CompletedNCT00698425Updated Aug 23, 2010

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

A Phase 1 interventional study of EyeGate II® Drug Delivery System and Citrate buffer in Healthy, sponsored by Eyegate Pharmaceuticals, Inc.. Completed at 1 site in India. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-08-23.

Sponsored by Eyegate Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 105
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study 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.

Read the 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 studied

Healthy

Keywords

Iontophoresis
Ophthalmology

In context

Lead sponsor

Eyegate Pharmaceuticals, Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy adults
Normal ophthalmic examination in both eyes

Exclusion criteria

Exclusion Criteria:

Presence of subjective ocular symptoms
Presence of conjunctival hyperemia, chemosis, watering, conjunctival discharge
Ocular trauma

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 105 participants (actual)

Study arms

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

Interventions

OtherEyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Also known as: Citrate buffer
DrugCitrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System

What researchers measure

Primary outcomes

Safety assessed through patient reported adverse events
Time frame: Prospective

Secondary outcomes

Ophthalmic examinations
Time frame: Prospective
Ocular discomfort on a visual analog scale (VAS)
Time frame: Prospective

Study locations

1 site

St. John's Medical College Hospital
Bangalore, Karnataka 560 034, India

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 23, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00698425
Lead sponsor: Eyegate Pharmaceuticals, Inc.
First posted: Jun 17, 2008
Start date: Mar 2008
Primary completion: Dec 2008
Completion: Jan 2009
Last update: Aug 23, 2010

Study contacts

Manjoo Reddy, MS

principal investigator · St Johns Medical College Hospital, Bangalore, India

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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