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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
501
Email Otonomy Central Contact for Trial Locations
San Diego, California, United States
Number of Subjects With Post-surgical Otorrhea
Absence or presence of otorrhea (drainage from the middle ear)
Time frame: Week 4
Number of Subjects With Post-surgical Otorrhea
Absence or presence of otorrhea (drainage from the middle ear)
Time frame: 8 weeks
Adverse Events
Evaluation of adverse events
Time frame: Up to Eight Weeks
Caregiver Burden - Ear Discharge Control
Ear Drop Caregiver Burden Questionnaire at Week 4
Time frame: Week 4
Caregiver Burden - Ear Discharge Control
Ear Drop Caregiver Burden Questionnaire at Week 8
Time frame: Week 8
Caregiver Burden - Ear Drops Administration
Ear Drop Caregiver Burden Questionnaire at Week 8
Time frame: Week 8
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