Study Finds, Water-free 0.1% Cyclosporine Solution for Treat
A Study was conducted to assess the efficacy, safety, and tolerability of a topical water-free cyclosporine A formulation (CyclASol 0.1% ophthalmic solution) in comparison with vehicle for the treatment of dry eye disease (DED).

328 patients were enrolled in this prospective study. The primary efficacy endpoint was change from baseline in total corneal fluorescein staining, and the second hierarchical primary efficacy endpoint was change from baseline in the Ocular Surface Disease Index score. Secondary efficacy and safety assessments included conjunctival lissamine green staining, visual analog scales for dry eye symptoms, and adverse event.

--Treatment with CyclASol 0.1% was superior to vehicle in the primary endpoint: total corneal fluorescein staining at week 4.

--This difference had already reached statistical significance after 2 weeks and was maintained throughout the study.

--The study did not statistically meet its second hierarchically tested primary endpoint: Ocular Surface Disease Index score.

--However, CyclASol 0.1% treatment showed statistically significant improvement compared with that of vehicle in the eye dryness score at week 4.

Conclusively, CyclASol 0.1 percent was found to be beneficial in the treatment of DED signs and symptoms. When compared to the vehicle, it dramatically reduced corneal and conjunctival stains and improved ocular dryness. CyclASol 0.1 percent was shown to be safe and tolerable.