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

NCT04200651 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 146602
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Cataract

Keywords

MIGS, Minimally invasive glaucoma surgery

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (5)

• Percentage of Eyes Requiring Supplemental Prednisolone Acetate 1% Eye Drops

  Up to 3 months postop

• Number of Eyes With Presenting With Cystoid Macular Edema (CME) as Seen on Optical Coherence Tomography (OCT)

  3 months postop

• Difference in Ocular Comfort Index (OCI) Score at 1 Month

  1 month postop

• Difference in Ocular Comfort Index (OCI) Score at 3 Months

  3 months postop

• Difference in Number of Eyes With Absence of Anterior Chamber (AC) Cells at 1 Month

  1 month postop

Study Arms (2)

DEXTENZA® arm

EXPERIMENTAL

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

Drug: Dexamethasone Ophthalmic Insert

Prednisolone acetate 1% arm

ACTIVE COMPARATOR

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

Drug: Prednisolone Acetate 1% Oph Susp

Interventions

Dexamethasone Ophthalmic Insert DRUG

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.

Also known as: DEXTENZA®

DEXTENZA® arm

Prednisolone Acetate 1% Oph Susp DRUG

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.

Also known as: PRED FORTE®, OMNIPRED®

Prednisolone acetate 1% arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The New York Eye Surgery Center: lead
• Ocular Therapeutix, Inc.: collaborator

Study Sites (1)

The New York Eye Surgery Center

The Bronx, New York, 10469, United States

Location

Related Publications (5)

• 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.

  PMID: 17898265 BACKGROUND

• 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.

  PMID: 28670710 BACKGROUND

• 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.

  PMID: 29502618 BACKGROUND

• 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.

  PMID: 25912144 BACKGROUND

• 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.

  PMID: 27486301 BACKGROUND

MeSH Terms

Conditions

Glaucoma; Cataract

Interventions

Calcium Dobesilate; prednisolone acetate; Methylprednisolone

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Early termination related to COVID-19 recruitment difficulties and loss to follow-up leading to small numbers of eyes analyzed. Length of follow-up limited to 3 months. Use of only three types of minimally invasive glaucoma surgery. Single-site, single-surgeon, open-label design.

Results Point of Contact

• Title: Dr. Nicholas Tan
• Organization: New York Eye Surgery Center; University of Colorado

tannicholas97@gmail.com

3476175971

Study Officials

• Nathan M Radcliffe, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Nathan M. Radcliffe, Attending Ophthalmologist

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 16, 2019
• Study Start: January 13, 2020
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: January 31, 2024
• Results First Posted: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)