Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types
Phase: NA
Conditions: Presbyopia
Sponsor: CooperVision International Limited (CVIL)



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1 
DOCUMENT CHANGE HISTORY 
 
Version 
number 
Version 
date 
Author 
Description of change(s) 
1.0 
06Dec2023 
Doerte Luensmann 
Original protocol 
1.1 
12Dec2023 
Doerte Luensmann 
Minor edits to section 5.3.3 (Inclusion/ Exclusion 
criteria) 
 
 
 
 
 
 
 
 
 
 
 

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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 ........................................................................................................ 9 
5.1 
Study design ................................................................................................................. 9 
5.1.1 
Overall design ........................................................................................................ 9 
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 ...................................................................................... 10 
5.3 
Study population ......................................................................................................... 11 
5.3.1 
Sample size calculation ........................................................................................ 11 
5.3.2 
Number of Participants ......................................................................................... 11 
5.3.3 
Inclusion and exclusion criteria ............................................................................. 12 
5.4 
Study materials ........................................................................................................... 13 
5.4.1 
Lenses ................................................................................................................. 14 
5.4.2 
Lens care products ............................................................................................... 14 
5.4.3 
Other products ..................................................................................................... 15 
5.4.4 
Rewetting drops ................................................................................................... 15 
5.4.5 
Disposing of study products ................................................................................. 15 
5.4.6 
Product accountability .......................................................................................... 15 
5.5 
Scheduled and unscheduled visits .............................................................................. 15 
5.5.1 
Visit 0, Screening & fitting visit ............................................................................. 16 

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5.5.2 
Repeated screening visits (Visit 0/R1 or Visit 0/R2) .............................................. 19 
5.5.3 
Visit 1-0 Dispense lens Pair #1 ............................................................................. 19 
5.5.4 
Visit 1-1 Optimize Pair #1 ..................................................................................... 20 
5.5.5 
Visit 1-2 Dispense (optimized) Pair #1 .................................................................. 21 
5.5.6 
Visit 1-3, 1-month follow-up Pair #1 ...................................................................... 22 
5.5.7 
Visit 2-0, Dispense Pair #2 ................................................................................... 22 
5.5.8 
Visit 2-1 Optimize Pair #2 ..................................................................................... 22 
5.5.9 
Visit 2-2 Dispense (optimized) Pair #2 .................................................................. 22 
5.5.10 
Visit 2-3, 1-month follow-up Pair #2 ...................................................................... 23 
5.5.11 
Exit visit ................................................................................................................ 23 
5.5.12 
Unscheduled visits ............................................................................................... 23 
5.6 
Study procedures ........................................................................................................ 24 
5.6.1 
Study lens fitting ................................................................................................... 25 
5.6.2 
 ......................................................................................................... 25 
5.6.3 
 ............................................................................................. 25 
6 
Monitoring protocol adherence .......................................................................................... 25 
7 
Potential risks and benefits to human participants ............................................................. 25 
8 
Adverse events .................................................................................................................. 26 
8.1 
Normal or adaptive symptoms ..................................................................................... 28 
8.2 
Procedures for adverse events .................................................................................... 28 
8.3 
Reporting adverse events ........................................................................................... 29 
9 
Discontinuation from the study ........................................................................................... 30 
10 
Device malfunctions ........................................................................................................... 31 
11 
Study completion and remuneration .................................................................................. 31 
12 
Statistical analysis and data management ......................................................................... 32 
12.1 
Statistical analysis ................................................................................................... 32 

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12.2 
Data management ................................................................................................... 33 
12.3 
Comments on source documents ............................................................................ 34 
13 
Protocol & other training .................................................................................................... 34 
14 
Study monitoring ................................................................................................................ 34 
15 
Study management............................................................................................................ 35 
15.1 
Statement of compliance ......................................................................................... 35 
15.2 
Ethics review ........................................................................................................... 35 
15.3 
Clinical trial registration ............................................................................................ 36 
15.4 
Protocol deviations .................................................................................................. 36 
15.4.1 
Major protocol deviations ..................................................................................... 36 
15.4.2 
Minor protocol deviations ..................................................................................... 36 
15.4.3 
Reporting and documenting protcol deviations ..................................................... 37 
15.5 
Premature termination of the study .......................................................................... 37 
15.6 
Study participant records ......................................................................................... 37 
15.7 
Retention of study records and data ........................................................................ 37 
16 
Report................................................................................................................................ 38 
 
 

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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 
Presbyopia is the gradual loss of the eyes' ability to focus on nearby objects and typically starts in 
patients around 40 years of age and continues to worsen over the next 20 years. This requires a 
frequent adjustment of the near prescription and as a result multifocal soft contact lenses are 
available with increasing near add increments. New lens materials and multifocal lens designs are 
introduced to the marked frequently and it is of interest to understand how these perform in 
comparison to existing products.  
CooperVision is interested to better understand the performance of their own frequent 
replacement lens Biofinity Multifocal (CONTROL) in comparison to the competitor product 
TOTAL30 multifocal (TEST), which has recently been launched by Alcon 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 insertion’, using a 0-100 scale, collected in office after 1 month 
of study lens wear.   
Also of interest are subjective feedback on comfort, vision and overall performance using 
ratings, agreement questions and preferences. 
4 
HYPOTHESIS 
H0. There is no statistical difference in lens handling for insertion after 1-month of wear between 
the Biofinity multifocal and TOTAL 30 multifocal lenses. 
H1. There is a statistical difference in lens handling for insertion after 1-month of wear between 
the Biofinity multifocal and TOTAL 30 multifocal 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 and Canada. Each lens 
type will be worn for approximately 4-6 weeks: the lens prescription of each lens type will be 

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optimized after 3-10 days wearing experience, prior to starting a 1-month (28-32 days) 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 
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 in the US and Canada.   
 
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. 

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5.3 STUDY POPULATION 
5.3.1 SAMPLE SIZE CALCULATION 
The sample size was calculated using lens handling data from a previous study comparing Lens 
A against lens B (CooperVision, data on file). In that study a 0-100 scale was also used and a 
target difference of 5 units on the 0-100 scale was chosen as a meaningful clinical difference in 0-
100 subjective responses. 
Using the 0-100 scale data described above for ‘lens handling for insertion’, where the data 
showed a standard deviation of 12.7 and when applying requirements of 80% power and alpha 
0.05 in a two-tailed t-test, a minimum sample size of 53 participants is recommended in order to 
detect a mean difference of 5 units. 
To account for dropout, up to 60 participants may be randomized and dispensed with study 
product in total, with the target of at least 53 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 
eliminate opportunity for the investigator to access personal health information before any 
consent for disclosure is provided by the potential participant.  

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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 53 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 spherical multifocal soft contact lenses, for the past 3 months 
minimum^;  
- Maximum of 4 participants (out of 12) per site may be habitual wearers of daily 
disposable lenses,  
- Maximum of 4 participants (out of 12) per site may be habitual wearers of Biofinity 
Multifocal, 
- Maximum of 4 participants (out of 12) per site may be habitual wearers of either 
TOTAL30 Multifocal or AirOptix plus HydraGlyde Multifocal 
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 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 to target the anticipated 
habitual lens distribution across all sites. If necessary, additional exceptions may be permitted after 
discussion with the study monitor or sponsor. 
 
A person will be excluded from the study if he/she: 
1. Is participating in any concurrent clinical or research trial; 

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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 criterion 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.   
Reimbursement to practice sites for study product expenses will be provided by CooperVision 
during or at the end of the study, after CORE has reconciled the invoices and the product 
accountability and dispensing logs. 

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5.4.3 OTHER PRODUCTS 
Sodium fluorescein will be used to assess corneal and conjunctival staining.  
5.4.4 REWETTING DROPS 
Participants will not be encouraged to use rewetting drops; however, those who habitually used 
rewetting drops will be allowed to continue using their normal drops.  
5.4.5 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. 
5.4.6 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 9 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. Some of the scheduled visits can occur on the same 
day, participants are therefore required to only attend 6 or 7 in-office visits. 
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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Participants will be assigned a unique alpha-numeric study ID after they sign the consent 
documentation i.e., before their eligibility for the study has been confirmed. Each site will use a 
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. 
 
 
10. 
 
 
 
 
 
 

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11. 
 
. 
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. 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
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. 

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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 fitting lenses of the TEST lens, only 
purchased lens supply is acceptable for dispense even during the optimization wear phase.)  
Procedures as follows: 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
3. 
 
 
 
4. 
 

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5. Assess lens fit: determine lens centration and overall acceptability. 
6. 
 
 
7. 
 
8. The participant will receive a pair of study lenses for dispense (and a backup pair if 
needed) and will be instructed to wear the lenses for at least 8 hours a day, 5 days a 
week. 
9. The participant will be instructed to use their habitual lens care products with the study 
lenses or if applicable as per section 5.4.2, will be dispensed with a monthly supply of 
Optifree Puremoist – the correct use of the product will be reviewed with the participant 
prior to dispense. 
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 3-10 days (inclusive) after visit 1-0. 
1. Confirm participant’s health and medications are unchanged. 
2. Ask participant about lens performance for acceptability of contact lens comfort and 
vision at distance and near. 
3. 
 
 
4. 
 
 
  
5. Assess lens fit: determine lens centration and overall acceptability. 
6. 
 
 
   
a. 
 
 
8. Remove lenses 
9. 
 

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7. If no power change is needed and if at least two pairs of optimized lenses (One pair for 
dispense, one pair as a backup if needed) 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. 
 
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. 
 
 
 
4. 
 
5. 
 
  
1. Ensure vision at distance and near is acceptable for participant. 
2. Assess lens fit: determine lens centration and overall acceptability. 
3. 
 
 
  
4. 
 
 
5. 
 
 
 
6. The participant will be scheduled to return for Visit 1-3.  

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5.5.6 VISIT 1-3, 1-MONTH FOLLOW-UP PAIR #1 
Participants will be asked to insert study lenses at least 2 hours prior to the visit. 
This visit will occur 28-32 days (inclusive) after visit 1-2. 
1. Confirm participant’s health and medications are unchanged. 
2. Ask participant about lens performance for acceptability of contact lens comfort and 
vision at distance and near. 
3. 
 
4. Ask participant to complete the ‘Subjective ratings at visit’ and ‘Experience survey’. 
5. 
 
 
6. Assess lens fit: determine lens centration and overall acceptability. 
7. 
 
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 3-10 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. 

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Assessments of Pair #2 will be conducted as described for Pair #1 at visit (Visit 1-2). 
 
5.5.10 VISIT 2-3, 1-MONTH FOLLOW-UP PAIR #2 
Participants will be asked to insert study lenses at least 2 hours prior to the visit. 
This visit will occur 28-32 days (inclusive) after visit 2-2. 
Assessments of Pair #2 will be conducted as described for Pair #1 at visit (Visit 1-3). 
Participants will be asked to complete a ‘Preference questionnaire’ to compare between Lens 
Pair #1 and Lens Pair #2. 
 
5.5.11 EXIT VISIT 
The study exit form will be completed when a participant exits the study. This form will be 
completed either at study completion, or if the participant is discontinued from the study at another 
time. A study exit form must be completed for all participants who have taken a study ID number. 
If in the opinion of the investigator post-study follow-up visits are required, the exit form will be 
completed after the last follow-up visit.  
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. 
 
5.5.12 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.  
 

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5.6.1 STUDY LENS FITTING  
Both lens types will be fit according to the manufacturers fitting guide, using the vertex-corrected 
spectacle refraction as a guide. Learnings from the first lens fit will not be applied to the second 
lens fit because it is of interest to determine how many lenses were needed to achieve the final 
lens prescription. 
5.6.2 
 
 
 
5.6.3 LENS FIT ASSESSMENT 
This will consist of two separate assessments:  
1. Centration:  
Perfectly centred,  
Slightly decentred,  
Markedly decentred but corneal coverage,  
Unacceptable decentration showing corneal exposure. 
   
2. Confirmation whether the lens fit is clinically acceptable:  Yes / No . 
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 10 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.  

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26 
All lenses used in this study are IDE exempt under 21 CFR 812.2(c)2. 
The habitual lens and the two study contact lens types will be worn as per their approved use; 
on a daily wear, monthly-replacement 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 (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-153 Protocol v1.1 12Dec2023 
 
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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 Adverse Events 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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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 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 
investigator) after stopping topical ocular medication following resolution of the ocular 
condition). 

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• 
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 Ethics Board 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. 
Participant remuneration will be paid as per site contract. 

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12 STATISTICAL ANALYSIS AND DATA MANAGEMENT 
12.1 STATISTICAL ANALYSIS 
All data will be analyzed by CORE at the University of Waterloo.  Descriptive statistics will be 
provided on information regarding demographics (e.g. age, sex).  
Differences between lenses and differences over time will be compared using either Paired t-
tests or Wilcoxon matched pairs. Analysis will be conducted using Statistica 13 and SPSS 27.0. 
The appropriate tests will be selected based on tests of normality - non-parametric tests will be 
used for data not showing a normal distribution. Means and standard deviations will be provided 
for each variable. Medians will be provided for those variables analyzed with non-parametric 
tests. For all tests, values of p<0.05 will be considered significant. 
For assessments conducted for each eye separately, the right eye will be used for analysis. If a 
general difference is found (paired t-test / Wilcoxon matched pairs) between OD and OS, a 
comment will be provided. Visual acuity data will be analyzed using OU. 
For the agreement and preference data, binomial testing will be used to analyze the count data 
of subjective answers: For agreement analysis, “strongly agree” and “agree” will be combined 
into a single “agreement” category; similarly, “strongly disagree” and “disagree” will be combined 
into a single “disagreement” category. The number of “neither agree/disagree” ratings will be 
evenly distributed to these two categories on the basis they would be equally likely to choose 
either. Comments regarding the clinical relevance of differences in subjective ratings will be 
based on the conclusion by Navascues-Cornago et al.3 that on a scale of 0-100, differences 
greater or equal to 7 points would generally represent a difference that a patient would notice.  
Equivalence testing will be conducted for ratings of comfort, dryness, vision clarity and overall 
satisfaction. Testing will be performed using Mintab 21.4. A value of 7 will be used as the margin 
for equivalence3. 
Equivalence testing of visual acuity will be conducted using an equivalence margin of 0.10 
logMAR.4-6 
Additional analysis will determine the number of lenses and fit attempts needed to determine the 
optimal lens prescription. 

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34 
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 frequent 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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35 
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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36 
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 ethics board: 
• 
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 ethics board 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 ethics board: 
• 
Logistical or administrative aspects of the study (e.g., study participant missed 
appointment, change in appointment date); 

EX-MKTG-153 Protocol v1.1 12Dec2023 
 
37 
• 
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 
An interim analysis will be initiated when approximately 30 participants have completed, and 
results will be provided in PowerPoint format. The final analysis will be initiated when the last 
participant has exited the study and the final report will be prepared as Word document.