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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: 0 mA-min (0 mA for 4 min) | Experimental | Ocular iontophoresis 0 mA-min (0 mA for 4 minutes) |
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| 2: 4 mA-min (2 mA for 2 min), + polarity | Experimental | Ocular iontophoresis 4 mA-min (2 mA for 2 minutes), positive polarity |
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| 3: 5 mA-min (2.5 mA for 2 min), + | Experimental | Ocular iontophoresis 5 mA-min (2.5 mA for 2 minutes), positive polarity |
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| 4: 6 mA-min (3 mA for 2 min), + polarity | Experimental | Ocular iontophoresis 6 mA-min (3 mA for 2 minutes), positive polarity |
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| 5: 7 mA-min (3.5 mA for 2 min), + | Experimental | Ocular iontophoresis 7 mA-min (3.5 mA for 2 minutes), positive polarity |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EyeGate II® Drug Delivery System | Other | Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed through patient reported adverse events | Prospective |
| Measure | Description | Time Frame |
|---|---|---|
| Ophthalmic examinations | Prospective | |
| Ocular discomfort on a visual analog scale (VAS) | Prospective |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manjoo Reddy, MS | St Johns Medical College Hospital, Bangalore, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. John's Medical College Hospital | Bangalore | Karnataka | 560 034 | India |
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| 6: 8 mA-min (4 mA for 2 min), + polarity | Experimental | Ocular iontophoresis 8 mA-min (4 mA for 2 minutes), positive polarity |
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| 7: 7 mA-min (3.5 mA for 2 min), - | Experimental | 7 mA-min (3.5 mA for 2 minutes), negative polarity |
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| 8: 8 mA-min (4 mA for 2 min), - polarity | Experimental | Ocular iontophoresis 8 mA-min (4 mA for 2 minutes), negative polarity |
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| 9: 20 mA-min (4 mA for 5 min), + | Experimental | Ocular iontophoresis 20 mA-min (4 mA for 5 minutes), positive polarity |
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| 10: 20 mA-min (2 mA for 10 min), + | Experimental | Ocular iontophoresis 20 mA-min (2 mA for 10 minutes), positive polarity |
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| 11: 20 mA-min (4 mA for 5 min), - | Experimental | Ocular iontophoresis 20 mA-min (4 mA for 5 minutes), negative polarity |
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| 12: 20 mA-min (2 mA for 10 min), - | Experimental | Ocular iontophoresis 20 mA-min (2 mA for 10 minutes), negative polarity |
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| 13: 0 mA-min (0 mA for 10.5 min) | Experimental | Ocular iontophoresis 0 mA-min (0 mA for 10.5 minutes) |
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| 14: 13.5 mA-min (4.5 mA for 3 min), + | Experimental | Ocular iontophoresis 13.5 mA-min (4.5 mA for 3 minutes), positive polarity |
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| 15: 15 mA-min (5 mA for 3 min), + | Experimental | Ocular iontophoresis 15 mA-min (5 mA for 3 minutes), positive polarity |
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| 16: 16.5 mA-min (5.5 mA for 3 min), + | Experimental | Ocular iontophoresis 16.5 mA-min (5.5 mA for 3 minutes), positive polarity |
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| 17: 18 mA-min (6 mA for 3 min), + | Experimental | Ocular iontophoresis 18 mA-min (6 mA for 3 minutes), positive polarity |
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| 18: 19.5 mA-min (6.5 mA for 3 min), + | Experimental | Ocular iontophoresis 19.5 mA-min (6.5 mA for 3 minutes), positive polarity |
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| 19: 20 mA-min (7 mA for 3.84 min), + | Experimental | Ocular iontophoresis 20 mA-min (7 mA for 3.84 minutes), positive polarity |
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| Citrate buffer | Drug | Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System |
|