Meniere's Disease
Conditions
Brief summary
This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total.
Interventions
DRUGOTO-104
Sponsors
Otonomy, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
includes, but is not limited to: * Subject has a diagnosis of definite unilateral Meniere's disease. * Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study.
Exclusion criteria
includes, but is not limited to: * Subject has an infection in the ear, sinuses, or upper respiratory system. * Subject is pregnant or lactating. * Subject has a history of immunodeficiency disease. * Subject has active or recent (\<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma. * Subject has experienced an adverse reaction to intratympanic injection of steroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of adverse events as a measure of safety and tolerability | Up to 1 Year |
Secondary
| Measure | Time frame |
|---|---|
| Change in hearing from baseline as assessed by audiometry | Up to 1 Year |
| Changes in patient condition assessed by otoscopy | Up to 1 Year |
| Changes in patient condition assessed by tympanometry | Up to 1 Year |
Countries
Canada
Outcome results
None listed