Two Multicenter Phase 3 Trials
Study designTwo Phase 3 randomized, controlled, blinded, multicenter studies compared the efficacy and safety of OTIPRIO with tubes vs tubes alone* in pediatric patients (N=532) with bilateral middle ear effusion requiring ear tube placement.
The median age of patients enrolled in the clinical trials was 1.5 years; 62% of patients were 6 months through 2 years of age and 38% of patients were greater than 2 years of age
The primary endpoint in both trials was the cumulative proportion of study treatment failures through Day 15
Treatment failure was defined as any of the following events: otorrhea as determined by a blinded assessor† on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up
Treatment with OTIPRIO reduced failure ratesOTIPRIO demonstrated statistically significant lower rates of treatment failure compared with tubes alone (P<0.001)
Administration of OTIPRIO did not lead to impairment in hearing function, middle ear function, or tube patency by Day 29
OTIPRIO demonstrated less otorrhea and less use of additional antibacterial drugs
Graph does not include the following two components of treatment failure: missed visits or lost-to-follow-up
Treatment failure was defined as any of the following events: otorrhea as determined by a blinded assessor† on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-upReason for failure was recorded as the earliest occurring treatment event. Patients were classified as a treatment failure due only to that component for the remainder of the study.
- *Tubes alone arm: patients received an administration of air (sham) during ear tube placement.
- †Blinded assessor: an independent, blinded clinician who observed and reported otorrhea during scheduled follow-up visits.