A Phase III Study of an Otic Formulation in Acute Otitis Externa

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Status Completed

Clinical Trial Summary

The purpose of this study is to determine if an otic formulation is safe and effective for the treatment of acute otitis externa (AOE).

n/a

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

See also
Status	Clinical Trial	Phase
Completed	`NCT02918773` - Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)	N/A
Not yet recruiting	`NCT04636957` - A Phase III Study of Ciprofloxacin Plus Fluocinolone in Acute Otitis Externa (AOE)	Phase 3
Completed	`NCT01447017` - A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis	Phase 2
Completed	`NCT01535599` - Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa	Phase 3
Completed	`NCT02801370` - Phase 3 Study of OTO-201 in Acute Otitis Externa	Phase 3
Terminated	`NCT00945802` - FST-201 In The Treatment of Acute Otitis Externa	Phase 3
Completed	`NCT03196973` - Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa	Phase 3
Recruiting	`NCT01584271` - Study of Ear Comfort Ear Drops to Treat AOE Cases Compared to DexOtic & Otidin(R)	Phase 2
Completed	`NCT02216071` - Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa	Phase 3
Completed	`NCT00961675` - FST-201 in the Treatment of Acute Otitis Externa	Phase 3
Completed	`NCT01535560` - Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa	Phase 3