Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Delivery Prior to Implantation of a Posterior Chamber IOL

Completed · Phase 2

Conditions studied: Cataract

In brief

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.

Key facts

Study ID

NCT01602068

Run by

Eyegate Pharmaceuticals, Inc.

People needed

45

Starts

2012-05-01

Expected to finish

2012-10-01

Last updated by the study team

2019-01-29

Who can join

Age: 18 and older. 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)
• 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

You may not qualify if…

• 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
• 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

Where it is running

• Site 501 — Miami, Florida, United States
• Site 503 — Tamarac, Florida, United States
• Site 502 — Washington, Missouri, United States

Full record on ClinicalTrials.gov

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