Comparison of Verofilcon A Daily Disposable Lenses to Somofilcon A Daily Disposable Lenses
Phase: NA
Conditions: Myopia
Sponsor: CooperVision, Inc.



EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
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EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
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DOCUMENT CHANGE HISTORY 
 
 
Version # 
Author 
Description of change(s) 
Date 
1.0 
Amir Moezzi 
Original protocol 
14nov2019 
1.1 
Amir Moezzi 
Clarified that a stopwatch will be used to measure 
NITBUT throughout the protocol 
Section 12.1 STATISTICAL ANALYSIS: Removed 
“The number of “neither agree nor disagree” 
responses will be evenly distributed to the two options 
on the basis they would be equally likely to choose 
either” from the end of this section. 
20nov2019 
1.2 
Amir Moezzi 
Expanded the power range of study lenses to between 
-0.50 to -10.00 D. This change is reflected in sections 
5.1.3 (inclusion #7) and 5.2.1 (Table 1). 
Added “or has any history of wearing one of the study 
contact lenses” in section 5.1.3 (exclusion #10) for 
clarification. 
16dec2020 
 
 
 

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
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Table of contents 
Document change history ............................................................................................................. 3 
1 
Introduction ........................................................................................................................... 8 
2 
Objectives ............................................................................................................................. 8 
3 
Hypothesis ............................................................................................................................ 9 
4 
Materials and methods .......................................................................................................... 9 
4.1.1 
Study design ............................................................................................................ 9 
4.1.2 
Overall design .......................................................................................................... 9 
4.1.3 
Randomization ....................................................................................................... 11 
4.1.4 
Masking ................................................................................................................. 11 
5 
Study population ................................................................................................................. 11 
5.1.1 
Sample size calculation ......................................................................................... 11 
5.1.2 
Number of participants ........................................................................................... 12 
5.1.3 
Inclusion and exclusion criteria .............................................................................. 12 
5.1.4 
Repeated screenings ............................................................................................. 13 
5.2 
Study materials ............................................................................................................. 13 
5.2.1 
Lenses ................................................................................................................... 13 
5.2.2 
Rewetting drops ..................................................................................................... 14 
5.2.3 
Ordering consumables ........................................................................................... 14 
5.2.4 
Contact lens dispensing ......................................................................................... 14 
5.2.5 
Contact lens disposal ............................................................................................. 14 
5.2.6 
Product accountability ............................................................................................ 15 
5.3 
Scheduled and unscheduled visits ................................................................................ 15 

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
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5.3.1 
Study visits ............................................................................................................ 15 
5.3.2 
Screening (Visit 1) ................................................................................................. 16 
5.3.3 
Dispensing lens type #1 (Visit 2) ............................................................................ 17 
5.3.4 
1-week follow-up of lens type #1 (Visit 3) ............................................................... 19 
5.3.5 
Dispensing lens type #2 (Visit 4) ............................................................................ 20 
5.3.6 
1-week follow-up of lens type #2 (Visit 5) ............................................................... 21 
5.3.7 
Study exit ............................................................................................................... 22 
5.3.8 
Unscheduled visits ................................................................................................. 22 
5.4 
Study procedures .......................................................................................................... 22 
5.5 
Recording findings of interest ...................................................................................... 23 
6 
Monitoring protocol adherence ............................................................................................ 23 
7 
Potential risks and benefits to human participants ............................................................... 24 
8 
Adverse events ................................................................................................................... 24 
8.1 
Normal or adaptive symptoms ...................................................................................... 26 
8.2 
Procedures for adverse events ..................................................................................... 27 
8.3 
Reporting adverse events ............................................................................................. 27 
9 
Discontinuation from the study ............................................................................................ 28 
10 
Device malfunctions ............................................................................................................ 29 
11 
Study completion and remuneration .................................................................................... 29 
12 
Statistical analysis and data management ........................................................................... 30 
12.1 
Statistical analysis ..................................................................................................... 30 
12.2 
Data management ..................................................................................................... 31 
12.3 
Comments on source documents .............................................................................. 31 

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
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13 
Protocol training .................................................................................................................. 31 
14 
Study monitoring ................................................................................................................. 31 
15 
Study management ............................................................................................................. 32 
15.1 
Statement of compliance ........................................................................................... 32 
15.2 
Ethics review ............................................................................................................. 32 
15.3 
Clinical trial registration ............................................................................................. 32 
15.4 
Protocol deviations .................................................................................................... 32 
15.4.1 
Major protocol deviations ....................................................................................... 33 
15.4.2 
Minor protocol deviations ....................................................................................... 33 
15.4.3 
Reporting and documenting protocol deviations ..................................................... 33 
15.5 
Premature termination of the study ............................................................................ 34 
15.6 
Study participant records ........................................................................................... 34 
15.7 
Retention of study records and data .......................................................................... 34 
16 
Report ................................................................................................................................. 34 
17 
References .......................................................................................................................... 34 
 
 

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
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 Confidentiality 
This is a private document and the property of the Centre for Ocular Research & Education. It 
is therefore confidential to the recipient and must not be quoted from or distributed beyond the 
company to which it is sent without the express written permission of the Director (or her/his 
designate) of the Centre for Ocular Research & Education. Release of information from this 
document is governed by the research agreement on file. 
 
Disclaimer 
This study will be conducted for research purposes only and is not intended to be used to support safety 
and efficacy in a regulatory submission. 
 
 
 

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
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1 
INTRODUCTION 
The 2018 International Contact Lens Prescribing report1 describes 32% of soft lenses are 
prescribed on a daily disposable (DD) basis worldwide (27% in US), compared with 13% and 51% 
on a one-to-two week and monthly replacement schedule, respectively (30% and 41% in US). 
There has been an upward trend in prescribing daily disposables for several years.2   
Until recently, DD lenses were mainly available in a hydrogel material. However, in line with the 
increasing market share of DD lens modality, more and more new silicone hydrogel (SiHy) DD 
lenses are becoming available. One of these new SiHy DD lenses are Precision1 lenses that has 
been recently introduced by Alcon. 
This study will evaluate the performance of Alcon’s Precision1 compared to CooperVision’s clariti 
1 day. All participants will habitually wear soft contact lenses, but they do not have to habitually 
wear daily disposable lenses. Participants from BOXER (EX-MKTG-107, phases 1 or 2) and MIKI 
(EX-MKTG-114) studies are not allowed to take part in this study. All lenses used in this study are 
spherical, silicone hydrogel daily disposables lenses that are approved by Health Canada.  
2 
OBJECTIVES 
The objective of the study is to evaluate and compare the performance of Alcon’s Precision1 lens 
(P1) to clariti 1 day (C1D), when worn on a daily disposable modality over a period of approximately 
one week each. C1D is considered the study test lens. P1 will be the control lens. 
The primary outcome variables of this study are: 
• 
Subjective ratings for ‘Lens handling for lens insertion’ (0 - 10 integer scale) for TEST lens 
compared to CONTROL, collected at the 1-week visit reflecting on a ‘typical day’ 
experience during the study; 
• 
Subjective ratings for ‘Lens handling for lens removal’ (0 - 10 integer scale) for TEST lens 
compared to CONTROL, collected at the 1-week visit reflecting on a ‘typical day’ 
experience. 
The secondary outcome variables are:  
• 
Centration (optimal, slight decentration, moderate decentration but not encroaching 
limbus, excessive & occasionally encroaching limbus), collected at dispense & 1-week 
visit; 
• 
Post-blink movement in primary gaze, mm, collected at dispense & 1-week visit; 

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
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• 
Push-up tightness in primary gaze (0-100), collected at dispense & 1-week visit. 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3 
HYPOTHESIS 
The study hypothesis is that: 
C1D will perform as well or better than P1 for the ratings of lens handing for lens insertion and 
lens removal; 0-10 integer scale, collected at the 1-week visit reflecting on a ‘typical day’ 
experience. 
4 
MATERIALS AND METHODS 
4.1.1 STUDY DESIGN 
4.1.2 OVERALL DESIGN 
The study is a prospective, double masked (investigator and participant), bilateral, randomized, 
one week cross-over dispensing study, which evaluates C1D (test lens) and P1 lenses (control 
lens).  

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
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o 
 
 
 
 
 
 
 
 
 
4.1.3 RANDOMIZATION 
A randomization schedule will be generated using a web-based program: (for example 
www.randomization.com) by CORE’s Data management team, and provided to the research 
assistants for the study. The schedule will determine the order of lens wear for participants in the 
study. Study investigators will remain masked to the randomization schedule until the study is 
completed and the database has been locked.  
4.1.4 MASKING 
Participants will be masked to the lens assignment. Lenses dispensed to participants may be either 
over-labelled or have part of the label obscured, however the safety information shall be clearly 
visible. Investigators will be masked as much as possible however it may not be possible to fully 
mask the investigators, because identifying lens markings may be visible during the biomicroscopy 
examination. 
5 
STUDY POPULATION 
5.1.1 SAMPLE SIZE CALCULATION 
 
 
 
 
A total sample size of 47 is recommended to detect a mean difference between lens handling for 
insertion of 0.8 units on the 0 to10 scale using a standard deviation of 1.9 with 80% power and 
alpha 0.05 in a two-tailed t-test. Therefore, the sample size needed for BASSET will be aimed at 
28 to complete (i.e. total of 47 minus the 19 completed participants from the BOXER phase1 pilot 
study). Therefore, it is recommended that at least 31 subjects are dispensed in the BASSET 
study, with a target of 28 to complete.  
   

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
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5.1.2 NUMBER OF PARTICIPANTS 
Participants will be screened using CORE records and advertising approved by the UW Office of 
Research Ethics. Approximately 31 participants will be dispensed with study products in the study, 
with a target of 28 completing the study.  
A documented informed consent process will be conducted with all participants prior to their 
enrolment in the study and prior to any data collection or measurements.  
5.1.3 INCLUSION AND EXCLUSION CRITERIA 
A person is eligible for inclusion in the study if he/she: 
1. Is at least 17 years of age and has full legal capacity to volunteer; 
2. Has read and signed an information consent letter; 
3. Is willing and able to follow instructions and maintain the appointment schedule; 
4. Habitually wears soft contact lenses in daily wear, for minimum of 6-months; 
5. Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses; 
6. Has an astigmatism of ≤ 1.00 D in subjective refraction; 
7. Can be fit with study contact lenses with a power between -0.50 and -10.00 DS; 
8. Demonstrates an acceptable fit with the study lenses; 
9. Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a 
week, and is willing to wear contact lenses for at least 12 hours a day in the study.  
A person may be excluded from the study if he/she: 
1. Is participating in any concurrent clinical or research study; 
2. Has any known active* ocular disease and/or infection; 
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome 
variable; 
4. Is using any systemic or topical medications that in the opinion of the investigator may 
affect a study outcome variable; 
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment because the 
associated hormonal changes cause changes in the tear layer which impact contact lens 
comfort. Verbal confirmation at the screening visit is sufficient; 
7. Is aphakic; 
8. Has undergone refractive error surgery;  

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
14 
Water content 
56% 
51% 
Sphere power (D) 
-0.50 to -6.00 (0.25 steps) 
-6.50 to -10.00 (0.50 steps) 
 
-0.50 to -6.00 (0.25 steps) 
-6.50 to -10.00 (0.50 steps) 
 
Base curve (mm) 
8.6 
8.3 
Diameter 
14.1 
14.2 
Replacement schedule 
Daily disposable 
Daily disposable 
5.2.2 REWETTING DROPS 
Participants who habitually use rewetting drops will be asked to refrain during the study, unless 
necessary for continued lens wear. Participants will keep track of rewetting drop usage, and this 
will be recorded at each visit. Rewetting drops may be used in the event of any clinical observation 
and/or adverse event noted during the study.  
5.2.3 ORDERING CONSUMABLES 
All study lenses (tests and control) will be provided by CooperVision or sourced from local 
commercial channels.  
5.2.4 CONTACT LENS DISPENSING 
Lenses will be provided to the participant after being transferred, complete with blister pack 
solution, to a contact lens cup; this will maintain participant masking and aid investigator masking. 
The use of saline for rinsing the contact lens prior to insertion is permitted if necessary. Saline will 
not be dispensed during the study.  
5.2.5 CONTACT LENS DISPOSAL  
Participants will be instructed to dispose of the worn lenses daily, and return any unworn lenses in 
their packaging at their next study visit. All contact lenses worn to each 1-week follow up visit will 
be collected and stored at -80C. These collected lenses will be shipped to CooperVision at the end 
of the study. The tear film deposits left on these lenses will be evaluated and analysed for 
composition and quantity, no genetic assessments will be conducted.  
Additionally, worn lenses associated with adverse events shall be retained at CORE and returned 
to CooperVision if requested to do so. Typical analysis in these cases relates to inspection for 
damage and/ or bacterial contamination. No genetic assessments will be conducted.  

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
19 
10. The participant will be asked to wear the study lenses for at least 12 hours per day and 5 
days per week. 
11. The participant will be provided with sufficient contact lens supply.  
12. The participant will be reminded to return for Visit 3 (1-week follow-up visit of study lens 
#1) and instructed to return used lens foils plus all leftover unworn lenses. 
5.3.4 1-WEEK FOLLOW-UP OF LENS TYPE #1 (VISIT 3) 
Participants will be asked to wear lenses for 6 to 8 hours prior to the visit appointment. Participants 
who attend without lenses in-situ (wearing lenses) for 6 to 8 hours will be rescheduled (unless they 
report problems when wearing the lenses). 
1. 
 
2. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3. 
 
 
 
 
 
5. Lens 
 fit will then be assessed and graded according to the CVI grading 
scales for the following: 
a) 
 

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
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b) 
 
 
c) Lens push-up tightness in primary gaze (0 – 100 scale); 
d) Centration in primary gaze (scale: optimal, slight decentration, moderate 
decentration but not encroaching limbus, excessive & occasionally encroaching 
limbus); 
e) Post-blink movement in primary gaze (mm);  
f) 
  
6. 
 
 
 
 
 
  
7. 
 
8. There will be a washout of 10 minutes after lens removal if Visit 4 is to be concurrent with 
this visit. 
5.3.5 DISPENSING LENS TYPE #2 (VISIT 4) 
1. The participant will be assigned the second pair (lens pair #2) of contact lenses (either 
test or control lens), which will be selected according to the randomization table.  
2. Lens pair #2 will be provided to participants in a manner, which does not unmask the 
participant or investigator, as described in Section 5.2.4.  
3. The participant will insert the lenses. 
4. The contact lenses will be allowed to settle for 10 minutes. 
5. The same procedures will be followed as described in Section 5.3.3 DISPENSING LENS 
PAIR #1 (VISIT 2), points 5 to 11. 
 
 
6. 
 
 
 

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
21 
5.3.6 1-WEEK FOLLOW-UP OF LENS TYPE #2 (VISIT 5) 
Participants will be asked to wear lenses for 6-8 hours prior to the visit. Participants who attend 
without wearing lenses for 6-8 hours will be rescheduled (unless they report problems when 
wearing the lenses).  
1. The same procedures will be carried out as described in Section 5.3.4 1-WEEK FOLLOW-
UP OF LENS TYPE #1 (VISIT 3), points 1 to 5. 
2. 
 
 
 
 
 
  
3. 
 
4. 
 
 
 
5. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
24 
15.4, major protocol deviations will be reported to the Sponsor and the University of Waterloo’s 
Office of Research Ethics (ORE) within 7 days of becoming aware of them (as per ORE’s 
guidelines).  
7 
POTENTIAL RISKS AND BENEFITS TO HUMAN PARTICIPANTS 
This is a minimal risk study because of the use of approved products and standard optometric 
assessments. 
Contact lenses in this study will be worn on a daily wear and daily disposable basis. Adverse events 
and/or complications in the daily wear of soft contact lenses can occur (e.g. inflammation and 
infection). Complications that may occur during the wearing of contact lenses include discomfort, 
dryness, aching or itching eyes, excessive tearing, discharge, hyperemia and variable or blurred 
vision. More serious risks may include photophobia, iritis, corneal edema or eye infection. Although 
contact lens-related infections are very infrequent, the possibility does exist. The incidence of 
infection due to daily-wear soft lenses is 0.035%. Almost always an infection will occur only in one 
eye. Thirty five million Americans who currently wear contact lenses assume this risk.  
When contact lenses are worn on a daily wear basis there is a small risk of an adverse event 
compared to not wearing contact lenses. When contact lenses are worn on an extended wear basis, 
there is a significantly increased risk of an adverse reaction compared with wearing contact lenses 
on a daily wear basis. 
Additionally, it is possible that participants may experience temporary discomfort associated with 
the study procedures /products including: burning and stinging, blurred vision, sandiness or 
grittiness, light sensitivity, dryness, itching, crusty eyes and foreign body sensation.  
Participants may not benefit directly from taking part in this study, other than having an opportunity 
to wear a different contact lens. However, their participation in this study may contribute to scientific 
research information that may be used in the development of new contact lens products.  
Information from this study may help researchers determine new soft contact lens designs to help 
other people in the future. This study will help the study sponsor to better understand the 
performance of the products being used in this study. 
8 
ADVERSE EVENTS 
See CORE SOP012_v02 for a description of all adverse events, including management and 
reporting. An ‘adverse event’ refers to any undesirable clinical occurrence in a participant, whether 

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
27 
not reported as adverse events unless in the investigator’s opinion they are unexpected in nature, 
severe or have a high rate of occurrence.  
8.2 PROCEDURES FOR ADVERSE EVENTS 
Treatment of an adverse event will depend on its nature and severity. Based on the clinical 
judgment of the investigator the participant may be referred to an ophthalmologist for treatment. 
The investigator will attempt to determine whether the reaction is related to the test device or a 
result of other factors. An adverse event form will be completed for each adverse event. If both 
eyes are involved, a separate adverse event form will be completed for each eye. Whenever 
possible, the adverse event will be photo-documented.  
Expenses incurred for medical treatment as part of study participation will be paid by the sponsor 
(bills and prescription receipts kept). The participant must be followed until resolution or no further 
change is anticipated and/or referred for further care with the appropriate health care professional 
and/or recorded as being under appropriate health care as per investigator’s discretion. A written 
report will be completed indicating the subsequent treatment and resolution of the condition. 
8.3 REPORTING ADVERSE EVENTS 
All potential Serious and Unanticipated Adverse Device Effects that are related or possibly related 
to participant’s participation will be reported to the Principal Investigator and the sponsor within 24 
hours of the investigator becoming aware of the event. The Investigator will report the event to the 
IRB as per IRB requirements (by fax, mail/delivery, phone, or email).  All fatal or life threatening 
events will be reported immediately to the IRB. 
Significant and Non-Significant Adverse Events will be reported to the sponsor as soon as possible, 
but no later than 5 working days after the occurrence. The Investigator will report the event to the 
ORE as per ORE requirements (by fax, mail/delivery, phone, or email). 
Sponsor contact details are:  
  
 
  
 
 
 
  
  
 
 
Details of all adverse events will be included in the study report. 

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
28 
9 
DISCONTINUATION FROM THE STUDY 
Participants discontinued from a study will be reimbursed $20 per hour for their active involvement 
in the study (including the initial screening visit).  Participants will be discontinued at the discretion 
of the investigator or sponsor in consideration of participant safety or protocol compliance, or at 
discretion of the participant.  The following is a list of possible reasons for discontinuation from the 
study: 
• 
Screening failure: Participants will be discontinued if they do not meet the inclusion and 
exclusion criteria outlined in section 5.1.3. 
• 
Unacceptable performance with products to be used in study: Participants may be 
discontinued if they are unable to achieve acceptable comfort and /or vision with the study 
products. 
• 
Positive slit lamp finding:  Participants may be permanently discontinued from the study 
depending on the severity of the condition and on the judgement of the investigator.   
• 
Adverse event: If a participant experiences an adverse event during the study they may 
be discontinued based on the clinical judgement of the investigator. 
• 
Symptoms: If the participant has persistent symptoms they may be discontinued based on 
the clinical judgement of the investigator. 
• 
Disinterest, relocation or illness: The participant may choose to discontinue due to 
reasons within or beyond their control. 
• 
Violation of protocol or non-compliance: The participant will be discontinued if they are 
unable or unwilling to follow the protocol specified visit schedules and/or study 
procedures. 
• 
Instillation of topical ocular medication: The participant will be discontinued if they elect to 
use a topical ocular medication during the study unless that topical ocular medication is 
prescribed for a limited duration (less than two weeks) to treat a transient condition; in this 
case the participant may remain an active participant (at the discretion of the investigator) 
after stopping topical ocular medication following resolution of the ocular condition). 
• 
Lost to follow-up: The participant will be discontinued if they cannot be contacted and do 
not return for a final exit visit, and if the investigator has made a reasonable effort to 
contact the participant for a final study visit. 
• 
Premature termination of the study by the sponsor, CORE or the Office of Research 
Ethics at the University of Waterloo. 

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
29 
A discontinuation form, stating the reason for discontinuation will be completed, which requires the 
signatures of both the participant and the investigator, except where the participant is lost to follow-
up in which case only the signature of the investigator is required.   
When a participant choses to discontinue from the study they will be given the opportunity to 
withdraw their data from the statistical analysis. This choice will be captured on the discontinuation 
form. 
All discontinuations including their reasons will be included in the final report. 
10 DEVICE MALFUNCTIONS 
A device malfunction means the failure of the device to meet its performance specification or 
otherwise perform as intended. Any defective lens that is likely to cause or contribute to a Serious 
Adverse Event should be reported to the Principal Investigator and the sponsor within 24 hours 
of the investigator becoming aware of the malfunction. The ORE would also be notified within 24 
hours of any device malfunction that may contribute to a Serious Adverse Event. 
Other defective lenses should be reported to the Sponsor as soon as possible (usually in weekly 
study updates to the Sponsor). 
This clinical study will also ascertain satisfaction or preference with subjective attributes such as 
comfort, vision, or lens handling. Responses to these subjective questionnaires will not be 
considered as complaints or device malfunctions. 
11 STUDY COMPLETION AND REMUNERATION 
At the last scheduled protocol visit a study completion form will be completed, which requires the 
signatures of both the participant and the investigator. Once their involvement in the study is 
complete, participants will be informed about receiving feedback following study completion in the 
Letter of Appreciation. Participant remuneration will be $20 per scheduled protocol visit hour 
(including the initial screening visit). Full details are given in the information consent letter.  

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
31 
All participants who were evaluated will be included in the analysis, unless their removal is agreed 
by the sponsor due to protocol deviations and/or adverse events. In the event of missing data, 
individual data points will not extrapolated from the collected data.  
12.2 DATA MANAGEMENT 
Data from this study will be retained by CORE for a minimum of 25 years on a password-protected 
server. After 25 years, data will be disposed of in accordance with the guidelines laid out by the 
University of Waterloo.  
At the completion of the study CORE will provide a copy of the study data to the sponsor when 
requested. All data will typically be sent using a secure file share system operated by the University 
of Waterloo called Sendit which uses 128bit (or 256bit) SSL encryption. This system provides a 
secure way to transfer files when email is not appropriate, whether because of file size, file type or 
concerns over security. Sendit includes features such as password protection, a restricted time 
period for download, IP logging and email notification of download. Files may be encrypted prior to 
transmission at the request of the sponsor. Using this method means that data files are only stored 
on University of Waterloo servers until they are downloaded by the sponsor. 
12.3 COMMENTS ON SOURCE DOCUMENTS 
Data analysis will not be conducted on comments which have been recorded in the source 
documents, however all comments will be entered into the study database. Only relevant and 
applicable comments will be included in the final report as deemed necessary by the lead 
investigator.  
13 PROTOCOL TRAINING 
All study personnel will be required to complete training prior to their involvement in the study.  
14 STUDY MONITORING 
Status reports will be provided to the study sponsor by email on a regular basis. Status reports will 
include: 
• 
The number of participants screened, enrolled, and randomized (i.e. assigned a study ID 
number), discontinued and completed. 
• 
Details of any protocol deviations. 
• 
Details of any adverse events. 

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
32 
• 
Reports of unintended events. 
Study monitoring visits may be conducted throughout the study and will be scheduled by the study 
sponsor in conjunction with the lead investigator. In addition study records may be inspected at 
CORE by the sponsor, the sponsor's designate, the Office of Research Ethics at the University of 
Waterloo, and by regulatory authorities in Canada and the United States, namely Health Canada 
and the United States Food and Drug Administration (FDA); however, no records containing 
identifiable/personal information will be permitted to leave the custody of CORE. 
15 STUDY MANAGEMENT 
15.1 STATEMENT OF COMPLIANCE 
This clinical study is designed to be in compliance with the ethical principles in the Declaration of 
Helsinki, with the ICH guidelines for Good Clinical Practice (GCP), with the University of Waterloo’s 
Guidelines for Research with Human Participants and with the Tri-Council Policy Statement: Ethical 
Conduct for Research Involving Humans, 2nd Edition.  
• 
Declaration of Helsinki 
• 
ICH E6 - International Conference on Harmonisation; Good Clinical Practice 
• 
http://iris.uwaterloo.ca/ethics/human/guidelines/index.htm 
• 
http://iris.uwaterloo.ca/ethics/human/ethicsReview/UWStatement.htm 
• 
http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/ 
 
15.2 ETHICS REVIEW 
This protocol will be submitted to and reviewed through the Office of Research Ethics (ORE) at the 
University of Waterloo. Notification of ethics clearance of the application is required prior to the 
commencement of the study. 
15.3 CLINICAL TRIAL REGISTRATION 
This study will be registered with ClinicalTrials.gov by the study sponsor.  
15.4 PROTOCOL DEVIATIONS 
Protocol deviations are unanticipated or unintentional changes to a study after it has received prior 
sponsor approval and ethics clearance. Protocol deviations can be major or minor.  

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
33 
15.4.1 MAJOR PROTOCOL DEVIATIONS 
Major protocol deviations may impact the research protocol, information consent document or other 
study materials, usually cannot be anticipated ahead of time and are often necessary to ensure the 
safety and welfare of the participants. 
The following are examples of protocol deviations that must be reported to the ORE: 
• 
Changes in procedures initiated to eliminate immediate risks/hazards to participants; 
• 
Enrollment of participants outside the protocol inclusion/exclusion criteria whether agreed 
to or not by the sponsor; 
• 
Medication / device / intervention errors (i.e. incorrect drug or dosage of drug / incorrect 
contact lens(es) dispensed / incorrect care system dispensed); 
• 
Inadvertent deviation in specific research intervention procedures or timing of the research 
intervention which could impact upon the safety or efficacy of the study-related 
intervention or upon the experimental design; 
• 
Information consent documentation violations: no documentation of informed consent; 
incorrect version of, or incomplete, informed consent documentation used. 
15.4.2 MINOR PROTOCOL DEVIATIONS 
Protocol deviations caused by or which originate with research participants are considered minor, 
and normally are not reported to the ORE unless these result in increased risk to the participant(s). 
The following are examples of protocol deviations that are considered minor and do not require 
reporting to the ORE: 
• 
Logistical or administrative aspects of the study (e.g., study participant missed 
appointment, change in appointment date); 
• 
Inadvertent deviation in specific research intervention procedures or timing of the research 
intervention which would not impact upon the safety or efficacy of the study-related 
intervention or upon the experimental design (i.e., missing a measurement during a 
session that is not considered critical for the study).  
15.4.3 REPORTING AND DOCUMENTING PROTOCOL DEVIATIONS 
Major protocol deviations must be reported to the ORE within 7 days of the deviation occurring (or 
its discovery) using the Protocol Deviation Report Form 107 (PDRF). Information from the PDRF 
is provided to the Clinical Research Ethics Committee (CREC) at the next monthly meeting. 

EX-MKTG-113 BASSET Protocol v1.2 16dec2020 
34 
All protocol deviations (major and minor) occurring during the study will be documented and 
included in the final report. 
15.5 PREMATURE TERMINATION OF THE STUDY 
The sponsor, CORE or the Office of Research Ethics at the University of Waterloo may terminate 
the study at any time for any reason. 
15.6 STUDY PARTICIPANT RECORDS 
Study participant records will be completed to comply with GCP guidelines. Records will contain: 
• 
Unique study acronym and/or code; 
• 
Participant ID; 
• 
Date enrolled; 
• 
Confirmation by investigator that participant met eligibility criteria; 
• 
Confirmation that participant received a signed and dated copy of informed 
consent; 
• 
Exit date; 
• 
Investigator’s signature confirming study exit. 
15.7 RETENTION OF STUDY RECORDS AND DATA 
Records and data from this study will be retained for a minimum of 25 years. Details regarding 
storage procedures are given in CORE SOP014_v01_Clinical data management.  
16 REPORT 
A report will be sent to the sponsors according to terms described in the study contract. 
17 REFERENCES 
1. Efron N, Morgan PB, Woods CA, et al. An international survey of daily disposable contact lens 
prescribing. Clinical & Experimental Optometry 2013;96:58-64. 
2. Morgan P, Woods C, Tranoudis I, et al. International contact lens prescribing in 2018. Contact Lens 
Spectrum 2019;34:26-32. 
3. Keir NJ, Richter D, Varikooty J, et al. End Of Day Comfort Interpreted Using A Novel Cumulative 
Comfort Score. Investigative Ophthalmology & Visual Science 2012;53:4728.