Healthy Volunteer
Conditions
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.
Interventions
DRUGTymbion Lidocaine/epinephrine solution
The external ear canal will be filled with Tymbion drug solution
COMBINATION_PRODUCTDevice: 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
Sponsors
Tusker Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion/
Exclusion criteria
Inclusion Criteria Group A: 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Day 0 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Tymbion Iontophoresis Unilateral treatment with active iontophoresis of Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine) using the Tusker Medical Tula Iontophoresis System.
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 | 19 |
| 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.
Tymbion Lidocaine/epinephrine solution: The external ear canal will be filled with Tymbion drug solution | 21 |
| Total | 40 |
Baseline characteristics
| Characteristic | Active Tymbion Iontophoresis | Total | Sham Tymbion Iontophoresis |
|---|---|---|---|
| Age, Continuous | 29.9 years STANDARD_DEVIATION 7.7 | 30.9 years STANDARD_DEVIATION 7.5 | 31.9 years STANDARD_DEVIATION 7.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 9 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 31 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) White | 14 Participants | 31 Participants | 17 Participants |
| Region of Enrollment United States | 19 participants | 40 participants | 21 participants |
| Sex: Female, Male Female | 7 Participants | 17 Participants | 10 Participants |
| Sex: Female, Male Male | 12 Participants | 23 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 21 |
| other Total, other adverse events | 1 / 19 | 0 / 21 |
| serious Total, serious adverse events | 0 / 19 | 0 / 21 |
Outcome results
Primary
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).
Time frame: Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Tymbion Iontophoresis | 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. | 4.2 millimeters | Standard Deviation 13.1 |
| Sham Tymbion Iontophoresis | 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. | 18.3 millimeters | Standard Deviation 24.1 |
Comparison: one-sided permutation test at 2.5% significancep-value: 0.0097one-sided permutation test