FST-201 In The Treatment of Acute Fungal 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 vehicle in the treatment of acute fungal otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute fungal otitis externa.

Official Title
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A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled Clinical Study Evaluating the Efficacy Of FST-201 (Dexamethasone 0.1%) Otic Suspension in Subjects With Acute Fungal Otitis Externa

Conditions
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Acute Fungal Otitis Externa

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a clinical diagnosis of AFOE of in one or both ears, based on 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) and/or 1 for pruritis (absent = 0, present = 1) Have appearance consistent with fungal debris, i.e. white or black appearance consistent with Aspergillus spp. or Candida spp. Be at least 18 years of age at Visit 1 (Day 1, Screening/Baseline) of either sex and any race Provide written informed consent Be willing and able to follow all instructions and attend all study visits If female and of child bearing potential, agree to and submit a urine sample for pregnancy testing at Visit 1 and upon their exit from the study. Post menopausal is defined as having no menses for 12 consecutive months. Exclusion Criteria: Have known sensitivity to any component of the study medications Have a current infection requiring systemic antimicrobial treatment Take any systemic (within 30 days) or otic corticosteroids (within 1 day) prior to Visit 1 Have used topical or systemic anti-inflammatory agents on the same day as Visit 1 and for the duration of the study Have used topical or systemic pain medications on the same day as Visit 1 and for the duration of the study Have used any topical otic treatment within 1 days prior to Visit 1

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 times two times a day.<br>|
| Placebo Comparator: vehicle<br> | Drug: Vehicle<br>* Instill four times two times a day<br>|

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 AFOE including ear inflammation, edema, tenderness, pruritis and otic discharge. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological resolution defined as absence of pre-treatment pathogenic fungal species. |  | 1 year |