Status:
COMPLETED
Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa
Lead Sponsor:
Exela Pharma Sciences, LLC.
Conditions:
Acute Otitis Externa
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to demonstrate the clinical therapeutic non-inferiority of EXL CDOS to commercially available Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic Suspension (Ciprodex®, ...
Detailed Description
This was a Phase 3, multicenter, randomized, double-blind, active-controlled, parallel-group study in adults and children (age 6 months and older) with a diagnosis of AOE with a 2-day screening period...
Eligibility Criteria
Inclusion
- Male or female, 6 months of age and over;
- Clinically documented AOE consistent with the diagnostic guidelines of the American Academy of Otolaryngology-Head and Neck Surgery Foundation in 1 or both ears;
- Inflammation and/or edema ≥2 on the AOE scale, and otorrhea and/or tenderness present;
- AOE of \<4 weeks duration;
- Intact tympanic membrane(s) in the treated ear(s);
- Willingness to refrain from swimming through the TOC/ Visit 5;
- For subjects with AOE associated with hearing aid use, willingness to discontinue the use of hearing aid(s) in the affected ear(s) through the TOC/Visit 5;
- Ability to complete the study in compliance with the protocol;
- For adult subjects, ability to understand and provide written informed consent; and
- For pediatric subjects, a parent or legal guardian has provided written informed consent; and
- For children age 6 and above, ability to understand and provide assent according to institutional requirements.
Exclusion
- Acute or chronic suppurative otitis media;
- Post-tympanostomy tube acute otorrhea;
- Malignant otitis externa;
- Suspected or overt fungal or viral ear infection;
- Congenital abnormalities or obstructive bony exostoses of the external auditory canal of the treated ear(s);
- Seborrheic dermatitis or other dermatologic conditions of the external auditory canal of the treated ear(s) which could confound evaluation;
- Mastoiditis or other suppurative infectious or non-infectious disorders of the treated ear(s);
- Malignant tumors of the external auditory canal of the treated ear(s);
- History of otologic surgery of the treated ear(s), with the exception of tympanic membrane surgery \>6 months prior to Baseline;
- Four or more episodes of otitis externa (OE) in the previous year;
- Uncontrolled diabetes mellitus;
- Immunosuppressive disorder, including known Human Immunodeficiency Virus infection;
- Renal insufficiency;
- Hepatitis or hepatic insufficiency;
- Receipt of systemic antibiotic concurrently or within 72 hours prior to Baseline;
- Receipt of topical otic antibiotic within 24 hours prior to Baseline;
- Use of systemic corticosteroid concurrently or within 30 days prior to Baseline;
- Use of topical otic corticosteroids concurrently or within 7 days prior to Baseline;
- Concurrent use of systemic or topical otic nonsteroidal or other anti-inflammatory drugs;
- Use of topical vinegar, alcohol, or other astringent otic preparations concurrently or within 24 hours prior to Baseline;
- Pregnancy, planned pregnancy, or lactation;
- Known sensitivity or intolerance to quinolone antibacterial agents;
- Previous participation in this trial;
- Participation in another investigational drug or vaccine trial concurrently or within 30 days; or
- Significant acute or chronic medical, neurologic, or psychiatric illness in the subject or parent/guardian that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
Key Trial Info
Start Date :
July 20 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2015
Estimated Enrollment :
499 Patients enrolled
Trial Details
Trial ID
NCT02216071
Start Date
July 20 2014
End Date
August 11 2015
Last Update
May 28 2021
Active Locations (48)
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1
Birmingham Pediatric Associates
Birmingham, Alabama, United States, 35205
2
Desert Clinical Research/Clinical Research Advantage, Inc.
Mesa, Arizona, United States, 85213
3
Children's Clinic of Jonesboro, PA
Jonesboro, Arkansas, United States, 72401
4
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72401