FST-201 In The Treatment of Acute Otitis Externa

Study Overview
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Brief Summary
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The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute otitis externa.

Official Title
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A Multi-Center, Randomized, Double-Masked Clinical Study Evaluating the Efficacy Of FST-201 (Dexamethasone 0.1%) Otic Suspension (Foresight Biotherapeutics, Inc.) Vs. Ciprodex (Ciprofloxacin 0.3%, Dexamethasone 0.1%) Otic Suspension (Alcon Laboratories, Inc.) in Subjects With Acute Otitis Externa

Conditions
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Acute Otitis Externa

Intervention / Treatment
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* Drug: FST-201 (dexamethasone 0.1%) Otic Suspension
* Drug: ciprofloxacin 0.3%, dexamethasone 0.1%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a clinical diagnosis of AOE in one or both ears, defined as a clinical score of at least 1 for edema (0-3 scale), 2 for overall inflammation (0-3 scale) and 1 for tenderness (absent=0, present=1). Be at least 18 years of age at Visit 1 (Day 1, Screening/Baseline) of either sex and any race. Provide written informed consent or parental assent. Be willing and able to follow all instructions and attend all study visits Exclusion Criteria: All subjects must not: Have known sensitivity to any component of the study medications Have a current infection requiring systemic antimicrobial treatment Have used topical or systemic pain meds on the same day as Screening/Baseline Visit 1 and for the duration of the study. Take any systemic (within 30 days) or otic corticosteroids (within 1 days) prior to Screening/Baseline Visit 1 Current use of topical or systemic non-steroidal or other anti-inflammatory drugs. Use any topical otic treatment with alcohol, vinegar, hydrogen peroxide or other astringent medication during the course of the study or on the same day as Screening/Baseline Visit 1 Have taken any antibiotics within 3 days prior to Visit 1 Have signs and symptoms of AOE for > 4 weeks at Screening/Baseline Visit 1 Have a non-intact or perforated tympanic membrane in the enrolled ear Have a clinical diagnosis of chronic suppurative otitis media, acute otitis media or acute otorrhea in patients with tympanostomy tubes Have a clinical diagnosis of malignant otitis externa Have overt fungal AOE Have a viral infection of the pinna or tympanic membrane (i.e herpes zoster) Have congenital abnormalities of the external auditory canal in the enrolled ear(s) Have obstructive bony exostoses in the enrolled ear(s) Have mastoid or other suppurative, non-infectious ear disorders (e.g, cholesteatoma) Have malignant tumors of the external auditory canal Have a history of otologic surgery. Surgery performed more than 1 year prior to Screening/Baseline Visit 1and limited to the tympanic membrane is allowed Have seborrheic dermatitis of the external auditory canal Have a current or prior history of immunosuppressive disorders Have acute or chronic renal insufficiency, hepatitis or diabetes mellitus Be pregnant, nursing or planning a pregnancy.

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FST-201 (dexamethasone 0.1%) Otic Suspension<br> | Drug: FST-201 (dexamethasone 0.1%) Otic Suspension<br>* Instill four drops two times a day<br>|
| Active Comparator: ciprofloxacin 0.3%, dexamethasone 0.1%<br> | Drug: ciprofloxacin 0.3%, dexamethasone 0.1%<br>* Instill four drops two times a day<br>* Other names: Ciprodex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall clinical cure as defined by absence of the signs and symptoms of AOE including ear inflammation, edema, tenderness and otic discharge. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological resolution defined as elimination of pre-treatment pathogenic bacteria. |  | 1 year |