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Iontophoretic Delivery of EGP-437 in Patients Who Have Undergone Cataract Surgery

Primary Purpose

Cataract, Anterior Chamber Inflammation, Pain, Postoperative

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone phosphate
Placebo
Sponsored by
Eyegate Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Undergoing unilateral cataract extraction and implantation of a monofocal IOL (at the time of enrollment)
  2. Age 18 to 85 years
  3. Receive, understand, and sign a copy of the written informed consent form (ICF)
  4. Are able to return for all study visits and willing to comply with all study-related instructions

Exclusion Criteria:

  1. Are undergoing implantation of a multifocal and/or depth enhancing IOL
  2. Are undergoing or have just undergone cataract surgery on the study eye that is deemed complex or may require manipulation of the iris
  3. The study eye has a small pupil or iris requiring manipulation due to synechiae and/ Tamsulosin (Flomax®, Boehringer Ingelheim) use
  4. Have a Seidel positive wound following surgical procedure despite suture and/or ReSure® Sealant placement
  5. Have had ocular surgery of any kind in the study eye within 3 months prior to baseline visit (Day 0)
  6. 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
  7. Are scheduled for surgery in the fellow eye within the study period
  8. 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]
  9. Have history of uveitis or inflammatory disease in the study eye
  10. Requires simultaneous supplemental surgery, such as glaucoma procedures or vitrectomy, in the study eye
  11. 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)
  12. 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)
  13. Have IOP ≥ 25 mmHg at baseline, a history of glaucoma, and/or require ocular anti-hypertensive medications
  14. Are known corticosteroid IOP responder in study eye
  15. Have received systemic administration of corticosteroid and/or immunosuppressants within the past 14 days prior to baseline visit (Day 0)
  16. Have received intravitreal, sub-Tenon, or any periocular corticosteroid treatment in either eye within the past 6 months prior to baseline visit (Day 0)
  17. Have open wounds/skin disease on the forehead area where the iontophoresis return electrode will be applied
  18. Have lesions of the eyelids or the ocular surface impeding the application of the iontophoresis applicator
  19. Have blepharospasm, blepharophimosis, or other eyelid anatomic variations precluding placement of the iontophoresis applicator
  20. Have known allergy to dexamethasone or dexamethasone phosphate or any medication to be used in this study
  21. Have history or diagnosis of ocular herpes, corneal lesion of suspected herpetic origin that could be worsened with steroid use
  22. Have optic neuritis of any origin
  23. Have clinically suspected or confirmed central nervous system or ocular lymphoma
  24. Have active hyphema, pars planitis, choroiditis, toxoplasmosis scar, vitreous hemorrhage, and/or clinically significant macular edema (CSME) that would compromise visual acuity recovery
  25. Have severe/serious ocular pathology or medical condition which may preclude study completion
  26. Have pacemaker and/or any other electrical sensitive support system
  27. Are pregnant or lactating female, or female of childbearing age and using inadequate birth control method
  28. 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)
  29. Have previously participated in a study with EGP-437

Sites / Locations

  • Site 901

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EGP-437

Placebo

Arm Description

40 mg/ml dexamethasone phosphate solution delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA

100 mM sodium citrate buffer solution (placebo) delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA

Outcomes

Primary Outcome Measures

AC cell count = 0
The proportion of subjects with an AC cell count of zero on Day 7
Pain score = 0
The proportion of subjects with a pain score of zero on Day 1

Secondary Outcome Measures

Full Information

First Posted
June 5, 2017
Last Updated
May 17, 2018
Sponsor
Eyegate Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03180255
Brief Title
Iontophoretic Delivery of EGP-437 in Patients Who Have Undergone Cataract Surgery
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 26, 2017 (Actual)
Primary Completion Date
November 7, 2017 (Actual)
Study Completion Date
November 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eyegate Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Anterior Chamber Inflammation, Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor, investigator, subject will all be masked to study treatment assignment.
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EGP-437
Arm Type
Experimental
Arm Description
40 mg/ml dexamethasone phosphate solution delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
100 mM sodium citrate buffer solution (placebo) delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA
Intervention Type
Combination Product
Intervention Name(s)
Dexamethasone phosphate
Intervention Description
Ocular iontophoretic delivery of a steroid
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sodium Citrate Buffer
Intervention Description
Ocular iontophoretic delivery of a placebo
Primary Outcome Measure Information:
Title
AC cell count = 0
Description
The proportion of subjects with an AC cell count of zero on Day 7
Time Frame
7 days' following first study treatment
Title
Pain score = 0
Description
The proportion of subjects with a pain score of zero on Day 1
Time Frame
1 day post-surgery and following first study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Brandano, BS
Organizational Affiliation
VP, Clinical Operations
Official's Role
Study Director
Facility Information:
Facility Name
Site 901
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Iontophoretic Delivery of EGP-437 in Patients Who Have Undergone Cataract Surgery

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