Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
- Meniere Disease
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
- Subject has experienced active vertigo during the lead-in period.
- Subject has documented asymmetric sensorineural hearing loss.
- Subject agrees to maintain their current treatments for Meniere's disease while on-study.
- Subject is pregnant or lactating.
- Subject has a history of immunodeficiency disease.
- Subject has a history of significant middle ear or inner ear surgery, or endolymphatic sac surgery in the affected ear.
- Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
- Subject has a history of vestibular migraine.
- Subject has used an investigational drug or device in the 3 months prior to screening.
- Subject has previously been randomized to a clinical study of OTO-104.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized, Double-blind, Placebo-controlled, Multicenter
- Primary Purpose
- Triple (Participant, Investigator, Outcomes Assessor)
- Otonomy, Inc.
Study ContactClinical Study Manager