Abstract
Purpose: :
To assess the efficacy of topical cyclosporine .05% (Restasis®) versus vehicle (Endura®) for the improvement of dry eye signs and change in daily activity impact of dry eye.
Methods: :
Prospective clinical evaluation of 56 patients with dry eye syndrome. Schirmer testing with anesthesia, noninvasive fluorescein break up time, and ocular surface vital dye staining were performed and the Ocular Surface Disease Index (OSDI) administered. Patients were randomized to either cyclosporine 0.05% twice a day or vehicle twice a day for 3 months. Study visits were at baseline and months 1, 2, and 3.
Results: :
Cyclosporine improved OSDI scores significantly more than vehicle (mean reduction of 11.4 points with cyclosporine, compared with a mean increase of 0.8 point with tears, P<.001). Dry eye ocular surface parameters also improved significantly with cyclosporine treatment compared with vehicle. Cyclosporine provided statistically significantly greater improvements in Schirmer’s scores (mean improvement of 1.4 mm, compared with a mean improvement of 0.3 mm with vehicle, P<.001) and tear break–up time (mean improvement of 1.7 secs with cyclosporine, compared with 0.4 secs with vehicle, P<.001) compared with vehicle. There were no statistically significant differences in vital eye staining.
Conclusions: :
The findings of the present study suggest that topical cyclosporine effectively treats dry eye and provides positive change in daily activity impact of dry eye.
Keywords: cornea: tears/tear film/dry eye • cyclosporine • quality of life