Phase 3 Study of OTO-201 in Acute Otitis Externa

Otonomy

Status and phase: Completed; Phase 3

Conditions: Acute Otitis Externa; Swimmer's Ear

Treatments: Drug: Sham Control; Drug: 12 mg ciprofloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02801370

201-201609

Details and patient eligibility

About

This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).

Enrollment: 262 patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria includes, but is not limited to:

• Subject is a male or female age 6 months or older
• Subject has a clinical diagnosis of unilateral or bilateral acute 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 eczematoid otitis externa
• Subject has diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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262 participants in 2 patient groups

OTO-201

Experimental group

Treatment:

Drug: 12 mg ciprofloxacin

Control

Sham Comparator group

Treatment:

Drug: Sham Control