Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease

Impact of Vertigo Experience on Daily Activities at Week 12 (Month 3) - The Number of Days Sick at Home or Bedridden

The count of days sick at home or bedridden for subsequent intervals was determined during the 4-week period between each visit. The count of days sick at home or bedridden was computed as the sum of the days in the Sick at home and Bedridden categories for each 4-week interval and was standardized to 28 days by multiplying by 28 days and dividing by the number of non-missing diary entries.

Time frame: 3 Months

Otoscopic Examination - Presence of Perforation in the Treated Ear at Week 12 (Month 3) Final Visit

Ear examinations were done at every visit. One of the important safety endpoints was an observation of a perforation in the ear drum did not heal properly after the injection. Reported here are the Week 12 (Month 3) final visit.

Time frame: 3 months

Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3)

The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (\<= 10 dB) to impairment at Month 3 (\>10 dB) when measured at 1000 Hz.

Time frame: Week 12 (Month 3)

Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3)

The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (\<= 10 dB) to impairment at Month 3 (\>10 dB) when measured at 2000 Hz.