Dose Ranging Study of OTO-201 in AOMT

Otonomy

Status and phase: Completed; Phase 2

Conditions: Acute Otitis Media; AOMT

Treatments: Other: Sham; Drug: 6 mg ciprofloxacin; Drug: 12 mg ciprofloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02719158

201-201508

Details and patient eligibility

About

Dose Ranging Study of OTO-201 in AOMT

Full description

This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled, blinded study in which eligible subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201, 12 mg OTO-201, or sham into the affected ear(s).

Enrollment: 95 patients

Sex: All

Ages: 6 months to 17 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 17 years, inclusive
• Subject has a clinical diagnosis of acute otitis media with tympanostomy tubes (AOMT)
• Subject's caregiver is willing to comply with the protocol an attend all study visits

Exclusion Criteria includes, but is not limited to:

• Subject has a history of sensorineural hearing loss
• Subject has tympanic membrane perforation other than the surgical tympanostomy tube perforation
• Subject has a history of known immunodeficiency disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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95 participants in 3 patient groups

6 mg OTO-201

Experimental group

Description:

6 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.1 mL supra-tympanostomy tube (STT) administration to the affected ear(s)

Treatment:

Drug: 6 mg ciprofloxacin

12 mg OTO-201

Experimental group

Description:

12 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.2 mL supra-tympanostomy tube (STT) administration to the affected ear(s)

Treatment:

Drug: 12 mg ciprofloxacin

Sham (empty syringe)

Sham Comparator group

Description:

Sham (empty syringe), single 0.1 mL STT administration to the affected ear(s)

Treatment:

Other: Sham