Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2

Safety and Efficacy of EXE844 Otic Suspension in the Treatment of Otitis Media at Time of Tympanostomy Tube Insertion

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).

Inclusion Criteria:

• 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 water-related activities.
• 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.

Exclusion Criteria:

• Previous otologic or otologic-related surgery within the past 30 days or ongoing complications.
• 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 the Investigator.
• 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.