Systane® Ultra Preservative Free Lubricant Eye Drops
Phase: NA
Conditions: Dry Eye
Sponsor: Alcon Research

 
 
 
 
 
Systane® Ultra Preservative Free Lubricant Eye Drops 
 
 
STUDY ID  
DEU894-I001 
 
 
PROTOCOL 
 
 
NCT05902364 

 
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Systane® Ultra Preservative Free Lubricant Eye Drops 
Version 2.0 / 03 November 2023 
Sponsor: 
Alcon Research LLC 
6201 South Freeway 
Fort Worth, Texas 76134 
 
Study Device: 
Systane® Ultra Preservative Free Lubricant Eye Drops 
 
 
Protocol Identifiers: 
DEU894-I001 
 
 
Sponsor Approval: 
 
_________________________________________ 
____________________ 
 
Date 
 
_________________________________________ 
____________________ 
 
Date 
 
CONFIDENTIAL 
This document is confidential and the property of Alcon Research LLC. This document contains 
confidential information and is limited in its distribution to Investigators, Ethics Committees and 
Competent Authorities only. Copying of the confidential information is not permitted without the 
written approval of the Sponsor. 

 
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STATEMENT OF COMPLIANCE 
This document is a protocol for a human research study. This study will be conducted in 
accordance with ethical principles that have their origin in the Declaration of Helsinki and 
according to International standards of Good Clinical Practice, applicable government regulations 
and Institutional research policies and procedures. 
All individuals responsible for the design and conduct of this study have completed Human 
Subjects Protection Training and are qualified to be conducting this research prior to the 
enrollment of any subjects. 
As Principal Investigator, I agree to conduct this clinical study in accordance with the design and 
specific provisions of this protocol. Modifications to the study are acceptable only with an 
approved protocol amendment. I agree to obtain approval from the Institutional Review Board 
(IRB)/Independent Ethics Committee (IEC) and/or regulatory bodies of competent jurisdiction, 
for the protocol and informed consent before initiating the study, to obtain consent from subjects 
prior to their enrollment in the study, to collect and record data as required by this protocol and 
case report forms, to prepare adverse event and study reports as required by this protocol, to 
provide documentation of my experience and qualifications to the Sponsor, to disclose any relevant 
financial interests or agreements related to the Sponsor or the investigation and to maintain study 
documentation for the period of time required. 
I agree to personally conduct or supervise the described investigation. I agree to maintain adequate 
and accurate records and to make those records available for inspection by the Sponsor, its 
representatives, applicable regulatory authorities, and the IRB/IEC. I agree to ensure that the 
confidential information contained in this document will not be used for any other purpose other 
than the evaluation or conduct of the clinical investigation without the prior written consent of the 
Sponsor. 
I certify that I have not been terminated from an investigation due to compliance failure 
(debarment). 
 
_________________________________________ 
____________________ 
Signature 
Date (DD MMM YYYY) 
 
_________________________________________ 
Print Name/Title of Principal Investigator 

 
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CONFIDENTIALITY STATEMENT 
The information contained in this document, especially unpublished data, is the property of 
Sponsor and therefore is confidential and may not be disclosed unless such disclosure is required 
by law or regulation. That Sponsor confidential information may be disclosed to the 
Investigator(s), potential Investigator(s) and necessary Investigator assistant(s) or study personnel. 
In any event, persons to whom the information is disclosed must be informed that the information 
is privileged or confidential and may not be further disclosed by them without written authorization 
from Sponsor. These restrictions on disclosure will apply equally to all future information supplied 
to the Investigator(s), potential Investigator(s) and necessary Investigator assistant(s) or study 
personnel, which is indicated as privileged or confidential. 
 

 
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Clinical Study Protocol 
TABLE OF CONTENTS 
Statement of Compliance ................................................................................................................ 2 
 
Confidentiality Statement ............................................................................................................... 4 
Table of Contents ............................................................................................................................ 5 
List of Tables .................................................................................................................................. 7 
List of Figures ................................................................................................................................. 7 
Study Synopsis ................................................................................................................................ 8 
Abbreviations ................................................................................................................................ 10 
1 
Study Contact Information .................................................................................................... 11 
1.1 
Sponsor Contact Information .......................................................................................... 11 
1.2 
Coordinating Principal Investigator Contact Information ............................................... 11 
1.3 
Key Study Personnel ....................................................................................................... 11 
1.3.1 
Clinical Study Monitor ........................................................................................... 11 
1.3.2 
Global Medical Safety ............................................................................................ 11 
1.3.3 
Statistician ............................................................................................................... 11 
2 
Introduction / Background and Rationale .............................................................................. 12 
3 
Study Device Description ...................................................................................................... 13 
4 
Preparation/Handling/Storage/Accountability ....................................................................... 14 
5 
Study Objectives .................................................................................................................... 14 
6 
Study Design.......................................................................................................................... 14 
6.1 
Overview of Study Design .............................................................................................. 14 
6.2 
Anticipated Duration of the Clinical Investigation ......................................................... 15 
6.3 
Effectiveness and Safety Endpoints ................................................................................ 15 
6.3.1 
Primary Effectiveness Endpoint ............................................................................. 15 
 
 
6.3.3 
Safety Endpoints ..................................................................................................... 15 
6.4 
Study Population ............................................................................................................. 16 
6.4.1 
Sample Size ............................................................................................................. 16 
6.4.2 
Subject Recruitment ................................................................................................ 16 
6.4.3 
Prior and Concomitant Therapy or Medications ..................................................... 16 
6.4.4 
Inclusion Criteria .................................................................................................... 17 
6.4.5 
Exclusion Criteria ................................................................................................... 17 
6.4.6 
Exit / Discontinuation Criteria ................................................................................ 18 
7 
Study Procedures ................................................................................................................... 20 
7.1 
Informed Consent ............................................................................................................ 20 
7.2 
Vulnerable Populations ................................................................................................... 20 
7.3 
Clinical Procedures and Assessments ............................................................................. 20 
7.3.1 
Demographics ......................................................................................................... 20 
7.3.2 
Medical History/Concomitant Medications ............................................................ 21 
7.3.3 
Efficacy Assessments.............................................................................................. 23 
7.3.4 
Safety Assessments ................................................................................................. 24 
7.4 
Follow-Up Procedures and Therapy Transitions ............................................................. 30 

 
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7.5 
Study Timetable / Schedule of Study Assessments ......................................................... 31 
7.6 
Deviations from the Clinical Protocol ............................................................................. 32 
7.7 
Clinical Study Termination ............................................................................................. 32 
7.8 
Subject Compensation ..................................................................................................... 33 
8 
Data Collection and Analysis ................................................................................................ 33 
8.1 
Subject Populations for Analysis .................................................................................... 33 
8.2 
Statistical Methods .......................................................................................................... 33 
8.3 
Interim Analyses .............................................................................................................. 33 
9 
Adverse Events and Device Deficiencies .............................................................................. 34 
9.1 
General Information ........................................................................................................ 34 
9.2 
Monitoring for Adverse Events ....................................................................................... 35 
9.3 
Procedures for Recording and Reporting ........................................................................ 35 
9.4 
Return Product Analysis .................................................................................................. 37 
9.5 
Follow-up of Subjects with Adverse Events ................................................................... 37 
9.6 
Pregnancy in the Clinical Study ...................................................................................... 38 
9.7 
Anticipated Clinical Benefits and Risks .......................................................................... 38 
9.7.1 
Known Potential Risks ............................................................................................ 38 
9.7.2 
Known Potential Benefits ....................................................................................... 38 
10 Data Handling and Record Keeping ...................................................................................... 39 
10.1 Confidentiality ................................................................................................................. 39 
10.2 Source Documents ........................................................................................................... 39 
10.3 Case Report Forms .......................................................................................................... 39 
10.4 Clinical Reports ............................................................................................................... 40 
10.5 Records Retention ........................................................................................................... 40 
11 Study Monitoring, Auditing, and Inspecting ......................................................................... 41 
11.1 Study Monitoring Plan .................................................................................................... 41 
11.2 Quality Assurance Procedures ......................................................................................... 42 
11.3 Auditing and Inspection .................................................................................................. 42 
12 Protocol Amendments After Study Initiation ........................................................................ 43 
13 Ethical Considerations ........................................................................................................... 43 
14 Study Finances ....................................................................................................................... 44 
14.1 Funding Source ................................................................................................................ 44 
14.2 Conflicts of Interest ......................................................................................................... 44 
15 Publication Plan ..................................................................................................................... 45 
16 References ............................................................................................................................. 45 
16.1 References Applicable to All Clinical Studies ................................................................ 45 
16.2 References Applicable to Clinical Studies Conducted in the United States ................... 45 
16.3 Cited References .............................................................................................................. 46 
17 Appendices and Attachments ................................................................................................ 47 
17.1 Glossary of Terms ........................................................................................................... 47 
17.2 Patient Questionnaires ..................................................................................................... 50 
17.2.1 
IDEEL-SB Questionnaire ....................................................................................... 50 
17.2.2 
CLDEQ-8 Questionnaire ........................................................................................ 52 
 
 
 

 
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LIST OF TABLES 
Table 1. 
Study Device............................................................................................................... 13 
Table 2. 
Precision for Various Percentages .............................................................................. 16 
Table 3. 
Targeted Medical History ........................................................................................... 21 
Table 4. 
Schedule of Study Assessments ................................................................................. 31 
 
LIST OF FIGURES 
Figure 1. Overall Study Design.................................................................................................. 15 
Figure 2. Corneal Regions for Recording Location ................................................................... 29 
Figure 3. Categorization of All AEs .......................................................................................... 34 
Figure 4. Categorization of All SAEs ........................................................................................ 34 
 

 
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ABBREVIATIONS 
Abbreviation 
Definition 
ADE 
Adverse device effect 
AE 
Adverse event 
ATP 
Artificial tear products 
BCVA 
Best corrected visual acuity 
CFR 
Code of Federal Regulations 
CL 
Contact lens 
CLDEQ-8 
Contact Lens Dry Eye Questionnaire 
CRF 
Case report form 
DED 
Dry eye disease 
EDC 
Electronic data capture 
eCRF 
Electronic case report form 
EU 
European Union 
FAS 
Full analysis set population 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GPCMS 
Global Product Complaint Management System 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
HP 
Hydroxypropyl 
ICF 
Informed consent form  
ICH 
International Conference on Harmonization 
IDEEL-SB 
Impact of Dry Eye on Everyday Life - Symptom Bother 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
logMAR 
Logarithm of the minimum angle of resolution 
NaFl 
Sodium fluorescein  
 
 
OD, OS 
Oculus dexter, Oculus sinister 
PEG 
Polyethylene glycol  
PF 
Preservative Free 
PG 
Propylene glycol  
PHI 
Protected Health Information 
PI 
Principal Investigator 
PMCF 
Post-market clinical follow-up 
PP 
Per-protocol population 
QID 
Four times a day 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 
SOP 
Standard operating procedures 
US 
United States 
 

 
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1 
STUDY CONTACT INFORMATION 
1.1 
Sponsor Contact Information 
1.2 
Coordinating Principal Investigator Contact Information  
The Coordinating Principal Investigator and coordinating institution will be listed in an attachment 
listing all participating sites. 
1.3 
Key Study Personnel 
1.3.1 
Clinical Study Monitor 
The clinical study will be monitored by: 
ICON Clinical Research 
South County Business Park 
Leopardstown 
Dublin 18, Ireland 
Clinical monitors will be assigned based on therapeutic area familiarity and availability. 
1.3.2 
Global Medical Safety 
Medical safety oversight will be provided by Alcon Global Medical Safety Representatives. 
1.3.3 
Statistician 
Biostatistical analysis will be provided by the ICON Clinical Research Biostatistics group. 

 
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2 
INTRODUCTION / BACKGROUND AND RATIONALE 
Dry eye disease (DED) is a common ocular disorder, which affects many individuals worldwide. 
The prevalence of DED with/without symptoms ranges from 5% to 50%; and based on signs alone, 
up to 75%.1 
DED is characterized by a loss of homeostasis of the tear film resulting in ocular symptoms of 
discomfort, irritation, and visual disturbance, all of which significantly impact the patients’ social 
and occupational quality of life.2,3 Tear ﬁlm insufﬁciency may be the result of inadequate aqueous 
tear production by the main and accessory lacrimal glands, excessive evaporation of the tears from 
the ocular surface, or a combination of both.2 
Common factors associated with DED include elder age, female gender, and the presence of auto-
immune disease. DED is also reported in younger and pediatric populations.4,5 Other modifiable 
factors that can contribute to DED include the use of computers and digital devices, the use of 
heating, ventilation, and air conditioning systems, diet and lifestyle.4 
Use of contact lens is also one of the reasons of DED, about 40% of contact lens wearers report 
dry eye symptoms.6 
While management of DED depends on the severity of symptoms and signs, use of artificial tear 
products (ATPs) that replace or supplement the deficient natural tear film is the mainstay treatment 
option.7 
Systane Ultra (polyethylene glycol [PEG]/propylene glycol [PG] with hydroxypropyl [HP] guar) 
has been shown to effectively alleviate signs and symptoms of dry eye, including conjunctival and 
cornea surface staining as well as patient-reported scores for treatment effectiveness and 
inconvenience. PEG/PG with HP guar has been shown to improve DED symptoms associated with 
cataract surgery, environmental conditions, and contact lens usage. Clinically, PEG/PG with HP 
guar lubricant eye drops have been shown to enhance tear film stability, visual function, comfort 
with contact lens wear, and improve visual acuity in patients with DED.8 
Systane Ultra Preservative Free (PF) are eye drops formulated without preservatives. 
This post-market clinical follow-up (PMCF) study aims to generate scientific evidence to address 
safety, performance, and clinical benefits of Systane Ultra PF in subjects with DED and contact 
lens (CL) wearers experiencing discomfort due to CL-related dryness. 

 
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3 
STUDY DEVICE DESCRIPTION 
Study device description is presented in Table 1. 
Table 1. 
Study Device 
Country 
CANADA 
Product  
SYSTANE™ ULTRA Lubricant Eye Drops 
Preservative Free 
SYSTANE™ ULTRA Lubricant Eye Drops 
Preservative Free 
Supply Type – 
Packaging and 
Labelling 
Supplied in sterile single-use plastic vials 
containing 0.5 mL  
Supplied in plastic bottles containing fill 
sizes of 3 mL or 10 mL. 
Per Instructions for 
Use / Package 
Insert 
Uses: 
For the temporary relief of burning and 
irritation due to dryness of the eye 
SYSTANE™ ULTRA Lubricant Eye Drops 
Preservative Free is indicated for the 
temporary relief of burning and irritation due 
to dryness of the eye. 
SYSTANE™ ULTRA Lubricant Eye Drops 
Preservative Free may be used to lubricate 
and rewet daily, extended wear and 
disposable silicone hydrogel and soft 
(hydrophilic) contact lenses. 
SYSTANE™ ULTRA Lubricant Eye Drops 
Preservative Free moistens your contact 
lenses, reduces discomfort with contact lens 
wear, and helps to remove particulate 
material that may cause irritation and/or 
discomfort. 
Storage Conditions 
Store at room temperature 
Do not store above 30°C 
 
Country 
AUSTRALIA / NEW ZEALAND 
Product  
SYSTANE ™ ULTRA UD Lubricant Eye 
Drops 
SYSTANE ™ ULTRA Lubricant Eye Drops 
Supply Type – 
Packaging and 
Labelling 
Supplied in sterile single-use plastic vials 
containing, 0.5 mL (packaged in multiples of 
5 vials or more). 
Supplied in plastic bottles containing fill 
sizes of 3 mL or 10 mL. 
Per Instructions 
for Use / Package 
Insert 
USES (Indications): 
SYSTANE™ ULTRA UD Lubricant Eye 
Drops is a dry eye therapy for the temporary 
relief of burning and irritation due to dryness 
of the eye. 
DIRECTIONS: 
SYSTANE™ ULTRA UD Lubricant Eye 
Drops may be used as needed throughout the 
day. May be used to treat dry eye associated 
with contact lens usage by instilling drops 
prior to inserting contact lenses and after the 
removal of contact lenses. Twist off the top 
of the single dose vial, place drops on the 
eye and blink. Discard the vial after use. 
SYSTANE™ ULTRA Lubricant Eye Drops 
is intended for use by consumers for the 
temporary relief of burning and irritation due 
to dryness of the eye. 
SYSTANE™ ULTRA Lubricant Eye Drops 
is also intended for consumers wearing soft 
(hydrophilic) and silicone hydrogel contact 
lenses, including daily, extended wear, and 
disposable lenses. 
Storage Conditions 
Store below 30°C 
Do not store above 30°C 

 
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4 
PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY 
The study device should be handled as per the instruction for use. 
Subjects will be asked to return the study device at Visit 3. Sites will account for the return of the 
study device accordingly, and are expected to dispose/destroy the study device per the standard 
practice. 
5 
STUDY OBJECTIVES 
The objective of this PMCF study is to assess the performance and safety of Systane Ultra PF in 
subjects experiencing dry eye symptoms (Group 1) and CL wearers experiencing discomfort due 
to CL-related dryness (Group 2). 
6 
STUDY DESIGN 
6.1 
Overview of Study Design 
This is a post-market, multicenter, non-comparative, open-label, prospective clinical study. 
The study will be conducted outside the US, where the Systane Ultra PF is commercially available, 
in clinical sites known to routinely manage subjects with DED and CL wearers. The overall study 
duration (first subject screened to last subject’s final study visit) is expected to be approximately 
2 months. 
Subjects will be enrolled into the study after signing the informed consent form (ICF).  
Subjects who meet all the inclusion criteria and none of the exclusion criteria will initiate treatment 
with Systane Ultra PF. Eligible study participants (Group 1 and Group 2) will receive the first dose 
of Systane Ultra PF at the Screening/Baseline visit and will be required to self-administer Systane 
Ultra PF four times daily up to Visit 3. The dose selected in this study is the dose approved for 
Systane Ultra PF for the management of DED. 
Subjects will participate in the study for approximately 30 days, with a phone call scheduled on 
Day 15 ± 2 (Visit 2) and a follow-up visit scheduled on Day 30 ± 2 (Visit 3). Subjects may have 
unscheduled visits if deemed necessary per the Investigator’s judgment. 
Subjects will be asked to complete patient questionnaires on Day 1 and at Visit 3 (Impact of Dry 
Eye on Everyday Life - Symptom Bother [IDEEL-SB] or Contact Lens Dry Eye Questionnaire 
[CLDEQ-8] and Comfortable Wear Time questions). In addition, the subjects will be instructed to 
document Systane Ultra PF dosing information on a daily basis using a subject diary. 

 
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A summary of the study design is shown in Figure 1. Study assessments are shown in the Schedule 
of Assessments (Table 4). 
The study will enroll 68 subjects with the objective of 54 subjects completing treatment (27 in 
Group 1 and 27 in Group 2). 
Figure 1. 
Overall Study Design 
 
CL: Contact lens; QID: Four times a day. 
Systane Ultra Preservative-free will be dispensed at Screening/Baseline visit. Subjects will be expected to attend one additional 
visit at Day 30 (±2days) after screening and a telephone call visit at Day 15 (±2days). 
 
6.2 
Anticipated Duration of the Clinical Investigation 
The anticipated duration of the clinical trial is approximately 2 months. The anticipated number of 
clinical sites is up to 5. This will result in an accrual rate of 6.8 subjects per site per month. 
6.3 
Effectiveness and Safety Endpoints 
6.3.1 
Primary Effectiveness Endpoint 
• Group 1: Dry eye questionnaire via IDEEL-SB at entry and at Visit 3 
• Group 2: Dry eye questionnaire via CLDEQ-8 at entry and at Visit 3 
6.3.3 
Safety Endpoints 
• Biomicroscopy findings (include corneal staining) 
• Best corrected visual acuity (BCVA) 
Systane Ultra Preservative-Free (1-2 drops in each eye QID) 
•
Group 1: subjects with mild to moderate dry eye  
•
Group 2: subjects with end of day CL-related dryness 
Visit 1 
Screening / 
Baseline visit
Visit 2 
Telephone call 
Visit 3  
Exit 

 
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• Adverse events (AEs) 
• Device deficiencies  
6.4 
Study Population 
The study population consists of adult male and female subjects (≥18 years old) with mild to 
moderate dry eye disease and CL wearers who experience discomfort due to CL related dryness. 
Subjects will be recruited from clinical sites outside the US, where Systane Ultra PF is 
commercially available. 
6.4.1 
Sample Size 
The study will recruit 68 subjects with a target to complete 54 evaluable subjects (27 in Group 1 
and 27 in Group 2). 
With a sample size of 54, a two-sided 95% confidence interval for a single proportion will extend 
0.060 from the observed proportion when the expected proportion is 0.0543 (AEs).  
Table 2 presents the precision for various rates of categorical outcomes. 
Table 2. 
Precision for Various Percentages 
Sample Size 
Precision (%) for Various Rates of Outcomes 
5% 
10% 
25% 
50% 
27 
8.22% 
11.32% 
16.33% 
18.86% 
54 
5.81% 
8.00% 
11.55% 
13.34% 
Precision calculated according to a simple asymptotic formula for a 2-sided 95% confidence interval for a proportion based on the normal 
approximation of the binomial distribution.9 
 
6.4.2 
Subject Recruitment 
Subjects will be recruited from the clinical practices of the participating Investigators and 
surrounding metropolitan areas. Additional advertisement is not expected to be required. 
6.4.3 
Prior and Concomitant Therapy or Medications 
Concomitant Medications 
Targeted concomitant medications (see Section 7.3.2) must be recorded in source documents and 
on the appropriate electronic case report form (eCRF).  
Prohibited Concomitant Medications 
For subjects who meet all of the inclusion criteria and none of the exclusion criteria, the initiation 

 
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of systemic medications known to cause dry eye (e.g., anti-histamine, anti-depressants, anti-
psychotics, benzodiazepines, etc.) or known to treat dry eye (e.g., Restasis, Xiidra, Cequa) is not 
permitted during the study. 
Rescue Medicine 
Not applicable. 
6.4.4 
Inclusion Criteria 
Subjects will be eligible to participate in the study if all of the following conditions exist: 
1. Subject must be at least 18 years of age.  
2. Subject must be able to understand and sign an IRB/IEC approved informed consent form.  
3. Subject must be willing and able to attend all study visits as required per protocol.  
4. Subject with mild to moderate dry eye (IDEEL-SB >16-64).a 
5. Subject with CL-related dry eye symptoms (CLDEQ-8 ≥12).b 
6. Subject with a comfortable wear time with habitual contact lenses, which is less than the 
total wear time by at least 3 hours.b 
7. Subject must be willing to discontinue use of all habitual artificial tear supplements and 
use only the study device as directed for the entire study duration. 
8. Subject using cyclosporine or other topical dry eye medications must be on a stable dosing 
regimen for ≥60 days prior to enrollment. 
a Assessed in Group 1 only (subjects with mild to moderate dry eye) 
b Assessed in Group 2 only (subjects with end of day CL-related dryness) 
6.4.5 
Exclusion Criteria 
Subjects will be excluded from participation in the study if any of the following conditions exist: 
1. Has suffered any ocular injury to either eye in the past 3 months prior to screening. 
2. Has undergone any other ocular surgery (including intraocular surgery) within the past 
6 months or has any ocular surgery planned during the study. 
3. Employee or family member of Investigators or Alcon. 

 
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4. Currently enrolled in any clinical trial. 
5. Use of any systemic medication known to cause dry eye (e.g., anti-histamine, anti-
depressants, anti-psychotics, benzodiazepines, etc.) for less than 1 month before the 
Screening visit. If subject was on a stable regimen for at least a month prior to the Screening 
visit, the dosing regimen must not have changed for the duration of their participation in 
this study. In addition, subjects who did not currently use any of these medications could 
not start a regimen while participating in the study. 
6.4.6 
Exit / Discontinuation Criteria 
Participation of a subject in this clinical study may be discontinued for any of the following 
reasons: 
• Screen failure 
• AE/serious adverse event (SAE) 
• Death 
• Lack of efficacy 
• Lost to follow-up 
• Physician decision 
• Protocol violation 
• Study terminated by Sponsor or regulatory authority 
• Technical problems with the study device 
• Withdrawal by subject 
If a subject withdraws prematurely from the study due to the above criteria or any other reason, 
study staff should make every effort to complete the full panel of assessments scheduled for the 
Early Exit Visit. The reason for subject withdrawal must be documented in the eCRF.  
In the case of subject lost to follow-up, attempts to contact the subject must be made and 
documented in the subject’s medical records. Withdrawn subjects will not be replaced. 
A subject will be considered lost to follow-up if he or she fails to return for scheduled visits and is 
unable to be contacted by the study site staff. The following actions must be taken if a subject fails 
to return to the clinic for a required study visit: 
• The site will attempt to contact the subject and reschedule the missed visit as soon as 
possible and counsel the subject on the importance of maintaining the assigned visit 
schedule and ascertain if the participant wishes to and/or should continue in the study. 

 
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• Before a participant is deemed lost to follow-up, the Investigator or designee will make 
every effort to regain contact with the subject (where possible, 3 telephone calls and, if 
necessary, a certified letter to the subject’s last known mailing address or local equivalent 
methods). These contact attempts should be documented in the subject’s medical record or 
study file.  
• Should the subject continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 

 
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7 
STUDY PROCEDURES 
7.1 
Informed Consent 
Subjects will be provided a consent form describing this study and providing sufficient information 
for subjects to make an informed decision about their participation in this study. The Investigator 
or his/her representative will explain the nature of the study to the subject and answer all questions 
regarding the study. 
Subjects must be informed that their participation is voluntary. Subjects will be required to sign a 
statement of informed consent that meets the requirements of 21 Code of Federal Regulations 
(CFR) 50, local regulations, International Conference on Harmonization (ICH) guidelines, Health 
Insurance Portability and Accountability Act (HIPAA) requirements, where applicable, and the 
IRB/IEC or study center. 
The medical record must include a statement that written informed consent was obtained before 
the subject was enrolled in the study and the date the written consent was obtained. The authorized 
person obtaining the informed consent must also sign the ICF. 
Subjects must be re-consented to the most current version of the ICF during their participation in 
the study. 
A copy of the ICF must be provided to the subject.  
7.2 
Vulnerable Populations 
Members of vulnerable populations will not be specifically targeted for recruitment. However, the 
intended subject population may include subjects who are considered to be vulnerable by 
definition. The procedures included in this protocol are sufficient to provide the necessary human 
subjects’ welfare protections without the need for additional procedures. 
7.3 
Clinical Procedures and Assessments 
After obtaining informed consent, assessments will be conducted for the enrolled subject as 
described in the sections below. The Investigator is responsible for ensuring that responsibilities 
for all assessments are delegated to appropriately qualified site personnel. 
7.3.1 
Demographics 
Age, sex, race, and ethnicity will be collected at the Screening/Baseline visit (D1). 

 
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7.3.2 
Medical History/Concomitant Medications 
Fully document concomitant medications (taken within the past 30 days prior to the 
Screening/Baseline Visit) and Medical History (within 1 year prior to the Screening/Baseline 
Visit) in the subject source documents (i.e., subject's chart). If the subject reports any condition in 
Table 3, the Investigator may ask for additional information at their discretion. 
AEs are collected from the time of informed consent. Any preexisting medical conditions or 
signs/symptoms present in a subject prior to the start of the study (i.e., before informed consent is 
signed) are not considered AEs in the study and should be recorded in the Medical History section 
of the eCRF. 
In the electronic data capture (EDC), only limited information regarding concomitant medications 
and medical history will be captured, as noted below.   
• Medical History: Document all ocular history and targeted systemic history. In the EDC, 
there is a prepopulated dropdown field with items of interest that is consistent with Table 3. 
• Concomitant medications: Document all ocular medications and targeted systemic 
medications used to treat conditions documented in Medical History and AEs. 
Table 3. 
Targeted Medical History 
Medical History 
Definition 
Active Respiratory 
Infections 
• 
Principal respiratory viruses known to cause ocular disease in humans: 
o 
Adenovirus 
o 
Influenza virus 
o 
Respiratory syncytial virus 
o 
Coronavirus 
o 
Rhinovirus 
o 
Human metapneumovirus 
Alcohol Abuse 
• 
Heavy drinking: current or past consumption of 4 or more servings of alcoholic 
beverages daily 
Atopic Disease 
• 
Atopy 
o 
Atopic dermatitis 
o 
Urticaria 
o 
Angioedema 
o 
Asthma  
o 
Allergic rhinitis 
Cancer 
• 
Cancers (potentially metastatic to eye or orbit), e.g., breast and lung cancer for 
women, gastrointestinal cancer for men, etc. 
• 
Cancers on active chemo- or radiotherapy 
Diabetes Mellitus 
• 
All Type I and II, some potential risk factors for retinopathy include: 
o 
Long duration 
o 
Insulin dependence 
o 
Increased Hemoglobin A1c levels 
o 
Elevated systolic blood pressure 

 
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Medical History 
Definition 
o 
Proteinuria 
o 
Decreased body mass index (BMI) 
Headache 
• 
Confirmed diagnosis (regardless of frequency of attacks) of: 
o 
Migraine with aura 
o 
Migraine without aura 
o 
Tension-type headache 
o 
Cluster headache 
• 
Headache with symptoms: 
o 
Systemic symptoms (e.g., fever, weight loss)  
o 
Neurologic symptoms/signs 
o 
Onset (sudden)  
o 
Older age (over 50 years)  
o 
Prior history (new headache)  
o 
Secondary illnesses (HIV or history of neoplasia) 
Hypertension 
• 
Chronic long-standing hypertension 
• 
Acute severe hypertension 
HIV Infection 
• 
Human immunodeficiency virus (HIV) disease with or without highly active 
antiretroviral therapy (HAART) 
• 
Low CD+ T-cell count (<100 cells /μL) is associated with severe ocular 
manifestations 
Lupus 
• 
Systemic Lupus Erythematosus (SLE) is a chronic, idiopathic, multisystem 
inflammatory disease characterized by hyperactivity of the immune system and 
prominent autoantibody production 
Multiple Sclerosis 
• 
Multiple sclerosis (MS) is a chronic relapsing and remitting, episodic 
demyelinating disease of the central nervous system 
Rheumatoid Arthritis  
• 
Rheumatoid Arthritis (RA) is a chronic inflammatory autoimmune disease of 
unknown etiology that affects approximately 1% of the global population 
Rosacea 
• 
Rosacea with any subtype below: 
o 
Erythemato-telangiectatic 
o 
Papulopustular 
o 
Phymatous 
o 
Ocular rosacea 
Sarcoidosis 
• 
Sarcoidosis is a systemic inflammatory disease of unknown etiology 
characterized by the formation of noncaseating granulomas. 
Scleroderma 
• 
Systemic sclerosis sine scleroderma is a rare, chronic autoimmune disease with 
unknown etiology. Its prominent features are fibrosis, vasculopathy, and 
impaired immune response. 
Seronegative 
spondyloarthropathies 
• 
Ankylosing spondylitis 
• 
Reactive arthritis 
• 
Bechet’s disease 
• 
Inflammatory bowel diseases 
• 
Psoriatic arthritis 
Sjogren’s Syndrome 
• 
Primary Sjogren’s syndrome 
• 
Secondary Sjogren’s syndrome 
Smoking 
• 
Current smoker (regardless of number of pack-years) 
• 
Former smoker (cessation < 20 years before the study) 

 
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Medical History 
Definition 
Systemic Herpes 
Zoster Infection 
• 
A viral infection caused by varicella-zoster characterized by painful rash with 
blisters. 
Thyroid Disorder 
• 
Hyperthyroidism (e.g., Graves’ disease) 
• 
Hypothyroidism (e.g., Hashimoto’s thyroiditis) 
• 
Euthyroid 
<Ocular – Other> 
• 
[Specify - if not indicated above] 
7.3.3 
Efficacy Assessments 
Planned time points for all efficacy assessments are provided in Table 4.  
7.3.3.1 
IDEEL-SB (Group 1) 
Dry eye symptoms will be assessed using the IDEEL-SB questionnaire (see Appendix 17.2.1) at 
the Screening/Baseline visit (D1), before Systane Ultra PF use, and at Visit 3 (and at unscheduled 
and at early exit visit, as necessary). 
The IDEEL-SB (Version 1) symptom bother module consists of 20 questions that assess general 
dry eye symptoms a subject experiences. It should be administered prior to performing any other 
study testing procedure. The subject’s response to each question will be entered on paper and 
scored to determine the eligibility of the subject to participate in the study. 
Administration and Scoring 
A paper copy of the IDEEL-SB module will be given to each subject for completion without 
assistance. All questions should be answered by the subject so please check the questionnaire 
before the subject leaves the study visit. 
Question 1 is scored on a 5-point Likert-type scale where 0 = None of the time, 1 = A little of the 
time, 2 = some of the time, 3 = Most of the time, and 4 = All of the time. Questions 2-20 are scored 
on a 4-point Likert-type scale where 0 = I did not have this symptom / Not Applicable, 1 = Not at 
all, 2 = Slightly, 3 = Moderately, 4 = Very much. 
The subject will be instructed to select a single response that best represents their answer. The 
score is calculated if at least 50% (10 items) of the 20 items within the dimension are completed; 
non-missing; otherwise the score is set to missing. The Symptom Bother score is calculated as the 
mean value of the non-missing item scores 1-20 multiplied by 25. 
 
The final calculated IDEEL-SB score for each patient will be entered into the study source 
documents to determine eligibility at the Screening Visit. 

 
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7.3.3.2 
CLDEQ-8 (Group 2) 
CL symptoms will be assessed using the CLDEQ-8 questionnaire (see Appendix 17.2.2) at the 
Screening/Baseline visit (D1), before Systane Ultra PF use, and at Visit 3 (and at unscheduled and 
at early exit visit, as necessary). 
The final calculated CLDEQ-8 score as the sum of the 8 questions will be entered into the study 
source documents to determine eligibility at the Screening/Baseline Visit. 
7.3.4 
Safety Assessments 
Planned time points for all safety assessments are provided in Table 4. 
7.3.4.1 
Adverse Events 
All AEs and SAEs will be collected at the time points specified in Table 4 from the time of 
informed consent completion until study participation is complete. Any preexisting medical 
conditions or signs/symptoms present in a subject prior to obtaining the informed consent are not 
considered AEs in the study and should be recorded in the Medical History section of the eCRF. 
See Section 9.2 and 9.3 for further details. 
7.3.4.2 
Slit Lamp Biomicroscopy 
Slit lamp biomicroscopy assessments will be performed using the ISO11980 grading at the 
Screening/Baseline visit (D1) and at Visit 3 (and at unscheduled and early exit visits, as necessary). 

 
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A biomicroscopy examination of the cornea, adnexa and anterior segment of the eye will be 
performed, OD and OS, at the Screening/Baseline visit (D1) and at Visit 3 (and at unscheduled and 
early exit visits, as necessary), and recorded on eCRFs. Record both eyes for the same subject if 
both are noted to have such a finding. 
If warranted, a short slit lamp video or slit lamp photograph should be recorded to demonstrate 
any abnormal findings or findings of interest during biomicroscopy (for example inferior arcuate 
staining). Record both eyes for the same subject if both are noted to have such a finding. 
• 
Limbal hyperemia (All Subjects) 
Limbal hyperemia (redness) will be recorded on a 5-point scale as follows: 
0 = None 
No hyperemia 
1 = Trace 
Slight limbal hyperemia (mild segmented) 
2 = Mild 
Mild limbal hyperemia (mild circumcorneal) 
3 = Moderate 
Significant limbal hyperemia (marked segmented) 
4 = Severe 
Severe limbal hyperemia (marked circumcorneal) 
 
• 
Bulbar Hyperemia (All Subjects) 
Bulbar conjunctival hyperemia (redness) will be recorded on a 5-point scale as follows: 
0 = None 
No hyperemia 
1 = Trace 
Slight regional hyperemia 
2 = Mild 
Diffuse hyperemia 
3 = Moderate 
Marked regional or diffuse hyperemia 
4 = Severe 
Diffuse episcleral or scleral hyperemia 
 
• 
Corneal Epithelial Edema (All Subjects) 
Corneal epithelial edema should be classified according to the number of microcysts observed. 
The presence/absence of fluid-filled or debris-filled cysts should be documented. 
0 = None 
No microcysts; normal transparency 
1 = Trace 
1 to 20 microcysts; barely discernable local epithelial haziness 
2 = Mild 
21 to 50 microcysts; faint but definite localized or generalized haziness 
3 = Moderate 
51 to 100 microcysts; significant localized or generalized haziness 
4 = Severe 
> 100 microcysts; definite widespread epithelial cloudiness giving a dull glass 
appearance to the cornea or numerous coalescing bullae 
 
• 
Corneal Stromal Edema (Group 2) 
Corneal stromal edema will be recorded on a 5-point scale as follows: 
0 = None 
No edema 
1 = Trace 
Just detectable clouding 
2 = Mild 
Faint corneal striae (2 or fewer) 

 
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3 = Moderate 
Pronounced corneal striae (3) 
4 = Severe 
Folds in descemet’s membrane and ≥ 4 pronounced striae 
 

 
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• 
Corneal Vascularization (All Subjects) 
Corneal vascularization will be recorded on a 5-point scale as follows: 
0 = None 
No vessel penetration 
1 = Trace 
< 1.00 mm vessel penetration 
2 = Mild 
≥ 1.00 mm to ≤ 1.5 mm vessel penetration 
3 = Moderate 
> 1.5 mm to ≤ 2.00 mm vessel penetration 
4 = Severe 
Vessel penetration > 2.0 mm 
 
• 
Conjunctival Compression/Indentation (Group 2) 
Bulbar conjunctival compression/indentation will be recorded on a 2-point scale as follows: 
0 = Absent 
1 = Present 
• 
Chemosis (All Subjects) 
Chemosis will be recorded on a 2-point scale as follows: 
0 = Absent 
1 = Present 
• 
Corneal Infiltrates (Group 2) 
The severity of corneal infiltrates will be recorded on a 5-point scale as follows: 
0 = None 
No infiltrates 
1 = Trace 
Single or multiple epithelial infiltrates < 1 mm in diameter 
2 = Mild 
Single or multiple epithelial infiltrates ≥ 1 mm and < 2 mm in diameter 
3 = Moderate 
Multiple infiltrates ≥ 2 mm and < 3 mm in diameter 
4 = Severe 
Multiple dense infiltrates ≥ 3 mm in diameter 
 
The location of infiltrates observed should be recorded in the source document, as indicated in 
Figure 2. In addition, the “Infiltrates” form should be completed including: 
o 
Eye (OD, OS) 
o 
Location (Central, Peripheral Superior, Peripheral Inferior, Peripheral Nasal, Peripheral 
Temporal) 
o 
Type (Focal, Diffuse) 
o 
Depth of Largest Infiltrate (Epithelial, Anterior Stromal, Mid/Posterior Stromal) 
o 
Number of Infiltrates (1, 2, 3, 4, 5, 6, 7, >7) 
o 
Size of the largest infiltrate (in mm) 
Additional findings (e.g., ‘Presence and type of discharge’ or ‘Degree of overlying epithelial 
defect’) should be captured in the corresponding Biomicroscopy panel, or AE Form (if applicable). 

 
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• 
Corneal Staining (All Subjects) 
o 
Corneal Staining Set Up 
All corneal staining observations should be carried out using a blue excitation light to full intensity 
and magnification at 16x in conjunction with a yellow barrier filter in the observation system 
(approximate beam width 10 mm and height 8 mm). 
Apply one drop of fresh, non-preserved, sterile saline to the tip of a Sodium Fluorescein (NaFl) 
impregnated strip. Allow saline to drip off the strip (i.e., without a shaking motion). 
Ask the subject to look up and nasally. Gently retract the lower lid and touch the strip to the inferior 
temporal bulbar conjunctiva, approximately 5 mm or more from the limbus, for 1 to 2 seconds, so 
that 1 to 2 mm of the flat side of the strip makes contact with the ocular surface. Withdraw the 
strip and release the lower lid. 
o 
Corneal Staining - Standard Assessment 
Record grade according to the following scale: 
0 = None 
No staining 
1 = Trace 
Minimal superficial staining or punctate staining 
a) 
Dimpling, discrete dot staining, or 
b) 
Trace superficial lens insertion marks or foreign body tracks 
2 = Mild 
Regional or diffuse punctate staining 
a) 
Central or generalized, or 
b) 
Peripheral including 3 to 9 o'clock staining, or 
c) 
Foreign body tracks 
3 = Moderate 
Dense coalescent staining up to 2 mm in diameter 
a) 
Corneal abrasion 
b) 
Foreign body track 
4 = Severe 
Dense coalescent staining greater than 2 mm in diameter 
 
The location of staining observed should be recorded in source documentation only, as indicated 
in Figure 2: 

 
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Figure 2. 
Corneal Regions for Recording Location 
 
Recurrent erosion and corneal ulceration should be recorded under “Other findings.” 
Inferior arcuate staining should be recorded under “Other findings.” 
• 
Conjunctival Staining (All Subjects) 
Conjunctival staining should be assessed immediately after corneal staining. Therefore, an 
additional application of NaFl is not required. However, if needed in order to make a sound 
judgment, one more application can be made following the instructions given in the section above 
and using a new NaFl strip. All conjunctival staining observations should be carried out using a 
blue excitation light in conjunction with a yellow barrier filter in the observation system after NaFl 
instillation. 
Conjunctival staining will be assessed on a 5-point scale: 
0 = None 
No staining 
1 = Trace 
Minimal regional staining 
2 = Mild 
Regional or diffuse punctate staining 
3 = Moderate 
Significant dense coalescent staining 
4 = Severe 
Severe dense geographical staining 
 
• 
Palpebral conjunctival observations (All Subjects) 
The severity of the maximal palpebral conjunctival response will be recorded on a 5-point scale as 
follows: 
0 = None 
Uniform satin appearance of the conjunctiva 
1 = Trace 
Slight conjunctival injection without texture 
2 = Mild 
Mild or scattered papillae/follicles less than 1 mm in diameter 
3 = Moderate 
Significant papillae/follicles less than 1 mm in diameter, and/or marked conjunctival 
injection 
Staining of the top of one papilla 
4 = Severe 
Localized or generalized papillae/follicles 1 mm or more in diameter 
Staining of the top of more than one papilla 

 
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• 
Other Findings (All Subjects) 
Record any other finding(s) and use the following scale to grade severity: 
0 = None 
No other significant biomicroscopic findings 
1 = Trace 
Minimal findings 
2 = Mild 
Mild findings 
3 = Moderate 
Significant findings 
4 = Severe 
Severe findings 
 
Note: If there are multiple other findings, on the eCRF for “Other” record the grade of the most 
severe in the “Result” field and record all findings (along with their individual grades) in the “If 
Other, Specify” field. 
7.3.4.3 
BCVA 
BCVA will be assessed per standard practice at the Screening/Baseline visit (D1) and at Visit 3 (and 
at unscheduled and early exit visits, as necessary). 
7.3.4.4 
Device Deficiencies 
Device deficiencies will be collected at the time points specified in Table 4. 
7.4 
Follow-Up Procedures and Therapy Transitions 
In this study, there are no specific follow-up procedures or therapy transitions required. Following 
study completion, subjects will return to their previous care provider. 
Alcon products associated with device deficiencies and/or product-related AEs should, if possible, 
be returned to Alcon and must include the complaint number, which will be provided by study 
Sponsor after the case is entered in the study Sponsor’s Global Product Complaint Management 
System (GPCMS). 
Return any recoverable Alcon Product associated with a product-related AE (adverse device effect 
[ADE], serious adverse device effect [SADE]) or device deficiency to the Sponsor. Procedures 
vary so Investigators must contact their assigned monitor for detailed guidance. Follow biohazard 
regulations if the product has touched the eye (i.e., place the product in a biohazard labeled bag). 
Include the SAE/ADE or device deficiency eCRF in the return package. Maintain a copy of 
shipment tracking information and all documents submitted with the product. 

 
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7.5 
Study Timetable / Schedule of Study Assessments 
The schedule of study assessments is provided in Table 4. 
Table 4. 
Schedule of Study Assessments 
Procedure/ Assessment 
Visit 1 
Screening + 
Baseline 
(Day1) 
Visit 2 (phone) 
15-day Follow-up 
(±2 days) 
Visit 3 
30-day/Exit 
(±2 days) 
Unscheduled 
Visit/Early 
Exit 
Informed consent 
X 
 
 
 
Demographics 
X 
 
 
 
Targeted medical history 
X 
 
 
 
Targeted concomitant medications 
X 
 
 
 
IDEEL-SB questionnairea 
X 
 
X 
(X) 
CL symptom assessed via  
CLDEQ-8b 
X 
 
X 
(X) 
 
 
 
 
 
Inclusion/Exclusion 
X 
 
 
 
Changes in concomitant medications 
 
X 
X 
X 
BCVA 
X 
 
X 
(X) 
 
 
 
 
 
Biomicroscopy findings (include 
corneal staining) 
X 
 
X 
(X) 
AEs 
X 
X 
X 
X 
Device deficiencies  
X 
X 
X 
X 
Exit form 
(X) 
 
X 
X 
Telephone follow-up for compliance 
check 
 
X 
 
 
AE: adverse event; BCVA: best corrected visual acuity; CLDEQ-8: Contact Lens Dry Eye Questionnaire;  
IDEEL-SB: Impact of Dry Eye on Everyday Life - Symptom Bother 
(X) assessment performed as necessary 
a Assessed in Group 1 (subjects with mild to moderate dry eye) 
b Assessed in Group 2 (subjects with end of day CL-related dryness) 
 

 
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7.6 
Deviations from the Clinical Protocol 
The Investigator and site personnel should conduct the study in compliance with the protocol and 
should use continuous vigilance to identify and report protocol deviations. The Investigator may 
not deviate from the protocol, except when necessary to eliminate an immediate hazard to a study 
subject, or when the change involves only logistical or administrative aspects of the study. Any 
significant deviation from the protocol must be reported immediately to the Sponsor or Sponsor’s 
representative and if applicable, to the relevant IRB/IEC, in accordance with the local regulation. 
7.7 
Clinical Study Termination 
The study Sponsor reserves the right to suspend or close the investigational site or suspend or 
terminate the study in its entirety at any time. 
The Investigator may initiate study-site closure at any time, provided there is reasonable cause and 
sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the Sponsor or Investigator may include but are not 
limited to: 
• For study termination: 
o Discontinuation of further study treatment development 
• For site termination: 
o Failure of the Investigator to comply with the protocol, the requirements of the 
IRB/IEC or local health authorities, the Sponsor's procedures, or Good Clinical 
Practice (GCP) guidelines 
o Inadequate or no recruitment (evaluated after a reasonable amount of time) of 
subjects by the Investigator 
o Total number of subjects included earlier than expected 
If the clinical study is prematurely terminated or suspended by the study Sponsor: 
• The study Sponsor (or its acting representative) shall: 
o Immediately notify the Investigator(s) and subsequently provide instructions for 
study termination. 
o Inform the Investigator and the regulatory authorities of the termination/suspension 
and the reason(s) for the termination/suspension.  
• The Investigator shall: 
o Promptly notify the IRB/IEC of the termination or suspension and of the reasons.  
o Provide subjects with recommendations for poststudy treatment options as needed. 

 
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7.8 
Subject Compensation 
Where permitted by the IRB/IEC, study subjects will be compensated for participation. 
8 
DATA COLLECTION AND ANALYSIS 
8.1 
Subject Populations for Analysis 
Two analysis data sets will be defined: 
• The Full Analysis Set (FAS) will include all subjects/eyes exposed to at least one dose of 
Systane Ultra PF. The Full Analysis Set will serve as the primary analysis set for all 
effectiveness and safety analyses. 
• The Per Protocol (PP) population is a subset of the FAS and will exclude subjects with 
major protocol deviations. The PP population will be a supportive set for effectiveness 
analyses, as necessary. 
8.2 
Statistical Methods 
This section is a summary of the planned statistical analyses. A Statistical Analysis Plan will be 
finalized prior to database lock and will include a more technical and detailed description of the 
statistical analyses described in this section.  
Statistical analyses will be presented by group (Group 1: subjects with mild to moderate dry eye; 
Group 2: subjects with end of day CL-related dryness). 
There is no statistical hypothesis for the endpoints in this study. Appropriate descriptive statistics 
will be computed and presented for all categorical and continuous endpoints. 
• For categorical variables, the number and percentage of subjects/eyes within each 
category of interest will be presented. 
• For continuous variables, the number of subjects/eyes with non-missing data, mean, 
standard deviation, range, median, minimum, and maximum will be presented. 
• There will be no imputation for missing data. 
All visual acuity results will be presented in logarithm of the minimum angle of resolution 
(logMAR) scale after applying appropriate transformations/conversions. 
8.3 
Interim Analyses 
This section is not applicable. 

 
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9 
ADVERSE EVENTS AND DEVICE DEFICIENCIES 
9.1 
General Information 
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical 
signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not 
related to the study device. Refer to the Glossary of Terms (Section 17.1) and figures below for 
categories of AEs and SAEs. 
Figure 3. 
Categorization of All AEs 
ADE
Device /
procedure-
related?
Meets 
seriousness 
criteria?
SAE
All AEs
AE
No
No
Yes
Yes
 
ADE: adverse device effect; AE: adverse event; SAE: serious adverse event 
Figure 4. 
Categorization of All SAEs 
All SAEs
Device /
procedure 
related?
SAE
SADE
No
Yes
 
SADE: serious adverse device effect; SAE: serious adverse event 

 
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Device Deficiencies  
A device deficiency is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. A device deficiency may or may not be associated 
with patient harm (i.e., ADE or SADE); however, not all ADEs or SADEs are due to a device 
deficiency. The Investigator should determine the applicable category listed in the Device 
Deficiency eCRF for the identified or suspect device deficiency and report any patient harm 
separately. Examples of device deficiencies include the following:  
• Failure to meet product specifications 
• Unsealed device packaging 
• Suspected product contamination 
9.2 
Monitoring for Adverse Events 
At each visit, after the subject has had the opportunity to spontaneously mention any problems, 
the Investigator should inquire about AEs by asking the standard questions shown below and report 
as applicable: 
• “Have you had any health problems since your last study visit?” 
• “Have there been any changes in the medicines you take because of a new health issue or 
worsening of an existing health issue since your last study visit?” 
In addition, changes in any protocol-specific parameters and/or questionnaires evaluated during 
the study are to be reviewed by the Investigator. Any untoward (unfavorable and unintended) 
change in a protocol-specific parameter or questionnaire response that is clinically relevant, in the 
opinion of the Investigator, is to be reported as an AE. These clinically relevant changes will be 
reported regardless of causality.  
9.3 
Procedures for Recording and Reporting 
AEs are collected from the time of informed consent completion and throughout the duration of 
the study. Any preexisting medical conditions or signs/symptoms present in a subject prior to 
obtaining informed consent are not considered AEs in the study and should be recorded in the 
Medical History section of the eCRF.  
For each recorded event, the ADEs and SAEs documentation must include: AE diagnosis of main 
symptom, date of occurrence, intensity (severity), treatment (if applicable), outcome, and 
assessments of the seriousness and causality. In addition, the Investigator must document all device 
deficiencies reported or observed with the study device on the Device Deficiency eCRF. The site 
must submit all available information on ADEs, SAEs, and device deficiencies to the study 

 
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Sponsor immediately as follows: 
• All SAEs must be reported immediately (within 24 hours) of the Investigator or site’s 
awareness.  
• ADEs that do not meet seriousness criteria and device deficiencies must be reported within 
10 calendar days of the Investigator or site’s awareness.  
• A printed copy of the completed SAE and ADE and/or Device Deficiency eCRF must be 
included with product returns. 
• Additional relevant information after initial reporting must be entered into the eCRF as 
soon as the data become available. 
• Any changes to concomitant medications must be documented on the appropriate eCRFs. 
• All relevant information from Discharge Summary, Autopsy Report, Certificate of Death 
etc., if applicable, must be documented in the narrative section of the SAE and ADE eCRF. 
Note: Should the EDC system become non-operational, the site must notify the Sponsor designee 
(ICON Clinical Research SAE Hotline) at +1-888-723-9952. The reported information must be 
entered into the EDC system once it becomes operational. 
Study Sponsor representatives may be contacted for any protocol-related question and their contact 
information is provided in the Project Team Contact List included in the Investigator Site File. 
Further, depending upon the nature of the AE or device deficiency being reported, the Study 
Sponsor (or designee) may request copies of applicable portions of the subject’s medical records. 
The Investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC. 
Intensity and Causality Assessments 
Where appropriate, the Investigator must assess the intensity (severity) of the AE based on medical 
judgment with consideration of any subjective symptom(s), as defined below: 
Intensity (Severity) 
Mild:  
An AE is mild if the subject is aware of but can easily tolerate the sign or symptom. 
Moderate:  
An AE is moderate if the sign or symptom results in discomfort significant enough 
to cause interference with the subject’s usual activities. 
Severe:  
An AE is severe if the sign or symptom is incapacitating and results in the subject’s 
inability to work or engage in their usual activities. 

 
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The Investigator must assess the causality for every AE in the study (Related or Not Related to the 
study treatment). An assessment of causality will also be performed by the study Sponsor utilizing 
the same definitions, as shown below: 
Causality 
Related 
An AE classified as related may be either definitely related or possibly related 
where a direct cause and effect relationship with the study treatment has not been 
demonstrated, but there is a reasonable possibility that the AE was caused by the 
study treatment. 
Not Related  An AE classified as not related may either be definitely unrelated or simply unlikely 
to be related (i.e., there are other more likely causes for the AE). 
The study Sponsor will assess the AEs and may upgrade the Investigator’s assessment of 
seriousness and/or causality. The study Sponsor will notify the Investigator of any AEs that is 
upgraded from nonserious to serious or from unrelated to related. 
9.4 
Return Product Analysis 
Alcon study products associated with device deficiencies and/or product-related AEs should be 
returned and must include the Complaint number, which will be provided by study Sponsor after 
the case is entered in the study Sponsor’s GPCMS. 
9.5 
Follow-up of Subjects with Adverse Events 
The Investigator is responsible for adequate and safe medical care of subjects during the study and 
for ensuring that appropriate medical care and relevant follow-up procedures are maintained after 
the study.  
The Investigator should provide the study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety evaluation 
of the study treatment. For AEs that are unresolved/ ongoing at time of subject exit from study, 
any additional information received at follow-up should be documented in the eCRFs up to study 
completion (i.e., database lock).  
All complaints received after this time period will be considered and processed as spontaneous 
(following the post-market vigilance procedures) and should be communicated to the study 
treatment’s manufacturer as per local requirements. 

 
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9.6 
Pregnancy in the Clinical Study 
Women of childbearing potential or women who become pregnant during the course of the study 
are not excluded from participation. Pregnancy should be included in the Pregnancy eCRF should 
a woman become pregnant during the data collection period or if a woman becomes pregnant 
during the study. Pregnancy is not reportable as an AE; however, complications may be reportable 
and will be decided on a case–by-case basis if information is available in medical records.  
9.7 
Anticipated Clinical Benefits and Risks 
9.7.1 
Known Potential Risks 
Systane Ultra PF may cause mild eye burning or irritation, itching or redness of the eyes, watery 
eyes, blurred vision, or unpleasant taste in the mouth. There may be a rare possibility of an allergic 
reaction, which could be severe. 
Systane Ultra PF must be stopped in the event of eye pain, changes in vision, redness or irritation 
of the eye(s) gets worse, persists or lasts more than 72 hours. 
9.7.2 
Known Potential Benefits  
Previous clinical studies showed that Systane Ultra is effective for the temporary relief of burning 
and irritation due to dryness of the eye. 

 
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10 DATA HANDLING AND RECORD KEEPING 
10.1 
Confidentiality 
Information about study subjects will be kept confidential and managed according to the 
requirements of the HIPAA of 1996, and/or the General Data Protection Regulation (EU 
2016/679), and applicable national and local regulations. Those regulations require a signed 
subject authorization informing the subject of the following:  
• What protected health information (PHI) will be collected from subjects in this study 
• Who will have access to that information and why 
• Who will use or disclose that information 
• The rights of a research subject to revoke their authorization for use of their PHI.  
In the event that a subject revokes authorization to collect or use PHI, the Investigator, by 
regulation, retains the ability to use all information collected prior to the revocation of subject 
authorization. For subjects that have revoked authorization to collect or use PHI, attempts should 
be made to obtain permission to collect at least vital status (i.e., that the subject is alive) at the end 
of their scheduled study period. 
10.2 
Source Documents 
Source Data are the clinical findings and observations, laboratory and test data, and other 
information contained in Source Documents. Source Documents are the original records (and 
certified copies of original records); including, but not limited to, hospital medical records, 
physician or office charts, physician or nursing notes, subject diaries or evaluation checklists, 
pharmacy dispensing records, recorded data from automated instruments, x-rays, etc. When 
applicable, information recorded on the eCRF shall match the Source Data recorded on the Source 
Documents. 
10.3 
Case Report Forms 
The study eCRF is the primary data collection instrument for the study. All data requested on the 
eCRF must be recorded. All missing data must be explained. If a space on the eCRF is left blank 
because the procedure was not done or the question was not asked, or if the item is not applicable 
to the individual case, please reference the eCRF Completion Guides on how to enter in the eCRF. 
An eCRF will be completed for each subject enrolled into the clinical study. The Investigator will 
review, approve and sign/date each completed eCRF; the Investigator’s signature serving as 
attestation of the Investigator’s responsibility for ensuring that all clinical and laboratory data 
entered on the eCRF are complete, accurate and authentic. 

 
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The electronic data capture method utilized will be in compliance with the Food and Drug 
Administration (FDA)’s electronic records and electronic signatures regulations at 21 CFR Part 11.  
10.4 
Clinical Reports 
The Investigator is responsible for the preparation and submission of annual progress reports as 
required by local IRBs/IECs. The Sponsor or designee is responsible for the preparation of the 
final Clinical Study Report, which will be submitted to appropriate IRBs/IECs by the Investigator. 
A Coordinating Investigator may be identified by the study Sponsor to review and endorse the 
final study report. In cases where a Coordinating Investigator is engaged, the study Sponsor will 
select the Coordinating Investigator based upon their experience, qualifications, active study 
participation, and their willingness and availability to take on this role.  
10.5 
Records Retention  
The Sponsor shall keep relevant clinical records for a period of at least 15 years after study 
completion unless local regulations or institutional policies require a longer retention period. 
The Investigator shall maintain relevant clinical records for 10 years. Investigators will notify the 
Sponsor at least 60 days prior to any destruction of records at the address listed below: 
Alcon Research LLC 
6201 South Freeway 
Fort Worth, Texas 76134 
Or via email to 
Record.Retention@Alcon.com 

 
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11 STUDY MONITORING, AUDITING, AND INSPECTING 
This study will be monitored according to GCP guidelines. The Investigator will allocate adequate 
time for such monitoring activities. The Investigator will also ensure that the monitor or other 
compliance or quality assurance reviewer is given access to all study-related documents and study 
related facilities (e.g., pharmacy, diagnostic laboratory, etc.), and has adequate space to conduct 
the monitoring visit. 
11.1 
Study Monitoring Plan 
The Sponsor will ensure that the study is adequately monitored and in accordance with the Study 
Clinical Monitoring Plan. 
Monitors will be appropriately trained, with scientific and/or clinical knowledge needed to monitor 
the clinical study adequately. Monitors are required to be thoroughly familiar with the protocol, 
the informed consent documentation provided to subjects, Sponsor and Sponsor’s Designee 
Standard Operating Procedures (SOPs), GCPs, and the applicable regulatory requirement(s). 
Site visits will be conducted by an authorized Sponsor representative to inspect study data, 
subjects’ medical records, and case report forms (CRFs) in accordance with current GCPs and the 
respective local and national government regulations and guidelines (if applicable). The study 
Investigator and the investigating site will permit authorized clinical research personnel and 
clinical monitors from Sponsor and/or designee(s) to review completed CRFs, IRB/IEC decisions, 
and Investigator, clinical site records, and facilities relevant to this study at regular intervals 
throughout the study per the monitoring plan. Additionally, subject charts and clinical records will 
be requested and reviewed so that protocol adherence and source documentation can be verified. 
Monitoring may be performed with in-person visits or remotely, when applicable. 
To ensure the rights, safety, and welfare of study subjects are being maintained, the monitor will 
review training records to ensure all study staff are trained on the study protocol and use of the 
study device. If the monitor discovers that an Investigator is not complying with the signed 
Investigator Agreement, the investigational plan, applicable laws, or any conditions of approval 
imposed by the reviewing IRB/IEC, the monitor will report to the Sponsor and take such steps 
necessary to promptly secure compliance. If compliance cannot be secured, the Investigator’s 
participation in the investigation may be terminated. Independent monitoring of the clinical study 
for clinical protocol compliance will be conducted periodically (i.e., at a minimum of annually) by 
qualified staff. 

 
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11.2 
Quality Assurance Procedures 
Quality control and quality assurance is the responsibility of the Investigator and designated study 
staff. Sponsor clinical representatives will provide training and support to ensure that data quality 
is optimal (accurate, valid, reliable, complete, and reported in a timely manner). 
This study shall adhere to US FDA standards, European Union (EU) Regulations, Health Canada 
Regulations as well as other applicable local standards of conduct regarding quality assurance. All 
parts of the US CFR applicable to clinical studies, including 21 CFR Parts 50 and 56, and 46 CFR 
164, European Union Medical Device Regulation [EU 2017/745], General Data Protection 
Regulation [EU 2016/679] and Medical Device Regulations SOR/98-282 and Food and Drugs Act 
must be followed. 
The Sponsor or its designee will perform the quality assurance and quality control activities of this 
study. However, responsibility for the accuracy, completeness, and reliability of the study data 
presented to the Sponsor lies with the Investigator generating the data. 
The Sponsor or Sponsor designee may arrange audits as part of the implementation of quality 
assurance to ensure that the study is being conducted in compliance with the protocol, Standard 
Operating Procedures, GCP, and all applicable regulatory requirements. Audits will be 
independent of and separate from the routine monitoring and quality control functions. Quality 
assurance procedures will be performed at the study sites and during data management to assure 
that data are adequate and well documented.  
The Investigator shall promptly notify the Sponsor or designee of any audits scheduled by any 
regulatory authorities and promptly forward copies of any audit reports received to the Sponsor or 
designee. 
The Study Sponsor or designee will secure agreement from all involved parties to ensure direct 
access to all study related sites, source data and documents, and reports for the purpose of 
monitoring and auditing by the Study Sponsor, and inspection by domestic and foreign regulatory 
authorities. Quality control will be applied to each stage of data handling to ensure that all data are 
reliable and have been processed correctly. Agreements made by the Study Sponsor with the 
Investigator/Institution and any other parties involved in the clinical study will be provided in 
writing as part of the protocol or as a separate agreement. 
11.3 
Auditing and Inspection 
The Investigator will permit study-related monitoring, audits, and inspections by the IRB/IEC, the 
Sponsor, government regulatory bodies, and institutional compliance and quality assurance groups 
of all study related documents (e.g., source documents, regulatory documents, data collection 
instruments, study data etc.). The Investigator will ensure the capability for inspections of 

 
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applicable study-related facilities (e.g., pharmacy, diagnostic laboratory, etc.). 
Participation as an Investigator in this study implies acceptance of potential inspection by 
government regulatory authorities and applicable institutional compliance and quality assurance 
offices. 
12 PROTOCOL AMENDMENTS AFTER STUDY INITIATION 
Should changes in the study plan or protocol become necessary in the course of the clinical trial, 
those specific changes will be discussed and agreed upon by the Sponsor, its acting representative 
if appropriate, Investigator, and appropriate IRB/IEC approval obtained before the changes are 
implemented. All changes must be documented as protocol amendments. 
13 ETHICAL CONSIDERATIONS 
This study is to be conducted according to US and international standards of GCP, including 
ISO 14155 GCPs, applicable government regulations and Institutional research policies and 
procedures. 
This protocol and any amendments will be submitted to a properly constituted IRB/IEC, in 
agreement with local legal regulations, for formal approval of the study conduct. The decision of 
the IRB/IEC concerning the conduct of the study will be made in writing to the Investigator and a 
copy of this decision will be provided to the Sponsor before commencement of this study. 
The study Sponsor will select Principal Investigators (PIs) that are qualified by education, training, 
and experience to assume responsibility for the proper conduct of this clinical trial. For this study, 
the PI and sub-Investigators must be health care professionals appropriately trained and/or 
licensed. 
The Investigator must ensure that all personnel involved in the conduct of the study are qualified 
to perform their assigned responsibilities through relevant education, training, and experience. The 
Investigator and all clinical study staff must conduct the clinical study in compliance with the 
protocol. The Investigator is not allowed to deviate from the protocol except to protect the rights, 
safety, and well-being of human subjects under emergency circumstances. Emergency deviations 
may proceed without prior approval of the Sponsor but shall be documented and reported to the 
Sponsor as soon as possible. Deviations from this protocol, regulatory requirements and/or GCP 
must be recorded and reported to the Sponsor prior to database lock. If needed, corrective and 
preventive action should be identified, implemented, and documented within the study records. 
Use of waivers to deviate from the clinical protocol is prohibited. 
Before clinical study initiation, this protocol, must be approved by an IRB/IEC. The Investigator 
must provide documentation of the IRB/IEC approval to the Study Sponsor. The approval must be 

 
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dated and must identify the applicable protocol, amendments (if any). The IRB/IEC must be 
provided with a copy of the Package Insert/Directions for Use, any periodic safety updates, and all 
other information as required by local regulation and/or the IRB/IEC. At the end of the study, the 
Investigator must notify the IRB/IEC about the study’s completion. The IRB/IEC also must be 
notified if the study is terminated prematurely. Finally, the Investigator must report to the IRB/IEC 
on the progress of the study at intervals stipulated by the IRB/IEC. 
Voluntary informed consent must be obtained in writing from every subject or legal representative, 
as applicable, and the process shall be documented before any data are being collected for this 
study. The Investigator must have a defined process for obtaining consent. Specifically, the 
Investigator, or their delegate, must explain the clinical study to each potential subject and the 
subject must indicate voluntary consent by signing and dating the approved informed consent 
form. The subject must be provided an opportunity to ask questions of the Investigator, and if 
required by local regulation, other qualified personnel. The Investigator must provide the subject 
with a consent form written in a language the subject understands. The consent document must 
meet all applicable local laws and provide subjects with information regarding the purpose, 
procedures, requirements, and restrictions of the study, along with any known risks and potential 
benefits associated with the study device and the study, the available compensation, and the 
established provisions for maintaining confidentiality of personal, protected health information. 
Subjects will be told about the voluntary nature of participation in the study and must be provided 
with contact information for the appropriate individuals should questions or concerns arise during 
the study. The subject also must be told that their records may be accessed by appropriate 
authorities and Sponsor-designated personnel. The Investigator must keep the original, signed 
copy of the consent (filed in subject’s medical records) and must provide a duplicate of the signed 
copy to each subject according to local regulations. 
14 STUDY FINANCES 
14.1 
Funding Source 
This study is financed by Alcon Research LLC. The Sponsor will secure a human clinical trial 
insurance certificate according to applicable country regulations, when required. 
14.2 
Conflicts of Interest 
Investigators are required to provide financial disclosure information to allow the Sponsor to 
submit the complete and accurate certification or disclosure statements required under US FDA 
21 CFR 54. In addition, the Investigator must provide to the Sponsor a commitment to promptly 
update this information if any relevant changes occur during the course of the investigation and 
for 1 year following the completion of the study. 

 
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Potential conflicts of interest will be subject to the processes and procedures of the institutions 
where the potential conflict exists. 
15 PUBLICATION PLAN 
Neither the complete nor any part of the results of the study carried out under this protocol, nor 
any of the information provided by the Sponsor for the purposes of performing the study, will be 
published, or passed on to any third party without the consent of the study Sponsor. Any 
Investigator involved with this study is obligated to provide the Sponsor with complete test results 
and all data derived from the study. 
At the conclusion of the trial, a multi-center manuscript may be prepared for publication in a 
reputable scientific journal. The publication of the principal results from any single center 
experience within the trial is not allowed until the publication of the multi-center results. Any and 
all exceptions to this rule require the prior written approval of the Sponsor. Investigators may 
publish study results, provided Sponsor receives a copy of any proposed oral presentation or 
written publication at least 60 days in advance of submission for publication for review. Sponsor 
has the right to comment on the appropriateness of the data analysis and presentation and have that 
comment reflected in the presentation. Investigator will meet with Sponsor prior to submission for 
publication for the purpose of making good faith efforts to discuss and resolve any issues or 
disagreement. Upon Sponsor’s request, Investigator shall remove from any such oral presentation 
or written publication any material provided to Investigator by Sponsor or any confidential 
material. In addition, if requested in writing by Sponsor, Investigator will withhold such 
publication an additional 60 days to allow for filing a patent application or taking such other 
measures as Sponsor deems appropriate to establish and preserve its proprietary rights. 
The clinical trial will be registered in a publicly accessible clinical trial registry in accordance with 
the Sponsor’s choice, and/or applicable national regulatory requirements. Clinical trial results will 
be posted within the registry in accordance with registry requirements. 
16 REFERENCES 
16.1 
References Applicable to All Clinical Studies 
• ISO 14155:2020 Clinical Investigation of Medical Devices for Human Subjects - Good 
Clinical Practice 
• ISO11980 Ophthalmic optics - Contact lenses and contact lens care products - Guidance 
for clinical investigations 
16.2 
References Applicable to Clinical Studies Conducted in the United States 
• 21 CFR 11: Electronic Records; Electronic Signatures 

 
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• 21 CFR 50: Protection of Human Subjects 
• 21 CFR 54: Financial Disclosures by Clinical Investigators 
• 21 CFR 56: Institutional Review Boards  
• 42 CFR 11: Clinical Trials Registration and Results Information Submission 
• 45 CFR 164: Security and Privacy 
16.3 
Cited References  
1. 
Stapleton F, Alves M, Bunya VY, et al. TFOS DEWS II Epidemiology Report. Ocul Surf. 
2017;15(3):334-365.  
2. 
Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II definition and classification 
report. Ocul Surf. 2017;15(3):276–283. 
3. 
Friedman NJ. Impact of dry eye disease and treatment on quality of life. Curr Opin 
Ophthalmol. 2010;21(4):310–316. 
4. 
Craig JP, Nelson JD, Azar DT, et al. TFOS DEWS II Report Executive Summary. Ocul 
Surf. 2017; 15:802-812. 
5. 
Gupta PK, Stevens MN, Kashyap N, et al. Prevalence of Meibomian Gland Atrophy in a 
Pediatric Population. Cornea. 2018;37(4):426-430.  
6. 
Markoulli M, Kolanu S. Contact lens wear and dry eyes: challenges and solutions. Clin 
Optom (Auckl). 2017 Feb 15;9:41-48.  
7. 
Jones L, Downie LE, Korb D, et al. TFOS DEWS II management and therapy report. Ocul 
Surf. 2017;15(3):575–628. 
8. 
Srinivasan S, Manoj V. A Decade of Effective Dry Eye Disease Management with Systane 
Ultra (Polyethylene Glycol/Propylene Glycol with Hydroxypropyl Guar) Lubricant Eye 
Drops. Clin Ophthalmol. 2021;15:2421-2435. 
9. 
Brown, L.D., Cai, T. T., & DasGupta, A., Interval estimation for a binomial proportion. 
Statistics in Medicine, 2001. 16(2): p. 101-133. 

 
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17 APPENDICES AND ATTACHMENTS 
17.1 
Glossary of Terms 
Names of Test 
Product(s) 
Throughout this document, test product(s) will be referred to as Systane 
Ultra Preservative Free (PF). 
Adverse Device Effect 
(ADE) 
Adverse event related to the use of an investigational medical device or 
comparator. 
Note: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or 
operation; any malfunction; and use error or intentional misuse. 
Adverse Event (AE) 
Untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or 
other persons, whether or not related to the investigational medical device 
or comparator and whether anticipated or unanticipated. 
Note: For subjects, this definition includes events related to the 
investigational medical device, comparator, or the procedures involved. 
For users or other persons, this definition is restricted to the use of 
investigational medical device or comparator. 
Requirements for reporting Adverse Events in the study can be found in 
Section 9.3. 
Anticipated Serious 
Adverse Device Effect 
(ASADE) 
An effect which, by its nature, incidence, severity, or outcome, has been 
identified in the risk assessment. 
Clinical Investigation 
Plan (CIP) 
The document(s) stating the rationale, objectives, design, and prespecified 
analysis, methodology, organization, monitoring, conduct, and record-
keeping of the clinical investigation.  
Note: The protocol and other documents referenced in the protocol (for 
example, the Statistical Analysis Plan, the Manual of Procedures, the 
Deviations and Evaluability Plan, and the Protocol Monitoring Plan) 
comprise the CIP. 
Clinical Investigation 
Report (CIR) / Clinical 
Study Report 
The document describing the design, execution, statistical analysis, and 
results of a clinical investigation. The Clinical Investigation Report is 
synonymous with the Clinical Study Report. 
Device Deficiency 
Inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, usability, safety, or performance.  
Note: This definition includes malfunctions, use errors, and inadequacy in 
the information supplied by the manufacturer, including labeling related to 
the investigational medical device or the comparator. 
Requirements for reporting Device Deficiencies in the study can be found 
in Section 9  
Interventional Clinical 
Trial 
A pre- or post-market clinical investigation where the assignment of a 
subject to a particular medical device is decided in advance by a clinical 
investigational plan or diagnostic or monitoring procedures requested in the 
CIP are in addition to those available as normal clinical practice and burden 
the subject.  

 
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Malfunction 
Failure of an investigational medical device to perform in accordance with 
its intended purpose when used in accordance with the instructions for use 
or clinical investigation plan (CIP), or Investigator’s brochure (IB). 
Noninterventional 
Study 
Clinical investigation that draws inferences about the possible effect of an 
intervention on subjects, but the Investigator has not assigned subjects into 
intervention groups based on a protocol and has not made any attempts to 
collect data on variables beyond those available throughout the course of 
normal clinical practice and burden to the subject. 
NOTE: The term “noninterventional” is synonymous with “observational.” 
Nonserious Adverse 
Event 
Adverse event that does not meet the criteria for a serious adverse event. 
Postmarketing / 
Postauthorization 
study 
Any study conducted within the conditions laid down in product labelling 
and other conditions laid down for the marketing of the product or under 
normal conditions of use. A postmarketing study falls either within the 
definitions of an interventional or a noninterventional study and may also 
fall within the definition of a postapproval study. 
Product Complaint 
Any oral, electronic, or written communication that alleges deficiencies 
related to the identity (labeling), quality, durability, reliability, safety, 
effectiveness, or performance of a marketed product, including failure of 
the product, labeling, or packaging to meet specifications, whether or not 
the product is related to or caused the alleged deficiency. A complaint may 
allege that an adverse event or medical device malfunction has occurred. 
Serious Adverse Device 
Effect (SADE) 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
Serious Adverse Event 
(SAE) 
Adverse event that led to any of the following:  
• 
Death. 
• 
A serious deterioration in the health of the subject, users or other 
persons as defined by one or more of the following: 
a) 
A life-threatening illness or injury. 
Note: Life-threatening means that the individual was at immediate 
risk of death from the event as it occurred, i.e., it does not include 
an event which hypothetically might have caused death had it 
occurred in a more severe form. 
b) 
Any potentially sight-threatening event or permanent 
impairment to a body structure or a body function including 
chronic diseases. 
c) 
In-patient hospitalization or prolonged hospitalization. 
d) 
A medical or surgical intervention to prevent a) or b).  
e) 
Any indirect harm as a consequence of incorrect diagnostic 
test results when used within manufacturer's instructions for 
use. 
• 
Fetal distress, fetal death, congenital abnormality or birth defect 
including physical or mental impairment. 
Note: Planned hospitalization for a preexisting condition, or a procedure 
required by the CIP, without serious deterioration in health, is not 
considered a serious adverse event. 
Refer to Section 9 for additional SAEs. 

 
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Serious Health Threat 
Signal from any adverse event or device deficiency that indicates an 
imminent risk of death, serious deterioration in state of health or a serious 
deterioration in the health in subjects, users or other persons, and that 
requires prompt remedial action for other subjects, users or other persons. 
Note: This would include events that are of significant and unexpected 
nature such that they become alarming as a potential serious health hazard 
or possibility of multiple deaths occurring at short intervals. 
Study Start 
The start of the study is considered to coincide with the enrollment of the 
first patient. 
Study Completion 
The completion of the study is considered to coincide with the study-level 
last subject last visit or the decision to terminate the study, whichever is 
later. 
Unanticipated Serious 
Adverse Device Effect 
(USADE) 
Serious adverse device effect, which by its nature, incidence, severity, or 
outcome has not been identified in the risk assessment.  
Use Error 
User action or lack of user action while using the medical device that leads 
to a different result than that intended by the manufacturer or expected by 
the user. 
Note: 
a) 
Use error includes the inability of the user to complete a task. 
b) 
Use errors can result from a mismatch between the characteristics 
of the user, user interface, task or use environment. 
c) 
Users might be aware or unaware that a use error has occurred. 
d) 
An unexpected physiological response of the patient is not by itself 
considered a use error. 
e) 
A malfunction of a medical device that causes an unexpected 
result is not considered a use error. 
Vulnerable Subject 
An individual who is unable to fully understand all aspects of the 
investigation that are relevant to the decision to participate, or who could be 
manipulated or unduly influenced as a result of a compromised position, 
expectation of benefits or fear of retaliatory response. 
 
 

 
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17.2 
Patient Questionnaires 
17.2.1 
IDEEL-SB Questionnaire 
 

 
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17.2.2 
CLDEQ-8 Questionnaire 
 

 
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