Clinical Efficacy and Safety of Preservative Free Cyclosporine in Dry Eye Disease.

Abstract

Dry eye disease (DED) is an ocular surface ailment with a high prevalence in the current era. One of the management principles involves the treatment of the underlying ocular surface inflammation. Topical Cyclosporine therapy is an effective treatment option. However, achieving an adequate drug concentration at the site of action and minimising the associated adverse drug effects, such as stinging and burning sensations at the site of instillation, are the biggest challenges. A preservative-free formulation of Cyclosporine 0.05% (Cyclisis-PF, Intas Pharmaceuticals, India) was studied in 50 patients with mild to moderate DED in a prospective interventional study. Eye drops were prescribed twice daily in addition to conventional treatment. At 12 weeks follow-up, the tear film stability was better in terms of improved tear break up time (TBUT) (p < 0.01), non-invasive break up time (NIBUT) (p < 0.001), Schirmer's test (p < 0.01), lipid layer thickness (LLT) (p = 0.006), tear meniscus height (TMH) (p < 0.01), corneal staining score (p < 0.01), and ocular surface disease index (OSDI) score (p < 0.01) at the three-month follow-up. Only five of the 50 (10%) patients had mild adverse drug effects in the form of mild stinging. However, none of the patients discontinued this drug. In conclusion, preservative free cyclosporine is a safe, effective and well tolerated treatment modality in cases of mild to moderate DED.