Loteprednol Etabonate 0.5% (Lotemax) versus Vehicle in the Management of Patients with KCS and at Least Moderate Inflammation

Abstract

Abstract: : Purpose: Some of the signs and symptoms of KCS are believed to be due to inflammatory mediators whose effect is increased by prolonged contact with the cornea and conjunctiva. The use of a steroid (eg: loteprednol etabonate ) may be justified in the management of this condition. Method: After a 2 week run-in on preservative free moisturizing drops, 64 patients with KCS entered a double masked randomized study and received either Lotemax® 0.5% QID (L) or vehicle (V).They were examined after 2 and 4 weeks on study drug, then after 2 weeks without study drug. Symptoms were scored on a visual analog scale (VAS) of 1 -100. Grading for Corneal staining (CS) was 0-4 in 5 areas, Conjunctival hyperemia (CH) as 0-3 in inferior bulbar (IB), nasal bulbar (NB) and inferior tarsal (IT), Lid margin hyperemia (LM) as 0-3. Results: In those patients who had at least moderate inflammation (Total CS >10 or CH >2 in any area, or both of these criteria) there was a significant difference between the treatment groups after 2 weeks on treatment. Table: Inflammatory signs/symptoms: differences between groups (L-V) for change from baseline .While none of the differences between V and L retained statistical significance at 4 weeks the L group was improved relative to the V group, this effect partially regressed when off treatment. Conclusions: The use of topical loteprednol etabonate 0.5% QID may be beneficial in patients who have KCS with at least a moderate inflammatory component.  

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Keywords: cornea: tears/tear film/dry eye • corticosteroids • clinical (human) or epidemiologic studies: tre