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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cataract, Anterior Chamber Inflammation, Pain, Postoperative

In brief

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).

Key facts

Study ID

NCT03180255

Run by

Eyegate Pharmaceuticals, Inc.

People needed

101

Starts

2017-07-26

Expected to finish

2017-11-27

Last updated by the study team

2018-05-21

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Site 901 — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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