Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers
Phase: NA
Conditions: Astigmatism
Sponsor: CooperVision, Inc.



EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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Study locations 
 
1. Study co-ordination & data management institution (no clinical visits) : 
 
 
Lyndon Jones (Director) 
CORE 
 
 
 
School of Optometry & Vision Science 
 
 
 
University of Waterloo 
 
 
 
200 Columbia Street West 
 
 
 
Waterloo, Ontario N2L 3G1 
 
 
 
CANADA 
 
 
2. Clinical research conducted at several in-practice study sites in the United States. 
Details of sites and PIs will be listed in the final report. 
 
 
 
 
 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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1 
DOCUMENT CHANGE HISTORY 
 
Version 
number 
Version 
date 
Author 
Description of change(s) 
1.0 
28jan2021 
Jill Woods 
Original protocol 
1.1 
01feb2021 
Jill Woods 
Modified sample size calculation; 
Added a preference survey to compare non-optimized 
habitual lenses to study lenses. 
1.2 
10Feb2021 
Jill Woods 
Clarified primary objective; 
Expanded subjective questions 
 
 
 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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Table of contents 
1 
Document change history .................................................................................................... 4 
2 
Introduction .......................................................................................................................... 9 
3 
Objectives ............................................................................................................................ 9 
4 
Hypothesis ........................................................................................................................... 9 
5 
Materials and methods ...................................................................................................... 10 
5.1 
Study design ............................................................................................................... 10 
5.1.1 
Overall design ...................................................................................................... 10 
5.1.2 
Randomization ..................................................................................................... 10 
5.1.3 
Masking................................................................................................................ 10 
5.2 
Investigational sites ..................................................................................................... 10 
5.2.1 
Number of sites .................................................................................................... 10 
5.2.2 
Investigator recruitment ........................................................................................ 11 
5.3 
Study population ......................................................................................................... 11 
5.3.1 
Sample size calculation ........................................................................................ 11 
5.3.2 
Number of participants ......................................................................................... 12 
5.3.3 
Inclusion and exclusion criteria ............................................................................. 12 
5.4 
Study materials ........................................................................................................... 13 
5.4.1 
Lenses ................................................................................................................. 14 
5.4.2 
Other products ..................................................................................................... 14 
5.4.3 
Rewetting drops ................................................................................................... 14 
5.4.4 
Disposing of study products ................................................................................. 15 
5.4.5 
Product accountability .......................................................................................... 15 
5.5 
Scheduled and unscheduled visits .............................................................................. 15 
5.5.1 
Visit 0 Screening & fitting visit .............................................................................. 16 
5.5.2 
Repeated screening visits (Visit 0/R1) .................................................................. 20 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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5.5.3 
Visit 1-0 Dispense Lens type #1 ........................................................................... 20 
5.5.4 
Visit 2-0, 1-week follow-up Lens type #1, Dispense Lens type #2 ........................ 22 
5.5.5 
Visit 3-0 1-week follow-up Lens type #2 ............................................................... 25 
5.5.6 
Study exit ............................................................................................................. 27 
5.5.7 
Unscheduled visits ............................................................................................... 27 
5.6 
Study procedures ........................................................................................................ 27 
5.6.1 
 ................................................................................................... 28 
5.6.2 
Visual acuity ......................................................................................................... 29 
5.6.3 
 ............................................................................................. 29 
6 
Monitoring protocol adherence .......................................................................................... 30 
7 
Potential risks and benefits to human participants ............................................................. 30 
8 
Adverse events .................................................................................................................. 31 
8.1 
Normal or adaptive symptoms ..................................................................................... 33 
8.2 
Procedures for adverse events .................................................................................... 33 
8.3 
Reporting adverse events ........................................................................................... 34 
9 
Discontinuation from the study ........................................................................................... 35 
10 
Device malfunctions ........................................................................................................... 36 
11 
Study completion and remuneration .................................................................................. 36 
12 
Statistical analysis and data management ......................................................................... 37 
12.1 
Statistical analysis ................................................................................................... 37 
12.2 
Data management ................................................................................................... 38 
12.3 
Comments on source documents ............................................................................ 39 
13 
Protocol & other training .................................................................................................... 39 
14 
Study monitoring ................................................................................................................ 39 
15 
Study management............................................................................................................ 40 
15.1 
Statement of compliance ......................................................................................... 40 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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15.2 
Ethics review ........................................................................................................... 40 
15.3 
Clinical trial registration ............................................................................................ 41 
15.4 
Protocol deviations .................................................................................................. 41 
15.4.1 
Major protocol deviations ..................................................................................... 41 
15.4.2 
Minor protocol deviations ..................................................................................... 41 
15.4.3 
Reporting and documenting protcol deviations ..................................................... 42 
15.5 
Premature termination of the study .......................................................................... 42 
15.6 
Study participant records ......................................................................................... 42 
15.7 
Retention of study records and data ........................................................................ 42 
16 
Report................................................................................................................................ 43 
17 
References ........................................................................................................................ 43 
 
 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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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. 
 
 
 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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2 
INTRODUCTION 
It is anticipated that more than 40% of contact lens wearers would benefit from a contact lens that 
corrects their astigmatism but this target is not reached in most countries.1 Daily disposable (DD) 
lenses account for 45% of all soft lens fits today2 and it is important that DDs correct astigmatism 
are available in order to grow this category. In the past DD lenses were mainly available in 
hydrogel materials, however, most of the new DDs use highly oxygen-permeable silicone hydrogel 
(SiHy) materials. 
The contact lens stabilisation design plays the major role in lens stability and maintaining on eye 
stability is a critical factor to achieve a good, stable vision. As well as visual performance, 
satisfaction with lens handling lens and lens comfort influence success with a contact lens. 
The goal of this study is to compare the performance of MyDay toric (Lens A), a SiHy DD toric 
lens from CooperVision Inc., which has successfully been established on the market with  
Precision1 for Astigmatism (Lens B), a DD SiHy toric lens recently launched by Alcon to the US 
market.  
3 
OBJECTIVES 
To compare the clinical performance of two different daily disposable, SiHy toric contact lens 
types, Lens A and Lens B, in existing soft lens wearers when worn for one week each. 
The primary outcome variable for this study is: 
• 
The rating for “Ease of overall lens handling for putting lenses on eyes, removing 
from eyes, opening packaging etc”, using a 0 - 10 integer scale, collected in the 
subjective Experience ratings after 1 week of wear (6-8 days).  
The secondary outcome variable is: 
• 
Visual acuity (Snellen converted to LogMAR) after 1 week of wear (6-8 days) 
4 
HYPOTHESIS 
The null hypothesis is that there will be no difference for the primary outcome variable between 
Lens A compared to Lens B.  

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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5 
MATERIALS AND METHODS 
5.1 STUDY DESIGN 
5.1.1 OVERALL DESIGN 
This study will be conducted at several optometry practices in the US. This study is a 
prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design 
involving two different daily disposable toric lens types. Each lens type will be worn for 
approximately one week, during which participants record their subjective lens-wear experience 
on three different days. 
5.1.2 RANDOMIZATION 
A randomization schedule will determine the order of Lens A and Lens B wear for the 
first/second week for each participant. Participants will be randomized immediately prior to their 
first lens dispense. 
This randomization schedule will be generated for each site using a web-based program: 
(www.randomization.com). The lens type that will be worn during the first week is called “Lens 
type #1”, the lens type dispended for the second week is called “Lens type #2”. The final study 
randomization schedule will be generated by CORE’s Database Administrator and provided to 
the research assistants at each site.  
5.1.3 MASKING 
At the fitting visit, only the participant will be masked of the lens type, the investigator will know 
which type is fit in order to make changes to the lens at this visit if needed. Strongly adhesive 
stickers will be placed on the packages/foils to mask the participant to the lens brand. At both 
dispense visits, participants and investigators will be masked to the lens type dispensed. In order 
to achieve this, unmasked study personnel will determine the lens order according to the 
randomization schedule and will over-labeled the lens packages/foils prior to dispense. 
5.2 INVESTIGATIONAL SITES 
5.2.1 NUMBER OF SITES 
This study will be conducted at several optometry practice sites in the United States.   
 

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5.2.2 INVESTIGATOR RECRUITMENT  
The principal investigator at each site will be required to fulfil the following criteria: 
• 
Is a licensed Optometrist with at least two years of contact lens fitting experience. 
• 
Can demonstrate training in Good Clinical Practice (GCP). 
• 
Accepts responsibility for the conduct of the study at their site. 
• 
Has in-office email and document scanning capabilities. 
• 
Will scan and send all study visit documents to CORE, ideally the same day* as the 
visit or at most within 2 days of the study visit.  
• 
Is willing to follow the study protocol and to co-operate with the study monitors at 
CORE. 
* Study documents are required as soon as possible because this allows for prompt lens 
ordering and timely data review, query and entry. 
5.3 STUDY POPULATION 
5.3.1 SAMPLE SIZE CALCULATION 
The sample size calculation was based on the standard deviations of paired differences from the 
subjective response data of a pilot study involving the spherical lenses of the toric lenses to be 
worn in this study, which used a 0-10 integer scale (10 being best).  
Variable (0-10 scale) 
Difference to detect 
Sample size 
Target Power 
Handling on insertion 
0.7 
34 
0.80 
Handling at removal 
0.5 
35 
0.80 
Comfort on insertion 
0.6 
39 
0.80 
Comfort at removal 
0.7 
45 
0.80 
Vision quality on insertion 
0.5 
24 
0.80 
Vision quality at removal 
0.5 
24 
0.80 
 
A sample size of 45 is sufficient to detect a mean difference of 0.7 units on a 0 to 10 scale for all 
the above responses, with 80% power and alpha 0.05 in a two-tailed t-test.  
Therefore, up to 52 participants will be dispensed with study products with the goal to complete at 
least 45.  
 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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5.3.2 NUMBER OF PARTICIPANTS 
Participants will be recruited using site records and databases where consent for contact about 
research has been provided. There will also be general advertising materials (eg. posters, social 
media posts) and all these, including email scripts, will be approved by the ethics review board. 
All initial individual-targeted recruitment activities, such as any direct mailing of recruitment 
scripts, will be conducted by practice staff that are not directly involved in conducting the 
research. This separation will reduce any undue influence of the optometrist-patient relationship. 
This process will also eliminate opportunity for the investigator to access personal health 
information before any consent for disclosure is provided by the potential participant.  
It is anticipated that up to 70 potential participants may attend a Screening visit and up to 52 
participants may be randomized and dispensed with study products, with a target of at least 45 
completing the study.  
 
5.3.3 INCLUSION AND EXCLUSION CRITERIA 
A person is eligible for inclusion in the study if he/she: 
1. Is at least 18 years of age and has full legal capacity to volunteer; 
2. Has read and signed an information consent letter; 
3. Self reports having a full eye examination in the previous two years; 
4. Anticipates being able to wear the study lenses for at least 12 hours a day, 7 days a 
week; 
5. Is willing and able to follow instructions and maintain the appointment schedule; 
6. Habitually wears toric soft contact lenses binocularly, of any replacement frequency, for 
the past 3 months minimum; 
7. Has refractive astigmatism at least -0.75DC in each eye, maximum -2.25DC; 
8. Has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees; 
9. Is myopic and requires a spectacle spherical component of - 1.00D to -6.50D inclusively; 
10. Can be fit and achieve binocular distance vision of at least 20/30 Snellen with the 
available lens parameters (see Table 1). 
A person will be excluded from the study if he/she: 
1. Is participating in any concurrent clinical or research study; 
2. Habitually wears one of the study contact lenses; 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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3. Has any known active* ocular disease and/or infection that contraindicates contact lens 
wear; 
4. Has a systemic condition that in the opinion of the investigator may affect a study 
outcome variable;  
5. Is using any systemic or topical medications that in the opinion of the investigator may 
affect contact lens wear or a study outcome variable; 
6. Has known sensitivity to the diagnostic sodium fluorescein used in the study; 
7. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment#; 
8. Has undergone refractive error surgery or intraocular surgery. 
 
* 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 dry eye are not considered 
active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or 
inflammation and are therefore not active. 
 
# Pregnant and lactating women are not being excluded from the study due to safety concerns but due to 
fluctuations in refractive error, accommodation and/ or visual acuity that occur secondary to systemic 
hormonal changes and water retention. It has further been shown that pregnancy could impact tear 
production, which could impact dry eye symptoms. Such fluctuations could affect the secondary outcome 
data, thereby negatively affecting study data integrity. 
 
5.4 STUDY MATERIALS 
Sites will be provided (if needed) with a trial kit of Lens A and will source their own trial kit of 
Lens B. The sites will use these trial kits to fit Lens B and Lens A lenses to determine the optimal 
lens power. The final lens prescription will be recorded on the respective fields on the data 
collection forms and lenses will be ordered as following: Lens B will be ordered through the site’s 
normal commercial route (Lenses from the fitting sets will not be used for dispense). CORE will 
coordinate the Lens A lens orders for each participant upon receipt of the lens order form, which 
is part of the study visit pack.  
Reimbursement to practice sites for study product expenses will be provided by CooperVision at 
the end of the study, after CORE has reconciled the invoices and the product accountability and 
dispensing logs. 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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5.4.4 DISPOSING OF STUDY PRODUCTS 
At the end of the study, all sites will return all unused products to CORE, unless otherwise 
directed. Worn lenses will be disposed of by participants and at the sites according to local 
regulations. 
5.4.5 PRODUCT ACCOUNTABILITY 
Accountability logs are completed to record all study products that were used for each 
participant, which includes products used during the visits and those dispensed to and returned 
by each participant. 
5.5 SCHEDULED AND UNSCHEDULED VISITS 
This study has a minimum of 4 scheduled study visits, including the screening visit. There is an 
option for repeated screening visit if needed. 
A scheduled 1-week follow-up visit may only take place when the participant attends wearing 
the study lenses for at least two hours that day. 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. 
Table 3 summarizes the scheduled study visits and study codes. 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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3. Participant demographics and medical history (age, sex, race, ethnicity, medical 
conditions, medications, allergies). 
4. Contact lens history (habitual lens information and wearing habits).  
5. 
 
 
 
6. Ask participant to complete subjective Experience ratings at the visit to reflect their 
experience over the last week with their habitual lenses (Note: the habitual lenses will not 
have been confirmed as offering the optimal prescription correction): 
• 
 
 
  
• 
Ease of lens handling for insertion onto eye (0 - 10 scale),  
• 
Ease of lens handling for removal from eye (0 - 10 scale), 
• 
Ease of overall lens handling for putting lenses on eyes, removing from eyes, 
opening packaging etc (0-10 scale), 
• 
 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7. 
 
 
 
 
 
 
 
 
 
 
 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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• 
 
 
 
 
 
 
8. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
9. Baseline monocular & binocular high contrast visual acuity (Snellen) with habitual contact 
lenses: distance (≥4m).  
10. 
 
 
  
 
 
 
 
 
  

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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ii. 
 
  
 
 
 
• 
 
11. The participant removes their habitual contact lenses.  
12.
 
13. Sphero-cylindrical refraction: monocular & binocular high contrast visual acuity (Snellen) 
in high room illumination: distance (≥4m).  
14. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
15. After a minimum 5-minute washout time after fluorescein insertion, the participant will be 
fit with the study lenses. 
16. 
 
 
 
 
  
 
 
 
  
 
  
 
, 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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• 
  
 
 
e. 
 
 
  
f. If any changes are made to the lens power, the above procedures (b to e) will be 
repeated. If the required lenses are not available, then they should be ordered 
and a repeat visit must be scheduled to repeat the fitting.  
17. 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. 
18. Schedule dispense visit (0-21 days after Visit 0) and order both study lens types in the 
final prescriptions – see section 5.4 for details.  
 
5.5.2 REPEATED SCREENING VISITS (VISIT 0/R1) 
In some circumstances a repeated screening may need to be scheduled. Examples include, but 
are not limited to: 
1. Incomplete information available at time of screening to determine eligibility (e.g. current 
lens brands worn, history from current eye care practitioner etc.) 
2. Study procedures unable to be completed in time scheduled for visit; 
3. Required study lenses not available at the time of the screening visit; 
4. A transient health condition which may affect the eye(s) (e.g. a common cold, active 
allergies, fatigue etc.) 
5. The short-term use of medications (e.g. antibiotics, antihistamines etc.) 
6. Reassessment of baseline ocular conditions (e.g. corneal and/or conjunctival staining, 
scars etc.) 
The maximum total number of screenings permitted will be 2, the initial and one repeat 
screening visit. 
 
5.5.3 VISIT 1-0 DISPENSE LENS TYPE #1 
This visit may or may not be subsequent to the screening visit, depending on lens availability but 
will occur no later than 21 days after Visit 0. Participant to attend this visit wearing spectacles. 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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The study procedures are outlined below: 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3. After a minimum 5-minute washout time after fluorescein insertion, participant to insert 
Lens type #1 according to the randomization table. 
4. Just after participant inserts the lenses, ask the participant to rate the following: 
• 
Ease of lens handling for lens insertion (0 – 10 integer scale); 
• 
 
• 
 
 
 
• 
 
5. After lenses have settled for 10 minutes, measure monocular & binocular high contrast 
visual acuity (Snellen) in high room illumination: distance (≥4m).  
6. 
 
 
  
 
 
 
  
 
 
7. 
 
  
 
 
• 
 
  

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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8. Dispense sufficient OVER-LABELLED lens supply to last until the next visit, plus spares 
as necessary (if applicable).  
9. Instruct the participant to wear the lenses for at least 12 hours a day, 7 days a week. 
10. Confirm that Visit 2-0 is scheduled 6-8 days after this Visit 1-0. 
 
5.5.4 VISIT 2-0, 1-WEEK FOLLOW-UP LENS TYPE #1, DISPENSE LENS TYPE #2 
Participants will be asked to arrive having worn Lens type #1 for at least 2 hours prior to the visit. 
This visit will occur 6-8 days (inclusive) after visit 1-0. 
The study procedures are outlined below: 
1. Confirm participant’s health and medications are unchanged. 
2. Collect all unworn study lenses. 
3. 
 
4. 
 
 
5. Ask participant to complete subjective Experience ratings at the visit to reflect their 
experience over the last week with the study lenses: 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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• 
 
 
  
• 
Ease of lens handling for insertion onto eye (0 - 10 scale),  
• 
Ease of lens handling for removal from eye (0 - 10 scale), 
• 
Ease of overall lens handling for putting lenses on eyes, removing from eyes, 
opening packaging etc (0-10 scale), 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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• 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
8. 
 
 
 
 
  
 
9. 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
  
 
 
 
 
 
 
10. Measure monocular & binocular high contrast visual acuity (Snellen) in high room 
illumination: distance (≥4m) 
11.
  

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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• 
  
 
  
 
  
 
 
12. The participant will remove the lenses 
13.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
14. Continue with the lens dispense for Lens type #2 as described in visit 1-0 starting point 
#3 to #9 
15. Confirm that Visit 3-0 has been scheduled 6-8 days after this Visit 2-0. 
 
5.5.5 VISIT 3-0 1-WEEK FOLLOW-UP LENS TYPE #2  
Participants will be asked to arrive having worn Lens type #2 lenses for at least 2 hours prior to 
the visit. This visit will occur 6-8 days (inclusive) after visit 2-0. 
The study procedures are outlined below: 
1. Confirm participant’s health and medications are unchanged. 
2. Collect all unworn study lenses. 
3. 
 
 
 
5. Ask participant to complete subjective Experience ratings at the visit to reflect their 
experience over the last week with the study lenses:  
• 
Same questions as those listed under Visit 2-0, point 4. 
6. 
 
 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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• 
 
7. 
 
 
 
 
8. 
 
 
 
 
9. 
 
 
 
 
 
 
10. 
 
 
 
 
 
11. 
 
 
 
 
 
   
12. Measure monocular & binocular high contrast visual acuity (Snellen, including 
modification factor) in high room illumination: distance (≥4m). 
13.
  
 
  
 
 
 
  
 
 
14. The participant will remove the lenses. 
15. 
 
 
 
 
 
 
 
 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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• 
 
 
 
 
 
 
16. Continue with Study Exit 
 
5.5.6 STUDY EXIT 
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.  
Exit visual acuity will be recorded with either the participant’s spectacles, refraction or habitual 
contact lenses. An exit biomicroscopy assessment will be conducted if not already completed on 
the same day for a concurrent study 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. 
 
5.5.7 UNSCHEDULED VISITS 
An unscheduled visit is defined as an interim visit requested by the participant or investigator 
due to an unanticipated problem. Data recorded at these visits will be entered into the database. 
Only relevant and applicable unscheduled visit information will be included in the final report as 
deemed necessary.  
 
5.6 STUDY PROCEDURES 
Table 4 summarizes the procedures conducted at each visit.  

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5.6.2 VISUAL ACUITY 
This will consist of high contrast Snellen acuity, measured in full room illumination at distance 
(≥4m). A modification factor will be recorded; for example 20/20+2 or 20/20-2 would indicate 
they read 2 letters beyond the 20/20 line or made 2 errors on the 20/20 line, respectively. Where 
no additional letters were read or missed, the correction factor will be recorded as ‘0’. 
 
5.6.3 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
  
 
 
 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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6 
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 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, 
major protocol deviations will be reported to the Sponsor and Sterling Institutional Review Board 
within 7 days of becoming aware of them (as per Sterling Institutional Review Board guidelines).  
7 
POTENTIAL RISKS AND BENEFITS TO HUMAN PARTICIPANTS 
There may be no direct benefits to the subjects in this study. Participation in a study may contribute 
to scientific research information that may be used in the development of new contact lens 
products. The subjects will receive an examination of the front part of their eyes and may have the 
opportunity to try a different type of soft contact lenses and/or different lens care products at no 
cost to them. The contact lens materials used in this study are commercially available as daily 
wear. This study will investigate participants’ wearing schedule intended for daily wear (NOT 
extended wear), similar to the average wearing time of 10-16 hours for daily wear lenses.  
This study is considered to be a non-significant risk study based on United State Food and Drug 
administration (FDA) and International Standards Organization (ISO) guidelines, because the 
study devices used as intended in this study (1) do not represent a potential for serious risk to the 
health, safety or welfare of the subject, and (2) are not implants, (3) are not used to support or 
sustain human life, (4) are not of substantial importance in diagnosing, curing, mitigating or treating 
disease or otherwise prevents impairment of human health.  
The two study contact lens types will be worn as per their approved use; on a daily wear, daily 
disposable basis. 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. 
Adverse events and/ or complications in daily wear of soft contact lenses can occur (eg: 
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 pain, 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 day-wear soft lenses is 0.035%. Almost 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
31 
always an infection will occur only in one eye.  This risk is assumed by 35-million Americans who 
currently wear contact lenses and only current soft lens wearers will be recruited for this study.  
A dye (fluorescein) normally used for eye examinations is being used in this study. Although 
rare, it is possible to have an allergic reaction to the dye. Participants will be asked if they have a 
known allergy or sensitivity to fluorescein. 
The assessments conducted in this study are routine clinical procedures and they include auto-
refraction, auto-keratometry, visual acuity, anterior ocular health assessment, and contact lens 
fitting will be used. In addition, high magnification imaging of the lens fit may be made using 35 
mm or digital cameras. Patients will be monitored frequently until the end of the study to reduce 
the occurrence of adverse or potential adverse events. Patients will be given instructions from 
their investigator regarding early symptoms and signs of adverse events.  
8 
ADVERSE EVENTS 
See CORE SOP012 for a description of all 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 events,’ or ‘non-significant 
adverse events,’ as defined below, Table 5.  
A number of conditions may result in temporary suspension until resolution. These include corneal 
infiltrates, corneal staining, limbal injection, bulbar injection or tarsal conjunctival abnormalities. 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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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 CORE’s lead study coordinator (details below) and 
also to the sponsor (details below) within 24 hours of the investigator becoming aware of the event. 
The site’s Principal Investigator will also report the event to Sterling IRB within 10 days of 
becoming aware of the Serious or Unanticipated event, using the Reportable Events Form. All 
fatal or life-threatening events will be reported immediately to the IRB. 
Significant and Non-Significant Adverse Events will be reported to CORE’s lead study coordinator 
and the sponsor as soon as possible, but no later than 5 working days after becoming aware of 
the occurrence.  
 
CORE contact details for adverse events are: 
  
 
  
  
 
 
  
 
 
 
 
Sponsor contact details for adverse events are:  
  
 
  
  
 
 
  
  

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
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Details of all adverse events will be included in the study report. 
9 
DISCONTINUATION FROM THE STUDY 
Participants may be discontinued at the discretion of the investigator or sponsor in consideration 
of participant safety or protocol compliance, or at discretion of the participant.  Participants 
discontinued from a study will be reimbursed US$25 per visit for their active involvement in the 
study (including the initial screening visit and all lens fitting visits).  Upon discontinuing, a 
participant will be offered the 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 5.2.3. 
• 
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 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
36 
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 to complete the final study exit, 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 Sterling IRB. 
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 CORE and the sponsor within 24 hours of the investigator 
becoming aware of the malfunction. Sterling IRB 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 CORE as soon as possible (usually in weekly study 
updates). 
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.  Participants will also be provided with a 
letter of appreciation.    
Once their involvement in the study is complete, participants will be informed about receiving 
feedback following study completion in the Letter of Appreciation. 

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39 
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 during the 
transfer.  
12.3 COMMENTS ON SOURCE DOCUMENTS 
Data analysis will not be conducted on comments which have been recorded in the source 
documents. Only relevant and applicable comments will be included in the final report as 
deemed necessary by CORE’s Lead Co-ordinator.  
13 PROTOCOL & OTHER 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. This will include training by CORE on the study 
protocol, study procedures, informed consent procedures, and on the randomization and 
participant masking procedures, as well as training for Good Clinical Practice.  
All site Principal Investigators and co-investigators will provide a scan of their curriculum vitae, 
license to practice optometry and evidence of professional indemnity insurance.  
14 STUDY MONITORING 
Each site will provide regular status reports to CORE. Status reports will include: 
• 
The number of participants screened, enrolled, and randomized (i.e. assigned a study ID 
number), discontinued and completed. 
• 
Details of all protocol deviations, adverse events, device malfunctions. 
• 
Reports of unintended events. 
CORE will collate the site updates and provide 2-weekly status reports to the study sponsor. 
Study monitoring visits to the sites may be conducted by CORE, the sponsor, or sponsor’s 
designate, throughout the study and will be scheduled in conjunction with the Principal 
Investigator at each site. In addition study records may be inspected by the sponsor, the 
sponsor's designate, Sterling Institutional Review Board, and by regulatory authorities in Canada 
and the United States, namely Health Canada and the United States Food and Drug 
Administration (FDA); however, they will not be permitted to take away any records containing 
identifiable personal information. 

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Study data review and data monitoring will be conducted by CORE personnel. To improve data 
integrity, data entry will be conducted by two people and the entries will be compared. Data 
queries will be reported to the site within 5 working days of receipt of initial data. A response 
resolving the query will be expected from the site within 5 working days of receipt of the query. 
All adverse events and protocol deviations will be reviewed by the site Principal Investigator and 
CORE’s Lead Co-ordinator. All serious adverse events and major protocol deviations will be 
reviewed by the site Principal Investigator and CORE’s Director and/or Head of Clinical 
Research. 
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/ 
 
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. 
15.2 ETHICS REVIEW 
This protocol will be submitted to and reviewed through the Sterling Institutional Review Board. 
Notification of ethics clearance of the application is required prior to the commencement of the 
study. 
This study will be conducted in accordance with Institutional Review Board regulations (U.S. 
21CFR Part 56.103) or applicable IEC regulations. Copies of all IRB/IEC correspondence with the 
investigator/sponsor will be kept on file. The study will commence upon approval from the following 
Institutional Review Board: Sterling Institutional Review Board; Telephone number: (888) 636-
1062 and email address: info@sterlingirb.com. 

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15.3 CLINICAL TRIAL REGISTRATION 
CooperVision will register this study with clinical trials.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. They will maintain the information on that site.  
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.  
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); 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
42 
• 
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 PROTCOL DEVIATIONS 
Major protocol deviations must be reported to the Sterling Institutional Review Board within 10 
days of the deviation occurring (or its discovery) using the Reportable Events Form. To facilitate 
timely reporting to the sponsor, all sites must notify CORE of a major protocol deviation as soon 
as possible. 
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 Sterling Institutional Review Board 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. 
An enrolment log will be maintained which will list all participants who attended for a screening 
visit. 
15.7 RETENTION OF STUDY RECORDS AND DATA 
When the study has been completed, all sites will send the original study product accountability 
and dispensing logs, and enrolment logs to CORE.  Each site should retain the original consent 
documents and the study data collection forms documentation for two years following the close 

EX-MKTG-122 PEAR Protocol v1.2 10feb2021 
43 
of the database in case data queries arise during the analysis and report writing stages. CORE 
may request that these originals be sent to them for storage and study data collections forms 
may be sent to the sponsor for storage. 
Records and data from this study will be retained at CORE for a minimum of 25 years. Details 
regarding storage procedures are given in CORE SOP014 Clinical data management.  
16 REPORT 
A report will be sent to the sponsor by CORE according to terms described in the study contract. 
17 REFERENCES 
1. Luensmann D, Schaeffer JL, Rumney NJ, et al. Spectacle prescriptions review to 
determine prevalence of ametropia and coverage of frequent replacement soft toric 
contact lenses. Cont Lens Anterior Eye 2018;41:412-20. 
2. Morgan PB, Woods C, Tranoudis I, et al. International contact lens prescribing in 2019. 
Contact Lens Spectrum 2020;35:26-32.