Ofloxacin Otic Drops for Ear Infection

Overseen By Brian Boudreau, PA-C

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Boston Children's Hospital

Disqualifiers: Concomitant procedures, Conductive hearing loss, Craniofacial abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3 days

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether using ofloxacin ear drops (Floxin Otic) during and after ear tube surgery can prevent blockages and drainage in the weeks following the procedure. It focuses on children receiving ear tubes due to frequent ear infections or Eustachian tube problems, without fluid behind their eardrums at the time of surgery. One ear will receive the drops, while the other will not, to determine any differences. Children aged 6 months to 10 years undergoing surgery for ear tubes without fluid in their ears are suitable candidates for this trial. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand its benefits for more patients.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What is the safety track record for Ofloxacin otic solution?

Research shows that ofloxacin ear drops are generally safe and effective for treating ear infections. Studies have found them safe for children aged six months and older. This treatment has been used successfully for conditions like swimmer's ear without major issues.

Most side effects are mild, such as itching or discomfort in the ear, and serious side effects are rare. The FDA has approved this treatment for ear infections, indicating a strong safety record. While this trial examines a new use, existing evidence supports its safety in similar situations. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about ofloxacin otic drops for treating ear infections because they offer a focused delivery method directly to the site of infection. Unlike systemic antibiotics, which treat infections throughout the body, ofloxacin drops target the bacteria in the ear, potentially reducing side effects and enhancing effectiveness. Additionally, these drops can be administered quickly and easily post-surgery, providing a convenient option for patients who need rapid relief. This direct approach could mean faster recovery times compared to traditional oral antibiotics.

What is the effectiveness track record for Ofloxacin otic solution in reducing tympanostomy tube occlusion and otorrhea?

Research has shown that ofloxacin ear drops effectively treat ear infections. In this trial, participants will receive ofloxacin otic solution in one ear, while the other ear will serve as a control with no intervention. A previous study demonstrated that ofloxacin 0.3% solution improved the overall cure rate and resolved symptoms like ear drainage and ear pain. Another study found that using ofloxacin drops once a day for a week effectively cured outer ear infections. Ofloxacin is well-tolerated and has successfully treated infections even in patients with ear tubes. Overall, ofloxacin ear drops have proven effective for treating ear infections, making them a reliable option for managing symptoms after surgery. ^{2 6 7 8 9}

Who Is on the Research Team?

Kenneth R. Whittemore, MD, MS

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Participant's caregiver understands the protocol and is willing to comply with the protocol

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

My child, aged 6 months to 10 years, is having ear tube surgery without any ear fluid.

Exclusion Criteria

I have had hearing loss that affects how sound travels to my inner ear.

I have been diagnosed with a craniofacial abnormality, Trisomy 21, primary ciliary dyskinesia, or cystic fibrosis.

I am having additional procedures along with my ear tube surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 drops of ofloxacin otic solution intra- and post-operatively 3 times per day for 3 days in one ear

3 days

Intra-operative and post-operative administration

Follow-up

Participants are monitored for tympanostomy tube occlusion and otorrhea at a 4-week follow-up appointment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ofloxacin otic solution

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Ear Experimental Treatment 1 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 Intervention Active Control 1 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.

Ofloxacin otic solution is already approved in United States, European Union for the following indications:

Approved in United States as Floxin Otic for:

• Acute purulent otorrhea in children with tympanostomy tubes

Approved in European Union as Ofloxacin otic solution for:

• Treatment of acute otitis externa and chronic suppurative otitis media with perforation of the tympanic membrane

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

Ofloxacin eardrops effectively eradicated most bacterial pathogens in patients with chronic suppurative otitis media before surgery, with 86% of patients in the 10-minute treatment group and 85% in the 3-minute treatment group testing culture negative for bacteria.

Despite the successful eradication of bacteria, the study found no significant improvement in the surgical success rates of tympanoplasty, as the rates of intact tympanic membranes were similar across all treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative topical ofloxacin solution for tympanoplasty: a randomized, controlled study. Tong, MC., Yue, V., Ku, PK., et al.[2019]

Ofloxacin otic solution is as effective as Cortisporin in treating otitis externa, with cure rates of 82% in adults and 97% in children for ofloxacin, compared to 84% in adults and 95% in children for Cortisporin.

Both treatments showed similar safety profiles, with no significant differences in adverse events or treatment outcomes between the two groups, indicating that ofloxacin can be a viable alternative to Cortisporin for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ofloxacin otic solution for treatment of otitis externa in children and adults. Jones, RN., Milazzo, J., Seidlin, M.[2019]

In a study involving 278 pediatric patients with otitis externa, once-daily ofloxacin otic solution (0.3%) was found to be as effective as the four-times-daily neomycin sulfate/polymyxin B sulfate/hydrocortisone otic suspension, with cure rates of 93.8% and 94.7%, respectively.

Ofloxacin treatment not only provided similar pain relief but also avoided the risk of ototoxicity associated with neomycin, making it a safer option for treating ear infections in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-daily ofloxacin otic solution versus neomycin sulfate/polymyxin B sulfate/hydrocortisone otic suspension four times a day: a multicenter, randomized, evaluator-blinded trial to compare the efficacy, safety, and pain relief in pediatric patients with otitis externa. Schwartz, RH.[2018]

In a multicenter study involving children under 12 with acute otorrhea and tympanostomy tubes, ofloxacin otic solution demonstrated a cure rate of 84.4%, significantly higher than the 64.2% and 70% cure rates from historical and current practice treatments, respectively.

Ofloxacin was found to be safe, with only 12.8% of treated subjects experiencing adverse events, and it effectively eradicated 96.3% of baseline pathogens in microbiologically evaluable cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical ofloxacin treatment of otorrhea in children with tympanostomy tubes. Dohar, JE., Garner, ET., Nielsen, RW., et al.[2019]

In a study of 56 patients with active chronic suppurative otitis media, those treated with 0.3% ofloxacin eardrops showed a significantly higher success rate, with 76% achieving dry ears after one week compared to only 26% in the Augmentin group.

The results indicate that ofloxacin eardrops are an effective treatment option for this condition, outperforming the standard antibiotic treatment in achieving ear dryness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ofloxacin eardrop treatment for active chronic suppurative otitis media: prospective randomized study. Yuen, PW., Lau, SK., Chau, PY., et al.[2013]

In a study using albino guinea pigs, both Ofloxacin and Fosfomycin sodium ear drops did not show significant ototoxicity, as measured by changes in compound action potentials (CAP) after application.

Even after seven consecutive days of administration, there were no lasting effects on hearing thresholds, indicating that these ear drops are safe for use in the middle ear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of ofloxacin (OFLX) and fosfomycin sodium (FOM) ear drops. Yamano, T., Morizono, T., Shiraishi, K., et al.[2013]

Ofloxacin otic solution 0.3% is highly effective in treating ear infections like otitis externa and chronic suppurative otitis media, with eradication rates ranging from 83.3% to 100% for common pathogens.

The treatment is well tolerated with minimal adverse effects and has not been associated with ototoxicity, making it a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A benefit-risk assessment of ofloxacin otic solution in ear infection. Wai, TK., Tong, MC.[2022]

Ofloxacin otic solution (0.3%) was found to be significantly more effective than other topical or systemic antibiotics for treating suppurative otitis media, with a higher overall cure rate and better resolution of symptoms like otorrhea and otalgia, based on a review of 11 clinical trials involving 1,484 participants.

The use of ofloxacin otic solution was associated with a lower incidence of adverse events compared to other topical antibiotics, indicating it is a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the effectiveness of ofloxaxin otic solution for the treatment of suppurative otitis media. Abes, G., Espallardo, N., Tong, M., et al.[2018]

Ofloxacin otic solution 0.3% is highly effective for treating ear infections, showing clinical cure rates over 80% for otitis externa and comparable efficacy to oral antibiotics for otitis media in children with tympanostomy tubes.

This treatment is well tolerated with minimal systemic absorption, resulting in low adverse event rates, and it is not associated with ototoxicity, making it a safer option for patients with non-intact tympanic membranes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ofloxacin otic solution: a review of its use in the management of ear infections. Simpson, KL., Markham, A.[2018]

Ofloxacin otic is equally effective as other treatments, such as polymyxin/neomycin plus hydrocortisone and ciprofloxacin otic, in curing otitis externa in children under 12 years old.

Ofloxacin otic is safer due to its lack of ototoxicity, making it a suitable choice for patients who may have undiagnosed tympanic membrane perforations, and its less frequent dosing may improve patient adherence and cure rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of ofloxacin and other otic preparations for otitis externa. Ruben, RJ.[2019]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK69645/

A systematic review of the effectiveness of ofloxaxin otic ... Subgroup analysis showed that 0.3% ofloxacin otic solution showed better results in terms of overall cure rate, resolution of otorrhea, otalgia, bacterial ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149291804901762

Efficacy of ofloxacin otic solution once daily for 7 days in ... Ofloxacin otic 0.3% solution administered once daily for 7 days was well tolerated and effective in achieving clinical and microbiologic cure of OE.

3. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/509179

Ofloxacin Otic Solution in Patients With Otitis Media This article reports the results of a study measuring the concentrations of ofloxacin in otorrhea, serum, and middle ear mucosa in patients with chronic ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15336469/

Efficacy of ofloxacin otic solution once daily for 7 days in ... Ofloxacin otic 0.3% solution administered once daily for 7 days was well tolerated and effective in achieving clinical and microbiologic cure of OE.

5. mayoclinic.org mayoclinic.org/drugs-supplements/ofloxacin-otic-route/description/drg-20065162

Ofloxacin (otic route) - Side effects & dosage Ofloxacin otic solution is used to treat infections of the ear canal. It also is used to treat infections of the middle ear in patients with nonintact tympanic ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2003/20799se2-006_floxin_lbl.pdf

FLOXIN® Otic (ofloxacin otic solution 0.3%) - accessdata.fda.gov Otitis Externa: The recommended dosage regimen for the treatment of otitis externa is: For pediatric patients (from 6 months to 13 years old): Five drops (0.25 ...

7. webmd.com webmd.com/drugs/2/drug-5488/ofloxacin-otic-ear/details

Ofloxacin otic (Floxin) - Uses, Side Effects, and More Ofloxacin otic is commonly used to treat the following types of ear infections caused by certain bacteria. Otitis externa (swimmer's ear), ...

8. reference.medscape.com reference.medscape.com/drug/floxin-oflaxacin-otic-343650

Floxin Otic, Oflaxacin Otic (ofloxacin otic) dosing, ... ... otic solution. 0.3%. <1 year old: Safety & efficacy not established. Otitis Externa. < 6 months. Safety and efficacy not established. 6 months to 12 years.

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2005/020799s016lbl.pdf

FLOXIN® Otic - accessdata.fda.gov Pediatric Use: Safety and efficacy have been demonstrated in pediatric patients of the following ages for the listed indications: • six months and older: otitis ...