Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with
bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will
receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the
middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The
study is designed to characterize safety and any procedural issues associated with TTT drug
administration of OTO-201.