On August 30th 2018, the enrolment of patients into the CIFLOTEX clinical trial was completed. This study has been carried out in 45 US centers, and 493 patients suffering from Acute Otitis Externa (AOE) have been included. The objective of the study is to assess the efficacy and safety of our combination of Ciprofloxacin + Fluocinolone (OTOVEL® in the US) administered as otic drops in single-use vials, when compared to Ciprofloxacin and Fluocinolone alone. The study had been requested by the FDA in order to obtain data of OTOVEL in the treatment of AOE, before approving this indication, which would be added to the currently approved AOMT (Acute Otitis Media with tympanostomy tubes). The final results of CIFLOTEX will be available before the end of this year.