A Prospective, Multicenter Study of the OMNI® Surgical System in Pseudophakic Eyes With Open Angle Glaucoma
Phase: NA
Conditions: Glaucoma, Open-Angle
Sponsor: Sight Sciences, Inc.

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
Page 1 of 60 
A PROSPECTIVE, MULTICENTER STUDY OF THE OMNI® SURGICAL SYSTEM IN 
PSEUDOPHAKIC EYES WITH OPEN ANGLE GLAUCOMA (ORION) 
PROTOCOL ID #: 
#06807 
CURRENT REVISION: 
Rev C 
REVISION DATE: 
June 4, 2020 
SPONSOR: 
Sight Sciences, Inc. 
4040 Campbell Avenue 
Suite 100 
Menlo Park, CA  94025 
877-266-1144
Agreement of Principal Investigator 
I, 
 agree to conduct this trial in accordance 
with this clinical protocol and any amendments. 
Signature 
Date 
Center Name 
City, State, Country 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation.  It must be held 
confidential and maintained in a secure location. 
Do not copy or distribute without written permission. 
NCT 04465630 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 2 of 60 
Revision History 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 3 of 60 
 
 
TABLE OF CONTENTS 
1 
PROTOCOL SYNOPSIS ................................................................................................................... 5 
2 
STUDY OBJECTIVE ......................................................................................................................... 8 
3 
BACKGROUND AND JUSTIFICATION FOR THE STUDY ..................................................................... 9 
4 
STUDY DEVICE ............................................................................................................................ 10 
4.1 
INDICATIONS FOR USE .......................................................................................................................... 10 
4.2 
DEVICE DESCRIPTION ........................................................................................................................... 11 
4.3 
TRAINING .......................................................................................................................................... 12 
5 
PRIOR INVESTIGATIONS .............................................................................................................. 12 
6 
STUDY DESIGN............................................................................................................................ 13 
6.1 
STUDY DEVICE .................................................................................................................................... 13 
6.2 
STUDY SITES ....................................................................................................................................... 13 
7 
STUDY ENDPOINTS ..................................................................................................................... 13 
7.1 
EFFECTIVENESS ENDPOINTS ................................................................................................................... 13 
7.2 
 
 
 
8 
 
 
 
 
 
9 
STUDY PROCEDURES .................................................................................................................. 17 
9.1 
STUDY SCHEDULE ................................................................................................................................ 17 
9.2 
NUMBER OF SUBJECTS, DURATION OF FOLLOW-UP AND STUDY DURATION .................................................... 18 
9.3 
INFORMED CONSENT AND POINT OF ENROLLMENT .................................................................................... 18 
9.4 
SCREENING VISIT ................................................................................................................................. 18 
9.5 
WASHOUT OF HYPOTENSIVE MEDICATIONS .............................................................................................. 19 
9.6 
BASELINE VISIT ................................................................................................................................... 20 
9.7 
SURGICAL PROCEDURE ......................................................................................................................... 21 
9.8 
FOLLOW-UP VISITS .............................................................................................................................. 21 
9.9 
MANAGEMENT OF IOP AFTER SURGERY .................................................................................................. 21 
9.10 
WITHDRAWAL AND DISCONTINUATION ............................................................................................... 22 
9.11 
SUBJECTS LOST TO FOLLOW-UP ......................................................................................................... 22 
10 
ADVERSE EVENTS (AES) .............................................................................................................. 23 
10.1 
DEFINITIONS OF AE, SAE, SADE, USADE .......................................................................................... 23 
10.2 
LIST OF ANTICIPATED POTENTIAL ADVERSE EVENTS ............................................................................... 24 
10.3 
REPORTING ADVERSE EVENTS AND UNANTICIPATED ADVERSE DEVICE EFFECTS ........................................... 25 
11 
STATISTICAL CONSIDERATIONS ................................................................................................... 26 
11.1 
SAMPLE SIZE CALCULATION .............................................................................................................. 26 
11.2 
ANALYSIS POPULATIONS .................................................................................................................. 28 
11.3 
DEMOGRAPHICS AND BASELINE CHARACTERISTICS ................................................................................ 28 
11.4 
EFFECTIVENESS ENDPOINTS AND ANALYSIS METHODS ........................................................................... 28 
 
Primary Effectiveness Endpoint ........................................................................................ 28 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 4 of 60 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
11.6 
INTERIM ANALYSIS .......................................................................................................................... 33 
11.7 
DEVIATION FROM THE STATISTICAL PLAN ............................................................................................ 33 
12 
MONITORING PROCEDURES ....................................................................................................... 34 
13 
DATA AND QUALITY MANAGEMENT ........................................................................................... 35 
13.1 
DATABASE MANAGEMENT ............................................................................................................... 35 
13.2 
SUBJECT IDENTIFICATION ................................................................................................................. 35 
13.3 
SUBJECT ACCOUNTABILITY ................................................................................................................ 35 
13.4 
CONFIDENTIALITY ........................................................................................................................... 35 
13.5 
SOURCE DATA AND CASE REPORT FORMS ........................................................................................... 35 
13.6 
RETENTION PERIOD......................................................................................................................... 36 
14 
PROTOCOL MODIFICATIONS AND DEVIATIONS ........................................................................... 36 
15 
DEVICE FAILURES AND MALFUNCTIONS ...................................................................................... 36 
16 
ETHICAL CONSIDERATIONS ......................................................................................................... 36 
16.1 
DECLARATION OF HELSINKI ............................................................................................................... 36 
16.2 
INSTITUTIONAL REVIEW BOARDS (IRB) ............................................................................................... 37 
16.3 
INFORMED CONSENT DOCUMENT (ICD) ............................................................................................. 37 
16.4 
PUBLIC LISTING OF STUDY ................................................................................................................ 37 
17 
STUDY ADMINISTRATION ........................................................................................................... 37 
17.1 
EARLY TERMINATION OR SUSPENSION OF THE STUDY OR AN INVESTIGATIONAL SITE ..................................... 37 
17.2 
INVESTIGATOR RESPONSIBILITIES ....................................................................................................... 38 
 
General Responsibilities of Investigators ......................................................................... 38 
 
Specific Responsibilities of Investigators .......................................................................... 38 
 
Investigator Records ........................................................................................................ 39 
 
Investigator Reports ......................................................................................................... 39 
17.3 
INVESTIGATOR AGREEMENT .............................................................................................................. 40 
18 
PUBLICATION POLICY .................................................................................................................. 40 
19 
BIBLIOGRAPHY ........................................................................................................................... 42 
20 
APPENDIX A – METHODS FOR EXAMS, TESTS AND QUESTIONNAIRES .......................................... 44 
20.1 
LIST OF STUDY PROCEDURES ............................................................................................................. 44 
20.2 
OSDI QUESTIONNAIRE ............................................................................................................... 45 
20.3 
VISUAL ACUITY WITH MANIFEST REFRACTION ....................................................................................... 45 
20.4 
MEASUREMENT OF INTRAOCULAR PRESSURE ........................................................................................ 46 
20.5 
VISUAL FIELD EXAMINATION ............................................................................................................. 49 
20.6 
DILATED FUNDUS EXAMINATION ........................................................................................................ 50 
20.7 
SLIT LAMP EXAMINATION ................................................................................................................. 50 
20.8 
GONIOSCOPY ................................................................................................................................. 53 
20.9 
OCULAR HYPOTENSIVE MEDICATIONS ................................................................................................ 53 
21 
APPENDIX B - DECLARATION OF HELSINKI ................................................................................... 53 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 6 of 60 
Inclusion Criteria 
Inclusion Criteria 
(At least one eye of each subject should pass the ocular 
eligibility criteria listed below. Only one eye of each 
subject is eligible to receive the study procedure): 
1. Male or female subjects, 22 years or older at the time 
of surgery 
2. History of uncomplicated cataract surgery and 
posterior chamber IOL implantation without 
compromise to the lens capsule, zonular 
dehiscence/rupture or vitreous prolapse, 6 months or 
more prior to Baseline Visit. 
3. 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
  
 
 
6. Scheduled for ab-interno transluminal viscoelastic 
delivery and trabeculotomy using the OMNI Surgical 
System. 
7. Shaffer grade of ≥ III in all four quadrants 
8. Able and willing to comply with the protocol, including 
all follow-up visits. 
9. Understands and signs the informed consent 
 
1 For combination IOP-lowering medications that consist of two or more IOP-lowering drugs, each IOP-
lowering drug component counts as a separate medication. 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 7 of 60 
Exclusion Criteria 
A subject who meets any of the criteria listed below will 
not receive the study procedure. Ocular criteria are 
applicable to study eye and non-ocular criteria are 
subject-related: 
1. Any of the following prior treatments for glaucoma: 
o Laser trabeculoplasty ≤3 months prior to 
Baseline visit 
o iStent or iStent Inject implanted ≤6 months 
prior to Baseline visit 
o Endocyclophotocoagulation (ECP) or 
Micropulse laser ≤ 6 months prior to Baseline 
visit 
o Trabeculectomy or other bleb forming 
procedure including Xen, Express, glaucoma 
draining device/valve 
o Prior canaloplasty, goniotomy, or 
trabeculotomy 
o Hydrus microstent 
o Suprachoroidal stent (e.g. Cypass, iStent Supra) 
2. Acute angle closure, traumatic, congenital, malignant, 
uveitic or neovascular glaucoma 
3. Concurrent IOP-lowering procedure other than use of 
the OMNI Surgical System at the time of surgery (e.g. 
ECP, CPC, etc.)  
4. In the Investigator’s judgement, predisposed to 
significant risk because of washout of ocular 
hypotensive medications 
5. Concurrent ocular pathology or systemic medical 
condition which, in the Investigator's judgment, would 
either place the subject at increased risk of 
complications, contraindicate surgery, place the 
subject at risk of significant vision loss during the study 
period (e.g., wet AMD, corneal edema, Fuch’s 
dystrophy, active intraocular infection or inflammation 
within 30 days prior to Screening Visit, etc.), or 
interfere with compliance to elements of the study 
protocol (e.g., returning to Investigator’s office for 
follow-up visits). 
6. History of penetrating keratoplasty or another corneal 
transplant 
7. BCVA of logMAR 1.0 (20/200) or worse in the fellow 
eye not due to cataract 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 8 of 60 
 
8. BCVA of logMAR 0.4 (20/50) or worse in the study eye 
not due to posterior capsular opacification (uneventful 
Nd:YAG laser capsulotomy 6 months prior to baseline 
is permitted only if there is no vitreous present in or in 
front of the iris plane at the time of baseline). 
9. Participation (≤ 30 days prior to baseline) in an 
interventional trial which could have a potential effect 
on the study outcome, as determined by the study 
investigator 
10. Women of childbearing potential if they are currently 
pregnant or intend to become pregnant during the 
study period; are breast-feeding; or are not in 
agreement to use adequate birth control methods to 
prevent pregnancy throughout the study 
Number of Subjects 
Enrolled and Treated 
 
Number of Sites 
 
 
Study Duration for Each 
Subject 
 
 
Total Study Duration 
 
 
 
 
 
Schedule of Visits 
 
 
Treatments 
Ab-interno transluminal viscoelastic delivery and 
trabeculotomy using the OMNI Surgical System as a 
standalone procedure in pseudophakic eyes 
2 STUDY OBJECTIVE 
To prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery 
and trabeculotomy performed with the OMNI Surgical System in pseudophakic eyes on 
intraocular pressure (IOP) and the use of IOP-lowering medications in patients with 
open angle glaucoma (OAG). 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 9 of 60 
3 BACKGROUND AND JUSTIFICATION FOR THE STUDY 
Glaucoma is a progressive disease leading to irreversible damage to retinal ganglion cells 
with the global burden expected to rise to 111.8 million people by the year 2040.2 OAG 
is the most prevalent form of glaucoma and it’s proven that lowering IOP is the only 
efficient way to slow down the progressive optic nerve damage and visual field loss.3 
Hypotensive eye drops are commonly used as the first line clinical management for 
OAG.4 Ocular side effects such as allergies, ocular surface disorders, blepharitis, 
pemphigoid, abnormal pigmentation etc. and systemic side effects such as bradycardia, 
headaches, depression, anxiety, confusion, dysarthria, hallucinations, lethargy, polyuria, 
weight loss, metabolic acidosis, etc. can occur during long term use of topical 
medications for management of OAG. 5 There is also a documented low rate of 
compliance and tolerability with eye drops that results in disease progression and loss of 
vision.6  The cost of these chronic medications and difficulty administering drops to the 
eyes contributes to poor compliance. 
 
Trabeculectomy and tube-shunt implantations remain the gold standard for surgical 
management of IOP.7 These interventions are associated with a long list of potential 
complications such as sclero-conjunctival scarring, hypotony, hypotony maculopathy, 
choroidal detachment, conjunctival leak, hyphema, and bleb related complications.8  
Surgical techniques that re-establish the aqueous outflow through the physiological 
pathways without the need for a bleb are gaining acceptance among glaucoma 
surgeons.9 Delivering viscoelastic in Schlemm's canal is one such procedure that is 
intended to restore the natural aqueous outflow system through microcatheterization 
and viscodilation of the entire length of the Schlemm's canal with a well-documented 
 
2 Tham YC, Li X, Wong TY, et al. Global prevalence of glaucoma and projections of glaucoma burden 
through 2040: a systematic review and meta-analysis. Ophthalmology. 2014;121:2081–2090. 
3 European Glaucoma Society. Terminology and guidelines for glaucoma 4th edition Savona, Italy: Editrice 
PubliComm, 2014. 
4 Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, et al. The Ocular Hypertension Treatment Study: a 
randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of 
primary open-angle glaucoma. Arch Ophthalmol. 2002; 120:701–713. 
5 Kenji Inoue. Managing adverse effects of glaucoma medications. Clin Ophthalmol. 2014; 8: 903–913. 
Published online 2014 May 12. doi:  10.2147/OPTH.S44708. 
6 Newman-Casey PA, Robin AL, Blachley T, Farris K, Heisler M, Resnicow K, Lee PP. The Most Common 
Barriers to Glaucoma Medication Adherence: A Cross-Sectional Survey. Ophthalmology. 2015 Jul; 
122(7):1308-16. 
7 Gedde SJ, Singh K, Schiffman JC, Feuer WJ. The Tube Versus Trabeculectomy Study: interpretation of 
results and application to clinical practice. Curr Opin Ophthalmol. 2012 Mar; 23(2):118-26. 
8 Zahid S, Musch DC, Niziol LM, Lichter PR, Collaborative Initial Glaucoma Treatment Study Group. Risk of 
endophthalmitis and other long-term complications of trabeculectomy in the Collaborative Initial 
Glaucoma Treatment Study (CIGTS). Am J Ophthalmol. 2013 Apr; 155(4):674-680, 680.e1. 
9 American Academy of Ophthalmology. Preferred practice pattern®. Primary open-angle glaucoma. San 
Francisco, CA. 2015. 
 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 10 of 60 
safety and efficacy profile in reducing IOP.10,11 Trabeculotomy is another such procedure 
that relieves the resistance to aqueous flow by cleaving the trabecular meshwork and 
the inner wall of Schlemm’s canal.12  
 
The OMNI™ Surgical System (Sight Sciences Inc, Menlo Park, CA) is a 510K-cleared 
manually operated device indicated for the delivery of small amounts of viscoelastic 
fluid and to cut trabecular meshwork tissue during trabeculotomy procedures. The 
OMNI™ Surgical System allows doctors to perform viscodilation of Schlemm’s canal in 
conjunction with trabeculotomy through single clear corneal incision.13,14,15   
 
This prospective, multicenter, single-arm, post-market clinical study will evaluate the 
impact of ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI™ 
Surgical System on IOP and the use of hypotensive medications in pseudophakic eyes 
with mild to moderate open angle glaucoma.  
4 STUDY DEVICE 
4.1 
INDICATIONS FOR USE 
The OMNI Surgical System has been 510k cleared by the US Food and Drug 
Administration (FDA) for the following indication for use: 
The OMNITM Surgical System is a manually operated device for delivery of small 
amounts of viscoelastic fluid, for example Healon® or Healon GV® from Abbott 
Medical Optics (AMO), Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, 
during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue 
during trabeculotomy procedures. 
 
10 Klink T, Sauer J, Körber NJ, et al. Quality of life following glaucoma surgery: canaloplasty versus 
trabeculectomy. Clin Ophthalmol. 2014;18;9:7-16. 
11 Lewis RA, von Wolff K, Tetz M, Körber NJ, Kearney JR, Shingleton B, Samuelson TW. Canaloplasty: 
circumferential viscodilation and tensioning of Schlemm’s canal using a flexible microcatheter for the 
treatment of open-angle glaucoma in adults: interim clinical study analysis. J Cataract Refract Surg 
2007; 33:1217–1226 
12 Grover DS, Godfrey DG, Smith O, Feuer WJ, Montes de Oca, Fellman RL.  Gonioscopy-Assisted 
Transluminal Trabeculotomy, A Novel Ab Interno Trabeculotomy:  technique report and preliminary 
results. Ophthalmology. 2014; 121:855-861. 
13 Clara Martinez‐Rubio, Ioan Alexandru Placinta, Rodrigo Molina‐Pallete, Paula Martínez Lopez‐Corell, 
Jorge Vila‐Arteaga. OMNI‐an initial experience with a new surgical glaucoma treatment device. ESCRS 
2018. 
14 Iwona Grabska‐Liberek, Julita Majszyk‐Ionescu, Agnieszka Skowyra, Monika Rogowska, Anna Plichta, 
Patrycja Duda, Ingrid Kane OMNI 360TM in Open‐Angle Glaucoma Treatment: A 6‐month Follow‐up. 
ESCRS 2018. 
15 Paula Martínez Lopez‐Corell, Rodrigo Molina‐Pallete, Clara Martinez‐Rubio, Ioan Alexandru Placinta, 
Jorge Vila‐Arteaga Procedural Steps For OMNI, A New Surgical Technique For Glaucoma Treatment, In 
Combination With Cataract Surgery ESCRS 2018. 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 11 of 60 
4.2 
DEVICE DESCRIPTION 
The OMNITM Surgical System (“OMNI”) is a sterile, single use, manually operated 
instrument used by ophthalmologists to deliver small, controlled amounts of viscoelastic 
into the anterior segment of the eye during ophthalmic surgery. It is also indicated to 
cut trabecular meshwork tissue during trabeculotomy procedures.  
The OMNI is designed to function with commonly used viscoelastic fluids made 
commercially available by companies such as Abbott Medical Optics (AMO), Bausch & 
Lomb, and Alcon. The OMNI dispenses fluid on the principle of exchanging volumes 
much like a syringe. The handheld instrument includes a cannula, microcatheter, 
internal reservoir and plunger tube, and finger wheels. The finger wheels on the handle 
of the device are used to advance and retract the microcatheter.  In addition, when the 
device is being used to deliver viscoelastic, retraction of the microcatheter causes the 
plunger tube to advance into the viscoelastic fluid reservoir thereby dispensing 
viscoelastic fluid.  
The microcatheter can be advanced/retracted up to 20 mm per cycle.  The 
microcatheter can be fully advanced/retracted up to 5 times (i.e. 5 full cycles of 20 mm 
each).  Dispensation of viscoelastic can only occur during the first two 20-mm cycles. 
One finger wheel is located on the top and bottom of each device handle.  This allows 
the OMNI device to be used in either eye (OD or OS) and in either hand of the surgeon 
(left or right), by turning the device 180 degrees along its vertical axis.   
Figure 1:  OMNI Surgical System 
 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 12 of 60 
4.3 
TRAINING 
Investigators participating in the study must be experienced in using the OMNI 2.0 
(OMNI NextGen) Surgical System.  All study staff will receive training on the protocol 
and execution of the study according to applicable regulations and Good Clinical 
Practices. 
5 PRIOR INVESTIGATIONS 
Several case-series studies have been performed to evaluate the results of ab-interno 
transluminal viscoelastic delivery and trabeculotomy performed with the OMNI device 
in patients with open angle glaucoma.  These prior investigations were not conducted in 
the same subject population as defined in this protocol. Thus, the data presented here 
will not be used for making assumptions for the current study. 
 
Grabska-Liberek, et al reported on 15 eyes (13 patients) with open angle glaucoma.16  
Eight eyes were treated with OMNI surgery alone and 7 eyes underwent OMNI surgery 
plus cataract extraction (OMNI + CE).  Preoperative mean IOP was 20.13 ± 4.44 mmHg 
(min IOP=13 mmHg, max IOP=38 mmHg). Postoperative IOP decreased to a mean of 
13.90 ± 4.45, 14.07 ± 2.52, 13.43 ± 2.95, 13.71 ± 2.58, 12.73 ± 2.00, 12.67 ± 3.32 and 
12.67 ± 1.75 mmHg at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months and 2 
years. The number of anti-glaucoma medications dropped from a mean of 2.60 
preoperatively to 0.07, 0.20, 0.29, 0.43, 0.82, 1.22 and 1.33. Complications were limited 
to IOP-spikes (nine eyes), hyphema (six eyes) and fibrin in the anterior chamber (five 
cases) that were resolved in the first week after surgery. 3 eyes underwent anterior 
chamber lavage for removal of blood- these patients didn't receive tranexamic acid 
during the surgery. 
 
Martinez‐Rubio, et al17 reported early safety and efficacy of transluminal viscoelastic 
delivery and trabeculotomy using the OMNI Surgical System in 20 eyes with primary 
open angle glaucoma, 13 of which were treated with the OMNI device and cataract 
surgery and 7 who were only treated with the OMNI device. Mean pre‐operative IOP 
was 24.2 ± 6.3 mmHg and the mean number of preoperative antiglaucoma drugs used 
by patients was 2.7. At 6 months, pressure had been reduced to an average of 15.9 ± 3.3 
and medications were reduced to an average of 1.1.  Early postoperative complications 
included one case of transient toxic anterior segment syndrome (TASS) and one case of 
transient hyphema. Early follow‐up data showed a reduction of IOP, with medication 
reduction, in treatment of moderate glaucoma in adults.  
 
16 Grabska-Liberek I, et al.  OMNI 360 in Open-Angle Glaucoma Treatment:  A 24-Month Follow-Up.  World 
ophthalmology congress (WOC) 2019. 
17 Martinez‐Rubio, et al. OMNI‐an initial experience with a new surgical glaucoma treatment device. 
European Society of Cataract & Refractive Surgeons (ESCRS) 2018. 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 13 of 60 
 
Figure 3:  Results for OMNI Surgery (Martinez‐Rubio et al) 
 
6 STUDY DESIGN 
This is a prospective, multicenter, single-arm, post-market study. 
 
6.1 
STUDY DEVICE 
The study device is the OMNI 2.0 (OMNI NextGen) Surgical System.  Subjects enrolled in 
the study will undergo ab-interno transluminal viscoelastic delivery and trabeculotomy 
using the OMNI Surgical System. 
6.2 
STUDY SITES 
This study will be conducted at up to 10 sites in the United States.   
7 STUDY ENDPOINTS 
7.1 
EFFECTIVENESS ENDPOINTS 
The Primary effectiveness endpoint is:    
 
• Proportion of eyes with a ≥ 20% decrease in unmedicated mean diurnal IOP 
(DIOP) at the 12-month (or 12-month washout) postoperative examination 
 
  
 
 
 
 
 
  

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 14 of 60 
7.2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8 STUDY SELECTION CRITERIA 
8.1 
INCLUSION CRITERIA 
At least one eye of each subject should pass the ocular eligibility criteria listed below. 
Only one eye of each subject is eligible to receive the study procedure: 
1. Male or female subjects, 22 years or older at the time of surgery 
2. History of uncomplicated cataract surgery and posterior chamber IOL implantation 
without compromise to the lens capsule, zonular dehiscence/rupture or vitreous 
prolapse, 6 months or more prior to Baseline Visit. 
3. 
 
 
 
 
 
 
 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 16 of 60 
7. BCVA of logMAR 1.0 (20/200) or worse in the fellow eye not due to cataract 
8. BCVA of logMAR 0.4 (20/50) or worse in the study eye not due to posterior capsular 
opacification ( uneventful Nd:YAG laser capsulotomy 6 months prior to baseline is 
permitted only if there is no vitreous present in or in front of the iris plane at the 
time of baseline).  
9. Participation (≤ 30 days prior to baseline) in an interventional trial which could have 
a potential effect on the study outcome, as determined by the study investigator 
10. Women of childbearing potential if they are currently pregnant or intend to become 
pregnant during the study period; are breast-feeding; or are not in agreement to use 
adequate birth control methods to prevent pregnancy throughout the study 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 18 of 60 
9.2 
NUMBER OF SUBJECTS, DURATION OF FOLLOW-UP AND STUDY DURATION 
 
 
 
 
 in the study will take approximately 9 months.  
Including the 13-month follow-up period, the study is expected to last 22 months. 
9.3 
INFORMED CONSENT AND POINT OF ENROLLMENT 
The IRB-approved informed consent will be presented and explained to each 
prospective subject by the investigator or a trained clinical professional.  Once the 
subject has had ample time to read the consent form, has been informed of all aspects 
of the study, and has had an opportunity to ask questions, the subject will be given a 
choice to voluntarily confirm his or her participation in the study as documented by 
completion of the Informed Consent.  After signing the Informed Consent and the HIPAA 
(Health Insurance Portability and Accountability Act) authorization, the subject can then 
proceed with the screening visit.  The subject has the right to withdraw from the study 
at any time without consequences, as indicated in the Informed Consent Document. 
 
The subject’s signed and dated informed consent must be obtained before conducting 
any study specific procedures that are not part of the standard of care.  Subjects are 
enrolled upon signing the ICD even if they subsequently fail to meet the eligibility 
criteria.   
 
The principal investigator(s) must retain the original, signed written Informed Consent 
Document.  A copy of the written Informed Consent Document must be given to the 
subject. 
9.4 
SCREENING VISIT 
After obtaining an understanding of the purpose of this study, then reviewing and 
signing the Informed Consent Document, all potential subjects will undergo an initial 
screening examination in order to determine their eligibility for the study. Exams and 
tests listed in the Screening column of Table 1 should be performed.  Refer to Appendix 
A for instructions for performing the exams. 
 
 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 19 of 60 
If a subject does not meet the inclusion/exclusion criteria, he/she may be re-screened 
after 30 calendar days. Subject should be exited from the study and assigned another 
subject identification number at the second screening. 
 
Exam data collected on subjects prior to enrollment as part of the routine clinical 
practice may serve as Screening data as long as it was collected within 15 days prior to 
the visit.  The only exceptions to this are: 
 
• IOP and IOP-lowering medications.  These data must be collected at the 
Screening visit. 
• Visual field:  Visual Fields conducted per the protocol method (Humphrey 24-2 
SITA standard) within 6 months of the screening visit will be acceptable. 
9.5 
WASHOUT OF HYPOTENSIVE MEDICATIONS 
Subjects on ocular hypotensive medication who meet all eligibility criteria at the 
screening visit will be instructed to discontinue their ocular hypotensive medication 
regimen, and to return for a Baseline visit after completing the appropriate washout 
period. The final eligibility assessment will happen at baseline visit. 
 
 
 
 
 
 
  
 
 
 
 
 
 
 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 21 of 60 
9.7 
SURGICAL PROCEDURE 
 
Eyes with complications related to previous glaucoma implants (such as displacement of 
implant) or IOL (such as posterior capsular rent or vitreous presentation) should be 
exited from the study. The region where the trabeculotomy procedure is performed 
(e.g. superior hemisphere) and the extent of trabeculotomy should be recorded on the 
case report forms. 
Surgeons should follow their standard intra-operative and peri-operative medication 
regimen.  
9.8 
FOLLOW-UP VISITS 
Follow-up visits should be performed according to the schedule provided in Table 1. All 
attempts should be made to conduct each follow-up visit within the time interval 
specified in Table 1.  Evaluations conducted outside the prescribed time period will be 
considered protocol deviations.   
9.9 
MANAGEMENT OF IOP AFTER SURGERY 
This protocol recommends that no IOP-lowering medications should be administered to 
subjects after the surgery (0 meds on postop day 1) unless medically warranted. 
Investigators should use their clinical judgement and best practices in determining when 
and why IOP-lowering medications should be reintroduced and if a subject requires 
surgical re-intervention to manage IOP. 
 
In the event of a steroid response (IOP increase), the Investigator should use his/her 
standard of care to treat an increase in IOP; however, hypotensive medications should 
be discontinued once the topical steroid has been discontinued within the reasonable 
timeframe as deemed appropriate by the investigator. 
 
If a pressure rise is observed, a paracentesis may be performed as necessary. If a 
paracentesis is performed and there is no protocol-defined adverse event, the 
paracentesis will be documented in the subject’s medical record, the applicable visit CRF 
and the Ocular Procedures log. If, however, the paracentesis is performed in 
conjunction with an AE, then the AE is recorded as such, and the paracentesis is also 
recorded on the AE CRF as a treatment for the protocol-defined AE (as well as the other 
CRFs mentioned above). 
 
Medications which have been re-started by the investigator may be discontinued if the 
investigator’s judgment is that the target intraocular pressure has been reached and the 
continued use of some or all of the therapy may not be required. Discontinuation of 
medications after re-introduction is recommended to be in the reverse order of re-

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 22 of 60 
introduction.  The rationale for discontinuation should also be documented in the study 
record  by the investigator.   
 
A record of all ocular hypotensive medications added, discontinued or changed will be 
documented on the appropriate Case Report Form for each scheduled visit or on a Case 
Report Form for an Unscheduled Visit, if necessary. 
 
Another potential reason for intervention is hypotony.  Intervention should only be 
considered if the hypotony has caused or is likely to cause sequelae such as a flat 
chamber or retinal detachment. No intervention is indicated when the vision is 
unchanged from screening, there is no persistent choroidal detachment, the anterior 
chamber is not flat with lens corneal touch, or the patient is asymptomatic.  No 
intervention should be undertaken for hypotony which is not causing, or threatening to 
cause, a reduction in vision. 
 
Secondary IOP-Lowering Interventions to Control IOP 
 
If the subject requires another glaucoma procedure to control their IOP, the subject 
should continue to be followed according to standard of care until the adverse event 
resolves or 1 month post-re-intervention, whichever is longer.  Following this, the 
subject should be withdrawn from the study. 
 
Subjects who have a secondary IOP-lowering intervention will be considered treatment 
failures for the purpose of the endpoint analyses.  These subjects will be included in the 
Safety Endpoint analyses through their withdrawal from the study. 
9.10 WITHDRAWAL AND DISCONTINUATION 
All subjects have the right to withdraw at any point during the study without prejudice.  
The investigator can discontinue any subject at any time at his/her discretion, or if 
continued participation in the study would result in harm to the subject.  All efforts 
should be made by the investigator to retain the subject in the study.  If a subject 
withdraws prematurely from the study, a genuine effort must be made to determine the 
reason(s) the subject discontinued the study.  The reason must be recorded in the 
subject’s file and on the Study Exit Form.   
9.11 SUBJECTS LOST TO FOLLOW-UP 
Subjects who do not show up for a follow-up must be contacted to attempt to have 
them come for the follow-up.  For those subjects who cannot be reached every attempt 
should be made and documented. If a subject misses two consecutive follow-up visits 
without any contact with the study staff, the subject will be considered lost-to-follow-up 
unless there is a further communication by the subject. 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 23 of 60 
10 ADVERSE EVENTS (AES) 
Adverse Events are defined below.  Adverse events that occur in the eye during the trial, 
whether they are considered to be device related or not, must be documented in the 
subject’s records.  Date of the event, its severity, treatment (if any) and the assessed 
relationship of the event to the study device will be recorded on the Adverse Event 
Form.  Conditions which exist at the time the subject is enrolled do not need to be 
recorded as adverse events unless they increase in severity during the study. Sites 
should document any known existing medical and ophthalmic conditions at the time of 
screening. 
 
10.1 DEFINITIONS OF AE, SAE, SADE, USADE 
Adverse Event 
Any untoward medical occurrence in a subject who has been 
treated with the device that does not necessarily have causal 
relationship with the treatment. 
Adverse Device 
Effect 
Any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease that is possibly related 
to the study device. 
Serious Adverse 
Event (SAE) 
Any untoward medical occurrence that: 
• Results in death 
• Is life-threatening 
• Requires in-patient hospitalization or prolongs existing 
hospitalization 
• Necessitates medical or surgical intervention to preclude 
permanent impairment of a body function or permanent 
damage to a body structure 
• Sight threatening 
Unanticipated 
Adverse Device 
Effect 
Any serious adverse effect on health or safety, any life-
threatening problem or death caused by, or associated with a 
device if that effect, problem, or death was not previously 
identified in nature, severity, or degree of incidence in the 
clinical investigational plan; or any other serious problem 
associated with a device that relates to the rights, safety, or 
welfare of subjects (21 CFR 812.3(s)). Any sight-threatening 
event, whether listed in the protocol or not, is considered to be 
reportable as a UADE 
 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 24 of 60 
10.2 LIST OF ANTICIPATED POTENTIAL ADVERSE EVENTS 
Anticipated potential adverse events listed below include those that might reasonably be 
expected to occur in this study because they are associated with glaucoma, ab-interno 
transluminal viscoelastic delivery, trabeculotomy, and/or the risk analysis for OMNI 
System.  Adverse events may occur intra-operatively or post-operatively. 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
19 To avoid double counting an event, events of IOP ≥ 10 mmHg above baseline IOP at ≥1 month visit that 
require management with systemic medication or secondary surgical intervention should be reported 
as “IOP increase requiring management with systemic medication at ≥1 month visit” or “Need for 
secondary surgery intervention to manage IOP,” respectively. 
20 Hypotony is defined as “early” if it occurs within 2 weeks of surgery and “late” if it occurs more than 2 
weeks after surgery 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 25 of 60 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
10.3 REPORTING ADVERSE EVENTS AND UNANTICIPATED ADVERSE DEVICE EFFECTS 
Identification, collection and reporting of adverse event information is the responsibility 
of the principal investigator.  The investigator records the date of the event, its severity, 
treatment (if any) and the assessed relationship of the event to the study device on the 
Adverse Event Case Report Form (AE CRF).   
Any ocular-related serious adverse event (SAE) should be reported to the study sponsor 
within one business day of learning of the event.  Non-ocular-related SAEs should be 
reported to the study sponsor within two working days of learning of the event.  Email 
the AE CRF to OMNIsafety@sightsciences.com. 
Any unanticipated adverse device effects (UADE) must be reported to the following 
two entities: 
1. The study sponsor – Within one working day of the investigator first learning of 
the event, e-mail the AE CRF to OMNIsafety@sightsciences.com; and  
2. The reviewing IRB – As soon as possible, but no later than 10 working days after 
the investigator first learns of the event, report per the IRB’s instructions.  
The sponsor will conduct an evaluation of unanticipated adverse device effects.  If the 
sponsor determines that an unanticipated adverse device effect presents an 
unreasonable risk to subjects, parts of the investigation presenting risks will be 
terminated.  Termination will occur no later than 5 working days after the sponsor 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 26 of 60 
makes such a determination and no later than 15 working days after the sponsor first 
received notice of the effect. 
11 STATISTICAL CONSIDERATIONS 
11.1  SAMPLE SIZE CALCULATION 
The sample size calculation is based on the following statistical hypotheses and 
assumptions for the primary and secondary effectiveness endpoints. 
Primary Effectiveness Endpoint 
The statistical hypotheses for the primary effectiveness endpoint, proportion of eyes 
with a ≥ 20% reduction in unmedicated mean diurnal IOP at the 12-month 
postoperative examination (P1), are H0: P1 ≤ 0.4 and Ha: P1 > 0.4.  The performance 
goal of 0.4 is based on Ahmed et al.21  that 56% of Hydrus pseudophakic eyes had an 
outcome of 0 medications and 20% IOP reduction and 11% of 2-iStent eyes had the 
same outcome.  The average of these two reported rates of 0 medications with IOP 
reduction of ≤ 20%, 33.5%, was used for determining the performance goal of this 
study.  However, the article mentioned that 20% of 2-iStent eyes did not have the 
terminal hypotensive medications washout.  As such, the rate of 11% of the 2 iStent 
eyes might be an under-estimation of the true rate of unmedicated IOP reduction of ≤ 
20%.  Therefore, a performance goal of 40% (the closest integer larger than 33.5%) is 
used as the performance goal of the primary effectiveness endpoint of the study. 
Based on the adjusted normal distribution approach with a one-sided significance level 
of 0.025 (or two-sided 0.05), a sample size of 91 eyes with evaluable data at 12 months 
provides a statistical power of 80% at a true P1 = 0.55. 
Only the study results demonstrate that the device is effective based on the primary 
effectiveness endpoint (i.e. one-sided p-value < 0.025), the formal statistical and clinical 
conclusions for the secondary effectiveness endpoints will be performed.  Therefore, 
the overall two-sided significance level for the secondary effectiveness endpoints will be 
0.05. 
 
 
  
 
21 Iqbal Ike K. Ahmed, MD, Antonio Fea, MD, PhD, Leon Au, MBBS, et al.  A Prospective Randomized Trial 
Comparing Hydrus and iStent Microinvasive Glaucoma Surgery Implants for Standalone Treatment of 
Open-Angle Glaucoma, The COMPARE Study. Ophthalmology. 2020 Jan;127(1):52-61. 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 28 of 60 
11.2 ANALYSIS POPULATIONS 
The intent-to-treat (ITT) analysis population includes all subjects who are enrolled and 
treated, regardless of whether or not they have a protocol deviation.  The per-protocol 
analysis population (PP) is a subset of ITT, which includes all subjects who have ab-
interno transluminal viscoelastic delivery and trabeculotomy, 12 month IOP (or 
hypotensive medications washed out IOP if the medications can be washed out) and 
medication data, and have no clinically significant protocol deviations. It should be 
noted that the ITT subjects with an uneventful study procedure but with SSIs before the 
12-month visit will be included in the PP population even if they do not have the 12-
month IOP and medication data.  The primary analyses on the primary and secondary 
endpoint analyses will be carried out on the per-protocol population.  
The safety data will be summarized based on the ITT population.  The primary and 
secondary endpoint analyses will also be performed on the ITT population.  
11.3 DEMOGRAPHICS AND BASELINE CHARACTERISTICS  
Demographic variables gender, race, ethnicity, and age will be summarized for all 
enrolled subjects treated with OMNI Surgical System, along with medical history.  
Descriptive statistical summaries of pre-treatment parameters (min, max, median, 
mean, standard deviation) will also be provided. The same analyses will be performed 
for the ITT and PP populations. 
11.4 EFFECTIVENESS ENDPOINTS AND ANALYSIS METHODS 
Descriptive statistics on continuous variables will include mean, standard deviation, 
median, minimum, and maximum.  Confidence intervals for change from baseline will be 
included for selected endpoints. Categorical variables will be summarized using 
frequency counts and percentages.  Exact confidence intervals for point estimates may 
be provided.  Statistical testing will be one-sided with a significance level of 0.025 or 
two-sided significance level of 0.05 unless specify otherwise.  Data listings of individual 
subject data may be provided. 
 
As described above, the primary analyses of the primary and secondary effectiveness 
endpoints will be based on the PP population, although the analyses will also be 
performed on the ITT population.  The safety data will be summarized based on the ITT 
population. 
11.4.1 
PRIMARY EFFECTIVENESS ENDPOINT 
Proportion of eyes with a ≥ 20% decrease in unmedicated mean diurnal IOP at the 12-
month postoperative examination compared to baseline will be calculated. The binomial 
distribution will be used to derive the exact 95% confidence interval of the percent.  The 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 29 of 60 
proportion will be compared against the performance goal of 0.4 (or 40%) based on 
binomial distribution. 
 
   
For the analyses based on the ITT population, the following imputation for subjects with 
missing 12-month data but without SSI may be performed: 
• The within-eye worst IOP (collected after 3 months postoperatively or IOP at 
baseline for the subjects with no data after postoperative 3 months) for the 
missing 12-month IOP and worst number of IOP lowering medications (collected 
after 3 months postoperatively or IOP-lowering medication data at baseline for 
the subjects with no data after postoperative 3 months) for the missing 12-
month number of IOP-lowering medications. 
• The worst IOP (collected after 3 months postoperatively or IOP at baseline for 
the subjects with no data after postoperative 3 months) during the study for the 
missing 12-month IOP and worst number of IOP-lowering medications 
(collected after 3 months postoperatively or IOP-lowering medication data at 
baseline for the subjects with no data after postoperative 3 months) during the 
study for the missing 12-month number of IOP-lowering medications. 
• The mean IOP during the study for the missing 12-month IOP and mean number 
of IOP-lowering medications during the study for the missing 12-month number 
of IOP-lowering medications. 
• The last-observed-carried-forward approach. 
11.4.2 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 30 of 60 
• 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
11.4.3 
COVARIATE ANALYSIS 
The following variables will be examined for their prognostic value to the primary and 
secondary effectiveness endpoints using the PP population with the imputation used for 
the IOP-related SSIs: 
• Age group (based on observed quartiles) 
• Gender (male and female) 
• Race (White and non-White) 
• Ethnicity 
• Baseline IOP group (based on observed quartiles) 
• Screening Number of IOP-lowing medications (0, 1, 2, 3 and 4) 
Note: the grouping of medication number may be changed based on the 
observed data. 
• Study site 
 
For the primary effectiveness endpoint and the second secondary effectiveness 
endpoint, Fisher’s test will be performed.  For the first secondary effectiveness 
endpoint, one-way ANOVA with one of the factors listed above will be used to check the 
possible covariate effects.   A p-value of 0.15 will be used for evaluating the possible 
covariate effects. 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 34 of 60 
12 MONITORING PROCEDURES 
Sight Sciences or contract research organization (CRO) personnel will monitor the study 
in a manner consistent with FDA regulations, good clinical practices and the clinical 
research standards adopted by Sight Sciences.  Study monitoring will be executed using 
on-site visits, via remote means, or a combination of both, and will involve the following 
elements: 
 
• Site Qualification:  Sight Sciences or CRO personnel will meet with investigators 
and clinical study staff prior to the initiation of the study in order to review the 
adequacy of the subject population, facilities, and equipment with respect to 
the needs of the study, and to familiarize the investigator with the study 
protocol.  If Sight Sciences or the CRO have recently been involved with an 
investigator for another study, a site qualification visit may not be necessary. 
• Site Initiation:  Sight Sciences and/or CRO personnel will meet with the 
investigator(s) and clinical study staff when the site is ready to begin enrolling 
subjects in order to train them in how to properly select subjects, perform the 
study procedure, and record study data.  This visit will include, but not be 
limited to a review of the following: 
o Detailed review of the protocol 
o Informed consent procedures 
o Instructions for the surgical procedure 
o Records and reports 
• Interim Monitoring:  Sight Sciences or CRO personnel will conduct routine visits 
either remotely or in-person, during the course of the study to review charts, 
perform source document verification, ensure proper adherence to the study 
protocol, and to review regulatory documents.  Interim monitoring visits and 
telephone consultation will occur as necessary during the course of the study 
to ensure the proper progress and documentation of the study findings. 
• Study Close Out Visit:  At the conclusion of the trial there will be a study 
closure visit during which several actions, including but not limited to the 
following, will be performed: 
o A final inspection of the study binder 
o Accountability and return of all devices and non-consumable ancillary 
study supplies to the sponsor 
o Discussion of record retention requirements with the investigator 
o Close-out notification to the IRB   

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 35 of 60 
13 DATA AND QUALITY MANAGEMENT 
13.1 DATABASE MANAGEMENT 
The study database will be designed using an electric data capture (EDC) system that is 
compliant with 21 CFR Part 11 and relevant guidance documents.  The EDC will be 
developed and maintained by an independent, qualified data management firm. 
 
The database will incorporate time-stamped audit trails, protection of human subjects, 
restricted access, and data security at the component level.  Each database module, 
including each individual eCRF, will be validated by conducting a series of standard tests 
that demonstrate usability and correctness of the database system.  The database will 
be maintained on an ongoing basis and will be routinely backed up.  
13.2 SUBJECT IDENTIFICATION 
The subjects will be identified by a six-digit subject number composed of a double-digit 
study identification number, a two-digit center identification number followed by a two 
to three-digit sequential subject number.  A subject identification number will be 
assigned after informed consent is obtained.  This will ensure that subject information 
contained in the study records is de-identified of personal information and kept 
confidential. 
13.3 SUBJECT ACCOUNTABILITY 
All subjects enrolled and treated in this clinical investigation shall be monitored for the 
duration of the investigation. The clinical investigation shall be considered completed 
when all subjects that have been enrolled in the investigation have reached the final 
reporting period, excluding subjects who were withdrawn.   
13.4 CONFIDENTIALITY 
All medical records associated with the clinical investigation will be made available for 
review by Sight Sciences personnel, its contract research organization (CRO) and 
governmental/regulatory agencies involved.  The results of the study may be published 
in the future for scientific and marketing purposes, but the identity of each subject will 
not be revealed.  All records will be stored in a secure area at the investigator’s facility, 
the CRO, the data management firm and at Sight Sciences, Inc per each organization’s 
own SOPs. 
13.5 SOURCE DATA AND CASE REPORT FORMS 
Source data will be entered into a validated electronic system at each site by trained 
personnel in accordance with 21 CFR Part 11 requirements.  Electronic entries will be 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 36 of 60 
100% verified against corresponding source data at the sites and queried/corrected if 
needed to the extent possible.  Medical site records serve as source data.  In addition, 
data that are collected exclusively for the purpose of this study and not normally 
recorded in the subjects’ medical records can be collected directly on the study 
worksheets provided by the sponsor and these study worksheets will serve as the 
source data.   
 
Source data and study worksheets are to be maintained at the site in the subject 
records or in the medical records.  All data entries must be made in accordance with 
ALCOA standards and GDP. 
13.6 RETENTION PERIOD 
Clinical sites are to retain any and all clinical trial material (documentation, photographs, 
etc.) for a period of two years from the date a marketing application is approved or two 
years after the investigation has been discontinued, or as directed by their institutional 
document retention requirements, whichever is the longest.  After that time, the items 
must be returned to Sight Sciences for archiving.   
14 PROTOCOL MODIFICATIONS AND DEVIATIONS 
Protocol modifications may occur during the study.   Each will be approved by the 
sponsor before implementation. Each will undergo Institutional Review Board (IRB) 
review and approval, as necessary. 
 
Any deviations from this protocol intended to protect the life or physical well-being of a 
subject in an emergency are to be reported to Sight Sciences, Inc. as well as the IRB as 
soon as possible, and no later than 5 working days after the emergency occurred. 
 
All protocol deviations will be documented using the Protocol Deviation form. 
15 DEVICE FAILURES AND MALFUNCTIONS 
All device failures or malfunctions should be recorded on the Customer Experience Form 
and reported to Sight Sciences Customer Service (877-266-1144). 
16 ETHICAL CONSIDERATIONS 
16.1 DECLARATION OF HELSINKI 
This study shall be conducted in accordance with the Declaration of Helsinki (Appendix 
D).   

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 37 of 60 
16.2 INSTITUTIONAL REVIEW BOARDS (IRB) 
The study shall not begin at a site until approval has been obtained from the reviewing 
IRB.  It is the Investigators’ responsibility to obtain and maintain written approval of the 
study protocol and Informed Consent documents from the appropriate IRB.  It is also the 
Investigators’ responsibility to notify that body about any amendments to these 
documents and to follow the IRBs rules regarding the reporting of Adverse Events and 
Protocol Deviations related to the device and/or this study.  Copies of all written 
approvals (identifying the study, the submitted and approved documents and the date 
reviewed) and the approved versions of the documents must be provided to Sight 
Sciences or its CRO.  
 
The Investigators must file all correspondence with the IRB and forward copies of such 
correspondence to Sight Sciences. 
16.3 INFORMED CONSENT DOCUMENT (ICD) 
An Informed Consent template that covers all protocol procedures and follows GCP 
Guidelines will be prepared by Sight Sciences and made available to each Investigator.  
The Investigator may adapt these templates to the requirements of the local IRB and of 
the institution where the study is conducted, but any revisions made to the ICD must be 
submitted to the sponsor for review prior to submission to the IRB.  A copy of each IRB-
approved ICD version is to be made available to Sight Sciences and its CRO.  The 
approved, IRB-stamped ICD is to be kept in its full length in the study Regulatory Binder.  
Original, signed ICDs are to be maintained in study records and must be made available 
for monitoring review.  
16.4 PUBLIC LISTING OF STUDY 
The study will be listed on the NIH website www.clinicaltrials.gov.  
17 STUDY ADMINISTRATION 
17.1 EARLY TERMINATION OR SUSPENSION OF THE STUDY OR AN INVESTIGATIONAL SITE 
Sight Sciences may terminate the study, in which case the investigators and associated 
IRBs will be notified in writing.  Possible reasons for study termination include but are 
not limited to: 
 
• The discovery of an unexpected, significant, or unacceptable risk to the study 
subjects implanted with the device 
• Withdrawal of FDA clearance of the OMNI device. 
• Insufficient enrollment in the study 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 38 of 60 
• The Sponsor determines that enough data has been collected for the study, and 
no further data are needed.  
 
Sight Sciences reserves the right to stop the study at a particular site any time after the 
initiation visit if there have been no subject enrollments or if there have been significant 
protocol deviations/violations at the site.     
 
Likewise, a principal investigator may terminate the study at his/her institution.  This 
decision must be followed by written notification to Sight Sciences within five working 
days, stating the reasons for termination. 
 
If the study is terminated, every effort should be made to obtain final follow-up from all 
subjects.   
 
In the event that there are significant human use issues with the device, the investigator 
will be consulted to make a determination of whether the study should be terminated 
or not. 
17.2 INVESTIGATOR RESPONSIBILITIES 
17.2.1 
GENERAL RESPONSIBILITIES OF INVESTIGATORS 
An Investigator is responsible for ensuring that an investigation is conducted according 
to the signed agreement, the investigational plan and applicable FDA regulations, for 
protecting the rights, safety, and welfare of subjects under the Investigator’s care, and 
for the control of devices under investigation. An Investigator also is responsible for 
ensuring that informed consent is obtained in accordance with 21 CFR part 50. 
17.2.2 
SPECIFIC RESPONSIBILITIES OF INVESTIGATORS 
1. 
Awaiting approval - An Investigator may determine whether potential subjects 
would be interested in participating in an investigation, but shall not request the 
written informed consent of any subject to participate, and shall not allow any 
subject to participate before obtaining IRB approval. 
2. 
Subject Qualification -The Investigator is responsible for ensuring that all subjects 
entering the study conform to the subject selection criteria. 
3. 
Compliance - An Investigator shall conduct an investigation in accordance with the 
signed agreement with the Sponsor, the investigational plan, all applicable FDA 
regulations, and any conditions of approval imposed by an IRB. 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 39 of 60 
17.2.3 
INVESTIGATOR RECORDS 
A participating Investigator shall maintain the following accurate, complete, and current 
records relating to the Investigator’s participation in an investigation for the period 
specified in Section 13.6:  
1. 
All correspondence with another Investigator, an IRB, the Sponsor, a clinical 
research associate (CRA) or monitor, or FDA, including required reports. 
2. 
Records of each subject’s case history and exposure to the device. Case histories 
include the study CRF’s/worksheets and supporting data including, for example, 
signed and dated consent forms and medical records.  Such records shall include: 
a) 
Documents evidencing informed consent. 
b) All relevant observations, including records concerning adverse device effects 
(whether anticipated or unanticipated), information and data on the condition 
of each subject upon entering, and during the course of, the investigation, 
including information about relevant previous medical history and the results 
of all diagnostic tests. 
3. 
The protocol, with documents showing the dates and reasons for each deviation 
from the protocol. 
4. 
Any other records that FDA requires to be maintained by regulation or by specific 
requirement for a category of investigations or a particular investigation. 
17.2.4 
INVESTIGATOR REPORTS 
An Investigator shall prepare and submit the following complete, accurate, and timely 
reports: 
1. 
Unanticipated Adverse Device Effects - An Investigator shall submit to the Sponsor 
and to the reviewing IRB a report of any unanticipated adverse device effect 
occurring during an investigation as soon as possible, but in no event later than 10 
working days after the Investigator first learns of the effect. 
2. 
Withdrawal of IRB Approval - An Investigator shall report to the Sponsor, within 5 
working days, a withdrawal of approval by the reviewing IRB of the Investigator’s 
part of an investigation. 
3. 
Progress - An Investigator shall submit progress reports on the investigation to the 
Sponsor, the monitor, and the reviewing IRB at regular intervals, but in no event 
less often than yearly. 
4. 
Deviations from the Investigational Plan - An Investigator shall document and 
report to the Sponsor any deviation from the investigational plan.  
5. 
Informed Consent - If an Investigator enrolls a subject without obtaining informed 
consent, the Investigator shall report such use to the Sponsor and the reviewing 
IRB within 5 working days after the use occurs. 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 40 of 60 
6. 
Final Report - An Investigator shall, within 3 months after termination or 
completion of the investigation or the Investigator’s part of the investigation, 
submit a final report to the Sponsor and the reviewing IRB. 
7. 
Other - An Investigator shall, upon request by a reviewing IRB or FDA, provide 
accurate, complete, and current information about any aspect of the investigation. 
17.3 INVESTIGATOR AGREEMENT 
The principal investigators in each center shall agree to the clinical protocol and any 
amendments and indicate their approval and agreement by signing and dating the cover 
page of the study protocol and the Investigator Responsibility Agreement. 
18 PUBLICATION POLICY 
Sight Sciences recognizes the value of disseminating research results.  It is understood 
that the Study is part of the Multi-Center Clinical Trial and publication of results is 
expected.  This publications policy applies to journal articles, conference abstracts, and 
conference presentations (posters and slides) covering Sight Sciences-sponsored clinical 
studies.  This policy is in addition to any arrangement contained in the Clinical Trial 
Agreement between Sight Sciences and the investigator.  
 
Multi-Site Data 
Clinical site investigators are encouraged to propose publications and abstracts that 
include clinical or research data from multiple clinical sites; such projects will be 
coordinated by Sight Sciences.  Authorship of papers and abstracts resulting from these 
projects will be determined collaboratively according to the following guidelines:  
 
• The first author on such publications will be the person who primarily wrote the 
paper and took the lead on the research.  In the case of clinical trial papers 
where all authors contributed equally, authorship order may be based on site 
enrollment or other criteria at Sight Sciences’ discretion. 
• Other authors include those who significantly contributed to the specific work.   
• At least one person from each clinical site whose study subjects appear in the 
work will be acknowledged in the manuscript/presentation in some way, either 
as an author group member, a non-author contributor, or listed in the 
acknowledgements, depending on the particular policies of the journal or 
conference. 
 
Single Site Data 
After publication of the multi-center study results in a peer-reviewed journal, or if 
Sponsor has not submitted a manuscript for publication in a peer-reviewed journal 
within twelve (12) months after the study has been completed, whichever occurs first, 
Investigators may publish the results of the Study generated by the Investigator, subject 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 41 of 60 
to the obligations of the Clinical Trial Agreement between Sight Sciences and the 
Investigator, and the prior approval of Sponsor in writing.   
 
Publications Review Policy 
Investigators must submit all presentations, posters, abstracts and manuscripts 
pertaining to this study to Sight Sciences for review in advance of their submission.  
Sight Sciences conducts this review to protect its proprietary rights to information, 
inventions, or products developed under the Study.  Please use the following guideline 
to determine the absolute minimum advance time for submitting an item to Sight 
Sciences for review: 
 
• Presentations/Posters: 5 business days in advance of presentation 
• Abstracts: 5 business days in advance of submission 
• Manuscripts: 30 calendar days in advance of submission for publication 
 
In accordance with the Clinical Trial Agreement, these items must receive written 
approval from Sight Sciences in order for them to be submitted or presented.  If an item 
is not received in the timeframe listed above, approval may not be granted due to 
insufficient time for considered review. In addition, since most of our Clinical Trial 
Agreements require that Sight Sciences has 60 days to review publications, Sight 
Sciences reserves the rights granted in those Agreements if circumstances require a 
longer review. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 42 of 60 
19 BIBLIOGRAPHY 
1.   Tham YC, Li X, Wong TY, et al. Global prevalence of glaucoma and projections of 
glaucoma burden through 2040: a systematic review and meta-analysis. 
Ophthalmology. 2014;121:2081–2090. 
2.   European Glaucoma Society. Terminology and guidelines for glaucoma 4th 
edition Savona, Italy: Editrice PubliComm, 2014. 
3.   Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, et al. The Ocular 
Hypertension Treatment Study: a randomized trial determines that topical ocular 
hypotensive medication delays or prevents the onset of primary open-angle 
glaucoma. Arch Ophthalmol. 2002; 120:701–713. 
4.   Kenji Inoue. Managing adverse effects of glaucoma medications. Clin 
Ophthalmol. 2014; 8: 903–913. Published online 2014 May 12. doi:  
10.2147/OPTH.S44708. 
5.   Newman-Casey PA, Robin AL, Blachley T, Farris K, Heisler M, Resnicow K, Lee 
PP. The Most Common Barriers to Glaucoma Medication Adherence: A Cross-
Sectional Survey. Ophthalmology. 2015 Jul; 122(7):1308-16. 
6. Gedde SJ, Singh K, Schiffman JC, Feuer WJ. The Tube Versus Trabeculectomy 
Study: interpretation of results and application to clinical practice. Curr Opin 
Ophthalmol. 2012 Mar; 23(2):118-26. 
7.   Zahid S, Musch DC, Niziol LM, Lichter PR, Collaborative Initial Glaucoma 
Treatment Study Group. Risk of endophthalmitis and other long-term 
complications of trabeculectomy in the Collaborative Initial Glaucoma Treatment 
Study (CIGTS). Am J Ophthalmol. 2013 Apr; 155(4):674-680, 680.e1. 
8.   American Academy of Ophthalmology. Preferred practice pattern®. Primary 
open-angle glaucoma. San Francisco, CA. 2015. 
9.   Klink T, Sauer J, Körber NJ, et al. Quality of life following glaucoma surgery: 
canaloplasty versus trabeculectomy. Clin Ophthalmol. 2014;18;9:7-16. 
10.   Lewis RA, von Wolff K, Tetz M, Körber NJ, Kearney JR, Shingleton B, Samuelson 
TW. Canaloplasty: circumferential viscodilation and tensioning of Schlemm’s 
canal using a flexible microcatheter for the treatment of open-angle glaucoma in 
adults: interim clinical study analysis. J Cataract Refract Surg 2007; 33:1217–1226 
11.   Grover DS, Godfrey DG, Smith O, Feuer WJ, Montes de Oca, Fellman RL.  
Gonioscopy-Assisted Transluminal Trabeculotomy, A Novel Ab Interno 
Trabeculotomy:  technique report and preliminary results. Ophthalmology. 2014; 
121:855-861. 
12.   Clara Martinez‐Rubio, Ioan Alexandru Placinta, Rodrigo Molina‐Pallete, Paula 
Martínez Lopez‐Corell, Jorge Vila‐Arteaga. OMNI‐an initial experience with a new 
surgical glaucoma treatment device. ESCRS 2018. 
13.   Iwona Grabska‐Liberek, Julita Majszyk‐Ionescu, Agnieszka Skowyra, Monika 
Rogowska, Anna Plichta, Patrycja Duda, Ingrid Kane OMNI 360TM in Open‐Angle 
Glaucoma Treatment: A 6‐month Follow‐up. ESCRS 2018. 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 43 of 60 
14.   Paula Martínez Lopez‐Corell, Rodrigo Molina‐Pallete, Clara Martinez‐Rubio, Ioan 
Alexandru Placinta, Jorge Vila‐Arteaga Procedural Steps For OMNI, A New 
Surgical Technique For Glaucoma Treatment, In Combination With Cataract 
Surgery ESCRS 2018. 
15.   Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, 
Mariotti SP Bull World Health Organ. Global data on visual impairment. 2016 
Nov; 82(11):844-51. 
16.   Bourne RRA, Stevens GA, White RA, et al. Causes of vision loss worldwide, 1990-
2010: a systematic analysis. Lancet Glob Heal. 2013;1:339–349. 
17.   Francis BA, Berke SJ, Dustin L, et al. Endoscopic cyclophotocoagulation 
combined with phacoemulsification versus phacoemulsification alone in 
medically controlled glaucoma. J Cataract Refract Surg. 2014;40:1313–1321. 
18.   Arthur SN, Cantor LB, Wudunn D, et al. Efficacy, Safety, and Survival Rates of 
IOP-lowering Effect of Phacoemulsification Alone or Combined With 
Canaloplasty in Glaucoma Patients. Journal of Glaucoma. 2013;23:316–320. 
19.   Armstrong JJ, Wasiuta T, Kiatos E, Malvankar-Mehta M, Hutnik CML. The Effects 
of Phacoemulsification on Intraocular Pressure and Topical Medication Use in 
Patients With Glaucoma: A Systematic Review and Meta-analysis of 3-Year Data. 
J Glaucoma. 2017 Jun;26(6):511-522. doi: 10.1097/IJG.0000000000000643. 
Review. 
20.   Samuelson TW, Chang DF, Marquis R, Flowers B, Lim KS, Ahmed IIK, Jampel HD, 
Aung T, Crandall AS, Singh K; HORIZON Investigators. A Schlemm Canal 
Microstent for Intraocular Pressure Reduction in Primary Open-Angle Glaucoma 
and Cataract: The HORIZON Study. Ophthalmology. 2018 Jun 23. pii: S0161-
6420(17)33810-1. doi: 10.1016/j.ophtha.2018.05.012. 
21.   Zhang ML, Hirunyachote P, and Jampel H. Combined surgery versus cataract 
surgery alone for eyes with cataract and glaucoma. Cochrane Database Syst Rev. 
2015; 7: CD008671 
22.   https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170043b.pdf 
23.   Vold S, Ahmed II, Craven ER, Mattox C, Stamper R, Packer M, Brown RH, 
Ianchulev T; CyPass Study Group. Two-Year COMPASS Trial Results: Supraciliary 
Microstenting with Phacoemulsification in Patients with Open-Angle Glaucoma 
and Cataracts. Ophthalmology. 2016 Oct;123(10):2103-12. doi: 
10.1016/j.ophtha.2016.06.032. 
24.   Grabska-Liberek I, et al.  OMNI 360 in Open-Angle Glaucoma Treatment:  A 6-
Month Follow-Up.  European Society of Cataract & Refractive Surgeons (ESCRS) 
2018.   
25.   Martinez‐Rubio, et al. OMNI‐an initial experience with a new surgical glaucoma 
treatment device. European Society of Cataract & Refractive Surgeons (ESCRS) 
2018. 
 
 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 44 of 60 
20 APPENDIX A – METHODS FOR EXAMS, TESTS AND QUESTIONNAIRES 
20.1 LIST OF STUDY PROCEDURES 
1. Informed Consent 
2. Demographics, Medical & Ocular History 
3. Medication Log 
4. 
 
5. BCVA 
6. 
 
7. IOP (Goldmann Tonometry) 
8. Unmedicated Diurnal IOP 
9. Slit Lamp Exam 
10. Gonioscopy  
11. Dilated Fundus Exam/C:D Ratio 
12. Eligibility Assessment 
13. 
 
14. AE Assessment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 46 of 60 
 
 
 
 
 
 
 
   
 
  
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
1. 
 
 
 
 
 
  
 
 
 
 
 
 
 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 47 of 60 
4. 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
7. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 52 of 60 
 
 
 
Posterior Capsule Opacification 
As a routine part of the slit lamp examination, posterior capsule opacification (PCO) will 
be evaluated using the following scale: 
 
 
 
 
 
 
 
 
 
 
 
NONE 
Minimal (Top left image) 
Mild (Top right image) 
Moderate (bottom left 
image) 
Severe (bottom right image) 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 53 of 60 
 
Other Slit Lamp Findings (complete for each finding) 
• 
Trace 
• 
Mild 
• 
Moderate 
• 
Severe 
 
 
 
 
 
 
 
 
 
 
 
20.9 OCULAR HYPOTENSIVE MEDICATIONS 
Each ocular hypotensive medication will be recorded on the study record.  If subjects 
are taking combination medications such as Cosopt this is to be counted as two 
medications even though this is only in 1 bottle. 
21 APPENDIX B - DECLARATION OF HELSINKI 
I. 
PREAMBLE 
 
1. 
The World Medical Association (WMA) has developed the Declaration of 
Helsinki as a statement of ethical principles for medical research involving 
human subjects, including research on identifiable human material and data. 
 
The Declaration is intended to be read as a whole and each of its constituent 
paragraphs should be applied with consideration of all other relevant 
paragraphs. 
 
2. 
Consistent with the mandate of the WMA, the Declaration is addressed 
primarily to physicians. The WMA encourages others who are involved in 
medical research involving human subjects to adopt these principles. 
 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 54 of 60 
II. 
GENERAL PRINCIPLES 
 
1. 
The Declaration of Geneva of the WMA binds the physician with the words, 
“The health of my patient will be my first consideration,” and the International 
Code of Medical Ethics declares that, “A physician shall act in the patient's best 
interest when providing medical care.” 
 
2. 
It is the duty of the physician to promote and safeguard the health, well-being 
and rights of patients, including those who are involved in medical research. 
The physician's knowledge and conscience are dedicated to the fulfilment of 
this duty. 
 
3. 
Medical progress is based on research that ultimately must include studies 
involving human subjects. 
 
4. 
The primary purpose of medical research involving human subjects is to 
understand the causes, development and effects of diseases and improve 
preventive, diagnostic and therapeutic interventions (methods, procedures 
and treatments). Even the best proven interventions must be evaluated 
continually through research for their safety, effectiveness, efficiency, 
accessibility and quality. 
 
5. 
Medical research is subject to ethical standards that promote and ensure 
respect for all human subjects and protect their health and rights. 
 
6. 
While the primary purpose of medical research is to generate new knowledge, 
this goal can never take precedence over the rights and interests of individual 
research subjects. 
7. 
It is the duty of physicians who are involved in medical research to protect the 
life, health, dignity, integrity, right to self-determination, privacy, and 
confidentiality of personal information of research subjects. The responsibility 
for the protection of research subjects must always rest with the physician or 
other health care professionals and never with the research subjects, even 
though they have given consent. 
 
8. 
Physicians must consider the ethical, legal and regulatory norms and standards 
for research involving human subjects in their own countries as well as 
applicable international norms and standards. No national or international 
ethical, legal or regulatory requirement should reduce or eliminate any of the 
protections for research subjects set forth in this Declaration. 
 
9. 
Medical research should be conducted in a manner that minimizes possible 
harm to the environment. 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 55 of 60 
 
10. Medical research involving human subjects must be conducted only by 
individuals with the appropriate ethics and scientific education, training and 
qualifications. Research on patients or healthy volunteers requires the 
supervision of a competent and appropriately qualified physician or other 
health care professional. 
 
11. Groups that are underrepresented in medical research should be provided 
appropriate access to participation in research. 
 
12. Physicians who combine medical research with medical care should involve 
their patients in research only to the extent that this is justified by its potential 
preventive, diagnostic or therapeutic value and if the physician has good 
reason to believe that participation in the research study will not adversely 
affect the health of the patients who serve as research subjects. 
 
13. Appropriate compensation and treatment for subjects who are harmed as a 
result of participating in research must be ensured. 
 
III. 
RISKS, BURDENS AND BENEFITS 
 
• 
In medical practice and in medical research, most interventions involve risks 
and burdens. 
 
Medical research involving human subjects may only be conducted if the 
importance of the objective outweighs the risks and burdens to the research 
subjects. 
 
• 
All medical research involving human subjects must be preceded by careful 
assessment of predictable risks and burdens to the individuals and groups 
involved in the research in comparison with foreseeable benefits to them and 
to other individuals or groups affected by the condition under investigation. 
 
Measures to minimize the risks must be implemented. The risks must be 
continuously monitored, assessed and documented by the researcher. 
 
• 
Physicians may not be involved in a research study involving human subjects 
unless they are confident that the risks have been adequately assessed and can 
be satisfactorily managed. 
 
When the risks are found to outweigh the potential benefits or when there is 
conclusive proof of definitive outcomes, physicians must assess whether to 
continue, modify or immediately stop the study. 
 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 56 of 60 
IV. 
VULNERABLE GROUPS AND INDIVIDUALS 
 
• 
Some groups and individuals are particularly vulnerable and may have an 
increased likelihood of being wronged or of incurring additional harm. 
 
All vulnerable groups and individuals should receive specifically considered 
protection. 
 
• 
Medical research with a vulnerable group is only justified if the research is 
responsive to the health needs or priorities of this group and the research 
cannot be carried out in a non-vulnerable group. In addition, this group should 
stand to benefit from the knowledge, practices or interventions that result 
from the research. 
 
V. 
SCIENTIFIC REQUIREMENTS AND RESEARCH PROTOCOLS 
 
• 
Medical research involving human subjects must conform to generally 
accepted scientific principles, be based on a thorough knowledge of the 
scientific literature, other relevant sources of information, and adequate 
laboratory and, as appropriate, animal experimentation. The welfare of 
animals used for research must be respected. 
 
• 
The design and performance of each research study involving human subjects 
must be clearly described and justified in a research protocol. 
 
The protocol should contain a statement of the ethical considerations involved 
and should indicate how the principles in this Declaration have been 
addressed. The protocol should include information regarding funding, 
sponsors, institutional affiliations, potential conflicts of interest, incentives for 
subjects and information regarding provisions for treating and/or 
compensating subjects who are harmed as a consequence of participation in 
the research study. 
 
In clinical trials, the protocol must also describe appropriate arrangements for 
post-trial provisions. 
 
VI. 
RESEARCH ETHICS COMMITTEES 
 
• 
The research protocol must be submitted for consideration, comment, 
guidance and approval to the concerned research ethics committee before the 
study begins. This committee must be transparent in its functioning, must be 
independent of the researcher, the sponsor and any other undue influence and 
must be duly qualified. It must take into consideration the laws and regulations 
of the country or countries in which the research is to be performed as well as 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 57 of 60 
applicable international norms and standards but these must not be allowed to 
reduce or eliminate any of the protections for research subjects set forth in 
this Declaration. 
 
The committee must have the right to monitor ongoing studies. The researcher 
must provide monitoring information to the committee, especially information 
about any serious adverse events. No amendment to the protocol may be 
made without consideration and approval by the committee. After the end of 
the study, the researchers must submit a final report to the committee 
containing a summary of the study’s findings and conclusions. 
 
VII. PRIVACY AND CONFIDENTIALITY 
 
• 
Every precaution must be taken to protect the privacy of research subjects and 
the confidentiality of their personal information. 
 
 
VIII. INFORMED CONSENT 
 
• 
Participation by individuals capable of giving informed consent as subjects in 
medical research must be voluntary. Although it may be appropriate to consult 
family members or community leaders, no individual capable of giving 
informed consent may be enrolled in a research study unless he or she freely 
agrees. 
 
• 
In medical research involving human subjects capable of giving informed 
consent, each potential subject must be adequately informed of the aims, 
methods, sources of funding, any possible conflicts of interest, institutional 
affiliations of the researcher, the anticipated benefits and potential risks of the 
study and the discomfort it may entail, post-study provisions and any other 
relevant aspects of the study. The potential subject must be informed of the 
right to refuse to participate in the study or to withdraw consent to participate 
at any time without reprisal. Special attention should be given to the specific 
information needs of individual potential subjects as well as to the methods 
used to deliver the information. 
 
After ensuring that the potential subject has understood the information, the 
physician or another appropriately qualified individual must then seek the 
potential subject’s freely-given informed consent, preferably in writing. If the 
consent cannot be expressed in writing, the non-written consent must be 
formally documented and witnessed. 
 
All medical research subjects should be given the option of being informed 
about the general outcome and results of the study. 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 58 of 60 
 
• 
When seeking informed consent for participation in a research study the 
physician must be particularly cautious if the potential subject is in a 
dependent relationship with the physician or may consent under duress. In 
such situations the informed consent must be sought by an appropriately 
qualified individual who is completely independent of this relationship. 
 
• 
For a potential research subject who is incapable of giving informed consent, 
the physician must seek informed consent from the legally authorized 
representative. These individuals must not be included in a research study that 
has no likelihood of benefit for them unless it is intended to promote the 
health of the group represented by the potential subject, the research cannot 
instead be performed with persons capable of providing informed consent, and 
the research entails only minimal risk and minimal burden. 
 
• 
When a potential research subject who is deemed incapable of giving informed 
consent is able to give assent to decisions about participation in research, the 
physician must seek that assent in addition to the consent of the legally 
authorized representative. The potential subject’s dissent should be respected. 
 
• 
Research involving subjects who are physically or mentally incapable of giving 
consent, for example, unconscious patients, may be done only if the physical or 
mental condition that prevents giving informed consent is a necessary 
characteristic of the research group. In such circumstances the physician must 
seek informed consent from the legally authorized representative. If no such 
representative is available and if the research cannot be delayed, the study 
may proceed without informed consent provided that the specific reasons for 
involving subjects with a condition that renders them unable to give informed 
consent have been stated in the research protocol and the study has been 
approved by a research ethics committee. Consent to remain in the research 
must be obtained as soon as possible from the subject or a legally authorized 
representative. 
 
• 
The physician must fully inform the patient which aspects of their care are 
related to the research. The refusal of a patient to participate in a study or the 
patient’s decision to withdraw from the study must never adversely affect the 
patient-physician relationship. 
 
• 
For medical research using identifiable human material or data, such as 
research on material or data contained in biobanks or similar repositories, 
physicians must seek informed consent for its collection, storage and/or reuse. 
There may be exceptional situations where consent would be impossible or 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 59 of 60 
impracticable to obtain for such research. In such situations the research may 
be done only after consideration and approval of a research ethics committee. 
 
IX. 
USE OF PLACEBO 
 
• 
The benefits, risks, burdens and effectiveness of a new intervention must be 
tested against those of the best proven intervention(s), except in the following 
circumstances: 
 
Where no proven intervention exists, the use of placebo, or no intervention, is 
acceptable; or 
 
Where for compelling and scientifically sound methodological reasons the use 
of any intervention less effective than the best proven one, the use of placebo, 
or no intervention is necessary to determine the efficacy or safety of an 
intervention 
 
and the patients who receive any intervention less effective than the best 
proven one, placebo, or no intervention will not be subject to additional risks 
of serious or irreversible harm as a result of not receiving the best proven 
intervention. 
 
Extreme care must be taken to avoid abuse of this option. 
 
X. 
POST-TRIAL PROVISIONS 
 
• 
In advance of a clinical trial, sponsors, researchers and host country 
governments should make provisions for post-trial access for all participants 
who still need an intervention identified as beneficial in the trial. This 
information must also be disclosed to participants during the informed consent 
process. 
 
XI. 
RESEARCH REGISTRATION AND PUBLICATION AND DISSEMINATION OF RESULTS 
 
• 
Every research study involving human subjects must be registered in a publicly 
accessible database before recruitment of the first subject. 
 
• 
Researchers, authors, sponsors, editors and publishers all have ethical 
obligations with regard to the publication and dissemination of the results of 
research. Researchers have a duty to make publicly available the results of 
their research on human subjects and are accountable for the completeness 
and accuracy of their reports. All parties should adhere to accepted guidelines 
for ethical reporting. Negative and inconclusive as well as positive results must 
be published or otherwise made publicly available. Sources of funding, 

Study of OMNI System in POAG 
Protocol #06807 Rev C 
CONFIDENTIAL 
Sight Sciences 
 
Page 60 of 60 
institutional affiliations and conflicts of interest must be declared in the 
publication. Reports of research not in accordance with the principles of this 
Declaration should not be accepted for publication. 
 
XII. UNPROVEN INTERVENTIONS IN CLINICAL PRACTICE 
 
In the treatment of an individual patient, where proven interventions do not exist, 
or other known interventions have been ineffective, the physician, after seeking 
expert advice, with informed consent from the patient or a legally authorized 
representative, may use an unproven intervention if in the physician's judgment it 
offers hope of saving life, re-establishing health or alleviating suffering. This 
intervention should subsequently be made the object of research, designed to 
evaluate its safety and efficacy. In all cases, new information must be recorded 
and, where appropriate, made publicly available.