10 completed, 1 terminated, 1 unknown. 9 Phase 3, 2 Phase 2, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 9 | Completed 8, Terminated 1 |
| Phase 2 | 2 | Completed 1, Unknown 1 |
| Not applicable | 1 | Completed 1 |
Follow Acute Otitis Externa: new trials by email Literature Review of Acute Otitis Externa trials Research Report on Acute Otitis Externa
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide Otic Solution in the Treatment of Acute Otitis Externa Ciprofloxacin-Fluocinolone Acetonide, 0.3%-0.025% Otic Solution, Ciprofloxacin 0.3% solution - Acute Otitis Externa | Phase 3 | Completed | Lee's Pharmaceutical Limited | 600 | 2021-01-04 | 2026-10-13 |
| Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa DF289 plus DF277, DF289, DF277 - Acute Otitis Externa | Phase 3 | Completed | Salvat | 493 | 2017-07-22 | 2021-04-09 |
| Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto) Smartphone otoscope, Conventional otoscope - Acute Otitis Media, Acute Otitis Externa | Not applicable | Completed | Emory University | 22 | 2016-10-15 | 2018-07-13 |
| Phase 3 Study of OTO-201 in Acute Otitis Externa 12 mg ciprofloxacin, Sham Control - Acute Otitis Externa, Swimmer's Ear | Phase 3 | Completed | Otonomy, Inc. | 262 | 2016-06-01 | 2020-10-19 |
| Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa Ciprodex®, EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension - Acute Otitis Externa | Phase 3 | Completed | Exela Pharma Sciences, LLC. | 499 | 2014-07-20 | 2021-05-28 |
| Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa AL-60371, 0.3% otic suspension, AL-60371 Vehicle - Acute Otitis Externa | Phase 3 | Completed | Alcon Research | 589 | 2012-04-01 | 2013-12-10 |
| Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa AL-60371, 0.3% Otic Suspension, AL-60371 Vehicle - Acute Otitis Externa | Phase 3 | Completed | Alcon Research | 768 | 2012-03-01 | 2014-07-08 |
| A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis DPK-060, Placebo for DPK-060 ear drops - Acute Otitis Externa | Phase 2 | Completed | DermaGen AB | 69 | 2011-11-01 | 2013-12-10 |
| Study of Ear Comfort Ear Drops to Treat AOE Cases Compared to DexOtic & Otidin(R) Natural Ear Comfort(TM), a botanical ear drops product - Acute Otitis Externa | Phase 2 | Unknown | Assuta Hospital Systems | 75 | 2011-07-01 | 2013-07-09 |
| FST-201 in the Treatment of Acute Otitis Externa FST201 (dexamethasone 0.1% with povidone-iodine 1%), Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% ) - Acute Otitis Externa | Phase 3 | Completed | Shire | 70 | 2009-08-31 | 2021-06-14 |
| FST-201 In The Treatment of Acute Otitis Externa FST-201 (dexamethasone 0.1%) Otic Suspension, ciprofloxacin 0.3%, dexamethasone 0.1% - Acute Otitis Externa | Phase 3 | Terminated | Shire | 5 | 2009-07-31 | 2021-05-27 |
| A Phase III Study of an Otic Formulation in Acute Otitis Externa Moxidex otic solution, Moxifloxacin otic solution, Dexamethasone phosphate otic solution - Acute Otitis Externa | Phase 3 | Completed | Alcon Research | 990 | 2008-06-01 | 2012-12-03 |
Otitis (3) · Otitis Externa (2) · Earache (1) · Otitis Media (1)
Ear Diseases (4) · Otorhinolaryngologic Diseases (4) · Neurologic Manifestations (1) · Otitis (1) · Pain (1) · Pathological Conditions, Signs and Symptoms (1) · Signs and Symptoms (1)
Ciprofloxacin (5) · Dexamethasone (3) · Adrenal Cortex Hormones (1) · Anti-Bacterial Agents (1) · Solutions (1)
Alcon Research (3) · Shire (2) · Assuta Hospital Systems (1) · DermaGen AB (1) · Emory University (1) · Exela Pharma Sciences, LLC. (1) · Lee's Pharmaceutical Limited (1) · Otonomy, Inc. (1) · Salvat (1)
United States (4) · American Samoa (1) · Canada (1) · China (1) · Israel (1) · Puerto Rico (1) · Spain (1) · Sweden (1)
Ali Hajimirsadeghi, MD (1) · Anders Luts, MD (1) · Andrea Shane, MD, MPH, MSc (1) · Andrzej Sloma, MD (1) · Bo Liu, MD (1) · Carl LeBel, PhD (1) · Dan Curiac, MD (1) · Dan Guttman, MD (1) · Madeleine Cosmo, MD (1) · Michael H Silverman, MD (1) · Sally Scheib, Sr. Clinical Project Lead (1)