Purpose: To evaluate the long-term effectiveness of the combination of topical cyclosporine drops and tacrolimus ointment in the treatment of steroid-dependent atopic keratoconjunctivitis (AKC).
Methods: Ten patients with moderate to severe AKC participated in the study. Topical cyclosporine 0.05% was used, as a monotherapy, 6 times daily during the first month of the study, followed by 4 times daily during the second month. The patients were then instructed to self-treat with topical cyclosporine at a dose ranging from 2 to 6 times daily depending on the severity of the disease. Tacrolimus ointment 0.03% was applied on the lid skin. Follow-up examinations were performed approximately every 3 months. Each patient completed a follow-up period of at least 12 months. Symptoms and signs of AKC were assessed on the day of enrollment, on days 28, 56, and 63, and at subsequent follow-up visits. Flare-ups of AKC requiring steroid use and progression of the disease findings were also recorded.
Results: All patients experienced significant improvement of their symptoms and signs during the first 2 months of the study. Two patients were lost to follow-up after the initial 2 months. One patient was noncompliant and continued the treatment only for 7 months. During the median treatment period of 21.5 months for the 7 continuing patients, a total of only 2 flare-up episodes were noted requiring topical steroids.
Conclusions: Adequate topical immunomodulation using topical calcineurin inhibitors may eliminate the need for steroids and favorably alter the long-term prognosis of patients with AKC.
*Ocular Surface Diseases and Dry Eye Clinic, The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD
†Yeditepe University Eye Hospital, Istanbul, Turkey
‡Allergan, Inc, Irvine, CA.
E. K. Akpek was supported in part by a William and Mary Greve Scholarship from Research to Prevent Blindness. The 0.05% cyclosporine eye drops (Restasis) used by the patients in this study and an unrestricted research grant were provided by Allergan, Inc.
M. E. Stern is the Vice President of Inflammation Research at Allergan, Inc.
The other authors disclose no conflicts of interest.
The study protocol was approved by the Institutional Review Board at Johns Hopkins University School of Medicine. The study is Health Information Portability and Accountability Act compliant and adhered to the tenets of the Declaration of Helsinki.
Reprints: Esen Karamursel Akpek, Ocular Surface and Dry Eye Clinic, The Wilmer Eye Institute, 600 North Wolfe St, Baltimore, MD 21237 (e-mail: firstname.lastname@example.org).
Received December 14, 2010
Accepted May 14, 2011