This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Call Otonomy call center for trial locations
London, Ontario, Canada
Evaluation of adverse events as a measure of safety and tolerability
Time frame: Up to 1 Year
Change in hearing from baseline as assessed by audiometry
Time frame: Up to 1 Year
Changes in patient condition assessed by otoscopy
Time frame: Up to 1 Year
Changes in patient condition assessed by tympanometry
Time frame: Up to 1 Year
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