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

NCT04687800 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: The McTENZA Study
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Dextenza 0.4mg

EXPERIMENTAL

Intracanalicular insert

Drug: Dextenza 0.4mg intracanalicular Insert

Durezol 0.05%

ACTIVE COMPARATOR

difluprednate ophthalmic emulsion

Drug: Durezol 0.05% Ophthalmic Emulsion

Interventions

Dextenza 0.4mg intracanalicular Insert DRUG

intracanalicular insert delivery system

Also known as: dexamethasone ophthalmic insert

Dextenza 0.4mg

Durezol 0.05% Ophthalmic Emulsion DRUG

Standard therapy, topical steroid drop

Also known as: difluprednate ophthalmic

Durezol 0.05%

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cathleen McCabe MD: lead
• Ocular Therapeutix, Inc.: collaborator

Study Sites (1)

The Eye Associates of Manatee

Bradenton, Florida, 34209, United States

Location

Related Links

• Sponsor/ site website

MeSH Terms

Conditions

Cataract

Interventions

Calcium Dobesilate; difluprednate

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Cathleen M McCabe, MD

  The Eye Associates of Manatee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open label prospective randomized comparative investigator -initiated study

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 29, 2020
• Study Start: December 1, 2020
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-11

Locations

US (1)