Clinical trial NCT04184999
Conditions: Dry Eye Syndromes
Sponsor: SR Cornea Consultants
Start date: 2019-08-10; Completion date: 2019-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the signs and symptoms of dry eye after cataract surgery between subjects randomized to receive intraoperative dexamethasone in addition to the use of a standard topical post-op treatment regimen.

Detailed description:
Forty patients requiring cataract surgery will be randomized to treatment of post-operative inflammation with a single intraoperative dexamethasone injection plus a standard course of topical ophthalmic corticosteroid drops or the standard treatment alone. Dry eye testing will be administered at baseline, 1 week and 3 weeks following surgery.

Arms: arm 1: dexamethasone intraocular suspension, 9% injected intracamerally at the time of cataract surgery + topical ophthalmic prednisolone acetate for 3 weeks post-operatively arm 2: topical ophthalmic prednisolone acetate for 3 weeks post-operatively
Interventions: intervention 1: dexamethasone intraocular suspension, 9% intervention 2: Prednisolone Acetate 1% Oph Susp
Intervention descriptions: intervention 1: single dose intracameral corticosteroid intervention 2: topical ophthalmic steroid drop

Protocol documents:
ICF_000.pdf: 
 
 
 
 
 
 
 
 
 
 
APPROVED BY SALUS IRB: 09 AUGUST 2019  
 
 
 
 
 
 
 
 
 
 
AN AGREEMENT TO BE IN A RESEARCH STUDY 
INFORMED CONSENT DOCUMENT
 
Sponsor: 
SR Cornea Consultants 
City and State: 
Oak Brook, IL 
 
Protocol Number and Title: 
10; Evaluation of Intraoperative use of Dexycu on 
the Signs and Symptoms of Dry Eye 
 
Study Doctor: 
Sanjay N. Rao, MD 
 
Address of Study Site(s): 
Hauser Ross Surgical Center 
 
 
 
1630 Gateway Drive 
Sycamore, IL 60178 
 
24-Hour Telephone Number: 800-243-2587  
 
INTRODUCTION 
You are being invited to take part in a medical research study. Before you decide to 
take part in this study, you should read this document. This document, called an 
informed consent document, explains the study. Please ask as many questions as 
needed so that you can decide if you want to be in the study. 
 
To be in this research study, you cannot already be in another medical research 
study. 
 
You must be honest and complete in providing your medical history. Giving false, 
incomplete, or misleading information about your medical history, including past and 
present drug use, could have very serious health consequences. 
 
PURPOSE OF THE STUDY 
This study is being done to see if the addition of a United States Food and Drug 
Administration (FDA) approved intraoperative injection of steroid improves the signs 
and symptoms of dry eye after cataract surgery.  The study medication is called 
Dexycu.  Dexycu is approved by the FDA and is indicated for the treatment of 
inflammation after eye surgery. 
 
WHAT WILL HAPPEN DURING THE STUDY 
You will have medical tests done to help the study doctor decide if you can be in the 
study. This is called “screening.” 
 
Screening does not guarantee entry into the study. Entry into the study will depend 
upon the results of your dry eye tests, study specific guidelines, and the decision of 
the study doctor. Even if you pass the screening tests, there is a chance that you 
will not be invited to take part in the study. There may be other reasons why you 
cannot take part in the study. The study doctor and/or the study staff will discuss 
these with you. 
 


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Informed Consent 
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About 40 males and females, ages 18 and older, who are having cataract surgery 
will take part in the study.  The study will take place at Hauser Ross Eye Institute 
and you will be in study for 21 days. 
 
PROCEDURE: 
If you are enrolled in the study, there is a 1 in 2 chance of receiving the study 
medication, Dexycu, during cataract surgery.  Whether you receive the 
intraoperative injection will be decided by chance (like the flip of a coin). 
 
If you qualify for the study, you will be asked to attend your standard postoperative 
visits in the study clinic at Day 1, Day 7, and Day 21.  On Day 7 and Day 21, you 
will have additional dry eye testing.  It is very important that you are able to keep 
these appointments as they are scheduled. 
 
While you are in the study, you can use some medicines, such as tear substitutes, 
steroid and antibiotic eyedrops (the standard drops after cataract surgery), as well 
as medications you were taking prior to the study.  If you become sick during the 
study for any reason, be sure to contact the study staff and explain what happened 
(even if you go to another doctor). 
 
The eye tests done during this study are not new or experimental. 
 
Screening Visit:   
At the screening visit, you will have a comprehensive cataract evaluation, including 
dry eye testing.  If it is determined that you have cataracts in both eyes, and you 
wish to proceed with surgery, you will be given the opportunity to participate in the 
study. 
 
Day of cataract surgery: 
Dexycu will be administered as a single intraocular injection if you are assigned to 
receive the injection. 
 
Visit 1: 
This visit is one day after your cataract surgery.  At the one day postoperative visit, 
you will be asked about the symptoms in your operated eye, have tests to measure 
your vision, have eye pressure measurements and eye dilation.  The eye tests done 
during this visit are not new or experimental.  The study staff will also review your 
postoperative medication regimen which will include anti-inflammatory eyedrops 
and antibiotic eyedrops. 
 
Visit 2: 
The second visit will be about 7 days after your surgery.  You will be asked again 
about the symptoms in your operated eye, any changes in medication you have 
taken and your general health.  The study doctor will do some of the same tests 
that he did at the first visit (put drops in your eyes, look at your eyes, test for how 


SR Cornea Consultants: 10 
Sanjay N. Rao, MD 
Informed Consent 
Page 3 of 7  
 
 
 
 
 
 
 
 
 
 
APPROVED BY SALUS IRB: 09 AUGUST 2019  
 
 
 
 
 
 
 
 
 
 
well you can see, and check the pressure inside your eyes).  In addition, you will 
have dry eye test called tear film osmolarity and corneal staining. 
 
Visit 3: 
The third visit will be about 21 days after your surgery.  You will be asked again 
about the symptoms in your operated eye, any changes in medication you have 
taken and your general health.  The study doctor will do some of the same tests 
that they did at the first visit (put drops in your eyes, look at your eyes, test for 
how well you can see, and check the pressure inside your eyes).  In addition, you 
will have dry eye tests called tear film osmolarity and corneal staining. 
 
SIDE EFFECTS AND OTHER RISKS 
Below is a list of the most common side effects of the study drug, Dexycu: 
 
Dexycu contains dexamethasone.  Dexamethasone is in a class of drugs called 
corticosteroids.  Corticosteroids are used to treat inflammation (swelling). The most 
common side effects are increases in eye pressure, temporary swelling in the cornea, 
and inflammation in the eye.  Other side effects of steroids may include: 
• 
Suppression of the immune system (decreased ability to fight infection) 
• 
Delayed healing 
• 
Increased Pressure in the eye 
• 
Secondary eye infections 
• 
Increased blood sugar levels 
• 
Swelling in the cornea 
• 
Swelling on the inside of the eye 
• 
Corneal endothelial cell loss (some cells in the eye can be lost) 
• 
Blurred vision 
• 
Photophobia (sensitivity to light) 
• 
Vitreous detachment  
 
UNFORESEEABLE RISKS  
All drugs can have side effects or affect another drug that you are taking.  
Therefore, the use of this study drug may involve risks to you that are presently 
unforeseen and unknown.   
 
Also, any drug may trigger a serious allergic or other reaction and may cause the 
following: 
• 
rash,  
• 
hives,  
• 
itching,  
• 
tingling and swelling of the face, lips, tongue, throat and/or vocal cords,  
• 
difficulty breathing,  
• 
wheezing,  
• 
very low blood pressure, 
• 
seizures (convulsions),  


SR Cornea Consultants: 10 
Sanjay N. Rao, MD 
Informed Consent 
Page 4 of 7  
 
 
 
 
 
 
 
 
 
 
APPROVED BY SALUS IRB: 09 AUGUST 2019  
 
 
 
 
 
 
 
 
 
 
• 
loss of consciousness, and  
• 
possibly death.   
 
Drugs may cause temporary changes in blood chemistries and other blood tests. 
 
You must tell the study doctor or study staff about all side effects that you have. If 
you are not honest about your side effects, it may not be safe for you to stay in the 
study. 
 
POSSIBLE BENEFITS OF THE STUDY 
The benefit of participating in this study may or may not be an improvement in 
signs and symptoms of dry eye after cataract surgery.  Many people who have 
cataract surgery experience dry eyes after surgery.  By participating in this study, 
we can better understand if an intraoperative injection of Dexycu can benefit the 
health of the eye and improve dry eye after surgery. 
 
PAYMENT FOR BEING IN THE STUDY  
You will not be paid for being in this study. 
 
The Study Doctor is a consultant to the sponsor of the research and has financial 
ties to the research. As a researcher in this study, he/she is interested not only in 
your health and well-being, but also in the results of this study. It is possible that 
sometimes these two goals may conflict with one another. Researchers protect the 
rights and interests of participants by carefully following the rules of the study. 
 
ADDITIONAL COSTS 
You do not have to pay for study visits,  dry eye tests, injection of Dexycu and 
postoperative visits that are done for the study. You or your insurance company 
may have to pay for routine care you would receive whether or not you are in the 
study. Your insurance company may or may not pay for procedures that are a part 
of a research study. You should contact your insurance company for more 
information. 
 
ALTERNATIVES TO PARTICIPATION 
There are other treatments available for dry eye after cataract surgery if you decide 
not to be in the study. These treatments include: 
• 
artificial tear substitutes 
• 
punctal occlusion 
• 
anti-inflammatory eyedrops 
 
You and your personal doctor can decide what treatment is best for you. 
 
RELEASE OF MEDICAL RECORDS AND PRIVACY 
Your study records will be kept private. There may be times when the study doctor 
will not be able to guarantee privacy, such as when your study medical records are 


SR Cornea Consultants: 10 
Sanjay N. Rao, MD 
Informed Consent 
Page 5 of 7  
 
 
 
 
 
 
 
 
 
 
APPROVED BY SALUS IRB: 09 AUGUST 2019  
 
 
 
 
 
 
 
 
 
 
requested by a court of law or when shared with a firm in another country that does 
not have privacy regulations in place. Salus IRB and accrediting agencies may 
inspect and copy your records, which may have your name on them. Therefore, 
your total privacy cannot be guaranteed. If information from this study is published 
or presented at scientific meetings, your name and other personal information will 
not be used. The following people will have access to your study records: 
• 
Sanjay N. Rao, MD, study doctor 
• 
Study Monitor or Auditor 
• 
SR Cornea Consultants 
• 
Salus IRB 
 
Salus IRB has approved this study and this informed consent document. Salus IRB is 
a committee of scientific and non-scientific individuals who review, require 
modifications to, and approve or disapprove research studies by following the federal 
laws. This group is also required by the federal regulations to provide periodic review 
of ongoing research studies. 
 
IN CASE OF AN INJURY RELATED TO THIS RESEARCH STUDY 
It is important that you tell your study doctor, if you feel that you have been 
injured because of taking part in this study. You can tell the study doctor in person 
or call them at the number listed on the first page of this consent document.  Any 
study and non-study related injuries will be paid by the principal investigator. 
Medical treatment will be provided at no cost to you or your insurance company for 
a research-related injury. 
 
LEGAL RIGHTS 
You do not lose any legal rights by signing this consent document. The above 
statement, “In Case of an Injury Related to This Research Study,” does not stop you 
from seeking legal help in case of negligence. 
 
NEW FINDINGS  
During the study, you will be told of any important new findings about the study. You 
can then decide if you still want to be in the study. 
 
WHOM TO CONTACT 
You may contact the study doctor  or study staff at the phone number listed on the 
first page of this consent document: 
• 
for answers to questions, concerns, or complaints about this research study,  
• 
to report a research related injury, or 
• 
for information about study procedures. 
  
If you need medical attention please go to the nearest emergency room. 
 
You may contact Salus IRB if you: 
• 
would like to speak with someone unrelated to the research, 


SR Cornea Consultants: 10 
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Informed Consent 
Page 6 of 7  
 
 
 
 
 
 
 
 
 
 
APPROVED BY SALUS IRB: 09 AUGUST 2019  
 
 
 
 
 
 
 
 
 
 
• 
have questions, concerns, or complaints regarding the research study, or  
• 
have questions about your rights as a research participant. 
 
Salus IRB 
 
2111 West Braker Lane, Suite 100 
Austin, TX 78758 
Phone: 855-300-0815 between 8:00 AM and 5:00 PM Central Time 
Email: salus@salusirb.com 
 
If you would like additional information about your rights, research in general, or 
IRBs, you may visit www.salusirb.com. 
 
LEAVING THE STUDY  
Taking part in this study is your choice. You may choose either to take part or not 
to take part in the study. You have the right to leave this study at any time. If you 
do not want to be in the study, there will be no penalty to you, and you will not lose 
any benefits to which you are otherwise entitled. 
 
If you wish to leave this study, please call the study doctor or study staff at the 
telephone number listed on the first page of this consent document to schedule study 
exit procedures. 
 
You are being invited to take part in this study because you are having cataract 
surgery. If you withdraw from the study you should contact your personal doctor to 
seek alternative treatment options. 
 
Your part in this study may be stopped at any time without your permission. The 
following people can stop your participation and/or the study itself: 
 
• 
Study Doctor 
• 
Sponsor Company 
• 
Salus IRB 
 
If you do not follow the study procedures you may be taken out of the study. 
 
If you withdraw from the study, no new data about you will be collected for study 
purposes. All data that have already been collected for study purposes will be shared 
with the study sponsor. 
 
 
 


SR Cornea Consultants: 10 
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Informed Consent 
Page 7 of 7  
 
 
 
 
 
 
 
 
 
 
APPROVED BY SALUS IRB: 09 AUGUST 2019  
 
 
 
 
 
 
 
 
 
 
AGREEMENT TO BE IN THE STUDY 
This consent document contains important information to help you decide if you want 
to be in this study. If you have any questions that are not answered in this consent 
document, please ask the person explaining this document or one of the study staff.   
 
By consenting to participate you agree that you have been given a copy of all pages 
of this consent document. You have had an opportunity to ask questions and 
received satisfactory answers to all your questions about this study. You understand 
that you are free to leave the study at any time without having to give a reason and 
without affecting your medical care. You understand that your study-related 
medical records may be reviewed by the company sponsoring the study and by 
government authorities. 
 
IF YOU DO NOT AGREE WITH THE STATEMENT ABOVE, 
YOU SHOULD NOT SIGN THIS INFORMED CONSENT DOCUMENT. 
 
 
 
 
Printed Name of Participant 
 
 
 
 
 
Signature of Participant 
 
 
 
 
 
 
 
Date 
 
 
 
Printed Name of Person Explaining Informed Consent Document 
 
 
 
 
 
Signature of Person Explaining Informed Consent Document          
Date 
 
You will be given a signed and dated copy of this informed consent document to 
keep. 
 
FOR SALUS IRB USE ONLY 
Initial draft 
mys: 09Aug19 

Prot_SAP_002.pdf: 
1 
 
 
 
Evaluation of Intraoperative use of Dexycu on the Signs and Symptoms of Dry Eye 
 
Sponsor:  
 
 
SR Cornea Consultants 
 
 
 
 
16 Kimberley Circle, Oak Brook, IL 60523 
847 668 5498 
Name and title of person(s) authorized to sign the protocol for 
the sponsor:  Sanjay Rao, MD 
 
Monitor: 
 
 
Sanjay Rao, MD 
Medical Expert: 
 
Sanjay Rao, MD 
 
 
 
 
  
 
Investigators:  
 
Sanjay Rao, MD 
 
 
 
 
Clinical Laboratory(ies): 
 NA 
 
 
 
 
 
 
 
 
 
Study Product:  
 
DEXYCU (dexamethasone intraocular suspension) 9% 
 
Protocol Number: 
 
NCT04184999 
 
 
 
 
April 10, 2019 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 


2 
 
Table of Contents 
 
Study Summary 
 
1. Introduction 
1.1 Background 
1.2 Investigational or Study Product 
1.3 Preclinical Data 
1.4 Clinical Data to Date 
1.5 Dose Rationale  
1.6 Risks/Benefits 
2. Study Objectives 
3. Study Design 
3.1 General Design 
3.2 Primary/Secondary Study Endpoints 
4. Subject Selection and Withdrawal 
      4.1 Inclusion Criteria 
      4.2 Exclusion Criteria 
      4.3 Subject Recruitment and Screening 
      4.4 Early Withdrawal of Subjects 
       5. Investigational Product 
 
      5.1 Description 
 
      5.2 Treatment Regimen 
 
      5.3 Method for Assigning Subjects to Treatment Groups 
 
      5.4 Subject Compliance Monitoring  
 
      5.5 Prior and Concomitant Therapy  
 
      5.6 Packaging, Receiving, Storage, Dispensing and Return  
        6.   Study Procedures 
        7.   Statistical Plan 
 
     7.1 Sample Size Determination 
 
     7.2 Statistical Methods 
 
     7.3 Subject Population(s) for Analysis 
        8.  Safety and Adverse Events 
 
     8.1 Definitions 
 
     8.2 Assessment of Safety and Efficacy  
 
     8.3 Recording and Reporting of Adverse Events 
 
     8.4 Unblinding Procedures 
 
     8.5 Stopping Rules 
 
     8.6 Medical Monitoring 
        9.  Data Handling and Record Keeping 
 
     9.1 Confidentiality 
 
     9.2 Source Documents 
 
     9.3 Records Retention 
       10.  Study Monitoring, Auditing, and Inspecting 
       11.  Ethical Considerations 
 
 
 
 
    
 


3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


4 
 
STUDY SUMMARY 
Title 
Evaluation of intraoperative use of Dexycu on the Signs and Symptoms of 
Dry Eye 
Protocol Number 
10 
Phase 
Phase IV 
Methodology 
Prospective Randomized Controlled Trial 
Study Duration 
3 weeks  
Study Center(s) 
Single-Center   
Objectives 
To evaluate the impact of intraoperative Dexycu during cataract surgery 
on the signs and symptoms of dry eye 
Number of subjects 
40 
Main Inclusion and 
Exclusion Criteria 
Inclusion:  Patients undergoing bilateral cataract surgery 
Exclusion:  Patients with severe ocular surface disease as defined by 
central corneal staining with fluorescein and/or a tear film osmolarity of 
greater than 340 in either eye 
Study product, Dose, 
Route, Regimen 
DEXYCU (dexamethasone intraocular suspension) 9%, administered as a 
single dose, intraocularly in the posterior chamber at the end of surgery.  
The dose is .005 mL of dexamethasone 9% (equivalent to 517 
micrograms) 
Duration of subjects 
participation  
Patients scheduled to undergo bilateral cataract surgery will be screened 
and have dry eye testing.  If enrolled in the study, patients will have dry 
eye testing at 1 week and 3 weeks after surgery. 
Reference product 
The control group will utilize a standard post-cataract surgery regimen 
of topical gatifloxacin and topical prednisolone acetate. 
 
 
 
 
 
 


5 
 
 


6 
 
1 Introduction 
Evaluation of intraoperative use of Dexycu on the Signs and Symptoms of Dry Eye is a clinical 
research protocol and the study will be conducted in accordance with the protocol, Good 
Clinical Practice Standards, and applicable regulatory requirements.  
 
1.1 Background 
Multiple studies have established the relationship between dry eye and cataract surgery. 
First, a majority of patients undergoing cataract surgery have dry eye signs including 
decreased tear break up time (63%) and positive corneal staining (77%). Second, patients 
experience an increase in dry eye symptoms after cataract surgery compared to baseline. 
Third, Snellen visual acuity and contrast sensitivity are impacted by dry eye after cataract 
surgery.   
 
The objective of this clinical research is to evaluate whether the signs and symptoms of dry 
eye after cataract surgery improve with the addition of a DEXYCU intraocular injection. 
 
1.2 Investigational/Study Product 
DEXYCU contains dexamethasone 9% as a sterile suspension for intraocular ophthalmic 
administration.  DEXYCU is provided as a kit for administration of a single dose of 0.005 mL 
of 9% dexamethasone.  
 
 1.3 Preclinical Data 
 
 Not applicable. 
 
1.4 Clinical Data to Date 
 
Clinical efficacy was evaluated in a randomized, double masked, placebo controlled trial 
(NCT2006888) in which subjects received either DEXYCU or placebo (vehicle).  A dose of 5 
microliters of DEXYCU or vehicle was administered by the physician at the end of the 
surgical procedure.  The primary efficacy endpoint for the study was the proportion of 
patients with anterior chamber cell clearing on postoperative day 8.  The percentage of 
patients with anterior chamber clearing at Day 8 was 2-% in the placebo group, and 57%, 
and 60% in the 342 and 517 microgram treatment groups. 
 
1.5 Dose Rationale  
 
See section 1.4 
 
1.6 Risk/Benefits 
 
The following adverse events rates are derived from three clinical trials in which 339 
patients received the 517 microgram dose of DEXYCU.  The most commonly reported 
adverse reactions occurred in 5-15% of subjects and included increases in intraocular 
pressure, corneal edema, and iritis.  Other ocular adverse reactions occurring in 1-5% of 
subjects included, corneal endothelial cell loss, blepharitis, eye pain, cystoid macular edema, 
dry eye, ocular inflammation, posterior capsular opacification, blurred vision, reduced 
visual acuity, vitreous floaters, foreign body sensation, photophobia, and vitreous 
detachment.   
 
2  Study Objectives 
The objective of this clinical research is to evaluate whether the signs and symptoms of dry 
eye after cataract surgery improve with the addition of a DEXYCU intraocular injection.  
Multiple studies have established that dry eye worsens after cataract surgery.  There is also 


7 
 
a strong body of evidence that shows that dry eye is inflammatory.  The objective of this 
study is to evaluate whether the intraocular use of steroid impacts dry eye. 
  
 
3 
Study Design 
3.1  General Design 
• The type/design of the study:  
o  Prospective randomized controlled trial 
• A description of the measures taken to minimize/avoid bias:  
o Patients undergoing bilateral cataract surgery will be randomized to the 
DEXYCU group (standard postoperative cataract regimen + intraoperative 
DEXYCU) in one eye or the STANDARD group (standard postoperative 
cataract regimen).  Randomization will be done after screening visit, prior to 
surgery on the first eye and will be done by coin flip.  Standard cataract 
regimen to be used: topical prednisolone acetate 1% qid and topical 
gatifloxacin qid for 1 week, then tid for 1 week, then bid for 1 week.  
• Expected duration of subject participation  
o 3 weeks after cataract surgery 
o Patients undergoing cataract surgery will have dry eye testing prior to 
surgery, 1 week after surgery, and 3 weeks after surgery 
• A summary description of the sequence and duration of all trial periods including 
follow-up, if any 
o Patients undergoing cataract surgery will have dry eye testing prior to 
surgery, 1 week after surgery, and 3 weeks after surgery 
 
 
3.2 Primary/Secondary Endpoints 
 
Primary endpoints:  
1) Tear film Osmolarity as measured on Tear Lab system 
2) Corneal Staining (Oxford grading scale 0-15) 
 
 
Secondary endpoint: 
3) Satisfaction questionnaire – How satisfied are you with your surgery? (Graded 0-4) 
 
 
 
 


8 
 
4 
Subject Selection and Withdrawal 
4.1 Inclusion Criteria 
1) Patients diagnosed with bilateral cataracts and scheduled to undergo bilateral cataract 
surgery 
2) Must be able to understand and sign an informed consent from that has been approved 
by an Institutional Review Board 
3) Patient is over the age of 18 
4) Patient must agree to comply with visit schedule and other requirements of the study 
5) Females who are not pregnant and are not lactating.  Females who are post-menopausal 
or surgically sterilized.    
 
If the answer to any of the inclusion criteria are NO, the subject is ineligible to continue 
study participation 
        4.2 Exclusion Criteria 
1) Patients with several ocular surface disease as defined by central corneal staining with 
fluorescein and/or a tear film osmolarity of greater than 340 in either eye 
 
        4.3 Subject Recruitment and Screening 
 Subjects will be recruited for the study from principal investigator’s clinical practice.  As 
part of the informed consent process, patients will be offered a DEXYCU injection and given 
a brochure/handout discussing DEXYCU.  As part of the standard cataract evaluation 
process, both tear film osmolarity and corneal staining will be performed. 
 
4.4 Early Withdrawal of Subjects 
 
Subjects will be carefully monitored after surgery, including visual acuity measurements, 
intraocular pressure measurements, anterior and posterior segment evaluation, as well as 
dry eye testing.  If patients have an intraocular pressure elevation over 35mm that requires 
additional medication, they will be withdrawn from the study.  Also, if patients require a 
deviation from the standard cataract postoperative regimen, they will be withdrawn from 
the study. 
 
5     Investigational Product  
5.1 Description  
Each kit of DEXYCU contains a single dose for a single patient.  The 2 mL glass vial is filled 
with 0.5 mL of 9% dexamethasone.  
 
5.2 Treatment/Dosing Regimen 
DEXYCU (dexamethasone intraocular suspension) 9%, administered as a single dose, 
intraocularly in the posterior chamber at the end of surgery.  The dose is .005 mL of 
dexamethasone 9% (equivalent to 517 micrograms)  
 
        5.3 Method for Assigning Subjects to Treatment/Dosing Groups 
 Patients undergoing bilateral cataract surgery will be randomized to the DEXYCU group 
(standard postoperative cataract regimen + intraoperative DEXYCU) in one eye or the 
STANDARD group (standard postoperative cataract regimen).  Randomization will be done 
after screening visit, prior to surgery on the first eye and will be done by coin flip.   Patients 
who are randomly assigned to the DEXYCU group will receive a sequentially numbered drug 
kit. 
 
        5.4 Subject Compliance Monitoring  


9 
 
The study team will assess and track compliance on each study visit (1 day, 1 week, 3 
weeks).  At all postoperative visits, the study team will monitor adherence to the eyedrop 
regimen.  If there is a significant deviation from the eyedrop regimen, the principal 
investigator will determine continuation in the study. 
 
A case report binder will be created for each subject in the study.  Binder tabs will include: 
Screening Visit 
Day 1 Visit 
Day 7 Visit 
Day 21 Visit 
Exit Form 
Early Exit Visit 
Nonserious Adverse Event Forms 
Serious Adverse Event Forms 
 
       
        5.5 Prior and Concomitant Therapy  
 All medications that subjects are taking prior to cataract surgery will be permitted.  
Subjects are also permitted to utilize artificial tears in addition to the therapeutic regimens.  
The use of artificial tears will be tracked by the study team. 
 
        5.6 Packaging, Receiving, Storage, Dispensing and Return 
Dexycu will be stored in a locked cabinet.  Usage of the medication will be logged.  
 
6 
Study Procedures 
Screening Visit 
Day 1 Postoperative Visit  
Day 7 Postoperative Visit 
Day 21 Postoperative Visit   
 
At all visits, visual acuity, eye pressure measurements, tear film osmolarity, and corneal 
staining will be measured and recorded.  At days 7 and 21, patient satisfaction scores will be 
measured. 
 
        7 Statistical Procedures 
        7.1 Sample Size Determination 
The determination of sample size was based on a review of similar cataract and dry eye 
studies.   As this is a single center, pilot study, it was determined that a sample size of 40 
patients would be feasible. 
 
 
   7.2 Statistical Methods 
An ANOVA analysis will be performed to compare the dry eye testing data between the 
DEXYCU group and the standard regimen group. 
 
 
   7.3 Subject Population(s) for Analysis 
All patient who met inclusion criteria and complete the study will be included in the 
selection of subjects to be included in the analyses. 
 
         8 Safety and Adverse Events 
         8.1 Definitions 


10 
 
An adverse event is any untoward medical occurrence in a patient who is administered a 
test article (DEXYCU).  The adverse event does not necessarily have a causal relationship 
with the treatment.  An adverse event can therefore be any unfavorable and unintended 
sign, symptom, or disease temporally associated with the use of the test article, whether or 
not related to the test article. 
 
A nonserious adverse event is defined as a change in a patient’s ophthalmic and or medical 
health that is not life-threatening, does not require hospitalization, does not prolong a 
current hospitalization and is not disabling.  Nonserious adverse events must be reported 
by use of a Nonserious Adverse Event Form and may also be reported by a telephone call.  
All nonserious advese events must be reported on a Nonserious Adverse Event Form 
whether they are considered related or unrelated to the test article. 
 
A serious adverse event is defined as any adverse experience occurring at any dose that 
results in any of the following outcomes: death; a life threatening adverse event, inpatient 
hospitalization, prolongation of existing hospitalization, or a persistent or significant 
disability/incapacity. 
 
 
    8.2 Recording and Reporting of Adverse Events 
An Adverse Event Form must be completed for all serious adverse events within 24 hours of 
the investigator’s knowledge of the event and to the Institutional Review Board according to 
their requirements.    
 
    
 
 
    8.4 Randomization Codes 
Patients undergoing bilateral cataract surgery will be randomized to the DEXYCU group 
(standard postoperative cataract regimen + intraoperative DEXYCU) in one eye or the 
STANDARD group (standard postoperative cataract regimen).  Randomization will be done 
after screening visit, prior to surgery on the first eye and will be done by coin flip.   Patients 
who are randomly assigned to the DEXYCU group will receive a sequentially numbered 
drug kit.   
 
 
 
 8.5 Stopping Rules 
Upon completion of the study, an “Exit Form” will be completed and signed by the 
Principal Investigator.  Patients who withdraw early from the study will complete an 
“Early Exit Visit” form detailing the last visit and reasons for early withdrawal. 
 
 
 8.6 Medical Monitoring 
The medical monitoring plan will be dictated by the protocol and recorded in the patient 
case report binder. 
 
         


11 
 
   
  9   Data Handling and Record Keeping 
 
  9.1 Confidentiality 
A confidential study binder will be maintained and secured in a locked cabinet by the 
principal investigator.   
 
All identifiable, sensitive information will be protected on a password protected, 
encrypted device. 
 
What information is being collected? 
Visit Date 
Date of Surgery 
Eye 
Concomitant Medication 
Ocular Symptoms (Graded 0-3) 
 
 
 
Foreign Body Sensation 
 
 
 
Tearing 
 
 
 
Photophobia 
Visual Acuity 
Intraocular Pressure 
Tear Film Osmolarity 
Corneal Staining 
Patient satisfaction score 
 
                 Will identifiers be removed? When? 
 
 
Identifiers will be removed 3 months after study completion 
                 How will the information be used? 
The information will be used to determine if Dexycu treatment impacts dry 
eye parameters after cataract surgery 
                 Will the information be sold to third parties? 
 
 
No 


12 
 
                 Will the information be used for future research? 
 
 
No 
                 Who has access? 
 
 
Only Principal Investigator 
                 When will the information be destroyed? 
 
 
12 months after study completion 
 
 
 
  9.2 Source Documents 
A case report binder will be created for each subject in the study.  Binder tabs will include: 
A.  Screening Visit 
B.  Day 1 Postoperative Visit 
C.  Day 7 Posteoperative Visit 
D.  Day 21 Postoperative Visit 
E.  Exit Form 
F.  Early Exit Visit 
G.  Nonserious Adverse Event Forms 
H.  Serious Adverse Event Forms 
 
A copy of the Source Documents are included.  
 
 
  9.4 Records Retention 
 
 
  Study records will be retained in a locked cabinet for 2 years.  
 
         10  Study Monitoring, Auditing, and Inspecting 
 
  The study and patients will be monitored on a weekly basis by the Principal Investigator.  
Patient will be followed as part of the study and will receive further follow-up per a        
standard cataract surgery protocol 3 months and 1 year after the study, as well as on as 
clinically needed basis.   
 
          11  Ethical Considerations 
There are no significant ethical considerations as the study is evaluating an FDA approved 
therapy.