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).
- Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and
eligible for bilateral myringotomy and tympanostomy tube insertion.
- Suspected bacterial infection at time of surgery in at least 1 ear.
- Willing to refrain from water immersion of the ears following surgery without the use
of adequate ear protection during swimming, bathing, showering and other
- Legally Authorized Representative (LAR) must read and sign the informed consent.
- Parent or caregiver must agree to comply with the requirements of the study and
administer study medication as directed, complete required study visits, and comply
with the protocol.
- Other protocol-specified inclusion criteria may apply.
- Previous otologic or otologic-related surgery within the past 30 days or ongoing
- Middle ear pathology in either ear other than otitis media.
- Current acute otitis externa (AOE), malignant otitis externa (MOE) or other
conditions which could interfere with evaluation of the study drug.
- Any systemic disease or disorder, complicating factor or structural abnormality that
would negatively affect the conduct or outcome of the study based upon assessment by
- Known or suspected allergy or hypersensitivity to quinolones or other active or
inactive ingredients present in the medications to be used in the study.
- Other protocol-specified exclusion criteria may apply.