Dry Eye SyndromePhase 2NCT00765804
Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye
A Phase 2 study testing EGP-437 with EyeGate® II System and Sodium citrate buffer solution with EyeGate® II System in people with Dry Eye Syndrome, run by Eyegate Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with dry eye. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- EGP-437 with EyeGate® II System and Sodium citrate buffer solution with EyeGate® II System
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2008to Feb 2009
- Phase
- Phase 2
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a reported history of dry eye in each eye
- Be at least 12 years of age
- Demonstrate a response when exposed to the Controlled Adverse Environment model
Who cannot join
- Have contraindications to the use of the test articles
- Have known allergy or sensitivity to the study medication or their components (including corticosteroids)
- Have any ocular infections, active ocular inflammation or preauricular lymphadenopathy
- Be current contact lens wearers or wear contacts during the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ophthalmic Research Associates
Andover, Massachusetts, 01810
Ophthalmic Research Associates
North Andover, Massachusetts, 01845
About this study
Official title: Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for Treatment of Dry Eye in the Controlled Adverse Environment Model
The purpose of this study is to assess the safety and efficacy of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with dry eye.
Read the detailed description
The objective of this study is to assess the safety and efficacy of Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 7.5 mA-min at 2.5 mA and Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 10.5 mA-min at 3.5 mA compared to placebo for the treatment of the signs and symptoms of dry eye.
- Conditions
- Dry Eye Syndrome
- Being tested
- EGP-437 with EyeGate® II System, Sodium citrate buffer solution with EyeGate® II System
- Keywords
- Dry Eye, Iontophoresis, Ophthalmic Delivery
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGP-437 with EyeGate® II SystemDrug
Also called Dexamethasone phosphate ophthalmic solution
Transscleral iontophoretic delivery of EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) delivered via EyeGate® II Drug Delivery System
Sodium citrate buffer solution with EyeGate® II SystemDrug
Also called Sodium citrate buffer solution
Transscleral iontophoretic delivery of sodium citrate buffer solution 100 mM delivered via EyeGate® II Drug Delivery System
| Study group | Role | What they receive |
|---|---|---|
| Low Dose: DP 7.5 mA-min at 2.5 mA | Active comparator | Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 7.5 mA-min at 2.5 mA Receives: Drug: EGP-437 with EyeGate® II System |
| High Dose: DP 10.5 mA-min at 3.5 mA | Active comparator | Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 10.5 mA-min at 3.5 mA Receives: Drug: EGP-437 with EyeGate® II System |
| Placebo: 10.5 mA-min at 3.5 mA | Placebo comparator | Ocular Iontophoresis with Placebo (sodium citrate buffer solution 100 mM at 10.5 mA-min at 3.5 mA) Receives: Drug: Sodium citrate buffer solution with EyeGate® II System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sign: Corneal fluorescein staining after CAE exposure at Visit 5
Corneal fluorescein staining after CAE exposure at Visit 5 as measured by the ORA scale.
Measured: Visit 5 (Day 7 ± 2 Days)
Symptom: Ocular discomfort during CAE exposure at Visit 5
Symptom: Ocular discomfort during CAE exposure at Visit 5 as measured by ORA scale.
Measured: Visit 5 (Day 7 ± 2 Days)
Secondary outcomes (2)
Sign: Fluorescein staining at each visit over 3 weeks
Fluorescein staining (each region) as measured by the ORA and NEI Scales at each of 7 visits over 3 weeks
Measured: 7 visits / 3 weeks
Symptom: Ocular discomfort pre and post CAE
Symptom: Ocular discomfort pre and post CAE (ORA Scale)at 3 visits (Visits 1, 3, and 5)
Measured: Visit 1 (Day -7 ± 2 Days), Visit 3 (Day 0), and Visit 5 (Day 7 ± 2 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyegate Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gail Torkildsen, MD, Principal investigator, ORA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765804
- Sponsor's protocol ID
- EGP-437-002
- Status last verified
- Aug 2010
- First submitted
- 2 Oct 2008
- Last updated
- 31 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for Treatment of Dry Eye in the Controlled Adverse Environment Model
- ClinicalTrials.gov ID
- NCT00765804
- Acronym / sponsor ID
- EGP-437-002
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry Eye, Iontophoresis, Ophthalmic Delivery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Eyegate Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 3 Oct 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 assess the safety and efficacy of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with dry eye.
Detailed description
The objective of this study is to assess the safety and efficacy of Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 7.5 mA-min at 2.5 mA and Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 10.5 mA-min at 3.5 mA compared to placebo for the treatment of the signs and symptoms of dry eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose: DP 7.5 mA-min at 2.5 mA | Active comparator | Drug: EGP-437 with EyeGate® II SystemOcular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 7.5 mA-min at 2.5 mA |
| High Dose: DP 10.5 mA-min at 3.5 mA | Active comparator | Drug: EGP-437 with EyeGate® II SystemOcular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 10.5 mA-min at 3.5 mA |
| Placebo: 10.5 mA-min at 3.5 mA | Placebo comparator | Drug: Sodium citrate buffer solution with EyeGate® II SystemOcular Iontophoresis with Placebo (sodium citrate buffer solution 100 mM at 10.5 mA-min at 3.5 mA) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Have a reported history of dry eye in each eye
- Be at least 12 years of age
- Demonstrate a response when exposed to the Controlled Adverse Environment model
Key exclusion criteria (4 listed)
- Have contraindications to the use of the test articles
- Have known allergy or sensitivity to the study medication or their components (including corticosteroids)
- Have any ocular infections, active ocular inflammation or preauricular lymphadenopathy
- Be current contact lens wearers or wear contacts during the study
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 |
|---|---|---|
| EGP-437 with EyeGate® II SystemAlso: Dexamethasone phosphate ophthalmic solutionTransscleral iontophoretic delivery of EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) delivered via EyeGate® II Drug Delivery System | Drug | High Dose: DP 10.5 mA-min at 3.5 mA, Low Dose: DP 7.5 mA-min at 2.5 mA |
| Sodium citrate buffer solution with EyeGate® II SystemAlso: Sodium citrate buffer solutionTransscleral iontophoretic delivery of sodium citrate buffer solution 100 mM delivered via EyeGate® II Drug Delivery System | Drug | Placebo: 10.5 mA-min at 3.5 mA |
Primary outcome
Sign: Corneal fluorescein staining after CAE exposure at Visit 5
Time frame: Visit 5 (Day 7 ± 2 Days)
Corneal fluorescein staining after CAE exposure at Visit 5 as measured by the ORA scale.
Symptom: Ocular discomfort during CAE exposure at Visit 5
Time frame: Visit 5 (Day 7 ± 2 Days)
Symptom: Ocular discomfort during CAE exposure at Visit 5 as measured by ORA scale.
2 secondary outcomes
Sign: Fluorescein staining at each visit over 3 weeks
Time frame: 7 visits / 3 weeks
Symptom: Ocular discomfort pre and post CAE
Time frame: Visit 1 (Day -7 ± 2 Days), Visit 3 (Day 0), and Visit 5 (Day 7 ± 2 Days)
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 31 Aug 2010.
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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.
Gail Torkildsen, MD principal investigator
ORA, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EGP-437 with EyeGate® II System and Sodium citrate buffer solution with EyeGate® II System in people with Dry Eye Syndrome, run by Eyegate Pharmaceuticals, Inc. at 2 sites in United States.
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 3 inclusion and 4 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 31 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 2 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Sign: Corneal fluorescein staining after CAE exposure at Visit 5 (time frame: Visit 5 (Day 7 ± 2 Days)). The study lists 2 primary outcomes in all. 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 31 Aug 2010.