OTO-313 in Subjects With Unilateral Subjective Tinnitus

Phase 2

Completed

Brief Summary: The purpose of this study is to determine the efficacy of OTO-313 in subjects with unilateral tinnitus and to determine the safety and tolerability of OTO-313 in subjects with unilateral tinnitus.

Recruitment & Eligibility

Inclusion Criteria

Subject has early-onset subjective unilateral tinnitus that is persistent (consistently aware of their tinnitus throughout much of the waking day).
Subject is able to use the 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, temporomandibular joint disease (TMJ) associated with tinnitus perception, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumor or stroke.
Subject is pregnant, lactating, or undergoing fertility treatment.
Subject has other clinically significant illness, medical condition or medical history at Screening or Baseline that, in the Investigator's opinion, would likely reduce the safety of study participation or compliance with study procedures.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
OTO-313	OTO-313	-

Primary Outcome Measures

Name	Time	Method
Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8	Week 4 and Week 8 (both had to meet criterion for the subject to be considered a "responder")	The TFI is a validated, 25-item questionnaire; index score from 0 to 100; higher scores indicate a greater problem with tinnitus. A responder is considered as any subject with at least a 13-point improvement from Baseline on the (TFI). This responder analysis required both Week 4 and Week 8 to have a 13-point improvement from Baseline.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Daily Tinnitus Loudness at Week 8	The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8.	Numerical rating scale (NRS) from 0 (No Tinnitus) to 10 (Extremely Loud Tinnitus) collected every day. Post-baseline weekly NRS scores will be calculated as the average score of all recorded diary entries within each study week.
Change From Baseline in Daily Tinnitus Annoyance at Week 8	The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8	Numerical rating scale from 0 (Not Annoying) to 10 (Extremely Annoying) collected every day. Post-baseline weekly NRS scores will be calculated as the average score of all recorded diary entries within each study week.
Patient Global Impression of Change at Week 8	Week 8 reported here	Change in overall tinnitus status as perceived by the subject as assessed at the Week 8 visit. Subjects were asked, "Since the beginning of the clinical study, how would you rate your tinnitus?" and had the choice to answer from very much worse (-3) to very much improved (3). The mean change from baseline at Week 8 is reported here.

Locations (46): Central California Clinical Research
🇺🇸
Fresno, California, United States
Breathe Clear Institute
🇺🇸
Torrance, California, United States
University of Colorado, Department of Otolaryngology
🇺🇸
Aurora, Colorado, United States
Colorado ENT & Allergy
🇺🇸
Colorado Springs, Colorado, United States
ENT and Allergy Associates of FL
🇺🇸
Boynton Beach, Florida, United States
ENT and Allergy Associates of Florida, LLC
🇺🇸
Port Saint Lucie, Florida, United States
Research Centers of America
🇺🇸
Hollywood, Florida, United States
Ear Research Foundation
🇺🇸
Sarasota, Florida, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
ChicagoENT
🇺🇸
Chicago, Illinois, United States
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Central California Clinical Research
🇺🇸Fresno, California, United States