NCT03119181

Study to Compare Active Tymbion Iontophoresis to Sham Tymbion Iontophoresis for Anesthesia of the Tympanic Membrane

A Prospective, Multicenter Study to Evaluate Effectiveness and Safety of Tymbion Iontophoresis and Tympanostomy Tube Placement Using the Tula Iontophoresis and Tube Delivery Systems for Adults in an Office Setting

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Tusker Medical · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A prospective, multicenter study to determine if active Tymbion iontophoresis is superior to sham Tymbion iontophoresis in providing anesthesia to the tympanic membrane (TM). The study will use the Tula iontophoresis systems for healthy adult volunteers in an office setting, called Group A of Protocol CPR007003. The protocol CPR007003 also includes a Group B study described in a separate Registration (NCT03197558).

Detailed description

The objective of the study is to determine if active Tymbion iontophoresis is superior to sham Tymbion iontophoresis in providing anesthesia to the tympanic membrane. In addition, safety will be evaluated by review of the occurrence of adverse events. The iontophoresis system (IPS) will be used to facilitate anesthetic delivery to the tympanic membrane (TM). The lidocaine-based solution used for local anesthesia of the TM is Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine). Group A will consist of 40 evaluable healthy adult subjects randomized (1:1) to receive unilateral treatment (1 ear) with either active Tymbion iontophoresis or sham Tymbion iontophoresis. The sham iontophoresis procedure will be identical to the active Tymbion iontophoresis, with the exception that the iontophoresis current will not be activated (ie, the same drug solution will be applied to ears in both arms). After the completion of the iontophoresis procedure, the tympanic membrane will be tapped with a dull otologic probe to test the level of anesthesia. The subject will rate the level of pain using the Visual Analogue Scale (VAS) immediately after the tap. Investigators and subjects will be blinded to treatment assignment. Safety assessments will be done post procedure and at follow as applicable.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Tymbion Lidocaine/epinephrine solution	The external ear canal will be filled with Tymbion drug solution
COMBINATION_PRODUCT	Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solution	The external ear canal will be filled with Tymbion drug solution. The Iontophoresis System (IPS) will be used to deliver current to the Tymbion solution to facilitate drug penetration into the tympanic membrane (TM) tissue to anesthetize (numb) the TM

Timeline

• Start date: 2017-04-27
• Primary completion: 2017-05-11
• Completion: 2017-05-11
• First posted: 2017-04-18
• Last updated: 2020-01-18
• Results posted: 2020-01-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study