Ear Drop Study For the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes Now Enrolling Patients

from Practice Update, Fall 2006

Approximately two million tympanostomy tubes are inserted annually for the treatment of recurrent otitis media with effusion in children. The vast majority of acute otitis media with otorrhea through tympanostomy tubes (AOMT) cases involve pediatric patients between the ages of one and 12 years of age. AOMT is the most common complication after insertion of tympanostomy tubes. The incidence rate of acute otorrhea during the postoperative period ranges from ten to 50 percent. Microorganisms commonly isolated from AOMT patients include: streptococcus pneumonia, haemophilus influenzae, moraxella catarrhalis, staphlyococcus aureus and pseudomonas aeruginosa.  Alcon Research Ltd. is conducting a clinical trial of topical moxidex otic, an investigational ear drop for the treatment of otitis media with otorrhea in patients with mtympanostomy tubes. Subjects will be treated with an antibiotic/steroid combination or an antibiotic alone.  No placebo will be administered.

Objective

Primary objective is to evaluate the efficacy of the topical eardrop for the treatment of patients with acute otitis media with tympanostomy tubes.

Overview of Study Design

This is a randomized, multicenter, double-masked, parallel group, active-controlled study. Patients will be enrolled and evaluated at four visits: baseline (Day 1), during therapy (Days 3-5), end of therapy (Days 8-10), and test of cure (Days 15-18).

Study Population

Approximately 660 total patients will be enrolled at approximately 66 study centers throughout the country.  Pediatric patients, six months to 12 years of age, with post tympanostomy tube otorrhea visible by the parent/guardian, and with ottorrhea of three weeks or less duration meet the inclusion criteria.