Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessation of otorrhea.

Detailed Description
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The results at the time of the interim analysis met the futility criteria and the study was subsequently stopped.

Official Title
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Proof of Concept of Single Application of AL-60371/AL-817 Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes Compared to CIPRODEX® (BID for 7 Days)

Conditions
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Acute Otitis Media

Intervention / Treatment
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* Drug: AL-60371/AL-817 otic suspension
* Drug: Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parent or guardian: Read and sign the informed consent. When required by the Institutional Review Board, child must agree to sign an approved assent form; Presence of otorrhea (visible by parent or guardian) of 21 days or less in duration; Presence of patent tympanostomy tubes; 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; Parent or guardian: Agree to comply with the requirements of the study, administer the study medication as directed, complete required study visits, and comply with the protocol; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: NOT otorrhea-free for at least seven days following tympanostomy tube surgery; Menarcheal females; Previous otologic surgery, except tympanic membrane, within one year of study entry; History of/or current acute or chronic non-tube otorrhea (through existing perforation of the eardrum); Current acute otitis externa, malignant otitis externa, or other conditions which could interfere with evaluation of the study drug; Diabetic (controlled or uncontrolled); Use of prohibited medications; Other protocol-defined 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: AL-60371/AL-817<br>AL-60371/AL-817 otic suspension, 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1) | Drug: AL-60371/AL-817 otic suspension<br> <br> |
| Active Comparator: CIPRODEX<br>Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension, 4 drops in affected ear(s) twice daily through tympanostomy tube for 7 days | Drug: Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension<br>* CIPRODEX®<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit | A sustained clinical cure at Day 3 was attained if otorrhea was absent at the Day 3 visit and continued to be absent through the last study visit (Day 8 or Early Exit). Proportion of subjects is reported as a percentage. | Day 3 post-treatment up to Day 8 or Early Exit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Microbiological Success at the Day 8 Visit | Microbiological success was attained if all pre-therapy bacteria were absent in the Day 8 specimen. In a subject with no otorrhea at Day 8, eradication of pre-therapy bacteria was presumed and the subject was considered a microbiological success. | Day 8 | 
| Median Time (in Days) to Cessation of Otorrhea | Median time (in days) to the cessation of otorrhea (ie, otorrhea was absent) was calculated as the number of days from the Day 1 (Visit 1) to the absence of otorrhea in the affected ear(s) as recorded by the parent/guardian via the twice-daily diary. Cessation of otorrhea was defined as ending on the first day that otorrhea was absent from the affected ear(s) and remained absent for any/all subsequent diary entries. | Time to event, up to Day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AOMT, tympanostomy tubes, Otorrhea, anti-infective