Safety and Tolerability Study of Transscleral Iontophoresis by the EyeGate® II Drug Delivery Device System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Single Center, Single-masked, Randomized, Dose Escalation Study to Evaluate Safety and Tolerability of Transscleral Iontophoresis Using Citrate Buffer Delivered by the EyeGate® II Drug Delivery Device System in Healthy Adult Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Other: EyeGate II® Drug Delivery System
* Drug: Citrate buffer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults Normal ophthalmic examination in both eyes Exclusion Criteria: Presence of subjective ocular symptoms Presence of conjunctival hyperemia, chemosis, watering, conjunctival discharge Ocular trauma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: 0 mA-min (0 mA for 4 min)<br>Ocular iontophoresis 0 mA-min (0 mA for 4 minutes) | Other: EyeGate II® Drug Delivery System<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>* Other names: Citrate buffer;Drug: Citrate buffer<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>|
| Experimental: 2: 4 mA-min (2 mA for 2 min), + polarity<br>Ocular iontophoresis 4 mA-min (2 mA for 2 minutes), positive polarity | Other: EyeGate II® Drug Delivery System<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>* Other names: Citrate buffer;Drug: Citrate buffer<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>|
| Experimental: 3: 5 mA-min (2.5 mA for 2 min), +<br>Ocular iontophoresis 5 mA-min (2.5 mA for 2 minutes), positive polarity | Other: EyeGate II® Drug Delivery System<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>* Other names: Citrate buffer;Drug: Citrate buffer<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>|
| Experimental: 4: 6 mA-min (3 mA for 2 min), + polarity<br>Ocular iontophoresis 6 mA-min (3 mA for 2 minutes), positive polarity | Other: EyeGate II® Drug Delivery System<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>* Other names: Citrate buffer;Drug: Citrate buffer<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>|
| Experimental: 5: 7 mA-min (3.5 mA for 2 min), +<br>Ocular iontophoresis 7 mA-min (3.5 mA for 2 minutes), positive polarity | Other: EyeGate II® Drug Delivery System<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>* Other names: Citrate buffer;Drug: Citrate buffer<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>|
| Experimental: 6: 8 mA-min (4 mA for 2 min), + polarity<br>Ocular iontophoresis 8 mA-min (4 mA for 2 minutes), positive polarity | Other: EyeGate II® Drug Delivery System<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>* Other names: Citrate buffer;Drug: Citrate buffer<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>|
| Experimental: 7: 7 mA-min (3.5 mA for 2 min), -<br>7 mA-min (3.5 mA for 2 minutes), negative polarity | Other: EyeGate II® Drug Delivery System<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>* Other names: Citrate buffer;Drug: Citrate buffer<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>|
| Experimental: 8: 8 mA-min (4 mA for 2 min), - polarity<br>Ocular iontophoresis 8 mA-min (4 mA for 2 minutes), negative polarity | Other: EyeGate II® Drug Delivery System<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>* Other names: Citrate buffer;Drug: Citrate buffer<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>|
| Experimental: 9: 20 mA-min (4 mA for 5 min), +<br>Ocular iontophoresis 20 mA-min (4 mA for 5 minutes), positive polarity | Other: EyeGate II® Drug Delivery System<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>* Other names: Citrate buffer;Drug: Citrate buffer<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>|
| Experimental: 10: 20 mA-min (2 mA for 10 min), +<br>Ocular iontophoresis 20 mA-min (2 mA for 10 minutes), positive polarity | Other: EyeGate II® Drug Delivery System<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>* Other names: Citrate buffer;Drug: Citrate buffer<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>|
| Experimental: 11: 20 mA-min (4 mA for 5 min), -<br>Ocular iontophoresis 20 mA-min (4 mA for 5 minutes), negative polarity | Other: EyeGate II® Drug Delivery System<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>* Other names: Citrate buffer;Drug: Citrate buffer<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>|
| Experimental: 12: 20 mA-min (2 mA for 10 min), -<br>Ocular iontophoresis 20 mA-min (2 mA for 10 minutes), negative polarity | Other: EyeGate II® Drug Delivery System<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>* Other names: Citrate buffer;Drug: Citrate buffer<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>|
| Experimental: 13: 0 mA-min (0 mA for 10.5 min)<br>Ocular iontophoresis 0 mA-min (0 mA for 10.5 minutes) | Other: EyeGate II® Drug Delivery System<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>* Other names: Citrate buffer;Drug: Citrate buffer<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>|
| Experimental: 14: 13.5 mA-min (4.5 mA for 3 min), +<br>Ocular iontophoresis 13.5 mA-min (4.5 mA for 3 minutes), positive polarity | Other: EyeGate II® Drug Delivery System<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>* Other names: Citrate buffer;Drug: Citrate buffer<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>|
| Experimental: 15: 15 mA-min (5 mA for 3 min), +<br>Ocular iontophoresis 15 mA-min (5 mA for 3 minutes), positive polarity | Other: EyeGate II® Drug Delivery System<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>* Other names: Citrate buffer;Drug: Citrate buffer<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>|
| Experimental: 16: 16.5 mA-min (5.5 mA for 3 min), +<br>Ocular iontophoresis 16.5 mA-min (5.5 mA for 3 minutes), positive polarity | Other: EyeGate II® Drug Delivery System<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>* Other names: Citrate buffer;Drug: Citrate buffer<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>|
| Experimental: 17: 18 mA-min (6 mA for 3 min), +<br>Ocular iontophoresis 18 mA-min (6 mA for 3 minutes), positive polarity | Other: EyeGate II® Drug Delivery System<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>* Other names: Citrate buffer;Drug: Citrate buffer<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>|
| Experimental: 18: 19.5 mA-min (6.5 mA for 3 min), +<br>Ocular iontophoresis 19.5 mA-min (6.5 mA for 3 minutes), positive polarity | Other: EyeGate II® Drug Delivery System<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>* Other names: Citrate buffer;Drug: Citrate buffer<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>|
| Experimental: 19: 20 mA-min (7 mA for 3.84 min), +<br>Ocular iontophoresis 20 mA-min (7 mA for 3.84 minutes), positive polarity | Other: EyeGate II® Drug Delivery System<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>* Other names: Citrate buffer;Drug: Citrate buffer<br>* Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed through patient reported adverse events |  | Prospective | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ophthalmic examinations |  | Prospective | 
| Ocular discomfort on a visual analog scale (VAS) |  | Prospective | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iontophoresis, Ophthalmology