Clinical Trial Search

Primary: Difference in Percentages of Treatment Responders at Month 12; Analyzed in the Overall Population — 35.3; 13.6 percentage of participants — p=<0.001

Primary: Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) and the Primary Timepoint Will be Week 12 of the Double-Blind Phase. — 2.7; 2.4; -0.9…

Primary: Number of Participants With AEs — 240 Participants

Primary: Physiological Cost Index (PCI) Ratio — 3.34 unit less

Primary: Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S) — -13.2; .06 score on a scale

Primary: Changes in the Pain Intensity Subscale — 18.07; 15.59; 20.92; 20.06 Scores on a scale

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Potentially Related to Presence of Particle Load in the GLASSIA Solution — 0; 0 Participants

Primary: Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs) — 1; 0; 0; 0 Participants

Primary: Total Score Related to Overall Life Interference Assessed at Baseline, Using Dyad Clinical Outcomes Assessment 1 (DCOA 1) Questionnaire — 29.5; 27.1 units on a scale

Primary: 10 Meter Walk Test (Walk Speed) — 0.72; 0.64; 0.85; 0.78 m/sec

Primary: Number of Participants With Seroconversion Response In 2019 — 5; 33; 11; 44 Participants — p=<0.001

Primary: Feasibility of Study Recruitment and Retention — 12; 8 Participants

Primary: Assessment of Both Systemic and Ocular Adverse Events — 0; 3; 0; 0 Number of TEAE

Primary: Number of Participants Experiencing Clinical Safety Laboratory Adverse Events — 0; 2; 0; 0 participants

Primary: Percentage of Subjects With 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS) — 75 percentage of subjects