Clinical Trial Search

Primary: Percentage of Ears That Showed Change in Visualization of the Tympanic Membrane (Ear Drum) Following 15 or 30 Minutes of Using the Test Product — 53.3; 85.7 percentage…

Primary: Skin Irritation — 0.22; 0.20; 0.13; 0.11 score on a scale

Primary: Percentage of Subjects With Therapeutic Cure — 14; 11; 53; 53 Participants

Primary: Elapsed Time in Minutes to Complete Bilateral Ear Impressions — 8.15; 6.28 Minutes

Primary: Number and Type of Contacts With Health Care Providers — 45; 14; 5; 3 Participants

Primary: Time to Cessation of Otorrhea — 6.83; 22; 4.94 days

Primary: Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet — 0.09; 0.53; 0.44 percentage of words correct — p=<0.001

Primary: Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment — 89.9 percentage of subjects

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

Primary: Real Ear Measures — 61.23; 60.23; 60.5; 64.53 dB SPL — p=<0.05

Primary: Percentage of Subjects With Sustained Clinical Cure at Day 8 — 77.1; 75.5; 65.3 percentage of participants

Primary: Number of Participants With Clinical Cure — 19; 18 Participants

Primary: Hearing Evaluation - Pure Tone Audiometry — 57.3 decibel hearing level

Primary: Number of Subjects With Adverse Events — 1 participants

Primary: Resolution of Otitis Media Symptoms — 14.2; 16.5; 7.5; 14.1 units on a scale — p=.002

Primary: Therapeutic Cure (Clinical + Microbiological Cure) — 63; 49; 20 Participants

Primary: Time to Cessation of Otorrhea — 7.69; 22; 3.75 days

Primary: Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear — 13; 27; 15; 23 participants

Primary: Change in Consonant-Nucleus-Consonant (CNC) Words Scores Over Time — 23.6; 22; 18.8; 42.7 Percentage of words correct

Primary: Patency of the Tympanostomy Tube at the Day-14 Visit. — 8; 11; 15; 12 Ear — p=.36

Primary: Otoscopic Examination: Auricle and Meatus — 1 ears

Primary: Percentage of Subjects With Sustained Clinical Cure at Day 8 — 76.2; 71.8; 56.8 percentage of participants

Primary: Number of Subjects With Post-surgical Otorrhea — 383; 118 Participants

Primary: Otoscopic Examination: Tympanic Membrane — 6; 8; 8 Participants

Primary: Adverse Events (AEs) — 10; 3; 6; 1 participants

Primary: Analysis of the Itching Change at the End of Treatment. — -1.63; -1.25 units on a scale

Primary: Root Mean Square Velocity Anterior-posterior [AP] in cm/s (RMSV) — 3.59; 3.30; 3.07 cm/s — p=0.005

Primary: SRT Change — 10.6 dB

Primary: Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment — 7; 12 participants — p=0.18

Primary: Primary Efficacy Endpoint — 1; 3; 1 Participants