Does Topical Otic Drop Use at Time of Tympanostomy Tube Surgery Improve Outcomes When no Middle Ear Effusion is Present
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03655665|
Recruitment Status : Not yet recruiting
First Posted : August 31, 2018
Last Update Posted : October 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Otitis Media||Drug: Ofloxacin otic solution||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Clinical effectiveness model. Each subject will serve as their own control. Subject's ears will be randomized.|
|Masking:||None (Open Label)|
|Official Title:||Does the Use of Topical Otic Drops at the Time of Tympanostomy Tube Placement Improve Outcomes When no Middle Ear Effusion is Present at the Time of Surgery|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2022|
Experimental: Treatment Ear
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.
Drug: Ofloxacin otic solution
Three drops of ofloxacin otic 0.3%. intra and post-operatively for 3 days post-surgery on one ear.
Other Name: Floxin Otic
No Intervention: No 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.
- Percentage of patients with tympanostomy tube occlusion [ Time Frame: 0-35 days post-op ]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.
- Percentage of patients with otorrhea (drainage from the ear) [ Time Frame: 0-35 days post-op ]Any drainage of liquid from the ear. Can be clear, bloody, or purulent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655665
|Contact: Kenneth R. Whittemore, MD, MS||(617)-355-2880||Kenneth.Whittemore@childrens.harvard.edu|
|Contact: Brian Boudreau, PA-C||(617)-355-2880||Brian.Boudreau@childrens.harvard.edu|
|Principal Investigator:||Kenneth R. Whittemore, MD, MS||Boston Children’s Hospital|