A Randomized, Double-blind, Placebo-controlled Phase 1/2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Subjective Tinnitus
Overview
- Phase
- Phase 1
- Intervention
- OTO-313
- Conditions
- Tinnitus, Subjective
- Sponsor
- Otonomy, Inc.
- Enrollment
- 43
- Locations
- 16
- Primary Endpoint
- Audiometry - Pure Tone Average Done Over 1000, 2000 and 4000 Hertz (HZ)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, plasma pharmacokinetics (PK), and exploratory efficacy of OTO-313 administered as an intratympanic injection for the treatment of subjective tinnitus.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject has subjective unilateral tinnitus and is consistently aware of their tinnitus throughout much of the waking day.
- •Subject is able to use the electronic diary to complete their daily tinnitus ratings
- •Subject's tinnitus is likely of cochlear origin, e.g., associated with sensorineural hearing loss; acute hearing loss from noise trauma, barotrauma, or traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma); age-related hearing loss; resolved otitis media; ototoxic drug exposure.
- •Subject is willing to comply with the protocol and attend all study visits.
Exclusion Criteria
- •Subject has pulsatile tinnitus, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumor or stroke.
- •Subject is pregnant or lactating.
- •Subject has other clinically significant illness, medical condition or medical history at Screening or Baseline (Day 1) that, in the Investigator's opinion, would likely reduce the safety of study participation or compliance with study procedures.
Arms & Interventions
OTO-313
Intervention: OTO-313
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Audiometry - Pure Tone Average Done Over 1000, 2000 and 4000 Hertz (HZ)
Time Frame: Up to end of study (Part A - Day 29 [4 weeks after dosing]), (Part B - Day 57 [8 weeks after dosing])
Mean Change from Baseline to End of Study (baseline to Day 29 \[4 weeks after dosing\](Part A) or baseline to Day 57 \[8 weeks after dosing\] (Part B)). in Pure Tone Average Hearing Thresholds; a negative change indicates improvement.
Otoscopic Examination - Presence of Perforation in the Treated Ear at the End of Study Visit (Day 29 [4 Weeks After Dosing] (Part A) or Day 57 [8 Weeks After Dosing] (Part B)).
Time Frame: Up to end of study (Part A - Day 29 [4 weeks after the injection], Part B - Day 57 [8 weeks after the injection])
Ear examinations were done at every visit. One of the important safety endpoints was an observation of a perforation in the ear drum that did not heal properly after the injection.