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

Cataract Clinical Trial

— SUSTAIN  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04200651
• Other study ID #: 146602
• Status: Terminated
• Phase: Phase 4
• Start date: January 13, 2020
• Est. completion date: July 12, 2023

Study information

• Verified date: January 2024
• Source: The New York Eye Surgery Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: July 12, 2023
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Glaucoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The New York Eye Surgery Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
The New York Eye Surgery Center	Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Intraocular Pressure (IOP) at 1 and 3 Months	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
Primary	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. 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
Primary	Difference in Eyes With Adverse Events Between Groups	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
Primary	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. These calculations were performed by subtracting the baseline glaucoma medications from the glaucoma medications at month 3.	3 months postop
Secondary	Percentage of Eyes Requiring Supplemental Prednisolone Acetate 1% Eye Drops	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
Secondary	Number of Eyes With Presenting With Cystoid Macular Edema (CME) 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	3 months postop
Secondary	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	1 month postop
Secondary	Difference in Ocular Comfort Index (OCI) Score at 3 Months	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
Secondary	Difference in Number of Eyes With Absence of Anterior Chamber (AC) Cells at 1 Month	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