Phase 3 Trials of Thermosensitive Ciprofloxacin Gel for Middle Ear Effusion in Children with Tubes.

ABSTRACT:

Objective

To investigate the efficacy, safety, and microbiology of a thermosensitive otic suspension of ciprofloxacin (OTO-201) in children with bilateral middle ear effusion undergoing tympanostomy tube placement.

Study design

Two randomized, double-blind, sham-controlled phase 3 trials. Patients were randomized to intratympanic OTO-201 or sham.

Setting

Children with bilateral middle ear effusion undergoing tympanostomy tube placement.

Subjects/methods

Studies evaluated 532 patients (6 months to 17 years old) in a combined analysis of efficacy (treatment failure: presence of otorrhea, otic or systemic antibiotic use, lost to follow-up, missed visits), safety (audiometry, otoscopy, tympanometry), and microbiology.

Results

There was a lower cumulative pro

SUBMITTER: Park AH 

PROVIDER: S-EPMC4971606 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature