CompletedPhase 3

Phase 3 Study of OTO-201 in Acute Otitis Externa

United States, Canada262 participantsStarted 2016-06

Plain-language summary

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).

Who can participate

Age range6 Months

SexALL

See this in plain English?

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 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

What they're measuring

Number of Subjects Considered a Clinical Cure at Day 8

Timeframe: At Day 8 (1 week after dosing)

Trial details

NCT IDNCT02801370

SponsorOtonomy, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-11

Results submitted2020-09-01

View on ClinicalTrials.gov More Acute Otitis Externa trials