Clinical trial NCT04200651
Conditions: Glaucoma Cataract
Keywords: MIGS, Minimally invasive glaucoma surgery
Sponsor: The New York Eye Surgery Center
Start date: 2020-01-13; Completion date: 2023-07-12
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

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.

Arms: arm 1: This arm will receive the DEXTENZA® insert after cataract surgery and MIGS. arm 2: This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.
Interventions: intervention 1: Dexamethasone Ophthalmic Insert intervention 2: Prednisolone Acetate 1% Oph Susp
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol documents:
Prot_SAP_000.pdf: 
The SUSTAIN Study (V3) 
 
 
 
 
 
Compound: 
Sustained Release Dexamethasone, 
0.4 mg 
IND Number: 
146602 
NCT: 
               04200651 
 
Study Name: 
Prospective Study on DEXTENZA® 
Safety and Efficacy following 
concomitant MIGS and Cataract 
Surgery 
 
Clinical Phase: 
Phase IV open label prospective 
 
Date of Issue: 
10/18/2020 
 
Primary Investigator: 
Nathan M. Radcliffe, MD 
 
 
Sub Investigator: 
Nicholas Tan 
 
Site Name & Location: 
New York Eye Surgery Center, 1101 
Pelham Pkwy N, The Bronx, NY 
10469 
Clinical Study Protocol 
ProSpective StUdy on DEXTENZA® SafeTy And EffIcacy following 
coNcomitant MIGS and Cataract Surgery 
The SUSTAIN Study 


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CLINICAL STUDY PROTOCOL SYNOPSIS 
 
TITLE 
Prospective Study on DEXTENZA® Safety and 
Efficacy following concomitant MIGS and Cataract 
Surgery 
 
SITE LOCATION(S) 
New York Eye Surgery Center, 1101 Pelham Pkwy N, 
The Bronx, NY 10469 
 
PRINCIPAL 
INVESTIGATOR 
Nathan M. Radcliffe, MD 
 
OBJECTIVE(S) 
To compare dexamethasone insert to topical 
corticosteroid use through 90 days in glaucomatous 
eyes undergoing MIGS and cataract surgery as 
measured by: visual acuity, IOP control, adverse 
events, control of inflammation, macular health, and 
patient comfort. 
STUDY DESIGN 
Prospective Fellow-Eye, Randomized Open-label 
Interventional Study 
 
STUDY DURATION 
Fourteen months, including enrollment period 
 
ESTIMATED STUDY 
COMPLETION DATE 
POPULATION 
February 2022 
Sample Size: 
40 eyes 
Target Population: 
Patients with cataract and glaucoma 
 
TREATMENT(S) 
Study Drug 
Dose/Route/Schedule: 
 
 
 
ENDPOINT(S) 
Sustained Release Dexamethasone, 0.4 mg 
 
All study eyes will receive cataract extraction, IOL 
placement, minimally-invasive glaucoma surgery, and 
a postoperative topical antibiotic prescription. 20 eyes 
will be randomized to receive Sustained Released 
Dexamethasone, 0.4 mg. 20 eyes will be prescribed a 
prednisolone acetate 1% regimen. 
Primary: 
1. Reduction in IOP at 1 and 3 months 
2. BCVA at 1 and 3 months 
3. Difference in adverse events between groups 
4. Difference in # of glaucoma meds at 3 months 
Secondary: 
1. Number of patients requiring supplemental 
prednisolone acetate 1% eye drops 
2. Incidence of CME at 90 days as seen on OCT 
3. Difference in Ocular Comfort Index between 
groups at 1 month and 3 months 
4. Difference in % of patients with absence of 


The SUSTAIN Study (V4) 
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anterior chamber cells at 30 days between groups 
 
 
TABLE OF CONTENTS 
Clinical Study Protocol Synopsis ......................................................................... 2 
List of Tables ........................................................................................................... 4 
1. 
Introduction ..................................................................................................... 5 
1.1 
Type of study ................................................................................................ 5 
1.2 
Introduction .................................................................................................. 5 
1.3 
Rationale....................................................................................................... 5 
1.4 
Purpose ......................................................................................................... 6 
1.5 
Rationale for Study Design .......................................................................... 6 
2. 
Study Objectives .............................................................................................. 7 
2.1 
Primary Objective ......................................................................................... 7 
2.2 
Secondary Objectives ................................................................................... 8 
3. 
Study Design .................................................................................................... 8 
3.1 
Study Description and Duration ................................................................. 8 
4. 
Selection, Withdrawal, and Replacement of Patients................................. 8 
4.1 
Study Population ......................................................................................... 8 
4.1.1 
Inclusion Criteria .............................................................................. 8 
4.1.2 
Exclusion Criteria ............................................................................. 9 
4.2 
Treatment Logistics and Accountability ................................................... 9 
4.2.1 
Packaging, Labeling, and Storage ................................................... 9 
4.2.2 
Supply and Disposition of Treatments ......................................... 10 
4.2.3 
Treatment Accountability .............................................................. 10 
4.3 
Concomitant Medications and Procedures .............................................. 10 
5. 
Study Schedule of Events and Visit Descriptions ..................................... 10 
5.1 
Schedule of Events ..................................................................................... 10 
5.2 
Study Visit Descriptions ........................................................................... 12 
5.2.1 
Study Procedures ............................................................................ 12 
5.2.2 
Unscheduled Visits ......................................................................... 13 
5.2.3 
Adverse Event Information Collection ......................................... 14 
5.3 
Rescue Criteria........................................................................................... 14 


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6. 
Risk/Benefit Assessment .............................................................................. 14 
6.1 
Risks ............................................................................................................ 14 
6.2 
Prevention of Risks ................................................................................... 14 
6.3 
Benefits ....................................................................................................... 14 
6.4 
Alternative Treatments .............................................................................. 15 
7. 
Safety Definitions, Reporting, and Monitoring ............................................ 15 
7.1 
Definitions .................................................................................................. 15 
7.1.1 
Adverse Event ................................................................................. 15 
7.1.2 
Serious Adverse Event ................................................................... 15 
7.2 
Recording and Reporting Adverse Events .............................................. 16 
8. 
Study Variables .............................................................................................. 16 
8.1 
Demographic and Baseline Characteristics ............................................. 16 
8.2 
Primary and Secondary Endpoints ........................................................... 16 
9. 
Statistical Plan .............................................................................................. 17 
10. 
Ethical and Regulatory Considerations ................................................. 17 
10.1 Good Clinical Practice Statement ............................................................ 17 
10.2 Recruiting ................................................................................................... 17 
10.3 Informed Consent ...................................................................................... 17 
10.4 Storage of Data .......................................................................................... 18 
10.5 Confidentiality of Data.............................................................................. 18 
10.6 Participant Comprehension and Capacity ............................................... 19 
10.7 Costs to Participants .......................................................................... 19 
10.8 Compensation to Participants ................................................................... 19 
10.9 Institutional Review Board ....................................................................... 19 
LIST OF TABLES 
Table 1 
Schedule of Events ............................................................................. 11 


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1. 
INTRODUCTION 
1.1 
Type of study 
This is a drug study. The IND number is: 146602. 
 
1.2 
Introduction 
 
Following cataract surgery, the standard of care for controlling ocular 
inflammation has historically been a topically applied anti-inflammatory eye 
drop regimen. Such drops utilize steroids or non-steroidal anti-inflammatory 
drugs, with steroid drops being more commonly prescribed (Juthani et al. 
2017). Sustained-release steroid inserts, such as the FDA-approved 
intracanicular dexamethasone insert DEXTENZA®, have provided a 
“dropless” alternative to steroid eye drop regimens. DEXTENZA® was shown 
to be safe and effective following cataract surgery, in terms of ocular pain and 
anterior chamber cell clearance, in a multi-center trial (Tyson et al. 2018). 
However, in prior studies of DEXTENZA®, none have specifically examined 
the safety and efficacy of the insert in a glaucoma patient population. 
Furthermore, none have examined the outcomes of the insertion of 
DEXTENZA® following both cataract surgery and a minimally invasive 
glaucoma surgery (MIGS). DEXTENZA® may be of utility to glaucoma 
patients because it can simplify one’s combined eye drops regimen. A 
complicated medication schedule is a significant risk factor for poor 
adherence to glaucoma medication instructions (Newman-Casey et al. 2015). 
Furthermore, given that steroid eye drops are already administered after 
concomitant cataract and MIGS surgery, it is highly plausible that 
DEXTENZA (which uses a steroid as its active ingredient) should be similar 
in safety. This prospective fellow-eye study will thus target glaucomatous 
eyes to explore the further applications of DEXTENZA®. 
 
1.3 
Rationale 
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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1.4 
Purpose 
The purpose of this study is to compare the safety and efficacy of sustained- 
release dexamethasone insert (DEXTENZA®) to steroid eye drops after 
glaucoma and cataract surgery. 
1.5 
Rationale for Study Design 
This prospective study will enroll 40 eyes from a variable number of total patients. The 
total patient number may vary due to the enrollment of both eyes from some patients 
where possible. All eyes will receive concomitant cataract and MIGS surgery. Each eye 
will be randomized to receive either 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.  
 
In terms of study procedures, the majority are among cataract and MIGS 
preoperative, perioperative, and postoperative standards of care. Such 
procedures include: pachymeter, indirect ophthalmoscope, slit lamp exam, 
BCVA, IOP, visual field, OCT RNFL, corneal endothelial microscopy and 
gonioscopy. The ocular response analyzer will record corneal hysteresis data. 
Corneal hysteresis, as a measure of  the  cornea’s  ability  to  dampen  in  
response  to  an  external  force,  has  been shown in multiple studies to serve as 
an independently valuable risk factor indicating glaucoma progression (Lam 
et al. 2010; Agarwal et al. 2012; Medeiros et al. 2013). To better inform the 
treatment of glaucoma patients during this study, the ocular response analyzer 
is a valid and useful tool. 
 
In terms of primary study endpoints, change in IOP values at 1 and 3 months 
are crucial for quantifying glaucoma outcome differences between groups. 
We will use three methods to comprehensively assess IOP changes, including 
Goldmann applanation tonometry, CATS tonometer prism, and the automatic 
IOP readings provided by the ocular response analyzer. Goldmann is the 
current standard of care, and thus will be the primary measure. However, 
CATS tonometry is a valuable supplement because it utilizes a modified 
prism that may better account for central corneal thickness and corneal 
hysteresis when providing IOP measurements (McCaffertey et al. 2019). 
Change in number of glaucoma medications from preop to 3 months postop 
will be serve as an additional metric to compare glaucoma outcomes. BCVA 
measurements using an ETDRS chart at 4 meters will indicate whether 
DEXTENZA® placement in this population affects the visual acuity 
improvement conferred by an IOL and MIGS. Recording adverse events is 
necessary not only for the integrity of the study, but also for evaluating the 
safety of the DEXTENZA® insert for this study population. 
 
In terms of secondary endpoints, the number of patients requiring 


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supplementary prednisolone acetate 1% eye drops will be recorded to 
compare ocular inflammation between groups. Checking for absence of 
anterior chamber cells at 30 days will provide another measure of control of 
inflammation. Incidence of cystoid macular edema at three months will be 
used to compare macular health between groups. 
 
In previous trials of sustained-release ocular therapeutics, authors have 
commented on the need to explore patient experience as an additional 
measure (Kindle et al. 2018). Two modalities will be used to evaluate patient 
experience between groups. The Ocular Comfort Index (OCI) will be used to 
quantify ocular comfort. The OCI is a 12-item Likert-style questionnaire 
designed to assess the severity of ocular surface irritation. Authors compared 
the OCI against  the Ocular Surface Disease Index and tear-break up time 
(TBUT) values, and also examined changes in OCI scores after application of 
lubricant to dry eyes (Johnson and Murphy 2007). Statistical analysis of those 
three constructs support the use of the OCI to help quantify dry eye disease  
severity. Although participants in this study will not represent a dry eye 
disease population, the OCI nevertheless provides quantifiable data on 
general discomfort in each eye. For sustained released dexamethasone 
specifically, some physicians may be wary that its location in the punctum 
may contribute to discomfort in a way that an intracameral or intravitreal 
steroid would not. The OCI would address such concerns directly. From a 
clinical utility standpoint,  the  OCI  is  favorable  due  to  the  questionnaire’s  
free  access,  an included Excel calculator for rudimentary data analysis, and 
the brevity of  the 12-item questionnaire. Administering the OCI at 1 month 
postop and 3 months postop will offer insight into both the immediate and 
delayed changes in ocular comfort for each group. 
 
2. 
STUDY OBJECTIVES 
2.1 
Primary Objective 
To determine the effect of dexamethasone insert through 90 days as 
measured by – 
• Visual acuity 
• IOP control 
• Adverse events 
2.2 
Secondary Objectives 
To determine the effect of dexamethasone insert through 90 days as 
measured by – 
• Control of inflammation 
• Macular health 
• Patient comfort 
 
3. 
STUDY DESIGN 
3.1 
Study Description and Duration 
This prospective, open-label, single-center, randomized, fellow-eye, 


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investigator-initiated clinical study seeks to investigate the safety and 
efficacy of the dexamethasone insert in glaucoma patients after concomitant 
MIGS and cataract surgery. After screening a given patient for inclusion 
and exclusion criteria, and gaining informed consent, the patient’s eligible 
eye will be randomized to either receive the dexamethasone insert after 
concomitant cataract-MIGS or to receive prednisolone acetate 1% eye 
drops after concomitant cataract-MIGS. For participants who enroll only a 
single eye, block randomization will be performed to ensure that the type 
of MIGS surgeries will be balanced between the two treatment groups. 
This stratification is necessary because it is possible that different MIGS 
devices can confound endpoint measurements, such as IOP control. A 
stratified block randomization schedule will be developed in advance by 
the sub-investigator through a computer program, and each assignment 
will be placed in opaque, sealed envelopes that will be labeled with the 
stratifying MIGS category. The primary investigator will only open an 
envelope after a patient is enrolled and the MIGS type that is suitable for 
the patient is determined. In the few cases where a patient enrolls both 
eyes, the same MIGS surgery will be performed for each eye. Under such 
a circumstance, simple randomization will be sufficient to determine 
whether the first or second eye operated on will receive the 
dexamethasone insert. The other eye will be placed in the prednisolone 
acetate 1% eye drops group.   
 
Per enrolled eye, the study period will last for approximately 90 days after 
surgery, consisting of four postop follow-up visits. At Day 1, Day 7, Day 
30, and Day 90, primary and secondary endpoints will be assessed 
alongside standard-of-care procedures. Adjusting for enrollment period, 
the study will last a total of approximately twelve months.  
 
4. 
SELECTION, WITHDRAWAL, AND REPLACEMENT OF PATIENTS 
4.1 
Study Population 
This study aims to enroll 40 eyes from patients with both cataract and glaucoma.   
 
 
4.1.1 
Inclusion Criteria 
A patient must meet the following criteria to be eligible for inclusion in the 
study: 
 
• At or over the age of 21 
• Cataract surgery candidate and glaucoma present in at least one eye 
• Minimally-invasive glaucoma surgery candidate in at least one 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. 


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4.1.2 
Exclusion Criteria 
A patient who meets any of the following criteria will be excluded from the 
study: 
• 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 non- 
steroidal 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 in either eye 
 
4.2 
Treatment Logistics and Accountability 
4.2.1 Packaging, Labeling, and Storage 
Intracanalicular dexamethasone insert must be stored in a secure area 
accessible only to the Investigator and their designee(s) and refrigerated and 
stored between 2o C and 80 C. Intracanalicular dexamethasone insert 
contains 0.4 mg dexamethasone and is designed to provide a sustained and 
tapered release of therapeutic levels of dexamethasone to the ocular surface 
for up to 30 days for the reduction of post-surgical inflammation and pain 
associated with ocular surgery. Dexamethasone is an anti-inflammatory 9-
fluoro-glucocorticoid (also termed a glucocorticoid agonist) and is the active 
ingredient found in MAXIDEX® 0.1% (dexamethasone ophthalmic 
suspension), which contains approximately 50 µg of dexamethasone per drop. 
 
Study inserts will be supplied by Ocular Therapeutix in a sealed foil pouch 
containing one intracanalicular dexamethasone insert in a foam carrier. 
 
Study inserts will be shipped to the site via overnight shipping using cold 
packs to maintain a temperature of 2° to 8° C. The Investigator, or an 
approved representative (e.g. pharmacist), will ensure that all study drug 
inserts are stored in a secured area, under recommended storage conditions 
and in accordance with applicable regulatory requirements. The shipping box 
is to be opened and stored immediately at the site in a refrigerator intended 


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for investigational products at a temperature of 2° to 8°C. 
 
When the insert is removed from the refrigerator, it should be visually 
inspected. Exposure of the insert to temperatures outside these limits it not 
recommended. Records of actual storage conditions (i.e. temperature log) at 
the study site must be maintained; and must include a record of the dates, 
when the refrigerator was checked, the initials of person checking, and the 
temperature. 
 
4.2.2 Supply and Disposition of Treatments 
Study insert will be shipped at a temperature of 2° to 8°C to the investigator 
as needed during the study. 
 
4.2.3 Treatment Accountability 
All study insert accountability records will be kept current. 
 
The investigator will account for all opened and unopened packaging of study 
inserts. These records will contain the dates, quantity, and study medication 
• Inserted in each patient, 
• disposed of at the site or returned to Ocular Therapeutix 
All accountability records will be made available for inspection by regulatory 
agency inspectors. 
 
4.3 
Concomitant Medications and Procedures 
At the discretion of their physician, patients may continue to receive all 
medications and standard treatments administered for other conditions. 
 
5. 
STUDY SCHEDULE OF EVENTS AND VISIT DESCRIPTIONS 
5.1 
Schedule of Events 
Study assessments and procedures are presented by visit in Table 1. 


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Table 1 
Schedule of Events 
 
Study Procedure 
Screening/ 
Baseline 
Surgica 
l Visit 
Day 0 
Day 1 
Day 7 
Day 30 
3 MTH 
post-op 
Early 
Termi 
nation 
Visit 
VISIT 1 
VISIT 2 
VISIT 3 
VISIT 4 
VISIT 5 
VISIT 6 
Windows for Visits 
(Day -90 to - 
1) 
(+/- 2 
days) 
(+/- 2 
days) 
(+/- 7 
days) 
(+/- 14 
days) 
Inclusion/Exclusion 
X 
Informed Consent 
X 
Demographics 
X 
Medical History and Concurrent 
Illnesses 
X 
Concomitant Medications (inc. 
glaucoma meds and supp. 
prednisolone) 
X 
X 
X 
X 
X 
BCVA (ETDRS at 4m) 
X 
X 
X 
X 
X 
Visual field mean deviation 
X 
X 
Ophthalmic Examination (dilated 
fundus exam) 
X 
X 
X 
X 
X 
Cataract density grade (scale 1 to 
4) and type 
X 
Glaucoma type and severity 
X 
OCT RNFL & Macula 
X 
X 
Intraocular Pressure (Goldmann 
and CATS) 
X 
X 
X 
X 
X 
Corneal Endothelial Specular 
Microscopy 
X 
 
 
 
X 
Gonioscopy 
X 
X 
Ocular Response Analyzer 
X 
X 
Pachymeter 
X 
Indirect Ophthalmoscope 
X 
X 
Indicate the incision type, 
location, and size (mm) 
X 
Type of IOL (e.g. monofocal, toric, 
multifocal, etc.) and lens power 
X 
X 
Type of MIGS device 
X 
X 
Record any surgical complications 
X 
X 
Subject reported AEs prior to or 
after surgery 
X 
X 
X 
X 
X 
X 
Intracanalicular dexamethasone 
insert 
X 
Ocular Comfort Index 
 
X 
X 
Anterior chamber cell count 
X 
X 
X 
X 
Anterior chamber cell flare 
X 
X 
X 
X 
Insert Visualization 
X 
X 
X 
X 
Prescribe post-operative topical 
therapy regimen 
X 


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5.2 
Study Visit Descriptions 
5.2.1 Study Procedures 
Screening/Baseline (Day -90 to -1) 
After the patient has provided informed consent, the following information 
will be collected: 
1. Inclusion/exclusion 
2. Demographics 
3. Medical history and concurrent illnesses 
4. Concomitant medications 
5. Best-corrected visual acuity as measured by ETDRS chart at 4m 
6. Visual field mean deviation 
7. Ophthalmic examination 
8. Grade cataract density and identify type 
9. Glaucoma type and severity 
10. OCT RNFL & Macula 
11. Goldmann Intraocular pressure and CATS intraocular pressure 
12. Corneal endothelial specular microscopy 
13. Gonioscopy 
14. Ocular Response Analyzer 
15. Pachymeter 
16. Indirect ophthalmoscope 
17. Type of IOL 
18. Type of MIGS device (Hydrus, iStent, canaloplasty, or Kahook Dual-Blade) 
19. Subject reported AEs prior to surgery 
 
Surgical visit/Day 0 
1. Indicate the incision type, location, and size 
2. Type of IOL 
3. Type of MIGS device (Hydrus, iStent, canaloplasty, or Kahook 
Dual-Blade) 
4. Record any surgical complications 
5. Intracanicular dexamethasone insert 
 
Day 1 postop (+/- 2 days) 
1. Concomitant medications 
2. Best-corrected visual acuity as measured by ETDRS chart at 4m 
3. Ophthalmic examination 
4. Goldmann Intraocular pressure and CATS intraocular pressure 
5. Subject reported AEs after surgery 
6. Anterior chamber cell count 
7. Anterior chamber cell flare 
8. Insert Visualization 
9. Prescribe post-operative topical therapy regimen 
 
Day 7 postop (+/- 2 days) 


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1. Concomitant medications 


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2. Best-corrected visual acuity as measured by ETDRS chart at 4m 
3. Ophthalmic examination 
4. Goldmann Intraocular pressure and CATS intraocular pressure 
5. Subject reported AEs after surgery 
6. Anterior chamber cell count 
7. Anterior chamber cell flare 
8. Insert Visualization 
 
Day 30 postop (+/- 7 days) 
1. Concomitant medications 
2. Best-corrected visual acuity as measured by ETDRS chart at 4m 
3. Ophthalmic examination 
4. Goldmann Intraocular pressure and CATS intraocular pressure 
5. Subject reported AEs after surgery 
6. Anterior chamber cell count 
7. Anterior chamber cell flare 
8. Insert Visualization 
9. Ocular Comfort Index 
 
3 month postop (+/- 14 days) 
1. Concomitant medications 
2. Best-corrected visual acuity as measured by ETDRS chart at 4m 
3. Ophthalmic examination 
4. Goldmann Intraocular pressure and CATS intraocular pressure 
5. Corneal endothelial specular microscopy 
6. Subject reported AEs after surgery 
7. Anterior chamber cell count 
8. Anterior chamber cell flare 
9. Insert Visualization 
10. OCT RNFL & Macula 
11. Visual field mean deviation 
12. Gonioscopy 
13. Ocular Response Analyzer 
14. Ocular Comfort Index 
15. Indirect ophthalmoscope 
 
 
5.2.2 Unscheduled Visits 
All attempts should be made to keep patients on the study schedule. 
Unscheduled visits may be necessary to repeat testing following abnormal 
laboratory results, for follow-up of AEs, or for any other reason, as warranted. 


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5.2.3 Adverse Event Information Collection 
The investigator (or designee) will record all AEs that occur during the study 
The definition of an AE and SAE, and information on the determination of 
severity and relationship to treatment are provided in Section 7. 
 
5.3 
Rescue Criteria 
Rescue criteria include any of the following: moderate to severe photophobia, 
moderate to severe ciliary or conjunctival injection, or excessive anterior 
chamber cells or flare. 
 
Rescue treatment would include supplementary prednisolone acetate 1% 
drops and/or topical NSAIDs, at the discretion of the study doctor. 
 
6. 
RISK/BENENFIT ASSESSMENT 
6.1 
Risks 
Use of corticosteroids on the eye, whether they are steroid drops or sustained- 
release inserts like DEXTENZA®, can worsen glaucoma with damage to the 
optic nerve by increasing intraocular pressure. Corticosteroids may suppress 
the host immune system and increase risk for bacterial infection, fungal 
infection, and viral infection. The use of steroids after eye surgery may delay 
healing and increase the incidence of bleb formation. DEXTENZA® may be 
ineffective. DEXTENZA® may cause discomfort in the eye. DEXTENZA® 
may involve unforeseeable risks. DEXTENZA® may involve additional risks 
that are currently unknown. Because DEXTENZA® is FDA approved for the 
treatment of postoperative ocular inflammation and pain, minimal overall  
risk to patients is anticipated. 
6.2 
Prevention of Risks 
At each follow-up visit, risks will be monitored through conversations with 
the participant regarding their postoperative issues and visualized thorough  
all components of the ophthalmic exam (please see Table 1). Rescue 
treatment will be administered as per the criteria of section 5.3. 
6.3 
Benefits 
For the eye receiving DEXTENZA®, a potential benefit is that the participant 
will not have to take steroid eye drops in that eye after surgery. 
DEXTENZA® may potentially be more comfortable and/or convenient than 
steroid eye drops. The results of this study will benefit future patients by 
providing clinical evidence comparing the safety and efficacy of DEXTENZA® 
to steroid eye drops in eyes with glaucoma and a cataract. 


The SUSTAIN Study (V4) 
October 18, 2020 
Page 16 
CONFIDENTIAL 
 
 
6.4 
Alternative Treatments 
Steroid eye drops are the standard-of-care alternative to DEXTENZA®. Also, 
DEXYCU® is another type of sustained-release dexamethasone drug that is 
currently FDA-approved for the same indication as DEXTENZA®. 
DEXYCU® is injected inside the eye, behind the iris of the eye. No currently 
published study has compared DEXTENZA® to DEXYCU®, so the relative 
advantages and disadvantages are not clearly known. 
 
 
7. 
SAFETY DEFINITIONS, REPORTING, AND MONITORING 
7.1 
Definitions 
7.1.1 Adverse Event 
An AE is any untoward medical occurrence in a patient administered a study 
drug which may or may not have a causal relationship with the study drug. 
Therefore, an AE is any unfavorable and unintended sign (including 
abnormal laboratory finding), symptom, or disease which is temporally 
associated with the use of a study drug, whether or not considered related to 
the study drug. 
 
An AE also includes any worsening (i.e. any clinically significant change in 
frequency and/or intensity) of a pre-existing condition that is temporally 
associated with the use of the study drug. 
 
7.1.2 Serious Adverse Event 
A SAE is any untoward medical occurrence that at any dose: 
• Results in death – includes all deaths, even those that appear to be 
completely unrelated to study drug (e.g. a car accident in which a patient 
is a passenger). 
• Is life-threatening – in the view of the investigator, the patient is at 
immediate risk of death at the time of the event. This does not include an 
AE that had it occurred in a more severe form, might have caused death. 
• Requires in-patient hospitalization or prolongation of existing 
hospitalization. In-patient hospitalization is defined as admission to a 
hospital or an emergency room for longer than 24 hours. Prolongation of 
existing hospitalization is defined as a hospital stay that is longer than 
was originally anticipated for the event, or is prolonged due to the 
development of a new AE as determined by the investigator or treating 
physician. 
• Results in persistent or significant disability/incapacity (substantial 
disruption of one’s ability to conduct normal life functions). 
• Is a congenital anomaly/birth defect 
• Is an important medical event – Important medical events may not be 
immediately life-threatening or result in death or hospitalization, but may 


The SUSTAIN Study (V4) 
October 18, 2020 
Page 17 
CONFIDENTIAL 
 
 
jeopardize the patient or may require intervention to prevent 1 of the  
other serious outcomes listed above (e.g., intensive treatment in an 
emergency room or at home for allergic bronchospasm; blood dyscrasias or 
convulsions that do not result in hospitalization; or development of drug 
dependency or drug abuse). Any malignancy (other than basal cell skin 
cancers) would be considered a medically important event. 
 
7.2 
Recording and Reporting Adverse Events 
All AEs and SAEs will be recorded only if they are medically relevant. 
 
All SAEs, regardless of assessment of causal relationship to study insert will 
be reported to Ocular Therapeutix. 
To report an SAE, Ocular Therapeutix will be contacted at the 
following: 
ocutx.pharmacovigilance@propharmagroup.com 
SAE hotline: 844-668-3948 
 
The investigator will promptly report to the IRB all unanticipated problems 
involving risks to patients. This includes death from any cause and all SAEs 
related to the use of the study insert. All SAEs will be reported to the IRB, 
regardless of assessed causality. 
 
8. 
STUDY VARIABLES 
8.1 
Demographic and Baseline Characteristics 
Baseline characteristics will include standard demography (e.g. age, race, 
weight, height, etc.), disease characteristics including medical history, and 
medication history for each patient. 
 
8.2 
Primary and Secondary Endpoints 
Primary Endpoints 
Effect of dexamethasone insert through Day 90 as measured by – 
1. Mean Reduction in IOP at 1 and 3 months as measured by Goldmann 
Applanation Tonometer and comparison between groups 
2. Mean change in ETDRS BCVA at 1 and 3 months and comparison 
between groups 
3. Difference in adverse events between the two groups 
4. Difference in number of glaucoma medications between the wo groups at 3 
months 
Secondary Endpoints 
Through Day 90 as measured by – 
1. Number of patients requiring supplemental prednisolone acetate 1% eye 
drops 
2. Incidence of CME at 90 days as seen on OCT 


The SUSTAIN Study (V4) 
October 18, 2020 
Page 18 
CONFIDENTIAL 
 
 
3. Difference in Ocular Comfort Index between the two groups at 1 month 
and 3 months 
4. Difference in percentage of patients with absence of anterior chamber cells 
at 30 days between groups 
 
9. 
STATISTICAL PLAN 
Primary endpoints and secondary endpoints will be analyzed through 
statistical hypothesis testing. Demographic and baseline characteristics will 
be summarized descriptively. Continuous variables will be summarized with 
mean, median, and standard deviation. Categorical variables will be 
summarized with frequency and percentage. 
 
10. 
ETHICAL AND REGULATORY CONSIDERATIONS 
10.1 Good Clinical Practice Statement 
It is the responsibility of the investigator(s) to ensure that this clinical study 
will be conducted in accordance with the ethical principles that have their 
origin in the Declaration of Helsinki, and that are consistent with the ICH 
guidelines for Good Clinical Practice (GCP) and applicable regulatory 
requirements. 
 
10.2 Recruiting 
Participants will be recruited from the New York Eye Surgery Center in the 
Bronx, NY. Potential participants will be identified based on information in 
their medical records and most recent exam findings. The investigator will 
discuss the study with potential participants at their check-up appointment. 
The potential participant will be provided with information on the study 
device, the study protocol, risks and benefits, patient data security, 
procedures if an adverse event occurs, travel compensation, and the informed 
consent form. The investigator will present reasonable alternatives to the 
study device. The investigator will emphasize that participation is entirely 
voluntary,  and  that  neither  the  patient’s  relationship  with  the  investigator 
nor his/her quality of care will be impacted by the decision to or to not 
participate. The investigator will encourage the potential participant to ask 
questions, and will respond to whatever questions arise. 
 
10.3 Informed Consent 
The principles of informed consent are described in ICH Guidelines for GCP. 
 
Ocular Therapeutix will have the right to review and comment on the 
informed consent form. 


The SUSTAIN Study (V4) 
October 18, 2020 
Page 19 
CONFIDENTIAL 
 
 
 
It is the responsibility of the investigator or designee (if acceptable by local 
regulations) to obtain written informed consent from each patient prior to 
his/her participation in the study and after the aims, methods, objectives, and 
potential hazards of the study have been explained to the patient in language 
that he/she can understand. The ICF will be signed and dated by the patient 
and by the investigator or authorized designee who reviewed the ICF with  
the patient. 
 
Patients who can write but cannot read will have the ICF read to them before 
signing and dating the ICF. 
Patients who can understand but who can neither write nor read will have 
the ICF read to them in presence of an impartial witness, who will sign and 
date the ICF to confirm that informed consent was given. 
 
The original ICF will be retained by the investigator as part of the patient’s 
study record, and a copy of the signed ICF will be given to the patient. 
 
If new safety information results in significant changes in the risk/benefit 
assessment, the ICF will be reviewed and updated appropriately. All study 
patients will be informed of the new information and provide their written 
consent if they wish to continue in the study. The original signed revised ICF 
will be maintained in the patient’s study record and a copy will be given to the 
patient. 
 
10.4 
Storage of Data 
Data from the study will be stored in paper files and electronically. The 
investigator, sub-investigator, study staff, and Ocular Therapeutix will have 
access to the data purely for research purposes. Microsoft Excel and the 
Medflow electronic medical record system will be used to manage and extract 
patient data. 
 
10.5 
Confidentiality of Data 
The investigator will take all appropriate measures to ensure that the 
anonymity of each study patient will be maintained. 
 
The patient’s and investigator’s personal data will be treated in compliance 
with all applicable laws and regulations. 
 
Paper files will be secured in a locked drawer accessible only to the 
investigator, the research assistant, and study staff. Medflow data will be 
stored under password protection in the servers of the New York Eye Surgery 


The SUSTAIN Study (V4) 
October 18, 2020 
Page 20 
CONFIDENTIAL 
 
 
Center. Excel spreadsheet data will be stored locally in the sub-investigator’s 
password-protected and antivirus-secured Macbook laptop. Participant  names 
will be coded by randomized numbers. 
10.6 
Participant Comprehension and Capacity 
To assess comprehension, the potential participant will be asked to “teach 
back” to the principal investigator what he/she learned about the study from 
the informed consent form. At minimum, they will be quizzed on: 1) What 
DEXTENZA® does; 2) Risks to participating; 3) How many follow-up visits 
they  are  expected   to  attend;  4)  How   late  the  participant’s   second   eye’s 
surgery can be scheduled after the first eye surgery; and 5) What happens in 
the event of a complication. Potential participants will also be asked to voice 
any questions they have to the principal investigator. 
 
10.7 
Costs to Participants 
The study doctor, Dr. Radcliffe, will be covering the costs of all procedures 
and necessary follow-ups associated with the study. 
10.8 
Compensation to Participants 
Participants will receive $10 at each post-surgical follow up visit, per eye, in order to 
cover the costs of travel. If a participant completes all four post-surgical follow-up visits 
in one eye, the participant will have received $40 in total. If a participant enrolls two eyes 
and completes a total of eight post-surgical follow-up visits, he or she will have received 
$80 in total. 
 
10.9 Institutional Review Board 
An appropriately constituted IRB, as described in ICH Guidelines for GCP, 
will review and approve: 
• The protocol, ICF, and any other materials to be provided to the patients 
(e.g. advertising) before any patient may be enrolled in the study 
• Any amendment or modification to the study protocol or ICF before 
implementation, unless the change is necessary to eliminate an 
immediate hazard to the patients, in which case the IRB will be informed 
as soon as possible 
 
Ongoing studies will be reviewed by the IRB/EC on an annual basis or at 
intervals appropriate to the degree of risk. 
 
In addition, the IRB will be informed of any event likely to affect the safety of 
patients or the continued conduct of the clinical study. 
 
A copy of the IRB approval letter will be sent to Ocular Therapeutix prior to 
shipment of drug insert supplies to the investigator. The approval letter will 
include the study title, the documents reviewed, and the date of the review. 


The SUSTAIN Study (V4) 
October 18, 2020 
Page 21 
CONFIDENTIAL 
 
 
Records of the IRB review and approval of all study documents (including 
approval of ongoing studies) will be kept on file by the investigator. 


The SUSTAIN Study (V4) 
October 18, 2020 
Page 22 
CONFIDENTIAL 
 
 
REFERENCES 
 
Agarwal DR, Ehrlich JR, Shimmyo M, et al. The relationship between corneal 
hysteresis and the magnitude of intraocular pressure reduction with topical 
prostaglandin therapy. Br J Ophthalmol. 2012 Feb;96(2):254-7. 
 
Johnson ME, Murphy PJ. Measurement of Ocular Surface Irritation on a 
Linear Interval Scale with the Ocular Comfort Index. Invest Ophthalmol Vis 
Sci. 2007;48(10):4451. 
 
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;7(7):CD010516. 
 
Kindle T, Ferguson T, Ibach M, et al. Safety and efficacy of intravitreal 
injection of steroid and antibiotics in the setting of cataract surgery and 
trabecular microbypass stent. Journal of Cataract & Refractive Surgery. 
2018;44(1):56-62. 
 
Lam A, Chen D, Tse J. The usefulness of waveform score from the Ocular 
Response Analyzer. Optomet Vis Sci. 2010;87:195–199. 
 
McCafferty SJ, Tetrault K, McColgin A, Chue W, Levine J, Muller M. Modified Goldmann 
prism intraocular pressure measurement accuracy and correlation to corneal biomechanical 
metrics: multicentre randomised clinical trial. Br J Ophthalmol. 2019;103(12):1840. 
 
Medeiros FA, Meira-Freitas D, Lisboa R, et al. Corneal hysteresis as a risk 
factor for glaucoma progression: a prospective longitudinal study. 
Ophthalmology. 2013;120:1533-1540. 
 
Newman-Casey PA, Robin AL, Blachley T, et al. The most common barriers   
to glaucoma medication adherence: a cross-sectional survey. Ophthalmology. 
2015;122(7):1308–1316. 
 
Potvin R, Fisher B. Transzonular vitreous injection vs a single drop 
compounded topical pharmaceutical regimen after cataract surgery. Clinical 
Ophthalmology. 2016;Volume 10:1297-1303. 


Clinical Study Protocol 
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ICF_001.pdf: 
STUDY: DEXTENZA® Safety and Efficacy following concomitant MIGS and Cataract Surgery 
STERLING IRB ID:  «IRB_ID» 
 
 
Page 1 of 8 
Version Date: 10/16/2020 
DATE APPROVED BY STERLING IRB: 10/20/20 
PARTICIPANT INFORMED CONSENT FORM AND 
AUTHORIZATION TO USE AND DISCLOSE MEDICAL INFORMATION 
 
STUDY TITLE: 
Prospective Study on DEXTENZA® Safety and Efficacy following 
concomitant MIGS and Cataract Surgery 
 
STUDY DOCTOR: 
«First_Name» «Middle_Name» «Last_Name», «Suffix» 
 
STUDY SITE: 
«Company_Name» 
 
 
 
«Address» 
 
 
 
«City_State_ZIP» 
 
TELEPHONE: 
«Telephone» 
 
 
 
«Telephone_2_if_applicable» 
 
SPONSOR: 
 
Ocular Therapeutix 
 
You are being asked to participate in a medical research study. Your participation in this research 
study is strictly voluntary, meaning that you may or may not choose to take part. To decide 
whether or not you want to be part of this research, the risks and possible benefits of the study 
are described in this form so that you can make an informed decision. This process is known as 
informed consent. This consent form describes the purpose, procedures, possible benefits and 
risks of the study. This form explains how your medical information will be used and who may see 
it. You may have a copy of this form to review at your leisure or to ask advice from others. You 
will receive a separate consent form that sets forth the purpose, procedures, benefits, and risks 
of the cataract and glaucoma surgeries.  
 
Dr. Radcliffe or the study staff will answer any questions you may have about this form or about 
the study. Please read this document carefully and do not hesitate to ask anything about this 
information. This form may contain words that you do not understand. Please ask Dr. Radcliffe or 
the study staff to explain the words or information that you do not understand. After reading the 
consent form, if you would like to participate, you will be asked to sign this form. You will be given 
a signed copy of your consent form to take home and keep for your records. 
 
BACKGROUND AND PURPOSE 
 
You are being asked to participate in this study because you have been diagnosed with glaucoma 
and a cataract in at least one eye. After simultaneous surgery for glaucoma and a cataract, 
patients must take multiple eye drops daily to control glaucoma, prevent infection, reduce 
inflammation, and relieve pain. Taking many eye drops is a burden that can be confusing. Patients 
may forget to take some drops. This can cause issues like slower healing time and cystoid 
macular edema, which can block vision.  
 
The purpose of this study is to compare the safety and efficacy of DEXTENZA® to steroid eye 
drops after glaucoma and cataract surgery. 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 


STUDY: DEXTENZA® Safety and Efficacy following concomitant MIGS and Cataract Surgery 
STERLING IRB ID:  «IRB_ID» 
 
 
Page 2 of 8 
Version Date: 10/16/2020 
DATE APPROVED BY STERLING IRB: 10/20/20 
eye’s moisture. DEXTENZA® delivers 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.  
 
DEXTENZA® can be used to replace anti-inflammatory steroid eye drops, which may make 
recovery after eye surgery easier and safer for patients. In this study, we are comparing 
DEXTENZA® to the current standard of care, steroid eye drops (prednisolone acetate 1%), to see 
how safe and effective DEXTENZA® can be for eyes with glaucoma and a cataract. This is a 
randomized study, meaning that the eye you enroll for this study has an equal chance of receiving 
either the steroid eye drops or DEXTENZA®. If you choose to enroll both eyes, then one of your 
eyes will receive the steroid eye drops, while the other will receive DEXTENZA®. This is an open-
label study, meaning that you will know whether your eye receives the DEXTENZA® insertion. 
DEXTENZA® is approved by the U.S. Food and Drug Administration (FDA) to treat inflammation 
and pain following eye surgery. It has not been tested in patients who are having glaucoma and 
cataract surgery at the same time, therefore its use in this study is investigational. 
 
Approximately 40 or less men and women age 21 and older will be enrolled in this study, and all 
participants will be recruited from the New York Eye Surgery Center in the Bronx, NY. A total of 
40 eyes will be involved in the study.  
 
DURATION 
 
You will be expected to participate in this study for 3 months after your surgery if you enroll one 
eye. If you enroll both eyes, you will be expected to participate for up to 6 months after your first 
eye’s surgery. 
 
PROCEDURES 
 
If your medical record indicates that you meet the inclusion criteria for this study, Dr. Radcliffe will 
discuss the study with you during your regular clinic visit. If you agree to participate, your eye will 
be assigned by chance, like the flip of a coin, to either the DEXTENZA® group or the prednisolone 
acetate 1% steroid eye drops group before surgery. If you agree to enroll both eyes in the study, 
then the other eye will be assigned to the group opposite the first eye. 
 
For the eye or eyes you enroll, you will receive minimally invasive glaucoma surgery and cataract 
surgery to treat your glaucoma and cataract. If your eye is randomized to receive DEXTENZA®, 
you will also receive an insertion of DEXTENZA® at the end of the operation. The operation 
without DEXTENZA®, including just glaucoma surgery and cataract surgery, typically takes 10-20 
minutes. DEXTENZA® adds less than five minutes to the operation. 
 
After the surgery, you will be expected to take antibiotic eye drops and glaucoma eye drops daily 
as standard of care for both eyes, unless Dr. Radcliffe states otherwise. If an eye received the 
DEXTENZA® insertion, you will not take steroid eye drops in that eye. If an eye does not receive 
the DEXTENZA® insertion, you will be required to take prednisolone acetate 1% steroid eye drops 
in that eye according to Dr. Radcliffe’s instructions. 
 


STUDY: DEXTENZA® Safety and Efficacy following concomitant MIGS and Cataract Surgery 
STERLING IRB ID:  «IRB_ID» 
 
 
Page 3 of 8 
Version Date: 10/16/2020 
DATE APPROVED BY STERLING IRB: 10/20/20 
You will be asked to come to 4 post-surgery follow-up visits for each eye you enroll, lasting 
approximately 15-30 minutes each, as follows: 
 
▪ 
1 day after surgery 
▪ 
1 week after surgery 
▪ 
1 month after surgery 
▪ 
3 months after surgery 
 
If you enroll both eyes, you will attend eight follow-up visits in total. 
 
All follow-up visits would be scheduled to check on your recovery even if you did not participate 
in this study. Standard of care assessments such as visual acuity, visual field testing, ophthalmic 
examination, recording side effects, and intraocular pressure measurements will be performed at 
some or all follow-up visits.  
 
At the 1 month follow-up and the 3 month follow-up visits, you will also be asked to complete a 
12-item questionnaire called the Ocular Comfort Index. This questionnaire will ask about how one 
eye feels. It will take about 5 more minutes to complete the survey. If you have difficulty reading, 
staff members will read to you the questionnaire in your preferred language for you to answer 
verbally. 
 
During this study, you are responsible for following Dr. Radcliffe’s instructions on treatment plan, 
coming to appointments on time, and reporting any issues you notice to Dr. Radcliffe or staff. 
 
POTENTIAL RISKS, SIDE EFFECTS, DISCOMFORTS, INCONVENIENCES 
 
Use of corticosteroids on the eye, whether they are steroid drops or sustained-release inserts like 
DEXTENZA®, can worsen glaucoma with damage to the optic nerve by increasing intraocular 
pressure. Corticosteroids may suppress the immune system and increase risk for bacterial 
infection, fungal infection, and viral infection. The use of steroids after eye surgery may delay 
healing and increase the incidence of bleb formation.  
 
DEXTENZA® may be ineffective. DEXTENZA® may cause discomfort in the eye. DEXTENZA® 
may involve risks that are unforeseeable to you, an embryo or fetus you carry, or an infant you 
are nursing. DEXTENZA® may involve additional risks that are currently unknown.  
 
POTENTIAL BENEFITS 
 
If your eye receives DEXTENZA®, a potential benefit is that you will not have to take steroid eye 
drops in that eye after surgery. DEXTENZA® may potentially be more comfortable and/or 
convenient than steroid eye drops. There is no guarantee that DEXTENZA® will help you. 
 
The results of this study will benefit future patients by providing clinical evidence comparing the 
safety and efficacy of DEXTENZA® to steroid eye drops in eyes with glaucoma and a cataract.  
 
 
 


STUDY: DEXTENZA® Safety and Efficacy following concomitant MIGS and Cataract Surgery 
STERLING IRB ID:  «IRB_ID» 
 
 
Page 4 of 8 
Version Date: 10/16/2020 
DATE APPROVED BY STERLING IRB: 10/20/20 
ALTERNATIVE TREATMENTS 
 
You can choose to receive DEXTENZA® without participating in this study. You can opt for the 
standard of care steroid eye drops without participating in this study. Alternatively, you can choose 
to receive a different type of sustained-release dexamethasone. The FDA-approved injection 
known as DEXYCU® is one example. DEXYCU® is injected inside the eye, behind the iris of the 
eye. No currently published study has compared DEXTENZA® to DEXYCU®, so the relative 
advantages and disadvantages are not clearly known. 
 
NEW INFORMATION 
 
You will be informed in a timely manner if new information that may influence your willingness to 
continue participation in the study becomes available.  
 
COMPENSATION TO YOU 
 
You will receive $10.00 for each completed follow-up visit. A completed visit means all scheduled 
study procedures have been carried out. If you have one eligible eye and enroll that eye, you can 
receive a maximum of $40 total from 4 follow-up visits. If you have two eligible eyes and enroll 
both, you can receive a maximum of $80 total from 8 follow-up visits. 
 
COSTS TO YOU 
 
Insertion of DEXTENZA® and completion of study-related questionnaires are being done only for 
this study. Therefore, you and your insurance provider will not be billed for these procedures.  You 
will not be charged for any pre-operative or post-operative clinic visits related to the study and will 
not be charged for study procedures that occur during those clinic visits. You and/or your 
insurance provider will be responsible for the costs of the glaucoma and cataract surgery and all 
medications related to your surgery. 
 
VOLUNTARY PARTICIPATION/WITHDRAWAL 
 
Your decision to participate is entirely voluntary. You may elect to receive alternative treatment.  
You may refuse to participate or withdraw from the study, at any time, without penalty or loss of 
benefits to which you are otherwise entitled. Your ongoing medical care will not be affected by 
your decision to be in this study or to withdraw from the study. If you decide to withdraw from the 
study, please talk to Dr. Radcliffe to make sure this is done safely. 
 
Your participation may be stopped without your consent by Dr. Radcliffe or the FDA for any 
reason. For example, your participation may be stopped: 
 
▪ 
if you do not undergo your second eye’s surgery within 90 days of the first surgery 
▪ 
if it is deemed to be in the best interest of your health and welfare. 
▪ 
if you fail to respond to the study implant. 
▪ 
if your disease worsens or you have severe or unacceptable side effects. 
▪ 
if you fail to follow instructions. 
 


STUDY: DEXTENZA® Safety and Efficacy following concomitant MIGS and Cataract Surgery 
STERLING IRB ID:  «IRB_ID» 
 
 
Page 5 of 8 
Version Date: 10/16/2020 
DATE APPROVED BY STERLING IRB: 10/20/20 
STUDY COMPLICATIONS AND COMPENSATION 
 
Every effort to prevent a study-related injury will be taken by Dr. Radcliffe and staff. Medical care 
will be made available to you to treat any physical injury incurred by you as a direct result of the 
study procedures. In the event you are injured as a direct result of the study in accordance with 
Dr. Radcliffe’s instructions and the study protocol, you should immediately contact Dr. Radcliffe 
and emergency treatment will be provided. Medical care for research-related injury will be 
provided by Dr. Radcliffe or another physician at the New York Eye Surgery Center at zero cost 
to you. 
 
You agree to cooperate in obtaining any proceeds from insurance or other third-party coverage 
that may be available. No financial payments or other forms of compensation (such as lost wages, 
physical therapy or other recovery needs, other loss of income or pain or suffering or discomfort) 
have been set aside for such injuries; however, you do not waive any of your legal rights or release 
anyone from liability for negligence by signing this document. 
 
CONFIDENTIALITY AND AUTHORIZATION TO COLLECT, USE AND DISCLOSE YOUR 
MEDICAL INFORMATION 
 
As a part of this research, records that contain information or data about you and your health may 
be collected and used. These records may identify you and will be kept as confidential as possible. 
To the extent permitted by applicable laws and regulations, the records identifying you will not be 
made publicly available. 
 
Under the privacy laws, you have the rights to decide who can use your protected health 
information (called PHI). When you sign this form, you are saying that you will allow the use of 
your protected health information for this study. 
 
The information that will be collected about you as a part of this research includes: 
 
▪ 
Name 
▪ 
Address 
▪ 
Telephone number 
▪ 
Birth date 
▪ 
Race 
▪ 
Sex 
▪ 
Family medical history 
▪ 
Allergies 
▪ 
Medications you take (current and past) 
▪ 
Information from the physical examination done by Dr. Radcliffe 
▪ 
Results of study tests and study procedures 
▪ 
Other information from other doctors’ offices, clinics, and/or hospitals that is needed for the 
study 
 
Information collected about you for the study will be kept in a research file that is separate from 
your medical chart. You will not be able to see your research file until after the end of the study. 
 


STUDY: DEXTENZA® Safety and Efficacy following concomitant MIGS and Cataract Surgery 
STERLING IRB ID:  «IRB_ID» 
 
 
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Version Date: 10/16/2020 
DATE APPROVED BY STERLING IRB: 10/20/20 
The study team will know your identity; however, your records will be labeled with a code that is 
randomly assigned to you. The research staff are the only people who will have this code and its 
key. 
 
The following groups may review and use your study information. They may review your study 
information to make sure that it is correct. They may also review your information to make sure 
that the study is being conducted properly. 
 
▪ 
The study sponsor (or sponsor representatives such as monitors and/or auditors) 
▪ 
The U.S. Food and Drug Administration (FDA) 
▪ 
Sterling Institutional Review Board (IRB) 
▪ 
The Department of Health and Human Service (DHHS) 
▪ 
Other government agencies in other countries 
▪ 
Other doctors, health care professionals or research staff who are involved in the study 
 
Your study information may be released to the groups listed above. If your study information is 
reviewed by these people, they may need to see your entire medical record; it is possible that 
your Social Security number may be included in the records reviewed. Because of this, it cannot 
be assured that your confidentiality will always be protected. It is possible that your information 
will be shared (re-disclosed) in a way that it would no longer be protected. However, this access 
to your records will be granted without violating your confidentiality to the extent permitted by 
applicable laws and regulations. By signing this form, you are authorizing this access to your 
records. 
 
The results of the study, including your information, may also be presented at meetings or in 
articles written about the study (publications). If the results of the study (including your research 
or health information) are published, your identity will remain confidential. 
 
This permission (also called an authorization) will have no end date. 
 
You have a right to see your study records; however, you will not be able to see your study records 
until after the study has ended. 
 
You may also take away (or withdraw) your permission for the use of your protected health 
information at any time. If you choose to withdraw your permission, you must write your Dr. 
Radcliffe a letter. 
 
Dr. Radcliffe’s mailing address is the New York Eye Surgery Center, 1101 Pelham Pkwy N, The 
Bronx, NY 10469. Dr. Radcliffe will still be able to use the health information collected about you 
before you withdrew your permission. Information that has already been sent to the sponsor of 
the study cannot be taken back. 
 
If you withdraw your permission after you have entered the study, you cannot continue 
participating in the study. If you refuse to give permission or withdraw your permission, your 
medical care and your relationship with the health care providers at the study center will not be 
affected. 
 


STUDY: DEXTENZA® Safety and Efficacy following concomitant MIGS and Cataract Surgery 
STERLING IRB ID:  «IRB_ID» 
 
 
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A description of this research study will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time.  
 
QUESTIONS 
 
If you have questions, concerns or complaints about the research study or you experience a 
research-related injury, please contact Dr. Radcliffe at (201) 925-0476 or the study staff at (718) 
519-1000. 
 
If you have questions regarding your rights as a research participant, or if you have questions, 
concerns, complaints about the research, would like information, or would like to offer input, you 
may contact the Sterling Institutional Review Board Regulatory Department, 6300 Powers Ferry 
Road, Suite 600-351, Atlanta, Georgia 30339 (mailing address) at telephone number 1-888-636-
1062 (toll free). 


STUDY: DEXTENZA® Safety and Efficacy following concomitant MIGS and Cataract Surgery 
STERLING IRB ID:  «IRB_ID» 
 
 
Page 8 of 8 
Version Date: 10/16/2020 
DATE APPROVED BY STERLING IRB: 10/20/20 
PARTICIPANT STATEMENT AND AUTHORIZATION 
 
I have read or have had read to me the Participant Informed Consent Form and Authorization to 
Use and Disclose Medical Information and I agree to participate voluntarily in this study. I give my 
permission to Dr. Radcliffe to use and disclose my protected health information as described in 
this consent form. 
 
I will receive a signed copy of this form, which has 8 pages. 
 
All my questions have been answered. 
 
I have not waived any of my legal rights by signing this document. 
 
 
____________________________________________ 
Printed Name of Participant 
 
 
____________________________________________ 
 
________________ 
Signature of Participant 
 
 
 
 
 
Date 
 
 
____________________________________________ 
Printed Name of Person Explaining Consent 
 
 
____________________________________________ 
 
________________ 
Signature of Person Explaining Consent 
 
 
 
Date 
(if other than the Principal Investigator) 
 
____________________________________________ 
 
________________ 
Signature of Principal Investigator 
 
 
 
 
Date