Safety and Tolerability Study of Transscleral Iontophoresis by the EyeGate® II Drug Delivery Device System
NCT ID: NCT00698425
Last Updated: 2010-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
105 participants
INTERVENTIONAL
2008-03-31
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1: 0 mA-min (0 mA for 4 min)
Ocular iontophoresis 0 mA-min (0 mA for 4 minutes)
EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
2: 4 mA-min (2 mA for 2 min), + polarity
Ocular iontophoresis 4 mA-min (2 mA for 2 minutes), positive polarity
EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
3: 5 mA-min (2.5 mA for 2 min), +
Ocular iontophoresis 5 mA-min (2.5 mA for 2 minutes), positive polarity
EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
4: 6 mA-min (3 mA for 2 min), + polarity
Ocular iontophoresis 6 mA-min (3 mA for 2 minutes), positive polarity
EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
5: 7 mA-min (3.5 mA for 2 min), +
Ocular iontophoresis 7 mA-min (3.5 mA for 2 minutes), positive polarity
EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
6: 8 mA-min (4 mA for 2 min), + polarity
Ocular iontophoresis 8 mA-min (4 mA for 2 minutes), positive polarity
EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
7: 7 mA-min (3.5 mA for 2 min), -
7 mA-min (3.5 mA for 2 minutes), negative polarity
EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
8: 8 mA-min (4 mA for 2 min), - polarity
Ocular iontophoresis 8 mA-min (4 mA for 2 minutes), negative polarity
EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
9: 20 mA-min (4 mA for 5 min), +
Ocular iontophoresis 20 mA-min (4 mA for 5 minutes), positive polarity
EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
10: 20 mA-min (2 mA for 10 min), +
Ocular iontophoresis 20 mA-min (2 mA for 10 minutes), positive polarity
EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
11: 20 mA-min (4 mA for 5 min), -
Ocular iontophoresis 20 mA-min (4 mA for 5 minutes), negative polarity
EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
12: 20 mA-min (2 mA for 10 min), -
Ocular iontophoresis 20 mA-min (2 mA for 10 minutes), negative polarity
EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
13: 0 mA-min (0 mA for 10.5 min)
Ocular iontophoresis 0 mA-min (0 mA for 10.5 minutes)
EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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
EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
15: 15 mA-min (5 mA for 3 min), +
Ocular iontophoresis 15 mA-min (5 mA for 3 minutes), positive polarity
EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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
EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
17: 18 mA-min (6 mA for 3 min), +
Ocular iontophoresis 18 mA-min (6 mA for 3 minutes), positive polarity
EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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
EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
19: 20 mA-min (7 mA for 3.84 min), +
Ocular iontophoresis 20 mA-min (7 mA for 3.84 minutes), positive polarity
EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Interventions
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EyeGate II® Drug Delivery System
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Normal ophthalmic examination in both eyes
Exclusion Criteria
* Presence of conjunctival hyperemia, chemosis, watering, conjunctival discharge
* Ocular trauma
18 Years
45 Years
ALL
Yes
Sponsors
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Eyegate Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Eyegate Pharmaceuticals, Inc.
Principal Investigators
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Manjoo Reddy, MS
Role: PRINCIPAL_INVESTIGATOR
St Johns Medical College Hospital, Bangalore, India
Locations
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St. John's Medical College Hospital
Bangalore, Karnataka, India
Countries
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Other Identifiers
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2008/Eyegate/01
Identifier Type: -
Identifier Source: org_study_id
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