CompletedPhase 2

OTO-201 for the Treatment of Otitis Externa

United States75 participantsStarted 2015-07

Plain-language summary

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.

Who can participate

Age range6 Months – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Otoscopic Examination: Tympanic Membrane

Timeframe: Up to 1 month

Otoscopic Examination: Middle Ear

Timeframe: Up to 1 month

Feasibility of Administration

Timeframe: Day1

Overall Adverse Events

Timeframe: up to 1 month

Trial details

NCT IDNCT02511561

SponsorOtonomy, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-11

Results submitted2020-09-01

View on ClinicalTrials.gov More Otitis Externa trials