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Safety and Tolerability Study of Transscleral Iontophoresis by the EyeGate® II Drug Delivery Device System
This study has been completed.
First Received: June 13, 2008   Last Updated: April 6, 2009   History of Changes
Sponsored by: Eyegate Pharmaceuticals, Inc.
Information provided by: Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00698425
  Purpose

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 Intervention Phase
Healthy
 Device: EyeGate II® Drug Delivery System
Drug: Citrate buffer
 Phase I

Drug Information available for: Citric acid Sodium Citrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety Study
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

Further study details as provided by Eyegate Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Safety assessed through patient reported adverse events [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ophthalmic examinations [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
  • Ocular discomfort on a visual analog scale (VAS) [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Enrollment: 105
Study Start Date: March 2008
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
0 mA-min (0 mA for 4 minutes)
Device: EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
2: Experimental
4 mA-min (2 mA for 2 minutes), positive polarity
Device: EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
3: Experimental
5 mA-min (2.5 mA for 2 minutes), positive polarity
Device: EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
4: Experimental
6 mA-min (3 mA for 2 minutes), positive polarity
Device: EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
5: Experimental
7 mA-min (3.5 mA for 2 minutes), positive polarity
Device: EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
6: Experimental
8 mA-min (4 mA for 2 minutes), positive polarity
Device: EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
7: Experimental
7 mA-min (3.5 mA for 2 minutes), negative polarity
Device: EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
8: Experimental
8 mA-min (4 mA for 2 minutes), negative polarity
Device: EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
9: Experimental
20 mA-min (4 mA for 5 minutes), positive polarity
Device: EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
10: Experimental
20 mA-min (2 mA for 10 minutes), positive polarity
Device: EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
11: Experimental
20 mA-min (4 mA for 5 minutes), negative polarity
Device: EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
12: Experimental
20 mA-min (2 mA for 10 minutes), negative polarity
Device: EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
13: Experimental
0 mA-min (0 mA for 10.5 minutes)
Device: EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
14: Experimental
13.5 mA-min (4.5 mA for 3 minutes), positive polarity
Device: EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
15: Experimental
15 mA-min (5 mA for 3 minutes), positive polarity
Device: EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
16: Experimental
16.5 mA-min (5.5 mA for 3 minutes), positive polarity
Device: EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
17: Experimental
18 mA-min (6 mA for 3 minutes), positive polarity
Device: EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
18: Experimental
19.5 mA-min (6.5 mA for 3 minutes), positive polarity
Device: EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
19: Experimental
20 mA-min (7 mA for 3.84 minutes), positive polarity
Device: EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698425

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

No publications provided

Responsible Party: Eyegate Pharmaceuticals, Inc. ( Stephen From, President and Chief Executive Officer )
Study ID Numbers: 2008/Eyegate/01
Study First Received: June 13, 2008
Last Updated: April 6, 2009
ClinicalTrials.gov Identifier: NCT00698425     History of Changes
Health Authority: India: Ethics Committees

Keywords provided by Eyegate Pharmaceuticals, Inc.:
Iontophoresis
Ophthalmology

Study placed in the following topic categories:
Anticoagulants
Citric Acid
Chelating Agents
Healthy

Additional relevant MeSH terms:
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
 Citric Acid
Chelating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009



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