Clinical trial NCT03119181: Study to Compare Active Tymbion Iontophoresis to Sham Tymbion Iontophoresis for Anesthesia of the Tympanic Membrane
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Volunteer
Lead sponsor: Tusker Medical
Sponsor class: INDUSTRY
First posted: 2017-04-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Exclusion Criteria Group A:

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.

Primary outcomes:
measure: 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.
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Camino ENT
state: California
city: Bethlehem
country: United States
facility: Specialty Physician Associates
state: Pennsylvania
Study officials:
References: