Clinical trials: Otitis
Ear Infection, Otitis Media
Clinical Study of the Solo+ Tympanostomy Tube Device
The objective of this study is to evaluate the safety and performance of the Solo+ Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure
- Trial name
- NCT04148417
- Testing
- Solo+ Tympanostomy Tube Device
- Where
- 2 sites in United States
- Volunteers
- 27 people
- Sponsor
- AventaMed DAC
Otitis Media
inVENT-In-Office Study
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of tympanostomy tubes (TT) under local anesthesia in an office/clinic setting.
- Trial name
- inVENT-IO (NCT01324271)
- Testing
- Acclarent Tympanostomy Tube Delivery system (TTDS)
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Integra LifeSciences Corporation
Otitis Media
Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children
This was a pilot study to determine the safety and effectiveness of a twice daily, seven-day dosing regimen in acute, pediatric, otitis media in children with tympanostomy tubes.
- Trial name
- NCT00781521
- Testing
- ofloxacin otic solution 0.3%
- Volunteers
- 96 people
- Sponsor
- Daiichi Sankyo
Acute Otitis Media
A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea
The purpose of this study is to determine if an otic formulation is safe and effective in treating peri-operative tube otorrhea.
- Trial name
- NCT00578773
- Testing
- Moxidex otic solution, Moxifloxacin otic solution, Tympanostomy tubes
- Volunteers
- 303 people
- Sponsor
- Alcon Research
Otitis Media
inVENT-visIOn Study
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TDS) for the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis in an…
- Trial name
- inVENT-visIOn (NCT01444391)
- Testing
- Tympanostomy tube placement (Acclarent iontophoresis device)
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Integra LifeSciences Corporation
Infections, Streptococcal
Study to Characterize and Identify Bacteria Causing Acute Otitis Media in Young Egyptian Children
The purpose of this epidemiological study is to identify and characterize the bacteria causing Acute Otitis Media episodes in children aged >= 3 months to < 5 years in Egypt.
- Trial name
- NCT01160055
- Testing
- Middle ear fluid and urine.
- Sponsor
- GlaxoSmithKline
Otitis Media
Clinical Evaluation of the OtoSight
The objective of this study is to evaluate the imaging capabilities and image analysis performance of the OtoSight Middle Ear Scope in pediatric patients undergoing tympanostomy tube placement for otitis media.
- Trial name
- NCT03890107
- Testing
- OtoSight Middle Ear Scope
- Where
- 2 sites in United States
- Volunteers
- 110 people
- Sponsor
- PhotoniCare, Inc.
Acute Otitis Media
Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media
Children ages 2 months to less than 19 years old, who have been diagnosed with a middle ear infection may receive either medicated ear drops (AR01) or glycerin (placebo) ear drops.
- Trial name
- AR01006 (NCT02044341)
- Testing
- AR01, Glycerin ear drops
- Where
- 29 sites in United States
- Volunteers
- 304 people
- Sponsor
- Arbor Pharmaceuticals, Inc.
Pain, Acute Otitis Media
Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Presenting With Acute Otitis Media
To assess the clinical safety and efficacy of the Benzocaine relative to placebo in pain relief associated with acute otitis media.
- Trial name
- NCT02092454
- Testing
- Benzocaine
- Where
- 3 sites in United States
- Volunteers
- 65 people
- Sponsor
- Otic Therapy, LLC
Chronic Otitis Media
Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis Media Who Had a Middle Ear Surgery
The objective of this multicentre study is to evaluate the standard of care of participants diagnosed with Chronic Otitis Media that have already gone through a first middle ear surgery but still have at least a moderate hearing…
- Trial name
- NCT04864912
- Testing
- Questionnaires and survey
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 69 people
- Sponsor
- Cochlear
Acute Otitis Media, Chronic Otitis Media
Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus
This is a non-randomized, multicenter, prospective, clinical study intended to evaluate the effectiveness of a method for iontophoretic delivery of a buffered lidocaine/epinephrine solution for provision of tympanic membrane…
- Conditions
- Acute Otitis Media, Chronic Otitis Media, Recurrent Acute Otitis Media
- Trial name
- IONTO (NCT00941993)
- Testing
- Iontophoresis System (Acclarent)
- Where
- United States
- Volunteers
- 109 people
- Sponsor
- Integra LifeSciences Corporation
Otitis Media
Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery
The purpose of this study is to describe the pharmacokinetics of AL-60371 otic suspension following two posologies of bilateral ototopical doses in pediatric subjects immediately after bilateral tympanostomy tube surgery.
- Trial name
- NCT01908764
- Testing
- AL-60371 otic suspension
- Sponsor
- Alcon Research
Otitis Media
Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media
Describe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media
- Trial name
- NCT00768534
- Where
- Germany
- Volunteers
- 2,138 people
- Sponsor
- Pfizer
Acute Otitis Media, AOMT
Open-Label Study of OTO-201 for Treatment of AOMT
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT).
- Trial name
- NCT02408796
- Testing
- OTO-201
- Where
- 5 sites in United States
- Volunteers
- 39 people
- Sponsor
- Otonomy, Inc.
Acute Otitis Media (AOM)
Safety and Efficacy of wSp Vaccine in Young Children
The goal of this clinical trial is to evaluate whether the wSp vaccine can prevent nasopharyngeal colonization by pneumococcal bacteria in healthy young children who have received routine PCV15 or PCV20 vaccination.
- Trial name
- wSp005 (NCT07216430)
- Testing
- wSp vaccine, Saline (0.9% NaCl)
- Where
- 7 sites in United States
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Serum Life Science Europe GmbH
Chronic Suppurative Otitis Media
Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media
Objective To observe the safety and tolerability of Pazufloxacin Mesylate Ear Drops of different concentrations in patients with simple chronic suppurative otitis media.
- Trial name
- NCT03675841
- Testing
- Pazufloxacin Mesilate ear drops
- Where
- China
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Lee's Pharmaceutical Limited
Acute Otitis Media
Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
The purpose of this study is to determine if the combination of DF289 plus DF277 is safe and effective in treating middle ear infections in children with ear tubes.
- Trial name
- NCT01395966
- Testing
- DF289, DF277, DF289 plus DF277
- Where
- Spain
- Volunteers
- 331 people
- Sponsor
- Salvat
Acute Otitis Externa
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
The 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).
- Trial name
- NCT01535599
- Testing
- AL-60371, 0.3% Otic Suspension, AL-60371 Vehicle
- Volunteers
- 768 people
- Sponsor
- Alcon Research
Infections, Streptococcal
A Study to Compare the Immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose Presentation to the Licensed 1-dose Synflorix™ (10Pn-PD-DiT) Vaccine When Co-administered With DTPw-combination Vaccine in Healthy Infants
The primary aim of the study is to demonstrate that an investigational 4-dose presentation of the 10Pn-PD-DiT vaccine with preservative is non-inferior to the licensed presentation of Synflorix (preservative-free) in terms of…
- Trial name
- NCT02447432
- Testing
- Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (4-dose presentation), Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (1-dose presentation), DTPw-HBV/Hib
- Where
- Bangladesh
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hunter Syndrome
An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients
The objective of this study is to evaluate the effect of anti-idursulfase antibodies on idursulfase safety (measured by infusion related adverse events) between patients who develop anti-idursulfase antibodies and patients who do…
- Trial name
- NCT00882921
- Testing
- Idursulfase
- Where
- 6 sites in United States, Brazil and 1 more
- Volunteers
- 26 people
- Sponsor
- Shire