HealthyPhase 1NCT00698425
Safety and Tolerability Study of Transscleral Iontophoresis by the EyeGate® II Drug Delivery Device System
A Phase 1 study testing EyeGate II® Drug Delivery System and Citrate buffer in people with Healthy, run by Eyegate Pharmaceuticals, Inc. at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- EyeGate II® Drug Delivery System and Citrate buffer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2008to Jan 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults
- Normal ophthalmic examination in both eyes
Who cannot join
- Presence of subjective ocular symptoms
- Presence of conjunctival hyperemia, chemosis, watering, conjunctival discharge
- Ocular trauma
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- EyeGate II® Drug Delivery System, Citrate buffer
- Keywords
- Iontophoresis, Ophthalmology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyeGate II® Drug Delivery SystemOther
Also called Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
Citrate bufferDrug
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
| Study group | Role | What they receive |
|---|---|---|
| 1: 0 mA-min (0 mA for 4 min) | Experimental | Ocular iontophoresis 0 mA-min (0 mA for 4 minutes) Receives: Other: EyeGate II® Drug Delivery System; Drug: Citrate buffer |
| 2: 4 mA-min (2 mA for 2 min), + polarity | Experimental | Ocular iontophoresis 4 mA-min (2 mA for 2 minutes), positive polarity Receives: Other: EyeGate II® Drug Delivery System; Drug: Citrate buffer |
| 3: 5 mA-min (2.5 mA for 2 min), + | Experimental | Ocular iontophoresis 5 mA-min (2.5 mA for 2 minutes), positive polarity Receives: Other: EyeGate II® Drug Delivery System; Drug: Citrate buffer |
| 4: 6 mA-min (3 mA for 2 min), + polarity | Experimental | Ocular iontophoresis 6 mA-min (3 mA for 2 minutes), positive polarity Receives: Other: EyeGate II® Drug Delivery System; Drug: Citrate buffer |
| 5: 7 mA-min (3.5 mA for 2 min), + | Experimental | Ocular iontophoresis 7 mA-min (3.5 mA for 2 minutes), positive polarity Receives: Other: EyeGate II® Drug Delivery System; Drug: Citrate buffer |
| 6: 8 mA-min (4 mA for 2 min), + polarity | Experimental | Ocular iontophoresis 8 mA-min (4 mA for 2 minutes), positive polarity Receives: Other: EyeGate II® Drug Delivery System; Drug: Citrate buffer |
| 7: 7 mA-min (3.5 mA for 2 min), - | Experimental | 7 mA-min (3.5 mA for 2 minutes), negative polarity Receives: Other: EyeGate II® Drug Delivery System; Drug: Citrate buffer |
| 8: 8 mA-min (4 mA for 2 min), - polarity | Experimental | Ocular iontophoresis 8 mA-min (4 mA for 2 minutes), negative polarity Receives: Other: EyeGate II® Drug Delivery System; Drug: Citrate buffer |
| 9: 20 mA-min (4 mA for 5 min), + | Experimental | Ocular iontophoresis 20 mA-min (4 mA for 5 minutes), positive polarity Receives: Other: EyeGate II® Drug Delivery System; Drug: Citrate buffer |
| 10: 20 mA-min (2 mA for 10 min), + | Experimental | Ocular iontophoresis 20 mA-min (2 mA for 10 minutes), positive polarity Receives: Other: EyeGate II® Drug Delivery System; Drug: Citrate buffer |
| 11: 20 mA-min (4 mA for 5 min), - | Experimental | Ocular iontophoresis 20 mA-min (4 mA for 5 minutes), negative polarity Receives: Other: EyeGate II® Drug Delivery System; Drug: Citrate buffer |
| 12: 20 mA-min (2 mA for 10 min), - | Experimental | Ocular iontophoresis 20 mA-min (2 mA for 10 minutes), negative polarity Receives: Other: EyeGate II® Drug Delivery System; Drug: Citrate buffer |
| 13: 0 mA-min (0 mA for 10.5 min) | Experimental | Ocular iontophoresis 0 mA-min (0 mA for 10.5 minutes) Receives: Other: EyeGate II® Drug Delivery System; Drug: Citrate buffer |
| 14: 13.5 mA-min (4.5 mA for 3 min), + | Experimental | Ocular iontophoresis 13.5 mA-min (4.5 mA for 3 minutes), positive polarity Receives: Other: EyeGate II® Drug Delivery System; Drug: Citrate buffer |
| 15: 15 mA-min (5 mA for 3 min), + | Experimental | Ocular iontophoresis 15 mA-min (5 mA for 3 minutes), positive polarity Receives: Other: EyeGate II® Drug Delivery System; Drug: Citrate buffer |
| 16: 16.5 mA-min (5.5 mA for 3 min), + | Experimental | Ocular iontophoresis 16.5 mA-min (5.5 mA for 3 minutes), positive polarity Receives: Other: EyeGate II® Drug Delivery System; Drug: Citrate buffer |
| 17: 18 mA-min (6 mA for 3 min), + | Experimental | Ocular iontophoresis 18 mA-min (6 mA for 3 minutes), positive polarity Receives: Other: EyeGate II® Drug Delivery System; Drug: Citrate buffer |
| 18: 19.5 mA-min (6.5 mA for 3 min), + | Experimental | Ocular iontophoresis 19.5 mA-min (6.5 mA for 3 minutes), positive polarity Receives: Other: EyeGate II® Drug Delivery System; Drug: Citrate buffer |
| 19: 20 mA-min (7 mA for 3.84 min), + | Experimental | Ocular iontophoresis 20 mA-min (7 mA for 3.84 minutes), positive polarity Receives: Other: EyeGate II® Drug Delivery System; Drug: Citrate buffer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed through patient reported adverse events
Measured: Prospective
Secondary outcomes (2)
Ophthalmic examinations
Measured: Prospective
Ocular discomfort on a visual analog scale (VAS)
Measured: Prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyegate Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Manjoo Reddy, MS, Principal investigator, St Johns Medical College Hospital, Bangalore, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698425
- Sponsor's protocol ID
- 2008/Eyegate/01
- Status last verified
- Aug 2010
- First submitted
- 13 Jun 2008
- Last updated
- 23 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00698425
- Acronym / sponsor ID
- 2008/Eyegate/01
- Conditions
- Healthy
- Keywords
- Iontophoresis, Ophthalmology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Eyegate Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 19
| Arm | Type | Receives |
|---|---|---|
| 1: 0 mA-min (0 mA for 4 min) | Experimental | Other: EyeGate II® Drug Delivery System, Drug: Citrate bufferOcular iontophoresis 0 mA-min (0 mA for 4 minutes) |
| 2: 4 mA-min (2 mA for 2 min), + polarity | Experimental | Other: EyeGate II® Drug Delivery System, Drug: Citrate bufferOcular iontophoresis 4 mA-min (2 mA for 2 minutes), positive polarity |
| 3: 5 mA-min (2.5 mA for 2 min), + | Experimental | Other: EyeGate II® Drug Delivery System, Drug: Citrate bufferOcular iontophoresis 5 mA-min (2.5 mA for 2 minutes), positive polarity |
| 4: 6 mA-min (3 mA for 2 min), + polarity | Experimental | Other: EyeGate II® Drug Delivery System, Drug: Citrate bufferOcular iontophoresis 6 mA-min (3 mA for 2 minutes), positive polarity |
| 5: 7 mA-min (3.5 mA for 2 min), + | Experimental | Other: EyeGate II® Drug Delivery System, Drug: Citrate bufferOcular iontophoresis 7 mA-min (3.5 mA for 2 minutes), positive polarity |
| 6: 8 mA-min (4 mA for 2 min), + polarity | Experimental | Other: EyeGate II® Drug Delivery System, Drug: Citrate bufferOcular iontophoresis 8 mA-min (4 mA for 2 minutes), positive polarity |
| 7: 7 mA-min (3.5 mA for 2 min), - | Experimental | Other: EyeGate II® Drug Delivery System, Drug: Citrate buffer7 mA-min (3.5 mA for 2 minutes), negative polarity |
| 8: 8 mA-min (4 mA for 2 min), - polarity | Experimental | Other: EyeGate II® Drug Delivery System, Drug: Citrate bufferOcular iontophoresis 8 mA-min (4 mA for 2 minutes), negative polarity |
| 9: 20 mA-min (4 mA for 5 min), + | Experimental | Other: EyeGate II® Drug Delivery System, Drug: Citrate bufferOcular iontophoresis 20 mA-min (4 mA for 5 minutes), positive polarity |
| 10: 20 mA-min (2 mA for 10 min), + | Experimental | Other: EyeGate II® Drug Delivery System, Drug: Citrate bufferOcular iontophoresis 20 mA-min (2 mA for 10 minutes), positive polarity |
| 11: 20 mA-min (4 mA for 5 min), - | Experimental | Other: EyeGate II® Drug Delivery System, Drug: Citrate bufferOcular iontophoresis 20 mA-min (4 mA for 5 minutes), negative polarity |
| 12: 20 mA-min (2 mA for 10 min), - | Experimental | Other: EyeGate II® Drug Delivery System, Drug: Citrate bufferOcular iontophoresis 20 mA-min (2 mA for 10 minutes), negative polarity |
| 13: 0 mA-min (0 mA for 10.5 min) | Experimental | Other: EyeGate II® Drug Delivery System, Drug: Citrate bufferOcular iontophoresis 0 mA-min (0 mA for 10.5 minutes) |
| 14: 13.5 mA-min (4.5 mA for 3 min), + | Experimental | Other: EyeGate II® Drug Delivery System, Drug: Citrate bufferOcular iontophoresis 13.5 mA-min (4.5 mA for 3 minutes), positive polarity |
| 15: 15 mA-min (5 mA for 3 min), + | Experimental | Other: EyeGate II® Drug Delivery System, Drug: Citrate bufferOcular iontophoresis 15 mA-min (5 mA for 3 minutes), positive polarity |
| 16: 16.5 mA-min (5.5 mA for 3 min), + | Experimental | Other: EyeGate II® Drug Delivery System, Drug: Citrate bufferOcular iontophoresis 16.5 mA-min (5.5 mA for 3 minutes), positive polarity |
| 17: 18 mA-min (6 mA for 3 min), + | Experimental | Other: EyeGate II® Drug Delivery System, Drug: Citrate bufferOcular iontophoresis 18 mA-min (6 mA for 3 minutes), positive polarity |
| 18: 19.5 mA-min (6.5 mA for 3 min), + | Experimental | Other: EyeGate II® Drug Delivery System, Drug: Citrate bufferOcular iontophoresis 19.5 mA-min (6.5 mA for 3 minutes), positive polarity |
| 19: 20 mA-min (7 mA for 3.84 min), + | Experimental | Other: EyeGate II® Drug Delivery System, Drug: Citrate bufferOcular iontophoresis 20 mA-min (7 mA for 3.84 minutes), positive polarity |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adults
- Normal ophthalmic examination in both eyes
Key exclusion criteria (3 listed)
- Presence of subjective ocular symptoms
- Presence of conjunctival hyperemia, chemosis, watering, conjunctival discharge
- Ocular trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EyeGate II® Drug Delivery SystemAlso: Citrate bufferTransscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System | Other | 10: 20 mA-min (2 mA for 10 min), +, 11: 20 mA-min (4 mA for 5 min), -, 12: 20 mA-min (2 mA for 10 min), -, 13: 0 mA-min (0 mA for 10.5 min), 14: 13.5 mA-min (4.5 mA for 3 min), +, 15: 15 mA-min (5 mA for 3 min), +, 16: 16.5 mA-min (5.5 mA for 3 min), +, 17: 18 mA-min (6 mA for 3 min), +, 18: 19.5 mA-min (6.5 mA for 3 min), +, 19: 20 mA-min (7 mA for 3.84 min), +, 1: 0 mA-min (0 mA for 4 min), 2: 4 mA-min (2 mA for 2 min), + polarity, 3: 5 mA-min (2.5 mA for 2 min), +, 4: 6 mA-min (3 mA for 2 min), + polarity, 5: 7 mA-min (3.5 mA for 2 min), +, 6: 8 mA-min (4 mA for 2 min), + polarity, 7: 7 mA-min (3.5 mA for 2 min), -, 8: 8 mA-min (4 mA for 2 min), - polarity, 9: 20 mA-min (4 mA for 5 min), + |
| Citrate bufferTransscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System | Drug | 10: 20 mA-min (2 mA for 10 min), +, 11: 20 mA-min (4 mA for 5 min), -, 12: 20 mA-min (2 mA for 10 min), -, 13: 0 mA-min (0 mA for 10.5 min), 14: 13.5 mA-min (4.5 mA for 3 min), +, 15: 15 mA-min (5 mA for 3 min), +, 16: 16.5 mA-min (5.5 mA for 3 min), +, 17: 18 mA-min (6 mA for 3 min), +, 18: 19.5 mA-min (6.5 mA for 3 min), +, 19: 20 mA-min (7 mA for 3.84 min), +, 1: 0 mA-min (0 mA for 4 min), 2: 4 mA-min (2 mA for 2 min), + polarity, 3: 5 mA-min (2.5 mA for 2 min), +, 4: 6 mA-min (3 mA for 2 min), + polarity, 5: 7 mA-min (3.5 mA for 2 min), +, 6: 8 mA-min (4 mA for 2 min), + polarity, 7: 7 mA-min (3.5 mA for 2 min), -, 8: 8 mA-min (4 mA for 2 min), - polarity, 9: 20 mA-min (4 mA for 5 min), + |
Primary outcome
Safety assessed through patient reported adverse events
Time frame: Prospective
2 secondary outcomes
Ophthalmic examinations
Time frame: Prospective
Ocular discomfort on a visual analog scale (VAS)
Time frame: Prospective
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2010.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manjoo Reddy, MS principal investigator
St Johns Medical College Hospital, Bangalore, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EyeGate II® Drug Delivery System and Citrate buffer in people with Healthy, run by Eyegate Pharmaceuticals, Inc. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessed through patient reported adverse events (time frame: Prospective). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2010.