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

Cathleen McCabe MD

Status and phase: Terminated; Phase 4

Conditions: Cataract

Treatments: Drug: Durezol 0.05% Ophthalmic Emulsion; Drug: Dextenza 0.4mg intracanalicular Insert

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04687800

The McTENZA Study

Details and patient eligibility

About

To monitor intraocular pressure in glaucoma patients after cataract surgery preformed in conjunction with minimally invasive glaucoma surgery (MIGS)

Full 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%

Enrollment: 1 patient

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Dextenza 0.4mg

Experimental group

Description:

Intracanalicular insert

Treatment:

Drug: Dextenza 0.4mg intracanalicular Insert

Durezol 0.05%

Active Comparator group

Description:

difluprednate ophthalmic emulsion

Treatment:

Drug: Durezol 0.05% Ophthalmic Emulsion