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

Sponsor
Cathleen McCabe MD (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04687800
Collaborator
Ocular Therapeutix, Inc. (Industry)
30
Enrollment
1
Location
2
Arms
35.9
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Dextenza 0.4mg intracanalicular Insert
  • Drug: Durezol 0.05% Ophthalmic Emulsion
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open label prospective randomized comparative investigator -initiated studyOpen label prospective randomized comparative investigator -initiated study
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Eye Associates of Manatee Bradenton Florida United States 34209

    Sponsors and Collaborators

    • Cathleen McCabe MD
    • Ocular Therapeutix, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Cathleen McCabe MD, Principal Investigator, The Eye Associates
    ClinicalTrials.gov Identifier:
    NCT04687800
    Other Study ID Numbers:
    • The McTENZA Study
    First Posted:
    Dec 29, 2020
    Last Update Posted:
    Apr 28, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cataract
    Dexamethasone
    Difluprednate

    Study Results

    No Results Posted as of Apr 28, 2022