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

Cataract Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04687800
• Other study ID #: The McTENZA Study
• Status: Terminated
• Phase: Phase 4
• Start date: December 1, 2020
• Est. completion date: October 24, 2022

Study information

• Verified date: November 2022
• Source: The Eye Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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%

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 24, 2022
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Dextenza 0.4mg intracanalicular Insert
intracanalicular insert delivery system
• Durezol 0.05% Ophthalmic Emulsion
Standard therapy, topical steroid drop

Locations

Country	Name	City	State
United States	The Eye Associates of Manatee	Bradenton	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Cathleen McCabe MD	Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Sponsor/ site website