Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)
Completed · Phase 1
Conditions studied: Otitis Media With Effusion in Children, Otitis Media Recurrent
In brief
The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects, immediately after bilateral tympanostomy tube surgery.
Key facts
- Study ID
- NCT02539654
- Run by
- Alcon Research
- People needed
- 14
- Starts
- 2015-11-17
- Expected to finish
- 2016-06-24
- Last updated by the study team
- 2018-08-07
Who can join
Age: 1 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and eligible for bilateral myringotomy and tympanostomy tube insertion;
- Legally Authorized Representative (LAR) must read and sign the informed consent;
- Parent or caregiver must agree to complete the required study visits and comply with the requirements of the study;
- Other protocol-specified inclusion criteria may apply.
You may not qualify if…
- Menarcheal females;
- Previous otologic or otologic-related surgery within the past 30 days or ongoing complications;
- Existing perforation of the eardrum;
- Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions which could interfere with evaluation of the study drug;
- Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study;
- Use of prohibited medications or inadequate washout of any medication including systemic and topical antibiotics, steroids and/or analgesics;
- Weighs less than 8 kg;
- Other protocol-specified exclusion criteria may apply.
Where it is running
- Contact Alcon Call Center for Trial Locations — Fort Worth, Texas, United States
Full record on ClinicalTrials.gov
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