Utilizing PROSE as a Drug Delivery Device for Preservative-Free Cyclosporine 0.05% for the Treatment of Dry Eye Disease: A Pilot Study.

PURPOSE: To evaluate the tolerability of utilizing Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE) as a drug delivery device for preservative-free cyclosporine 0.05% for the treatment of dry eye disease.

PATIENTS AND

METHODS

Fourteen current daily PROSE wearers were enrolled, with four screen failures and one subject that did not complete the study protocol due to burning and stinging. Nine subjects, 18 eyes completed the study protocol. All participants were instructed to instill one drop of preservative-free cyclosporine 0.05% in the PROSE reservoir and then fill the rest of the reservoir with preservative-free normal saline. After applying the PROSE and wearing for 6 hours, the PROSE was removed, and the protocol was repeated for at least another 4 additional hours of wear. Baseline, 1 week and 1 month symptom and sign data were collected.

RESULTS

At one month, OSDI improved by an average of 3.83 ± 6.87 from baseline (p = 0.07) and there was no statistically significant change in best corrected visual acuity. Without comparing with placebo, there was statistically significant (p < 0.05) improvement in mean per subject and mean per eye corneal fluorescein staining, conjunctival lissamine staining, and conjunctival hyperemia by slit lamp examination at one-month follow-up.

CONCLUSION

Utilizing PROSE as a drug delivery system for non-preserved cyclosporine 0.05% was well tolerated in regard to both ocular symptoms and ocular surface signs. Results from this pilot study are suggestive of efficacy. The results of this study support progressing this protocol to a larger scale randomized controlled double blinded prospective clinical trial.