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

NCT ID: NCT03119181

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-27
• Study Completion Date: 2017-05-11

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Active Tymbion Iontophoresis

Unilateral treatment with active iontophoresis of Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine) using the Tusker Medical Tula Iontophoresis System.

Group Type: EXPERIMENTAL

Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solution

Intervention Type: COMBINATION_PRODUCT

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

Sham Tymbion Iontophoresis

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.

Group Type: SHAM_COMPARATOR

Tymbion Lidocaine/epinephrine solution

Intervention Type: DRUG

The external ear canal will be filled with Tymbion drug solution

Interventions

Tymbion Lidocaine/epinephrine solution

The external ear canal will be filled with Tymbion drug solution

Intervention Type: DRUG

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

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

2% lidocaine HCl/ 1:100,000 epinephrine; Tymbion; Tula Iontophoresis System; 2% lidocaine HCl/1:100,000 epinephrine; Tymbion

Eligibility Criteria

Inclusion Criteria

1. Healthy adults, 18-50 years old

2. Subject is able and willing to comply with the protocol and attend all study visits

3. Subject is able and willing to provide informed consent

4. 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.

5. Subject is able to read and understand English

Exclusion Criteria

1. Pregnant or lactating females.

2. Prior ear iontophoresis procedure

3. Subjects with conductive hearing loss.

4. 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.

5. Familial history of insensitivity to lidocaine or other local anesthetics of the amide type.

6. Significantly atrophic, retracted, bimeric, monomeric or atelectatic tympanic membrane.

7. Perforated tympanic membrane.

8. Subjects with known history of ear surgery or TM condition that has the potential to affect the sensitivity of the TM

9. Otitis externa.

10. Damaged/denuded skin in the auditory canal.

11. Subjects with electrically sensitive support systems

12. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane.

13. Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure.

14. Other conditions that would preclude performing the study procedure including ear plug incompatibility.

15. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tusker Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Camino ENT

San Jose, California, United States

Specialty Physician Associates

Bethlehem, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CPR007003 - Group A

Identifier Type: -

Identifier Source: org_study_id