Subjects With Acute Otitis Externa
Information source: Foresight Biotherapeutics
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Otitis Externa
Intervention: dexamethasone 0.1% with 1% PVP-I preservative (Drug); ciprofloxacin 0.3%, dexamethasone 0.1% (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Foresight Biotherapeutics Overall contact:
Melissa Earl, Phone: 951-653-5566, Email: m.earl@imedsonline.com
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.
Clinical Details
Official title: A Multi-Center, Randomized, Double-Masked Clinical Study Evaluating the Efficacy Of FST-201 (Dexamethasone 0.1% With 1.0% Povidone-iodine Preservative) Otic Suspension (Foresight Biotherapeutics, Inc.) Vs. Ciprodex (Ciprofloxacin 0.3%, Dexamethasone 0.1%) Otic Suspension (Alcon Laboratories, Inc.) in Subjects With Acute Otitis Externa
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Overall clinical cure as defined by absence of the signs and symptoms of AOE including ear inflammation, edema, tenderness and otic discharge.
Secondary outcome: Microbiological resolution defined as elimination of pre-treatment pathogenic bacteria.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Melissa Earl, Phone: 951-653-5566, Email: m.earl@imedsonline.com
Sarasota, Florida 34239, United States; Recruiting
Herbert Silverstein, MD, Principal Investigator
ENT Associates of South Florida, Boynton Beach, Florida 33426, United States; Recruiting
Joshua Light, MD, Principal Investigator
Ear Institute of Texas, San Antonio, Texas 78258, United States; Recruiting
Lance Jackson, MD, Principal Investigator
Austin Ear, Nose, and Throat Clinic, Austin, Texas 78705, United States; Recruiting
Bradford Winegar, MD, Principal Investigator
San Antonio Ear, Nose, and Throat Research, San Antonio, Texas 78229, United States; Recruiting
Diana Henderson, MD, Principal Investigator
San Antonio Ear, Nose, and Throat Research, San Antonio, Texas 78215, United States; Recruiting
Devang Desai, MD, Principal Investigator
Additional Information
Starting date: July 2009
Ending date: July 2010
Last updated: July 23, 2009
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