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Otiprio Versus Ciprodex Tympanostomy Tube Outcomes

Primary Purpose

Otorrhea, Otitis Media With Effusion in Children

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Otiprio
Ciprodex
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otorrhea focused on measuring Tympanostomy tube placement, Otiprio, Ciprodex drops, Ear drops, Middle ear

Eligibility Criteria

6 Months - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children (6 months to 10 years)
  • Clinical diagnosis of bilateral middle ear effusion or recurrent acute otitis media requiring tympanostomy tube placement

Exclusion Criteria:

  • Patient having any other concurrent surgery
  • History of mastoid surgery, chronic or recurrent bacterial infections
  • Tympanic membrane perforations
  • History of immunodeficiency disease
  • Abnormalities of the tympanic membrane or middle ear
  • Otic or systemic corticosteroid within 7 days of surgery
  • Topical or systemic antimicrobials or antifungal agents prior to their particular washout intervals
  • Concurrent use of anti-inflammatory agents
  • Allergy to the medications used in this study and their components
  • Menarcheal or postmenarcheal female.

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Otiprio by surgeon

Ciprodex by surgeon

Ciprodex by surgeon and parent

Arm Description

Otiprio will be administered through the tympanic membrane by the otolaryngologist immediately after tympanostomy placement.

Ciprodex drops will be instilled by the otolaryngologist into the affected ear immediately after tympanostomy surgery.

Ciprodex drops will be instilled by the otolaryngologist into the ear immediately after tympanostomy tube surgery. The parent or guardian will administer Ciprodex drops into the ears twice daily for five days after surgery.

Outcomes

Primary Outcome Measures

Post operative otorrhea
Otorrhea is drainage from the ear. Evaluation will be performed by a blind assessor via otoscopy.
Tympanostomy tube blockage
Tympanostomy tube blockage is when the placed tube becomes clogged or obstructed. Evaluation will be performed by a blind assessor via otoscopy.

Secondary Outcome Measures

Resolution of effusion post operatively
Effusion is the presence of middle ear fluid. Evaluation will be performed by a blind assessor via otoscopy.

Full Information

First Posted
November 16, 2017
Last Updated
September 12, 2018
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03347461
Brief Title
Otiprio Versus Ciprodex Tympanostomy Tube Outcomes
Official Title
Otiprio Versus Ciprodex to Reduce Tympanostomy Tube Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Low use of Otiprio among otolaryngologists.
Study Start Date
October 2018 (Anticipated)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Otolaryngologists routinely administer ear drops at the time of tympanostomy tube placement in order to prevent tube otorrhea; however, there is a lack of consensus as to which drops are the most effective, and whether a post-operative regimen should be used. Utilizing drops postoperatively places the onus of administration on parents who may have various difficulties in delivering the drops to their child's ears. Additionally, prescribing drops postoperatively is a health care cost. The purpose of this study is to determine if there is a difference in prevention of tympanostomy tube failure (defined as tube blockage or otorrhea) between Otiprio administered once intraoperatively, Ciprodex otic dropgs administered once intraoperatively, and Ciprodex otic drops administered intraoperatively with a postoperative course.
Detailed Description
Tympanostomy tube placement is indicated in children with recurrent acute otitis media or chronic otitis media with effusion. Ear dishcarge, otorrhea, is the most common complication following tympanostomy tube placement and occurs in up to 25% of patients. Otorrhea can lead to tube obstruction, making the tube ineffective in ventilating the middle ear or improving hearing. Otolaryngologists routinely administer ear drops at the time of tympanostomy tube placement in order to prevent otorrhea and tube blockage; however, there is lack of consensus as to which drops are the most effective and what dosing regimen should be used. Options for prevention of otorrhea and tympanostomy tube blockage include intraoperative single-dose application of topical drops or postoperative prolonged application of topical drops. One issue with the prolonged application of drops after surgery is the requirement of parents to administer the drops at home. Thus, the delivery of medication to the middle ear is variable given the difficulty of administering ear drops to a child. Another option exists as a one-time application at the time of surgery, but provides an extended duration of medication in the middle ear. Otiprio is a single-dose suspension of ciprofloxacin and has been FDA approved since February 2015 for use in pediatric patients with otitis media with effusion who require tympanostomy tube placement. Otiprio exists as a liquid at or below room temperature and transitions into a gel after exposure to body temperature in the middle ear. Administrated as an injection into the middle ear at the time of tympanostomy tube placement, Otipiro slowly releases antibiotic treatment over the course of a week, eliminating the need for parents to administer drops. The study is a prospective, randomized (1:1:1), single-blind, trial of three treatment groups in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement. Approximately 300 subjects will be randomized: 100 randomized to receive Otiprio intraoperatively, 100 randomized to receive Ciprodex intraoperatively, and 100 randomized to receive Ciprodex intraoperatively with five days of Ciprodex drops postoperatively. All participants will undergo tympanostomy tube placement in the operating room as clinically indicated by an Otolaryngologist. Prior to the surgery, the patient will be randomized to one of the three trial arms. During the operation, the surgeon, who will be blinded until completion of tube placement as to which arm the participant is randomized, will administer Otiprio as a one-time intratympanic injection or Ciprodex, by administering 3-5 drops into each ear canal. For the trial arm that includes a 5 day course of Ciprodex postoperatively, the patient's parents will be instructed on how to administer the drops. As per standard of care, all participants will be assessed at a postoperative visit 2-4 weeks post surgery. A blinded assessor to the randomized study arm will perform otoscopy (ear exam) during that visit to determine if there is presence of otorrhea or tympanostomy tube blockage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otorrhea, Otitis Media With Effusion in Children
Keywords
Tympanostomy tube placement, Otiprio, Ciprodex drops, Ear drops, Middle ear

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Otiprio by surgeon
Arm Type
Experimental
Arm Description
Otiprio will be administered through the tympanic membrane by the otolaryngologist immediately after tympanostomy placement.
Arm Title
Ciprodex by surgeon
Arm Type
Active Comparator
Arm Description
Ciprodex drops will be instilled by the otolaryngologist into the affected ear immediately after tympanostomy surgery.
Arm Title
Ciprodex by surgeon and parent
Arm Type
Active Comparator
Arm Description
Ciprodex drops will be instilled by the otolaryngologist into the ear immediately after tympanostomy tube surgery. The parent or guardian will administer Ciprodex drops into the ears twice daily for five days after surgery.
Intervention Type
Drug
Intervention Name(s)
Otiprio
Other Intervention Name(s)
ciprofloxacin otic suspension
Intervention Description
Otiprio is a single-dose, physician-administered, sustained-exposure otic fluoroquinolone antibacterial for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement surgery. Otoprio (6% ciprofloxacin, 60 mg/mL) will be administered through the tube lumen by the otolaryngologist immediately after tympanostomy surgery.
Intervention Type
Drug
Intervention Name(s)
Ciprodex
Other Intervention Name(s)
ciprofloxacin and dexamethasone
Intervention Description
Ciprodex is a combined antibiotic and steroid ear drop used to treat otitis media with tympanostomy tubes. Four drops of Ciprodex (0.14mL) instilled by the otolaryngologist into the affected ear immediately after tympanostomy surgery. Each mL of Ciprodex contains ciprofloxacin hydrochloride 0.3 % (equivalent to 3 mg ciprofloxacin base) and dexamethasone 0.1 % equivalent to 1 mg dexamethasone
Primary Outcome Measure Information:
Title
Post operative otorrhea
Description
Otorrhea is drainage from the ear. Evaluation will be performed by a blind assessor via otoscopy.
Time Frame
Post operative visit 2-4 weeks after tube placement
Title
Tympanostomy tube blockage
Description
Tympanostomy tube blockage is when the placed tube becomes clogged or obstructed. Evaluation will be performed by a blind assessor via otoscopy.
Time Frame
Post operative visit 2-4 weeks after tube placement
Secondary Outcome Measure Information:
Title
Resolution of effusion post operatively
Description
Effusion is the presence of middle ear fluid. Evaluation will be performed by a blind assessor via otoscopy.
Time Frame
Post operative visit 2-4 weeks after tube placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children (6 months to 10 years) Clinical diagnosis of bilateral middle ear effusion or recurrent acute otitis media requiring tympanostomy tube placement Exclusion Criteria: Patient having any other concurrent surgery History of mastoid surgery, chronic or recurrent bacterial infections Tympanic membrane perforations History of immunodeficiency disease Abnormalities of the tympanic membrane or middle ear Otic or systemic corticosteroid within 7 days of surgery Topical or systemic antimicrobials or antifungal agents prior to their particular washout intervals Concurrent use of anti-inflammatory agents Allergy to the medications used in this study and their components Menarcheal or postmenarcheal female.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Weber, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Otiprio Versus Ciprodex Tympanostomy Tube Outcomes

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