CataractPhase 2NCT01602068
Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Delivery Prior to Implantation of a Posterior Chamber IOL
A Phase 2 study testing Dexamethasone Phosphate Ophthalmic and 100 mM Sodium Citrate Buffer in people with Cataract, run by Eyegate Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to placebo in patients undergoing cataract surgery with implantation of a posterior chamber intraocular lens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Dexamethasone Phosphate Ophthalmic and 100 mM Sodium Citrate Buffer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2012to Oct 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing unilateral cataract extraction and implantation of a monofocal IOL (at the time of enrollment)
- Male or female 18 years or older
- Receive, understand, and sign a copy of the written informed consent form
- Be able to return for all study visits and willing to comply with all study-related instructions
Who cannot join
- Subjects not meeting the inclusion criteria
- Subjects being implanted with a multifocal IOL
- Ocular surgery of any kind in the study eye within 6 months prior to baseline visit
- Cataract surgery on the fellow eye within 6 weeks, including 2 weeks without topical ocular medication, prior to baseline visit
- Scheduled for surgery in the fellow eye within the study period
- Have anterior chamber inflammation as measured by slit lamp examination at baseline. Anterior chamber cell and/or flare grade > 0
Show all 27Show fewer
- Have used any topical ocular medication in either eye, other than tear substitute for dry eye, at least 2 weeks prior to baseline visit
- Have IOP ≥ 25 mmHg at baseline, a history of glaucoma, or require ocular anti-hypertensive medications
- Be known corticosteroid intraocular pressure responder in either eye
- Have used topical corticosteroid or NSAID treatment in either eye ≤ 48 hours prior to baseline visit
- Systemic administration of corticosteroid within the past 14 days prior to baseline visit
- Have received intravitreal, sub-Tenon's, or any periocular corticosteroid treatment in either eye within the past 6 months prior to baseline visit
- Have open wounds/ skin disease on the forehead area where the iontophoresis return electrode will be applied
- Have severe lesions of the eyelids or the ocular surface impeding the application of the iontophoresis applicator
- Have blepharospasm, blepharophimosis, or other eyelid anatomic variations precluding the placement of the iontophoresis applicator
- Have significant Fuch's Corneal Dystrophy
- Have known allergy to dexamethasone or dexamethasone phosphate or any medication to be used in this study
- Have history or diagnosis of ocular herpes, corneal lesion of suspected herpetic origin
- Have optic neuritis of any origin
- Have clinically suspected or confirmed central nervous system or ocular lymphoma
- Have active hyphema, pars planitis, choroiditis, Behçet's disease, clinically significant macular edema, toxoplasmosis scar, or vitreous hemorrhage
- Have severe/serious ocular pathology or medical condition which may preclude study completion
- History of HIV/AIDS
- Have pacemaker and/or any other electrical sensitive support system
- Be pregnant or lactating female, or female of childbearing age and using inadequate birth control method
- Have participated in another investigational device or drug study within 30 days of baseline visit
- Have already participated in this study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Site 501
Miami, Florida, 33176
Site 503
Tamarac, Florida, 33321
Site 502
Washington, Missouri, 63090
About this study
Official title: A Prospective, Multi-Center, Randomized, Double-Masked, Negative-Controlled Clinical Trial Designed to Compare the Safety and Efficacy of EGP-437 (Dexamethasone Phosphate Ophthalmic Solution) Delivered by EyeGate® II Iontophoresis to Placebo in Patients Undergoing Cataract Surgery With Implantation of a Posterior Chamber Intraocular Lens
The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to placebo in patients undergoing cataract surgery with implantation of a posterior chamber intraocular lens.
Read the detailed description
Phase 2, proof-of-concept (POC) clinical trial designed to evaluate the safety and efficacy of ocular iontophoretic delivery of dexamethasone phosphate ophthalmic solution compared to ocular iontophoresis with a placebo (100 mM citrate buffer of pH 5.7) in patients planning to have cataract surgery with implantation of a posterior chamber intraocular lens (IOL). The population studied was comprised of males and females scheduled for unilateral cataract surgery with implantation of a posterior chamber IOL. Eligible patients were enrolled into the study and were randomized on Day 1 in a 1:1 ratio into one of the following two treatment arms. Treatments were administered on the day prior (Day -1) to cataract surgery (Day 0). Subjects were scheduled to return to the clinic on Days 1, 7, 14, and 28. All subjects were scheduled to exit the study on Day 28. Subjects were asked to complete a daily pain score assessment questionnaire for the first 14 days post-surgery (Days 0 - 14).
- Conditions
- Cataract
- Being tested
- Dexamethasone Phosphate Ophthalmic, 100 mM Sodium Citrate Buffer
- Keywords
- Iontophoresis, Cataract Surgery, Ophthalmology, Posterior Chamber Intraocular Lens Implant
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Phosphate OphthalmicDrug
Also called Active arm, Arm 1
Transcleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)
100 mM Sodium Citrate BufferDrug
Also called In-active control arm, Arm 2
Transcleral iontophoresis delivery of 100 mM sodium citrate buffer solution
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Phosphate Ophthalmic | Experimental | Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery) Receives: Drug: Dexamethasone Phosphate Ophthalmic |
| 100 mM Sodium Citrate Buffer | Placebo comparator | Placebo (100 mM sodium citrate buffer solution) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery) Receives: Drug: 100 mM Sodium Citrate Buffer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With AC Cell Count of Zero on Day 7
Percentage of patients with anterior chamber (AC) cell count of zero on Day 7 as compared between the active and placebo groups
Measured: At Day 7 (plus or minus two days) following the study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CataractStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyegate Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Trattler, M.D., Principal investigator, Center For Excellence In Eye Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602068
- Sponsor's protocol ID
- EGP-437-005
- Status last verified
- Jan 2019
- First submitted
- 16 May 2012
- Last updated
- 29 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Randomized, Double-Masked, Negative-Controlled Clinical Trial Designed to Compare the Safety and Efficacy of EGP-437 (Dexamethasone Phosphate Ophthalmic Solution) Delivered by EyeGate® II Iontophoresis to Placebo in Patients Undergoing Cataract Surgery With Implantation of a Posterior Chamber Intraocular Lens
- ClinicalTrials.gov ID
- NCT01602068
- Acronym / sponsor ID
- EGP-437-005
- Conditions
- Cataract
- Keywords
- Iontophoresis, Cataract Surgery, Ophthalmology, Posterior Chamber Intraocular Lens Implant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Eyegate Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 18 May 2012 (estimated)
- Results
- Posted 21 May 2018
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 efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to placebo in patients undergoing cataract surgery with implantation of a posterior chamber intraocular lens.
Detailed description
Phase 2, proof-of-concept (POC) clinical trial designed to evaluate the safety and efficacy of ocular iontophoretic delivery of dexamethasone phosphate ophthalmic solution compared to ocular iontophoresis with a placebo (100 mM citrate buffer of pH 5.7) in patients planning to have cataract surgery with implantation of a posterior chamber intraocular lens (IOL). The population studied was comprised of males and females scheduled for unilateral cataract surgery with implantation of a posterior chamber IOL. Eligible patients were enrolled into the study and were randomized on Day 1 in a 1:1 ratio into one of the following two treatment arms. Treatments were administered on the day prior (Day -1) to cataract surgery (Day 0). Subjects were scheduled to return to the clinic on Days 1, 7, 14, and 28. All subjects were scheduled to exit the study on Day 28. Subjects were asked to complete a daily pain score assessment questionnaire for the first 14 days post-surgery (Days 0 - 14).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Phosphate Ophthalmic | Experimental | Drug: Dexamethasone Phosphate OphthalmicDexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery) |
| 100 mM Sodium Citrate Buffer | Placebo comparator | Drug: 100 mM Sodium Citrate BufferPlacebo (100 mM sodium citrate buffer solution) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing unilateral cataract extraction and implantation of a monofocal IOL (at the time of enrollment)
- Male or female 18 years or older
- Receive, understand, and sign a copy of the written informed consent form
- Be able to return for all study visits and willing to comply with all study-related instructions
Key exclusion criteria (27 listed)
- Subjects not meeting the inclusion criteria
- Subjects being implanted with a multifocal IOL
- Ocular surgery of any kind in the study eye within 6 months prior to baseline visit
- Cataract surgery on the fellow eye within 6 weeks, including 2 weeks without topical ocular medication, prior to baseline visit
- Scheduled for surgery in the fellow eye within the study period
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 OphthalmicAlso: Active arm, Arm 1Transcleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) | Drug | Dexamethasone Phosphate Ophthalmic |
| 100 mM Sodium Citrate BufferAlso: In-active control arm, Arm 2Transcleral iontophoresis delivery of 100 mM sodium citrate buffer solution | Drug | 100 mM Sodium Citrate Buffer |
Primary outcome
Percentage of Subjects With AC Cell Count of Zero on Day 7
Time frame: At Day 7 (plus or minus two days) following the study treatment
Percentage of patients with anterior chamber (AC) cell count of zero on Day 7 as compared between the active and placebo groups
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
William Trattler, M.D. principal investigator
Center For Excellence In Eye Care
3 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 Dexamethasone Phosphate Ophthalmic and 100 mM Sodium Citrate Buffer in people with Cataract, run by Eyegate Pharmaceuticals, Inc. at 3 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 4 inclusion and 27 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 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 21 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects With AC Cell Count of Zero on Day 7 (time frame: At Day 7 (plus or minus two days) following the study treatment). 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 29 Jan 2019.