Topical cyclosporine helps prevent dry eye progression

Topical cyclosporine 0.05% (Restasis, Allergan) limited progression or improved dry eye severity levels in most patients, while the use of artificial tears alone led to worsening of disease severity levels in nearly one-third of patients in a 12-month randomized study. The rapid progression of the disease in patients using artificial tears and the improvements in the patients using cyclosporine suggest that medication use could be beneficial for many individuals with level 2 dry eye disease.

Key Points

Chicago-Topical cyclosporine 0.05% (Restasis, Allergan) effectively limited progression of dry eye disease as well as alleviated the signs and symptoms in a recent 12-month study. The outcomes also suggested that progression can occur much more rapidly than generally assumed, which indicates that some patients might benefit from earlier use of cyclosporine, according to Sanjay N. Rao, MD.

"What was surprising from this study was the finding that dry eye can be rapidly progressive," said Dr. Rao, a corneal specialist and medical director at Lakeside Eye Clinic in Chicago. Up to one-third of the patients who were using artificial tears had worsening of dry eye severity level over the year of the study compared with just 6% of those receiving cyclosporine.

While most ophthalmologists understand that dry eye disease is progressive, the assumption has been that a worsening in disease severity typically takes years to develop.

More aggressive treatment

Those findings have changed his practice, Dr. Rao said. Before the study, he, like many other clinicians who treat significant numbers of patients with dry eye disease, tended to reserve cyclosporine for the more severe cases because it was assumed that these patients would benefit most.

"What the change in my practice has been is that I've become a lot more aggressive in treating patients with level 2 dry eye because I'm worried that if I keep treating them with palliative therapy, like artificial tears, the disease could progress over time," Dr. Rao said.

His treatment algorithm for patients who have level 2 dry eye, use artificial tears more than three or four times a day, and have risk factors for progression is to start treating them with cyclosporine.

"In general, it works much better when we do so because the cyclosporine tends to work a lot better in the patients with moderate disease than if you wait until the disease is very severe," he explained. "From a patient selection standpoint, these patients do better. Their symptoms are controlled better and the likelihood that you'll get them to a level of comfort is much better if you're treating patients with level 2 disease as opposed to waiting for the disease to get severe enough to be into that level 3 category."

Most consensus groups that have studied dry eye have emphasized making treatment decisions based on severity level, but Dr. Rao noted that he and others have taken the concept a step further by suggesting that clinicians also look at individual risk factors such as age, medications, previous refractive surgery, and other ocular morbidity.

In this single-center, 12-month evaluation, 74 patients with dry eye disease were randomly assigned to twice-daily treatment with either cyclosporine 0.05% or artificial tears (Refresh Endura, Allergan). Study visits took place at baseline and months 4, 8, and 12 between February 2006 and January 2007. The outcome measures were dry eye severity levels, Schirmer's scores, Ocular Surface Disease Index, tear break-up time, ocular surface staining, and goblet cell density. International Task Force (ITF) consensus guidelines for diagnosing and treating dysfunctional tear syndrome were used to determine progression.

Findings from this study were presented in a poster at the annual meeting of the Association for Research in Vision and Ophthalmology. In the study, 41 patients were randomly assigned to cyclosporine and 33 to artificial tears; 36 and 22 patients, respectively, completed the study. The mean age of patients in the cyclosporine group was 47.5 ± 5.9 years; it was 48.2 ± 6.3 years in the artificial tears group. Two-thirds of the patients in both groups had level 2 disease severity at baseline based on the ITF guidelines.