Reasonable requests for deidentified patient data relating to the study findings, including any outcome measures, will be available through the corresponding author for 5 years following the publication date.

Acknowledgments

Leslie Lemieux assisted in the administration of this study. Partial results of this study were presented at the annual meeting of the American Society of Cataract and Refractive Surgery in San Diego, California in May 2023.

Disclosure

Dr John Hovanesian reports grants and personal fees from ImprimisRx and personal fees from Allergan during the conduct of the study. Dr Thomas Chester reports personal fees from Allergan, personal fees from Dompe, personal fees from Glaukos, personal fees from Novartis, personal fees from Oyster Point, grants and personal fees from Sight Sciences, personal fees from Sun Ophthalmics, personal fees from Tarsus, and personal fees from Versea outside the submitted work. The authors report no other conflicts of interest in this work.

Additional information

Funding

This study was funded by Research InSight, LLC under an independent research grant from Imprimis Rx, a Harrow Company, which did not give direction in the design or conduct of this study. Dr. Hovanesian is a consultant to ImprimisRx.