OTO-201 for the Treatment of Otitis Externa

Otonomy

Status and phase: Completed; Phase 2

Conditions: Otitis Externa

Treatments: Drug: OTO-201 (ciprofloxacin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02511561

201-201506

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 6 months to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

0.1 mL OTO-201

Experimental group

Description:

Ciprofloxacin

Treatment:

Drug: OTO-201 (ciprofloxacin)

0.2 mL OTO-201

Experimental group

Description:

Ciprofloxacin

Treatment:

Drug: OTO-201 (ciprofloxacin)

0.4 mL OTO-201

Experimental group

Description:

Ciprofloxacin

Treatment:

Drug: OTO-201 (ciprofloxacin)