Abstract:

Objectives: To investigate the efficacy and safety of a generic Cyclosporine 0.05% ophthalmic emulsion in chronic dry eye disease. Materails and Methods: Thirty patients with dry eye disease were included in this observational, prospective study. Patients were examined at baseline, at month -1,-3 and 6 of the study. The following were evaluated at each visit: CDVA (corrected distance visual acuity), corneal and conjunctival staining (Oxford) score, TBUT (tear break-up time), Schirmer-2 score, OSDI (Ocular Surface Disease Index) score, patient’s subjective rating scale of ocular discomfort, daily use of concomittant artificial tears, the researcher's assessment of the global treatment response, and IOP (intraocular pressure). In addition, drug-related side effects were evaluated individually in each examination. When initiating dry eye treatment, cyclosporine was combined with topical loteprednol etabonate 0.5%. Results: There was a statistically significant improvement from baseline in corneal and conjunctival staining (decrease in mean Oxford score), TBUT, Schirmer-2 values, OSDI score, patient’s subjective rating score for ocular discomfort, and mean physician’s subjective assessment of global response to treatment at all follow-up visits (p<0.001). The mean daily use of artifical drops decreased statistically at all time points (<0.001). The most commonly reported adverse events were ocular burning (6.7%), followed by stinging (3.3%), conjunctival hyperemia (3.3%), foreign body sensation (3.3%), and visual disturbance (3.3%). Conclusion: Generic cyclosporine 0.05% ophthalmic emulsion with loteprednol etabonate 0.5% on initiation treatment has well-tolerability and improves subjective and objective measures of dry eye disease.

Keywords: