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Anti-bacterial

Ofloxacin Otic Drops for Ear Infection

Phase 4

Recruiting

Led By Kenneth R. Whittemore, MD, MS

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant has a history of Eustachian tube dysfunction (ETD) or recurrent acute otitis media (AOM) requiring surgery for bilateral TT placement

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-35 days post-op

Awards & highlights

Study Summary

This trial studies whether using drops in the ear during and after a tympanostomy tube procedure reduces tube blockage and drainage in the first 4 weeks.

Who is the study for?

This trial is for children aged 6 months to 10 years with a history of Eustachian tube dysfunction or recurrent ear infections needing ear tube surgery, without fluid behind the eardrum on surgery day. Caregivers must understand and follow the study rules. Kids can't join if they're having other procedures like adenoidectomy at the same time, have conductive hearing loss, craniofacial abnormalities, Trisomy 21, primary ciliary dyskinesia, cystic fibrosis or immunodeficiency.Check my eligibility

What is being tested?

The study tests if using Ofloxacin otic drops during and after ear tube surgery helps prevent blockage and drainage from the tubes in kids without middle ear fluid. Each child's one ear gets treated randomly while the other serves as control. The main focus is checking for any blockages or drainage within four weeks post-surgery.See study design

What are the potential side effects?

Potential side effects of Ofloxacin otic solution may include local irritation or itching inside the ear, dizziness, rash around the ear; rarely allergic reactions might occur. Generally considered safe with minimal systemic absorption.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had ear problems that needed surgery for tubes in both ears.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-35 days post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-35 days post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-35 days post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tympanostomy

Secondary outcome measures

Percentage of patients with otorrhea (drainage from the ear)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment EarExperimental Treatment1 Intervention

Participants will serve their own control. Participants will receive 3 drops of ofloxacin otic solution intra- and post-operatively 3 times per day for 3 days in ONE ear. Ear sidedness will be randomized by participant.

Group II: No InterventionActive Control1 Intervention

Participants will serve their own control. Participants will receive no intervention in the ear contralateral to the treated ear. Ear sidedness will be randomized by participant.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ofloxacin

FDA approved

0 / 1Eligibility criteria met