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.

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.