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

August 20, 2010 updated by: Eyegate Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety assessed through patient reported adverse events
Time Frame: Prospective
Prospective

Secondary Outcome Measures

Outcome Measure
Time Frame
Ophthalmic examinations
Time Frame: Prospective
Prospective
Ocular discomfort on a visual analog scale (VAS)
Time Frame: Prospective
Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eyegate Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Manjoo Reddy, MS, St Johns Medical College Hospital, Bangalore, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 16, 2008

First Posted (ESTIMATE)

June 17, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 23, 2010

Last Update Submitted That Met QC Criteria

August 20, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/Eyegate/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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