Clinical trial NCT04396990
Conditions: Refractive Surgery
Sponsor: Vance Thompson Vision
Start date: 2020-06-08; Completion date: 2020-09-28
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral PRK surgery.

Detailed description:
Prospective Open-label Interventional Study Randomized, self-controlled design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, BID 1 week following bilateral PRK surgery. All eyes will receive topical moxifloxacin QID for one week. Moxifloxacin in used post-op regardless of the research. Post-operative evaluations to be performed on Day 3 and Day 4, Month 1, and Month 3. Phone call survey to be performed on Week 2.

Arms: arm 1: Will receive Dextenza post-operative arm 2: Will receive standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week
Interventions: intervention 1: Dextenza 0.4Mg Ophthalmic Insert intervention 2: Topical Prednisolone
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 treatment

Protocol documents:
ICF_002.pdf: 
IRB APPROVED 
May 13, 2020 
 
1 
 
RESEARCH SUBJECT CONSENT FORM 
TITLE: 
A Randomized, Controlled, Masked (Reading Center) 
Prospective Study of the Effectiveness and Safety of the 
Ocular Therapeutix Dextenza (dexamethasone Ophthalmic 
insert) 0.4 mg for the treatment of post-operative 
inflammation and pain in patients who have undergone 
PhotoREfractive Keratectomy (PRK)- 
 
PROTOCOL NO.: 
The RESTORE Study  
 
ASPIRE® Protocol #20201216 
 
SPONSOR: 
John P. Berdahl, MD  
INVESTIGATOR: 
John P. Berdahl, MD 
SITE(S): 
Vance Thompson Vision 
 
3101 W 57th St 
  
Sioux Falls, South Dakota 57108 
 
United States 
 
SUB-INVESTIGATOR: 
Mitch Ibach, OD 
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 approximately 12-14 weeks. 
 


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Why is this research being done? 
The purpose of this research is to evaluate the efficacy and safety of Dextenza for the 
treatment of postoperative pain and inflammation following Photorefractive Keratectomy 
(PRK) surgery compared to a standard steroid drop regimen. The use of DEXTENZA 
(dexamethasone ophthalmic insert) 0.4 mg in this study is considered investigational.  
 
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 6 visits, 
including one surgery day and 5 office visits, as well as 1 phone call survey. The study 
will have 2 groups; one group of 10 eyes that will receive Dextenza and one group of 10 
eyes that will receive topical steroid drops. Each participant will have one eye in each 
group. You will also receive topical antibiotic drops to be used in both eyes for one 
week. 
 
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 PRK 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 safe 
and well tolerated in a similar patient population that underwent ophthalmic surgery. 
 
Will being in this research benefit me? 
The most important benefits that you may expect from taking part in this research is 
reduction of pain and inflammation post-surgery. 
 
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 or Dextenza. 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 because you are scheduled to 
have PRK surgery in both your eyes.  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. 


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• If you don’t understand, ask questions. 
• Ask all the questions you want before you decide. 
 
Why is this research being done? 
The purpose of this research is to evaluate the efficacy and safety of Dextenza for the 
treatment of postoperative pain and inflammation following PRK surgery. 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.  Each eye will receive a different steroid therapy after 
the PRK surgery.  
 
The study drug, Dextenza, is approved by the FDA for the treatment of pain and 
inflammation following ophthalmic surgery. Dextenza is an intracanalicular insert 
containing 0.4mg dexamethasone steroid designed to elute preservative-free drug over 
30 days. The insert removes the need for topical administration of dexamethasone (or 
other similar steroid) eye drops in that eye following surgery. 
 
The other eye will receive topical dexamethasone or similar steroid eye drops.  
 
About 20 subjects will take part in this research. 
 
How long will I be in this research? 
We expect that your taking part in this research will last approximately 12-14 weeks. 
 
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/Surgical History: 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 question to find out whether you are having any 
changes in health or side effects during the study.  
• Numerical Rating Scale (NRS Pain Scale): You will be asked to rate your pain 
from 0 (no pain) to 10 (most pain).  
• SPEED Questionnaire: You will be asked questions about your dry eye symptoms.  
• COMTOL Questionnaire: You will be asked questions about your personal 
experience and satisfaction with the study insert. 
• Urine Pregnancy Test: If you are a woman able to have children, you must have a 
pregnancy test by giving a urine sample. 


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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. 
• 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.  
• Pentacam: A special light beam will be used to take a picture of the inside of you 
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 a week and then 2 drops a day for an additional week in the eye that 
did not receive the Dextenza insert.  
 
Screening Visit 
Before you do anything in this study, you will be asked to sign and date this consent 
form. A copy of the signed and dated consent form will be given to you to take home. 
At this visit, the following procedures and tests will be done: 
• Inclusion/exclusion 
• Demographics 
• Medical History and Concurrent Illnesses 
• Concomitant Medications 
• Randomization 
• Uncorrected Distance visual acuity as measured by ETDRS chart at 4m 
• Manifest Refraction 
• Best-corrected visual acuity as measured by ETDRS chart at 4m 
• Corneal haze (via AS-OCT) 
• Intraocular pressure 
• Corneal Staining 
• Slit Lamp Exam 
• Ophthalmic Examination (dilated fundus exam) 
• Subject reported AEs prior to or after surgery 
• Ocular pain assessment 
• Modified Speed questionnaire  
 


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Surgery Day 
At this visit, the following procedures and tests will be done for the study: 
• Concomitant medications 
• Confirm treatment group 
• Record any surgical complications 
• Subject reported AEs prior to or after surgery  
• Intracanalicular dexamethasone insert in one eye 
• Prescribe post-operative topical therapy regimen 
 
Post-Operative Day 3 
At this visit, the following procedures and tests will be done: 
• Concomitant medications 
• Intraocular pressure 
• Corneal staining 
• Slit lamp exam 
• Subject reported AEs prior to or after surgery  
• Insert visualization 
• Ocular pain assessment 
 
Post-Operative Day 4 
At this visit, the following procedures and tests will be done: 
• Concomitant medications 
• Intraocular pressure 
• Corneal staining 
• Slit lamp exam 
• Subject reported AEs prior to or after surgery  
• Insert visualization 
• Ocular pain assessment 
Phone Call 1: Day 14 
During this call, the following procedures will be done: 
• Subject reported AEs prior to or after surgery  
• Ocular pain assessment 
 
Post-Operative Day 28  
At this visit, the following procedures and tests will be done: 
• Concomitant medications 
• Uncorrected Distance visual acuity as measured by ETDRS chart at 4m 
• Manifest refraction 
• Best-corrected visual acuity as measured by ETDRS chart at 4m 
• Corneal haze 
• Intraocular pressure 
• Corneal staining 
• Slit lamp exam 
• Subject reported AEs prior to or after surgery 
• Insert visualization 


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• Ocular pain assessment 
• Modified Speed questionnaire  
• Adapted COMTOL Survey 
 
Post-Operative Month 3  
At this visit, the following procedures and tests will be done: 
• Concomitant medications 
• Uncorrected Distance visual acuity as measured by ETDRS chart at 4m 
• Manifest refraction 
• Best-corrected visual acuity as measured by ETDRS chart at 4m 
• Corneal haze 
• Intraocular pressure 
• Corneal staining 
• Slit lamp exam 
• Subject reported AEs prior to or after surgery 
• Insert visualization 
 
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 PRK surgery. Side effects from the Dextenza and the topical 
steroid drops may include: 
• bacterial infections,  
• viral infections,  
• fungal infections,  
• increased intraocular pressure,  
• pain  
• swelling 
• redness and  


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• glaucoma.  
 
Previous studies in adults have shown that treatment with Dextenza is safe and well 
tolerated in an appropriate patient population.  The most common non-eye side effect 
experienced was a headache.  
 
One of the reasons for this study is to learn more about the safety and efficacy of 
Dextenza for the treatment of postoperative pain and inflammation following PRK 
surgery. 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. If you have 
any health-related problems during your treatment, you should contact the Principal 
Investigator (John Berdahl, MD) 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 investigational drugs is an allergic 
reaction. If you experience any allergic reactions please notify the study doctor. 
 
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 PRK 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 
• The Institutional Review Board (IRB) that reviewed this research 


IRB APPROVED 
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We may publish the results of this research. However, we will keep your name and 
other identifying information confidential. 
 
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. 
 
Efforts will be made to keep your study-related information confidential.  However, there 
may be circumstances where this information must be released.  For example, personal 
information regarding your participation in this study may be disclosed if required by 
state law.   
 
Also, your records may be reviewed by the following groups (as applicable to the 
research): 
• 
Office for Human Research Protections or other federal, state, or international 
regulatory agencies; 
• 
U.S. Food and Drug Administration; 
• 
The sponsor supporting the study, their agents or study monitors 
• 
The Institutional Review Board (IRB) that reviewed this research 
If this study is related to your medical care, your study-related information may be 
placed in your permanent hospital, clinic, or physician’s office records.  
You may also be asked to sign a separate Health Insurance Portability and 
Accountability Act (HIPAA) research authorization form if the study involves the use of 
your protected health information. 
 
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 an Institutional Review Board (“IRB”). An IRB is a 
group of people who perform independent review of research studies. You may talk to 
them at 1-877-366-5414 (toll-free), email@aspire-irb.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. 
 


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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 cannot provide you with compensation as a 
result of any injury.  If you are injured as a result of this study, you do not give up your 
right to pursue a claim through the legal system. 
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. Your 
participation to the study could be terminated for example, if you are unable to follow the 
study procedures or if medical events occur that could impact your safety, or if too many 
subjects have been enrolled. 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.   
 
Will I be paid for taking part in this research? 
You will not receive compensation for your participation in the study. You will receive 
PRK at no cost to you. 
 


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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 
My signature below documents that the information in the consent form and any other 
written information was accurately explained to, and apparently understood by, the 
subject, and that consent was freely given by the subject. 
 
 
 
Signature of witness to consent process 
 
Date 

Prot_001.pdf: 
The RESTORE Study (V1) 
December 17, 2019 
 
Page 1 
 
CONFIDENTIAL 
 
 
Investigator-Initiated Study Protocol 
 
 
A Randomized, Controlled, Masked (Reading Center) Prospective Study of 
the Effectiveness and Safety of the Ocular Therapeutix Dextenza 
(dexamethasone Ophthalmic insert) 0.4 mg for the treatment of post-
operative inflammation and pain in patients who have undergone 
PhotoREfractive Keratectomy (PRK) 
 
The RESTORE Study 
 
 
 
Compound: 
DEXTENZA (dexamethasone 
ophthalmic insert) 0.4 mg for 
intracanalicular use 
 
 
Study Name: 
A Randomized, Controlled, Masked 
(Reading Center) Prospective Study 
of the Effectiveness and Safety of the 
Ocular Therapeutix Dextenza 
(dexamethasone ophthalmic insert) 
0.4 mg for the treatment of post-
operative inflammation and pain in 
patients who have undergone 
Photorefractive Keratectomy (PRK)- 
The RESTORE Study 
 
 
Clinical Phase: 
Prospective, Randomized, Controlled, 
Masked Investigator-Initiated Trial 
 
 
Date of Issue: 
December 17, 2019 
 
 
Primary Investigator: 
John Berdahl, MD 
 
 
Sub Investigator: 
Mitch Ibach, OD 
 
Site Name & Location: 
Vance Thompson Vision Center 
3101 West 57th Street 
Sioux Falls, South Dakota 
57108 
 
 
 
 


The RESTORE Study (V1) 
 
December 17, 2019 
 
Page 2 
 
CONFIDENTIAL 
CLINICAL STUDY PROTOCOL SYNOPSIS 
TITLE 
A Randomized, Controlled, Masked (Reading 
Center) Prospective Study of the Effectiveness and 
Safety of the Ocular Therapeutix Dextenza 
(dexamethasone ophthalmic insert) 0.4 mg for the 
treatment of post-operative inflammation and pain 
in patients who have undergone Photorefractive 
Keratectomy (PRK) 
SITE LOCATION(S) 
 
Vance Thompson Vision Center 
3101 West 57th Street 
Sioux Falls, South Dakota 
57108 
PRINCIPAL 
INVESTIGATOR 
John Berdahl, MD 
OBJECTIVE(S) 
To determine patient preference and treatment 
outcomes with an intracanalicular dexamethasone 
(0.4mg) insert compared to standard steroid drop 
regimen in the contralateral eye following bilateral 
PRK surgery. 
STUDY DESIGN 
Prospective Open-label Interventional Study 
Randomized, self-controlled design in which one 
eye (Group A) receives Dextenza and the second 
eye (Group B) receives prednisolone acetate 1% 
QID 1 week, BID 1 week following bilateral PRK 
surgery. All eyes will receive topical moxifloxacin 
QID for one week. Moxifloxacin in used post-op 
regardless of the research.  Post-operative 
evaluations to be performed on Day 3 and Day 4, 
Month 1, and Month 3. Phone call survey to be 
performed on Week 2.  
STUDY DURATION 
3 months 
ESTIMATED STUDY 
COMPLETION DATE 
January 2021 
POPULATION 
 
Sample Size: 
N=20 (40 eyes) 
Target Population: 
Patients planning to undergo bilateral 
Photorefractive Keratectomy (PRK) surgery. 
TREATMENT(S) 
 


The RESTORE Study (V1) 
 
December 17, 2019 
 
Page 3 
 
CONFIDENTIAL 
Study Drug 
 
 
 
Dose/Route/Schedule: 
DEXTENZA (dexamethasone ophthalmic insert) 
0.4 mg for intracanalicular use  
 
All patients will be enrolled for bilateral PRK 
surgery. The first eye will be randomized to Group 
A or B; the second eye will be selected for the 
opposite group. Group A will receive Dextenza at 
the time of PRK surgery while Group B will receive 
prednisolone acetate 1% QID 1 week, BID 1 week 
following bilateral PRK surgery. All eyes will 
receive topical moxifloxacin QID for 1 week. 
Moxifloxacin is used post-op regardless of the 
research.  
 
ENDPOINT(S) 
 
Primary: 
Adapted COMTOL Survey 
 
 
Secondary: 
 
 
 
 
 
 
 
 
Safety: 
Percentage of eyes epithelialized at POD 4 
Corneal Staining 
Corneal haze 
Ocular Pain Assessment 
Uncorrected distance visual acuity  
Corrected distance visual acuity 
Manifest refraction spherical equivalent 
Modified SPEED questionnaire  
 
IOP spikes (increase of 10 mm Hg or greater than 
baseline) 
Adverse events 
 


The RESTORE Study (V1) 
 
December 17, 2019 
 
Page 4 
 
CONFIDENTIAL 
TABLE OF CONTENTS 
Clinical Study Protocol Synopsis ................................................................................ 2 
List of Tables ................................................................................................................... 5 
1. 
Introduction and Rationale .................................................................................. 6 
1.1 
Introduction ......................................................................................................... 6 
1.2 
Rationale ............................................................................................................... 6 
1.2.1 
Rationale for Study Design .................................................................. 7 
2. 
Study endpoints ...................................................................................................... 7 
2.1 
Primary Endpoint ............................................................................................... 7 
2.2 
Secondary Endpoints ......................................................................................... 7 
2.3 
Safety Endpoints ................................................................................................. 8 
3. 
Study Design ............................................................................................................ 8 
3.1 
Study Description and Duration ..................................................................... 8 
4. 
Selection, Withdrawal, and Replacement of Patients .................................... 8 
4.1 
Study Population ................................................................................................ 8 
4.1.1 
Inclusion Criteria .................................................................................... 8 
4.1.2 
Exclusion Criteria ................................................................................... 9 
4.2 
Treatment Logistics and Accountability ....................................................... 9 
4.2.1 
Packaging, Labeling, and Storage ...................................................... 9 
4.2.2 
Supply and Disposition of Treatments ............................................ 10 
4.2.3 
Treatment Accountability ................................................................... 10 
4.3 
Concomitant Medications and Procedures ................................................. 10 
5. 
Study Schedule of Events and Visit Descriptions ......................................... 10 
5.1 
Schedule of Events ........................................................................................... 10 
5.2 
Study Visit Descriptions ................................................................................. 11 
5.2.1 
Study Procedures .................................................................................. 11 
5.2.2 
Unscheduled Visits ............................................................................... 14 
5.2.3 
Adverse Event Information Collection............................................. 14 
5.3 
Rescue Criteria .................................................................................................. 15 
6. 
Safety Definitions, Reporting, and Monitoring .............................................. 15 
6.1 
Definitions .......................................................................................................... 15 
6.1.1 
Adverse Event ....................................................................................... 15 


The RESTORE Study (V1) 
 
December 17, 2019 
 
Page 5 
 
CONFIDENTIAL 
6.1.2 
Serious Adverse Event ........................................................................ 15 
6.2 
Recording and Reporting Adverse Events .................................................. 16 
7. 
Study Variables ..................................................................................................... 16 
7.1 
Demographic and Baseline Characteristics ............................................... 16 
8. 
Ethical and Regulatory Considerations........................................................... 16 
8.1 
Good Clinical Practice Statement ................................................................. 16 
8.2 
Informed Consent ............................................................................................. 16 
8.3 
Patient Confidentiality and Data Protection ............................................. 17 
8.4 
Institutional Review Board ............................................................................ 17 
 
LIST OF TABLES 
Table 1 
Schedule of Events ................................................................................... 11 
  
 


The RESTORE Study (V1) 
 
December 17, 2019 
 
Page 6 
 
CONFIDENTIAL 
1. 
INTRODUCTION AND RATIONALE 
1.1 
Introduction 
 
Photorefractive Keratectomy (PRK) is a well-studied, FDA approved, 
refractive surgery option for many patients. Post-operatively patients are 
commonly treated with antibiotic drops for infection prophylaxis, steroid drops 
for inflammation and corneal haze prevention, and finally NSAIDs (non-
steroidal anti-inflammatory drugs) for pain management. Although the types 
of medications are standardized, there are many different protocols that vary 
based on surgeon and practice preference.  
 
Post-operative drop regimens frequently induce both concerns and 
questions for patients undergoing ocular surgery. Poor compliance with post-
operative medications can lead to unexpected and or unsatisfactory outcomes.  
With refractive surgery visual outcomes and safety at such a high level, patient 
satisfaction and experience can be altered by post-operative convenience.  
 
Dextenza (dexamethasone 0.4mg ophthalmic insert) is a steroid eluting 
intracanalicular plug approved on-label for the treatment of pain and post-
operative 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.  
 
The tear film is a key component in corneal epithelial healing as well as 
refractive outcomes in PRK. In many studies, inflammation and inflammation 
markers are a driver to decreasing tear film homeostasis. With an 
intracanalicular steroid plug there is potential benefit to restoring tear film 
homeostasis sooner, combined with increased tear volume, leading to improved 
epithelialization and refractive outcomes. Finally, intracanalicular steroid 
plugs offer patients a preservative free steroid option to further promote 
epithelial health by decreasing topical preservatives. 
 
1.2 
Rationale 
 
DEXTENZA (dexamethasone 0.4mg ophthalmic insert) has increasing 
research and evidence for post-cataract surgery patients, but a gap remains in 
many other ophthalmic surgeries. Refractive surgery, similar to cataract 
surgery, has post-operative visual acuity as a major determinant of surgery 
success. 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 RESTORE Study (V1) 
 
December 17, 2019 
 
Page 7 
 
CONFIDENTIAL 
1.2.1 
Rationale for Study Design 
 
This prospective contralateral eye study will compare the outcomes of 
20 patients undergoing bilateral PRK. In one eye the patient will receive a 
topical steroid and the contralateral eye will receive a Dextenza ophthalmic 
insert. Both eyes will receive a topical antibiotic. 
The primary endpoint of patient preference and pain was chosen based 
on previous studies that have shown decreasing topical medications increases 
patient satisfaction. Secondary endpoints including SPEED survey and 
corneal staining were chosen to test the hypothesis of less ocular surface 
disease with Dextenza. Time to epithelialization will be studied to see the 
positive or neutral effects of steroid plus punctal occlusion on epithelialization. 
Finally, the other secondary endpoints are standard measures for PRK.  
The study inclusion and exclusion criteria were chosen based on patients 
who normally would be successful with laser refractive surgery. The study 
follow-up visits were based on the Vance Thompson Vision standard post-
operative follow-up protocols.  
 
2. 
STUDY ENDPOINTS 
2.1 
Primary Endpoint 
To determine at Month 1 (Day 28 +/-3 days):  
• Patient preference as measured by adapted COMTOL survey at Month 
1 following surgery. 
 
2.2 
Secondary Endpoints 
To determine at Post-Operative Day 3 and 4: 
• Percentage of eyes epithelialized at Day 3 and Day 4. 
To determine through Month 1 (Day 28 +/- 3 days): 
• Mean pain score per eye (Group A vs. Group B) as measured by the 
Numerical Rating Scale (NRS) at Day 3, Day 4, Week 2 (collected via 
telephone survey), and Month 1. 
• Patient preference as measured by a modified SPEED questionnaire at 
Pre-op Visit and Month 1. 
To determine through Month 3 (+/- 4 days): 
• Incidence and grade of post-operative corneal haze as measured by 
Heidelberg Anterior Segment OCT at Pre-op Visit, Month 1, and 
Month 3. 
• Post-operative corneal staining score as measured by the National Eye 
Institute (NEI) grading system at Day 3, Day 4, Month 1, and Month 3. 


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• Uncorrected visual acuity as measured by ETDRS chart at 4m at Month 
1 and Month 3. 
• Best-corrected visual acuity as measured by ETDRS chart at 4m at 
Month 1 and Month 3 
• Manifest Refraction Spherical Equivalent as measured by the 
Optometrist at Month 1 and Month 3.  
2.3 
Safety Endpoints 
To determine through Month 3 (+/- 4 days): 
• Incidence of increased IOP >10 mmHg above baseline at all timepoints 
• Occurrence of adverse events at all timepoints 
 
3. 
STUDY DESIGN 
3.1 
Study Description and Duration 
This 
prospective, 
open-label, 
single-center, 
randomized, 
investigator-
sponsored clinical study seeks to investigate the outcomes of patients 
undergoing bilateral PRK surgery with the treatment of a dexamethasone 
intracanalicular insert compared to topical standard of care steroid. All eyes 
will receive treatment. Additionally, all eyes will receive topical moxifloxacin 
QID for 1 week. Moxifloxacin is used post-op regardless of the research.  
 
Twenty patient eyes undergoing bilateral PRK surgery will be randomized to 
receive either Dextenza (Group A) OR standard of care prednisolone acetate 
1% QID for 1 week, BID for 1 week (Group B). The contralateral eye will receive 
treatment with either Dextenza or topical prednisolone as a comparator based 
on randomization of first eye to Group A or Group B. Post-operative 
evaluations to be performed on Day 3, Day 4, phone call survey at Week 2, 
Month 1, and Month 3. 
 
4. 
SELECTION, WITHDRAWAL, AND REPLACEMENT OF PATIENTS 
4.1 
Study Population 
The study aims to enroll 20 patients planning to undergo bilateral PRK 
surgery. 
 
4.1.1 
Inclusion Criteria 
A patient’s study eye must meet the following criteria to be eligible for 
inclusion in the study: 
• Any adult patient who is planned to undergo bilateral PRK surgery. 
• Willing and able to comply with clinic visits and study related 
procedures 
• Willing and able to sign the informed consent form 
 


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4.1.2 
Exclusion Criteria 
A patient who meets any of the following criteria will be excluded from the 
study: 
• Patients under the age of 18. 
• Patients who are pregnant (must be ruled out in women of child-
bearing age with pregnancy test). 
• Active infectious ocular or systemic disease. 
• Patients with active infectious ocular or extraocular disease. 
• Patients actively treated with local or systemic immunosuppression 
including systemic corticosteroids. 
• Patients with known hypersensitivity to Dexamethasone. 
• Patients with severe disease that warrants critical attention, deemed 
unsafe for the study by the investigator. 
• Patients with a history of ocular inflammation or macular edema. 
• Patients with allergy or inability to receive intracameral antibiotic. 
• Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) 
greater than 1,200 mg/day 
• Patients with a corticosteroid implant (i.e. Ozurdex).  
• Patient with corneal pathology which pre-disposes them to 
unsatisfactory outcomes.  
• Patients who do not have 20/20 snellen visual acuity potential pre-
operatively.  
• MRSE greater than 6 diopters.  
• Greater than 2 diopters anisometropia. 
 
4.2 
Treatment Logistics and Accountability 
4.2.1 Packaging, Labeling, and Storage 
Intracanalicular dexamethasone insert must be stored in a secure area 
accessible only to the Investigator and their designee(s) and refrigerated and 
stored between 2o C and 80 C. Intracanalicular dexamethasone insert contains 
0.4 mg dexamethasone and is designed to provide a sustained and tapered 
release of therapeutic levels of dexamethasone to the ocular surface for up to 
30 days for the reduction of post-surgical inflammation and pain associated 
with ocular surgery. Dexamethasone is an anti-inflammatory 9-fluoro-
glucocorticoid (also termed a glucocorticoid agonist) and is the active 
ingredient found in MAXIDEX® 0.1% (dexamethasone ophthalmic 
suspension), which contains approximately 50 μg of dexamethasone per drop.  
Study inserts will be supplied by Ocular Therapeutix in a sealed foil pouch 
containing one intracanalicular dexamethasone insert in a foam carrier. 
Study inserts will be shipped to the site via overnight shipping using cold 
packs to maintain a temperature of 2° to 8° C. The Investigator, or an 
approved representative (e.g. pharmacist), will ensure that all study drug 


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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. 
 
4.2.2 Supply and Disposition of Treatments 
Study insert will be shipped at a temperature of 2° to 8°C to the investigator 
as needed during the study.  
 
4.2.3 Treatment Accountability 
All study insert accountability records will be kept current. 
 
The investigator will account for all opened and unopened packaging of study 
inserts.  These records will contain the dates, quantity, and study medication 
• Inserted in each patient, 
• disposed of at the site or returned to Ocular Therapeutix 
All accountability records will be made available for inspection by regulatory 
agency inspectors. 
 
4.3 
Concomitant Medications and Procedures 
At the discretion of their physician, patients may continue to receive all 
medications and standard treatments administered for other conditions. 
 
5. 
STUDY SCHEDULE OF EVENTS AND VISIT DESCRIPTIONS 
5.1 
Schedule of Events 
Study assessments and procedures are presented by visit in Table 1. 
 
 
 
 
 
 
 
 
 
 
 


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Table 1 
 
Schedule of Events 
 
Study Procedure 
 
Screening/ 
Baseline 
 
 
 
Surgical 
Visit  
Day 0 
 
 
 
 
 
Day 3 
 
 
 
 
 
 
Day 4 
 
 
 
 
 
 
Day 14 
 
 
 
 
 
Day 28 
 
 
 
3 MTH 
post-op  
 
 
 
Early 
Terminat
ion 
Visit 
VISIT 1 
VISIT 2 
VISIT 3 
VISIT 4 
Phone 
call 1 
VISIT 5 
VISIT 6 
 
Windows for Visits 
(Day -30 to 
-1) 
 
 
 
(+/- 2 
days) 
(+/- 3 
days) 
(+/- 3 
days) 
 
Inclusion/Exclusion 
X 
 
 
 
 
 
 
 
Informed Consent 
X 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
Medical History and 
Concurrent Illnesses 
X 
 
 
 
 
 
 
 
Concomitant Medications 
X 
X 
X 
X 
 
X 
X 
 
Randomization 
X 
 
 
 
 
 
 
 
Confirm Treatment Group 
 
X 
 
 
 
 
 
 
Uncorrected Distance VA 
testing 
X 
 
 
 
 
X 
X 
 
Manifest Refraction 
X 
 
 
 
 
X 
X 
 
BCVA (ETDRS at 4m) 
X 
 
 
 
 
X 
X 
 
Corneal Haze (via AS-OCT) 
X 
 
 
 
 
X 
X 
 
Intraocular Pressure 
X 
 
X 
X 
 
X 
X 
 
Corneal Staining 
X 
 
X 
X 
 
X 
X 
 
Slit Lamp Exam 
X 
 
X 
X 
 
X 
X 
 
Ophthalmic Examination 
(dilated fundus exam) 
X 
 
 
 
 
 
 
 
Ocular Pain Assessment 
X 
 
X 
X 
X 
X 
 
 
SPEED Questionnaire 
X 
 
 
 
 
X 
 
 
COMTOL Survey 
 
 
 
 
 
X 
 
 
Record any surgical 
complications 
 
 
X 
 
 
 
 
 
 
Subject reported AEs prior to 
or after surgery 
X 
X 
X 
X 
X 
X 
X 
 
Intracanalicular 
dexamethasone insert* 
 
 
X 
 
 
 
 
 
 
Prescribe post-operative 
topical therapy regimen** 
 
X 
 
 
 
 
 
 
Insert Visualization 
 
 
X 
X 
 
X 
X 
 
 
*Eye Randomized to Group A 
**Specific for each eye based on Group A or B 
5.2 
Study Visit Descriptions 
5.2.1 Study Procedures 
Visit 1: Screening/Baseline (Day -30 to -1) 
After the patient has provided informed consent, the following information will 
be collected: 
• Inclusion/exclusion 


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CONFIDENTIAL 
• Demographics 
• Medical History and Concurrent Illnesses 
• Concomitant Medications 
• Randomization 
• Uncorrected Distance visual acuity as measured by ETDRS chart at 
4m 
• Manifest Refraction 
• Best-corrected visual acuity as measured by ETDRS chart at 4m 
• Corneal haze (via AS-OCT) 
• Intraocular pressure 
• Corneal Staining 
• Slit Lamp Exam 
• Ophthalmic Examination (dilated fundus exam) 
• Subject reported AEs prior to or after surgery 
• Ocular pain assessment 
• Modified Speed questionnaire  
 
 
Visit 2: Surgical Day 0 
• Concomitant medications 
• Confirm treatment group 
• Record any surgical complications 
• Subject reported AEs prior to or after surgery  
• Intracanalicular dexamethasone insert 
• Prescribe post-operative topical therapy regimen 
 
 
Visit 3: Day 3 
• Concomitant medications 
• Intraocular pressure 
• Corneal staining 
• Slit lamp exam 
• Subject reported AEs prior to or after surgery  
• Insert visualization 
• Ocular pain assessment 
 
Visit 4: Day 4 
• Concomitant medications 
• Intraocular pressure 
• Corneal staining 
• Slit lamp exam 
• Subject reported AEs prior to or after surgery  
• Insert visualization 
• Ocular pain assessment 


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Phone Call 1: Day 14 (+/- 2 days) 
• Subject reported AEs prior to or after surgery  
• Ocular pain assessment 
 
Visit 5: Day 28 (+/- 3 days) 
• Concomitant medications 
• Uncorrected Distance visual acuity as measured by ETDRS chart at 
4m 
• Best-corrected visual acuity as measured by ETDRS chart at 4m 
• Manifest refraction 
• Corneal haze 
• Intraocular pressure 
• Corneal staining 
• Slit lamp exam 
• Subject reported AEs prior to or after surgery 
• Insert visualization 
• Ocular pain assessment 
• Modified Speed questionnaire  
• Adapted COMTOL Survey 
 
Visit 6: Month 3 (+/- 3 days) 
• Concomitant medications 
• Uncorrected Distance visual acuity as measured by ETDRS chart at 
4m 
• Best-corrected visual acuity as measured by ETDRS chart at 4m 
• Manifest refraction 
• Corneal haze 
• Intraocular pressure 
• Corneal staining 
• Slit lamp exam 
• Subject reported AEs prior to or after surgery 
• Insert visualization 
 
Medical and Ocular History obtained: The site will ask and document all past 
Ocular history, relevant medical history and surgical history. A list of current 
medications, dose, route, start date and indications will be obtained and 
documented for each subject. There will be a subsequent diagnosis and start 
date for each medication. 
BCDVA on ETDRS chart: (manifest refraction performed if vision is worse 
than 20/20 with current MRx). The BCDVA will be captured on an ETDRS 
worksheet and calculated  


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Slit Lamp Examination (SLE): Slit lamp examination will be performed on 
the study eye and fellow eye of each subject by a masked examiner, and will 
include assessment of the lids and lashes, conjunctiva, tear film, cornea, 
anterior chamber, iris, and lens. At the screening/Day 0 visit, and 30 day/exit 
visit SLE will be performed both prior to and following application of the 
ELM or Lipiflow.   
Corneal Staining: A drop of fluorescein will be instilled on the eye, then the 
masked examiner will use the cobalt blue filter on the slit-lamp to examine 
the cornea. A grading scale of 0 to 3 is used to evaluate each of the five areas 
on the cornea. 0 being no staining to 3 being severe staining. All areas are 
then added together for a maximum score of 15.  
 
National Eye Institute/Industry Grading System  
 
 
 
5.2.2 Unscheduled Visits 
All attempts should be made to keep patients on the study schedule.  
Unscheduled visits may be necessary to repeat testing following abnormal 
laboratory results, for follow-up of AEs, or for any other reason, as warranted. 
 
If patient presents on POD 4 and have not epithelialized, patient will be 
brought in on POD 5 to re-assess epithelialization and remove bandage contact 
lens (BCL). This will be collected as an unscheduled visit.  
 
5.2.3 Adverse Event Information Collection 
The investigator (or designee) will record all AEs that occur during the study  
The definition of an AE and SAE, and information on the determination of 
severity and relationship to treatment are provided in Section 6. 


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5.3 
Rescue Criteria 
If the investigator determines either eye requires additional post-operative 
treatment, topical prednisolone acetate 1% therapy may be added to the 
DEXTENZA eye or increased dosing frequency may be offered to eyes 
receiving topical prednisolone acetate 1%. The investigator may also 
prescribe either or both topical cyclosporine 0.05% or topical cyclosporine 
0.09%.  
6. 
SAFETY DEFINITIONS, REPORTING, AND MONITORING 
6.1 
Definitions 
6.1.1 Adverse Event 
An AE is any untoward medical occurrence in a patient administered a study 
drug which may or may not have a causal relationship with the study drug.  
Therefore, an AE is any unfavorable and unintended sign (including 
abnormal laboratory finding), symptom, or disease which is temporally 
associated with the use of a study drug, whether or not considered related to 
the study drug.   
 
An AE also includes any worsening (i.e. any clinically significant change in 
frequency and/or intensity) of a pre-existing condition that is temporally 
associated with the use of the study drug. 
 
6.1.2 Serious Adverse Event 
A SAE is any untoward medical occurrence that at any dose: 
• Results in death – includes all deaths, even those that appear to be 
completely unrelated to study drug (e.g. a car accident in which a patient 
is a passenger). 
• Is life-threatening – in the view of the investigator, the patient is at 
immediate risk of death at the time of the event.  This does not include an 
AE that had it occurred in a more severe form, might have caused death. 
• Requires in-patient hospitalization or prolongation of existing 
hospitalization.  In-patient hospitalization is defined as admission to a 
hospital or an emergency room for longer than 24 hours.  Prolongation of 
existing hospitalization is defined as a hospital stay that is longer than 
was originally anticipated for the event, or is prolonged due to the 
development of a new AE as determined by the investigator or treating 
physician. 
• Results in persistent or significant disability/incapacity (substantial 
disruption of one’s ability to conduct normal life functions). 
• Is a congenital anomaly/birth defect 
• Is an important medical event – Important medical events may not be 
immediately life-threatening or result in death or hospitalization, but may 
jeopardize the patient or may require intervention to prevent 1 of the 
other serious outcomes listed above (e.g., intensive treatment in an 


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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. 
 
6.2 
Recording and Reporting Adverse Events 
All AEs and SAEs will be recorded only if they are medically relevant. 
 
All SAEs, regardless of assessment of causal relationship to study insert will 
be reported to Ocular Therapeutix. 
To report an SAE, Ocular Therapeutix will be contacted at the 
following: 
ocutx.pharmacovigilance@propharmagroup.com 
SAE hotline: 844-668-3948 
 
The investigator will promptly report to the IRB all unanticipated problems 
involving risks to patients.  This includes death from any cause and all SAEs 
related to the use of the study insert.  All SAEs will be reported to the IRB, 
regardless of assessed causality. 
 
7. 
STUDY VARIABLES 
7.1 
Demographic and Baseline Characteristics 
Baseline characteristics will include standard demography (e.g. age, race, 
weight, height, etc.), disease characteristics including medical history, and 
medication history for each patient. 
 
 
8. 
ETHICAL AND REGULATORY CONSIDERATIONS 
8.1 
Good Clinical Practice Statement 
It is the responsibility of the investigator(s) to ensure that this clinical study 
will be conducted in accordance with the ethical principles that have their 
origin in the Declaration of Helsinki, and that are consistent with the ICH 
guidelines for Good Clinical Practice (GCP) and applicable regulatory 
requirements. 
 
8.2 
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 


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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. 
 
8.3 
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.   
 
8.4 
Institutional Review Board  
An appropriately constituted IRB, as described in ICH Guidelines for GCP, 
will review and approve:  
• The protocol, ICF, and any other materials to be provided to the patients 
(e.g. advertising) before any patient may be enrolled in the study  
• Any amendment or modification to the study protocol or ICF before 
implementation, unless the change is necessary to eliminate an 
immediate hazard to the patients, in which case the IRB will be informed 
as soon as possible  
 
Ongoing studies will be reviewed by the IRB/EC on an annual basis or at 
intervals appropriate to the degree of risk.  
 
In addition, the IRB will be informed of any event likely to affect the safety of 
patients or the continued conduct of the clinical study. 
 


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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. 
 
 
 


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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.