OTO-201 for the Treatment of Otitis Externa

Otitis Externa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02511561
• Other study ID #: 201-201506
• Status: Completed
• Phase: Phase 2
• Start date: July 2015
• Est. completion date: November 2015

Study information

• Verified date: September 2020
• Source: Otonomy, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Otitis
• Otitis Externa

Intervention

Drug:
• OTO-201 (ciprofloxacin)

Locations

Country	Name	City	State
United States	Email Otonomy Central Contact for Trial Locations	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Otonomy, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set)	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	Day 15 (two weeks from dosing)
Secondary	Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set)	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	Day 15 (2 weeks from dosing)