Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery (SUSTAIN)

January 7, 2024 updated by: Nathan M. Radcliffe, MD, The New York Eye Surgery Center
In this study, the investigators are comparing dexamethasone ophthalmic insert (DEXTENZA®) to the current standard of care, prednisolone acetate 1% eye drops, in a glaucoma population receiving both cataract and minimally-invasive glaucoma surgery (MIGS). DEXTENZA® and prednisolone acetate 1% drops are both steroids used to control inflammation after eye surgery. DEXTENZA®'s method of delivery differs by offering a sustained release of steroid that does not necessitate postoperative anti-inflammatory eye drops. The investigators hypothesize that DEXTENZA® will be as safe as prednisolone acetate 1% drops and as effective at controlling postoperative inflammation following concomitant cataract-MIGS in a glaucoma population. The investigators also hypothesize that DEXTENZA® will be preferred by patients over prednisolone acetate 1% drops.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Glaucoma and cataract surgery patients face an outsize postoperative burden. In addition to taking frequent anti-inflammatory eye drops, they often continue their glaucoma medications. This can cause patient confusion and nonadherence, potentially leading to poor healing, slower recovery period, and/or cystoid macular edema. DEXTENZA®, as a sustained release anti-inflammatory insert, could help preclude adherence difficulties and increase comfort by reducing eye drop load. However, glaucoma surgeons may hesitate to adopt DEXTENZA® due to concerns regarding safety with respect to elevated intraocular pressure. This prospective study will address those concerns directly, providing timely and high-quality clinical evidence comparing DEXTENZA® to standard-of-care steroid eye drops. For physicians and patients, the results of this study will prove immediately useful for therapeutic decision-making.

Study Type

Interventional

Enrollment (Actual)

25

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 Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10469
        • The New York Eye Surgery Center

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Cataract surgery candidate and glaucoma present in at least one eye.
  • Minimally-invasive glaucoma surgery candidate in that same eye. Defined by having ocular hypertension requiring a medication, OR as by having mild, moderate, or severe glaucoma that is sufficiently stable and appropriate for operation.

Exclusion Criteria:

  • Maintains regular use (daily or more) of systemic or ocular steroids at time of enrollment
  • Maintains regular use (daily or more) of systemic or ocular nonsteroidal anti-inflammatory drugs at time of enrollment
  • Anterior chamber cells present at time of enrollment
  • Recent febrile illness that precludes or delays participation for 3 months
  • Pregnancy or lactation
  • Known allergy to dexamethasone
  • Known allergy to prednisolone
  • Treatment with another investigational drug within the last 20 years
  • Current recreational drug use
  • Preexisting ocular pathology likely to confound the visual acuity or comfort endpoints including but not limited to: severe corneal scarring, ocular surface disease, diabetic retinopathy, or macular edema
  • Corneal or retinal procedures (laser or incisional) during the study period and 6 months prior

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DEXTENZA® arm
This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.
Drug: Dexamethasone Ophthalmic Insert
DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.
Other Names:
  • DEXTENZA®
Active Comparator: Prednisolone acetate 1% arm
This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.
Drug: Prednisolone Acetate 1% Oph Susp
Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.
Other Names:
  • PRED FORTE®, OMNIPRED®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Intraocular Pressure (IOP) at 1 and 3 Months
Time Frame: 1 month postop, 3 months postop

Using quantitative IOP readings to compare ocular safety between arms. Since the outcome examined was a "change," baseline, month 1 postop, and month 3 postop data were used in the calculations.

1 month change calculation: Month 1 postop value - Baseline value 3 month change calculation: Month 3 postop value - Baseline value
1 month postop, 3 months postop
Change in Best-corrected Visual Acuity (BCVA) at 1 and 3 Months
Time Frame: 1 month postop, 3 months postop

Using quantitative BCVA measurements, as determined by ETDRS chart at 4 meters, to compare ocular safety and effectiveness between arms. Since the outcome examined was a "change," baseline, month 1 postop, and month 3 postop data were used in the calculations.

1 month change calculation: Month 1 postop value - Baseline value 3 month change calculation: Month 3 postop value - Baseline value
1 month postop, 3 months postop
Difference in Eyes With Adverse Events Between Groups
Time Frame: Up to 3 months postop
Using the average number of eyes with adverse events that occur in each arm to compare safety between arms through 3 months of postoperative follow-up
Up to 3 months postop
Difference in Number of Glaucoma Medications at 3 Months
Time Frame: 3 months postop
Using the average number of glaucoma medications added or subtracted to each arm to compare safety between arms. These calculations were performed by subtracting the baseline glaucoma medications from the glaucoma medications at month 3.
3 months postop

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Eyes Requiring Supplemental Prednisolone Acetate 1% Eye Drops
Time Frame: Up to 3 months postop
Recording the percentage of eyes in the DEXTENZA® arm that require anti-inflammatory rescue with supplemental ocular steroid. This will provide insight into anti-inflammatory effectiveness of DEXTENZA®
Up to 3 months postop
Number of Eyes With Presenting With Cystoid Macular Edema (CME) as Seen on Optical Coherence Tomography (OCT)
Time Frame: 3 months postop
Using the number of CME cases in each arm, as visualized by OCT, to compare safety and effectiveness between arms
3 months postop
Difference in Ocular Comfort Index (OCI) Score at 1 Month
Time Frame: 1 month postop
Using the Ocular Comfort Index survey to compare patients' self-reported ocular comfort between arms, providing insight into drug effectiveness. The minimum score is 0 and the maximum score is 100, with 100 indicating the most ocular irritation and discomfort and 0 indicating the least ocular irritation and discomfort
1 month postop
Difference in Ocular Comfort Index (OCI) Score at 3 Months
Time Frame: 3 months postop
Using the Ocular Comfort Index survey to compare patients' self-reported ocular comfort between arms, providing insight into drug effectiveness. The minimum score is 0 and the maximum score is 100, with 100 indicating the most ocular irritation and discomfort and 0 indicating the least ocular irritation and discomfort
3 months postop
Difference in Number of Eyes With Absence of Anterior Chamber (AC) Cells at 1 Month
Time Frame: 1 month postop
Comparing the number of eyes with complete AC clearance of inflammatory cells, as determined by slit lamp exam, between arms to evaluate drug effectiveness
1 month postop

Collaborators and Investigators

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

Sponsor

The New York Eye Surgery Center

Collaborators

Ocular Therapeutix, Inc.

Investigators

  • Principal Investigator: Nathan M Radcliffe, MD, New York Eye Surgery Center; New York Eye and Ear Infirmary of Mount Sinai

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.

General Publications

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)

January 13, 2020

Primary Completion (Actual)

July 12, 2023

Study Completion (Actual)

July 12, 2023

Study Registration Dates

First Submitted

December 12, 2019

First Submitted That Met QC Criteria

December 12, 2019

First Posted (Actual)

December 16, 2019

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 7, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 146602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

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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