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Phase 3 Study of OTO-201 in Acute Otitis Externa

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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

262 participants in 2 patient groups

OTO-201
Experimental group
Treatment:
Drug: 12 mg ciprofloxacin
Control
Sham Comparator group
Treatment:
Drug: Sham Control

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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