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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00698425

Enrollment

105

Registered

2008-06-17

Start date

2008-03-31

Completion date

2009-01-31

Last updated

2010-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Iontophoresis, Ophthalmology

Brief 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.

Interventions

OTHEREyeGate II® Drug Delivery System

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

DRUGCitrate buffer

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety assessed through patient reported adverse events	Prospective

Secondary

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026