Efficacy and Safety of Topical Unpreserved 0.1% Fluorometholone Ophthalmic Solution on Dry Eye Syndrome

PURPOSE: To evaluate the efficacy and safety of topical unpreserved 0.1% fluorometholone (FML) ophthalmic solution in patients with dry eye syndrome. METHODS: Patients with mild to moderate dry eye syndrome were divided into the control group (Group I), topical unpreserved 0.1% FML group (Group II), and topical preserved 0.1% FML group (Group III). Intraocular pressure (IOP), Ocular Surface Disease Index (OSDI), tear film break-up time (TF-BUT), Oxford stain score (OSS), and tear osmolarity (Tosm) were evaluated at 2 weeks, 4 weeks, 8 weeks, and 12 weeks (Trial 1). Patients with severe dry eye syndrome were divided into 1% methylprednisolone (MP) group (Group I) and 0.1% unpreserved FML group (Group II). Same parameters were evaluated in both groups (Trial 2). RESULTS: In clinical trial I, OSS scores of Group II were lower than other groups (p < 0.05). For severe dry eye patients in clinical trial 2, there were no significant differences in all parameters between the 2 groups. CONCLUSIONS: Topical unpreserved 0.1% fluorometholone was shown to be an effective and relatively safe treatment in patients with dry eye syndrome.

The Effect of Topical Corticosteroids on the Intraocular Pressure

The ability of topical corticosteroids to induce an increase in intraocular pressure(IOP) limits the usefullness in ocular disease. To evaluate of the effects of different types of corticosteroids on the IOP, we applied two kinds of corticosteroics to 103 outpatients without intraocular disease. Subjects were randomly divided into two groups. The first group consisted of 67 patients were treated with 0.12% prednisolone. The second group consisted of 36 patients were treated with 0.1% fluorometholone. In the first group, following six weeks of topical application, patients demonstrated significant increase in the IOP (p0.05). In the first group, 72 of 134 eyes(54%) demonstrated increase in the rop. In the second group, 34 of 72 eyes (47%) demonstrated increase in the IOP. The IOP response failed to correlate significantly with sex, age, baseline IOP, refractive error and cup/disc ratio in two different corticosteroids (p>0.05). These findings do emphasize the need to measure the IOP of all patients who undergoing topical steroids application for an extended period.