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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eyegate Pharmaceuticals, Inc.
• Treatments: BB 1101; Citric Acid; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ophthalmic Solutions; Pharmaceutical Solutions; Sodium Citrate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Have participated in another investigational device or drug study within 30 days of baseline visit

• Have already participated in this study