Healthy Volunteer Clinical Trial
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
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).
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.
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