title: Tolerance of ocular iontophoresis in healthy volunteers.
abstract: To evaluate ocular tolerance, healthy volunteers were iontophoresed transclerally using novel OcuPhor trade mark hydrogel drug delivery applicators filled with balanced salt solution. In this three-period crossover study in 24 male and female subjects, 16 subjects received 0 mA and two of the following DC currents: 0.1, 0.5., 1.0, 2.0, 3.0, or 4.0 mA for 20 min; 6 subjects received 3 mA for 20 min and 1.5 mA for 40 min (both equivalent to 60 mAmin total charge). Safety and tolerance were determined by subjective VAS and objective ophthalmic assessments. Subjects were evaluated before and up to 22 hr after dosing. The applicators were well-tolerated and no clinically significant changes in symptomology or in ophthalmic assessments were seen following exposure to 0-3.0 mA for 20 min or 1.5 mA for 40 min. At 4.0 mA 2 of 4 subjects reported a burning sensation under the applicator during dosing which resolved by 22 hr post-dose; superficial changes in fluorescein staining were observed at 1 hr, but not at 22 hr. The OcuPhor trade mark system has promise for noninvasive drug delivery to the eye.
authors.affiliation: Research and Development, Iomed, Inc., Salt Lake City, Utah 84120-9941, USA. tparkinson@iomed.com
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Parkinson
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Ferguson
authors.forename: Salvatore
authors.initials: S
authors.lastname: Febbraro
authors.forename: Arash
authors.initials: A
authors.lastname: Bakhtyari
authors.forename: Martin
authors.initials: M
authors.lastname: King
authors.forename: Mohan
authors.initials: M
authors.lastname: Mundasad
mesh_terms: D000328:Adult; D015331:Cohort Studies; D003287:Contrast Media; D018592:Cross-Over Studies; D016503:Drug Delivery Systems; D005123:Eye / Q000503:physiopathology; D005260:Female; D019793:Fluorescein; D006801:Humans; D007478:Iontophoresis / Q000009:adverse effects / Q000379:methods; D008297:Male; D010147:Pain Measurement; D012016:Reference Values; D012965:Sodium Chloride / Q000008:administration & dosage*; D013194:Staining and Labeling; D013997:Time Factors
chemical_list: D003287:Contrast Media; D012965:Sodium Chloride; D019793:Fluorescein