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NCT03655665 · ClinicalTrials.gov registry record · Phase 4
Does Topical Otic Drop Use at Time of Tympanostomy Tube Surgery Improve Outcomes When no Middle Ear Effusion is Present
A Phase 4 study of Otitis Media, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 125
- Enrollment target
- 1
- Study location
NCT03655665: Recruiting Phase 4 study of Otitis Media, sponsored by Boston Children's Hospital.
NCT03655665 is a Phase 4 study of Otitis Media that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 125 participants, below the 4,335-participant average among 14 other Otitis Media trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03655665, a Phase 4 study of Otitis Media, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 125 participants
- Enrollment target
- 1
- Study location
Study Summary
To determine whether the use of topical otic drops intra-operative and post-operative during tympanostomy tube placement reduces the rate of tympanostomy tube occlusion and post-operative otorrhea (ear drainage) during the initial 4-week post-operative period in subjects with no middle ear effusion (fluid behind the ear drum) present at the time of surgery. A within subject controlled study design will be utilized to study this effect. Subjects with absent middle ear effusion who are receiving tympanostomy tube placement will receive a standard protocol of Floxin topical drops during surgery and after surgery in one ear. Selection of ear (right ear or left ear) will be randomized. The primary measured outcome will be the rate of tympanostomy tube occlusion within first 4 weeks postoperatively. The secondary measured outcome is the rate of tympanostomy tube otorrhea (drainage) within first 4 weeks postoperatively.
Primary Outcome
Any non-"large volume" ear canal volume (less than 1.00cc volume) measurement at 4 week visit, in conjunction with physical examination notable for occluded TT, would be consistent with tube occlusion.
Conditions Studied
Interventions
- DRUG Ofloxacin otic solution
Study Locations (1)
Massachusetts
- Boston Children's Hospital at Waltham - Waltham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2019-05-16 |
| Est. Completion | 2026-09 |
| Phase | Phase 4 |
What NCT03655665 shows while recruiting
NCT03655665 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 4,335-participant average among 14 other Otitis Media trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Otitis Media appearing as the primary indexed condition, and to 1 intervention - of which Ofloxacin otic solution is the first listed.
NCT03655665 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03655665 about?
NCT03655665 is a clinical study titled "Does Topical Otic Drop Use at Time of Tympanostomy Tube Surgery Improve Outcomes When no Middle Ear Effusion is Present". To determine whether the use of topical otic drops intra-operative and post-operative during tympanostomy tube placement reduces the rate of tympanostomy tube occlusion and post-operative otorrhea (ear drainage) during the initial 4-week post-operative period in subjects with no middle ear effusion ...
What is the current status of trial NCT03655665?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 125 participants. The study started on 2019-05-16. Estimated completion is 2026-09.
What conditions does trial NCT03655665 study?
This clinical trial studies the following conditions: Otitis Media.
What interventions are being tested in trial NCT03655665?
The interventions under investigation include: Ofloxacin otic solution (DRUG).
Who is sponsoring clinical trial NCT03655665?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03655665 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Otitis Media
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03655665's enrollment target sits among peer trials
125 9th of 14 higher than 6 of 14 other Otitis Media trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Otitis Media trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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