NCT00698425

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Eyegate Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	EyeGate II® Drug Delivery System	Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
DRUG	Citrate buffer	Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2008-06-17
• Last updated: 2010-08-23

Locations

1 site across 1 country: India