OPEN-LABEL, MULTI-CENTER, PHASE 1b/2a CLINICAL TRIAL DESIGNED TO EVALUATE THE SAFETY AND EFFICACY OF IONTOPHORETIC DEXAMETHASONE PHOSPHATE OPHTHALMIC SOLUTION IN PATIENTS HAVING UNDERGONE CATARACT SURGERY WITH IMPLANTATION OF A POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution, EGP-437®, using the EyeGate® II Drug Delivery System (EGDS) in patients having undergone cataract surgery with implantation of a posterior chamber intraocular lens (IOL)

Detailed Description
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This will be a Phase 1b/2a, open-label, multi-site study, in which a total of up to 20 eyes of up to 20 patients will be enrolled. Patients having undergone unilateral cataract surgery with implantation of a posterior chamber monofocal intraocular lens (IOL) who are interested in participating in the study will be provided an informed consent form prior to screening. Screening/Baseline procedures which include best corrected visual acuity (BCVA), slit lamp examination, conjunctival injection, and intraocular pressure (IOP) by tonometry will be used to determine eligibility just prior to cataract surgery on Day 0. Eligible subjects will undergo iontophoresis treatment immediately post-cataract surgery on Day 0 and Day 7, and will return to the clinic for examination on Days 1, 14, and 28.

Official Title
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OPEN-LABEL, MULTI-CENTER, PHASE 1b/2a CLINICAL TRIAL DESIGNED TO EVALUATE THE SAFETY AND EFFICACY OF IONTOPHORETIC DEXAMETHASONE PHOSPHATE OPHTHALMIC SOLUTION IN PATIENTS HAVING UNDERGONE CATARACT SURGERY WITH IMPLANTATION OF A POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Conditions
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Patients Having Undergone Unilateral Cataract Extraction and Implantation of a Monofocal

Intervention / Treatment
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* Drug: Experimental: Dexamethasone Phosphate Ophthalmic solution (40 mg/mL) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have undergone 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 Be able to return for all study visits and willing to comply with all study-related instructions Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone Phosphate Ophthalmic Solution<br> | Drug: Experimental: Dexamethasone Phosphate Ophthalmic solution (40 mg/mL) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA<br>* Experimental: Dexamethasone Phosphate Ophthalmic solution (40 mg/mL) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA<br>* Other names: EGP-437;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with an anterior chamber cell count of zero on Day 14 |  | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with a pain score of zero on Day 7 |  | Day 7 |