Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa
A Phase 3, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study of the Comparative Efficacy and Safety of EXL CDOS in Subjects With Acute Otitis Externa
1 other identifier
interventional
499
2 countries
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2014
Shorter than P25 for phase_3
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 20, 2014
CompletedFirst Submitted
Initial submission to the registry
August 11, 2014
CompletedFirst Posted
Study publicly available on registry
August 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2015
CompletedResults Posted
Study results publicly available
May 28, 2021
CompletedMay 28, 2021
September 1, 2020
1.1 years
August 11, 2014
August 13, 2020
May 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Clinical Cure of AOE
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).
7 days after the completion of therapy; at Day 15 (+/- 1 day)
Secondary Outcomes (1)
Number of Participants With Microbiological Cure (MC)
7 days after the completion of therapy; at Day 15 (+/- 1 day)
Other Outcomes (1)
Number of Participants With Adverse Events
Each monitoring visit through 15 +/- 1 days
Study Arms (2)
Ciprodex®, RLD
ACTIVE COMPARATORCiprodex®, Otic Suspension, Twice daily for 7 days
EXL CDOS
EXPERIMENTALEXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days
Interventions
Treatment of acute otitis externa (AOE) when administered twice daily for 7 days
Treatment of acute otitis externa (AOE) when administered twice daily for 7 days
Eligibility Criteria
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;
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Birmingham Pediatric Associates
Birmingham, Alabama, 35205, United States
Desert Clinical Research/Clinical Research Advantage, Inc.
Mesa, Arizona, 85213, United States
Children's Clinic of Jonesboro, PA
Jonesboro, Arkansas, 72401, United States
NEA Baptist Clinic
Jonesboro, Arkansas, 72401, United States
Southland Clinical Research Center
Anaheim, California, 92804, United States
Southland Clinical Reseach Center
Bellflower, California, 90706, United States
Alessi Institute
Beverly Hills, California, 90212, United States
American Clinical Trials
Buena Park, California, 90620, United States
MCS Clinical Trials
Los Angeles, California, 90017, United States
Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc
Sacramento, California, 95815, United States
Benchmark Research
Sacramento, California, 95822, United States
Clinix Health Services of Colorado/Clinical Research Advantage, Inc.
Centennial, Colorado, 80112, United States
Colorado ENT & Allergy
Colorado Springs, Colorado, 80909, United States
Colorado Springs Health Partners/Clinical Research Advantage, Inc.
Colorado Springs, Colorado, 80920, United States
Direct Helpers Medical Center
Hialeah, Florida, 33012, United States
Palm Springs Research Institute
Hialeah, Florida, 33012, United States
Abel & Buchheim PR, Inc.
Miami, Florida, 33165, United States
Integrity Clinical Trials, LLC
Miami, Florida, 33165, United States
Pediatrics & Adolescent Medicine, PA
Marietta, Georgia, 30062, United States
Urban Family Practice/Clinical Research Advantage
Marietta, Georgia, 30067, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67203, United States
Horizon Research Group, LLC
Eunice, Louisiana, 70535, United States
Woburn Pediatric Associates
Woburn, Massachusetts, 01801, United States
Pioneer Clinical Research
Bellevue, Nebraska, 68005, United States
Clinical Research Center for Nevada, LLC
Las Vegas, Nevada, 89104, United States
ProMetrix Clinical Studies
Morganville, New Jersey, 07751, United States
Whitehouse Station Family Medicine
Whitehouse Station, New Jersey, 08889, United States
Asheboro Research Associates
Asheboro, North Carolina, 27203, United States
Piedmont Ear, Nose, and Throat Associates
Winston-Salem, North Carolina, 27103, United States
Sterling Research Group, Ltd
Cincinnati, Ohio, 45246, United States
Hometown Urgent Care and Research
Dayton, Ohio, 45424, United States
Cyn3rgy Research
Gresham, Oregon, 97030, United States
Research Across America
Dallas, Texas, 75234, United States
Gulf Coast Medical Research
Houston, Texas, 77025, United States
Gulf Coast Medical Research
Missouri City, Texas, 77459, United States
Benchmark Research
San Angelo, Texas, 76904, United States
Mercury Clinical Research, Inc
Splendora, Texas, 77372, United States
Gulf Coast Medical Research
Sugar Land, Texas, 77478, United States
Ericksen Research & Development
Clinton, Utah, 84015, United States
J. Lewis Research/First Med East
Salt Lake City, Utah, 84121, United States
J. Lewis Research/Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
Chyrsalis Clinical Research
St. George, Utah, 84790, United States
Pi-Coor Clinical Research, LLC
Burke, Virginia, 22015, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902, United States
Heugenot Pediatrics, PC
Midlothian, Virginia, 23113, United States
Zain Research, LLC
Richland, Washington, 97030, United States
Advance Medical Concepts, PSC
Cidra, 00739, Puerto Rico
Clinical Research Puerto Rico
San Juan, 00909, Puerto Rico
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Aruna Koganti, VP Clinical Programs
- Organization
- Exela Pharma Sciences
Study Officials
- STUDY CHAIR
Michael H Silverman, MD
BioStrategics Consulting Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2014
First Posted
August 13, 2014
Study Start
July 20, 2014
Primary Completion
August 11, 2015
Study Completion
August 11, 2015
Last Updated
May 28, 2021
Results First Posted
May 28, 2021
Record last verified: 2020-09