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EyeGate II Drug Delivery System, buffer

Phase 1

Healthy | Unknown | Other |Kiora Pharmaceuticals, Inc.|Last Updated: Aug 23, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment105

FDA Designations

No designations recorded

Clinical trial landscape

EyeGate II Drug Delivery System, buffer · 1 trial · 1 indication

Phase 1 1
NCT00698425Safety and Tolerability Study of Transscleral Iontophoresis by the EyeGate® II Drug Delivery Device SystemHealthy
COMPLETED105 Analytics
PHASE1COMPLETED
Safety and Tolerability Study of Transscleral Iontophoresis by the EyeGate® II Drug Delivery Device System
Healthy
NCT00698425105
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Study Endpoints

Primary Endpoints

Safety assessed through patient reported adverse events
Prospective

Secondary Endpoints

Ophthalmic examinations
Prospective
Ocular discomfort on a visual analog scale (VAS)
Prospective
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1: 0 mA-min (0 mA for 4 min)EXPERIMENTALOcular iontophoresis 0 mA-min (0 mA for 4 minutes)
2: 4 mA-min (2 mA for 2 min), + polarityEXPERIMENTALOcular iontophoresis 4 mA-min (2 mA for 2 minutes), positive polarity
3: 5 mA-min (2.5 mA for 2 min), +EXPERIMENTALOcular iontophoresis 5 mA-min (2.5 mA for 2 minutes), positive polarity
4: 6 mA-min (3 mA for 2 min), + polarityEXPERIMENTALOcular iontophoresis 6 mA-min (3 mA for 2 minutes), positive polarity
5: 7 mA-min (3.5 mA for 2 min), +EXPERIMENTALOcular iontophoresis 7 mA-min (3.5 mA for 2 minutes), positive polarity
6: 8 mA-min (4 mA for 2 min), + polarityEXPERIMENTALOcular iontophoresis 8 mA-min (4 mA for 2 minutes), positive polarity
7: 7 mA-min (3.5 mA for 2 min), -EXPERIMENTAL7 mA-min (3.5 mA for 2 minutes), negative polarity
8: 8 mA-min (4 mA for 2 min), - polarityEXPERIMENTALOcular iontophoresis 8 mA-min (4 mA for 2 minutes), negative polarity
9: 20 mA-min (4 mA for 5 min), +EXPERIMENTALOcular iontophoresis 20 mA-min (4 mA for 5 minutes), positive polarity
10: 20 mA-min (2 mA for 10 min), +EXPERIMENTALOcular iontophoresis 20 mA-min (2 mA for 10 minutes), positive polarity
11: 20 mA-min (4 mA for 5 min), -EXPERIMENTALOcular iontophoresis 20 mA-min (4 mA for 5 minutes), negative polarity
12: 20 mA-min (2 mA for 10 min), -EXPERIMENTALOcular iontophoresis 20 mA-min (2 mA for 10 minutes), negative polarity
13: 0 mA-min (0 mA for 10.5 min)EXPERIMENTALOcular iontophoresis 0 mA-min (0 mA for 10.5 minutes)
14: 13.5 mA-min (4.5 mA for 3 min), +EXPERIMENTALOcular iontophoresis 13.5 mA-min (4.5 mA for 3 minutes), positive polarity
15: 15 mA-min (5 mA for 3 min), +EXPERIMENTALOcular iontophoresis 15 mA-min (5 mA for 3 minutes), positive polarity
16: 16.5 mA-min (5.5 mA for 3 min), +EXPERIMENTALOcular iontophoresis 16.5 mA-min (5.5 mA for 3 minutes), positive polarity
17: 18 mA-min (6 mA for 3 min), +EXPERIMENTALOcular iontophoresis 18 mA-min (6 mA for 3 minutes), positive polarity
18: 19.5 mA-min (6.5 mA for 3 min), +EXPERIMENTALOcular iontophoresis 19.5 mA-min (6.5 mA for 3 minutes), positive polarity
19: 20 mA-min (7 mA for 3.84 min), +EXPERIMENTALOcular iontophoresis 20 mA-min (7 mA for 3.84 minutes), positive polarity

Interventions

NameTypeDescription
EyeGate II® Drug Delivery SystemOTHERTransscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate bufferDRUGTransscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

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

Countries:India
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Frequently asked questions about EyeGate II Drug Delivery System, buffer

What is the EyeGate II Drug Delivery System, buffer used for?

The EyeGate II Drug Delivery System, buffer is an investigational device being studied for use in healthy volunteers. It is designed for transscleral iontophoresis, a method of delivering medication through the eye. The system is currently in Phase 1 clinical development and is not yet approved for any medical condition.

Who makes the EyeGate II Drug Delivery System, buffer?

Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) is developing the EyeGate II Drug Delivery System, buffer. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug delivery device.

What phase is the EyeGate II Drug Delivery System, buffer in?

The EyeGate II Drug Delivery System, buffer is in Phase 1 clinical development. It is an investigational device and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the device remains under investigation for potential future applications.

What clinical trials is the EyeGate II Drug Delivery System, buffer in?

The EyeGate II Drug Delivery System, buffer has one completed Phase 1 clinical trial, NCT00698425, titled "Safety and Tolerability Study of Transscleral Iontophoresis by the EyeGate® II Drug Delivery Device System." This trial enrolled 105 healthy volunteers in India and was a controlled, randomized study.

Is the EyeGate II Drug Delivery System, buffer the same as the EyeGate II Drug Delivery Device System?

Yes, the EyeGate II Drug Delivery System, buffer is part of the EyeGate II Drug Delivery Device System. The clinical trial NCT00698425 refers to the device system, and the buffer is a component used in the delivery process. Both names refer to the same investigational platform being developed by Kiora Pharmaceuticals.