A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of Two Doses of OCS 01 Compared to Vehicle in the Treatment of Inflammation and Pain Following Cataract Surgery
Phase: PHASE2
Conditions: Inflammation Corneal, Pain, Postoperative
Sponsor: Oculis

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Clinical Trial Protocol: 
Protocol Title: 
A Randomized, Double-masked, Vehicle-controlled Study 
Evaluating the Efficacy and Safety of Two Doses of 
OCS-01 compared to Vehicle in the Treatment of 
Inflammation and Pain Following Cataract Surgery 
IND# 
 
Protocol Number: 
DX216 
Study Phase: 
2 
Product Name: 
OCS-01 ophthalmic suspension 
Indication: 
Inflammation and pain following cataract surgery  
Investigator: 
Multi-center clinical investigation 
 
Sponsor: 
Oculis ehf.  
Álfheimar 74, 6. hæð 
104 Reykjavik | Iceland 
Tel. +354 546 4440 
 
Contract Research 
Organizations: 
Ora, Inc. 
300 Brickstone Square 
Andover, MA 01810 
U.S.A 
Phone: +1-978-685-8900 
 
 
 
 
 
Date 
Original Protocol: 
24 May 2019 
Amendment 1: 
08 August 2019 
 
Confidentiality Statement 
This protocol contains confidential, proprietary information of Ora, Inc. and Oculis. Further 
dissemination, distribution, or copying of this protocol or its contents is strictly prohibited. 
 
 

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ORA PERSONNEL 
Department Sr. Vice President: 
 
 
 
Project Manager: 
  
 
Medical Monitor 
 
 
 
 
 
 
 
 
 

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5. Use anti-inflammatory agents, analgesics/pain relievers 
(including opioids, narcotics, and other pain medications), 
or immunomodulating agents, systemically or in either eye, 
and/or currently using or have any historic use of 
medications for benign prostatic hyperplasia (BPH) from the 
washout period through the duration of the study. Washout 
periods for medications prior to the day of cataract surgery 
are as follows: 
a. Topical ocular steroids: 14 days; 
b. Periocular injection of any corticosteroid solution: 
28 days; 
c. Intraocular treatment with a corticosteroid including 
dexamethasone drug delivery systems: 56 days after 
implantation; fluocinolone acetonide drug delivery 
systems: 48 months after implantation; any other 
intravitreal injection: 95 days after injection; 
Note: While it is expected that subjects requiring an 
intraocular treatment with a corticosteroid will be excluded 
due to underlying exclusionary conditions, subjects who 
otherwise meet all eligibility criteria will be required to 
follow the above-mentioned washout intervals. 
d. Any systemic treatment with a corticosteroid 
including oral: 14 days; systemic or parenteral 
sustained/extended release: 180 days; 
Note: Inhaled, intranasal, and topical dermatologic steroids 
(except on the face and periocular region) are allowed. 
Topical dermatologic steroids on the face and periocular 
region require a 7 day washout. 
e. Topical ocular non-steroidal anti-inflammatory drugs 
(NSAIDs): 7 days; 
f. Systemic analgesics/pain relievers (e.g. gabapentin, 
pregabalin, and opioids): 14 days; 
Note: Use of an opioid during cataract surgery is allowed; 
g. Systemic acetaminophen, NSAIDs, acetylsalicylic 
acid, or other anti-inflammatory agents: 7 days; 
Note: Use of up to 81 mg of acetylsalicylic acid dosed once 
daily is allowed if dosage has been stable for at least 
30 days prior to surgery and will remain stable for the 
duration of the study. 
h. Medications for BPH (e.g. alpha adrenergic blocking 
agents including tamsulosin, silodosin, alfuzosin, 
and finasteride): all current or previous use of BPH 
medications excludes participation in this study.  ; 
i. Cyclosporine: 56 days or immunomodulating or 
immunosuppressive agents (e.g. calcineurin 
inhibitors, antiproliferative agents, mammalian target 

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14. Have cystoid macular edema, diabetic retinopathy, or 
diabetic macular edema; compromised macular function; 
significant macular diseases; or a history of macular edema 
in the study eye; 
15. Have previous ocular trauma with visible scarring or any 
deformities due to the trauma in the study eye that in the 
opinion of the Investigator may affect the pharmacokinetics 
of the study medication, intraocular inflammation, or the 
normal healing process; 
16. Have the potential for ocular hemorrhage in the study eye 
that may interfere with evaluation of post-surgery 
inflammation; 
17. Have a planned use of femtosecond laser or any other 
ophthalmic surgical procedure (e.g. MIGS [minimally 
invasive glaucoma surgery], vitrectomy, relaxing incisions, 
iridectomy, conjunctival excisions, use of iris hooks or other 
iris dilators, etc.) in addition to the cataract extraction 
procedure via phacoemulsification and PCIOL implantation 
in the study eye; 
18. Have a planned use of anterior capsule staining for 
capsulorhexis (i.e. trypan blue) during cataract surgery; 
19. Have had corneal or retinal surgery (laser or incisional) in 
the study eye within 6 months of Visit 1 (Day -1 to Day -28 
[prior to surgery]), or be planning to have laser or incisional 
surgery during the study period in the study eye (other than 
cataract surgery); 
20. Have surgery planned or scheduled for the contralateral eye 
during the 3-week study period; 
21. Have an immunosuppressive or an autoimmune disease that 
in the opinion of the Investigator could affect intraocular 
inflammation or the normal healing process of the eye; 
22. Have active or chronic/recurrent ocular or systemic disease 
that is uncontrolled and will likely affect wound healing; 
23. Currently have a suspected or known malignancy or be 
currently receiving anti-neoplastic therapy; 
24. Have previously been enrolled in this clinical study, have 
planned to participate in another clinical trial during the 
follow-up period that could confound the treatment or 
outcomes of this investigation, or be currently in the follow-
up period of a previous clinical trial;  
25. Be enrolled in the study if the Investigator determines that 
the subject should not be included for reasons not already 
specified (e.g. systemic or other ocular disease/abnormality), 
if the health of the subject or the validity of the study 
outcomes may be compromised by the subject’s enrollment; 
26. Be a female who is currently pregnant, planning a 

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2 TABLE OF CONTENTS 
1 
SYNOPSIS .................................................................................................................3 
2 
TABLE OF CONTENTS .......................................................................................13 
List of Abbreviations ..............................................................................................16 
3 
INTRODUCTION...................................................................................................17 
3.1 
Background ...................................................................................................17 
3.2 
Study Rationale .............................................................................................18 
3.3 
Dosage ............................................................................................................18 
3.4 
Placebo Justification .....................................................................................19 
3.4.1 Rationale ........................................................................................................19 
3.4.2 Measures To Ensure Safe Participation in the Study ...............................20 
4 
STUDY OBJECTIVES AND HYPOTHESIS ......................................................21 
4.1 
Study Objective .............................................................................................21 
4.2 
Study Hypothesis ..........................................................................................21 
5 
OVERALL STUDY DESIGN ................................................................................21 
6 
STUDY POPULATION .........................................................................................21 
6.1 
Number of Subjects (approximate) .............................................................21 
6.2 
Study Population Characteristics ...............................................................21 
6.3 
Inclusion Criteria .........................................................................................22 
6.4 
Exclusion Criteria .........................................................................................22 
6.5 
Rescue Criteria .............................................................................................25 
6.6 
Withdrawal Criteria (if applicable) ............................................................25 
7 
STUDY PARAMETERS ........................................................................................26 
7.1 
Efficacy Measures .........................................................................................26 
7.1.1   Primary Efficacy Measure ...................................................................26 
7.1.2   Secondary Efficacy Measure ...............................................................26 
7.1.3   Primary Efficacy Analyses ..................................................................26 
7.1.4   Secondary Efficacy Analyses ..............................................................26 
7.2 
Safety Measures ............................................................................................27 
8 
STUDY MATERIALS ............................................................................................27 
8.1 
Study Treatment(s) .......................................................................................27 
8.1.1   Study treatment(s) ...............................................................................27 
8.1.2   Instructions for Use and Administration .............................................27 
9 
STUDY METHODS AND PROCEDURES .........................................................28 
9.1 
Subject Entry Procedures ............................................................................28 
9.1.1   Overview .............................................................................................28 
9.1.2   Informed Consent ................................................................................28 
9.1.3   Washout Intervals ................................................................................28 
9.1.4   Procedures for Final Study Entry ........................................................28 
9.1.5   Methods for Assignment to Treatment Groups: ..................................28 
9.2 
Concurrent Therapies ..................................................................................29 
9.2.1   Prohibited Medications/Treatments.....................................................29 
9.2.2   Rescue Medications .............................................................................30 
9.2.3   Special Diet or Activities .....................................................................30 

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9.3 
Examination Procedures ..............................................................................30 
9.4 
Schedule of Visits, Measurements and Dosing ..........................................33 
9.4.1   Scheduled Visits ..................................................................................33 
9.4.2   Unscheduled Visits ..............................................................................33 
9.5 
Compliance with Protocol ............................................................................33 
9.6 
Subject Disposition .......................................................................................33 
9.6.1   Completed Subjects .............................................................................33 
9.6.2   Discontinued subjects ..........................................................................33 
9.7 
Study Termination .......................................................................................34 
9.8 
Study Duration .............................................................................................34 
9.9 
Monitoring and Quality Assurance ............................................................34 
10 
ADVERSE EVENTS ..............................................................................................34 
10.1 Adverse Event ...............................................................................................34 
10.1.1   Severity ..............................................................................................35 
10.1.2   Relationship to Study Drug ...............................................................35 
10.1.3   Expectedness .....................................................................................35 
10.2 Serious Adverse Events ................................................................................36 
10.3 Procedures for Reporting Adverse Events .................................................37 
10.3.1   Reporting a Suspected Unexpected Adverse Reaction .....................37 
10.3.2   Reporting a Serious Adverse Event ...................................................37 
10.4 Procedures for Unmasking of Study Drug .................................................37 
10.5 Type and Duration of the Follow-up of Subjects after Adverse Events ..37 
11 
STATISTICAL METHODS ..................................................................................38 
11.1 Statistical Hypotheses ...................................................................................38 
11.2 Analysis Populations ....................................................................................39 
11.3 Sample Size Determination ..........................................................................39 
11.4 Interim Analysis ...........................................................................................39 
11.5 Efficacy Analysis ...........................................................................................40 
11.5.1   General Statistical Considerations .....................................................40 
11.5.2   Primary Efficacy Analysis .................................................................40 
11.5.3   Secondary Efficacy Analyses ............................................................40 
11.6 Safety Analysis ..............................................................................................41 
11.7 Handling of Missing Data ............................................................................41 
11.8 Demographics and Medical History ...........................................................42 
12 
COMPLIANCE WITH GOOD CLINICAL PRACTICES, ETHICAL 
CONSIDERATIONS, AND ADMINISTRATIVE ISSUES ...............................42 
12.1 Protection of Human Subjects.....................................................................42 
12.1.1 Subject Informed Consent ...........................................................................42 
12.1.2   Institutional Review Board Approval ................................................42 
12.1.3   Ethical Conduct of the Study .............................................................43 
12.2 Subject Confidentiality ................................................................................43 
12.3 Documentation ..............................................................................................43 
12.3.1   Retention of Documentation..............................................................43 
12.4 Labeling, Packaging, Storage, Accountability, and Return or Disposal of Study 
Drug ...............................................................................................................44 
12.4.1   Labeling/Packaging ...........................................................................44 

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12.4.2   Storage of Study Drug .......................................................................44 
12.4.3   Accountability of Study Drug ...........................................................44 
12.4.4   Return or Disposal of Study Drug .....................................................44 
12.5 Recording of Data on Source Documents and Case Report Forms .........44 
12.6 Handling of Biological Specimens ...............................................................45 
12.7 Publications ...................................................................................................45 
REFERENCES .................................................................................................................46 
Appendix 1:  Schedule of Visits and Measurements .....................................................48 
Appendix 2:  Examination Procedures, Tests, Equipment, and Techniques .............49 
Appendix 3: Protocol Amendment Summary ...............................................................58 
Appendix 4:  Ora Approvals ...........................................................................................64 
Appendix 5:  Investigator’s Signature ...........................................................................65 
 
 
 

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List of Abbreviations 
γCD 
γ-cyclodextrin 
AE 
adverse event 
BID 
twice a day 
BPH 
benign prostatic hyperplasia 
CI 
confidence interval 
CD 
cyclodextrin 
CFR 
Code of Federal Regulations 
eCRF 
electronic case report form 
EMA 
European Medicines Agency 
ETDRS 
Early Treatment of Diabetic Retinopathy Study 
FAS 
full analysis set 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
IB 
Investigator’s Brochure 
ICF 
informed consent form 
ICH 
International Conference on Harmonisation 
IOP 
intraocular pressure 
IRB 
institutional review board 
IUD 
intrauterine device 
LOCF 
last observation carried forward 
MIGS 
minimally invasive glaucoma surgery 
mTOR 
mammalian target of rapamycin 
NSAID 
non-steroidal anti-inflammatory drug 
PCIOL 
Posterior chamber intraocular lens 
PI 
Principal Investigator 
PP 
per protocol 
PT 
preferred term 
QD 
once a day 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SOC  
system organ class 
TEAE 
treatment-emergent adverse events 
VA 
visual acuity 
 
 

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3 INTRODUCTION 
3.1 Background 
An estimated 95 million people worldwide are affected by cataracts, with cataract surgery being 
the most commonly performed surgical procedure in many countries (Liu, Wilkins et al. 2017). 
The current preferred treatments for ocular inflammation include the use of topical 
corticosteroids and/or non-steroidal anti-inflammatory drugs (NSAIDs), which may be 
contraindicated in some populations. Corticosteroids, which are considered the mainstay 
treatment for ocular inflammation, can be associated with adverse events (AEs), especially when 
frequent or prolonged dosing is needed, such as in patients where post-operative inflammation is 
severe and/or prolonged (Weber, Kodjikian et al. 2013). 
In general, drug penetration from the ocular surface via topical administration into the eye 
encounters multiple barriers. This results in a bioavailability inside the eye that is generally well 
below 5%. In spite of this very low topical bioavailability, aqueous eye drops are the patient-
preferred dosage form, especially in treatment of diseases of the anterior eye tissues, accounting 
for over 90% of the market (Loftsson and Stefansson 2017). 
Dexamethasone is a corticosteroid that has been used in the form of eye drops (Maxidex®, 
Alcon, United States of America) to treat inflammation caused by surgery, infections, or injury 
(Alcon Laboratories 2002). Dexamethasone has limited solubility in water and does not readily 
permeate from the eye’s aqueous exterior into the eye. Studies have shown that cyclodextrins 
(CDs) are able to enhance topical bioavailability of dexamethasone from aqueous eye drops 
(Usayapant, Karara et al. 1991, Kristinsson, Fridriksdottir et al. 1996, Sigurdsson, 
Konraethsdottir et al. 2007, Loftsson and Stefansson 2017). CDs have also been incorporated 
into other Food and Drug Administration (FDA) approved ophthalmic drops  to increase drug 
solubility (Alcon Laboratories 2000). Oculis is developing a novel drug delivery platform 
composed of the active ingredient, dexamethasone, and CD nanoparticles (OCS-01, previously 
called DexNP), which aid in delivery of the active pharmaceutical ingredient from the ocular 
surface to both the anterior and posterior segments of the eye. CD-based dexamethasone eye 
drop solutions have been tested in human patients and show excellent penetration into the 
anterior segment of the eye (Kristinsson, Fridriksdottir et al. 1996, Saari, Nelimarkka et al. 2006, 
Tanito, Hara et al. 2011). Some of the earliest formulations of dexamethasone CD solutions (0.32 
or 0.67% dexamethasone, 2-hydroxypropyl-β-cyclodextrin), were tested in a clinical trial 
conducted in Iceland 20 years ago (Kristinsson, Fridriksdottir et al. 1996). In 125 patients 
undergoing cataract surgery, concentrations of dexamethasone were significantly higher after 
application of dexamethasone CD suspension compared to Maxidex® (P < 0.001), indicating 
that the CD-based drug delivery system enhances both the solubility and permeability of 
dexamethasone to the anterior segment of the human eye. Notably, no toxic effects were 
observed with the use of dexamethasone CD suspension.  
In a more recent study (Johannesson, Moya-Ortega et al. 2014), levels of dexamethasone were 
assessed in the tear fluid of healthy subjects treated with a topical application of 1.5% DexNP or 
Maxidex®. Six (6) subjects received DexNP in one eye and Maxidex® in the contralateral eye. 
Results reveal that treatment with DexNP results in a 19-fold higher concentration of 
dexamethasone compared to treatment with Maxidex®. Notably, 4 hours post-instillation, the 

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In addition, several studies have been completed in both Europe and in the US to evaluate a 
study drug for ocular pain and inflammation using a placebo-controlled trial design. Some 
examples include:  
NCT00198445: Safety and Efficacy Study of Topical Bromfenac Versus Placebo to 
Treat Ocular Inflammation After Cataract Surgery 
NCT01367249: Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing 
Cataract Surgery 
NCT01426854: Nepafenac Compared to Placebo for Ocular Pain and Inflammation  
NCT01318499: Nepafenac 0.3% Two Study 
NCT00405730: Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac 
Trometamol 0.5% Eye Drops, Solution and Placebo 
NCT00430092:  Difluprednate 0.5% Eye Drops Compared to Placebo for Inflammation 
Following Ocular Surgery  
NCT02208297: Lotemax 0.38% Gel Compared to Placebo for Inflammation and Pain 
Following Cataract Surgery 
3.4.2 Measures To Ensure Safe Participation in the Study 
Placebo-controlled studies may only be ethically conducted when patients at a controlled risk are 
included, patients are fully informed of all the potential risks, patients are carefully monitored, 
and adequate protocol safety measures are in place. In this proposed trial a number of general 
protective measures are incorporated into the study protocol with the intention to minimize the 
risk to patients.  
The following specific measures are included in the protocol: 
• Patients at low risk are selected and they will be fully informed of their chances of 
randomization to the placebo group during informed consent. 
• Patients are carefully monitored for pain and inflammation following cataract surgery. 
• The rescue and withdrawal criteria minimize patients risk and will allow proper medical 
care. 
Based on the above rationale and the measurements for a safe medical supervision for the 
patients, Oculis believes that it is scientifically and ethically appropriate to use placebo control in 
the study DX216. 

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5. Use anti-inflammatory agents, analgesics/pain relievers (including opioids, narcotics, and 
other pain medications), or immunomodulating agents, systemically or in either eye, 
and/or currently using or have any history of use of medications for benign prostatic 
hyperplasia (BPH) from the washout period through the duration of the study. Washout 
periods for medications prior to the day of cataract surgery are as follows: 
a. Topical ocular steroids: 14 days; 
b. Periocular injection of any corticosteroid solution: 28 days; 
c. Intraocular treatment with a corticosteroid including dexamethasone drug delivery 
systems: 56 days after implantation; fluocinolone acetonide drug delivery 
systems: 48 months after implantation; any other intravitreal injection: 95 days 
after injection; 
Note: While it is expected that subjects requiring an intraocular treatment with a 
corticosteroid will be excluded due to underlying exclusionary conditions, subjects who 
otherwise meet all eligibility criteria will be required to follow the above-mentioned 
washout intervals. 
d. Any systemic treatment with a corticosteroid including oral: 14 days; systemic or 
parenteral sustained/extended release: 180 days; 
Note: Inhaled, intranasal, and topical dermatologic steroids (except on the face and 
periocular region) are allowed. Topical dermatologic steroids on the face and periocular 
region require a 7 day washout. 
e. Topical ocular NSAIDs: 7 days; 
f. Systemic analgesics/pain relievers (e.g. gabapentin, pregabalin, and opioids): 
14 days; 
Note: Use of an opioid during cataract surgery is allowed; 
g. Systemic acetaminophen, NSAIDs, acetylsalicylic acid, or other anti-
inflammatory agents: 7 days; 
Note: Use of up to 81 mg of acetylsalicylic acid dosed once daily is allowed if dosage has 
been stable for at least 30 days prior to surgery and will remain stable for the duration of 
the study. 
h. Medications for BPH (e.g. alpha adrenergic blocking agents including tamsulosin, 
silodosin, alfuzosin, and finasteride): all current or previous use of BPH 
medications excludes participation in this study.  ; 
i. Cyclosporine: 56 days or immunomodulating or immunosuppressive agents (e.g. 
calcineurin inhibitors, antiproliferative agents, mammalian target of rapamycin 
(mTOR) inhibitors, etc.): 2 months  
j. Mast cell stabilizers or anti-histamines (e.g. β2-adrenergic agonists. cromoglicic 
acid, ketotifen, brompheniramine, cetirizine, diphenhydramine): 7 days; 
6. Require the use of a contact lens or a collagen shield within 72 hours prior to Visit 2 
(Day 1 [18 to 30 hours post-surgery]) or for the remainder of the study period in either 
eye;  

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7. Require use of non-diagnostic topical ophthalmic medications in either eye for the 
duration of the study with the exception of the following, which are allowed: mydriatics, 
anesthetics, antiseptics, balanced salt solution, viscoelastics, prophylactic antibiotics, 
non-prostaglandin analog IOP-lowering agents, lid scrubs for mild blepharitis, or 
artificial tears for the management of dry eye (allowed topical medication should not be 
instilled at the same time as the study drug.  Study medication should be instilled at least 
30 minutes after any prior allowed topical medication.  In addition, any other allowed 
topical medication should not be instilled within 2 hours following instillation of study 
medication);  
8. Have an IOP 
 
 Subjects taking IOP-lowering medication must not be on more than 1 IOP-
lowering medication. Prostaglandin analogs are not allowed within 4 weeks of Visit 2 
(Day 1 [18 to 30 hours post-surgery]). 
Note: Combination IOP agents count as 2 medications. 
9. Currently have or have a history of herpes keratitis in the study eye; 
10. Have corneal abrasions or ulcers in the study eye (not including the surgical clear corneal 
wound from cataract surgery); 
11. Have evidence of acute external ocular infections (bacterial, viral, and/or fungal such as 
vaccinia, varicella, and other viral diseases of the cornea and conjunctiva), corneal 
endothelial dystrophies, intraocular infections, dysthyroid ophthalmopathy, active 
chalazion, or uncontrolled blepharitis in the study eye; 
12. Have uncontrolled and clinically significant dry eye syndrome in the study eye (use of 
artificial tears is allowed); 
13. Have active or a history of chronic or recurrent inflammatory eye disease (e.g. iritis, 
scleritis, uveitis, iridocyclitis, or rubeosis iritis) in either the fellow eye or the study eye; 
14. Have cystoid macular edema, diabetic retinopathy, or diabetic macular edema; 
compromised macular function; significant macular diseases; or a history of macular 
edema in the study eye; 
15. Have previous ocular trauma with visible scarring or any deformities due to the trauma in 
the study eye that in the opinion of the Investigator may affect the pharmacokinetics of 
the study medication, intraocular inflammation, or the normal healing process; 
16. Have the potential for ocular hemorrhage in the study eye that may interfere with 
evaluation of post-surgery inflammation; 
17. Have a planned use of femtosecond laser or any other ophthalmic surgical procedure (e.g. 
minimally invasive glaucoma surgery [MIGS], vitrectomy, relaxing incisions, iridectomy, 
conjunctival excisions, use of iris hooks or other iris dilators, etc.) in addition to the 
cataract extraction procedure via phacoemulsification and PCIOL implantation in the 
study eye; 
18. Have a planned use of anterior capsule staining for capsulorhexis (i.e. trypan blue) during 
cataract surgery; 

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9.2 Concurrent Therapies 
The use of any concurrent medication, prescription, or over-the-counter, is to be recorded on the 
subject’s source document and corresponding electronic case report form (eCRF) along with the 
reason the medication was taken. 
Concurrent enrollment in another study drug or device study is not permitted. 
9.2.1   Prohibited Medications/Treatments 
Prohibited medications and washout periods are summarized in Table 1. 
• Ocular surgical intervention scheduled on the contralateral eye within 3 weeks post-
cataract surgery; or corneal or retinal surgery (laser or incisional) in the study eye within 
6 months of Visit 1 (Day -1 to Day -28 [prior to surgery]); or laser or incisional surgery 
during the study period in the study eye (other than cataract surgery); 
• Use of a contact lens or a collagen shield 72 hours prior to Visit 2 (Day 1 [18 to 30 hours 
post-surgery]) and for the remainder of the study period in either eye;  
• Use anti-inflammatory agents, analgesics/pain relievers (including opioids, narcotics, and 
other pain medications), or immunomodulating agents, systemically or in either eye, 
and/or currently using or have any historic use of medications for benign prostatic 
hyperplasia (BPH) from the washout period through the duration of the study; 
• Non-diagnostic topical ophthalmic medications in either eye for the duration of the study 
with the exception of the following mydriatics, anesthetics, antiseptics, balanced salt 
solution, viscoelastics, prophylactic antibiotics, non-prostaglandin analog IOP lowering 
agents, lid scrubs, or artificial tears (allowed topical medication should not be instilled at 
the same time as the study drug.  Study medication should be instilled at least 30 minutes 
after any prior allowed topical medication.  In addition, any other allowed topical 
medication should not be instilled within 2 hours following instillation of study 
medication); 
• Planned use of anterior capsule staining for capsulorhexis (i.e. trypan blue) during 
cataract surgery; 
• Concurrent enrollment or enrollment within the follow-up period in another study drug or 
device study is not allowed. 
Table 1: Non-allowed Medications and Washout Periods 
Medication 
Washout Period 
Topical ocular steroids 
14 days 
Periocular injection of any corticosteroid solution 
28 days 
Intraocular treatment with a corticosteroid 
56 days after implantation 
Fluocinolone acetonide drug delivery systems 
48 months after implantation 
Intravitreal injection 
95 days after injection 
Systemic treatment with a corticosteroid including oral 
14 days 
Systemic or parenteral sustained/extended release corticosteroid 
180 days 
Topical ocular NSAIDs 
7 days 
Systemic analgesics/pain relievers (e.g. gabapentin, pregabalin, and opioids) 
14 days 

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• Ocular inflammation assessment of the anterior chamber cell and flare (study eye only)  
• IOP  
• Dilated indirect ophthalmoscopy  
Visit 2 — Day 1 (18 to 30 hours post-surgery) 
• Review inclusion/exclusion criteria 
• Medical and medications update 
• Ocular pain (study eye only)  
• Pin-hole VA  
• Slit lamp biomicroscopy  
• Ocular inflammation assessment of the anterior chamber cell and flare (study eye only)  
• Randomization 
• Dose and dispense study medication and dosing diary 
• Query for AEs 
Visit 3 — Day 2 (Telephone Call) 
• Ocular pain (study eye only)  
Visit 4 — Day 4 (± 1 day window) 
• Medical and medications update 
• Ocular pain (study eye only)  
• Pin-hole VA 
• Slit Lamp Biomicroscopy  
• Ocular inflammation assessment of the anterior chamber cell and flare (study eye only)  
• IOP 
• Query for AE 
Visit 5 — Day 8 (± 1 day window) 
• Medical and medications update 
• Ocular pain (study eye only)  
• Pin-hole VA  
• Slit lamp biomicroscopy  
• Ocular inflammation assessment of the anterior chamber cell and flare (study eye only)  

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• IOP 
• Query for AEs 
Visit 6 — Day 15 (± 2 day window) 
• Medical and medications update 
• Ocular pain (study eye only)  
• Pin-hole VA  
• Slit lamp biomicroscopy  
• Ocular inflammation assessment of the anterior chamber cell and flare (study eye only)  
• IOP 
• Query for AEs 
Visit 7 — Day 22 (± 2 day window) 
• Urine pregnancy test (if applicable) 
• Medical and medications update 
• Ocular pain (study eye only)  
• Pin-hole VA 
• Slit lamp biomicroscopy  
• Ocular inflammation assessment of the anterior chamber cell and flare (study eye only)  
• IOP 
• Dilated indirect ophthalmoscopy  
• Query for AEs 
• Exit from study 
AEs (both elicited and observed) will be monitored throughout the study. All AEs (both elicited 
and observed) will be promptly reviewed by the Investigator for accuracy and completeness. All 
AEs will be documented on the appropriate eCRF. 
If a female has a positive pregnancy test during the study, then the Investigator will notify the 
site’s monitor immediately. The Investigator shall request from the subject and/or the subject’s 
physician copies of all related medical reports during the pregnancy and shall document the 
outcome of the pregnancy. The Investigator will retain these reports together with the subject’s 
source documents and will provide a copy of all documentation to the site’s monitor. 

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9.4 Schedule of Visits, Measurements and Dosing 
9.4.1   Scheduled Visits 
Refer to Appendix 1:  Schedule of Visits and Measurements for a schedule of visits and 
measurements. 
9.4.2   Unscheduled Visits 
In the case of an AE, an unscheduled visit may occur. The Investigator may perform additional 
assessments at their discretion. All additional assessments will be documented in the subject’s 
source document and eCRF. 
9.5 Compliance with Protocol 
This study will be conducted in compliance with the protocol, the ethical principles that have 
their origin in the Declaration of Helsinki, and the ICH consolidated Guideline E6 for Good 
Clinical Practice (GCP) (European Medicines Agency/ Committee for Medicinal Products for 
Human Use/ICH/135/1995). 
9.6 Subject Disposition 
9.6.1   Completed Subjects 
A completed subject is defined as having completed all 7 visits. Subjects who have discontinued 
from the study or withdrawn consent/assent will not be considered completed subjects.  
9.6.2   Discontinued subjects 
Subjects may be discontinued prior to their completion of the study due to the following: 
• AEs 
• Protocol violations 
• Subject’s decision (e.g. withdrawal of consent) 
• Administrative reasons (e.g. inability to continue, lost to follow up) 
• Sponsor termination of study 
• Principal Investigator’s (PI) decision 
• other 
Note: In addition, any subject may be discontinued for any sound medical reason. 
If at any time during the study the Investigator deems that the subject’s safety has been 
compromised or the subject has been non-compliant, the subject may be withdrawn from the 
study. 

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Any subject who wishes to withdraw from the study for any reason is entitled to do so at any 
time without obligation. 
Notification of a subject’s discontinuation and the reason for discontinuation will be made to Ora 
and/or the Sponsor and will be clearly documented on the eCRF. 
Any subject who discontinues study drug or who is administered rescue therapy will remain 
enrolled in the study and continue to participate in all subsequent visits for safety and efficacy 
assessments. If a subject discontinues participation in the study early, every attempt will be made 
to complete the exit procedures required at the final study visit (Visit 7). 
9.7 Study Termination 
The study may be stopped at any time by the Investigator (at their respective site), the Sponsor, 
and/or Ora with appropriate notification. 
9.8 Study Duration 
Subjects may be screened from Day -28 to Day -1 prior to surgery. The study will involve 7 
visits including a follow-up visit at Visit 7 (Day 22). Overall study duration will be 20-52 days, 
including the screening visit and a follow-up visit. 
9.9 Monitoring and Quality Assurance 
During the course of the study an Ora monitor, or designee, will make routine site visits to 
review protocol compliance, assess test article accountability, and ensure the study is being 
conducted according to the pertinent regulatory requirements. The review of the subjects’ 
medical records will be performed in a manner to ensure that data protection and subject 
confidentiality rights are adequately maintained. Further details of the study monitoring will be 
outlined in a Monitoring Plan. 
Regulatory authorities of domestic and foreign agencies, Ora Quality Assurance, and/or its 
designees may carry out on-site inspections and/or audits that may include source data checks. 
Therefore direct access to the original source data will be required for inspections and/or audits. 
All inspections and/or audits will be carried out giving consideration to data protection as well as 
subject confidentiality to the extent that local, national, and international laws apply. 
10 ADVERSE EVENTS 
10.1 Adverse Event 
An AE is defined as any untoward medical occurrence associated with the use of a drug in 
humans, whether or not the event is considered drug-related. An AE can therefore be any 
unfavorable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease 
occurring after the subject started dosing with the study drug, without any judgment about 
causality. Any pre-existing medical condition that worsens after administration of the study drug 
will also be considered a new AE. Study drug includes the study drug under evaluation (OCS-01) 

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and any comparator drug, placebo (vehicle), or any other medications required by the protocol 
given during any stage of the study. 
Documentation regarding the AE should be made as to the nature, date of onset, end date, 
severity, relationship to study drug, action(s) taken, seriousness, and outcome of any sign or 
symptom observed by the physician or reported by the subject upon indirect questioning. 
10.1.1   Severity 
Severity of an AE is defined as a qualitative assessment of the degree of intensity of an AE as 
determined by the Investigator or reported to him/her by the subject. The assessment of severity 
is made irrespective of the relationship to study drug or the seriousness of the event and should 
be evaluated according to the following scale: 
• Mild: AE is noticeable to the subject, but is easily tolerated and does not interfere with 
the subject’s daily activities. 
• Moderate: AE is bothersome, possibly requiring additional therapy, and may interfere 
with the subject’s daily activities. 
• Severe: AE is intolerable, necessitates additional therapy or alteration of therapy, and 
interferes with the subject’s daily activities. 
10.1.2   Relationship to Study Drug 
The relationship of each AE to the study drug should be determined by the Investigator using 
these explanations: 
• Suspected: A reasonable possibility exists that the study drug caused the AE. 
• Not Suspected: A reasonable possibility does not exist that the study drug caused the AE. 
“Suspected adverse reaction” means any AE for which there is a reasonable possibility that the 
study drug caused the AE.  “Reasonable possibility” means there is evidence to suggest a causal 
relationship between the study drug and the AE. Types of evidence that would suggest a causal 
relationship between the study drug and the AE include: a single occurrence of an event that is 
uncommon and known to be strongly associated with drug exposure (e.g. angioedema, hepatic 
injury, Stevens-Johnson Syndrome); one or more occurrences of an event that is not commonly 
associated with drug exposure, but is otherwise uncommon in the population exposed to the drug 
(e.g. tendon rupture); an aggregate analysis of specific events observed in a clinical trial (such as 
known consequences of the underlying disease or condition under investigation or other events 
that commonly occur in the study population independent of drug therapy) that indicates those 
events occur more frequently in the drug treatment group than in a concurrent or historical 
control group. 
10.1.3   Expectedness 
The expectedness of an AE should be determined based upon existing safety information about 
the study drug using these explanations: 

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• Unexpected: an AE that is not listed in the Investigator’s Brochure (IB) or is not listed at 
the specificity or severity that has been observed. 
• Expected: an AE that is listed in the IB at the specificity and severity that has been 
observed. 
AEs that are mentioned in the IB as occurring with a class of drugs or as anticipated from the 
pharmacological properties of the drug, but are not specifically mentioned as occurring with the 
particular drug under investigation are to be considered unexpected. 
Preliminary determination of classification of an AE as unexpected is the responsibility of the 
Investigator and subject to the Medical Monitor’s final determination. 
10.2 Serious Adverse Events 
An AE is considered serious if, in the view of either the Investigator or Sponsor, it results in any 
of the following outcomes: 
• Death; 
• A life-threatening AE; 
Note: An AE is considered “life-threatening” if, in the view of either the Investigator or 
Sponsor, its occurrence places the subject at immediate risk of death. It does not include an 
AE that, had it occurred in a more severe form, might have caused death. 
• Inpatient hospitalization or prolongation of existing hospitalization; 
Note: The term “inpatient hospitalization” refers to any inpatient admission (even if less 
than 24 hours). For chronic or long-term inpatients, inpatient admission includes transfer 
within the hospital to an acute/intensive care inpatient unit. Inpatient hospitalization does 
not include: emergency room visits; outpatient/same-day/ambulatory procedures; 
observation/short stay units; rehabilitation facilities; hospice facilities; nursing homes; or 
clinical research/Phase 1 units. 
Note: The term “prolongation of existing hospitalization” refers to any extension of an 
inpatient hospitalization beyond the stay anticipated or required for the reason for the initial 
admission as determined by the Investigator or treating physician. 
• A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions; 
Note: A SAEs specifically related to visual threat would be interpreted as any potential 
impairment or damage to the subject’s eyes (e.g., hemorrhage, retinal detachment, central 
corneal ulcer, or damage to the optic nerve). 
• A congenital anomaly/birth defect. 
Important medical events that may not result in death, are life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical judgment, they 

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may jeopardize the patient or subject and may require medical or surgical intervention to prevent 
one of the outcomes listed in this definition. 
10.3 Procedures for Reporting Adverse Events 
All AEs and their outcomes must be reported to Ora, the study Sponsor, and the IRB as required 
by the IRB, federal, state, or local regulations and governing health authorities and recorded on 
the appropriate eCRF. 
10.3.1   Reporting a Suspected Unexpected Adverse Reaction 
All AEs that are ‘suspected’ and ‘unexpected’ are to be reported to Ora, the study Sponsor, and 
the IRB as required by the IRB, regional and local regulations, and governing health authorities. 
10.3.2   Reporting a Serious Adverse Event 
To ensure subject safety, all SAEs, regardless of their relationship to the study drug, must be 
immediately reported. All information relevant to the SAE must be recorded on the appropriate 
case report forms. The Investigator is obligated to pursue and obtain information requested by 
Ora and/or the Sponsor in addition to that information reported on the case report form. All 
subjects experiencing an SAE must be followed-up with and the outcome reported. 
In the event of an SAE, the Investigator must notify Ora and the Sponsor upon becoming aware 
of a SAE; obtain and maintain in his/her files including all pertinent medical records, 
information, and medical judgments from colleagues who assisted in the treatment and follow-up 
of the subject; provide Ora and the study Sponsor with a complete case history, which includes a 
statement as to whether the event was or was not suspected to be related to the use of the study 
drug; and inform the IRB of the AE within their guidelines for reporting SAEs. 
Investigators are to contact the study’s Medical Monitor or designee upon becoming aware of a 
SAE. 
10.4 Procedures for Unmasking of Study Drug 
The randomization code should be broken only in the event of a medical emergency, or when 
knowing the treatment assignment is absolutely necessary for the medical management of the 
study subject. When possible (i.e. in non-emergency situations), the study Sponsor or 
representative should be notified prior to unmasking study drug. In emergency situations, the 
Investigator must notify the Sponsor within 24 hours after determining that it is necessary to 
unmask the treatment assignment. The Investigator must also indicate in source documents and 
in the eCRF that the mask was broken and provide the date, time, and reason for breaking the 
mask. Any AE or SAE associated with breaking the mask must be recorded and reported as 
specified in this protocol. 
10.5 Type and Duration of the Follow-up of Subjects after Adverse Events 
AEs will be followed until the condition is resolved or stabilized. 

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rescue medication will be imputed as failures for success/failure endpoints and will be imputed 
using LOCF for other endpoints. To check robustness of results, sensitivity analyses of the 
primary efficacy endpoints will include analyses of observed data only, imputing data from 
subject visits after discontinuation for lack of efficacy or receipt of rescue medication as failures. 
Tipping point analysis and multiple imputation methods using monotone methodology will also 
be used to impute missing data as additional sensitivity analyses. PP analyses will use observed 
data only, with the exception of subjects who have missing data due to discontinuation for lack 
of efficacy or for subjects who receive rescue medication; for these subjects, missing data after 
discontinuation or data after receiving rescue medication will be imputed as failures for 
success/failure endpoints and will be imputed using LOCF for other endpoints.  
11.8 Demographics and Medical History 
Subject demographics comprising age, gender, race, and ethnicity will be presented using 
discrete or continuous summary statistics as appropriate. 
12 COMPLIANCE WITH GOOD CLINICAL PRACTICES, ETHICAL 
CONSIDERATIONS, AND ADMINISTRATIVE ISSUES 
This study will be conducted in compliance with the protocol, with GCPs including ICH 
Guidelines, and in general, consistent with the Declaration of Helsinki. In addition, all applicable 
local, state, and federal requirements relevant to the use of study drugs in the countries involved 
will be adhered to. 
12.1 Protection of Human Subjects 
12.1.1 Subject Informed Consent 
Informed consent must take place before any study specific procedures are initiated. Signed and 
dated written informed consent must be obtained from each subject prior to enrollment into the 
study.  
All ICFs must be approved for use by the Sponsor and receive approval/favorable opinion from 
an IRB prior to their use. If the consent form requires revision (e.g., due to a protocol 
amendment or significant new safety information), it is the investigator’s responsibility to ensure 
that the amended informed consent is reviewed and approved by Ora prior to submission to the 
governing IRB and that it is read, signed and dated by all subjects subsequently enrolled in the 
study as well as those currently enrolled in the study. 
12.1.2   Institutional Review Board Approval 
This study is to be conducted in accordance with IRB regulations (U.S. 21 Code of Federal 
Regulations [CFR] Part 56.103). The Investigator must obtain appropriate IRB approval before 
initiating the study and re-approval at least annually. 
Only an IRB approved version of the ICF will be used. 

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12.1.3   Ethical Conduct of the Study 
This study will be conducted in accordance with the ethical principles that originated with the 
Declaration of Helsinki. 
12.2 Subject Confidentiality 
All personal study subject data collected and processed for the purposes of this study should be 
maintained by the Investigator and his/her staff with adequate precautions as to ensure that the 
confidentiality of the data in accordance with local, state, and federal laws and regulations. 
Monitors, auditors and other authorized representatives of Ora, the Sponsor, the IRB approving 
this study, the FDA, the Department of Health and Human Services, other domestic government 
agencies, and other foreign regulatory agencies will be granted direct access to the study 
subject’s original medical and study records for verification of the data and/or clinical trial 
procedures. Access to this information will be permitted to the aforementioned individuals to the 
extent permitted by law. 
A report of the results of this study may be published or sent to the appropriate health authorities 
in any country in which the study drug may ultimately be marketed, but the subject’s identity 
will not be disclosed in these documents. 
12.3 Documentation 
Source documents may include a subject’s medical records, hospital charts, clinic charts, the 
Investigator’s study subject files, as well as the results of diagnostic tests such as X-rays, 
laboratory tests, and electrocardiograms.  The Investigator’s copy of the eCRF serves as the 
Investigator’s record of a subject’s study-related data. 
12.3.1   Retention of Documentation 
All study related correspondence, subject records, consent forms, record of the distribution and 
use of all study drug and copies of case report forms should be maintained on file for at least two 
years after the last approval of a marketing application in an ICH region and until there are no 
pending or contemplated marketing applications in an ICH region; or until at least two years 
have elapsed since the formal discontinuation of clinical development of the study drug. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or by an agreement with the Sponsor. It is the responsibility of the Sponsor to 
inform the investigator/institution as to when these documents no longer need to be retained. 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping study records, custody must be transferred to a person who will accept 
the responsibility.  The Sponsor must be notified in writing of the name and address of the new 
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and have access to the system. Data will not be entered for screen failure subjects. An audit trail 
will be maintained within the electronic system to capture all changes made within the eCRF 
database. After the end of the study and database lock, compact discs (CDs) containing copies of 
all applicable subjects’ eCRFs will be provided to each Investigator Site to be maintained on file 
by the Investigator. 
12.6 Handling of Biological Specimens 
Not applicable 
12.7 Publications 
Authorship and manuscript composition will reflect joint cooperation among all parties involved 
in the study. Authorship will be established prior to the writing of the manuscript. The study 
Sponsor will have the final decision regarding the manuscript and publication. 

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REFERENCES 
Alcon Laboratories, I. (2000). PAZEO (olopatadine hydrochloride ophthalmic solution) 0.7%. 
Alcon Laboratories, I. (2002). Maxidex 0.1 % (dexamethasone ophthalmic suspension). 
CIOMS (2016). International Ethical Guidelines for Health-related Research Involving Humans. 
Geneva. 
Fong, R., B. E. Silverstein, J. H. Peace, J. I. Williams and J. L. Vittitow (2018). "Submicron 
loteprednol etabonate ophthalmic gel 0.38% for the treatment of inflammation and pain after 
cataract surgery." J Cataract Refract Surg 44(10): 1220-1229. 
Jabs, D. A., R. B. Nussenblatt, J. T. Rosenbaum and G. Standardization of Uveitis Nomenclature 
Working (2005). "Standardization of uveitis nomenclature for reporting clinical data. Results of 
the First International Workshop." Am J Ophthalmol 140(3): 509-516. 
Johannesson, G., P. Hallberg, A. Eklund, A. Behndig and C. Linden (2014). "Effects of topical 
anaesthetics and repeated tonometry on intraocular pressure." Acta Ophthalmol 92(2): 111-115. 
Johannesson, G., M. D. Moya-Ortega, G. M. Asgrimsdottir, S. H. Lund, M. Thorsteinsdottir, T. 
Loftsson and E. Stefansson (2014). "Kinetics of gamma-cyclodextrin nanoparticle suspension 
eye drops in tear fluid." Acta Ophthalmol 92(6): 550-556. 
Krag, S. and A. Hessellund (2014). "Topical dexamethasone-cyclodextrin microparticle eye 
drops for uveitic macular oedema." Acta Ophthalmol 92(8): e689-690. 
Kristinsson, J. K., H. Fridriksdottir, S. Thorisdottir, A. M. Sigurdardottir, E. Stefansson and T. 
Loftsson (1996). "Dexamethasone-cyclodextrin-polymer co-complexes in aqueous eye drops. 
Aqueous humor pharmacokinetics in humans." Invest Ophthalmol Vis Sci 37(6): 1199-1203. 
Liu, Y. C., M. Wilkins, T. Kim, B. Malyugin and J. S. Mehta (2017). "Cataracts." Lancet 
390(10094): 600-612. 
Loftsson, T. and E. Stefansson (2017). "Cyclodextrins and topical drug delivery to the anterior 
and posterior segments of the eye." Int J Pharm 531(2): 413-423. 
McCaffery, M. and A. Beebe (1994). "Pain: clinical manual for nursing practice." Nurs Stand 
9(11): 55. 
Ohira, A., K. Hara, G. Johannesson, M. Tanito, G. M. Asgrimsdottir, S. H. Lund, T. Loftsson 
and E. Stefansson (2015). "Topical dexamethasone gamma-cyclodextrin nanoparticle eye drops 
increase visual acuity and decrease macular thickness in diabetic macular oedema." Acta 
Ophthalmol 93(7): 610-615. 

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Rajpal, R. K., R. Fong and T. L. Comstock (2013). "Loteprednol etabonate ophthalmic gel 0.5% 
following cataract surgery: integrated analysis of two clinical studies." Adv Ther 30(10): 907-
923. 
Saari, K. M., L. Nelimarkka, V. Ahola, T. Loftsson and E. Stefansson (2006). "Comparison of 
topical 0.7% dexamethasone-cyclodextrin with 0.1% dexamethasone sodium phosphate for 
postcataract inflammation." Graefes Arch Clin Exp Ophthalmol 244(5): 620-626. 
Samudre, S. S., F. A. Lattanzio, Jr., P. B. Williams and J. D. Sheppard, Jr. (2004). "Comparison 
of topical steroids for acute anterior uveitis." J Ocul Pharmacol Ther 20(6): 533-547. 
Shulman, S., G. Johannesson, E. Stefansson, A. Loewenstein, A. Rosenblatt and Z. Habot-
Wilner (2015). "Topical dexamethasone-cyclodextrin nanoparticle eye drops for non-infectious 
Uveitic macular oedema and vitritis - a pilot study." Acta Ophthalmol 93(5): 411-415. 
Sigurdsson, H. H., F. Konraethsdottir, T. Loftsson and E. Stefansson (2007). "Topical and 
systemic absorption in delivery of dexamethasone to the anterior and posterior segments of the 
eye." Acta Ophthalmol Scand 85(6): 598-602. 
Tanito, M., K. Hara, Y. Takai, Y. Matsuoka, N. Nishimura, P. Jansook, T. Loftsson, E. 
Stefansson and A. Ohira (2011). "Topical dexamethasone-cyclodextrin microparticle eye drops 
for diabetic macular edema." Invest Ophthalmol Vis Sci 52(11): 7944-7948. 
Usayapant, A., A. H. Karara and M. M. Narurkar (1991). "Effect of 2-hydroxypropyl-beta-
cyclodextrin on the ocular absorption of dexamethasone and dexamethasone acetate." Pharm Res 
8(12): 1495-1499. 
Weber, M., L. Kodjikian, F. E. Kruse, Z. Zagorski and C. M. Allaire (2013). "Efficacy and safety 
of indomethacin 0.1% eye drops compared with ketorolac 0.5% eye drops in the management of 
ocular inflammation after cataract surgery." Acta Ophthalmol 91(1): e15-21. 

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Appendix 1:  Schedule of Visits and Measurements 

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Appendix 2:  Examination Procedures, Tests, Equipment, and Techniques 
 
Pin-hole Visual Acuity .................................................................................................................. 50 
Slit-lamp Evaluation ..................................................................................................................... 52 
During Slit Lamp Biomicroscopy: Ocular Inflammation Assessment of the Anterior Chamber 
Cell and Flare (Study Eye Only) ................................................................................................... 53 
Ocular Pain Grading Scale (Study Eye Only)............................................................................... 54 
Intraocular Pressure Procedures .................................................................................................... 55 
Dilated Indirect Ophthalmoscopy ................................................................................................. 56 
 
 

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Appendix 5:  Investigator’s Signature 
Protocol Title: 
A Randomized, Double-masked, Vehicle-Controlled Study Evaluating 
the Efficacy and Safety of Two Doses of OCS-01 compared to Vehicle 
in the Treatment Inflammation and Pain Following Cataract Surgery 
Protocol Number: 
DX216 
Protocol Date: 
08Aug2019 
I agree to implement and conduct the study diligently and in strict compliance with the protocol, 
good clinical practices and all applicable laws and regulations. I agree to maintain all 
information supplied by the Sponsor and its agents in confidence and, when this information is 
submitted to an Institutional Review Board (IRB), Ethical Review Committee (ERC) or another 
group, it will be submitted with a designation that the material is confidential. 
I have read this protocol in its entirety, including the above statement, and I agree to all aspects. 
Signed: 
Date: 
Name: 
Title: 
Affiliation: 
Address: 
Telephone number: