Acute Fungal Otitis Externa
Conditions
Brief summary
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.
Interventions
Instill four drops times two times a day.
DRUGVehicle
Instill four times two times a day
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Microbiological resolution defined as absence of pre-treatment pathogenic fungal species. | 1 year |
Countries
United States
Outcome results
None listed