Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa

Completed · Phase 3

Conditions studied: Acute Otitis Externa

In brief

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®, Alcon) in the treatment of acute otitis externa (AOE) when administered twice daily for 7 days.

Key facts

Study ID

NCT02216071

Run by

Exela Pharma Sciences, LLC.

People needed

499

Starts

2014-07-20

Expected to finish

2015-08-11

Last updated by the study team

2021-05-28

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Birmingham Pediatric Associates — Birmingham, Alabama, United States
• Desert Clinical Research/Clinical Research Advantage, Inc. — Mesa, Arizona, United States
• Children's Clinic of Jonesboro, PA — Jonesboro, Arkansas, United States
• NEA Baptist Clinic — Jonesboro, Arkansas, United States
• Southland Clinical Research Center — Anaheim, California, United States
• Southland Clinical Reseach Center — Bellflower, California, United States
• Alessi Institute — Beverly Hills, California, United States
• American Clinical Trials — Buena Park, California, United States
• MCS Clinical Trials — Los Angeles, California, United States
• Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc — Sacramento, California, United States
• Benchmark Research — Sacramento, California, United States
• Clinix Health Services of Colorado/Clinical Research Advantage, Inc. — Centennial, Colorado, United States
• Colorado ENT & Allergy — Colorado Springs, Colorado, United States
• Colorado Springs Health Partners/Clinical Research Advantage, Inc. — Colorado Springs, Colorado, United States
• Direct Helpers Medical Center — Hialeah, Florida, United States
• Palm Springs Research Institute — Hialeah, Florida, United States
• Abel & Buchheim PR, Inc. — Miami, Florida, United States
• Integrity Clinical Trials, LLC — Miami, Florida, United States
• Pediatrics & Adolescent Medicine, PA — Marietta, Georgia, United States
• Urban Family Practice/Clinical Research Advantage — Marietta, Georgia, United States
• Professional Research Network of Kansas, LLC — Wichita, Kansas, United States
• Horizon Research Group, LLC — Eunice, Louisiana, United States
• Woburn Pediatric Associates — Woburn, Massachusetts, United States
• Pioneer Clinical Research — Bellevue, Nebraska, United States
• Clinical Research Center for Nevada, LLC — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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