Efficacy and Safety for the Combination of Neomycin, Beclomethasone, Clotrimazole and Lignocaine for the Treatment of Otitis Media with Perforation and Otitis Externa: Post-Marketing Surveillance Study

Bacterial and/ or fungal infection of the middle or external ear can be painful and sometimes the infection can be of mixed nature i.e. caused due to both bacteria and fungi. The combination of antibiotics and antifungals can be used for the treatment of mixed ear infections, along with it, anti-inflammatory agent and anaesthetics can be combined to relieve the discomfort caused by the infection. This study was conducted to test the efficacy and safety for the combination of Neomycin, Beclomethasone, Clotrimazole and Lignocaine for the treatment of middle or external ear infection. Method: Of enrolled 200, 177 patients completed the study. Efficacy was evaluated by symptom score (SS) scale which was an eleven-point scale ranging from 0 to 10 where 0 was no symptom to 10 was the maximum tolerated symptoms. All patients were asked to report SS on SS scale for ear pain, ear discharge and ear itching on day 1, 3 and 5. Safety assessment was made by analysing the adverse events reported by the patient. Results: SS of ear pain was reduced from 6.158 at baseline visit to 3.050 at day 3 to 0.468 at day 5. SS of ear discharge reduced from 6.175 at baseline to 2.768 at day 3 to 0.491 at day 5. SS of ear itching reduced from 4.694 at baseline to 1.604 at day 3 to 0.299 at day 5. Conclusion: The investigational product was found to be efficacious and safe for the treatment of otitis media and externa.