Trial Outcomes & Findings for Does Topical Otic Drop Use at Time of Tympanostomy Tube Surgery Improve Outcomes When no Middle Ear Effusion is Present (NCT NCT03655665)
NCT ID: NCT03655665
Last Updated: 2026-08-19
Results Overview
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.
TERMINATED
PHASE4
9 participants
0-35 days post-op
2026-08-19
Participant Flow
Unit of analysis: Ear
Participant milestones
| Measure |
All Study Participants
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.
Ofloxacin otic solution: Three drops of ofloxacin otic 0.3%. intra and post-operatively for 3 days post-surgery on one ear.
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|---|---|
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Overall Study
STARTED
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9 9
|
|
Overall Study
Treatment Ear
|
9 9
|
|
Overall Study
No Treatment Ear
|
9 9
|
|
Overall Study
COMPLETED
|
9 9
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=9 Participants
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.
Ofloxacin otic solution: Three drops of ofloxacin otic 0.3%. intra and post-operatively for 3 days post-surgery on one ear.
|
|---|---|
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Age, Categorical
<=18 years
|
9 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
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0 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
|
Age, Continuous
|
2.34 years
n=9 Participants
|
|
Sex: Female, Male
Female
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4 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
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5 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 0-35 days post-opPopulation: None of the ears analyzed were found to have tube occlusion at the time of follow up visit.
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.
Outcome measures
| Measure |
Treatment Ear
n=9 Participants
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.
Ofloxacin otic solution: Three drops of ofloxacin otic 0.3%. intra and post-operatively for 3 days post-surgery on one ear.
|
No Intervention
n=9 Participants
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.
|
|---|---|---|
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Percentage of Patients With Tympanostomy Tube Occlusion
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0-35 days post-opAny drainage of liquid from the ear. Can be clear, bloody, or purulent
Outcome measures
| Measure |
Treatment Ear
n=9 Participants
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.
Ofloxacin otic solution: Three drops of ofloxacin otic 0.3%. intra and post-operatively for 3 days post-surgery on one ear.
|
No Intervention
n=9 Participants
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.
|
|---|---|---|
|
Percentage of Patients With Otorrhea (Drainage From the Ear)
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0 Participants
|
0 Participants
|
Adverse Events
Treatment Ear
No Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place