OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement

Summary

The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.

Timeline

Start

2013-11

Primary completion

2014-05

Completion

2014-06

Publications

• Mair EA, Park AH, Don D, Koempel J, Bear M, LeBel C. Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement: Two Randomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2016 May 1;142(5):444-51. doi: 10.1001/jamaoto.2016.0001.

Drugs

Indications