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

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ClinicalTrials.gov Identifier: NCT04200651
Recruitment Status : Recruiting
First Posted : December 16, 2019
Last Update Posted : March 22, 2022
Sponsor:
Collaborator:
Ocular Therapeutix, Inc.
Information provided by (Responsible Party):
Nathan M. Radcliffe, MD, The New York Eye Surgery Center

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.

Condition or disease Intervention/treatment Phase
Glaucoma Cataract Drug: Dexamethasone Ophthalmic Insert Drug: Prednisolone Acetate 1% Oph Susp Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This prospective study will enroll 40 eyes from a variable number of total patients. The total patient number may vary due to some binocular enrollment from patients who meet eligibility criteria in both eyes. All eyes will receive concomitant cataract and MIGS surgery. Each eye will be randomized to receive either DEXTENZA® insertion at the end of the surgery or to a standard of care prednisolone acetate 1% eye drop regimen. All eyes will receive the standard of care topical ofloxacin antibiotic regimen. The experimental group will consist of the 20 eyes receiving DEXTENZA® insertion. The control group will consist of the 20 eyes placed on the prednisolone eye drop regimen.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : April 30, 2023


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 Name: 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 Name: PRED FORTE®, OMNIPRED®




Primary Outcome Measures :
  1. 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

  2. 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

  3. Difference in adverse events between groups [ Time Frame: Up to 3 months postop ]
    Using the average number of adverse events that occur in each arm to compare safety between arms

  4. 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


Secondary Outcome Measures :
  1. Percentage of patients requiring supplemental prednisolone acetate 1% eye drops [ Time Frame: Up to 3 months postop ]
    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®

  2. Incidence of cystoid macular edema (CME) at 3 months 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. 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

  4. 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

  5. Difference patients with absence of anterior chamber (AC) cells at 1 month [ Time Frame: 1 month postop ]
    Comparing the percentages of patients with complete AC clearance of inflammatory cells, as determined by slit lamp exam, between arms to evaluate drug effectiveness



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04200651


Contacts
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Contact: Nicholas E Tan, BA 347-617-5971 tannicholas97@gmail.com
Contact: Nathan M Radcliffe, MD 201-925-0476 drradcliffe@gmail.com

Locations
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United States, New York
The New York Eye Surgery Center Recruiting
Bronx, New York, United States, 10469
Contact: Gerard Scalera, BA         
Sponsors and Collaborators
The New York Eye Surgery Center
Ocular Therapeutix, Inc.
Investigators
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Principal Investigator: Nathan M Radcliffe, MD New York Eye Surgery Center; New York Eye and Ear Infirmary of Mount Sinai
Publications:
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Responsible Party: Nathan M. Radcliffe, MD, Dr. Nathan M. Radcliffe, Attending Ophthalmologist, The New York Eye Surgery Center
ClinicalTrials.gov Identifier: NCT04200651    
Other Study ID Numbers: 146602
First Posted: December 16, 2019    Key Record Dates
Last Update Posted: March 22, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nathan M. Radcliffe, MD, The New York Eye Surgery Center:
MIGS, Minimally invasive glaucoma surgery
Additional relevant MeSH terms:
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Glaucoma
Cataract
Ocular Hypertension
Eye Diseases
Lens Diseases
Dexamethasone
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Neuroprotective Agents
Protective Agents