Trial | NCT00698425

Trial | NCT00698425 Report issue

Title

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

Phase
Phase 1

Lead Sponsor
Eyegate Pharmaceuticals, Inc.

Study Type
Interventional

Status
Completed No Results Posted

Indication/Condition
Healthy

Intervention/Treatment
citric acid ...
EyeGate II® Drug Delivery System Citrate buffer

Study Participants
105

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.

Study Started

Mar 31

2008

Primary Completion

Dec 31

2008

Study Completion

Jan 31

2009

Last Update

Aug 23

2010

Estimate

Other EyeGate II® Drug Delivery System

Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System

Other names: Citrate buffer

Drug Citrate buffer

Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System

4: 6 mA-min (3 mA for 2 min), + polarity Experimental

Ocular iontophoresis 6 mA-min (3 mA for 2 minutes), positive polarity

Other EyeGate II® Drug Delivery System
Drug Citrate buffer

5: 7 mA-min (3.5 mA for 2 min), + Experimental

Ocular iontophoresis 7 mA-min (3.5 mA for 2 minutes), positive polarity

Other EyeGate II® Drug Delivery System
Drug Citrate buffer

1: 0 mA-min (0 mA for 4 min) Experimental

Ocular iontophoresis 0 mA-min (0 mA for 4 minutes)

Other EyeGate II® Drug Delivery System
Drug Citrate buffer

2: 4 mA-min (2 mA for 2 min), + polarity Experimental

Ocular iontophoresis 4 mA-min (2 mA for 2 minutes), positive polarity

Other EyeGate II® Drug Delivery System
Drug Citrate buffer

3: 5 mA-min (2.5 mA for 2 min), + Experimental

Ocular iontophoresis 5 mA-min (2.5 mA for 2 minutes), positive polarity

Other EyeGate II® Drug Delivery System
Drug Citrate buffer

6: 8 mA-min (4 mA for 2 min), + polarity Experimental

Ocular iontophoresis 8 mA-min (4 mA for 2 minutes), positive polarity

Other EyeGate II® Drug Delivery System
Drug Citrate buffer

7: 7 mA-min (3.5 mA for 2 min), - Experimental

7 mA-min (3.5 mA for 2 minutes), negative polarity

Other EyeGate II® Drug Delivery System
Drug Citrate buffer

8: 8 mA-min (4 mA for 2 min), - polarity Experimental

Ocular iontophoresis 8 mA-min (4 mA for 2 minutes), negative polarity

Other EyeGate II® Drug Delivery System
Drug Citrate buffer

9: 20 mA-min (4 mA for 5 min), + Experimental

Ocular iontophoresis 20 mA-min (4 mA for 5 minutes), positive polarity

Other EyeGate II® Drug Delivery System
Drug Citrate buffer

10: 20 mA-min (2 mA for 10 min), + Experimental

Ocular iontophoresis 20 mA-min (2 mA for 10 minutes), positive polarity

Other EyeGate II® Drug Delivery System
Drug Citrate buffer

11: 20 mA-min (4 mA for 5 min), - Experimental

Ocular iontophoresis 20 mA-min (4 mA for 5 minutes), negative polarity

Other EyeGate II® Drug Delivery System
Drug Citrate buffer

12: 20 mA-min (2 mA for 10 min), - Experimental

Ocular iontophoresis 20 mA-min (2 mA for 10 minutes), negative polarity

Other EyeGate II® Drug Delivery System
Drug Citrate buffer

13: 0 mA-min (0 mA for 10.5 min) Experimental

Ocular iontophoresis 0 mA-min (0 mA for 10.5 minutes)

Other EyeGate II® Drug Delivery System
Drug Citrate buffer

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

Other EyeGate II® Drug Delivery System
Drug Citrate buffer

15: 15 mA-min (5 mA for 3 min), + Experimental

Ocular iontophoresis 15 mA-min (5 mA for 3 minutes), positive polarity

Other EyeGate II® Drug Delivery System
Drug Citrate buffer

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

Other EyeGate II® Drug Delivery System
Drug Citrate buffer

17: 18 mA-min (6 mA for 3 min), + Experimental

Ocular iontophoresis 18 mA-min (6 mA for 3 minutes), positive polarity

Other EyeGate II® Drug Delivery System
Drug Citrate buffer

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

Other EyeGate II® Drug Delivery System
Drug Citrate buffer

19: 20 mA-min (7 mA for 3.84 min), + Experimental

Ocular iontophoresis 20 mA-min (7 mA for 3.84 minutes), positive polarity

Other EyeGate II® Drug Delivery System
Drug Citrate buffer

Criteria

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

No Results Posted