Clinical Trial: OTO-201 for the Treatment of Otitis Externa

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration for Treatment of Otitis Externa

Brief 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.

Detailed Summary:
Sponsor: Otonomy, Inc.

Current Primary Outcome:

  • Safety as assessed by adverse events [ Time Frame: Up to 1 month ]
    Evaluation of adverse events
  • Safety as assessed by otoscopic exams [ Time Frame: Up to 1 month ]
    Evaluation of otoscopic exams
  • Feasibility of administration [ Time Frame: Day1 ]
    Questionnaire


Original Primary Outcome: Same as current

Current Secondary Outcome: Clinical effect as assessed signs and symptoms of otitis externa [ Time Frame: Up to Two Weeks ]

Assessment of signs (edema, erythema, otorrhea) and symptoms (otalgia, tenderness)


Original Secondary Outcome: Same as current

Information By: Otonomy, Inc.

Dates:
Date Received: July 28, 2015
Date Started: July 2015
Date Completion:
Last Updated: January 21, 2016
Last Verified: January 2016