CataractPhase 2NCT03180255
Iontophoretic Delivery of EGP-437 in Patients Who Have Undergone Cataract Surgery
A Phase 2 study testing Dexamethasone phosphate in people with Cataract and Anterior Chamber Inflammation, run by Eyegate Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
Phase 2b trial evaluating the safety and efficacy of EGP-437, versus placebo using the EyeGate® II Drug Delivery System (EGDS) in patients having undergone cataract surgery with implantation of a monofocal posterior chamber intraocular lens (IOL). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cataract, Anterior Chamber Inflammation, Pain, Postoperative
- What is being tested?
- Dexamethasone phosphate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2017to 27 Nov 2017
- 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 18 to 85 years
- 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)
- Age 18 to 85 years
- Receive, understand, and sign a copy of the written informed consent form (ICF)
- Are able to return for all study visits and willing to comply with all study-related instructions
Who cannot join
- Are undergoing implantation of a multifocal and/or depth enhancing IOL
- Are undergoing or have just undergone cataract surgery on the study eye that is deemed complex or may require manipulation of the iris
- The study eye has a small pupil or iris requiring manipulation due to synechiae and/ Tamsulosin (Flomax®, Boehringer Ingelheim) use
- Have a Seidel positive wound following surgical procedure despite suture and/or ReSure® Sealant placement
- Have had ocular surgery of any kind in the study eye within 3 months prior to baseline visit (Day 0)
- Have undergone cataract surgery in the fellow eye within 4 weeks prior to baseline visit (Day 0) and still require post-operative medications in that fellow eye
Show all 29Show fewer
- Are scheduled for surgery in the fellow eye within the study period
- Have anterior chamber inflammation as measured by slit lamp examination in the study eye at the baseline visit (Day 0) [Defined as anterior chamber (AC) cell and/or flare grade > 0]
- Have history of uveitis or inflammatory disease in the study eye
- Requires simultaneous supplemental surgery, such as glaucoma procedures or vitrectomy, in the study eye
- Have used any topical ocular medication in either eye, other than tear substitute for dry eye, within the past 2 weeks prior to baseline visit (Day 0)
- Have used topical corticosteroid or nonsteroidal anti-inflammatory drug (NSAID) treatment in either eye < 48 hours prior to the baseline visit (Day 0) (excluding the use of topical NSAIDs, pre-operatively on Day 0 and administered at the clinic site under the investigator's oversight)
- Have IOP ≥ 25 mmHg at baseline, a history of glaucoma, and/or require ocular anti-hypertensive medications
- Are known corticosteroid IOP responder in study eye
- Have received systemic administration of corticosteroid and/or immunosuppressants within the past 14 days prior to baseline visit (Day 0)
- Have received intravitreal, sub-Tenon, or any periocular corticosteroid treatment in either eye within the past 6 months prior to baseline visit (Day 0)
- Have open wounds/skin disease on the forehead area where the iontophoresis return electrode will be applied
- Have lesions of the eyelids or the ocular surface impeding the application of the iontophoresis applicator
- Have blepharospasm, blepharophimosis, or other eyelid anatomic variations precluding placement of the iontophoresis applicator
- 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 that could be worsened with steroid use
- Have optic neuritis of any origin
- Have clinically suspected or confirmed central nervous system or ocular lymphoma
- Have active hyphema, pars planitis, choroiditis, toxoplasmosis scar, vitreous hemorrhage, and/or clinically significant macular edema (CSME) that would compromise visual acuity recovery
- Have severe/serious ocular pathology or medical condition which may preclude study completion
- Have pacemaker and/or any other electrical sensitive support system
- Are 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 (Day 0) (other clinical trial participation while participating in EGP-437-009 would be prohibited per protocol)
- Have previously participated in a study with EGP-437
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Center, Double-Masked, Randomized, Placebo-Controlled Phase 2b Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients Having Undergone Cataract Surgery With Implantation of a Posterior Chamber Intraocular Lens (IOL)
Phase 2b trial evaluating the safety and efficacy of EGP-437, versus placebo using the EyeGate® II Drug Delivery System (EGDS) in patients having undergone cataract surgery with implantation of a monofocal posterior chamber intraocular lens (IOL).
Read the detailed description
This will be a Phase 2b, double-masked, multi-site study, in which a total of up to 100 eyes of up to 100 subject will be enrolled at up to 8 clinical sites in the United States. The study has 2 different treatment arms consisting of the following iontophoresis treatment regimen:
Treatment Arm 1, up to 50 subjects will receive the following study treatment:
40 mg/ml dexamethasone phosphate solution delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA on Day 0 (immediately following cataract surgery), Day 1 (24 hours' post-cataract surgery), Day 4, and a potential Day 7 treatment that will be administered for subjects who have ≥11 AC cells per high-power field on slit lamp examination.
Treatment Arm 2, up to 50 subjects will receive the following study treatment:
100 mM sodium citrate buffer solution (placebo) delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA on Day 0 (immediately following cataract surgery), Day 1 (24 hours' post-cataract surgery), Day 4, and a potential Day 7 treatment that will be administered for subjects who have ≥11 AC cells per high-power field on slit lamp examination.
Subjects will come in for 6 visits over 28 days.
The primary efficacy endpoint (PEP) will evaluate 1) the proportion of subjects with an AC cell count of zero on Day 7 and 2) the proportion of subjects with a pain score of zero on Day 1.
- Conditions
- Cataract, Anterior Chamber Inflammation, Pain, Postoperative
- Being tested
- Dexamethasone phosphate, Placebo
- Medical subject headings
- Cataract, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone phosphateCombination product
Ocular iontophoretic delivery of a steroid
PlaceboOther
Also called Sodium Citrate Buffer
Ocular iontophoretic delivery of a placebo
| Study group | Role | What they receive |
|---|---|---|
| EGP-437 | Experimental | 40 mg/ml dexamethasone phosphate solution delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA Receives: Combination Product: Dexamethasone phosphate |
| Placebo | Placebo comparator | 100 mM sodium citrate buffer solution (placebo) delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AC cell count = 0
The proportion of subjects with an AC cell count of zero on Day 7
Measured: 7 days' following first study treatment
Pain score = 0
The proportion of subjects with a pain score of zero on Day 1
Measured: 1 day post-surgery and following first study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start26 Jul 2017
- Primary completion7 Nov 2017
- Study completion27 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Double-masked, randomized, placebo-controlled, multi-center, Phase 2b clinical trial designed to evaluate the efficacy and safety of transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution in patients having undergone cataract surgery with implantation of a monofocal posterior chamber IOL.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyegate Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Brandano, BS, Study director, VP, Clinical Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180255
- Sponsor's protocol ID
- EGP-437-009
- Status last verified
- May 2018
- First submitted
- 5 Jun 2017
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Double-Masked, Randomized, Placebo-Controlled Phase 2b Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients Having Undergone Cataract Surgery With Implantation of a Posterior Chamber Intraocular Lens (IOL)
- ClinicalTrials.gov ID
- NCT03180255
- Acronym / sponsor ID
- EGP-437-009
- Conditions
- Cataract, Anterior Chamber Inflammation, Pain, Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Eyegate Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 7 Nov 2017 (actual)
- Study completion
- 27 Nov 2017 (actual)
- First posted
- 8 Jun 2017 (actual)
- 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.
Phase 2b trial evaluating the safety and efficacy of EGP-437, versus placebo using the EyeGate® II Drug Delivery System (EGDS) in patients having undergone cataract surgery with implantation of a monofocal posterior chamber intraocular lens (IOL).
Detailed description
This will be a Phase 2b, double-masked, multi-site study, in which a total of up to 100 eyes of up to 100 subject will be enrolled at up to 8 clinical sites in the United States. The study has 2 different treatment arms consisting of the following iontophoresis treatment regimen:
Treatment Arm 1, up to 50 subjects will receive the following study treatment:
40 mg/ml dexamethasone phosphate solution delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA on Day 0 (immediately following cataract surgery), Day 1 (24 hours' post-cataract surgery), Day 4, and a potential Day 7 treatment that will be administered for subjects who have ≥11 AC cells per high-power field on slit lamp examination.
Treatment Arm 2, up to 50 subjects will receive the following study treatment:
100 mM sodium citrate buffer solution (placebo) delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA on Day 0 (immediately following cataract surgery), Day 1 (24 hours' post-cataract surgery), Day 4, and a potential Day 7 treatment that will be administered for subjects who have ≥11 AC cells per high-power field on slit lamp examination.
Subjects will come in for 6 visits over 28 days.
The primary efficacy endpoint (PEP) will evaluate 1) the proportion of subjects with an AC cell count of zero on Day 7 and 2) the proportion of subjects with a pain score of zero on Day 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-masked, randomized, placebo-controlled, multi-center, Phase 2b clinical trial designed to evaluate the efficacy and safety of transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution in patients having undergone cataract surgery with implantation of a monofocal posterior chamber IOL.
| Arm | Type | Receives |
|---|---|---|
| EGP-437 | Experimental | Combination Product: Dexamethasone phosphate40 mg/ml dexamethasone phosphate solution delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA |
| Placebo | Placebo comparator | Other: Placebo100 mM sodium citrate buffer solution (placebo) delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA |
Who may qualify
- Ages
- 18 to 85 years
- 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)
- Age 18 to 85 years
- Receive, understand, and sign a copy of the written informed consent form (ICF)
- Are able to return for all study visits and willing to comply with all study-related instructions
Key exclusion criteria (29 listed)
- Are undergoing implantation of a multifocal and/or depth enhancing IOL
- Are undergoing or have just undergone cataract surgery on the study eye that is deemed complex or may require manipulation of the iris
- The study eye has a small pupil or iris requiring manipulation due to synechiae and/ Tamsulosin (Flomax®, Boehringer Ingelheim) use
- Have a Seidel positive wound following surgical procedure despite suture and/or ReSure® Sealant placement
- Have had ocular surgery of any kind in the study eye within 3 months prior to baseline visit (Day 0)
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 phosphateOcular iontophoretic delivery of a steroid | Combination product | EGP-437 |
| PlaceboAlso: Sodium Citrate BufferOcular iontophoretic delivery of a placebo | Other | Placebo |
Primary outcome
AC cell count = 0
Time frame: 7 days' following first study treatment
The proportion of subjects with an AC cell count of zero on Day 7
Pain score = 0
Time frame: 1 day post-surgery and following first study treatment
The proportion of subjects with a pain score of zero on Day 1
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 21 May 2018.
- Individual participant dataSharing planned: No
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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.
Lisa Brandano, BS study director
VP, Clinical Operations
1 site 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 in people with Cataract and Anterior Chamber Inflammation, run by Eyegate Pharmaceuticals, Inc. at 1 site 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 29 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 21 May 2018. 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 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?
AC cell count = 0 (time frame: 7 days' following first study treatment). 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 21 May 2018; AzTrials last refreshed its copy on 8 Nov 2026.