In patients with otitis media presenting with otoscopy-confirmed otorrhea who had tympanostomy tube insertion or tympanic perforation, to evaluate the safety, tolerability, and the proportion of patients with cessation of otorrhea after ear-drop administration of YH1177 or YH1177-D for 14 days and therefore to determine the optimal clinical dose.
Patients with otitis media presenting with otoscopy-confirmed otorrhea who had tympanostomy tube insertion or tympanic perforation. Screening should be completed within 7 days prior to randomization. patients with otitis media presenting with otoscopy-confirmed otorrhea who had tympanostomy tube insertion or tympanic perforation at randomization visit will be randomized in one of the defined groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
135
Chonnam National Universitiy Hospital
Gwangju, Chonnam, South Korea
The proportion of patients achieving cessation of otorrhea on Day 15.
The proportion of patients achieving cessation of otorrhea (grade 0) on Day 15, as evidenced by otoscopy
Time frame: Day 15
The proportion of patients with cessation of otorrhea on Day 8.
The proportion of patients with cessation of otorrhea on Day 8 as evidenced by otoscopy.
Time frame: Day 8
The proportion of patients with cessation of otorrhea on Day 22.
The proportion of patients with cessation of otorrhea on Day 22 as evidenced by otoscopy.
Time frame: Day 22
Proportion of patients with improved otorrhea at each visit, as evidenced by otoscopy
'improved otorrhea' is defined as at least one level decrease from baseline in the otorrhea severity grading scale
Time frame: Day 8
Proportion of patients with improved otorrhea at each visit, as evidenced by otoscopy
'improved otorrhea' is defined as at least one level decrease from baseline in the otorrhea severity grading scale
Time frame: Day 15
Proportion of patients with improved otorrhea at each visit, as evidenced by otoscopy
'improved otorrhea' is defined as at least one level decrease from baseline in the otorrhea severity grading scale
Time frame: Day 22
Microbiological eradication
Proportion of patients with microbiological eradicationat each visit
Time frame: Day 8, 15, 22
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