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

Primary Purpose

Glaucoma, Cataract

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Dexamethasone Ophthalmic Insert

Prednisolone Acetate 1% Oph Susp

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring MIGS, Minimally invasive glaucoma surgery

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The New York Eye Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DEXTENZA® arm

Prednisolone acetate 1% arm

Arm Description

This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.

This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.

Outcomes

Primary Outcome Measures

Change in intraocular pressure (IOP) at 1 and 3 months

Using quantitative IOP readings to compare ocular safety between arms

Change in best-corrected visual acuity (BCVA) at 1 and 3 months

Using quantitative BCVA measurements, as determined by ETDRS chart at 4 meters, to compare ocular safety and effectiveness between arms

Difference in adverse events between groups

Using the average number of adverse events that occur in each arm to compare safety between arms

Difference in number of glaucoma medications at 3 months

Using the average number of glaucoma medications added or subtracted to each arm to compare safety between arms

Secondary Outcome Measures

Percentage of patients requiring supplemental prednisolone acetate 1% eye drops

Recording the percentage of those in the DEXTENZA® arm that require anti-inflammatory rescue with supplemental ocular steroid. This will provide insight into anti-inflammatory effectiveness of DEXTENZA®

Incidence of cystoid macular edema (CME) at 3 months as seen on optical coherence tomography (OCT)

Using the number of CME cases in each arm, as visualized by OCT, to compare safety and effectiveness between arms

Difference in Ocular Comfort Index (OCI) score at 1 month

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

Difference in Ocular Comfort Index (OCI) score at 3 months

Difference patients with absence of anterior chamber (AC) cells at 1 month

Comparing the percentages of patients with complete AC clearance of inflammatory cells, as determined by slit lamp exam, between arms to evaluate drug effectiveness

Full Information

NCT ID

NCT04200651

First Posted

December 12, 2019

Last Updated

July 26, 2023

Sponsor

The New York Eye Surgery Center

Collaborators

Ocular Therapeutix, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04200651

Brief Title

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

Acronym

SUSTAIN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

January 13, 2020 (Actual)

Primary Completion Date

July 12, 2023 (Actual)

Study Completion Date

July 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The New York Eye Surgery Center

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

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.

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.

6. Conditions and Keywords

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

Glaucoma, Cataract

Keywords

MIGS, Minimally invasive glaucoma surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

This prospective study enrolled 29 eyes from 25 total patients. The protocol permitted some binocular enrollment from patients who met eligibility criteria in both eyes. All eligible eyes received concomitant cataract and MIGS surgery. Each eye was randomized to receive either DEXTENZA® insertion at the end of the surgery or to a standard of care prednisolone acetate 1% eye drop regimen via block randomization. All eyes received the standard of care topical ofloxacin antibiotic regimen. The experimental group consisted of the eyes receiving DEXTENZA® insertion. The control group consisted of the eyes placed on the prednisolone eye drop regimen.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DEXTENZA® arm

Arm Type

Experimental

Arm Description

This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.

Arm Title

Prednisolone acetate 1% arm

Arm Type

Active Comparator

Arm Description

This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.

Intervention Type

Drug

Intervention Name(s)

Dexamethasone Ophthalmic Insert

Other Intervention Name(s)

DEXTENZA®

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Prednisolone Acetate 1% Oph Susp

Other Intervention Name(s)

PRED FORTE®, OMNIPRED®

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in intraocular pressure (IOP) at 1 and 3 months

Description

Using quantitative IOP readings to compare ocular safety between arms

Time Frame

1 month postop, 3 months postop

Title

Change in best-corrected visual acuity (BCVA) at 1 and 3 months

Description

Using quantitative BCVA measurements, as determined by ETDRS chart at 4 meters, to compare ocular safety and effectiveness between arms

Time Frame

1 month postop, 3 months postop

Title

Difference in adverse events between groups

Description

Using the average number of adverse events that occur in each arm to compare safety between arms

Time Frame

Up to 3 months postop

Title

Difference in number of glaucoma medications at 3 months

Description

Using the average number of glaucoma medications added or subtracted to each arm to compare safety between arms

Time Frame

3 months postop

Secondary Outcome Measure Information:

Title

Percentage of patients requiring supplemental prednisolone acetate 1% eye drops

Description

Time Frame

Up to 3 months postop

Title

Incidence of cystoid macular edema (CME) at 3 months as seen on optical coherence tomography (OCT)

Description

Using the number of CME cases in each arm, as visualized by OCT, to compare safety and effectiveness between arms

Time Frame

3 months postop

Title

Difference in Ocular Comfort Index (OCI) score at 1 month

Description

Time Frame

1 month postop

Title

Difference in Ocular Comfort Index (OCI) score at 3 months

Description

Time Frame

3 months postop

Title

Difference patients with absence of anterior chamber (AC) cells at 1 month

Description

Comparing the percentages of patients with complete AC clearance of inflammatory cells, as determined by slit lamp exam, between arms to evaluate drug effectiveness

Time Frame

1 month postop

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nathan M Radcliffe, MD

Organizational Affiliation

New York Eye Surgery Center; New York Eye and Ear Infirmary of Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

The New York Eye Surgery Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10469

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is not a plan to make IPD available.

Citations:

PubMed Identifier

17898265

Citation

Johnson ME, Murphy PJ. Measurement of ocular surface irritation on a linear interval scale with the ocular comfort index. Invest Ophthalmol Vis Sci. 2007 Oct;48(10):4451-8. doi: 10.1167/iovs.06-1253.

Results Reference

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PubMed Identifier

28670710

Citation

Juthani VV, Clearfield E, Chuck RS. Non-steroidal anti-inflammatory drugs versus corticosteroids for controlling inflammation after uncomplicated cataract surgery. Cochrane Database Syst Rev. 2017 Jul 3;7(7):CD010516. doi: 10.1002/14651858.CD010516.pub2.

Results Reference

background

PubMed Identifier

29502618

Citation

Kindle T, Ferguson T, Ibach M, Greenwood M, Schweitzer J, Swan R, Sudhagoni RG, Berdahl JP. Safety and efficacy of intravitreal injection of steroid and antibiotics in the setting of cataract surgery and trabecular microbypass stent. J Cataract Refract Surg. 2018 Jan;44(1):56-62. doi: 10.1016/j.jcrs.2017.10.040.

Results Reference

background

PubMed Identifier

25912144

Citation

Newman-Casey PA, Robin AL, Blachley T, Farris K, Heisler M, Resnicow K, Lee PP. The Most Common Barriers to Glaucoma Medication Adherence: A Cross-Sectional Survey. Ophthalmology. 2015 Jul;122(7):1308-16. doi: 10.1016/j.ophtha.2015.03.026. Epub 2015 Apr 24.

Results Reference

background

PubMed Identifier

27486301

Citation

Fisher BL, Potvin R. Transzonular vitreous injection vs a single drop compounded topical pharmaceutical regimen after cataract surgery. Clin Ophthalmol. 2016 Jul 18;10:1297-303. doi: 10.2147/OPTH.S112080. eCollection 2016.

Results Reference

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

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