Conditions: Otitis Media With Effusion in Children Otitis Media Recurrent
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 404
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).

Detailed description:

Arms:
arm 1: EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion arm 2: EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion arm 3: Bilateral myringotomy and tympanostomy tube insertion

Interventions: intervention 1: EXE844 Sterile Otic Suspension, 0.3% intervention 2: Tympanostomy Tube Insertion
Intervention descriptions: intervention 1: None intervention 2: Surgical procedure for treating pediatric cases of recurrent or chronic otitis media

Protocol document: