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Completed

NCT Number: NCT02511561

OTO-201 for the Treatment of Otitis Externa

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.

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Key information

Conditions

Otitis Externa Ear Diseases Otitis Otorhinolaryngologic Diseases

Age range

6 month–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Email Otonomy Central Contact for Trial Locations

San Diego, California, 92121, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OTO-201 (ciprofloxacin)

Drug

Primary outcomes

  1. Otoscopic Examination: Tympanic Membrane

    Time frame: Up to 1 month

    Number of subjects with a tympanic membrane that was rated as "Not able to Visualize" or "Abnormal" at Baseline that was rated as "Normal" at Day 29 (final study day)

  2. Otoscopic Examination: Middle Ear

    Time frame: Up to 1 month

    Number of subjects with a middle ear that was rated as "Not Able to Visualize" or "Abnormal" at Baseline that had a middle ear rated as "Normal" at Day 29 (final study visit)

  3. Feasibility of Administration

    Time frame: Day1

    Ease of administering OTO-201 to the external ear canal. Number of subjects that investigators rated ease of administration as either "easy" or "very easy".

  4. Overall Adverse Events

    Time frame: up to 1 month

    Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing

Secondary outcomes

  1. Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set)

    Time frame: Day 15 (two weeks from dosing)

    Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows:

    None = 0 Mild = 1 Moderate = 2 Severe = 3

  2. Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set)

    Time frame: Day 15 (2 weeks from dosing)

    Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows:

    None = 0 Mild = 1 Moderate = 2 Severe = 3

Sponsors and collaborators

Lead sponsor

Otonomy, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 30, 2015
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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