Spanish pharmaceutical group SALVAT has finished enrolling patients with acute otitis media (middle ear infection) in its Phase III study designed to assess the efficacy and safety of a new otic solution comprising ciprofloxacin and fluocinolone.
A combination of ciprofloxacin 0.3% and fluocinolone 0.025%, the otic solution is designed to reach the middle ear and will be assessed for the treatment of acute otitis media in paediatric patients with tympanostomy tubes (AOMT).
The latest Phase III study is part of the company’s Phase III clinical programme, which involves two identically-designed randomised and double-blind studies.
The aim of both the studies is to evaluate efficacy and safety of the otic solution combination against only ciprofloxacin and only fluocinolone for one week, with a primary endpoint of theraputic superiority of the combination over each component.
The therapeutic superiority of sustained microbiological cure is the principal secondary endpoint, with preliminary results expected in September 2013.
A total of 330 patients from eight countries were enrolled in the first trial, while enrolment of same number of patients in the second trial is expected to be completed in November 2013.
The novel combination will be available in preservative-free, single-use, sterile containers for the treatment of AOMT, according to the company.
Image: A view of the tympanic membrane showing acute otitis media. Photo: Courtesy of Sharinginhealth.ca.