Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses
Phase: NA
Conditions: Presbyopia
Sponsor: CooperVision, Inc.



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1 
DOCUMENT CHANGE HISTORY 
 
Version 
number 
Version 
date 
Author 
Description of change(s) 
1.0 
27Oct2022 
Doerte Luensmann 
Original protocol 
1.1 
16Nov2022 
Doerte Luensmann 
Update in section 7 (Potential risks and benefits to 
human participants), the wording has been changed as 
recommended by STERLING IRB. 
 
 
 
 
 
 
 
 
 
 
 

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Table of contents 
1 
Document change history .................................................................................................... 5 
2 
Introduction ........................................................................................................................ 10 
3 
Objectives .......................................................................................................................... 10 
4 
Hypothesis ......................................................................................................................... 10 
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................................................................................................................ 11 
5.2 
Investigational Sites .................................................................................................... 11 
5.2.1 
Number of Sites ................................................................................................... 11 
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 ............................................................................. 13 
5.4 
Study materials ........................................................................................................... 14 
5.4.1 
Lenses ................................................................................................................. 15 
5.4.2 
Other products ..................................................................................................... 15 
5.4.3 
Rewetting drops ................................................................................................... 15 
5.4.4 
Disposing of study products ................................................................................. 16 
5.4.5 
Product accountability .......................................................................................... 16 
5.5 
Scheduled and unscheduled visits .............................................................................. 16 
5.5.1 
Visit 0, Screening & fitting visit ............................................................................. 17 
5.5.2 
Repeated screening visits (Visit 0/R1 or Visit 0/R2) .............................................. 20 

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5.5.3 
Visit 1-0 Dispense lens Pair #1 ............................................................................. 20 
5.5.4 
Visit 1-1 Optimize Pair #1 ..................................................................................... 21 
5.5.5 
Visit 1-2 Dispense (optimized) Pair #1 .................................................................. 22 
5.5.6 
Visit 1-3, 2-week follow-up Pair #1 ....................................................................... 22 
5.5.7 
Visit 2-0, Dispense Pair #2 ................................................................................... 23 
5.5.8 
Visit 2-1 Optimize Pair #2 ..................................................................................... 23 
5.5.9 
Visit 2-2 Dispense (optimized) Pair #2 .................................................................. 23 
5.5.10 
Visit 2-3, 2-week follow-up Pair #2 ....................................................................... 23 
5.5.11 
Exit visit ................................................................................................................ 24 
5.5.12 
Unscheduled visits ............................................................................................... 24 
5.6 
Study procedures ........................................................................................................ 24 
 
 
 
 
 
 
6 
Monitoring protocol adherence .......................................................................................... 26 
7 
Potential risks and benefits to human participants ............................................................. 26 
8 
Adverse events .................................................................................................................. 27 
8.1 
Normal or adaptive symptoms ..................................................................................... 29 
8.2 
Procedures for adverse events .................................................................................... 29 
8.3 
Reporting adverse events ........................................................................................... 30 
9 
Discontinuation from the study ........................................................................................... 31 
10 
Device malfunctions ........................................................................................................... 32 
11 
Study completion and remuneration .................................................................................. 32 
12 
Statistical analysis and data management ......................................................................... 33 
12.1 
Statistical analysis ................................................................................................... 33 
12.2 
Data management ................................................................................................... 34 

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12.3 
Comments on source documents ............................................................................ 35 
13 
Protocol & other training .................................................................................................... 35 
14 
Study monitoring ................................................................................................................ 35 
15 
Study management............................................................................................................ 36 
15.1 
Statement of compliance ......................................................................................... 36 
15.2 
Ethics review ........................................................................................................... 36 
15.3 
Clinical trial registration ............................................................................................ 37 
15.4 
Protocol deviations .................................................................................................. 37 
15.4.1 
Major protocol deviations ..................................................................................... 37 
15.4.2 
Minor protocol deviations ..................................................................................... 37 
15.4.3 
Reporting and documenting protcol deviations ..................................................... 38 
15.5 
Premature termination of the study .......................................................................... 38 
15.6 
Study participant records ......................................................................................... 38 
15.7 
Retention of study records and data ........................................................................ 38 
16 
Report................................................................................................................................ 39 
 
 

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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. 
 
 
 

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2 
INTRODUCTION 
The market for multifocal soft contact lenses is continuing to grow and new lens designs are 
introduced regularly for daily disposable and frequent replacement wear schedules.  
CooperVision is interested in comparing the performance of their own daily disposable (DD) 
MyDay multifocal (CONTROL) contact lens to the competitor product ACUVUE OASYS MAX 1-
DAY MULTIFOCAL (TEST), which is manufactured by Johnson & Johnson Vision Care Inc..  
3 
OBJECTIVES 
The objective of the study is to compare the lens performance of CONTROL and TEST. 
The primary outcome variable for this study is: 
• 
 ‘Lens handling for removal, using a 0-100 scale, collected after 2 weeks of wear.   
 
 
4 
HYPOTHESIS 
The null hypothesis is that there will be no difference between the ratings of ‘Lens handling for 
removal, collected after 2 weeks of wear for CONTROL and TEST lenses.  
5 
MATERIALS AND METHODS 
5.1 STUDY DESIGN 
5.1.1 OVERALL DESIGN 
This is a prospective, randomized, participant-masked, crossover, bilateral dispensing study 
conducted at approximately 5 clinical practice sites in the United States. Each lens type will be 
worn for approximately 3-4 weeks: the lens prescription of each lens type will be optimized after 
3-8 days wearing experience, prior to starting a 2-week (14-21 day) wear period. 
5.1.2 RANDOMIZATION 
Participants will wear the CONTROL and TEST lenses in a randomized order.  
A randomization schedule will be generated for each site using a web-based program (for 
example, www.randomization.com or similar). to determine the order CONTROL and TEST lens 

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wear. The final study randomization schedule will be generated by CORE’s Database 
Administrator and provided to each site.  
5.1.3 MASKING 
Lens packages/foils will be over-labeled with strongly adhesive stickers to mask the participant 
to the lens brand. 
It is not possible for the study investigators to be masked because of the need to follow the 
specific lens fitting guide during the lens prescription optimization visit (Visits 0, 1-1, 2-1).  
5.2 INVESTIGATIONAL SITES 
5.2.1 NUMBER OF SITES 
This study will be conducted at approximately 5 optometry practice sites.   
 
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) by the already trained 
principal investigator. 
• 
Accepts responsibility for the conduct of the study at their site. 
• 
Has in-office email and either document scanning capabilities or fax. 
• 
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 a timely data 
review, query and entry. 
5.3 STUDY POPULATION 
5.3.1 SAMPLE SIZE CALCULATION 
The sample size was calculated using data from a previous study for lens handling on removal 
comparing Lens A against lens B (CooperVision, data on file). In that study a 0-10 scale was used. 
Note: this study will use a subjective rating scale of 0-100, integer steps. 
  

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Using a standard deviation of 27.4 units, 80% power and alpha level of 0.05 in a two-tailed paired 
t-test, a minimum sample size of 51 completed participants is recommended in order to detect a 
mean difference of 11 units in lens handling for removal from eyes on the 0-100 scale collected at 
the 2-week follow-up visit.  
To account for potential dropouts, approximately to 60 participants may be randomized and 
dispensed with study product in total, with the target of at least 51 completing the study.  
 
 
Figure 1: Sample size calculation graph 
 
5.3.2 NUMBER OF PARTICIPANTS 
Participants will be recruited using site records, databases and advertising materials (e.g., 
posters, email scripts) 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 

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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 80 potential participants may attend a Screening visit and 
approximately 60 participants may be randomized and dispensed with study products, with a 
target of 51 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 42 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 8 hours a day, 5 days a week; 
5. Is willing and able to follow instructions and maintain the appointment schedule; 
6. Habitually wears multifocal soft contact lenses, for the past 3 months minimum^;  
- Maximum of 7 participants per site should be habitual wearers of daily disposable 
lenses  
o Maximum of 3 habitual wearers per site of 1-Day Acuvue Moist Multifocal 
o Maximum of 1 habitual wearer per site of ACUVUE OASYS MAX 1-Day 
MULTIFOCAL 
o Maximum of 3 habitual wearers per site of MyDay Multifocal 
- Maximum of 7 participants per site should be habitual wearers of frequent 
replacement lenses 
o Maximum of 1 habitual wearer per site of ACUVUE OASYS for PRESBYOPIA 
7. Has refractive astigmatism no higher than -0.75DC; 
8. Is presbyopic and requires a reading addition of at least +0.75D and no more than 
+2.50D; 
9. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 
logMAR) which participants also deem to be ‘acceptable’, with the available study lens 
parameters (Distance sphere +4 to -6; near addition as per study design). 
 
^Exceptions may be permitted after discussion with the study monitor or sponsor. 
 

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A person will be excluded from the study if he/she: 
1. Is participating in any concurrent clinical or research trial; 
2. Has any known active* ocular disease and/or infection that contraindicates contact lens 
wear; 
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 contact lens wear or a study outcome variable; 
5. Has known sensitivity to the diagnostic sodium fluorescein used in the study; 
6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; 
7. 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. 
 
Age ≥42 years is an inclusion criteria because presbyopia is unlikely in persons aged <42 years 
and, if present, may not be due solely to presbyopic changes representative of the wider 
population. 
 
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. It has further been shown that pregnancy could impact tear 
production, which could impact dry eye symptoms. Such fluctuations could affect data, thereby 
negatively affecting study data integrity. 
5.4 STUDY MATERIALS 
Each site will have an inventory of the CONTROL lens on site which will be used for fitting and 
dispensing the CONTROL lens.  
For the TEST lens, trial lenses for the fitting can either be ordered based on the participant’s 
refraction and/or latest contact lens prescription or a fitting set of the test lens may be used if 
available. Following a successful lens fit commercial TEST lenses will be ordered.   

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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 to be 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 12 scheduled study visits, including the screening visit, though 
some visits may be scheduled concurrently on the same day. There is an option for repeated 
screening and lens fitting visits as needed. 
A scheduled follow-up visit may only take place when the participant attends wearing the 
study lenses for at least two 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. 
Table 3 summarizes the scheduled study visits and study codes. 

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different letter preceding the participant ID number. For example, participant 01 at site W will be 
W01, and participant 01 at site Z will be Z01. Ineligible participants will be discontinued from the 
study. 
The investigator will determine participant eligibility using the inclusion and exclusion criteria. 
The study procedures are outlined below: 
1. The participant is expected to insert their habitual multifocal contact lenses at least 2 
hours before attending the visit  
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 and will be assigned a study ID. 
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.  
7. 
. 
8. 
 
  
9. Determine ocular dominance according to the instructions described in the respective 
fitting guides. 
10. 
 
 
 
 
 
 
 
 

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e. 
 
 
 
11. After a minimum 5-minute washout time after fluorescein insertion, the participant will be 
fit with the study lenses. 
12. The investigator will fit both study lenses (CONTROL and TEST) using the provided 
lenses (CONTROL) or using the office fitting set or pre-ordered fitting lenses (TEST). The 
manufacturers fitting guidelines will be followed. 
Trial fitting of both study lenses: 
a. 
 
 
  
b. The contact lenses will be provided to participants in a manner that does not 
unmask the participant as described in Section 5.1.3. 
c. The participant will insert the lenses, allow to settle for at least 10 minutes. 
d. 
 
e. 
 
 
  
f. 
 
 
g. 
 
 
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. If additional fitting lenses need to be ordered to determine the final lens power, schedule 
a re-screening visit. Both study lenses have to be tested on eye in the final power before 
any of the study lens types can be dispensed. 
Order commercial boxes of the TEST lens (Ideally 30-packs, one per eye) and schedule the 
Dispense visit.  

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5.5.2 REPEATED SCREENING VISITS (VISIT 0/R1 OR VISIT 0/R2) 
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. Study products 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 3, the initial and two repeat screening 
visits. 
 
5.5.3 VISIT 1-0 DISPENSE LENS PAIR #1  
This visit may or may not be subsequent to the screening visit, depending on lens 
availability. (A full inventory of the control lenses will be available at the site, however the test 
lens must likely be ordered first – do NOT dispense lenses fitting lenses of the TEST lens, 
only purchased lens supply is acceptable for dispense.)  
Participant to attend this visit wearing spectacles. 
Procedures as follows: 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
3. 
 
 
 
4. After lenses have settled for at least 10 minutes continue with assessments 
5. 
 

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6. 
 
 
7. 
 
8. The participant will receive lens supply (if applicable) and will be instructed to wear the 
lenses for at least 8 hours a day, 5 days a week. 
9. The participant will receive a 1-week lens supply (3-8 days inclusive) and will be 
instructed to wear the lenses for at least 8 hours a day, 5 days a week. 
10. Visit 1-1 will be scheduled. 
 
5.5.4 VISIT 1-1 OPTIMIZE PAIR #1  
Participants will be asked to insert study lenses at least 2 hours prior to the visit. 
This visit will occur 3-8 days (inclusive) after visit 1-0. 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
 
 
 
 
  
 
6. If lens power changes are required, and required lens power is not on site, the lens/es 
will be ordered and assessed at an additional visit. If the required lens power is on site, 
participant will remove lens(es) from the eye and insert the new fitting lens(es) on eye.   
a. Allow settling time of 10 minutes before evaluation of vision and over-refraction to 
assess the final lens power needed. 
8. Remove lenses 
9. 
 
7. If no power change is needed or if a 2-week supply of optimized lenses are available on 
site continue with visit 1-2 concurrently. Otherwise order the new power lenses and 
schedule Visit 1-2 for another time. If new lenses need to be ordered, participants will be 
allowed to wear habitual MF lenses in the meantime. 
 

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5.5.5 VISIT 1-2 DISPENSE (OPTIMIZED) PAIR #1  
This visit may be conducted immediately following Visit 1-1 (if no prescription change is needed) 
or can be scheduled after Visit 1-1. 
Participant to attend this visit wearing spectacles. 
Procedures as follows: 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
3. After a minimum 5-minute washout time after fluorescein insertion, participant to insert 
new pair of Pair #1 multifocal lenses according to the randomization table. (Ensure 
participant is masked of the lens label) 
4. After lenses have settled for at least 10 minutes continue with assessments 
5. 
 
  
1. 
 
 
3. 
 
 
  
4. The participant will receive a 2-week lens supply (14-21 days) and will be instructed to 
wear the lenses for at least 8 hours a day, 5 days a week. 
5. The participant will be scheduled to return for Visit 1-3.  
 
5.5.6 VISIT 1-3, 2-WEEK FOLLOW-UP PAIR #1 
Participants will be asked to insert study lenses at least 2 hours prior to the visit. 
This visit will occur 14-21 days (inclusive) after visit 1-2. 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
 

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4. 
 
 
 
 
7. The participant will remove the lenses. 
8. 
 
9. Continue with visit 2-0. 
 
5.5.7 VISIT 2-0, DISPENSE PAIR #2 
This visit is subsequent to Visit 1-3. 
Assessments of Pair #2 will be conducted as described for Pair #1 at visit (Visit 1-0). 
 
5.5.8 VISIT 2-1 OPTIMIZE PAIR #2  
Participants will be asked to insert study lenses at least 2 hours prior to the visit. 
This visit will occur 3-8 days (inclusive) after visit 2-0. 
Assessments of Pair #2 will be conducted as described for Pair #1 at visit (Visit 1-1). 
 
5.5.9 VISIT 2-2 DISPENSE (OPTIMIZED) PAIR #2  
This visit may be subsequent to Visit 2-1 (if no prescription change is needed) or is scheduled 
after Visit 2-1. 
Assessments of Pair #2 will be conducted as described for Pair #1 at visit (Visit 1-2). 
 
5.5.10 VISIT 2-3, 2-WEEK FOLLOW-UP PAIR #2 
Participants will be asked to insert study lenses at least 2 hours prior to the visit. 
This visit will occur 14-21 days (inclusive) after visit 2-2. 
Assessments of Pair #2 will be conducted as described for Pair #1 at visit (Visit 1-3). 
 
 

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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 (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 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 
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-144 Protocol v1.1 16Nov2022 
 
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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 the occurrence. Each 
site’s Principal Investigator will report the event to the IRB as per IRB requirements (by fax, 
mail/delivery, phone, or email). 
 
 
  
 
  
 
 
 
  
 
 
 
 
  
  
 
  
 
 
 
  
  

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31 
 
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$20 per hour 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-144 Protocol v1.1 16Nov2022 
 
32 
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 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. 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 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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Participant remuneration will be approximately US$165 for completing the study and will be 
provided to the participant at their last visit. This is calculated at $20 per hour for the 1 hour of at 
home ratings questionnaires and 7.25 hours of predicted scheduled visits, though if additional 
fitting time is required, this may increase. 
12 STATISTICAL ANALYSIS AND DATA MANAGEMENT 
12.1 STATISTICAL ANALYSIS 
All data will be analyzed by CORE at the University of Waterloo.  Unmasked data analysis will 
be conducted using Statistica 10, Statsoft or other suitable software.  Descriptive statistics will 
be provided on demographic data (age, gender, refractive error distribution, etc.). Table 7  lists 
the primary and other outcome variables and anticipated statistical procedures. 
Visual acuity results will be converted to LogMAR for analysis purposes. 
Comparisons will be made between the study lenses for the variables measured at the 2-week 
visits. Additionally, the subjective ratings completed on days 1, 6 and 13 of each phase will be 
compared. A binomial test will be used to analyze the results for the count data of subjective 
preferences and experience responses. Where relevant, the number of “neither agree or 
disagree” responses will be evenly distributed to the two options on the basis they would be 
equally likely to choose either. 
Additional analysis will determine the number of lenses and fit attempts needed to determine the 
optimal lens prescription. 
Because of the phenomenon of binocular summation, binocular visual acuity will be analysed, 
not right eye data. For other variables, such as lens fit, the right eye data will be reported and 
compared. 
Where appropriate, data may be presented as both mean and as counts by ‘bucket’ groups. 

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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.  
Prior to starting the study, all site Principal Investigators and co-investigators will provide 
CooperVision with a scan of their curriculum vitae, license to practice optometry, GCP training 
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. 
Study data review and data monitoring will be conducted by CORE personnel. To improve data 
integrity, data entry will be conducted by one person and a second person will visually compare 

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the data entry to the source documents. 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 Coordinator. 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 Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use Guidelines for Good Clinical Practice 
• 
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 
(2018) 
• 
https://uwaterloo.ca/research/office-research-ethics/research-human-participants  
 
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); 

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• 
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 ten years following the close 

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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. 
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.