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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: Tymbion Lidocaine/epinephrine solution
* Combination Product: Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solution


Participation Criteria
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Eligibility Criteria
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Key Inclusion/Exclusion Criteria Inclusion Criteria Group A: Healthy adults, 18-50 years old Subject is able and willing to comply with the protocol and attend all study visits Subject is able and willing to provide informed consent Subjects with air conduction hearing thresholds of 25 dB HL or better at standard frequencies up to 2000 Hz, and 45 dB or better at 4000 Hz. Subject is able to read and understand English Exclusion Criteria Group A: Pregnant or lactating females. Prior ear iontophoresis procedure Subjects with conductive hearing loss. Subjects with history of sensitivity or allergic reaction to lidocaine HCl, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the anesthetic drug formulation. Familial history of insensitivity to lidocaine or other local anesthetics of the amide type. Significantly atrophic, retracted, bimeric, monomeric or atelectatic tympanic membrane. Perforated tympanic membrane. Subjects with known history of ear surgery or TM condition that has the potential to affect the sensitivity of the TM Otitis externa. Damaged/denuded skin in the auditory canal. Subjects with electrically sensitive support systems Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane. Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure. Other conditions that would preclude performing the study procedure including ear plug incompatibility. Health conditions that, in the opinion of the investigator, would present undue risk to the subject, based on device/anesthetic drug product label warnings and precautions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Tymbion Iontophoresis<br>Unilateral treatment with active iontophoresis of Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine) using the Tusker Medical Tula Iontophoresis System. | Combination Product: Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solution<br>* 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<br>* Other names: Tymbion;|
| Sham Comparator: Sham Tymbion Iontophoresis<br>The sham iontophoresis procedure will be identical to the active Tymbion iontophoresis in that Tymbion (2% lidocaine/ 1:100,000 epinephrine solution) will be placed in the external ear canal, however the iontophoresis current delivery (which facilitates penetration of drug into the tympanic membrane tissue) will not be activated. | Drug: Tymbion Lidocaine/epinephrine solution<br>* The external ear canal will be filled with Tymbion drug solution<br>* Other names: Tymbion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject-reported Visual Analog Scale (VAS) Pain Score Following Tympanic Membrane Tap for Subjects Treated With Active Tymbion Iontophoresis Compared to VAS Score for Subjects Treated With Sham Tymbion Iontophoresis. | The VAS consists of a 100 millimeter (mm) line with a statement at each end representing the extreme limits of pain intensity (where 0 represents No pain and 100 represents The worst imaginable pain). The subject reports their pain intensity by making a mark along the line and the line is measured to convert the subject response to numeric score (0-100 in millimeters). The data will be summarized as the difference in mean VAS scores between the two treatment groups (active Tymbion iontophoresis compared to sham Tymbion iontophoresis). | Day 0 |