Safety and Tolerability Study of Transscleral Iontophoresis by the EyeGate® II Drug Delivery Device System
This study has been completed.
Sponsor:
Eyegate Pharmaceuticals, Inc.
Information provided by:
Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00698425
First received: June 13, 2008
Last updated: August 20, 2010
Last verified: August 2010
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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 |
Other: EyeGate II® Drug Delivery System Drug: Citrate buffer |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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 |
Resource links provided by NLM:
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 |
|---|---|
|
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
Other Name: Citrate buffer
|
|
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
Other Name: Citrate buffer
|
|
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
Other Name: Citrate buffer
|
|
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
Other Name: Citrate buffer
|
|
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
Other Name: Citrate buffer
|
|
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
Other Name: Citrate buffer
|
|
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
Other Name: Citrate buffer
|
|
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
Other Name: Citrate buffer
|
|
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
Other Name: Citrate buffer
|
|
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
Other Name: Citrate buffer
|
|
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
Other Name: Citrate buffer
|
|
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
Other Name: Citrate buffer
|
|
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
Other Name: Citrate buffer
|
|
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
Other Name: Citrate buffer
|
|
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
Other Name: Citrate buffer
|
|
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
Other Name: Citrate buffer
|
|
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
Other Name: Citrate buffer
|
|
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
Other Name: Citrate buffer
|
|
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
Other Name: Citrate buffer
|
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 | |
| 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: | Stephen From, President and Chief Executive Officer, Eyegate Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00698425 History of Changes |
| Other Study ID Numbers: | 2008/Eyegate/01 |
| Study First Received: | June 13, 2008 |
| Last Updated: | August 20, 2010 |
| Health Authority: | India: St. John's Medical College & Hospital Ethics Committee |
Keywords provided by Eyegate Pharmaceuticals, Inc.:
|
Iontophoresis Ophthalmology |
Additional relevant MeSH terms:
|
Citric Acid Anticoagulants Hematologic Agents Therapeutic Uses |
Pharmacologic Actions Chelating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013