Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa
Public ClinicalTrials.gov record NCT02216071. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02216071
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 499 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 6 Months and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 20, 2014 (Actual)
- Primary completion
- Aug 11, 2015 (Actual)
- Completion
- Aug 11, 2015 (Actual)
- Last update posted
- May 28, 2021
2014 – 2015
United States locations
- U.S. sites
- 46
- U.S. states
- 20
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Pediatric Associates | Birmingham | Alabama | 35205 | — |
| Desert Clinical Research/Clinical Research Advantage, Inc. | Mesa | Arizona | 85213 | — |
| Children's Clinic of Jonesboro, PA | Jonesboro | Arkansas | 72401 | — |
| NEA Baptist Clinic | Jonesboro | Arkansas | 72401 | — |
| Southland Clinical Research Center | Anaheim | California | 92804 | — |
| Southland Clinical Reseach Center | Bellflower | California | 90706 | — |
| Alessi Institute | Beverly Hills | California | 90212 | — |
| American Clinical Trials | Buena Park | California | 90620 | — |
| MCS Clinical Trials | Los Angeles | California | 90017 | — |
| Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc | Sacramento | California | 95815 | — |
| Benchmark Research | Sacramento | California | 95822 | — |
| Clinix Health Services of Colorado/Clinical Research Advantage, Inc. | Centennial | Colorado | 80112 | — |
| Colorado ENT & Allergy | Colorado Springs | Colorado | 80909 | — |
| Colorado Springs Health Partners/Clinical Research Advantage, Inc. | Colorado Springs | Colorado | 80920 | — |
| Direct Helpers Medical Center | Hialeah | Florida | 33012 | — |
| Palm Springs Research Institute | Hialeah | Florida | 33012 | — |
| Abel & Buchheim PR, Inc. | Miami | Florida | 33165 | — |
| Integrity Clinical Trials, LLC | Miami | Florida | 33165 | — |
| Pediatrics & Adolescent Medicine, PA | Marietta | Georgia | 30062 | — |
| Urban Family Practice/Clinical Research Advantage | Marietta | Georgia | 30067 | — |
| Professional Research Network of Kansas, LLC | Wichita | Kansas | 67203 | — |
| Horizon Research Group, LLC | Eunice | Louisiana | 70535 | — |
| Woburn Pediatric Associates | Woburn | Massachusetts | 01801 | — |
| Pioneer Clinical Research | Bellevue | Nebraska | 68005 | — |
| Clinical Research Center for Nevada, LLC | Las Vegas | Nevada | 89104 | — |
| ProMetrix Clinical Studies | Morganville | New Jersey | 07751 | — |
| Whitehouse Station Family Medicine | Whitehouse Station | New Jersey | 08889 | — |
| Asheboro Research Associates | Asheboro | North Carolina | 27203 | — |
| Piedmont Ear, Nose, and Throat Associates | Winston-Salem | North Carolina | 27103 | — |
| Sterling Research Group, Ltd | Cincinnati | Ohio | 45246 | — |
| Hometown Urgent Care and Research | Dayton | Ohio | 45424 | — |
| Cyn3rgy Research | Gresham | Oregon | 97030 | — |
| Research Across America | Dallas | Texas | 75234 | — |
| Gulf Coast Medical Research | Houston | Texas | 77025 | — |
| Gulf Coast Medical Research | Missouri City | Texas | 77459 | — |
| Benchmark Research | San Angelo | Texas | 76904 | — |
| Mercury Clinical Research, Inc | Splendora | Texas | 77372 | — |
| Gulf Coast Medical Research | Sugar Land | Texas | 77478 | — |
| Ericksen Research & Development | Clinton | Utah | 84015 | — |
| J. Lewis Research/First Med East | Salt Lake City | Utah | 84121 | — |
| J. Lewis Research/Foothill Family Clinic South | Salt Lake City | Utah | 84121 | — |
| Chyrsalis Clinical Research | St. George | Utah | 84790 | — |
| Pi-Coor Clinical Research, LLC | Burke | Virginia | 22015 | — |
| Pediatric Research of Charlottesville, LLC | Charlottesville | Virginia | 22902 | — |
| Heugenot Pediatrics, PC | Midlothian | Virginia | 23113 | — |
| Zain Research, LLC | Richland | Washington | 97030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02216071, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 28, 2021 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02216071 live on ClinicalTrials.gov.