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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
153
Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8
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.
Time frame: Week 4 and Week 8 (both had to meet criterion for the subject to be considered a "responder")
Change From Baseline in Daily Tinnitus Loudness at 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.
Time frame: The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8.
Change From Baseline in Daily Tinnitus Annoyance at 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.
Time frame: The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8
Patient Global Impression of Change at Week 8
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.
Time frame: Week 8 reported here
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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
Delray Beach, Florida, United States
Research Centers of America
Hollywood, Florida, United States
ENT and Allergy Associates of Florida, LLC
Plantation, Florida, United States
ENT and Allergy Associates of Florida, LLC
Port Saint Lucie, Florida, United States
Ear Research Foundation
Sarasota, Florida, United States
...and 38 more locations