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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Glaucoma, Cataract

Intervention / Treatment
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* Drug: Dexamethasone Ophthalmic Insert
* Drug: Prednisolone Acetate 1% Oph Susp


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEXTENZA® arm<br>This arm will receive the DEXTENZA® insert after cataract surgery and MIGS. | Drug: Dexamethasone Ophthalmic Insert<br>* 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.<br>* Other names: DEXTENZA®;|
| Active Comparator: Prednisolone acetate 1% arm<br>This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS. | Drug: Prednisolone Acetate 1% Oph Susp<br>* 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.<br>* Other names: PRED FORTE®, OMNIPRED®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intraocular pressure (IOP) at 1 and 3 months | Using quantitative IOP readings to compare ocular safety between arms | 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 | 1 month postop, 3 months postop | 
| Difference in adverse events between groups | Using the average number of adverse events that occur in each arm to compare safety between arms | 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 | 3 months postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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® | Up to 3 months postop | 
| 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 | 3 months postop | 
| 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 | 
| 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 | 
| 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 | 1 month postop | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MIGS, Minimally invasive glaucoma surgery