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

Study Overview
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Brief Summary
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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).

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

Conditions
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Otitis Media With Effusion in Children, Otitis Media Recurrent

Intervention / Treatment
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* Drug: EXE844 Sterile Otic Suspension, 0.3%
* Procedure: Tympanostomy Tube Insertion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXE844 for 7 Days + Tubes<br>EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion | Drug: EXE844 Sterile Otic Suspension, 0.3%<br> <br> Procedure: Tympanostomy Tube Insertion<br>* Surgical procedure for treating pediatric cases of recurrent or chronic otitis media<br>|
| Experimental: EXE844 for 3 Days + Tubes<br>EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion | Drug: EXE844 Sterile Otic Suspension, 0.3%<br> <br> Procedure: Tympanostomy Tube Insertion<br>* Surgical procedure for treating pediatric cases of recurrent or chronic otitis media<br>|
| Active Comparator: Tubes Only<br>Bilateral myringotomy and tympanostomy tube insertion | Procedure: Tympanostomy Tube Insertion<br>* Surgical procedure for treating pediatric cases of recurrent or chronic otitis media<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Sustained Clinical Cure at Day 8 | A sustained clinical cure was attained if otorrhea was absent in the study ear at Day 8 (EOT) per the Investigator assessment and continued to be absent through the end of the study. Participants were considered a treatment failure if, at any time during the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward). | Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Microbiological Success at Day 14 | Microbiological success was attained if all pretherapy bacteria were absent in the study ear for the Test-of-Cure (TOC) (Day 14) specimen. Participants were considered a treatment failure if, at any time during the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward). | Day 14 | 
| Time to Cessation of Otorrhea | Time (in days) to the 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 via the BID diary. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward). | Up to Day 14 |