Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes

Phase 3

Completed

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

• Registration Number: NCT02600559
• Lead Sponsor: Otonomy, Inc.

Brief Summary

This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-05
• Study First Posted: 2015-11-09
• Primary Completion: 2016-07
• Study Completion: 2016-07
• 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: 501

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Post-surgical Otorrhea	8 weeks	Absence or presence of otorrhea (drainage from the middle ear)

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Up to Eight Weeks	Evaluation of adverse events
Caregiver Burden - Ear Drops Administration	Week 8	Ear Drop Caregiver Burden Questionnaire at Week 8
Caregiver Burden - Ear Discharge Control	Week 8	Ear Drop Caregiver Burden Questionnaire at Week 8

Trial Locations

Locations (1)

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