OTO-201 for the Treatment of Otitis Externa

NCT02511561 | Completed Phase 2 Results

• 1 other identifier: 201-201506
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Otitis Externa

Keywords

Otitis externa; Swimmer's ear; Ear infection

Outcome Measures

Primary Outcomes (4)

• Otoscopic Examination: Tympanic Membrane

  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)

  Up to 1 month

• Otoscopic Examination: Middle Ear

  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)

  Up to 1 month

• Feasibility of Administration

  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".

  Day1

• Overall Adverse Events

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

  up to 1 month

Secondary Outcomes (2)

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

  Day 15 (two weeks from dosing)

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

  Day 15 (2 weeks from dosing)

Study Arms (3)

0.1 mL OTO-201

EXPERIMENTAL

Ciprofloxacin

Drug: OTO-201 (ciprofloxacin)

0.2 mL OTO-201

EXPERIMENTAL

Ciprofloxacin

Drug: OTO-201 (ciprofloxacin)

0.4 mL OTO-201

EXPERIMENTAL

Ciprofloxacin

Drug: OTO-201 (ciprofloxacin)

Interventions

OTO-201 (ciprofloxacin) DRUG

0.1 mL OTO-201; 0.2 mL OTO-201; 0.4 mL OTO-201

Eligibility Criteria

• Age: 6 Months - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subject has tympanic membrane perforation
• Subject has a history of known immunodeficiency disease
• Subject has fungal otitis externa, based on clinical signs

Sponsors & Collaborators

• Otonomy, Inc.: lead

Study Sites (1)

Email Otonomy Central Contact for Trial Locations

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Otitis Externa; Otitis

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Otonomy

medinfo@otonomy.com

1-800-826-6411

Study Officials

• Carl LeBel, PhD

  Otonomy, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: July 30, 2015
• Study Start: July 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 19, 2020
• Results First Posted: September 22, 2020

Record last verified: 2020-09

Locations

US (1)