The purpose of this Phase 2 clinical trial is to evaluate the safety, tolerability and efficacy of AC102 administered as single intratympanic injection compared to oral steroid treatment in patients with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
210
Drug: AC102 Single intratympanic injection
Active comparator: Prednisolone Tablets taken daily by mouth
Placebo Tablets taken daily by mouth
Change in pure tone audiometry (PTA; dB)
Mean change in absolute hearing thresholds measured by PTA from baseline to Day 28
Time frame: 28 days
Absolute improvement of speech recognition measured in quiet compared to baseline using standardized word lists
Scores between 0% to 100% correctly understood words at predefined sound pressure levels are determined
Time frame: 14, 28, 56, 84 days
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Placebo Single intratympanic injection
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