To evaluate loteprednol etabonate ophthalmic 0.5%suspension, versus placebo f or treatment of the inflammatory component of keratoconjunctivitis sicca in pati ents with delayed tear clearance. Randomized, double masked, placebo controlle d clinical trial. Sixty four patients with keratoconjunctivitis sicca and delay ed tear clearance were randomly assigned to receive either loteprednol or vehicl e 4 times a day for 4 weeks. Patients were evaluated at weeks 2 and 4 of treatme nt and 2 weeks after treatment was discontinued. Symptoms were scored using a vi sual analog scale (VAS) of 1 to 100. Corneal fluorescein staining was scored 0 t o 4 in five areas. Conjunctival injection was graded 0 to 3 in the inferior bulb ar, nasal bulbar, and inferior tarsal areas. Lid margin injection was graded 0 t o 3. Safety was assessed by funduscopy, lens examination, biomicroscopy, visual acuity, and Goldmann tonometry, and by monitoring adverse events and changes in symptoms. In subsets of patients with at least moderate clinical inflammation, t here was a significant difference between the loteprednol treated group and veh icle treated group after 2 weeks of therapy. The differences did not reach stat istical significance at 4 weeks, although the loteprednol treated patients reta ined their improvement compared with the vehicle treated group. Safety evaluations showed both treatments to be well tolerated and simil ar in the frequency and type of adverse event reported. The use of topical lotep rednol etabonate 0.5%4 times a day may be beneficial in patients who have kerat oconjunctivitis sicca with at least a moderate inflammatory component. To evaluate loteprednol etabonate ophthalmic 0.5% suspension, versus placebo f or treatment of the inflammatory component of keratoconjunctivitis sicca in pati ents with delayed tear clearance. Randomized, double masked, placebo controlle d clinical trial. Sixty four patients with keratoconjunctivitis sicca and delay ed tear Patients were evaluated at weeks 2 and 4 of treatme nt and 2 weeks after treatment was discontinued. Symptoms were scored using a vi sual analog scale (VAS) of 1 to 100. Corneal fluorescein staining was scored 0 to 4 in five areas. Conjunctival injection was graded 0 to 3 in the inferior bulb ar, nasal bulbar, and inferior tarsal areas. by funduscopy, lens examination, biomicroscopy, visual acuity, and goldmann tonometry, and by monitoring adverse events and changes in symptoms. h at least moderate clinical inflammation, t here was a significant difference between the loteprednol treated group and vehicle icle treated group after 2 weeks of therapy. The differences did not reach stat istical significance at 4 weeks, although the loteprednol treated patients retained their improvement compared with the vehicle treated group. Safety evaluations showed both both well berated and simil ar in the frequency and type of adverse event reported. The use of topical lotep rednol etabonate 0.5% 4 times a day may be beneficial in patients who have kerat oconjunctivitis sicca with at least a moderate inflammatory component.