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

Phase 4

Terminated

• Conditions: Cataract
• Interventions: Drug: Durezol 0.05% Ophthalmic Emulsion; Drug: Dextenza 0.4mg intracanalicular Insert

• Registration Number: NCT04687800
• Lead Sponsor: Cathleen McCabe MD

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%

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-29
• Primary Completion: 2022-10-24
• Study Completion: 2022-10-24
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Durezol 0.05%	Durezol 0.05% Ophthalmic Emulsion	difluprednate ophthalmic emulsion
Dextenza 0.4mg	Dextenza 0.4mg intracanalicular Insert	Intracanalicular insert

Primary Outcome Measures

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

Trial Locations

Locations (1)

The Eye Associates of Manatee; 🇺🇸 Bradenton, Florida, United States