Topical cyclosporine continues to be effective for several months,small study shows

Los Angeles-Results of a small clinical trial demonstrated that topical cyclosporine A (Restasis, Allergan) increased tear volume in both new and established patients with dry eye. The mean increase was higher in new patients than among established patients, but the results show that the drug continues to be effective over a period of at least several months, said James H. Peace, MD, medical director of the Diabetic Eye Medical Center in Inglewood, CA.

Results showed that topical cyclosporine significantly increased tear volume in patients with dry eye. There was a mean increase of 8 mm in the Schirmer score in all enrolled patients, an 8.6-mm increase in new patients, and a 7.4-mm increase in patients who had used cyclosporine at least 3 months before the study began.

While an increase in tear production among the new patients would be expected, similar improvement in established patients would not necessarily have been predicted, Dr. Peace said.

"We feel that it is probably due to what we required once patients were enrolled in the study. We were checking them every 30 days, and it was a way of reminding them and encouraging them to use the medication properly," he explained. "When people are taking drops long-term, they normally slack off a little. But when you remind them, they can still get added benefit. If you continue to encourage them to take their drops, you will see an improvement."

The drug was safe and well tolerated, with no adverse events reported during the study.

According to Dr. Peace, these outcomes show not only that cyclosporine is effective and that reminders may improve compliance but also the importance of continuing to take the drug long enough for results to become apparent and for improvement to continue.

"Even after 3 months, you can get an improvement in your Schirmer score," he said.

Most patients in the study were female (12/13 of new patients and 9/10 of established patients) and black (11/13 of new patients and 7/10 of established patients).