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Amy Cohen, Michael A. Patane, Manjoo Reddy, Carol Assang, Stephen From; Clinical Experience with the EyeGate® II Delivery System (EGDS): Safety and Tolerability in Healthy Adult Volunteers. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3224.
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To identify the maximum tolerated ocular iontophoresis current level, dose, and treatment time.
This Phase 1, single center, randomized, single-masked, comparative group, safety and tolerability study evaluated single dose levels of 100 mM citrate buffer solution delivered through transscleral iontophoresis in healthy volunteers. 105 subjects between 18 and 45 years old with normal ophthalmic examinations in both eyes were enrolled and randomized. Iontophoresis current levels and treatment times ranged from 0 to 7.0 mA and 2 to 10 minutes respectively; the maximum iontophoresis current dose was 20.0 mA-min. This study was conducted in three stages (Stages 1 - 3) and consisted of 7 visits over 3 weeks. Subjects received iontophoresis treatment at study visit Day 0 and returned to the clinic for follow-up visits on Days 1, 2, 7, 14, and 21. Safety assessments included medical and ophthalmic evaluations (e.g., external eye and slit lamp examinations, visual acuity assessments, tonometry, and comfort assessments during and after iontophoresis treatment). Fundus photography, follow-up laboratory testing, ECGs, EEGs, and ERGs were also performed. Adverse events (AEs) were elicited from subjects or observed by investigators throughout the study.
All stages of the study were executed, all study subjects successfully completed the study, and no dose limiting effects were found at the maximal levels studied (7 mA of iontophoresis current levels, 10 minute treatment times, and 20 mA-min current doses). 16/105 study subjects experienced a total of 24 AEs, including one SAE (unrelated): 16 AEs were reported by 11/50 (22%) subjects in Stage 1; 5 AEs were reported by 2/25 (8%) subjects in Stage 2; and 3 AEs were reported by 3/30 (10%) subjects in Stage 3. All AEs resolved without sequelae. Subject-reported comfort scores demonstrated that subjects found the treatments comfortable and easily tolerated.
This study was intended to define a maximum tolerable iontophoresis current level, current dose, and/or iontophoresis treatment time. Since all subjects successfully completed the treatment, this study did not reach maximum tolerated treatment parameters for the EGDS.
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