Comparative analysis of efficacy and adverse effects of tacrolimus vs cyclosporine in chronic dry eye disease: a tertiary care hospital based study

Background: Dry eye disease (DED) is the very common and underdiagnosed ocular condition affecting vision, quality of life, and the outcomes of cataract or refractive surgery. Dry eye disease (DED), either alone or in combination with other conditions, is a frequent cause of ocular irritation that leads the patients to seek ophthalmic care. Due to a wide variety of presenting symptoms, it is often unrecognized and this causes great frustration of the patient and treating physician. While these symptoms often improve with appropriate treatment, usually in majority of the cases the disease may not be curable. Aim of the study was to compare the efficacy of tacrolimus and cyclosporine in dry eye disease.Methods: This was a single centred, 3 months prospective study. Patients with unilateral or bilateral dry eye disease and an ocular surface disease index score >12, atleast one eye with schirmer score <5mm and TBUT <10 s were enrolled in the study. The enrolled patients were randomly divided into two groups, twenty-five patients in Group 1 and twenty three patients in Group 2 completed the follow up. Group 1(n =25) who received 0.03% tacrolimus eye ointment twice daily for consecutive 3 months and Group 2 (n= 23) received 0.05% cyclosporine eye drops twice daily for consecutive 3 months the primary efficacy outcome was Schirmer score after 3 months. The secondary outcomes were TBUT and adverse effects.Results: After 3 months, both the treatment groups showed significant improvement in mean Schirmer score (p<0.001) and mean TBUT (p <0.0001). However, on comparing both the groups, mean Schirmer score and mean TBUT, results were comparable. No patient discontinued treatment because of minor ocular adverse effects.Conclusions: Dry eye patients demonstrated improvement in Schirmer score and TBUT after 3 months of treatment with tacrolimus 0.03% ointment and cyclosporine 0.05% eye drops