GlaucomaPhase 4SUSTAINNCT04200651
Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery
A Phase 4 study testing Dexamethasone Ophthalmic Insert and Prednisolone Acetate 1% Oph Susp in people with Glaucoma and Cataract, run by The New York Eye Surgery Center at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 21 years and older
- What is being tested?
- Dexamethasone Ophthalmic Insert and Prednisolone Acetate 1% Oph Susp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2020to 12 Jul 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The New York Eye Surgery Center
The Bronx, New York, 10469
About this study
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.
Read the 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.
- Being tested
- Dexamethasone Ophthalmic Insert, Prednisolone Acetate 1% Oph Susp
- Keywords
- MIGS, Minimally invasive glaucoma surgery
- Medical subject headings
- Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Ophthalmic InsertDrug
Also called DEXTENZA®
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 SuspDrug
Also called PRED FORTE®, OMNIPRED®
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.
| Study group | Role | What they receive |
|---|---|---|
| DEXTENZA® arm | Experimental | This arm will receive the DEXTENZA® insert after cataract surgery and MIGS. Receives: 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. Receives: Drug: Prednisolone Acetate 1% Oph Susp |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 3 months postop
Secondary outcomes (5)
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®
Measured: Up to 3 months postop
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
Measured: 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
Measured: 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
Measured: 3 months postop
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
Measured: 1 month postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start13 Jan 2020
- Primary completion12 Jul 2023
- Study completion12 Jul 2023
Why it stopped: COVID-19 challenges to recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The New York Eye Surgery Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Responsible party
- Principal investigator, Nathan M. Radcliffe, MD, The New York Eye Surgery Center
- Investigators
- Nathan M Radcliffe, MD, Principal investigator, New York Eye Surgery Center; New York Eye and Ear Infirmary of Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200651
- Sponsor's protocol ID
- 146602
- Acronym
- SUSTAIN
- Status last verified
- Jan 2024
- First submitted
- 12 Dec 2019
- Last updated
- 31 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
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.
PubMed 17898265Juthani 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.
PubMed 28670710Kindle 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.
PubMed 29502618Newman-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.
PubMed 25912144Fisher 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.
PubMed 27486301
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery
- ClinicalTrials.gov ID
- NCT04200651
- Acronym / sponsor ID
- SUSTAIN / 146602
- Keywords
- MIGS, Minimally invasive glaucoma surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 challenges to recruitment
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The New York Eye Surgery CenterUniversity, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 16 Dec 2019 (actual)
- Results
- Posted 31 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| DEXTENZA® arm | Experimental | Drug: Dexamethasone Ophthalmic InsertThis arm will receive the DEXTENZA® insert after cataract surgery and MIGS. |
| Prednisolone acetate 1% arm | Active comparator | Drug: Prednisolone Acetate 1% Oph SuspThis arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone Ophthalmic InsertAlso: DEXTENZA®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. | Drug | DEXTENZA® arm |
| Prednisolone Acetate 1% Oph SuspAlso: PRED FORTE®, OMNIPRED®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. | Drug | Prednisolone acetate 1% arm |
Primary outcome
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. 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
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. 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
Difference in Eyes With Adverse Events Between Groups
Time frame: Up to 3 months postop
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
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. These calculations were performed by subtracting the baseline glaucoma medications from the glaucoma medications at month 3.
5 secondary outcomes
Percentage of Eyes Requiring Supplemental Prednisolone Acetate 1% Eye Drops
Time frame: Up to 3 months postop
Number of Eyes With Presenting With Cystoid Macular Edema (CME) as Seen on Optical Coherence Tomography (OCT)
Time frame: 3 months postop
Difference in Ocular Comfort Index (OCI) Score at 1 Month
Time frame: 1 month postop
Difference in Ocular Comfort Index (OCI) Score at 3 Months
Time frame: 3 months postop
Difference in Number of Eyes With Absence of Anterior Chamber (AC) Cells at 1 Month
Time frame: 1 month postop
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17898265Johnson 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.
- Background: PubMed 28670710Juthani 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.
- Background: PubMed 29502618Kindle 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.
- Background: PubMed 25912144Newman-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.
- Background: PubMed 27486301Fisher 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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan M Radcliffe, MD principal investigator
New York Eye Surgery Center; New York Eye and Ear Infirmary of Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone Ophthalmic Insert and Prednisolone Acetate 1% Oph Susp in people with Glaucoma and Cataract, run by The New York Eye Surgery Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intraocular Pressure (IOP) at 1 and 3 Months (time frame: 1 month postop, 3 months postop). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04200651, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.