Conditions: Otitis Media With Effusion in Children Otitis Media Recurrent
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 14
Healthy volunteers: no

Brief summary:
The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects, immediately after bilateral tympanostomy tube surgery.

Detailed description:

Arms:
arm 1: EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion

Interventions: intervention 1: EXE844 Sterile Otic Suspension, 0.3% intervention 2: Tympanostomy Tube Insertion
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: