Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)

An Open-Label, Single-Dose, Pharmacokinetic Study of EXE844 Sterile Otic Suspension, 0.3% in Pediatric Subjects Following Tympanostomy Tube Surgery

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.

Inclusion Criteria:

• Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and eligible for bilateral myringotomy and tympanostomy tube insertion;
• Legally Authorized Representative (LAR) must read and sign the informed consent;
• Parent or caregiver must agree to complete the required study visits and comply with the requirements of the study;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Menarcheal females;
• Previous otologic or otologic-related surgery within the past 30 days or ongoing complications;
• Existing perforation of the eardrum;
• 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;
• Use of prohibited medications or inadequate washout of any medication including systemic and topical antibiotics, steroids and/or analgesics;
• Weighs less than 8 kg;
• Other protocol-specified exclusion criteria may apply.