FST-201 In The Treatment of Acute Otitis Externa

A Multi-Center, Randomized, Double-Masked Clinical Study Evaluating the Efficacy Of FST-201 (Dexamethasone 0.1%) Otic Suspension (Foresight Biotherapeutics, Inc.) Vs. Ciprodex (Ciprofloxacin 0.3%, Dexamethasone 0.1%) Otic Suspension (Alcon Laboratories, Inc.) in Subjects With Acute Otitis Externa

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.

Study Overview

• Status: Terminated
• Conditions: Acute Otitis Externa
• Intervention / Treatment: Drug: FST-201 (dexamethasone 0.1%) Otic Suspension; Drug: ciprofloxacin 0.3%, dexamethasone 0.1%

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • ENT Associates of South Florida
    • Sarasota, Florida, United States, 34239
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Ear, Nose, and Throat Clinic
    • San Antonio, Texas, United States, 78215
      • San Antonio Ear, Nose, and Throat Research
    • San Antonio, Texas, United States, 78229
      • San Antonio Ear, Nose, and Throat Research
    • San Antonio, Texas, United States, 78258
      • Ear Institute of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FST-201 (dexamethasone 0.1%) Otic Suspension	Drug: FST-201 (dexamethasone 0.1%) Otic Suspension; Instill four drops two times a day
Active Comparator: ciprofloxacin 0.3%, dexamethasone 0.1%	Drug: ciprofloxacin 0.3%, dexamethasone 0.1%; Instill four drops two times a day; Other Names: Ciprodex

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Microbiological resolution defined as elimination of pre-treatment pathogenic bacteria.	1 year

Collaborators and Investigators

• Sponsor: Shire

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2009
• Primary Completion (Actual): July 31, 2010
• Study Completion (Actual): July 31, 2010

Study Registration Dates

• First Submitted: July 23, 2009
• First Submitted That Met QC Criteria: July 23, 2009
• First Posted (Estimate): July 24, 2009

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 24, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis Externa; Otitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101; Ciprofloxacin
• Other Study ID Numbers: FST201-AOE-02