Phase 3 N=262 Phase 3 Study of OTO-201 in Acute Otitis Externa
Acute Otitis Externa · Swimmer's Ear
Primary: Number of Subjects Considered a Clinical Cure at Day 8 — 91; 63 Participants
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Phase 2 N=75 OTO-201 for the Treatment of Otitis Externa
Otitis Externa
Primary: Otoscopic Examination: Tympanic Membrane — 6; 8; 8 Participants
Phase 3 N=693 Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
Acute Otitis Externa
Primary: Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit — 71.7; 33.3 percentage of participants
Phase 3 N=549 Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
Acute Otitis Externa
Primary: Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit — 68.7; 40.0 Percentage of participants
Phase 3 N=499 Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa
Acute Otitis Externa
Primary: Number of Participants With Clinical Cure of AOE — 190; 191 Participants
Phase 3 N=493 Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
Acute Otitis Externa
Primary: Therapeutic Cure (Clinical + Microbiological Cure) — 63; 49; 20 Participants
Phase 2 N=69 A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis
Acute Otitis Externa
Primary: Adverse Events (AEs) — 10; 3; 6; 1 participants
Phase 3 N=385 Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT)
Otitis Media With Effusion in Children · Otitis Media Recurrent
Primary: Percentage of Subjects With Sustained Clinical Cure at Day 8 — 76.2; 71.8; 56.8 percentage of participants
Phase 3 N=356 Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2
Otitis Media With Effusion in Children · Otitis Media Recurrent
Primary: Percentage of Subjects With Sustained Clinical Cure at Day 8 — 77.1; 75.5; 65.3 percentage of participants
Phase 2 N=39 Open-Label Study of OTO-201 for Treatment of AOMT
Acute Otitis Media · AOMT
Primary: Number of Ears With Otorrhea (Drainage From the Middle Ear) — 8 affected ears
Phase 1 N=24 Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media and Reduction of Ear Pain in Adults With Acute Otitis Media
Acute Otitis Media
Primary: Number of Participants With Adverse Events — 2; 6 Participants
N/A N=22 Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)
Acute Otitis Media · Acute Otitis Externa
Primary: Number of Antibiotic Prescriptions — 140; 115; 6; 7 Emergency department encounters
Phase 2 N=112 Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media
Acute Otitis Media
Primary: Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) — -4.3; -5.0; -4.6; -4.9 units on a scale
Phase 4 N=291 Acute Otitis Media (AOM) Therapy Trial in Young Children
Acute Otitis Media
Primary: The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment — 20; 9; 1; 2…
N/A N=119 Ear Drops for Children With Otitis Media
Acute Otitis Media
Primary: Resolution of Otitis Media Symptoms — 14.2; 16.5; 7.5; 14.1 units on a scale — p=.002
Phase 2 N=95 Dose Ranging Study of OTO-201 in AOMT
Acute Otitis Media · AOMT
Primary: Number of Subjects With Adverse Events — 19; 14; 4 Participants
N/A N=101 Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media
Chronic Otitis Media
Primary: Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear — 13; 27; 15; 23 participants
N/A N=52 Osteopathic Otitis Media Research Study
Otitis Media With Effusion
Primary: Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media — 26; 16; 12; 22 Ears — p=0.02
N/A N=210 Homeopathic Ear Drops for Otitis Media Study
Otitis Media
Primary: Severity of Symptoms of Otitis Media — 2.0; 2.0 units on a scale
Phase 3 N=266 OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
Otitis Media With Effusion
Primary: Percentage of Participants Who Were Treatment Failures. — 21.3; 45.5 percentage of treatment failures
Phase 3 N=266 OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
Otitis Media With Effusion
Primary: Percentage of Participants Who Were Treatment Failures — 24.6; 44.8 percentage of treatment failures
Phase 3 N=501 Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
Otitis Media
Primary: Number of Subjects With Post-surgical Otorrhea — 383; 118 Participants
Phase 1 N=14 Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)
Otitis Media With Effusion in Children · Otitis Media Recurrent
Primary: Maximum Analyte Plasma Concentration (Cmax) — 2.44; 1.61 ng/mL
Phase 3 N=179 Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis)
Otomycosis
Primary: Percentage of Subjects With Therapeutic Cure — 14; 11; 53; 53 Participants
Phase 3 N=135 Clinical Study to Assess the Efficacy and Safety of DF277 Compared to Placebo in the Treatment of Otic Eczema
Otic Eczema
Primary: Analysis of the Itching Change at the End of Treatment. — -1.63; -1.25 units on a scale
Phase 2 N=103 A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months
Acute Otitis Media
Primary: Number of Participants With Adverse Events — 48; 36 Participants
Phase 3 N=118 SVT-15652 Otic Solution for the Treatment of Otomycosis
Otomycosis
Primary: Therapeutical Cure (Clinical and Mycological Cure) — 48; 10 Participants
Phase 2 N=65 Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis
Otomycosis
Primary: Primary Efficacy Endpoint — 1; 3; 1 Participants
Phase 3 N=33 Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
Bilateral Middle Ear Effusion
Primary: Otoscopic Examination: Auricle and Meatus — 1 ears
Phase 3 N=110 SVT-15652 Otic Solution for the Treatment of Otomycosis.
Otomycosis
Primary: Therapeutic Cure (Clinical and Mycological Cure) — 59; 8 Participants