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
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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
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=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=16 A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion
Otitis Media With Effusion
Primary: Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear — 1; 0 participants
N/A N=69 Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis Media Who Had a Middle Ear Surgery
Chronic Otitis Media
Primary: Number and Type of Contacts With Health Care Providers — 45; 14; 5; 3 Participants
Phase 3 N=91 Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays
Otitis Media, Serous · Negative Middle Ear Pressure · Rhinitis
Primary: Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment — 7; 12 participants — p=0.18
Phase 3 N=331 Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
Acute Otitis Media
Primary: Time to Cessation of Otorrhea — 6.83; 22; 4.94 days
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 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 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
N/A N=250 Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media
Acute Otitis Media
Primary: The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year — 1.48; 1.56 Occurrences per child-year — p=0.66
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 3 N=331 Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
Acute Otitis Media
Primary: Time to Cessation of Otorrhea — 7.69; 22; 3.75 days
Phase 2 N=25 Effect of Simethicone on Eustachian Tube Dysfunction
Otitis Media
Primary: Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) — 0.17; 0.24; 0.19; 0.23 ratio — p==0.93
N/A N=323 Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter
Eustachian Tube Dysfunction
Primary: Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks — 73; 10 Participants
N/A N=25 Singapore Tympanostomy Tube Delivery System Study
Otitis Media
Primary: Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events. — 94.6 percentage of ears
Phase 3 N=53 Evaluation of the Tympanostomy Tube Delivery System
Otitis Media With Effusion · Acute Otitis Media
Primary: Safety of Tympanostomy Tube (TT) Delivery System — 0.0 percentage of ears
N/A N=16 Clinical Study of the Tympanostomy Tube Delivery System
Otitis Media With Effusion
Primary: Device Success — 21 devices
N/A N=40 Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil
Upper Respiratory Infection · Acute Otitis Media
Primary: Lactobacillus Rhamnosus GG in Middle Ear Effusion and Adenoid Tonsil — 4; 1 Samples — p=0.05
N/A N=276 Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss
Hearing Loss
Primary: Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB) — -19.74; -14.41 score on a scale — p=0.003
Phase 3 N=370 In-Office Tympanostomy Tube Placement in Children (OTTER)
OME - Otitis Media With Effusion · AOM - Acute Otitis Media
Primary: Procedural Success: — 103; 91 Participants
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…
Phase 4 N=81 Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy
Barotrauma;Ear
Primary: Requirement of Oxymetalozine Rescue for Ear Pain During Hyperbaric Therapy Compression — 8; 11 Participants
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=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 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=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 4 N=99 A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
Acute Otitis Media · Otitis Media · Ear Infection
Primary: Incidence of Acute Otitis Media — 30; 27 participants with AOM