In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery
Phase: PHASE4
Conditions: Cataract
Sponsor: Vance Thompson Vision

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Appendix A 
Protocol 
 
 
Investigator-Initiated Study Protocol 
 
 
In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery 
 
The PREPARE Study 
 
 
 
Compound: 
DEXTENZA (dexamethasone 
ophthalmic insert) 0.4 mg, for 
intracanalicular use 
 
 
Study Name: 
In Clinic Optometrist Insertion of 
Dextenza Prior to Cataract Surgery 
 
The Prepare Study 
 
 
 
Clinical Phase: 
Investigator-Initiated Clinical Trial 
 
 
Date of Issue: 
9/24/2020 
 
 
Primary Investigator: 
Mitch Ibach, OD 
 
 
Sub Investigator: 
Justin Schweitzer, OD 
John Berdahl, MD 
Doug Wallin, OD 
Keith Rasmussen, OD 
Vance Thompson, MD 
Larae Zimprich, OD 
Jason Schmit, OD 
Daniel Terveen, MD 
 
Site Name & Location: 
Vance Thompson Vision Center 
3101 West 57th Street 
Sioux Falls, South Dakota 
57108 
 
 
 
 

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CLINICAL STUDY PROTOCOL SYNOPSIS 
TITLE 
The PREPARE Study 
SITE LOCATION(S) 
 
Vance Thompson Vision Center 
3101 West 57th Street 
Sioux Falls, South Dakota 
57108 
PRINCIPAL 
INVESTIGATOR 
Mitch Ibach, OD 
 
OBJECTIVE(S) 
To evaluate the clinical outcomes with optometrist 
pre-surgical insertion of DEXTENZA in the clinical 
office setting in patients undergoing same-day 
cataract surgery compared to standard of care 
steroid therapy. 
STUDY DESIGN 
Prospective Open-label Interventional Study 
STUDY DURATION 
2-3 months from start-up 
ESTIMATED STUDY 
COMPLETION DATE 
Insert date of study completion  
POPULATION 
 
Sample Size: 
N=60 (30 patients, 60 eyes) 
Target Population: 
Patients planning to undergo sequential bilateral 
cataract surgery. 
TREATMENT(S) 
 
 
 
Study Drug 
 
 
 
Dose/Route/Schedule: 
DEXTENZA (dexamethasone ophthalmic insert) 0.4 
mg, for intracanalicular use  
 
All patients will be enrolled for cataract surgery. 
Each study subject will have their first eye 
randomized to either the Control Group or the 
Experimental Group. The second eye will be selected 
for the opposite group. All eyes will receive 
intracameral 
dexamethasone+moxifloxacin+ketorolac (DMK) at 
the time of surgery. All eyes will be placed on topical 
antibiotic (Vigamox 0.5%) QID for one week and 
topical NSAID ((Prolensa (Bromfenac 0.07%)) QD for 
one month.  
 
Experimental Group (Treatment A): 30 eyes will 
receive DEXTENZA insertion, placed in the office by 
the optometrist prior to their same-day cataract 
surgery. 
 
Control Group (Treatment B): 30 eyes will receive 

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topical prednisolone acetate 1% QID for one week, TID 
for one week, BID for one week, QD for one week. 
 
ENDPOINT(S) 
 
Primary: 
To determine the effect of dexamethasone 
intracanalicular insert through Week 4 as measured 
by: 
x Mean anterior chamber cell/flare score as 
measured by Slit Lamp Biomicroscopy 
evaluation using grading scale of 0 to 4 + 
(SUN Working Group Grading Scheme) at 
post-op Day 1, Day 7, and Week 4.  
x Mean pain score as measured by Visual 
Analog Score numerical grading scale 0-10 at 
post-op Day 1, Day 7, and Week 4. 
To determine patient preference through Week 4 as 
measured by: 
x Adapted COMTOL Questionnaire at Week 4.  
Secondary: 
To determine the effect of dexamethasone 
intracanalicular insert through Week 4 or 12: 
x Incidence of increased intraocular pressure 
(IOP) >10mmHg above baseline as measured 
by Goldmann Applanation Tonometer at post-
op Day 1, Day 7, and Week 4. 
x Incidence of Cystoid Macular Edema (CME) as 
measured by optical coherence tomography 
(OCT) at post-op Week 4. 
To determine physician ease of insertion following 
dexamethasone intracanalicular insert placement 
prior to same-day surgery as measured by: 
x Physician Ease of Use Survey following 
dexamethasone intracanalicular placement on 
Surgical Visit Day 0.  
To determine eye drop therapy burden on the patient 
through Week 4 as measured by: 
x Eye Drop Burden Questionnaire at post-op 
Day 7 and Week 4.  
 
 

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TABLE OF CONTENTS 
Clinical Study Protocol Synopsis .................................................................................... 21 
List of Tables ....................................................................................................................... 23 
1. 
Introduction and Rationale ...................................................................................... 24 
1.1 Introduction ............................................................................................................. 24 
1.2 Rationale ................................................................................................................... 24 
1.2.1 
Rationale for Study Design ...................................................................... 24 
2. 
Study Objectives ......................................................................................................... 25 
2.1 Primary Objective ................................................................................................... 25 
2.2 Secondary Objectives ............................................................................................. 25 
3. 
Study Design ................................................................................................................ 26 
3.1 Study Description and Duration ......................................................................... 26 
4. 
Selection, Withdrawal, and Replacement of Patients ........................................ 26 
4.1 Study Population .................................................................................................... 26 
4.1.1 
Inclusion Criteria ........................................................................................ 26 
4.1.2 
Exclusion Criteria ....................................................................................... 26 
4.2 Treatment Logistics and Accountability ........................................................... 27 
4.2.1 
Packaging, Labeling, and Storage .......................................................... 27 
4.2.2 
Supply and Disposition of Treatments .................................................. 27 
4.2.3 
Treatment Accountability ......................................................................... 27 
4.3 Concomitant Medications and Procedures ....................................................... 28 
5. 
Study Schedule of Events and Visit Descriptions ............................................... 28 
5.1 Schedule of Events ................................................................................................. 28 
5.2 Study Visit Descriptions ....................................................................................... 30 
5.2.1 
Study Procedures ........................................................................................ 30 
5.2.2 
Unscheduled Visits ..................................................................................... 32 
5.2.3 
Adverse Event Information Collection................................................... 32 
5.3 Rescue Criteria ........................................................................................................ 33 
6. 
Safety Definitions, Reporting, and Monitoring .................................................... 33 
6.1 Definitions ................................................................................................................ 33 
6.1.1 
Adverse Event ............................................................................................. 33 
6.1.2 
Serious Adverse Event .............................................................................. 33 
6.2 Recording and Reporting Adverse Events ........................................................ 34 
7. 
Study Variables ........................................................................................................... 34 
7.1 Demographic and Baseline Characteristics ..................................................... 34 
8. 
Ethical and Regulatory Considerations ................................................................. 34 
8.1 Good Clinical Practice Statement ....................................................................... 34 
8.2 Informed Consent ................................................................................................... 35 
8.3 Patient Confidentiality and Data Protection ................................................... 35 
8.4 Institutional Review Board .................................................................................. 35 
 
LIST OF TABLES 
Table 1 
Schedule of Events ............................. Error! Bookmark not defined. 
  

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Introduction and Rationale 
Introduction 
 
Dextenza (dexamethasone 0.4mg ophthalmic insert) is a steroid eluting 
intracanalicular plug approved on-label for the treatment of pain and postoperative 
inflammation in patients who’ve undergone ocular surgery. Utilizing Dextenza, in place 
of ophthalmic steroid drops, will provide patients with a lessened number of post-
operative drops which decreases both contamination possibilities and improper drug 
installation. Dextenza’s hydrogel technology is proposed to offer patients a gradual 
sustained delivery of steroid to the ocular surface which may decrease subjective post-
operative pain.  
 
 
Post-operative drop regimens frequently induce both concerns and questions for 
patients undergoing ocular surgery. Poor compliance with postoperative medications can 
lead to unexpected and or unsatisfactory outcomes. In post-operative cataract surgery 
patients, un-treated or non-resolving inflammation can lead to pain, anterior chamber 
inflammation, and potentially cystoid macular edema (CME). Lessening the risk of these 
adverse events due to drop complications is a key benefit of Dextenza. There may be 
future possibilities to combine intracameral medication combinations (antibiotic, steroid, 
NSAID) plus Dextenza to further reduce the patient post-operative drop burden.  
 
 
On introduction to the market, Dextenza was most commonly inserted in the 
operating room (OR) pre-cataract surgery, but other instillation protocols will increase 
practitioner adoption and patient access. Increasing optometrist administration in clinic 
allows for another route for insurance reimbursement while freeing up ophthalmologists 
in the OR.  
 
 
Rationale 
 
DEXTENZA (dexamethasone 0.4mg ophthalmic insert) has increasing research 
and evidence for post-cataract surgery patients, but a gap remains in best practices for 
instillation timing and protocols. In clinic insertion provides another route for device 
administration which can help foster additional reimbursement codes.  
 
 
 Dextenza’s ability to treat post-operative inflammation while also increasing 
remaining tear volume by punctal occlusion has potential to improve visual outcomes for 
patients while also decreasing post-operative drop inconvenience. The studied patient 
population is having their initial cataract evaluation and surgery on the same day, 
decreasing patient inconvenience, adding Dextenza is another arrow in the quiver.  
 
 
Rationale for Study Design 
 
This prospective contralateral eye study will compare the outcomes of 30 patients 
undergoing cataract surgery. All eyes will receive intracameral DMK at the conclusion of 
surgery. All eyes will be treated with Vigamox 0.5% QID for 1 week and Prolensa 

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(bromfenac 0.07%) QD for 1 month. After randomization, one eye per patient will 
receive Dextenza in place of topical steroid while the other eye has topical prednisolone 
acetate 1% QID 1 week, TID 1 week, BID 1 week, and QD 1 week.  The primary 
endpoints of anterior chamber cell and mean pain score correlate to the initial FDA 
approval trial for Dextenza. The study inclusion and exclusion criteria were chosen based 
on patients who normally would be successful with cataract surgery, including the 
absence of pre-existing intraocular inflammation or macular edema. The study follow-up 
visits were based on the Vance Thompson Vision standard postoperative follow-up 
protocols.  
 
 
Study Objectives 
Primary Objective 
To determine the effect of dexamethasone intracanalicular insert through 
Week 4 as measured by: 
x Mean anterior chamber cell score as measured by Slit Lamp 
Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working 
Group Grading Scheme) at post-op Day 1, Day 7, and Week 4.  
x Mean pain score as measured by Visual Analog Score numerical 
grading scale 0-10 at post-op Day 1, Day 7, and Week 4. 
To determine patient preference through Week 4 as measured by: 
x Adapted COMTOL Questionnaire at Week 4. 
 
Secondary Objectives 
To determine the effect of dexamethasone intracanalicular insert through 
Week 4 or 12: 
x Mean anterior chamber flare score as measured by Slit Lamp 
Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working 
Group Grading Scheme) at post-op Day 1, Day 7, and Week 4.  
x Incidence of increased intraocular pressure (IOP) >10mmHg above 
baseline as measured by Goldmann Applanation Tonometer at post-op 
Day 1, Day 7, and Week 4. 
x Incidence of Cystoid Macular Edema (CME) as measured by optical 
coherence tomography (OCT) at post-op Week 4. 
To determine physician ease of insertion following dexamethasone 
intracanalicular insert placement prior to same-day surgery as measured by: 
x Physician Ease of Use Survey following dexamethasone 
intracanalicular placement on Surgical Visit Day 0.  
To determine eye drop therapy burden on the patient through Week 4 as 
measured by: 
x Eye Drop Burden Questionnaire at post-op Day 7 and Week 4.  
 

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Study Design 
Study Description and Duration 
This prospective, open-label, randomized, investigator-sponsored clinical 
study seeks to investigate a new protocol for in-clinic Dextenza insertion by 
optometrists at the day of surgery.  This three month study will study the 
clearance of intraocular pain and inflammation comparing topical steroids 
versus Dextenza.  
 
Selection, Withdrawal, and Replacement of Patients 
Study Population 
The study aims to enroll 30 patients undergoing routine sequential bilateral 
cataract surgery. 
 
Inclusion Criteria 
A patient’s study eye must meet the following criteria to be eligible for 
inclusion in the study: 
x Patients 18 years of age or older, undergoing routine, uncomplicated, 
sequential bilateral cataract surgery.  
x Willing and able to comply with clinic visits and study related 
procedures 
x Willing and able to sign the informed consent form 
 
 
Exclusion Criteria 
A patient who meets any of the following criteria will be excluded from the 
study: 
x Patients under the age of 18. 
x Patients who are pregnant (must be ruled out in women of child-
bearing age with pregnancy test). 
x Active infectious ocular or systemic disease. 
x Patients with active infectious ocular or extraocular disease. 
x Patients actively treated with local or systemic immunosuppression 
including systemic corticosteroids. 
x Patients with known hypersensitivity to Dexamethasone. 
x Patients with severe disease that warrants critical attention, deemed 
unsafe for the study by the investigator. 
x Patients with proliferative diabetic retinopathy or uncontrolled 
diabetes as deemed by an A1C > 10.0. 
x Patients with a history of ocular inflammation or macular edema. 
x Patients with a pre-existing epiretinal membrane (ERM) 
x Patients with allergy or inability to receive intracameral antibiotic. 
x Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) 
greater than 1,200 mg/day 

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x Patients with a corticosteroid implant (i.e. Ozurdex).  
 
Treatment Logistics and Accountability 
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 
suVSHQVLRQZKLFKFRQWDLQVDSSUR[LPDWHO\ǍJRIGH[DPHWKDVRQHSHUGURS 
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 
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. 
 
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.  
 
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 
x 
Inserted in each patient, 
x 
disposed of at the site or returned to Ocular Therapeutix 

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All accountability records will be made available for inspection by regulatory 
agency inspectors. 
 
Concomitant Medications and Procedures 
At the discretion of their physician, patients may continue to receive all 
medications and standard treatments administered for other conditions. 
 
Study Schedule of Events and Visit Descriptions 
Schedule of Events 
Study assessments and procedures are presented by visit in Table 1 below. 

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Table 1 
Schedule of Events 
 
 
Study Procedure 
 
Screening/ 
Baseline 
 
 
 
First 
Eye 
Surgical 
Visit 
Day 0 
 
 
 
 
First 
Eye 
Day 1 
 
 
 
 
Second 
Eye 
Surgical 
Visit 
Day 0 
 
 
 
 
Second 
Eye 
Day 1 
 
 
 
 
 
 
Day 7 
Both 
Eyes 
 
 
 
 
 
 
Day 30 
Both 
Eyes 
 
 
Day 90 
post-op  
Both 
Eyes 
 
 
Early 
Termination 
Visit 
VISIT 1 
VISIT 2 
VISIT 3 
VISIT 4 
VISIT 5 
VISIT 
6 
VISIT 7 
VISIT 8 
 
Windows for Visits 
(Day -30 to 0) 
 
 
 
 
+/- 2 
day 
from 
first 
eye sx 
+/- 5 
days 
from 
first eye 
sx 
+/- 7 
days  
from 
first eye 
sx 
 
Inclusion/Exclusion 
X 
 
 
 
 
 
 
 
 
Informed Consent 
X 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
Medical History and Concurrent Illnesses 
X 
X 
X 
X 
X 
X 
X 
X 
 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
X 
 
Uncorrected Distance VA  
X 
 
X 
 
X 
X 
X 
X 
 
MRX 
X 
 
 
 
 
X 
X 
X 
 
BCVA (ETDRS at 4m) 
X 
 
 
 
 
X 
X 
X 
 
Ophthalmic Examination (dilated fundus 
exam) 
X 
 
 
 
 
 
X 
 
 
Slit lamp exam 
X 
 
X 
 
X 
X 
X 
X 
 
Grade cataract density (scale 1 to 4) 
 
X 
 
X 
 
 
 
 
 
OCT  
X 
 
 
 
 
 
X 
 
 
Intraocular Pressure 
X 
 
X 
 
X 
X 
X 
X 
 
Indicate the incision type, location, and 
size (mm) 
 
 
X 
 
X 
 
 
 
 
 
Type of IOL (e.g. monofocal, toric, 
multifocal, etc.) and lens power 
 
 
X 
 
X 
 
 
 
 
 
Record any surgical complications 
 
 
X 
 
X 
 
 
 
 
 
Subject reported AEs prior to or after 
surgery 
 
 
X 
X 
X 
X 
X 
X 
X 
 
Intracanalicular dexamethasone insert 
(*if randomized to Dextenza arm) 
 
 
X 
 
X 
 
 
 
 
 
Intracameral injection of 
NSAID+antibiotic+steroid combo 
 
X 
 
X 
 
 
 
 
 
Physician Ease of Use Survey 
 
X 
 
X 
 
 
 
 
 
Eye Drop Burden Questionnaire 
 
 
 
 
 
X 
X 
 
 
Adapted COMTOL Questionnaire 
 
 
 
 
 
 
X 
 
 
Ocular Pain Assessment 
X 
 
X 
 
X 
X 
X 
X 
 
Anterior chamber cell count 
X 
 
X 
 
X 
X 
X 
X 
 
Anterior chamber cell flare 
X 
 
X 
 
X 
X 
X 
X 
 
Insert Visualization 
 
X 
X 
X 
X 
X 
X 
X 
 
Prescribe post-operative topical therapy 
regimen (*specific to each study group) 
 
X 
 
X 
 
 
 
 
 

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5.2    Study Visit Descriptions 
5.2.1 Study Procedures 
Screening/Baseline 
After the patient has provided informed consent, the following information 
will be collected (if the data was collected within 30 days of the screening 
exam it may be pulled forward from the subject previous exam): 
x 
Inclusion/exclusion 
x 
Demographics 
x 
Medical history and concurrent illnesses 
x 
Concomitant medications 
x 
Distance VA 
x 
MRX 
x 
BCVA 
x 
Ophthalmic Examination (dilated fundus exam) 
x 
Slit lamp Exam 
x 
OCT 
x 
IOP 
x 
Ocular Pain Assessment 
x 
Anterior Chamber Cell Count 
x 
Anterior Chamber Cell Flare 
 
Surgical Visit Day 0 First Eye 
x 
Medical history and concurrent illnesses 
x 
Concomitant medications 
x 
Grade Cataract Density (scale 1 to 4) 
x 
Indicate incision type, location, and size 
x 
Type of IOL and lens power 
x 
Record any surgical complications 
x 
Subject reported AEs prior to or after surgery 
x 
Insert intracanalicular dexamethasone insert (*if randomized to 
Dextenza arm) 
x 
Physician Ease of Use Survey 
x 
Intracameral injection of NSAID+abx+steroid combo 
x 
Insert visualization 
x 
Prescribe post-operative regimen (*specific to each eye) 
 
Day 1 First Eye (To be completed prior to 2nd eye sx) 
x 
Medical history and concurrent illnesses 
x 
Concomitant medications 
x 
Distance VA 
x 
Slit lamp Exam 
x 
IOP 
x 
Subject reported AEs prior to or after surgery 
x 
Ocular Pain Assessment 

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x 
Anterior Chamber Cell Count 
x 
Anterior Chamber Cell Flare 
x 
Insert visualization 
 
Surgical Visit Day 0 Second Eye (To be completed one day after first eye sx) 
x 
Medical history and concurrent illnesses 
x 
Concomitant medications 
x 
Grade Cataract Density (scale 1 to 4) 
x 
Indicate incision type, location, and size 
x 
Type of IOL and lens power 
x 
Record any surgical complications 
x 
Subject reported AEs prior to or after surgery 
x 
Insert intracanalicular dexamethasone insert (*if randomized to 
Dextenza arm) 
x 
Physician Ease of Use Survey 
x 
Intracameral injection of NSAID+abx+steroid combo 
x 
Insert visualization 
x 
Prescribe post-operative regimen (*specific to each eye) 
 
 
Day 1 Second Eye 
x 
Medical history and concurrent illnesses 
x 
Concomitant medications 
x 
Distance VA 
x 
Slit lamp Exam 
x 
IOP 
x 
Subject reported AEs prior to or after surgery 
x 
Ocular Pain Assessment 
x 
Anterior Chamber Cell Count 
x 
Anterior Chamber Cell Flare 
x 
Insert visualization 
 
Day 7 (+/- 2 days from first eye sx) 
x 
Medical history and concurrent illnesses 
x 
Concomitant medications 
x 
Distance VA 
x 
MRX 
x 
BCVA 
x 
Slit lamp Exam 
x 
IOP 
x 
Subject reported AEs prior to or after surgery 
x 
Eye Drop Burden Questionnaire 
x 
Ocular Pain Assessment 
x 
Anterior Chamber Cell Count 

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x 
Anterior Chamber Cell Flare 
x 
Insert visualization 
 
Day 28-35 (+/- 5 days from first eye sx) 
x 
Medical history and concurrent illnesses 
x 
Concomitant medications 
x 
Distance VA 
x 
MRX 
x 
BCVA 
x 
Ophthalmic examination (dilated fundus exam) 
x 
Slit lamp Exam 
x 
OCT 
x 
IOP 
x 
Subject reported AEs prior to or after surgery 
x 
Eye Drop Burden Questionnaire 
x 
Adapted COMTOL Questionnaire 
x 
Ocular Pain Assessment 
x 
Anterior Chamber Cell Count 
x 
Anterior Chamber Cell Flare 
x 
Insert visualization 
 
Month 3 (+/- 7 days from first eye sx) 
x 
Medical history and concurrent illnesses 
x 
Concomitant medications 
x 
Distance VA 
x 
BCVA 
x 
Slit lamp Exam 
x 
IOP 
x 
Subject reported AEs prior to or after surgery 
x 
Ocular Pain Assessment 
x 
Anterior Chamber Cell Count 
x 
Anterior Chamber Cell Flare 
x 
Insert visualization 
 
 
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. 
 
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 

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severity and relationship to treatment are provided in Section 6. 
 
Rescue Criteria 
x Patients should be rescued at any time at the discretion of the 
investigator. 
x The following rescue criteria are to be applied by the investigator: 
o *UDGH3 anterior chamber cells 
o Ocular pain score of > 5 due to ocular inflammation 
x Patients requiring rescue therapy will be prescribed: topical steroid and 
topical NSAID per the discretion of the investigator. 
If a patient requires rescue therapy in the eye containing the dexamethasone 
insert, the insert will not be removed, and subjects will be followed for safety. 
 
Safety Definitions, Reporting, and Monitoring 
Definitions 
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. 
 
Serious Adverse Event 
A SAE is any untoward medical occurrence that at any dose: 
x 
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). 
x 
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. 
x 
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 

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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. 
x 
Results in persistent or significant disability/incapacity (substantial 
disruption of one’s ability to conduct normal life functions). 
x 
Is a congenital anomaly/birth defect 
x 
Is an important medical event – Important medical events may not be 
immediately life-threatening or result in death or hospitalization, but may 
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. 
 
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. 
 
Study Variables 
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. 
 
Ethical and Regulatory Considerations 
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. 
 

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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. 
 
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. 
 
Patient Confidentiality and Data Protection 
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.   
 
Institutional Review Board  
An appropriately constituted IRB, as described in ICH Guidelines for GCP, 
will review and approve:  
x 
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  
x 
Any amendment or modification to the study protocol or ICF before 
implementation, unless the change is necessary to eliminate an 

The PREPARE Study (V1) 
 
February, 2021 
 
Page 36 
 
CONFIDENTIAL 
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. 
 
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 PREPARE Study (V1) 
 
February, 2021 
 
Page 37 
 
CONFIDENTIAL 
 
APPENDICES 
 
Protocol Appendix A: Ease of use Survey 
Protocol Appendix B: Eye Drop Burden Questionnaire 
Protocol Appendix C: Adapted COMTOL 
 
 
REFERENCES 
 
 
1. DEXTENZA [PACKAGE INSERT]. BEDFORD, MA: OCULAR THERAPEUTIX, 
INC; 2019.  
 
2. Walters TR, Bafna S, Vold S, et al. Efficacy and Safety of Sustained 
Release Dexamethasone for the Treatment of Ocular Pain and 
Inflammation after Cataract Surgery: Results from Two Phase 3 
Studies. J Clin Exp Ophthalmol. 2016;7(4):1-11.  
 
3. Tyson SL, Bafna S, Gira JP, et al. Multicenter randomized phase 3 
study of a sustained-release intracanalicular dexamethasone insert for 
treatment of ocular inflammation and pain after cataract surgery. 
[published correction appears in J Cataract Refract Surg. 
2019;45(6):895]. J Cataract Refract Surg. 2019;45(2):204-212. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

The PREPARE Study (V1) 
 
February, 2021 
 
Page 38 
 
CONFIDENTIAL 
 
Protocol Appendix A: Ease of Use Survey 
 
The investigator will grade the level of ease of insertion of the intracanalicular 
insert on a 0 to 10-point scale. 
 
The Investigator will record ease of insertion procedure on the appropriate Case 
Report Form. 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Very Easy  
 
 
 
 
 
 
 
 
 
            
                                                                                                                                   Very Hard 

The PREPARE Study (V1) 
 
February, 2021 
 
Page 39 
 
CONFIDENTIAL 
Protocol Appendix B: Eye Drop Burden Questionnaire 
 
 
 
Never 
 
1 
Rarely 
 
2 
Sometimes 
 
3 
Usually 
 
4 
Always 
 
5 
1.  
I forget to 
administer my eye 
drops. 
 
 
 
 
 
2.  
It is difficult 
and/or frustrating 
to administer my 
eye drops. 
 
 
 
 
 
3.  
My eye drops 
burn and/or sting 
when I administer 
them. 
 
 
 
 
 
4.  
My eye drop 
treatment 
interferes with the 
daily activities of 
my life. 
 
 
 
 
 
5.  
I forget to wash 
my hands prior to 
administering my 
eye drops. 
 
 
 
 
 
6.  
I accidentally 
administer more 
and/or less than 
one eye drop to 
the eye. 
 
 
 
 
 
7.  
The drops miss 
my eye when I 
administer them. 
 
 
 
 
 
8.   
The bottle tip 
touches my eye 
when using my 
eye drops. 
 
 
 
 
 
 
 
Add up the numbers for each statement to calculate the total Eye Drop Burden 
Score. 
 
Total Eye Drop Burden Score = ___ 
 
Low Eye Drop Burden: 8-18 
Moderate Eye Drop Burden: 19-29 
High Eye Drop Burden: 30-40 
 

The PREPARE Study (V1) 
 
February, 2021 
 
Page 40 
 
CONFIDENTIAL 
Protocol Appendix C: Adapted COMTOL  
 
Comparison of Ophthalmic Medications for Tolerability (COMTOL) Questionnaire (adapted to 
compare physician & patient administered ‘fewer-drops’ regimen ((Treatment A- Experimental 
Group)) to patient-only administered total topical therapy ((Treatment B- Control Group)). 
 
Interviewer: Please read the following verbatim! 
 
Thank you for participating in our study. Your evaluation of the test “fewer-drops” treatment 
(Treatment A- Experimental Group) that the surgeon and you administered following your 
surgery compared to the total eyedrops (Treatment B- Control Group) you administered 
following surgery is most valuable to us. We would greatly appreciate your assistance by 
answering the following questions as best as possible. All answers are confidential. 
 
Every patient received both treatment regimens. Every patient received Treatment A in one eye 
and Treatment B in the opposite eye. For clarification, here are the definitions of each treatment 
group: 
 
Treatment A (Experimental Group- fewer-drops, physician & patient administered):  
 
x Dextenza (steroid punctal plug/insert) + Vigamox drops 4x/day for 1st week + Prolensa drops 
1x/day for one month 
 
Treatment B (Control Group- total topical eyedrop therapy, patient-only administered): 
 
x Prednisolone drops 4x/day for 1st week, 3x/day for 2nd week, 2x/day for 3rd week, 1x/day for 
4th week + Vigamox drops 4x/day for 1st week + Prolensa drops 1x/day for one month 
 
 
1. (Interviewer: Questions 1 and 2 are to be asked only at the Month 1 Visit). 
Now that you tried both test regimens, did you prefer the Treatment A (fewer-drops, physician & 
patient administered) regimen or the Treatment B (total eyedrop therapy, patient-only administered) 
regimen? 
 (Interviewer: Please check the appropriate response below). 
___________ Treatment A regimen (Experimental Group-fewer drops) 
___________ Treatment B regimen (Control Group-all drops) 
___________ Neither (Do not read) 
 
 
 
2.  Why did you prefer your selected treatment?  (Interviewer: Read response from Question 
1) 
 
 
 
 

The PREPARE Study (V1) 
 
February, 2021 
 
Page 41 
 
CONFIDENTIAL 
 
 
 
 
 
 
 
‘Fewer-Drops’ Physician/Patient-Administered Therapy (Treatment A): Patient Reported 
Outcomes 
 
3. (Interviewer: Read the following). I am going to read to you a list of various side effects 
that may occur in some patients who receive Treatment A regimen (‘fewer-drops’ 
physician & patient administered regimen) following ophthalmic surgery.  You may have 
experienced none, some, or all these side effects during the past month. As I read the list, 
please tell me if you experienced that side effect. (Interviewer: Check affirmative 
responses on the far left column of the list below Question #4. Place a check under the 
column marked “I did not have the symptom” below Question #4 for those symptoms 
not experienced by the patient. If patient experienced none of these side effects, please 
check "None of these symptoms" below and go to Question #6). 
 
4. (Interviewer: Refer to Question #3 and read the following). I am now going to read to 
you the side-effects you said you experienced in the last question.  For each side effect I 
mention, please tell me how frequently you experienced each side effect during the past 
month. (interviewer- hand respondent Card "A" with frequency scales.) That is, did 
you experience the side effect rarely, a few times, often, use ally, almost always, or 
always? (Interviewer:  Place check under appropriate column below for each checked 
side effect mentioned by respondent). 
 
 

The PREPARE Study (V1) 
 
February, 2021 
 
Page 42 
 
CONFIDENTIAL 
 
 
 
5. (Interviewer: Refer to Question #4 and read the following). I am again going to repeat 
the side-effects you just mentioned. For each side effect I mention, please tell me if you 
have been bothered by it: not at all, a little, some, quite a bit, very much so, or extremely 
so? (Interviewer: Place check under appropriate columns below) 
 
 
 
I Did Not 
Have the 
Symptom 
 
Rarely 
A Few 
Times 
Fairly 
Often 
Usually 
Almost 
Always 
Always 
__ 
Burning/stinging in 
eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Redness in eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Blurred vision 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Bitter taste 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Unusual taste 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Itchy eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Discharge from eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Swelling of eyelids 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Brow ache 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Dimming of vision    
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Difficulty in focusing 
from near to far 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Dry eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Trouble reading 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Trouble seeing at 
night 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Tearing 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
None of these 
symptoms 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 

The PREPARE Study (V1) 
 
February, 2021 
 
Page 43 
 
CONFIDENTIAL 
 
 
 
6. During the past month has your quality of life been interfered with by these side effects:  
not at all, a little, some, quite a bit, very much so, or extremely so? 
 
__ Not at all 
__ A little 
__ Some 
__ Quite a bit 
__ Very much so 
__ Extremely so 
 
 
 
 
 
 
 
 
 
 
7. (Interviewer). I am now going to show you a list of activities you might do during a 
typical day. You may perform none, some, or all of these activities.  For each one on the 
list, please tell me whether you perform it on a routine basis. (Interviewer: Hand 
 
 
Not at all 
 
A little 
Some 
Quite a bit 
Very much so 
Extremely so 
__ 
Burning/stinging in 
eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Redness in eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Blurred vision 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Bitter taste 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Unusual taste 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Itchy eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Discharge from eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Swelling of eyelids 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Brow ache 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Dimming of vision    
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Difficulty in focusing 
from near to far 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Dry eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Trouble reading 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Trouble seeing at 
night 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Tearing 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 

The PREPARE Study (V1) 
 
February, 2021 
 
Page 44 
 
CONFIDENTIAL 
respondent Card B with activities and check each activity below that  is  mentioned  by  
respondent.  Then circle those activities for each patient on Card B) 
 
__ Driving during the day 
__ Driving at night 
__ Lifting or carrying groceries 
__ Climbing 1 flight of stairs 
__ Walking several blocks 
__ Reading the newspaper 
__ Reading other than the newspaper 
 
 
8. (Interviewer:)  I am now going to repeat each of the activities you just said you do 
routinely.  For each one, please tell me if you were limited at all in performing each 
activity in the past month because of the Treatment A regimen (fewer-drops regimen 
administered by the physician & patient). That is, were you limited:  not at all, a little, 
some, quite a bit, very much so, or extremely so? (Interviewer: Please check off under 
appropriate column below) 
 
 
 
9. If you were limited in performing any activities due to the Treatment A regimen 
(fewer-drops physician & patient administered regimen), during the past month, has 
your quality of life been interfered with by these activity limitations: not at all, a little, 
some, quite a bit, very much so, or extremely so? 
 
__ Not at all 
__ A little 
__ Some 
__ Quite a bit  
__ Very much so  
__ Extremely so  
 
 
 
 
 
 
Not at all 
 
A little 
Some 
Quite a bit 
Very much so 
Extremely so 
__ 
Driving during day 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Driving at night 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Lifting or carrying 
groceries 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Climbing 1 flight of stairs 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Walking several blocks 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Reading the newspaper 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Reading other than the 
newspaper 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 

The PREPARE Study (V1) 
 
February, 2021 
 
Page 45 
 
CONFIDENTIAL 
 
Total Topical Eyedrop therapy patient-administered: Patient Reported Outcomes 
 
10. (Interviewer: Read the following). I am going to read to you a list of various side effects 
that may occur in some patients who receive Treatment B (self-administered total 
eyedrop therapy following ophthalmic surgery).  You may have experienced none, 
some, or all these side effects during the past month. As I read the list, please tell me if 
you experienced that side effect. (Interviewer: Circle affirmative responses on the list 
below. Place a check under the column marked “I did not have the symptom” below for 
those symptoms not experienced by the patient. If patient experienced none of these 
side effects, please check "None of these symptoms" below and go to Question # 10). 
 
11.  (Interviewer: Refer to Question #7 and read the following). I am now going to read to 
you the side-effects you said you experienced in the last question.  For each side effect I 
mention, please tell me how frequently you experienced each side effect during the past 
month. (interviewer- hand respondent Card "A" with frequency scales.) That is, did 
you experience the side effect rarely, a few times, often, usually, almost always, or 
always? (Interviewer:  Place check under appropriate column below for each circled 
side effect mentioned by respondent). 
 
 
 
 
 
I Did Not 
Have the 
Symptom 
 
Rarely 
A Few 
Times 
Fairly 
Often 
Usually 
Almost 
Always 
Always 
__ 
Burning/stinging in 
eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Redness in eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Blurred vision 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Bitter taste 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Unusual taste 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Itchy eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Discharge from eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Swelling of eyelids 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Brow ache 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Dimming of vision    
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Difficulty in focusing 
from near to far 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Dry eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Trouble reading 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Trouble seeing at 
night 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Tearing 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
None of these 
symptoms 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 

The PREPARE Study (V1) 
 
February, 2021 
 
Page 46 
 
CONFIDENTIAL 
 
 
 
 
12. 
(Interviewer: Refer to Question #7 and read the following). I am again going to repeat 
the side-effects you just mentioned. For each side effect I mention, please tell me if you have 
been bothered by it: not at all, a little, some, quite a bit, very much so, or extremely so? 
(Interviewer: Place check under appropriate columns below) 
 
 
 
13. During the past month has your quality of life been interfered with by these side effects:  
not at all, a little, some, quite a bit, very much so, or extremely so? 
 
__ Not at all 
__ A little 
__ Some 
__ Quite a bit 
__ Very much so 
__ Extremely so 
 
 
 
 
 
 
 
Not at all 
 
A little 
Some 
Quite a bit 
Very much so 
Extremely so 
__ 
Burning/stinging in 
eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Redness in eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Blurred vision 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Bitter taste 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Unusual taste 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Itchy eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Discharge from eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Swelling of eyelids 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Brow ache 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Dimming of vision    
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Difficulty in focusing 
from near to far 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Dry eyes 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Trouble reading 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Trouble seeing at 
night 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Tearing 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 

The PREPARE Study (V1) 
 
February, 2021 
 
Page 47 
 
CONFIDENTIAL 
 
 
 
 
 
 
14. (Interviewer). I am now going to show you  a list of activities you  might do during a 
typical day. You may perform none, some, or all of these activities.  For each one on the 
list, please tell me whether you perform it on a routine basis. (Interviewer: Hand 
respondent Card B with activities and check each activity below that is  mentioned  by  
respondent.  Then circle those activities for each patient on Card B) 
 
__ Driving during the day 
__ Driving at night 
__ Lifting or carrying groceries 
__ Climbing 1 flight of stairs 
__ Walking several blocks 
__ Reading the newspaper 
__ Reading other than the newspaper 
 
 
15. (Interviewer:)  I am now going to repeat each of the activities you just said you do 
routinely.  For each one, please tell me if you were limited at all in performing each 
activity in the past month because of Treatment B (total topical eyedrops you 
administered). That is, were you limited:  not at all, a little, some, quite a bit, very much 
so, or extremely so? (Interviewer: Please check off under appropriate column below) 
 
 
 
 
16. If you were limited in performing any activities due to Treatment B (total topical 
eyedrops you administered), during the past month, has your quality of life been 
interfered with by these activity limitations: not at all, a little, some, quite a bit, very 
much so, or extremely so? 
 
__ Not at all 
 
 
Not at all 
 
A little 
Some 
Quite a bit 
Very much so 
Extremely so 
__ 
Driving during day 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Driving at night 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Lifting or carrying 
groceries 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Climbing 1 flight of stairs 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Walking several blocks 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Reading the newspaper 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
__ 
Reading other than the 
newspaper 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 
(     ) 

The PREPARE Study (V1) 
 
February, 2021 
 
Page 48 
 
CONFIDENTIAL 
__ A little 
__ Some 
__ Quite a bit  
__ Very much so  
__ Extremely so  
 
 
 
 
 
17. During the past month, how often did you miss one or more doses of the eyedrop 
medication? 
 
__ I did not miss any doses 
__ Rarely  
__ A few times 
__ Fairly often 
__ Usually 
__ Almost always  
__ Always 
 
 
 
 
 
18. Overall, how satisfied, if at all, have you been with the regimen you stated you 
preferred? (Interviewer: Hand respondent Card C with satisfaction scales) Would you 
say you were totally satisfied, very satisfied, somewhat satisfied, somewhat dissatisfied, 
very dissatisfied or totally dissatisfied? (Interviewer: Record only one response below) 
 
__ Totally satisfied 
__ Very satisfied 
__ Somewhat satisfied 
__ Somewhat dissatisfied 
__ Very dissatisfied 
__ Totally dissatisfied 
 
 
Thank respondent and terminate interview. 
 
 
Signature of Interviewer 
 
 
 
 
           Date 
 
 
 
 
 
 

The PREPARE Study (V1) 
 
February, 2021 
 
Page 49 
 
CONFIDENTIAL 
 
Card A 
 
I did not have the symptom 
 
Rarely 
 
A few times 
 
Fairly often 
 
Usually 
 
Almost always 
 
Always 
 
 
 
 
Card B 
 
Driving during the day 
 
Driving at night 
 
Lifting or carrying groceries 
 
Climbing 1 flight of stairs 
 
Walking several blocks 
 
Reading the newspaper 
 
Reading other than the newspaper 
 
 
 
 
Card C 
 
Totally satisfied 
 
Very satisfied 
 
Somewhat satisfied 
 
Somewhat dissatisfied 
 
Very dissatisfied 
 
Totally dissatisfied