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

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ClinicalTrials.gov Identifier: NCT00698425
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : August 23, 2010
Sponsor:
Information provided by:
Eyegate Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Other: EyeGate II® Drug Delivery System Drug: Citrate buffer Phase 1

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  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official 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
Study Start Date : March 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Citrate buffer

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




Primary Outcome Measures :
  1. Safety assessed through patient reported adverse events [ Time Frame: Prospective ]

Secondary Outcome Measures :
  1. Ophthalmic examinations [ Time Frame: Prospective ]
  2. Ocular discomfort on a visual analog scale (VAS) [ Time Frame: Prospective ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698425


Locations
India
St. John's Medical College Hospital
Bangalore, Karnataka, India, 560 034
Sponsors and Collaborators
Eyegate Pharmaceuticals, Inc.
Investigators
Principal Investigator: Manjoo Reddy, MS St Johns Medical College Hospital, Bangalore, India

Responsible Party: Stephen From, President and Chief Executive Officer, Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00698425     History of Changes
Other Study ID Numbers: 2008/Eyegate/01
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: August 23, 2010
Last Verified: August 2010

Keywords provided by Eyegate Pharmaceuticals, Inc.:
Iontophoresis
Ophthalmology

Additional relevant MeSH terms:
Citric Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action