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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
Must not have
History of conductive hearing loss, as determined from their last audiogram prior to tympanostomy tube procedure
Current diagnosis of craniofacial abnormalities, Trisomy 21, primary ciliary dyskinesia, cystic fibrosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-35 days post-op
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Approved for 5 Other Conditions

Summary

This trial tests if using Floxin ear drops can prevent complications like tube blockage and ear drainage in patients without fluid behind their eardrum. Ofloxacin ear drops have been used in previous studies to prevent postoperative blockage of tympanic ventilation tubes and infection.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had hearing loss that affects how sound travels to my inner ear.
Select...
I have been diagnosed with a craniofacial abnormality, Trisomy 21, primary ciliary dyskinesia, or cystic fibrosis.
Select...
I am having additional procedures along with my ear tube surgery.
Select...
I have fluid in my middle ear on the day of my ear tube surgery.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tympanostomy
Secondary study objectives
Percentage of patients with otorrhea (drainage from the ear)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Topical antibiotics, such as Floxin (ofloxacin), are commonly used to treat ear infections by directly targeting the bacteria causing the infection. These antibiotics work by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination. This leads to the death of the bacteria and resolution of the infection. The use of topical antibiotics is particularly important for ear infection patients as it delivers high concentrations of the drug directly to the site of infection, reducing systemic side effects and promoting faster relief of symptoms such as pain and inflammation.
Diagnostic accuracy and the observation option in acute otitis media: the Capital Region Otitis Project.

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
783 Previous Clinical Trials
5,581,156 Total Patients Enrolled
Kenneth R. Whittemore, MD, MSPrincipal InvestigatorBoston Children's Hospital

Media Library

Ofloxacin otic solution (Anti-bacterial) Clinical Trial Eligibility Overview. Trial Name: NCT03655665 — Phase 4
Ear Infection Research Study Groups: Treatment Ear, No Intervention
Ear Infection Clinical Trial 2023: Ofloxacin otic solution Highlights & Side Effects. Trial Name: NCT03655665 — Phase 4
Ofloxacin otic solution (Anti-bacterial) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03655665 — Phase 4
~19 spots leftby Nov 2025