Objectives: The aim was to compare the effects of topical cyclosporine A and artificial tears combination with artificial tears alone in patients with dysfunctional tear syndrome (DTS).
Methods: Forty-two eyes of 42 patients with DTS were enrolled in the study. The inclusion criteria for the study were Schirmer I (without anesthesia) scores below 10 mm/5 min and tear film break-up time (BUT) below 10 sec. The patients were randomly divided into two groups. The study group (22 patients) underwent 0.05% cyclosporine A treatment twice a day and preservative-free artificial tears for four times a day for 4 months. The control group (20 patients) was administered only preservative-free artificial tears four times a day for 4 months. The BUT, Schirmer test scores, corneal fluorescein staining, conjunctival lissamine green staining, and goblet cell density derived by impression cytology were recorded before and after treatment in each group.
Results: In the study group, all parameters improved statistically significantly after treatment at the 4-month follow-up compared with the pretreatment values (P<0.001 for all). In the control group, corneal fluorescein staining (P<0.001) and conjunctival lissamine green staining (P=0.014) improved, but BUT and Schirmer scores did not change significantly after treatment. At the end of the 4-month follow-up, the study group demonstrated statistically significantly better BUT (P=0.020), Schirmer scores (P=0.002), goblet cell density (P=0.006), corneal fluorescein staining (P=0.003), and conjunctival lissamine green staining (P=0.017) scores than did the control group.
Conclusions: Topical cyclosporine A and artificial tears treatment significantly increases goblet cell density, decreases the signs of DTS, and improves ocular surface health.