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

NCT03119181 | Completed Phase 2 Results FDA Drug FDA Device

• 1 other identifier: CPR007003 - Group A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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).

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Active Tymbion Iontophoresis

EXPERIMENTAL

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

Sham Tymbion Iontophoresis

SHAM COMPARATOR

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

Interventions

Tymbion Lidocaine/epinephrine solution DRUG

The external ear canal will be filled with Tymbion drug solution

Also known as: 2% lidocaine HCl/ 1:100,000 epinephrine, Tymbion

Sham Tymbion Iontophoresis

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

Also known as: Tula Iontophoresis System, 2% lidocaine HCl/1:100,000 epinephrine, Tymbion

Active Tymbion Iontophoresis

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Tusker Medical: lead

Study Sites (2)

Camino ENT

San Jose, California, 95138, United States

Location

Specialty Physician Associates

Bethlehem, Pennsylvania, 18017, United States

Location

MeSH Terms

Interventions

Lidocaine; Epinephrine; Myo-Inositol-1-Phosphate Synthase

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Intramolecular Lyases; Isomerases; Enzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Laura England, PhD
• Organization: Tusker Medical

lengland@tuskermed.com

(650) 223-6909

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 18, 2017
• Study Start: April 27, 2017
• Primary Completion: May 11, 2017
• Study Completion: May 11, 2017
• Last Updated: January 18, 2020
• Results First Posted: January 6, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)