Evaluation of a single-administration ototopical treatment for canine otitis externa: a randomised trial

Objective To evaluate the efficacy and safety of a new, single-administration Otic Solution containing florfenicol, terbinafine and mometasone furoate for the treatment of canine otitis externa (OE). Design The clinical efficacy and safety study was a multicentre, controlled, masked and randomised field study conducted over 30 days. Two hundred and twenty-one (221) client-owned dogs of varying breeds with diagnosed bacterial and/or fungal OE were enrolled. Procedure Dogs were randomised to either Otic Solution or control groups. Evaluations were conducted over a minimum period of 30 days with a primary effectiveness endpoint based on the improvement in a clinical severity score at the final visit (day 30). Safety analyses were based on clinical and laboratory parameters and the occurrence of adverse events. Results The Otic Solution group demonstrated a significantly higher treatment success rate compared with that observed for the control group (72.5 per cent v 11.1 per cent, P value=0.0001) for cases of OE caused by Staphylococcus pseudintermedius and Malassezia pachydermatis. No significant safety findings were reported. Conclusions/clinical relevance This new ototopical formulation provides safe and effective treatment of canine OE and is an important alternative antimicrobial for this indication. The single-administration dosage regimen eliminates opportunities for client dosage administration errors and medication stockpiling.