Dose Ranging Study of OTO-201 in AOMT

Phase 2

Completed

• Conditions: Acute Otitis Media; AOMT
• Interventions: Drug: 6 mg ciprofloxacin; Drug: 12 mg ciprofloxacin; Other: Sham

• Registration Number: NCT02719158
• Lead Sponsor: Otonomy, Inc.

Brief Summary

Dose Ranging Study of OTO-201 in AOMT

Detailed Description

This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled, blinded study in which eligible subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201, 12 mg OTO-201, or sham into the affected ear(s).

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-21
• Study First Submitted QC: 2016-03-21
• Study First Posted: 2016-03-25
• Primary Completion: 2016-06
• Study Completion: 2016-07
• Status Verified: 2020-09
• Results First Submitted: 2020-09-01
• Results First Submitted QC: 2020-09-01
• Results First Posted: 2020-09-24
• Last Update Submitted: 2020-09-24
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6 mg OTO-201	6 mg ciprofloxacin	6 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.1 mL supra-tympanostomy tube (STT) administration to the affected ear(s)
12 mg OTO-201	12 mg ciprofloxacin	12 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.2 mL supra-tympanostomy tube (STT) administration to the affected ear(s)
Sham (empty syringe)	Sham	Sham (empty syringe), single 0.1 mL STT administration to the affected ear(s)

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Adverse Events	Up to 1 month	Number of subjects with adverse events during the study from dosing up to 1 month after dosing
Otoscopic Examination: Auricle and Meatus	Up to 1 month	Number of affected ears (i.e., those ears that were infected) whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The auricle and meatus of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the auricle and meatus with treatment (i.e., a safety measure).
Otoscopic Examination: Tympanic Membrane	Up to 1 month	Number of affected ears (i.e., those ears that were infected) whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The tympanic membrane of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the tympanic membrane with treatment (i.e., a safety measure).

Secondary Outcome Measures

Name	Time	Method
Absence of Otorrhea	Up to Two Weeks	Absence of otorrhea (middle ear drainage)

Trial Locations

Locations (1)

Contact Otonomy call center for trial locations; 🇺🇸 San Diego, California, United States