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

Phase 3

Completed

Interventions: Drug: EXE844 Sterile Otic Suspension, 0.3%
Procedure: Tympanostomy Tube Insertion

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).

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
EXE844 for 3 Days + Tubes	Tympanostomy Tube Insertion	EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
EXE844 for 7 Days + Tubes	EXE844 Sterile Otic Suspension, 0.3%	EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion
EXE844 for 7 Days + Tubes	Tympanostomy Tube Insertion	EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion
EXE844 for 3 Days + Tubes	EXE844 Sterile Otic Suspension, 0.3%	EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion
Tubes Only	Tympanostomy Tube Insertion	Bilateral myringotomy and tympanostomy tube insertion

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Sustained Clinical Cure at Day 8	Day 8	Sustained clinical cure was defined as the absence of otorrhea in the study ear at Day 8 (end of treatment (EOT)) per the Investigator assessment. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).

Secondary Outcome Measures

Name	Time	Method
Time to Cessation of Otorrhea	Up to Day 14	The time to cessation of otorrhea in the enrolled ear(s) was calculated as the number of days from the day of surgery to the absence of otorrhea (ie, no discharge) as reported by the parent/caregiver. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).
Percentage of Subjects With Microbiological Success at Day 14	Day 14	Microbiological success was attained if all pretherapy bacteria were absent in the study ear for the test-of-cure (TOC) specimen, which was presumed a success for subjects with no otorrhea at Day 14. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).