Introduction. In conditions of widespread resistance of pathogens to traditional antimicrobial drugs, active attention is paid to the development of topical antimicrobial drugs for the effective treatment of inflammatory pathology of the middle ear.Aim. To study the efficacy and safety of a new dosage form of the drug Dioxydin® (2.5 mg/ml ear drops) in the treatment of patients with acute purulent otitis media and exacerbation of chronic purulent otitis media in comparison with ear drops containing 0.3% ciprofloxacin solution.Materials and methods. A multicenter randomized comparative clinical trial included adults with acute purulent otitis media or exacerbation of chronic purulent otitis media and during 6 face-to-face visits (days 1st, 3rd, 6th, 9th, as well as a therapy completion visit and a follow-up visit), the effect of drugs was evaluated according to examination, otoscopy, microbiological and audiometric examinations. Safety was assessed by the frequency of adverse events and the results of blood, urine tests and vital signs.Results. The achievement of the primary criteria was evaluated among 164 participants randomized into 2 groups: the proportion of patients with no indications for systemic antibacterial therapy at Visit 2 and with no ear pain at Visit 4, Dioxydin® ear drops had no less effectiveness than the comparison drug (64.6 and 89.9% versus 68.3 and 87.3%, respectively). In terms of the frequency of elimination of the pathogen and improvement of air conduction, the compared drugs also had no statistically significant differences, and according to some secondary criteria, Dioxydin® significantly exceeded 0.3% ciprofloxacin solution (the proportion of patients with a pronounced decrease in pain and congestion in the ear, as well as hyperemia of the eardrum). According to the safety criteria, the compared drugs had no significant differences.Conclusions. The results of the study confirmed the high efficacy and safety of Dioxydin® ear drops in the treatment of otitis media in adults.
