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

Phase 2, proof-of-concept (POC) clinical trial designed to evaluate the safety and efficacy
of ocular iontophoretic delivery of dexamethasone phosphate ophthalmic solution compared to
ocular iontophoresis with a placebo (100 mM citrate buffer of pH 5.7) in patients planning to
have cataract surgery with implantation of a posterior chamber intraocular lens (IOL). The
population studied was comprised of males and females scheduled for unilateral cataract
surgery with implantation of a posterior chamber IOL. Eligible patients were enrolled into
the study and were randomized on Day 1 in a 1:1 ratio into one of the following two treatment
arms. Treatments were administered on the day prior (Day -1) to cataract surgery (Day 0).
Subjects were scheduled to return to the clinic on Days 1, 7, 14, and 28. All subjects were
scheduled to exit the study on Day 28. Subjects were asked to complete a daily pain score
assessment questionnaire for the first 14 days post-surgery (Days 0 - 14).

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