A Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes
Acute Otitis MediaThe purpose of this study is to determine if an otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.
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).
Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract...
Otitis MediaTonsillitis2 moreThis study was performed in children with upper respiratory tract infections (acute ear infection, infection of the tonsils or throat, or bacterial inflammation of the bronchi) who needed treatment with an antibiotic (clarithromycin). The study investigated a new technology which delivers the antibiotic in a straw (dose sipping technology, DST) in comparison to a marketed syrup.
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.
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.
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.
Dose Ranging Study of OTO-201 in AOMT
Acute Otitis MediaAOMTDose Ranging Study of OTO-201 in AOMT
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.
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute...
Acute Otitis ExternaThe purpose of this study was to demonstrate the superiority of AL-60371, 0.3% Otic Suspension relative to AL-60371 Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).