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

Primary Purpose

Cataract

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Dextenza 0.4mg intracanalicular Insert

Durezol 0.05% Ophthalmic Emulsion

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

The Eye Associates of Manatee

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dextenza 0.4mg

Durezol 0.05%

Arm Description

Intracanalicular insert

difluprednate ophthalmic emulsion

Outcomes

Primary Outcome Measures

Mean Intraocular Pressure from Baseline

Sustained tapered release of Dextenza compared to Durezol 4 week taper as measured by mean IOP from baseline.

Secondary Outcome Measures

Full Information

NCT ID

NCT04687800

First Posted

December 8, 2020

Last Updated

November 8, 2022

Sponsor

Cathleen McCabe MD

Collaborators

Ocular Therapeutix, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04687800

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Terminated

Why Stopped

Inability to enroll due to lack of access to the Ambulatory Surgery Center.

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

October 24, 2022 (Actual)

Study Completion Date

October 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Cathleen McCabe MD

Collaborators

Ocular Therapeutix, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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%

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

Open label prospective randomized comparative investigator -initiated study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dextenza 0.4mg

Arm Type

Experimental

Arm Description

Intracanalicular insert

Arm Title

Durezol 0.05%

Arm Type

Active Comparator

Arm Description

difluprednate ophthalmic emulsion

Intervention Type

Drug

Intervention Name(s)

Dextenza 0.4mg intracanalicular Insert

Other Intervention Name(s)

dexamethasone ophthalmic insert

Intervention Description

intracanalicular insert delivery system

Intervention Type

Drug

Intervention Name(s)

Durezol 0.05% Ophthalmic Emulsion

Other Intervention Name(s)

difluprednate ophthalmic

Intervention Description

Standard therapy, topical steroid drop

Primary Outcome Measure Information:

Title

Mean Intraocular Pressure from Baseline

Description

Sustained tapered release of Dextenza compared to Durezol 4 week taper as measured by mean IOP from baseline.

Time Frame

30 days - IOP measured at day 1, day 14 and day 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cathleen M McCabe, MD

Organizational Affiliation

The Eye Associates of Manatee

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Eye Associates of Manatee

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34209

Country

United States

12. IPD Sharing Statement

Links:

URL

https://www.theeyeassociates.com/

Description

Sponsor/ site website

Learn more about this trial

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

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