Topical cyclosporine 0.05% (Restasis®; Allergan) treats inflammation associated with dry eye by increasing the eyes' natural tear production. Initially, many eyecare providers reserved cyclosporine for their more serious dry eye cases. However, it now is widely accepted that inflammatory mediators and the immune system cells they activate are key elements in pushing mildly symptomatic dry eye conditions toward potentially serious ocular surface disease. In theory, then, treating dry eye in its early stages should help prevent progression to more debilitating forms of the disease.
We designed a study to answer the question: Does early intervention with cyclosporine successfully prevent disease progression? In the study, patients were randomized to receive either an artificial tear (Refresh Endura® [which has since been renamed Refresh Dry Eye Therapy®]) either alone or with cyclosporine. By the end of the 12-month study, the cyclosporine group was doing significantly better than the tears-only group in every measure tested (Schirmer, tear film breakup time, goblet cell density, corneal staining, and International Task Force level).
The results of the study call for rethinking the conventional wisdom that moderate dry eye is best managed conservatively with artificial tears and that dry eye progresses slowly or not at all in many patients. On the contrary, this study found that there was measurable progression after only 1 year in about a third of the patients treated with artificial tears. Furthermore, the control group in this study was not untreated. Rather, the controls were treated with a very good artificial tear, which is the standard of care in mild to moderate dry eye disease.
In short, these results indicate that eyecare practitioners should consider changing their treatment algorithms for dry eye disease, because treating sooner and more aggressively may prevent a significant number of patients from progressing to more severe levels of the disease. My rule of thumb is: If patients have level 2 dry eye, plus any risk factors for progression, and are using artificial tears more than 4 times a day, I start them on cyclosporine to improve their dry eye signs and symptoms and, based on the results reported here, hopefully limit disease progression.
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