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Topical Otic Drops for Tympanostomy Tube Placement Without Middle Ear Effusion
NCT03655665Phase 4
Key facts
- Status
- Terminated
- Start
- May 2019
- Primary completion
- Jun 2024
- Countries
- 1
- Sponsor
- Boston Children's Hospital
- Drugs
- ofloxacin
- Conditions
- otitis media
01
Overview
Phase 4, randomised, open-label trial of ofloxacin in otitis media (2 arms), sponsored by Boston Children's Hospital. Primary endpoint: Percentage of Patients With Tympanostomy Tube Occlusion at 35 days. Started May 2019; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Treatment Ear
Participants receive 3 drops of ofloxacin otic solution intra- and post-operatively 3 times per day for 3 days in ONE ear.
No Intervention
Participants receive no intervention in the ear contralateral to the treated ear.
03
Who it enrols
Children aged 6 months to 10 years with a history of Eustachian tube dysfunction or recurrent acute otitis media requiring bilateral tympanostomy tube placement, without middle ear fluid on the day of surgery.
04
Endpoints
Primary
Percentage of Patients With Tympanostomy Tube Occlusion
Secondary
Percentage of Patients With Otorrhea (Drainage From the Ear)
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