Safety and Tolerability Study of Transscleral Iontophoresis by the EyeGate® II Drug Delivery Device System

August 20, 2010 updated by: Eyegate Pharmaceuticals, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560 034
        • St. John's Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Citrate buffer
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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 Names:
  • Citrate buffer
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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 Names:
  • Citrate buffer
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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 Names:
  • Citrate buffer
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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 Names:
  • Citrate buffer
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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 Names:
  • Citrate buffer
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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 Names:
  • Citrate buffer
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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 Names:
  • Citrate buffer
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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 Names:
  • Citrate buffer
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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 Names:
  • Citrate buffer
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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 Names:
  • Citrate buffer
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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 Names:
  • Citrate buffer
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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 Names:
  • Citrate buffer
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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 Names:
  • Citrate buffer
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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 Names:
  • Citrate buffer
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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 Names:
  • Citrate buffer
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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 Names:
  • Citrate buffer
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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 Names:
  • Citrate buffer
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System
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 Names:
  • Citrate buffer
Drug: Citrate buffer
Transscleral iontophoresis using citrate buffer delivered by EyeGate II® Drug Delivery System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Safety assessed through patient reported adverse events
Time Frame: Prospective
Prospective

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Ophthalmic examinations
Time Frame: Prospective
Prospective
Ocular discomfort on a visual analog scale (VAS)
Time Frame: Prospective
Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eyegate Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Manjoo Reddy, MS, St Johns Medical College Hospital, Bangalore, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2008

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2008/Eyegate/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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