A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose...
Acute Otitis MediaA phase 3 randomized, multicenter, double blind, double dummy study to assess the efficacy, safety, and compliance of a single dose of azithromycin extended release compared with a 10-day course of amoxicillin/clavulanate twice daily in children at high risk for persistent or recurrent ear infections
Middle Ear Disease Before Age 3, Treatment With Ear Tubes, and Literacy and Attentional Abilities...
Otitis MediaMiddle Ear EffusionMiddle-ear disease (infection and fluid) is the most common illness in young children after the common cold. Because hearing loss accompanies middle-ear disease, and because early life is a period of rapid development, concern has existed that sustained periods of middle-ear disease might cause lasting impairments of learning, speech development, language development, or behavior and social adjustment. Earlier phases of this research found that the insertion of ear tubes in children younger than 3 years of age with persistent middle-ear disease did not affect their development at 3, 4, or 6 years of age. This study examines the children's literacy, attention, and related abilities at 9 to 11 years of age.
Clinical Study of the Tympanostomy Tube Delivery System
Otitis Media With EffusionThe objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube [TT(s)] in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy...
Otitis MediaThis is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.
OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube...
Otitis Media With EffusionThe purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis...
Acute Otitis MediaThe primary objective is to compare the effect of treatment with a combination of ear solutions on the reduction of pain symptoms at 1 hour after dosing in children with acute otitis media.
Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Presenting With...
PainAcute Otitis MediaTo assess the clinical safety and efficacy of the Benzocaine relative to placebo in pain relief associated with acute otitis media.
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
Acute Otitis ExternaThe purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating AOE
Shared Decision Making in Parents of Children With Acute Otitis Media
Acute Otitis MediaThis study will evaluate the efficacy of shared decision making in treatment of Acute Otitis Media in the Emergency Department setting.
A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute...
Acute Otitis MediaThe purpose of this study is to develop a better understanding of the safety, tolerability and efficacy of intranasal OP0201 as an adjunct treatment to oral antibiotics for the treatment of Acute Otitis Media (AOM) in infants and children.