Otiprio Versus Ciprodex Tympanostomy Tube Outcomes

NCT03347461 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: H-37078
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Otorrhea; Otitis Media With Effusion in Children

Keywords

Tympanostomy tube placement; Otiprio; Ciprodex drops; Ear drops; Middle ear

Outcome Measures

Primary Outcomes (2)

• Post operative otorrhea

  Otorrhea is drainage from the ear. Evaluation will be performed by a blind assessor via otoscopy.

  Post operative visit 2-4 weeks after tube placement

• 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.

  Post operative visit 2-4 weeks after tube placement

Secondary Outcomes (1)

• Resolution of effusion post operatively

  Post operative visit 2-4 weeks after tube placement

Study Arms (3)

Otiprio by surgeon

EXPERIMENTAL

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

Drug: Otiprio

Ciprodex by surgeon

ACTIVE COMPARATOR

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

Drug: Ciprodex

Ciprodex by surgeon and parent

ACTIVE COMPARATOR

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.

Drug: Ciprodex

Interventions

Otiprio DRUG

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.

Also known as: ciprofloxacin otic suspension

Otiprio by surgeon

Ciprodex DRUG

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

Also known as: ciprofloxacin and dexamethasone

Ciprodex by surgeon; Ciprodex by surgeon and parent

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Interventions

Ciprofloxacin; Dexamethasone

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Peter Weber, MD

  Boston Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 20, 2017
• Study Start: October 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: September 14, 2018

Record last verified: 2018-09

Locations

US (1)