What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Topical antibiotics like Floxin (ofloxacin) used for ear infections can cause side effects such as ear discomfort, itching, or a bitter taste. Oral antibiotics commonly used for ear infections, such as amoxicillin-clavulanate, may cause gastrointestinal issues like diarrhea, nausea, and vomiting, as well as skin rashes. Azithromycin, another oral antibiotic, can also cause gastrointestinal disturbances and, less commonly, allergic reactions such as skin eruptions.

What prior FDA approvals exist?

The FDA has approved several topical antibiotics for the treatment of ear infections, including ofloxacin (Floxin) and ciprofloxacin. These medications are used to reduce infection and inflammation in conditions such as acute otitis media and chronic suppurative otitis media. Ofloxacin is often used post-tympanostomy tube surgery to prevent otorrhea and tympanostomy tube occlusion. Ciprofloxacin, another commonly used topical antibiotic, has been compared to placebo in clinical trials and shown to be effective in managing ear infections. These treatments are part of a broader range of antibiotics, including amoxicillin/clavulanate and azithromycin, which are also used to treat ear infections but are administered orally.

What other types of research exist?

Promising alternatives to Floxin for ear infection treatment in 2024 include topical ciprofloxacin, topical gentamicin, and Triz-EDTA as an adjunctive treatment. Emerging therapies and new surgical techniques are also being explored for recurrent acute otitis media.

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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 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

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

0 / 5Eligibility criteria met

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.