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Completed

NCT Number: NCT00698425

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

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St. John's Medical College Hospital

Bangalore, Karnataka, 560 034, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EyeGate II® Drug Delivery System

Other

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

Other names: Citrate buffer

Citrate buffer

Drug

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

Primary outcomes

  1. Safety assessed through patient reported adverse events

    Time frame: Prospective

Secondary outcomes

  1. Ophthalmic examinations

    Time frame: Prospective

  2. Ocular discomfort on a visual analog scale (VAS)

    Time frame: Prospective

Sponsors and collaborators

Lead sponsor

Eyegate Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Jun 17, 2008
Registry last updated
Aug 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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