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Long-Term Outcomes of Topical Cyclosporine 0.05% Treatment in Patients with Dry Eye

Daliya Dzhaber, MD


Daliya Dzhaber



  1. The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, MD

Purpose: To assess the long-term efficacy and safety of topical cyclosporine 0.05% (CsA) in treating clinical signs of dry eye.

Methods: A retrospective chart review and data analysis of patients with dry eye who were treated using CsA for at least a period of one year and with a consistent follow-up was performed. The Schirmer’s test without anesthesia, tear film break–up time (TBUT), conjunctival lissamine green staining and corneal fluorescein staining were considered as the parameters to define clinical improvement. Patient symptoms and side effects were queried at each visit.

Results: Of the dry eye patients seen during a period of 5 years (2009 to 2013), 79 were treated using CsA for at least 12 months (mean 55.5±33.2, range, 12-115 months) and had regularly follow-ups, at least once a year. As of the last visit, 60 patients (75.9%) were still on CsA with a mean duration of treatment of 46.5±29.6 (range, 12-115 months) months. Of those, 35 patients were improved and stable only on CsA. 25 were doing well on CsA and other treatments; mainly lubricating drops. The Shirmer’s test without anesthesia, corneal fluorescein staining, conjunctival lissamine green staining, and TBUT improved significantly as of last visit compared to baseline in all of the patients (P<0.05 for each). 19 patients (24.1%) were off CsA as of last follow-up visit: 4 could not tolerate it and discontinued. 5 did not experience improvement requiring physician recommended change in treatment. Another 10 patients discontinued treatment due to improvement of symptoms and signs, after a treatment period of 45.1±23.0 (range, 14-86 months) months. Three of those needed re-introduction of CsA due to worsening of symptoms, after a period of 26.5±34.7 (range, 2-51months) months off treatment. 7 patients were off treatment for a period of 30.7±20.6 (range, 11-78 months) months and had no significant dry eye as of last visit. No significant side effects were noted in any of the patients in this cohort.      

Conclusions: Topical CsA treatment is safe and was associated with significant improvement in clinical signs of dry eye in the majority of the patients. A small portion of the patients were able to achieve long-term drug-free relief suggesting that CsA may restore tear film homeostasis.  


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