Otiprio Versus Ciprodex Tympanostomy Tube Outcomes

PHASE4WithdrawnINTERVENTIONAL
0
Timeline

Start Date

October 31, 2018

Primary Completion Date

June 30, 2019

Study Completion Date

June 30, 2019

Conditions
OtorrheaOtitis Media With Effusion in Children
Interventions
DRUG

Otiprio

Otiprio is a single-dose, physician-administered, sustained-exposure otic fluoroquinolone antibacterial for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement surgery. Otoprio (6% ciprofloxacin, 60 mg/mL) will be administered through the tube lumen by the otolaryngologist immediately after tympanostomy surgery.

DRUG

Ciprodex

Ciprodex is a combined antibiotic and steroid ear drop used to treat otitis media with tympanostomy tubes. Four drops of Ciprodex (0.14mL) instilled by the otolaryngologist into the affected ear immediately after tympanostomy surgery. Each mL of Ciprodex contains ciprofloxacin hydrochloride 0.3 % (equivalent to 3 mg ciprofloxacin base) and dexamethasone 0.1 % equivalent to 1 mg dexamethasone

Trial Locations (1)

02118

Boston Medical Center, Boston

Sponsors
All Listed Sponsors
lead

Boston Medical Center

OTHER