A randomized placebo-controlled trial of the efficacy and safety of a terbinafine, florfenicol and betamethasone topical ear formulation in dogs for the treatment of bacterial and/or fungal otitis externa

BACKGROUND: Treatment of infected otitis externa (OE) relies on the topical application of specific formulations that most often contain an antibiotic, an antifungal and a glucocorticoid. This study is to report the results of a randomized, placebo-controlled field trial evaluating the efficacy and safety of OSURNIA™ (Elanco Animal Health, a division of Eli Lilly and Company, Greenfield, IN), a novel topical ear medication containing florfenicol, terbinafine and betamethasone acetate in an adaptable gel. The study includes 284 dogs with bacterial and/or fungal OE who were randomly assigned to receive two doses of Osurnia or its vehicle, one week apart. Dogs were evaluated at various time points through Day 45, and a total clinical score (TCS) was calculated based on pain, erythema, exudate, swelling, odor and ulceration. The primary outcome measure was the rate of treatment success (RTS), defined as a TCS of 0, 1 or 2 on Day 45. Before and after treatment, a “clap test” was performed to subjectively assess hearing, and blood and urine were collected for routine clinical pathology. RESULTS: The RTS was significantly higher in ears treated with Osurnia (64.78%) than with placebo (43.42%). There was no significant interaction between efficacy and duration of history, recurrence of otitis or body weight. Adverse events were similar between groups. All dogs treated with Osurnia maintained their hearing, and there were no relevant clinical pathology changes. CONCLUSIONS: The application of two doses of Osurnia, one week apart, is effective and safe to treat microbial otitis externa in dogs.