Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
Completed
Otonomy, Inc.
Phase 3
2015-10-01
This is an 8-week, multicenter, open-label study in which eligible subjects with a history of
otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is
designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement
with common concurrent surgeries and any middle ear effusion status.
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study
in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a
single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external
auditory canal of the affected ear(s).
Otiprio Versus Ciprodex Tympanostomy Tube Outcomes
Withdrawn
Boston Medical Center
Phase 4
2018-10-01
Otolaryngologists routinely administer ear drops at the time of tympanostomy tube placement
in order to prevent tube otorrhea; however, there is a lack of consensus as to which drops
are the most effective, and whether a post-operative regimen should be used. Utilizing drops
postoperatively places the onus of administration on parents who may have various
difficulties in delivering the drops to their child's ears. Additionally, prescribing drops
postoperatively is a health care cost. The purpose of this study is to determine if there is
a difference in prevention of tympanostomy tube failure (defined as tube blockage or
otorrhea) between Otiprio administered once intraoperatively, Ciprodex otic dropgs
administered once intraoperatively, and Ciprodex otic drops administered intraoperatively
with a postoperative course.
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