OTO-201 for the Treatment of Otitis Externa

Phase 2

Completed

• Conditions: Otitis Externa
• Interventions: Drug: OTO-201 (ciprofloxacin)

• Registration Number: NCT02511561
• Lead Sponsor: Otonomy, Inc.

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 Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-28
• Study First Submitted QC: 2015-07-28
• Study First Posted: 2015-07-30
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2020-09
• Results First Submitted: 2020-09-01
• Results First Submitted QC: 2020-09-01
• Last Update Submitted: 2020-09-21
• Results First Posted: 2020-09-22
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.1 mL OTO-201	OTO-201 (ciprofloxacin)	Ciprofloxacin
0.2 mL OTO-201	OTO-201 (ciprofloxacin)	Ciprofloxacin
0.4 mL OTO-201	OTO-201 (ciprofloxacin)	Ciprofloxacin

Primary Outcome Measures

Name	Time	Method
Otoscopic Examination: Tympanic Membrane	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)
Otoscopic Examination: Middle Ear	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)
Feasibility of Administration	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".
Overall Adverse Events	up to 1 month	Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set)	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
Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set)	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

Trial Locations

Locations (1)

Email Otonomy Central Contact for Trial Locations; 🇺🇸 San Diego, California, United States