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

November 8, 2022 updated by: Cathleen McCabe MD

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Bradenton, Florida, United States, 34209
        • The Eye Associates of Manatee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dextenza 0.4mg
Intracanalicular insert
Drug: Dextenza 0.4mg intracanalicular Insert
intracanalicular insert delivery system
Other Names:
  • dexamethasone ophthalmic insert
Active Comparator: Durezol 0.05%
difluprednate ophthalmic emulsion
Drug: Durezol 0.05% Ophthalmic Emulsion
Standard therapy, topical steroid drop
Other Names:
  • difluprednate ophthalmic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Intraocular Pressure from Baseline
Time Frame: 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.
30 days - IOP measured at day 1, day 14 and day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cathleen McCabe MD

Collaborators

Ocular Therapeutix, Inc.

Investigators

  • Principal Investigator: Cathleen M McCabe, MD, The Eye Associates of Manatee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

October 24, 2022

Study Completion (Actual)

October 24, 2022

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 29, 2020

Study Record Updates

Last Update Posted (Actual)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The McTENZA Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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