Acute Otitis Externa
Conditions
Brief summary
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.
Interventions
Instill four drops two times a day
DRUGciprofloxacin 0.3%, dexamethasone 0.1%
Instill four drops 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 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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Microbiological resolution defined as elimination of pre-treatment pathogenic bacteria. | 1 year |
Countries
United States
Outcome results
None listed