OTO-201 for the Treatment of Otitis Externa
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 80 |
| Updated: | 4/21/2016 |
| Start Date: | July 2015 |
| End Date: | November 2015 |
A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration for Treatment of Otitis Externa
This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa.
Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study
is designed to characterize safety, procedural factors and clinical effect of OTO-201
administered in subjects with otitis externa.
Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study
is designed to characterize safety, procedural factors and clinical effect of OTO-201
administered in subjects with otitis externa.
Inclusion Criteria includes, but is not limited to:
- Subject is a male or female aged 6 months to 80 years, inclusive
- Subject has a clinical diagnosis of unilateral otitis externa
- Subject or subject's caregiver is willing to comply with the protocol and attend all
study visits
Exclusion Criteria includes, but is not limited to:
- Subject has tympanic membrane perforation
- Subject has a history of known immunodeficiency disease
- Subject has fungal otitis externa, based on clinical signs
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