Phase 2
N=43
OTO-313 in Subjects With Subjective Tinnitus
Tinnitus, Subjective
Bottom Line
View on ClinicalTrials.gov: NCT03918109 ↗Enrolled (actual)
43
Serious AEs
2.3%
Results posted
Dec 2022
Primary outcome: Primary: Audiometry - Pure Tone Average Done Over 1000, 2000 and 4000 Hertz (HZ) — -0.3; 0.71; -0.8; 0.3 decibels
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- OTO-313 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otonomy, Inc.
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Audiometry - Pure Tone Average Done Over 1000, 2000 and 4000 Hertz (HZ) |
-0.3; 0.71; -0.8; 0.3 | — |
| PRIMARY 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)). |
0; 0; 0; 0; 0; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03918109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.