To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear
Phase: NA
Conditions: Myopia
Sponsor: CooperVision, Inc.



EX-MKTG-132 STINGRAY Protocol 28mar2022 
2

EX-MKTG-132 STINGRAY Protocol 28mar2022 
3
 
DOCUMENT CHANGE HISTORY 
 
Version 
date 
Author 
Description of change(s) 
09dec2021 
Jason Chau 
Original protocol 
14dec2021 
Jill Woods 
Revised CooperVision signature on front page;  
03feb2022 
Marc Schulze 
Several minor edits, including: 
• 
Added At-Home questionnaire to sections 4.1.1, 
4.4.3, 4.5, 4.5.2 & 4.5.3 
• 
Updated section on randomization (4.1.2) 
• 
Added/clarified eligibility criteria (section 4.2.3) 
• 
Modified lens storage section (4.3.6) for clarity 
• 
Modified order of procedures for the screening 
visit (section 4.5.1) 
• 
Clarification regarding scales/scale steps used 
for lens fit assessments (sections 4.5.2 and 
4.5.3) 
• 
Added additional in-office questionnaire item 
and removed duplicate item (4.5.3) 
• 
Correction of grammatical errors and typos 
28mar2022 
Marc Schulze 
• 
Updated protocol author to Marc Schulze as 
Jason Chau has left CORE as of 22Mar2022 
• 
OptiFree Puremoist solution has been 
reclassified from “drug” to “medical device” on 
the Health Canada website. Table 2 (section 
4.3.2) was updated accordingly to now reflect 
the MDALL number.  
• 
Clarification regarding number of study days (3) 
and number of study visits (5 including exit); this 
applies to sections (4.1.1, 4.1.2, 4.4, 4.4.2) 
• 
Corrected randomization time-point in 4.1.2 
(should be at V2 not V1) 
 
 
 

EX-MKTG-132 STINGRAY Protocol 28mar2022 
4
Table of contents 
Document change history ............................................................................................................ 3 
1 
Introduction .......................................................................................................................... 8 
2 
Objectives ............................................................................................................................ 8 
3 
Hypothesis ........................................................................................................................... 8 
4 
Materials and methods ........................................................................................................ 8 
4.1 
Study design ................................................................................................................. 8 
4.1.1 
Overall design ...................................................................................................... 9 
4.1.2 
Randomization ..................................................................................................... 9 
4.1.3 
Masking ................................................................................................................ 9 
4.2 
Study population ......................................................................................................... 10 
4.2.1 
Sample size calculation ...................................................................................... 10 
4.2.2 
Number of participants ....................................................................................... 10 
4.2.3 
Inclusion and exclusion criteria ........................................................................... 11 
4.3 
Study materials ........................................................................................................... 12 
4.3.1 
Lenses ............................................................................................................... 12 
4.3.2 
Lens care system ............................................................................................... 12 
4.3.3 
Drugs ................................................................................................................. 12 
4.3.4 
Rewetting drops ................................................................................................. 12 
4.3.5 
Ordering consumables ....................................................................................... 13 
4.3.6 
 
4.3.7 
Contact lens disposal ......................................................................................... 13 
4.3.8 
Product accountability ........................................................................................ 14 
4.4 
Scheduled and unscheduled visits .............................................................................. 14 
4.4.1 
Screening ........................................................................................................... 14 
4.4.2 
Repeated screening ........................................................................................... 14 

EX-MKTG-132 STINGRAY Protocol 28mar2022 
5
4.4.3 
Scheduled study visits ........................................................................................ 15 
4.4.4 
Unscheduled visits ............................................................................................. 15 
4.5 
Study procedures ........................................................................................................ 16 
4.5.1 
Visit 1 Screening and Fit Visit ............................................................................. 17 
4.5.2 
Visit 2 Dispense Pair # 1 .................................................................................... 18 
4.5.3 
Visit 3 1-Month Follow-Up Pair #1 & Dispense Pair #2 ....................................... 20 
4.5.4 
Visit 4 1-Month Follow-Up Pair #2 ...................................................................... 22 
4.5.5 
Exit visit .............................................................................................................. 23 
5 
Monitoring protocol adherence .......................................................................................... 23 
6 
Potential risks and benefits to human participants ............................................................. 23 
7 
Adverse events .................................................................................................................. 24 
8 
Discontinuation from the study ........................................................................................... 26 
9 
Study completion and remuneration .................................................................................. 28 
10 
Statistical analysis and data management ......................................................................... 28 
10.1 
Statistical analysis ................................................................................................... 28 
10.2 
Data management ................................................................................................... 29 
10.3 
Comments on source documents ............................................................................ 29 
11 
Protocol training ................................................................................................................. 30 
12 
Study monitoring ................................................................................................................ 30 
13 
Study management............................................................................................................ 30 
13.1 
Statement of compliance ......................................................................................... 30 
13.2 
Ethics review ........................................................................................................... 31 
13.3 
Clinical trial registration ............................................................................................ 31 
13.4 
Protocol deviations .................................................................................................. 31 
13.4.1 
Major protocol deviations.................................................................................... 31 
13.4.2 
Minor protocol deviations.................................................................................... 31 

EX-MKTG-132 STINGRAY Protocol 28mar2022 
6
13.4.3 
Reporting and documenting protcol deviations ................................................... 32 
13.5 
Premature termination of the study .......................................................................... 32 
13.6 
Study participant records ......................................................................................... 32 
13.7 
Retention of study records and data ........................................................................ 32 
14 
Report................................................................................................................................ 33 
 
 

EX-MKTG-132 STINGRAY Protocol 28mar2022 
7
 
 
 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. 
 
 
 

EX-MKTG-132 STINGRAY Protocol 28mar2022 
8
1 
INTRODUCTION 
As new lenses come to market it is of interest to compare the performance of the new product to 
the performance of established products. This study will evaluate the performance of two 
monthly replacement silicone hydrogel lenses after one month of bilateral wear, in habitual 
frequent replacement (FRP) soft contact lens (CL) wearers. The established product is 
CooperVision’s Biofinity Sphere (Lens A) and the new product to market is the recently launched 
Total 30 (lens B) manufactured by Alcon Inc..  
2 
OBJECTIVES 
To evaluate the performance of two monthly replacement silicone hydrogel contact lenses in 
habitual FRP CL wearers when worn for 1-month.  
The primary outcome variables for this study are: 
• 
Lens handling on removal (0-10 scale, 0.5 steps) at 1-month visit  
 
 
 
 
 
  
 
 
 
 
 
   
 
3 
HYPOTHESIS 
The null hypothesis is that there will be no difference between Lens A and Lens B for the 
primary outcome variable of lens handling on removal (0-10 scale, 0.5 steps) collected after 1-
month of wear. 
 
4 
MATERIALS AND METHODS 
4.1 STUDY DESIGN 

EX-MKTG-132 STINGRAY Protocol 28mar2022 
9
4.1.1 OVERALL DESIGN 
This study will be a prospective, randomized, double-masked, single-site, 1-month cross-over 
design involving bilateral eye daily wear of two different monthly replacement CL types. Each 
lens will be worn bilaterally for approximately one month. 
There are 5 scheduled study visits that take place on 3 different days, including the screening 
and exit visits: 
Visit 1: Screening/eligibility, baseline assessments and fitting of both study lenses   
Visit 2: Subject randomization and Dispense of study lens Pair #1 (this will be combined with 
Visit 1 if participant meets all eligibility criteria at V1 ) 
Visit 3: 1-month follow up of study Pair #1, dispense of study Pair #2 
• 
1 
Visit 4: 1-month follow up of study Pair #2, and study exit 
• 
 
EXIT: Anticipated to follow immediately after Visit 4 unless participant discontinues early 
 
 
4.1.2 RANDOMIZATION 
A randomization schedule will determine the order of wear of lens A and lens B for the first and 
second month, for each participant. Participants will be randomized at the beginning of Visit 2 
after eligibility has been confirmed during V1. 
A randomization schedule will be generated by CORE’s data management team and provided to 
the unmasked research assistant(s) for the study. It will be included in the final report. Study 
investigators will remain masked to the randomization schedule until the study is completed and 
the database is locked.  
4.1.3 MASKING 
Participants will be masked to the lens assignment. Lenses dispensed to participants may have 
the foil label completely removed or have all or part of the label obscured. 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. 

EX-MKTG-132 STINGRAY Protocol 28mar2022 
10
 
4.2 STUDY POPULATION 
4.2.1 SAMPLE SIZE CALCULATION 
The sample size was calculated using data of ‘lens handling at removal’ ratings collected in a 
previous study using a 0-10 rating scale. This data showed a standard deviation of paired 
differences of 1.02. With an alpha level of 0.05 in a paired difference test, and power of 84%, a 
minimum sample size of 20 participants is recommended in order to determine a statistically 
significant difference of 0.71 between study lenses , Figure 1. 
To account for dropout, up to 25 participants may be randomized and dispensed with study 
product in total, with the target of at least 20 completing the study.  
 
Figure 1: Sample size calculation graph 
 
4.2.2 NUMBER OF PARTICIPANTS 
Participants will be recruited using CORE records and advertising approved by the UW Office of 
Research Ethics. Approximately 25 eligible participants may be dispensed with study products, 

EX-MKTG-132 STINGRAY Protocol 28mar2022 
11
with a target of at least 20 completing the study. Informed consent will be obtained for all 
participants prior to their enrolment in the study and prior to any study data collection. 
4.2.3 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. Self-reports having had a full eye examination within the previous 2 years; 
3. Has read and signed an information consent letter; 
4. Is willing and able to follow instructions and maintain the appointment schedule; 
5. Is a habitual wearer of frequent replacement contact lenses; 
6. Anticipates no difficulty wearing the contact lenses for 6 days/week and 8 hours/day 
during the study; 
7. Has refractive astigmatism no higher than -0.75DC in each eye; 
8. Can be successfully fit with both study lens types; 
9. Achieves at least 0.4 logMAR VA monocularly and at least 0.2 logMAR VA binocularly 
with each study lens type. 
 
A person will be excluded from the study if he/she: 
1. Is participating in any concurrent clinical research study; 
2. Has any known active* ocular disease and/or infection; 
3. Has an unstable systemic condition that in the opinion of the investigator may affect 
vision or contact lens comfort across the 2-month study duration; 
4. Is using any systemic or topical medications in an irregular routine that in the opinion of 
the investigator may affect vision or contact lens comfort across the 2-month study 
duration;  
5. Has known sensitivity to the diagnostic sodium fluorescein to be used in the study; 
6. Is an employee of the Centre for Ocular Research & Education. 
 
* For the purposes of this study, active ocular disease is defined as infection or inflammation 
which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid 
abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival 
staining and mild dry eye are not considered active ocular disease. Neovascularization and 

EX-MKTG-132 STINGRAY Protocol 28mar2022 
13
Participants will not be encouraged to use rewetting drops; however, those who habitually used 
rewetting drops will be allowed to continue using their normal drops. Rewetting drop use will be 
recorded at each visit.  
4.3.5 ORDERING CONSUMABLES 
All study lenses will be provided by CooperVision or sourced from local commercial channels.  
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
  
  
  
 
  
4.3.7 CONTACT LENS DISPOSAL 
Participants will be instructed to wear the lenses daily and remove at the end of the day to 
clean/store them in the OptiFree PureMoist provided. All contact lenses worn to each 1-month 
follow up visit will be collected and stored as per the instructions in section 4.3.6 above. These 
worn lenses will later be shipped to CooperVision for deposition and surface analysis and 
subsequent disposal. No genetic materials will be analysed. Unworn lenses may be transferred 

EX-MKTG-132 STINGRAY Protocol 28mar2022 
14
to another study or destroyed, according to instructions from CooperVision at the end of the 
study. 
4.3.8 PRODUCT ACCOUNTABILITY 
Accountability logs will be kept to include the number of lenses and lens care system bottles 
received, dispensed, unused and disposed of. All products dispensed to participants will be 
recorded in the study binder. A manifest will be created for the worn lenses collected, stored and 
shipped. 
4.4 SCHEDULED AND UNSCHEDULED VISITS 
This study has a total of 5 study visits, including the screening and exit visits. They are as 
follows: 
• 
Visit 1: Includes screening, baseline assessments, randomization and fitting of both study 
lenses   
• 
Visit 2: Randomization & Dispense of study lens Pair #1 (this will be combined with Visit 
1 if all eligibility criteria met at V1) 
• 
Visit 3: 1-month follow up of study Pair #1, dispense of study Pair #2 
• 
Visit 4: 1-month follow up of study Pair #2 
• 
EXIT: Typically occurring immediately after Visit 4 unless participant discontinues early 
The scheduled follow-up visits 3 and 4 may only take place when the participant attends wearing 
the study lenses for a minimum of 6 hours. If this is not the case, and the participant is not 
experiencing any problems with the lenses, the appointment will be rescheduled, ideally within 
the visit window.  
Visits that fall outside of the specified visit windows will be designated as protocol deviations and 
at the end of the study, the data collected during protocol deviations will be assessed for their 
suitability to be included in the analysis population.  
4.4.1 SCREENING  
The investigator will determine participant eligibility at Visit 1 using the inclusion and exclusion 
criteria. Participants will be assigned a study ID number after they sign the consent 
documentation process, i.e. before their eligibility for the study has been confirmed. Ineligible 
participants will be discontinued from the study. 
4.4.2 REPEATED SCREENING  

EX-MKTG-132 STINGRAY Protocol 28mar2022 
17
 
4.5.1 VISIT 1 SCREENING AND FIT VISIT 
Informed consent shall be obtained in writing from the participant and the process shall be 
documented before any procedure specific to the clinical investigation is carried out. Participants 
will be assigned a study ID after they sign the consent documentation, i.e. before their eligibility 
for the study has been confirmed.  
The investigator will determine participant eligibility using the inclusion and exclusion criteria. 
Ineligible participants will be discontinued from the study.  
The study procedures to be conducted at this visit are detailed below: 
1. The participant is expected to attend the screening / baseline visit wearing either their 
habitual contact lenses or spectacles.  
2. The participant will be required to read and sign an Informed Consent Form prior to 
enrollment. When the participant has signed the consent form, the participant will be 
considered enrolled in the study. 
3. Participant demographics and medical history (age, sex, medical conditions, 
medications, allergies). 
4. Contact lens history (habitual lens information and wearing habits).  
5. 
 
 
 
6. The participant removes their habitual contact lenses (if applicable).  
7.
 
 
 
 
 
 
 
 

EX-MKTG-132 STINGRAY Protocol 28mar2022 
18
c. 
 
 
 
 
 
 
12. Trial fitting of both study lenses. For logistical purposes to ensure the appropriate fitting 
for each lens type, the study investigator will not be masked during the trial fitting of the 
lenses. 
a. 
 
 
. 
b. The contact lenses will be provided to participants in a manner that does not 
unmask the participant as described in Section 4.1.3. 
c. The participant will insert the lenses. 
d. 
 
 
 
 
 
 
 
 
13. The investigator will confirm that the participant meets the eligibility specifications set out 
in the inclusion criteria and exclusion criteria and is eligible to continue in the study. 
14. 
 
   
 
4.5.2 VISIT 2 DISPENSE PAIR # 1 
This visit may or may not be immediately subsequent to the screening visit, depending on lens 
availability but will occur no later than 30 days after Visit 1.  

EX-MKTG-132 STINGRAY Protocol 28mar2022 
20
c) 
 
 
  
 
 
 
 
  
11. The participant will be asked to wear the study lenses for at least 8 hours per day and 6 
days per week. 
12. 
 
 
13. The participant will be provided with instructions for the safe wear & care of the contact 
lenses as well as sufficient care product supply.  
14. 
 
 
4.5.3 VISIT 3 1-MONTH FOLLOW-UP PAIR #1 & DISPENSE PAIR #2 
Participants will be asked to attend this visit after wearing Lens Pair #1 for at least 6 hours. This 
visit will occur 28-31 days (inclusive) after visit 2. 
The study procedures are outlined below: 
1. Review changes to medical history and medications. 
2. The participant will be asked to score their subjective responses and rate their typical 
wearing schedule and reflect on their overall satisfaction 
 
 during the month for the lens performance items listed below:  
a) 
 
 
 
d) Overall satisfaction with handling for lens removal (0 – 10 scale, 0.5 steps); 
e) 
 
 
 

EX-MKTG-132 STINGRAY Protocol 28mar2022 
22
6. 
 
7. Study lens collection at 1-month: following the instructions listed in section 4.3.6, lenses 
will be removed from participant’s eyes and stored.  
8. 
 
 
 
 
 
 
 
 
 
9. 5-minute wash-out period following the lens removal. 
10. The participant will be assigned the second pair (lens pair #2) of contact lenses (either 
Lens A or Lens B), which will be selected according to the randomization table.  
11. Lens pair #2 will be provided to participants in a manner, which does not unmask the 
participant or investigator, as described in Section 4.1.3.  
12. The same procedures will be followed to dispense study lens #2 as described in Section 
4.5.2 DISPENSING LENS PAIR #1 (VISIT 2), points 6 to 13. 
13. 
 
 Additional lens case and care products will be provided as needed. 
 
4.5.4 VISIT 4 1-MONTH FOLLOW-UP PAIR #2 
Participants will be asked to attend this visit after wearing Lens Pair #2 for at least 6 hours. This 
visit will occur 28-31 days (inclusive) after visit 3. 
The study procedures are outlined below: 
1. The same procedures will be carried out for study lens #2 as described in Section 4.5.3 
1-MONTH FOLLOW-UP OF LENS TYPE #1 (VISIT 3), points 1 to 8. 
2. 
 
 
 

EX-MKTG-132 STINGRAY Protocol 28mar2022 
23
 
4.5.5 EXIT VISIT 
The study exit form will be completed when a participant exits the study. This form will be 
completed either at study completion, or if the participant is discontinued from the study at 
another time. A study exit form must be completed for all participants who have taken a study ID 
number. If in the opinion of the investigator post-study follow-up visits are required, the exit form 
will be completed after the last follow-up visit.  
 
 
. 
After the exit assessments have been completed, the participant and investigator will complete 
the study completion and remuneration forms. At this time the participant will be considered as 
having exited the study. 
 
5 
MONITORING PROTOCOL ADHERENCE 
Adherence to study visit windows, lens wearing schedule, and time windows around other data 
collection points (i.e. subjective ratings) will be monitored internally by CORE. Deviations from 
the study plan as described in the protocol will be reported in the study report. As described in 
Section 13.4.3, 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). 
6 
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 according to their approved use ie. worn daily on a 
monthly replacement schedule, and participants will be asked to wear them for a minimum of 6 
days a week, 8 hours a day. Adverse events and/ or complications in daily wear of soft contact 
lenses can occur (eg: inflammation and infection). 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 

EX-MKTG-132 STINGRAY Protocol 28mar2022 
24
adverse reaction compared with wearing contact lenses on a daily wear basis. Participants in 
this study will be instructed to remove and clean the lenses at the end of each day, using the 
products and lens case provided.  
Additionally, it is possible that participants may experience temporary discomfort associated with 
the study procedures and contact lens wear including: burning and stinging, blurred vision, 
sandiness or grittiness, light sensitivity, dryness, itching, crusty eyes and foreign body sensation.  
Parts or all of this study will be conducted during the COVID-19 pandemic. Therefore, risks of 
infection with COVID-19 exist through participation. These risks arise due to possible exposure 
during commute to and from the study visit as well as during the study visit, particularly due to 
the closeness of the investigator and participant (within 2m for some assessments). The 
potential effects of COVID-19 are not yet fully known and may include long-term health 
consequences. In a small percentage, infection with COVID-19 can lead to serious illness, 
hospitalization, and in rare cases to complications leading to death. Individuals aged 60 and 
above and those with underlying medical conditions are considered at a greater risk for severe 
illness from the COVID-19 virus.   
In consideration of risks associated with COVID-19, CORE has implemented a series of on-site 
safety procedures which have been reviewed and approved by the University of Waterloo. 
These include, but are not limited to, self-screening of investigators and participants prior to 
entering the building, maintaining physical distancing as much as possible, frequent 
handwashing, wearing of face masks by the investigator and participant, and frequent room and 
equipment hygiene and decontamination. In addition, members of CORE and participants follow 
the University policies regarding Covid-19 vaccination. 
Participants will not benefit directly from taking part in this study. Information from this study may 
help researchers come up with new soft contact lens designs to help others in the future. This 
study may help the study sponsor to better understand the performance of the products being 
used in this study. 
7 
ADVERSE EVENTS 
See CORE SOP012 AE Reporting for a description of the reporting of adverse events, including 
management and reporting. An ‘adverse event’ refers to any undesirable clinical occurrence in a 
participant, whether it is considered to be device-related or not. Adverse events (AE) may be 
classified as ‘unanticipated adverse device effects’, ‘serious adverse events’, ‘significant adverse 

EX-MKTG-132 STINGRAY Protocol 28mar2022 
27
option of their data being withdrawn from future statistical analysis. 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 4.2.3. 
• 
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-132 STINGRAY Protocol 28mar2022 
28
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.   
All discontinuations including their reasons will be included in the final report. 
9 
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.  The participants will also be provided 
with a letter of appreciation.  This letter provides information on how to seek the study results 
when the study is completed. 
After signing the completion forms, participant remuneration will be provided in the form of a 
cheque and documentation will be signed to confirm receipt. Remuneration will be calculated at 
a rate of $20 per visit hour (including the initial screening visit). Full details are given in the 
information consent letter. 
10 STATISTICAL ANALYSIS AND DATA MANAGEMENT 
10.1 STATISTICAL ANALYSIS 
Primary comparisons will be between study lenses (e.g. in-office subjective ratings of lens 
handling collected after 1 month).  
All data will be analyzed by CORE at the University of Waterloo. Unmasked data analysis will be 
conducted using Statistica, SPSS or other appropriate software. Descriptive statistics will be 
provided on information regarding baseline variables (age, gender, refractive error distribution, 
etc.).  
 
 
Table 7 lists the primary outcome variables and anticipated statistical procedures. 
Table 7: Statistical procedures 

EX-MKTG-132 STINGRAY Protocol 28mar2022 
30
Data analysis will not be conducted on comments which have been recorded in the source 
documents. Only highlighted 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.  
11 PROTOCOL TRAINING 
All study personnel will be required to complete training prior to their involvement in the study. 
Records of training will be kept at CORE. 
 
12 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 enrolled (i.e. assigned a study ID number), screened, 
dispensed, discontinued and completed. 
• 
Details of protocol deviations. 
• 
Reports of unintended events. 
Study monitoring will be conducted by CORE personnel. Consent documentation will be 
reviewed by a person not involved in the consent process. To improve data integrity, data entry 
will be conducted by one person and a second person will visually compare the data entry to the 
source documents. All adverse events and protocol deviations will be reviewed by the Lead 
Investigator. All serious adverse events and major protocol deviations will be reviewed by the 
Principal Investigator. 
13 STUDY MANAGEMENT 
13.1 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 

EX-MKTG-132 STINGRAY Protocol 28mar2022 
31
• 
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/ 
 
13.2 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. 
13.3 CLINICAL TRIAL REGISTRATION 
The sponsor will register this study with clinicaltrials.gov in accordance with section 801 of the 
Food and Drug Administration (FDA) Act which mandates the registration of certain clinical trials 
of drugs and medical devices. 
13.4 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.  
13.4.1 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. 
13.4.2 MINOR PROTOCOL DEVIATIONS 

EX-MKTG-132 STINGRAY Protocol 28mar2022 
32
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).  
13.4.3 REPORTING AND DOCUMENTING PROTCOL 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. 
All protocol deviations (major and minor) occurring during the study will be documented, 
reported to the sponsor and included in the final report. 
13.5 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. 
13.6 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. 
13.7 RETENTION OF STUDY RECORDS AND DATA 

EX-MKTG-132 STINGRAY Protocol 28mar2022 
33
Records and data from this study will be retained for a minimum of 25 years. Details regarding 
storage procedures are given in CORE SOP014 Clinical data management.  
 
14 REPORT 
A report will be sent to the sponsors according to terms described in the study contract.