The purpose of this study is to evaluate the safety and tolerability of a single iontophoretic dose of buffered solution administered through the EyeGate® II Drug Delivery System in healthy adult human volunteers.
This is a single center, randomized, single-masked, comparative group, safety and tolerability study of single dose levels of citrate buffer delivered through transcleral iontophoresis administered via the EyeGate® II Drug Delivery System. The current study will also determine the safety and tolerability of the dose ranges of transcleral iontophoresis from 2 mA through 7 mA and will determine the safety and tolerability of the application of the Eyegate II system on the eye for time ranges of up to 10.5 minutes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
105
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
St. John's Medical College Hospital
Bangalore, Karnataka, India
Safety assessed through patient reported adverse events
Time frame: Prospective
Ophthalmic examinations
Time frame: Prospective
Ocular discomfort on a visual analog scale (VAS)
Time frame: Prospective
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