Comparison Of Therapeutic Effects Of Once-Daily Fluorometholone 0.1% Versus Twice-Daily Cyclosporine 0.05% In Patients With Dry Eye Disease: A Randomized, Assessor-Blinded Clinical Trial

To compare the therapeutic effects of once-daily fluorometholone (FML) 0.1% versus twice-daily cyclosporine (CsA) 0.05% after 4 short-term FML induction treatment in dry eye disease (DED).

This prospective, randomized, assessor-blinded study included 32 patients diagnosed with DED and 18 patients completed the trial. 

All participants received induction therapy with  FML 0.1% four times a day for 4 weeks, then they were randomized into two groups: Group 1 continued with FML once a day, and Group 2 with CsA 0.05% twice a day, for 8 weeks. Clinical parameters and inflammation/oxidative stress markers in tear fluid were evaluated at baseline, week 4, and week 12.

18 patients completed the study, and the mean age was 54.0±10.7 years. Both groups showed significant improvements in symptoms, tear break-up time, corneal staining score, and MGD stage after the 4-week induction phase (all P-value <0.05). These therapeutic effects were maintained in both groups throughout the maintenance phase (all P-value <0.05). Tear osmolarity and inflammatory markers (IL-6 and 8-oxo-dG) also improved significantly in both groups throughout the study period (all P-value <0.05).

Steroid induction therapy followed by maintenance with either low-dose FML or nanoemulsion CsA effectively improves symptoms, tear stability, and inflammation in DED with MGD, providing practical long-term treatment options.