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Ear drops after tube surgery: do they prevent blockage?

NCT ID NCT03655665

Disease control Sponsor: Boston Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 4 times

Summary

This study looked at whether using antibiotic ear drops during and after ear tube surgery reduces the chance of tube blockage or ear drainage in children. Only 9 children took part, and each child received drops in one ear but not the other. The study was stopped early, so the findings are not conclusive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ofloxacin otic solution (Floxin Otic)
What this could lead to
If it works, this could point toward a simple way to prevent ear tube blockage and drainage after surgery in children.
What could go wrong
This was a very small, early study that was terminated early, so results are limited and may not apply to all children. The drops may cause irritation or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

9 people

The number who actually took part.

Started

May 2019

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 10 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant has a history of Eustachian tube dysfunction (ETD) or recurrent acute otitis media (AOM) requiring surgery for bilateral TT placement * Participant's caregiver understands the protocol and is willing to comply with the protocol * Children ages 6 months to 10 years undergoing surgery for bilateral tympanostomy tube placement without middle ear fluid on the day of their surgery Exclusion Criteria: * Participant is having concomitant procedures performed at the time of their tympanostomy tube surgery (i.ei.e. adenoidectomy, airway endoscopy, nasal cautery). * Historyof conductive hearing loss, as determined from their last audiogram prior to tympanostomy tube procedure * Middle ear effusion present in either their left or right ear on the day of tympanostomy tube surgery * Current diagnosis of craniofacial abnormalities, Trisomy 21, primary ciliary dyskinesia, cystic fibrosis * History of a known immunodeficiency disease

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Conditions

The condition(s) this trial relates to.

eustachian tube disorder otitis media otitis media, susceptibility to

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Otitis media

Contacts and locations

Locations

  • Boston Children's Hospital at Waltham

    Waltham, Massachusetts, 02453, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.