Clinical trial NCT05023304
Conditions: Cataract
Sponsor: Vance Thompson Vision
Start date: 2021-08-23; Completion date: 2022-10-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:

Arms: arm 1: Randomized to dexamethasone ophthalmic insert 0.4mg placed prior to cataract surgery, on the day of surgery. arm 2: Randomized to topical prednisolone acetate 1% four times per day for one week, three times per day for one week, two times per day for one week, and one time per day for one week starting after 4 hours after surgery.
Interventions: intervention 1: Dextenza 0.4Mg Ophthalmic Insert intervention 2: Topical prednisolone acetate
Intervention descriptions: intervention 1: The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration. intervention 2: Standard of care topical drop regimen with four week taper

Protocol documents:
ICF_002.pdf: 
 
IRB APPROVED 
 
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RESEARCH SUBJECT CONSENT FORM 
 
TITLE: 
In Clinic Optometrist Insertion of Dextenza Prior to Cataract 
Surgery 
 
PROTOCOL NO.: 
The Prepare Study 
 
IRB Protocol #20212533 
 
SPONSOR: 
Vance Thompson Vision  
 
INVESTIGATOR: 
Mitchel Ibach, OD 
 
3101 W. 57th Street 
 
Sioux Falls, SD 57108 
 
United States 
 
STUDY-RELATED 
PHONE NUMBER(S): 
605-361-3937 
 
605-361-3937 (24 hours) 
 
RESEARCH CONSENT SUMMARY 
 
You are being asked for your consent to take part in a research study. This document provides a 
concise summary of this research. It describes the key information that we believe most people 
need to decide whether to take part in this research. Later sections of this document will provide 
all relevant details. 
 
What should I know about this research? 
• Someone will explain this research to you. 
• Taking part in this research is voluntary. Whether you take part is up to you. 
• If you don’t take part, it won’t be held against you. 
• You can take part now and later drop out, and it won’t be held against you 
• If you don’t understand, ask questions. 
• Ask all the questions you want before you decide. 
 
How long will I be in this research? 
We expect that your taking part in this research will last 4 months or less. 
 
Why is this research being done? 
The purpose of this research is 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. 
 


 
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What happens to me if I agree to take part in this research? 
If you decide to take part in this research study, the general procedures include 8 visits, including 
two surgery day and 6 office visits. The study will have 2 groups, each patient will have one eye 
in each group. One group of 30 eyes will receive DEXTENZA and one group of 30 eyes will 
receive topical steroid drops. You will also receive topical antibiotic and NSAID drops to be 
used in both eyes post-operatively. 
 
Could being in this research hurt me? 
The risks associated with participation in this clinical research study are expected to be similar to 
other therapeutic corticosteroid topical drop options for the treatment of postoperative pain and 
inflammation following cataract surgery and my include bacterial infections, viral infections, 
fungal infections, increased intraocular pressure, and glaucoma. Previous studies in adults have 
shown that treatment with DEXTENZA is generally well tolerated in a similar patient population 
that underwent ophthalmic surgery. The use of Dextenza in this study is considered 
investigational because it will be given before surgery instead of the approved standard of care 
when it is given after surgery. 
 
Will being in this research benefit me? 
The most important benefits that you may expect from taking part in this research are reduction 
of pain and inflammation post-surgery, however this cannot be guaranteed. 
 
What other choices do I have besides taking part in this research? 
Instead of being in this research, your choices may include a current standard of care topical 
corticosteroid ophthalmic drop regimen. Please discuss with your doctor other alternatives that 
may be available to you. 
 
DETAILED RESEARCH CONSENT 
 
You are being invited to take part in a research study.  A person who takes part in a research 
study is called a research subject, or research participant.  
 
What should I know about this research? 
• Someone will explain this research to you. 
• This form sums up that explanation. 
• Taking part in this research is voluntary. Whether you take part is up to you. 
• You can choose not to take part. There will be no penalty or loss of benefits to which you 
are otherwise entitled. 
• You can agree to take part and later change your mind. There will be no penalty or loss of 
benefits to which you are otherwise entitled. 
• If you don’t understand, ask questions. 
• Ask all the questions you want before you decide. 
 


 
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Why is this research being done? 
The purpose of this research is 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. This is a prospective, single-center, open-
label clinical trial; it is being conducted only here at your doctor’s office, and both you and your 
physician will know the treatment type and dosage of the study medication.   
 
The study drug, DEXTENZA, is approved by the FDA for the treatment of pain and 
inflammation following ophthalmic surgery. DEZTENZA is an intracanalicular (within the short 
channel near the inner corner of the eyelid) insert containing 0.4mg dexamethasone steroid 
designed to elute preservative-free drug over 30 days. The insert may remove the need for topical 
administration of dexamethasone (or other similar steroid) eye drops following surgery. 
 
About 30 subjects will take part in this research. 
 
How long will I be in this research? 
You will be scheduled for the following study visits: First and Second eye surgery days, the day 
after each surgery, and then Day 7, Day 30 and Day 90 following both eye surgeries. We expect 
that your taking part in this research will last approximately 3 months. 
 
What happens to me if I agree to take part in this research? 
During the study, the following procedures will be done. Some of these exams will happen more 
than once while you are in the study. 
 
• Medical History and Concurrent Illnesses: You will also be asked questions about your 
overall health, past diseases, and surgeries. 
• Concomitant Medications: You will be asked questions about the medications, vitamins, or 
other supplements you take. 
• Demographics: You will be asked questions such as your date of birth, race, and ethnic 
background.  
• Adverse Events: You will be asked questions to find out whether you are having any 
changes in health or side effects during the study.  
• Ocular Pain Assessment on the Numerical Rating Scale (NRS Pain Scale): You will be 
asked to rate your pain from 0 (no pain) to 10 (most pain).  
• Adapted COMTOL Questionnaire: You will be asked questions about your personal 
experience and satisfaction with the study insert. 
• Eye Drop Burden Questionnaire: You will be asked 8 questions about your experience 
administering the post-op drops. 
• Urine Pregnancy Test: If you are a woman able to have children, you must have a 
pregnancy test by giving a urine sample. 
o The study doctor or staff will tell you if the pregnancy test results are positive. The 
results of the pregnancy testing must be negative for you to stay in the study. 
• Best Corrected Visual Acuity: Your vision will be measured using an eye chart. 


 
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• Slit-Lamp Biomicroscopy: The study doctor will look into the front of your eye using a 
machine that has a bright light. 
• IOP (Intraocular Pressure): You will have drops put in your eyes to numb them. Once your 
eyes are numb, the pressure inside of your eyes will be measured by using a machine that 
gently touches the surface of your eyes. 
• Dilated Fundus Examination: The study doctor will put dilating drops in your eyes, once 
your eyes are dilated, the doctor will look at the back of your eye with a bright light.  
• OCT: A special light beam will be used to take a picture of the back of your eye. 
• Insertion of Dextenza: The study drug is a small insert that is placed in the punctum, a 
natural opening in the eye lid. The study doctor will first apply anesthetic drops to the eye to 
numb the eye. The study doctor will then place a small probe into the punctum to open the 
punctum to allow for the insert. The insert will then be placed into the punctum with forceps, 
which are like tweezers. Normal saline drops will then be applied to your eye.  
• Application of 1% prednisolone acetate: You will be required to insert the drops 4 times a 
day for the first week, 3 times a day for the second week, 2 times a day for the third week, 
and once a day for the fourth week in the eye that did not receive the Dextenza insert. 
• Application of Moxifloxacin (Vigamox 0.5%) antibiotic drops: You will be required to 
insert the drops 4 times a day for a week in both eyes. 
• Intracameral (into the front chamber of the eye) injection of NSAID (ketorolac) + 
antibiotic (moxifloxacin) + steroid (dexamethasone) combo (DMK): You will be given an 
injection of standard operative medications during cataract surgery. 
• Application of NSAID (Prolensa) drops:  You will be required to apply the drops once 
every day for one month in both eyes. 
 
What are my responsibilities if I take part in this research? 
If you take part in this research, you will be responsible to:  
• Follow the instructions you are given. 
• Come to the study clinic for all visits with the study doctor or study staff. 
• Tell the study doctor or study staff about any changes in your health or the way you feel. 
• Tell the study doctor or study staff about any changes in your medications or new 
medications you may have taken. 
• Tell the study doctor or study staff if you want to stop being in the study at any time. 
 
It is important for you to be honest with your study doctor about your medical history and any 
medicines or supplements you are taking in order to prevent any harm to you in taking part in 
this study. 
 
Could being in this research hurt me? 
The risks associated with participation in this clinical research study are expected to be similar to 
other corticosteroid therapeutic options for the treatment of postoperative pain and inflammation 
following cataract surgery and may include bacterial infections, viral infections, fungal 
infections, increased intraocular pressure, and glaucoma. Previous studies in adults have shown 
that treatment with Dextenza is generally well tolerated in an appropriate patient population.  
  


 
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Dextenza may cause the following side effects. These include: 
• Vision problems. 
• Seeing “floaters” in your vision. 
• Eye pain or redness. 
• Feeling like something is in your eye. 
• Eyelid swelling. 
• Dry eyes. 
• Headache. 
• Visual sensitivity to light. 
 
1% prednisolone acetate eye drops may cause stinging/burning of the eyes upon application. Use 
of these eye drops for a prolonged period of time or in high doses may cause serious eye 
problems such as high pressure inside the eyes and cataracts.  
 
Moxifloxacin eye drops may cause the following side effects. These include: 
• Red, irritated, itchy, or teary eyes. 
• Blurred vision. 
• Eye pain. 
• Dry eyes. 
• Broken blood vessels in the eyes. 
• Runny nose. 
• Cough. 
 
Intracameral injection of NSAID + antibiotic + steroid combo (DMK) may cause the following 
side effects. These include:    
• Eye irritation and infection. 
• Eye burning/stinging. 
• Headache. 
• Fever. 
• Tissue damage. 
• Cornea problems. 
 
NSAID (Prolensa) eye drops may cause the following side effects. These include:  
• Visual sensitivity to light. 
• Blurred vision. 
• Eye pain or redness. 
• Eye irritation or itching. 
• Eyelid swelling. 
• Bleeding in the eye. 
• Headache. 
• Conjunctival Hyperemia (increased amount of blood in the lining of the eye). 
 


 
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It is important that you tell the study staff about possible complications you experience while 
participating in the study. Not all risks can be predicted and there may be risks that are unknown 
at this time. If you have any health-related problems during your treatment, you should contact 
the Principal Investigator (Mitchel Ibach, OD) of the study at Vance Thompson Vision, Sioux 
Falls as soon as possible. It is not possible to predict in advance if any problems will develop, but 
if they do occur you will be promptly treated. The study protocol also permits your doctor to 
administer “rescue medication”, or a different medication that he/she sees as an option for you in 
the case that Dextenza is not working for your pain and inflammation. A possible side effect to 
any of the drugs used in this study or the investigational drug is an allergic reaction. If you 
experience any allergic reactions, please notify the study doctor. 
 
You cannot participate in this study if you are pregnant.  If you are pregnant or become pregnant 
during the study, the study drugs may involve unforeseeable risks to the unborn baby. 
 
Will it cost me money to take part in this research? 
There will be no additional cost to you for taking part in this research.  
 
Will being in this research benefit me? 
There have been positive findings with use of the dexamethasone insert in the treatment of 
postoperative pain and inflammation. You may benefit by having your pain and inflammation 
reduced, however there is no promise your pain and inflammation will be reduced. Information 
from this study might help researchers to come up with new tests or medications to help others in 
the future.  
 
What other choices do I have besides taking part in this research? 
There are other treatments available for postoperative pain and inflammation. 
 
Currently, corticosteroid ophthalmic topical drops are used for the treatment of postoperative 
pain and inflammation in cataract surgery. 
 
You do not need to participate in this study to be treated for your condition. You should discuss 
your alternatives to participating in this research with the study doctor or study staff. In addition, 
you may discuss your options with your regular health care provider.  
 
What happens to the information collected for this research? 
Your private information and your medical record will be shared with individuals and 
organizations that conduct or watch over this research, including: 
• The research sponsor 
• People who work with the research sponsor 
• Government agencies, such as the Food and Drug Administration 
• WCG IRB, the Institutional Review Board (IRB) that reviewed this research 
 
We may publish the results of this research. However, we will keep your name and other 
identifying information confidential. 


 
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We protect your information from disclosure to others to the extent required by law. We cannot 
promise complete secrecy. 
 
A description of this clinical trial 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. 
 
Data or specimens collected in this research might be deidentified and used for future research or 
distributed to another investigator for future research without your consent. 
 
Who can answer my questions about this research? 
If you have questions, concerns, or complaints, or think this research has hurt you or made you 
sick, talk to the research team at the phone number listed above on the first page. 
 
This research is being overseen by WCG IRB. An IRB is a group of people who perform 
independent review of research studies. You may talk to them at 855-818-2289 or 
researchquestions@wcgirb.com if:  
• You have questions, concerns, or complaints that are not being answered by the research 
team. 
• You are not getting answers from the research team. 
• You cannot reach the research team. 
• You want to talk to someone else about the research. 
• You have questions about your rights as a research subject. 
 
What if I am injured because of taking part in this research? 
In the event that you should be injured in the course of a research study, you will be provided 
with the necessary medical care at Vance Thompson Vision. However, this statement does not 
mean that either such medical care of hospitalization, if necessary, will be free of charge.  
Furthermore, we do not intend to provide you with compensation as a result of any injury.  
 
Can I be removed from this research without my approval? 
The study doctor may end your participation in the study without your permission at any time.  
The Sponsor may also choose to terminate the entire study at any time. Possible reasons for 
removal include: 
• It is in your best interest 
• You have a side effect that requires stopping the research 
• You need a treatment not allowed in this research 
• You become pregnant 
• The research is canceled by the FDA or the sponsor 
• You are unable to take the research medication 
• You are unable to keep your scheduled appointments 
 


 
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We will tell you about any new information that may affect your health, welfare, or choice to 
stay in this research. If you are withdrawn from the study, you may be asked to have the 
appropriate medical tests and follow-up to evaluate your health and safety. 
 
What happens if I agree to be in this research, but I change my mind 
later? 
Participation in this study is voluntary and it is entirely your decision whether or not you take 
part in this study.  If after reading this information and talking with the medical staff you choose 
not to take part, or if you change your mind after agreeing and signing the consent form, for any 
reason, your decision will be respected.  If you decide not to participate in this study, or end your 
participation for any reason, you may receive a standard treatment, and no prejudice or bias will 
be show toward you for routine medical care. 
 
You can stop taking part in this study at any time.  If you decide to take part in this study, but 
later withdraw for any reason, study data collected prior to your withdrawal may still be used. 
 
If you decide to stop being part of the study, you should:  
• 
tell the study doctor immediately.  
• 
see the study doctor to be examined 
 
If you withdraw your consent to participate in this study, then no new information will be 
collected from you with the exception of information for adverse events occurring at the time of 
your withdrawal.   
 
For taking part in this research, you may be paid up to a total of $400 for completion of the 
study. You will be paid for the visits you complete. You will be compensated within 8 weeks of 
your final study visit. Your post-operative drops will also be provided to you at no charge.  
 
Statement of Consent:  
 
Your signature documents your consent to take part in this research. 
 
 
 
 
Signature of adult subject capable of consent 
 
Date 
 
 
 
Signature of person obtaining consent 
 
Date 
 

Prot_001.pdf: 
The PREPARE Study (V1) 
Page 20 
CONFIDENTIAL 
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 
 
 
 
 


The PREPARE Study (V1) 
 
February, 2021 
 
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CONFIDENTIAL 
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 


The PREPARE Study (V1) 
 
February, 2021 
 
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CONFIDENTIAL 
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.  
 
 


The PREPARE Study (V1) 
 
February, 2021 
 
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CONFIDENTIAL 
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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CONFIDENTIAL 
(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.  
 


The PREPARE Study (V1) 
 
February, 2021 
 
Page 26 
 
CONFIDENTIAL 
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 


The PREPARE Study (V1) 
 
February, 2021 
 
Page 27 
 
CONFIDENTIAL 
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 


The PREPARE Study (V1) 
 
February, 2021 
 
Page 28 
 
CONFIDENTIAL 
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. 


The PREPARE Study (V1) 
 
February, 2021 
 
Page 29 
 
CONFIDENTIAL 
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 
 
 
 
 
 


The PREPARE Study (V1) 
 
February, 2021 
 
Page 30 
 
CONFIDENTIAL 
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 


The PREPARE Study (V1) 
 
February, 2021 
 
Page 31 
 
CONFIDENTIAL 
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 


The PREPARE Study (V1) 
 
February, 2021 
 
Page 32 
 
CONFIDENTIAL 
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 


The PREPARE Study (V1) 
 
February, 2021 
 
Page 33 
 
CONFIDENTIAL 
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 


The PREPARE Study (V1) 
 
February, 2021 
 
Page 34 
 
CONFIDENTIAL 
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. 
 


The PREPARE Study (V1) 
 
February, 2021 
 
Page 35 
 
CONFIDENTIAL 
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 
 
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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 
 
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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 
 
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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) 
 
 
 
 


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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) 
 
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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) 
 
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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