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

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ClinicalTrials.gov Identifier: NCT03180255
Recruitment Status : Completed
First Posted : June 8, 2017
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Eyegate Pharmaceuticals, Inc.

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).

Condition or disease Intervention/treatment Phase
Cataract Anterior Chamber Inflammation Pain, Postoperative Combination Product: Dexamethasone phosphate Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor, investigator, subject will all be masked to study treatment assignment.
Primary Purpose: Treatment
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)
Actual Study Start Date : July 26, 2017
Actual Primary Completion Date : November 7, 2017
Actual Study Completion Date : November 27, 2017


Arm Intervention/treatment
Experimental: EGP-437
40 mg/ml dexamethasone phosphate solution delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA
Combination Product: Dexamethasone phosphate
Ocular iontophoretic delivery of a steroid

Placebo Comparator: Placebo
100 mM sodium citrate buffer solution (placebo) delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA
Other: Placebo
Ocular iontophoretic delivery of a placebo
Other Name: Sodium Citrate Buffer




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180255


Locations
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United States, Florida
Site 901
Jacksonville, Florida, United States, 32204
Sponsors and Collaborators
Eyegate Pharmaceuticals, Inc.
Investigators
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Study Director: Lisa Brandano, BS VP, Clinical Operations
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Responsible Party: Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03180255    
Other Study ID Numbers: EGP-437-009
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Inflammation
Pain, Postoperative
Pathologic Processes
Lens Diseases
Eye Diseases
Postoperative Complications
Pain
Neurologic Manifestations
Dexamethasone
Sodium Citrate
Dexamethasone 21-phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anticoagulants