Dry EyePhase 3NCT01129856
Safety and Efficacy Study of EGP-437 (Dexamethasone Phosphate Formulated for Ocular Iontophoresis) to Treat Dry Eye
A Phase 3 study testing Dexamethasone phosphate ophthalmic solution and Sodium citrate buffer solution in people with Dry Eye, run by Eyegate Pharmaceuticals, Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) using the EyeGate® II Iontophoresis 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
- What is being tested?
- Dexamethasone phosphate ophthalmic solution and Sodium citrate buffer solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2010to Apr 2011
- Phase
- Phase 3
- 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 at Visits 1 and 2
Who cannot join
- Have contraindications to the use of the test articles
- Have known allergy or sensitivity to the study medications or their components
- 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Andover Eye Associates
Andover, Massachusetts, 01810
Central Maine Eye Care
Lewiston, Maine, 04240
Total Eye Care
Memphis, Tennessee, 38119
Virginia Eye Consultants
Norfolk, Virginia, 23502
The Eye Care Group
Waterbury, Connecticut, 06708
About this study
Official title: Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for the Treatment of Dry Eye in the Controlled Adverse Environment (CAE) Model
The purpose of this study is to assess the safety and efficacy of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) using the EyeGate® II Iontophoresis system in patients with dry eye.
Read the detailed description
Dry eye is the most prevalent form of ocular discomfort and irritation. Estimates range from 20 million people in the United States being affected with mild to moderate dry eye, to as many as one out of every five Americans.
EyeGate completed a single-center, randomized, double-masked, placebo-controlled Phase 2 efficacy study in 105 subjects with mild to moderate dry eye disease, utilizing the Controlled Adverse Environment (CAE), a clinical model which allows for standardized measurement of dry eye signs and symptoms in the investigation of therapeutic agents. In this Phase 2 study, the improvements documented in dry eye signs and symptoms relative to the placebo group indicated that the ocular iontophoresis treatments with EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) had both a rapid onset of action and a long-term effectiveness.
The Phase 3 study is intended to confirm and extend the results from the Phase 2 study, utilizing the CAE model. The study is designed to assess the safety and efficacy of EGP-437 at two different dose levels: Ocular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA and Ocular Iontophoresis with EGP-437 6.5 mA-min at 2.5 mA compared to Ocular Iontophoresis with placebo (sodium citrate buffer solution) for the treatment of the signs and symptoms of dry eye.
- Conditions
- Dry Eye
- Being tested
- Dexamethasone phosphate ophthalmic solution, Sodium citrate buffer solution
- Keywords
- Dry eye, Keratoconjunctivitis sicca, Iontophoresis, Ophthalmic drug delivery, EGP-437, Dexamethasone phosphate
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone phosphate ophthalmic solutionDrug
Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)
Sodium citrate buffer solutionDrug
Sodium citrate buffer solution 100 mM
| Study group | Role | What they receive |
|---|---|---|
| Ocular Iontophoresis EGP-437, Low Dose | Active comparator | Ocular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA Receives: Drug: Dexamethasone phosphate ophthalmic solution |
| Ocular Iontophoresis EGP-437, High Dose | Active comparator | Ocular Iontophoresis with EGP-437 6.5 mA-min at 2.5 mA Receives: Drug: Dexamethasone phosphate ophthalmic solution |
| Ocular Iontophoresis Placebo | Placebo comparator | Ocular Iontophoresis with Placebo 6.5 mA-min at 2.5 mA Receives: Drug: Sodium citrate buffer solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sign: Differences in corneal fluorescein staining (inferior region, Ora Scale) Visit 1 Pre-CAE to Visit 6 compared to placebo; Symptom: Ocular discomfort at Visit 5 as compared to placebo
Measured: Up to 10 weeks
Secondary outcomes (1)
Sign: Corneal fluorescein staining (each region, Ora Scale); Symptom: Ocular discomfort pre- and post-CAE (Ora Scale)
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyegate Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gail L Torkildsen, MD, Principal investigator, Andover Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129856
- Sponsor's protocol ID
- EGP-437-003
- Status last verified
- Apr 2011
- First submitted
- 20 May 2010
- Last updated
- 27 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for the Treatment of Dry Eye in the Controlled Adverse Environment (CAE) Model
- ClinicalTrials.gov ID
- NCT01129856
- Acronym / sponsor ID
- EGP-437-003
- Conditions
- Dry Eye
- Keywords
- Dry eye, Keratoconjunctivitis sicca, Iontophoresis, Ophthalmic drug delivery, EGP-437, Dexamethasone phosphate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Eyegate Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 25 May 2010 (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 EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) using the EyeGate® II Iontophoresis system in patients with dry eye.
Detailed description
Dry eye is the most prevalent form of ocular discomfort and irritation. Estimates range from 20 million people in the United States being affected with mild to moderate dry eye, to as many as one out of every five Americans.
EyeGate completed a single-center, randomized, double-masked, placebo-controlled Phase 2 efficacy study in 105 subjects with mild to moderate dry eye disease, utilizing the Controlled Adverse Environment (CAE), a clinical model which allows for standardized measurement of dry eye signs and symptoms in the investigation of therapeutic agents. In this Phase 2 study, the improvements documented in dry eye signs and symptoms relative to the placebo group indicated that the ocular iontophoresis treatments with EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) had both a rapid onset of action and a long-term effectiveness.
The Phase 3 study is intended to confirm and extend the results from the Phase 2 study, utilizing the CAE model. The study is designed to assess the safety and efficacy of EGP-437 at two different dose levels: Ocular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA and Ocular Iontophoresis with EGP-437 6.5 mA-min at 2.5 mA compared to Ocular Iontophoresis with placebo (sodium citrate buffer solution) 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 |
|---|---|---|
| Ocular Iontophoresis EGP-437, Low Dose | Active comparator | Drug: Dexamethasone phosphate ophthalmic solutionOcular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA |
| Ocular Iontophoresis EGP-437, High Dose | Active comparator | Drug: Dexamethasone phosphate ophthalmic solutionOcular Iontophoresis with EGP-437 6.5 mA-min at 2.5 mA |
| Ocular Iontophoresis Placebo | Placebo comparator | Drug: Sodium citrate buffer solutionOcular Iontophoresis with Placebo 6.5 mA-min at 2.5 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 at Visits 1 and 2
Key exclusion criteria (4 listed)
- Have contraindications to the use of the test articles
- Have known allergy or sensitivity to the study medications or their components
- 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 |
|---|---|---|
| Dexamethasone phosphate ophthalmic solutionTransscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) | Drug | Ocular Iontophoresis EGP-437, High Dose, Ocular Iontophoresis EGP-437, Low Dose |
| Sodium citrate buffer solutionSodium citrate buffer solution 100 mM | Drug | Ocular Iontophoresis Placebo |
Primary outcome
Sign: Differences in corneal fluorescein staining (inferior region, Ora Scale) Visit 1 Pre-CAE to Visit 6 compared to placebo; Symptom: Ocular discomfort at Visit 5 as compared to placebo
Time frame: Up to 10 weeks
1 secondary outcome
Sign: Corneal fluorescein staining (each region, Ora Scale); Symptom: Ocular discomfort pre- and post-CAE (Ora Scale)
Time frame: Up to 10 weeks
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 27 Apr 2011.
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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 L Torkildsen, MD principal investigator
Andover Eye Associates
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone phosphate ophthalmic solution and Sodium citrate buffer solution in people with Dry Eye, run by Eyegate Pharmaceuticals, Inc. at 5 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 27 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Differences in corneal fluorescein staining (inferior region, Ora Scale) Visit 1 Pre-CAE to Visit 6 compared to placebo; Symptom: Ocular discomfort at Visit 5 as compared to placebo (time frame: Up to 10 weeks). 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 27 Apr 2011.