To evaluate the efficacy and safety of topical unpreserved 0.1% fluorometholone (FML) ophthalmic solution in patients with dry eye syndrome.

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).

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.

Topical unpreserved 0.1% fluorometholone was shown to be an effective and relatively safe treatment in patients with dry eye syndrome.