Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
To monitor intraocular pressure in glaucoma patients after cataract surgery preformed in conjunction with minimally invasive glaucoma surgery (MIGS)

Detailed Description
-----------------
The purpose of this study is to monitor glaucoma patients intraocular pressure (IOP) after cataract surgery performed in conjunction with minimally invasive glaucoma surgery. After qualifying for this study, subjects will be randomized in a 1:1 allocation of one of two arms. The purpose of this study is to determine if Dextenza (dexamethasone) 0.4mg intracanalicular insert delivery system, provides a decreased risk of elevated post-operative IOP vs. standard therapy controlled topical steroid Durezol (Difluprednate ophthalmic emulsion) 0.05%

Official Title
-----------------
A Randomized, Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Conjunction With Cataract Surgery Performed in Combination With Minimally Invasive Glaucoma Surgery

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Drug: Dextenza 0.4mg intracanalicular Insert
* Drug: Durezol 0.05% Ophthalmic Emulsion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or Older Mild-to-moderate primary open angle glaucoma and visually significant cataract with plans to undergo clear cornea cataract surgery with Phacoemulsification and implantation of posterior chamber IOL combined with minimally invasive glaucoma surgery ( MIGS) procedure in both eyes. Exclusion Criteria: Use of Topical steroid, systemic steroid or intravitreal steroid implants within last 3 months Previous Corneal surgery or pathology Active or history of chronic or recurrent inflammatory eye disease in either eye Ocular Pain in either eye Proliferative diabetic retinopathy in either eye Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye. Laser or incisional ocular surgery during the study period and 6 months prior in either eye Systemic concomitant pain medication management with the pharmacology class of Oxycodone Systemic NSAIDS use >/=750 mg daily Clinically significant macular edema History of cystoid macular edema in either eye

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Open label prospective randomized comparative investigator -initiated study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dextenza 0.4mg<br>Intracanalicular insert | Drug: Dextenza 0.4mg intracanalicular Insert<br>* intracanalicular insert delivery system<br>* Other names: dexamethasone ophthalmic insert;|
| Active Comparator: Durezol 0.05%<br>difluprednate ophthalmic emulsion | Drug: Durezol 0.05% Ophthalmic Emulsion<br>* Standard therapy, topical steroid drop<br>* Other names: difluprednate ophthalmic;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intraocular Pressure from Baseline | Sustained tapered release of Dextenza compared to Durezol 4 week taper as measured by mean IOP from baseline. | 30 days - IOP measured at day 1, day 14 and day 30 |