Randomization and treatment
tinnitus
TINNITUS
Patients were randomized 1:1 to receive either 0.32 mg OTO-313 (1.6 mg/mL solution of gacyclidine in medium chain triglycerides) or placebo (solution of medium chain triglycerides). There were no differences in viscosity or appearance between OTO-313 and placebo. Randomized patients received a single (0.2 mL volume) intratympanic injection of either OTO-313 or placebo to the affected (study) ear at the Baseline visit. Patients remained recumbent for at least 15 min after the injection. To ensure approximately equal numbers of patients between OTO-313 and placebo, randomization was stratified by study site, duration of tinnitus (≥ 2 to ≤ 6 months since onset, > 6 to ≤ 12 months since onset), and the average TFI score at Screening and Baseline (≥ 32 to ≤ 53 points, ≥ 54 to ≤ 100 points). Patients were evaluated over a 16-weeks post-treatment period and returned for clinical site visits at Weeks 4, 8, 12, and 16.