Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa
- Conditions
- Acute Otitis Externa
- Interventions
- Registration Number
- NCT02216071
- Lead Sponsor
- Exela Pharma Sciences, LLC.
- 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®, Alcon) in the treatment of acute otitis externa (AOE) when administered twice daily for 7 days.
- 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 followed by a 2-week participation period. Subjects were administered study drug, EXL CDOS or RLD, 4 drops in the affected ear(s) BID for 7 days. The primary endpoint, the proportion of subjects with a clinical AOE score of 0, was measured at the TOC Visit on Day 15.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 499
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EXL CDOS EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days Ciprodex®, RLD Ciprodex® Ciprodex®, Otic Suspension, Twice daily for 7 days
- Primary Outcome Measures
Name Time Method Number of Participants With Clinical Cure of AOE 7 days after the completion of therapy; at Day 15 (+/- 1 day) The primary efficacy endpoint was the clinical cure of AOE, defined as the proportion of subjects with a clinical AOE score of 0 at the TOC Visit. Subjects with AOE in both ears were considered to have achieved clinical cure of AOE if the clinical AOE score was 0 for both ears. The clinical AOE score was defined as the sum of scores for inflammation and edema (0=absent, 1=mild, 2=moderate, 3=severe) and tenderness and otorrhea (0=absent, 1=present).
- Secondary Outcome Measures
Name Time Method Number of Participants With Microbiological Cure (MC) 7 days after the completion of therapy; at Day 15 (+/- 1 day) The secondary efficacy endpoint was the microbiological cure of AOE, defined as the proportion of subjects with microbiological cure at the TOC Visit. Subjects with AOE in both ears were considered to have achieved microbiological cure if microbiological cure was achieved in both ears.
Trial Locations
- Locations (45)
Southland Clinical Reseach Center
🇺🇸Bellflower, California, United States
Advance Medical Concepts, PSC
🇵🇷Cidra, Puerto Rico
Birmingham Pediatric Associates
🇺🇸Birmingham, Alabama, United States
Clinix Health Services of Colorado/Clinical Research Advantage, Inc.
🇺🇸Centennial, Colorado, United States
Desert Clinical Research/Clinical Research Advantage, Inc.
🇺🇸Mesa, Arizona, United States
Southland Clinical Research Center
🇺🇸Anaheim, California, United States
Children's Clinic of Jonesboro, PA
🇺🇸Jonesboro, Arkansas, United States
Alessi Institute
🇺🇸Beverly Hills, California, United States
Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc
🇺🇸Sacramento, California, United States
Abel & Buchheim PR, Inc.
🇺🇸Miami, Florida, United States
Pediatrics & Adolescent Medicine, PA
🇺🇸Marietta, Georgia, United States
Pioneer Clinical Research
🇺🇸Bellevue, Nebraska, United States
ProMetrix Clinical Studies
🇺🇸Morganville, New Jersey, United States
Whitehouse Station Family Medicine
🇺🇸Whitehouse Station, New Jersey, United States
Hometown Urgent Care and Research
🇺🇸Dayton, Ohio, United States
Sterling Research Group, Ltd
🇺🇸Cincinnati, Ohio, United States
Research Across America
🇺🇸Dallas, Texas, United States
J. Lewis Research/First Med East
🇺🇸Salt Lake City, Utah, United States
J. Lewis Research/Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States
Pi-Coor Clinical Research, LLC
🇺🇸Burke, Virginia, United States
Pediatric Research of Charlottesville, LLC
🇺🇸Charlottesville, Virginia, United States
Clinical Research Puerto Rico
🇵🇷San Juan, Puerto Rico
Ericksen Research & Development
🇺🇸Clinton, Utah, United States
Direct Helpers Medical Center
🇺🇸Hialeah, Florida, United States
Palm Springs Research Institute
🇺🇸Hialeah, Florida, United States
Clinical Research Center for Nevada, LLC
🇺🇸Las Vegas, Nevada, United States
American Clinical Trials
🇺🇸Buena Park, California, United States
Benchmark Research
🇺🇸San Angelo, Texas, United States
Horizon Research Group, LLC
🇺🇸Eunice, Louisiana, United States
Asheboro Research Associates
🇺🇸Asheboro, North Carolina, United States
Urban Family Practice/Clinical Research Advantage
🇺🇸Marietta, Georgia, United States
Colorado ENT & Allergy
🇺🇸Colorado Springs, Colorado, United States
Professional Research Network of Kansas, LLC
🇺🇸Wichita, Kansas, United States
Colorado Springs Health Partners/Clinical Research Advantage, Inc.
🇺🇸Colorado Springs, Colorado, United States
Integrity Clinical Trials, LLC
🇺🇸Miami, Florida, United States
Cyn3rgy Research
🇺🇸Gresham, Oregon, United States
Woburn Pediatric Associates
🇺🇸Woburn, Massachusetts, United States
Heugenot Pediatrics, PC
🇺🇸Midlothian, Virginia, United States
Piedmont Ear, Nose, and Throat Associates
🇺🇸Winston-Salem, North Carolina, United States
Mercury Clinical Research, Inc
🇺🇸Splendora, Texas, United States
Gulf Coast Medical Research
🇺🇸Sugar Land, Texas, United States
Chyrsalis Clinical Research
🇺🇸Saint George, Utah, United States
Zain Research, LLC
🇺🇸Richland, Washington, United States
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
MCS Clinical Trials
🇺🇸Los Angeles, California, United States