Dose Ranging Study of OTO-201 in AOMT
- Conditions
- Acute Otitis MediaAOMT
- Interventions
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
Not provided
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
Contact Otonomy call center for trial locations🇺🇸San Diego, California, United States