FST-201 In The Treatment of Acute Fungal Otitis Externa

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