ClinicalTrials.Veeva
Menu

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

E

EyeGate Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Citrate buffer
Other: EyeGate II® Drug Delivery System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00698425
2008/Eyegate/01

Details and patient eligibility

About

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.

Full 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.

Read more

Enrollment

105 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

105 participants in 19 patient groups

1: 0 mA-min (0 mA for 4 min)
Experimental group
Description:
Ocular iontophoresis 0 mA-min (0 mA for 4 minutes)
Treatment:
Other: EyeGate II® Drug Delivery System
Drug: Citrate buffer
2: 4 mA-min (2 mA for 2 min), + polarity
Experimental group
Description:
Ocular iontophoresis 4 mA-min (2 mA for 2 minutes), positive polarity
Treatment:
Other: EyeGate II® Drug Delivery System
Drug: Citrate buffer
3: 5 mA-min (2.5 mA for 2 min), +
Experimental group
Description:
Ocular iontophoresis 5 mA-min (2.5 mA for 2 minutes), positive polarity
Treatment:
Other: EyeGate II® Drug Delivery System
Drug: Citrate buffer
4: 6 mA-min (3 mA for 2 min), + polarity
Experimental group
Description:
Ocular iontophoresis 6 mA-min (3 mA for 2 minutes), positive polarity
Treatment:
Other: EyeGate II® Drug Delivery System
Drug: Citrate buffer
5: 7 mA-min (3.5 mA for 2 min), +
Experimental group
Description:
Ocular iontophoresis 7 mA-min (3.5 mA for 2 minutes), positive polarity
Treatment:
Other: EyeGate II® Drug Delivery System
Drug: Citrate buffer
6: 8 mA-min (4 mA for 2 min), + polarity
Experimental group
Description:
Ocular iontophoresis 8 mA-min (4 mA for 2 minutes), positive polarity
Treatment:
Other: EyeGate II® Drug Delivery System
Drug: Citrate buffer
7: 7 mA-min (3.5 mA for 2 min), -
Experimental group
Description:
7 mA-min (3.5 mA for 2 minutes), negative polarity
Treatment:
Other: EyeGate II® Drug Delivery System
Drug: Citrate buffer
8: 8 mA-min (4 mA for 2 min), - polarity
Experimental group
Description:
Ocular iontophoresis 8 mA-min (4 mA for 2 minutes), negative polarity
Treatment:
Other: EyeGate II® Drug Delivery System
Drug: Citrate buffer
9: 20 mA-min (4 mA for 5 min), +
Experimental group
Description:
Ocular iontophoresis 20 mA-min (4 mA for 5 minutes), positive polarity
Treatment:
Other: EyeGate II® Drug Delivery System
Drug: Citrate buffer
10: 20 mA-min (2 mA for 10 min), +
Experimental group
Description:
Ocular iontophoresis 20 mA-min (2 mA for 10 minutes), positive polarity
Treatment:
Other: EyeGate II® Drug Delivery System
Drug: Citrate buffer
11: 20 mA-min (4 mA for 5 min), -
Experimental group
Description:
Ocular iontophoresis 20 mA-min (4 mA for 5 minutes), negative polarity
Treatment:
Other: EyeGate II® Drug Delivery System
Drug: Citrate buffer
12: 20 mA-min (2 mA for 10 min), -
Experimental group
Description:
Ocular iontophoresis 20 mA-min (2 mA for 10 minutes), negative polarity
Treatment:
Other: EyeGate II® Drug Delivery System
Drug: Citrate buffer
13: 0 mA-min (0 mA for 10.5 min)
Experimental group
Description:
Ocular iontophoresis 0 mA-min (0 mA for 10.5 minutes)
Treatment:
Other: EyeGate II® Drug Delivery System
Drug: Citrate buffer
14: 13.5 mA-min (4.5 mA for 3 min), +
Experimental group
Description:
Ocular iontophoresis 13.5 mA-min (4.5 mA for 3 minutes), positive polarity
Treatment:
Other: EyeGate II® Drug Delivery System
Drug: Citrate buffer
15: 15 mA-min (5 mA for 3 min), +
Experimental group
Description:
Ocular iontophoresis 15 mA-min (5 mA for 3 minutes), positive polarity
Treatment:
Other: EyeGate II® Drug Delivery System
Drug: Citrate buffer
16: 16.5 mA-min (5.5 mA for 3 min), +
Experimental group
Description:
Ocular iontophoresis 16.5 mA-min (5.5 mA for 3 minutes), positive polarity
Treatment:
Other: EyeGate II® Drug Delivery System
Drug: Citrate buffer
17: 18 mA-min (6 mA for 3 min), +
Experimental group
Description:
Ocular iontophoresis 18 mA-min (6 mA for 3 minutes), positive polarity
Treatment:
Other: EyeGate II® Drug Delivery System
Drug: Citrate buffer
18: 19.5 mA-min (6.5 mA for 3 min), +
Experimental group
Description:
Ocular iontophoresis 19.5 mA-min (6.5 mA for 3 minutes), positive polarity
Treatment:
Other: EyeGate II® Drug Delivery System
Drug: Citrate buffer
19: 20 mA-min (7 mA for 3.84 min), +
Experimental group
Description:
Ocular iontophoresis 20 mA-min (7 mA for 3.84 minutes), positive polarity
Treatment:
Other: EyeGate II® Drug Delivery System
Drug: Citrate buffer

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Research sites

Find research sitesLearn about CTV for professionals

Resources

Contact CTV support

Legal

Privacy NoticeTerms
© Copyright 2026 Veeva Systems