Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Delivery Prior to Implantation of a Posterior Chamber IOL
Condition: Cataract
MeSH terms: Cataract
Intervention: Dexamethasone Phosphate Ophthalmic; 100 mM Sodium Citrate Buffer
Intervention description: Transcleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis); Transcleral iontophoresis delivery of 100 mM sodium citrate buffer solution
Intervention MeSH terms: Dexamethasone; Citric Acid; Sodium Citrate; Dexamethasone 21-phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Iontophoresis; Cataract Surgery; Ophthalmology; Posterior Chamber Intraocular Lens Implant

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.
    

Eligibility 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