Evaluation of Monthly Replacement Lens Designs in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use
Phase: NA
Conditions: Ametropia
Sponsor: CooperVision, Inc.



EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
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Study locations 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2. Clinical research conducted at in-practice study sites: 
 
It is anticipated that between 4 and 6 sites in the United States of America and/or 
Canada will be identified and contracted for this study. The details of all sites and all 
principal Investigators will be included in the study report. 
 
 
 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
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1 
DOCUMENT CHANGE HISTORY 
 
Version 
number 
Version 
date 
Author 
Description of change(s) 
1.0 
01nov2021 Doerte Luensmann 
Original protocol 
2.0 
17nov2021 Doerte Luensmann 
CORE protocol number updated (Title page) 
 
 
 
 
 
 
 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
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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 ..................................................................................................... 9 
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 ................................................................................................... 14 
5.4.4 
Rewetting drops ................................................................................................. 14 
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 & fit visit .................................................................................. 16 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
6 
5.5.2 
Repeated screening visits (Visit 0 or Visit 0/R1) .................................................. 18 
5.5.3 
Visit 1-0 Dispense Lens type #1 ......................................................................... 18 
5.5.4 
Visit 2-0, 1-month follow-up Lens type #1, Dispense Lens type #2 ...................... 20 
5.5.5 
Visit 3-0 1-month follow-up Lens type #2 ............................................................ 21 
5.5.6 
Study Exit .......................................................................................................... 22 
5.5.7 
Unscheduled visits ............................................................................................. 22 
5.6 
Study procedures...................................................................................................... 23 
5.6.1 
 ................................................................................................ 24 
5.6.2 
 ...................................................................................................... 24 
5.6.3 
................................................................................... 24 
5.6.4 
 ........................................................................................... 24 
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 ......................................................................................... 28 
9 
Discontinuation from the study ........................................................................................ 29 
10 
Device malfunctions ........................................................................................................ 31 
11 
Study completion and remuneration ................................................................................ 31 
12 
Statistical analysis and data management ....................................................................... 31 
12.1 
Statistical analysis ................................................................................................. 31 
12.2 
Data management ................................................................................................. 32 
12.3 
Comments on source documents........................................................................... 33 
13 
Protocol & other training .................................................................................................. 33 
14 
Study monitoring ............................................................................................................. 33 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
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15 
Study management ......................................................................................................... 34 
15.1 
Statement of compliance ....................................................................................... 34 
15.2 
Ethics review ......................................................................................................... 34 
15.3 
Clinical trial registration ......................................................................................... 35 
15.4 
Protocol deviations ................................................................................................ 35 
15.4.1 
Major protocol deviations ................................................................................... 35 
15.4.2 
Minor protocol deviations ................................................................................... 36 
15.4.3 
Reporting and documenting protcol deviations.................................................... 36 
15.5 
Premature termination of the study ........................................................................ 36 
15.6 
Study participant records ....................................................................................... 36 
15.7 
Retention of study records and data ...................................................................... 37 
16 
Report ............................................................................................................................ 37 
 
 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
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 Confidentiality 
This is a private document and the property of the Centre for Ocular Research & Education. It 
is therefore confidential to the recipient and must not be quoted from or distributed beyond the 
company to which it is sent without the express written permission of the Director (or her/his 
designate) of the Centre for Ocular Research & Education. Release of information from this 
document is governed by the research agreement on file. 
 
Disclaimer 
This study will be conducted for research purposes only. 
 
 
 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
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2 
INTRODUCTION 
As new lenses come to market it is of interest to compare the performance of the new product to 
the performance of established products. The goal of this study is to compare the performance of 
Biofinity Energys (Lens A), a SiHy monthly replacement lens from CooperVision Inc., which has 
successfully been established on the market with TOTAL30 (Lens B), a SiHy monthly replacement 
lens recently launched by Alcon Inc.  
3 
OBJECTIVES 
To evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual 
wearers of frequent replacement (FRP) lenses who report use of digital devices at least 6 hours 
per day. Each study lens type will be worn for 1-month.  
The primary outcome variable for this study is: 
• 
Lens handling on removal (0-10 scale, 0.5 steps) collected in the Day 27 At-
Home Subjective ratings.   
4 
HYPOTHESIS 
The null hypothesis is that there will be no difference for lens handling on removal on day 27 
between Lens A compared to Lens B, captured in the Day 27 At-home Subjective Ratings form.  
5 
MATERIALS AND METHODS 
5.1 STUDY DESIGN 
5.1.1 OVERALL DESIGN 
This study is a prospective, bilateral eye, double-masked, randomized, 1-month cross-over, 
daily-wear design involving two different FRP lens types. Each lens type will be worn for 
approximately one month, during which participants record their subjective lens-wear experience 
on several different days at home and during study visits. 
5.1.2 RANDOMIZATION 
A randomization schedule will determine the order of Lens A and Lens B wear for the 
first/second month for each participant. Participants will be randomized immediately prior to their 
first lens dispense. 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
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This randomization schedule will be generated for each site using a web-based program: 
(www.randomization.com). The lens type that will be worn during the first month is called “Lens 
type #1”, the lens type dispended for the second month is called “Lens type #2”. The final study 
randomization schedule will be generated by CORE’s Database Administrator and provided to 
the research assistants at each site.  
5.1.3 MASKING 
At the fitting visit, only the participant will be masked of the lens type, the investigator will know 
which type is being fit in order to make changes to the lens at this visit if needed.  
At both dispense visits, participants and investigators will be masked to the lens type dispensed. 
In order to achieve this, unmasked study personnel will determine the lens order according to 
the randomization schedule and will over-labeled the lens packages/foils prior to dispense. 
5.2 INVESTIGATIONAL SITES 
5.2.1 NUMBER OF SITES 
This study will be conducted in between four and six optometry practice sites in the US and/or 
Canada, depending on their ability to recruit sufficient number of participants. The exact site 
locations and names of the principal Investigators will be listed in the final study report. 
 
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 prompt lens 
ordering and timely data review, query and entry. 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
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5.3 STUDY POPULATION 
5.3.1 SAMPLE SIZE CALCULATION 
The sample size calculation was based on “lens handling for removal” using data at 2 weeks from 
a study comparing MyDay Multifocal (CooperVision) to Dailies Total 1 Multifocal (Alcon Inc) in 
which participants used a 0-10 scale (10 being best).  
A minimum sample size of 60 is required to detect a paired difference between groups of 1.0 unit 
on a 0-10 scale for “lens handling for removal” with 80% power and alpha 0.05 in a two-tailed t-
test. Therefore, up to 66 participants may be dispensed with study products with the goal to 
complete at least 60.  
 
 
Figure 1: Sample size calculation graph 
 
5.3.2 NUMBER OF PARTICIPANTS 
Participants will be recruited using site records, databases and advertising materials (eg. 
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 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
12 
reduce any undue influence of the optometrist-patient relationship. This process will also 
eliminate opportunity for the investigator to access personal health information before any 
consent for disclosure is provided by the potential participant.  
It is anticipated that up to 80 potential participants may attend a Screening visit and up to 65 
participants may be randomized and dispensed with study products, with a target of at least 60 
completing the study.  
 
5.3.3 INCLUSION AND EXCLUSION CRITERIA 
A person is eligible for inclusion in the study if he/she: 
1. Is at least 18 years of age and no older than 35 years, and has full legal capacity to 
volunteer; 
2. Has read and signed an information consent letter; 
3. Is willing and able to follow instructions and maintain the appointment schedule; 
4. Self-reports having a full eye examination in the previous two years; 
5. Self-reports spending on most days at least 6 hours cumulative (not necessarily in one 
single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smart-
phone; 
6. Has healthy eyes with no health condition or medication that contra-indicate contact lens 
wear, in the opinion of the investigator; 
7. Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week; 
8. Habitually wears soft frequent replacement contact lenses, for the past 3 months 
minimum (NOTE: the habitual contact lens brand is restricted such that no more than one 
third are to be the Biofinity Energy brand (or their equivalent private label brand name) 
and no more than one third are to be an Alcon brand; 
9. Has refractive astigmatism no higher than -0.75DC in each eye; 
10. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens 
parameters are sphere +6.00 to -6.00D, 0.25D steps). 
A person will be excluded from the study if he/she: 
1. Is participating in any concurrent clinical or research study; 
2. Has any known active* ocular disease and/or infection that contraindicates contact lens 
wear; 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
13 
3. Has a systemic or ocular 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. 
 
The upper age limit of 35years is in place to eliminate the influence of presbyopia (age-related 
difficulties focusing at close range) on eye strain with extended close work or digital device use.  
Pregnant and lactating women are not being excluded from the study due to safety concerns but 
due to fluctuations in refractive error, accommodation and/ or visual acuity that occur secondary 
to systemic hormonal changes and water retention. It has further been shown that pregnancy 
could impact tear production, which could impact dry eye symptoms. Such fluctuations could 
affect data, thereby negatively affecting study data integrity. 
5.4 STUDY MATERIALS 
It is anticipated that sites will pre-order the study contact lenses (Lens A and Lens B) for each 
potential participant prior to them attending for the screening/fit visit. This order will be based on 
their habitual contact lens power. One commercial pack of 6 lenses will be ordered per eye 
unless both eyes require the same prescription, when only one 6-pack of lenses will be ordered. 
This will mean that there will be study lenses on site at the time of the screening visit and unless 
there are changes required to the prescription, the dispense visit will be able to occur 
immediately after the screening/fit visit. 
Reimbursement to practice sites for study product expenses will be provided by CooperVision 
after recruitment has been completed and CORE has reconciled the invoices. 
CORE will provide all sites with the study paperwork. This will include participant informed 
consent letters and study data collection forms, product accountability logs and the participant 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
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5.4.5 DISPOSING OF STUDY PRODUCTS 
At the end of the study, all sites will dispose of all unused products after lens reconciliation has 
been completed, unless otherwise directed. Worn lenses will be disposed of according to local 
regulations. 
5.4.6 PRODUCT ACCOUNTABILITY 
Accountability logs must be kept by each site to include the number of contact lenses received 
and on hand at the end of the study. All products dispensed to participants must be recorded in 
participant dispensing logs. 
5.5 SCHEDULED AND UNSCHEDULED VISITS 
This study has a minimum of 4 scheduled study visits, including the screening visit. There is an 
option for repeated screening visit if needed. 
A scheduled 1-month follow-up visits may only take place when the participant attends 
wearing the study lenses for at least two hours that day. If this is not the case and the participant 
is not experiencing any problems with the lenses, the appointment will be rescheduled, ideally 
within the visit window.   
Visits that fall outside of the specified visit windows will be designated as protocol deviations and 
at the end of the study, the data collected during protocol deviations will be assessed for their 
suitability to be included in the analysis population. 
Table 2 summarizes the scheduled study visits and study codes. 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
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d. 
 
  
 
 
 
 
13. The investigator will confirm that the participant meets the eligibility specifications set out 
in the inclusion criteria and exclusion criteria and is eligible to continue in the study. 
14. If the required prescriptions for both lens types are available, the lens Dispense visit (1-0) 
will occur on the same day, otherwise the correct lens powers will be ordered and the 
Dispense visit will be scheduled once both lens types are on site (within 0-21 days after 
Visit 0).  
 
5.5.2 REPEATED SCREENING VISITS (VISIT 0 OR VISIT 0/R1) 
In some circumstances a repeated screening may need to be scheduled. Examples include, but 
are not limited to: 
1. Incomplete information available at time of screening to determine eligibility (e.g. current 
lens brands worn, history from current eye care practitioner etc.) 
2. Study procedures unable to be completed in time scheduled for visit; 
3. 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. 
 
 
The maximum total number of screenings permitted will be 2, the initial and one repeat 
screening visit. 
 
5.5.3 VISIT 1-0 DISPENSE LENS TYPE #1 
This visit may or may not be immediately subsequent to the screening visit, depending on lens 
availability but will occur no later than 21 days after Visit 0.  
The study procedures are outlined below: 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
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1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.
 
 
 
 
4. If
 
 
 
5. 
 
  
 
 
 
 
 
  
 
  
 
 
7. Provide and explain to participant the subjective at-home rating forms to be completed on 
Days 
 27 (
). Fill in the 
days and dates on these forms. Explain the ratings will include: 
• 
  
 
 
 
 
 
 
 
 
 
 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
20 
• 
 
 
 
• 
Ease of lens handling for removal (0 – 10 scale, 0.5 steps). 
• 
 
 
 
 
 
 
 
 
 
 
 
 
8. The participant will be instructed to use their habitual lens care products and to wear the 
lenses for at least 8 hours a day, 6 days a week. 
9. Visit 2-0 will be scheduled 28-32, inclusive, days after Visit 1-0. 
 
5.5.4 VISIT 2-0, 1-MONTH FOLLOW-UP LENS TYPE #1, DISPENSE LENS TYPE 
#2 
Participants will be asked to insert Lens type #1 at least 2 hours prior to the visit. This visit will 
occur 28-32 days (inclusive) after visit 1-0. 
The study procedures are outlined below: 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
3. 
 
  
 
 
 
 
  
 
 
 
  
 
  
 
 
6. The participant will remove the lenses. 
7. 
 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
21 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
8. Continue with the lens dispense for Lens type #2 as described in visit 1-0 starting point 
#4 to #8. 
9. Visit 3-0 will be scheduled 28-32 days after Visit 2-0. 
 
5.5.5 VISIT 3-0 1-MONTH FOLLOW-UP LENS TYPE #2  
Participants will be asked to insert Lens type #2 lenses at least 2 hours prior to the visit. This 
visit will occur 28-32 days (inclusive) after visit 2-0. 
The study procedures are outlined below: 
1. Confirm participant’s health and medications are unchanged. 
2. 
. 
3. 
 
  
 
 
 
 
 
5. 
 
 
10. 
  
 
 
 
  
 
  
 
 
6. The participant will remove the lenses. 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
22 
7. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8. Continue with Study Exit. 
 
5.5.6 STUDY EXIT 
The study exit form will be completed when a participant exits the study. This form will be 
completed either at study completion, or if the participant is discontinued from the study at another 
time. A study exit form must be completed for all participants who have taken a study ID number. 
If in the opinion of the investigator post-study follow-up visits are required, the exit form will be 
completed after the last follow-up visit.  
 
 
 
 
After the exit assessments have been completed, the participant and investigator will complete 
the study completion and remuneration forms. At this time the participant will be considered as 
having exited the study. 
 
5.5.7 UNSCHEDULED VISITS 
An unscheduled visit is defined as an interim visit requested by the participant or investigator 
due to an unanticipated problem. Data recorded at these visits will be entered into the database. 
Only relevant and applicable unscheduled visit information will be included in the final report as 
deemed necessary.  
 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
24 
5.6.1 STUDY LENS FITTING  
Both lens types will be fit according to the manufacturers fitting guide. 
 
 
 
 
 
 
 
  
 
  
  
 
 
  
 
 
  
 
 
   
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
25 
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 business days of becoming aware of them (as per Sterling Institutional Review Board 
guidelines).  
7 
POTENTIAL RISKS AND BENEFITS TO HUMAN PARTICIPANTS 
There may be no direct benefits to the subjects in this study. Participation in a study may contribute 
to scientific research information that may be used in the development of new contact lens 
products. The subjects will receive an examination of the front part of their eyes and may have the 
opportunity to try a different type of soft contact lenses and/or different lens care products at no 
cost to them. The contact lens materials used in this study are commercially available as daily 
wear. This study will investigate participants’ wearing schedule intended for daily wear (NOT 
extended wear), similar to the average wearing time of 10-16 hours for daily wear lenses.  
This study is considered to be a non-significant risk study based on United State Food and Drug 
administration (FDA) and International Standards Organization (ISO) guidelines, because the 
study devices used as intended in this study (1) do not represent a potential for serious risk to the 
health, safety or welfare of the subject, and (2) are not implants, (3) are not used to support or 
sustain human life, (4) are not of substantial importance in diagnosing, curing, mitigating or treating 
disease or otherwise prevents impairment of human health.  
The two study contact lens types will be worn as per their approved use; on a daily wear, 
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 (eg: 
inflammation and infection). Complications that may occur during the wearing of contact lenses 
include discomfort, dryness, aching or itching eyes, excessive tearing, discharge, hyperemia and 
variable or blurred vision.  More serious risks may include pain, photophobia, iritis, corneal 
edema or eye infection. Although contact lens-related infections are very infrequent, the 
possibility does exist.  The incidence of infection due to day-wear soft lenses is 0.035%. Almost 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
28 
21 
Conjunctivitis (bacterial, viral or allergic) 
Notify sponsor as 
soon as possible, 
within 5 working 
days; ORE 
reporting as per 
requirements 
22 
Papillary conjunctivitis if ≥ mild scattered papillae/follicles approximately 1mm 
in diameter (e.g. ISO 11890 Grade 2), if 2 grade change from baseline 
23 
Asymptomatic corneal infiltrative events 
24 
Any sign and/or symptom for which temporary lens discontinuation for > 1 day 
is recommended (if not already classified) 
20 
Other sign and/or symptom warranting classification as a non-significant 
adverse event 
 
8.1 NORMAL OR ADAPTIVE SYMPTOMS 
Transient symptoms such as end-of-day dryness, lens awareness, itching or burning or other 
discomfort may occur with contact lens wear and may occasionally reduce wearing time. These 
are not reported as adverse events unless in the investigator’s opinion they are unexpected in 
nature, severe or have a high rate of occurrence.  
8.2 PROCEDURES FOR ADVERSE EVENTS 
Treatment of an adverse event will depend on its nature and severity. Based on the clinical 
judgment of the investigator the participant may be managed at the practice or referred to another 
eye care practitioner for treatment. The investigator will attempt to determine whether the reaction 
is related to the test device or a result of other factors. An adverse event form will be completed 
for each adverse event. If both eyes are involved, a separate adverse event form will be completed 
for each eye. Whenever possible, the adverse event will be photo-documented.  
Expenses incurred for medical treatment as part of study participation will be paid by the sponsor 
(bills and prescription receipts kept). The participant must be followed until resolution or no further 
change is anticipated and/or referred for further care with the appropriate health care professional 
and/or recorded as being under appropriate health care as per investigator’s discretion. A written 
report will be completed indicating the subsequent treatment and resolution of the condition. 
8.3 REPORTING ADVERSE EVENTS 
All potential Serious and Unanticipated Adverse Device Effects that are related or possibly related 
to participant’s participation will be reported to 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. 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
29 
The site’s Principal Investigator will also report the event to Sterling IRB within 10 business days 
of becoming aware of the Serious or Unanticipated event, using the Reportable Events Form. All 
fatal or life-threatening events will be reported immediately to the IRB. 
Significant and Non-Significant Adverse Events will be reported to CORE’s lead study coordinator 
and the sponsor as soon as possible, but no later than 5 working days after becoming aware of it. 
 
 
  
 
  
 
 
 
  
 
 
 
 
  
  
 
  
 
 
 
  
 
 
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 per visit for their active involvement in the study 
(including the initial screening visit and all lens fitting visits).  Upon discontinuing, a participant 
will be offered the option of their data being withdrawn from future statistical analysis. The 
following is a list of possible reasons for discontinuation from the study: 
• 
Screening failure: Participants will be discontinued if they do not meet the inclusion and 
exclusion criteria outlined in section 5.2.3. 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
30 
• 
Unacceptable performance with products to be used in study: Participants may be 
discontinued if they are unable to achieve acceptable comfort and /or vision with the 
study products. 
• 
Positive slit lamp finding:  Participants may be permanently discontinued from the study 
depending on the severity of the condition and on the judgement of the investigator.   
• 
Adverse event: If a participant experiences an adverse event during the study they may 
be discontinued based on the clinical judgement of the investigator. 
• 
Symptoms: If the participant has persistent symptoms, they may be discontinued based 
on the clinical judgement of the investigator. 
• 
Disinterest, relocation or illness: The participant may choose to discontinue due to 
reasons within or beyond their control. 
• 
Violation of protocol or non-compliance:  The participant will be discontinued if they are 
unable or unwilling to follow the protocol specified visit schedules and/or study 
procedures. 
• 
Instillation of topical ocular medication:  The participant will be discontinued if they elect 
to use a topical ocular medication during the study unless that topical ocular medication 
is prescribed for a limited duration (less than two weeks) to treat a transient condition; in 
this case the participant may remain an active participant (at the discretion of the 
investigator) after stopping topical ocular medication following resolution of the ocular 
condition). 
• 
Lost to follow-up:  The participant will be discontinued if they cannot be contacted and do 
not return to complete the final study exit, and if the investigator has made a reasonable 
effort to contact the participant for a final study visit. 
• 
Premature termination of the study by the sponsor, CORE or Sterling IRB. 
A discontinuation form, stating the reason for discontinuation will be completed, which requires 
the signatures of both the participant and the investigator except where the participant is lost to 
follow-up in which case only the signature of the investigator is required.   
When a participant chooses 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. 

EX-MKTG-130 BREAM Protocol v2.0 17nov2021 
31 
All discontinuations including their reasons will be included in the final report. 
10 DEVICE MALFUNCTIONS 
A device malfunction means the failure of the device to meet its performance specification or 
otherwise perform as intended. Any defective lens that is likely to cause or contribute to a Serious 
Adverse Event should be reported to CORE and the sponsor within 24 hours of the investigator 
becoming aware of the malfunction. STERLING IRB would also be notified within 10 business 
days of any device malfunction that may contribute to a Serious Adverse Event. 
Other defective lenses should be reported to CORE as soon as possible. 
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 provided at the end of their study involvement. 
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.). 
 
 
 
 
 
 
 

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out by the University of Waterloo. More details regarding storage procedures are provided in 
section 15.7 and also in CORE SOP014 Clinical data management. 
At the completion of the study CORE will provide a copy of the study database in Excel format to 
the sponsor when requested. Data will typically be sent using Sendit. This system provides a 
secure way to transfer files when email is not appropriate, whether because of file size, file type 
or concerns over security. Sendit includes features such as password protection, a restricted 
time period for download, IP logging and email notification of download. Files may be encrypted 
prior to transmission at the request of the sponsor. Using this method means that data files are 
only stored on University of Waterloo servers 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 Coordinator.  
13 PROTOCOL & OTHER TRAINING 
All study personnel will be required to complete training prior to their involvement in the study. 
Records of training will be kept at CORE. This will include training by CORE on the study 
protocol, study procedures, informed consent procedures, and on the randomization and 
participant masking procedures, as well as training for Good Clinical Practice.  
All site Principal Investigators and co-investigators will provide CooperVision Inc with a scan of 
their curriculum vitae, license to practice optometry and evidence of professional indemnity 
insurance.  
14 STUDY MONITORING 
Each site will provide regular status reports to CORE. Status reports will include: 
• 
These may include but are not limited to participant enrollment status, cases of 
discontinuation etc. 
• 
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 

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34 
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 
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 Conference on Harmonisation; Good Clinical Practice 
• 
http://iris.uwaterloo.ca/ethics/human/guidelines/index.htm 
• 
http://iris.uwaterloo.ca/ethics/human/ethicsReview/UWStatement.htm 
• 
http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/ 
 
Informed consent shall be obtained in writing from the participant and the process shall be 
documented before any procedure specific to the clinical investigation is carried out. 
15.2 ETHICS REVIEW 
This protocol will be submitted to and reviewed through the Sterling Institutional Review Board. 
Notification of ethics clearance of the application is required prior to the commencement of the 
study. 

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35 
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. 
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 Sterling 
Institutional Review 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. 

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36 
15.4.2 MINOR PROTOCOL DEVIATIONS 
Many protocol deviations which are caused by or originate with research participants are 
considered minor, and normally are not reported to the Sterling Institutional Review 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 Sterling Institutional 
Review Board : 
• 
Logistical or administrative aspects of the study (e.g., study participant missed 
appointment, change in appointment date); 
• 
Inadvertent deviation in specific research intervention procedures or timing of the 
research intervention which would not impact upon the safety or efficacy of the study-
related intervention or upon the experimental design (i.e., missing a measurement during 
a session that is not considered critical for the study).  
15.4.3 REPORTING AND DOCUMENTING PROTCOL DEVIATIONS  
Major protocol deviations must be reported to the Sterling Institutional Review Board within 10 
business 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; 

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• 
Investigator’s signature confirming study exit. 
An enrolment log will be maintained at each site 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 electronic copies of the study product 
accountability and dispensing logs to CORE for review.  Each site should retain the original 
consent documents and the study data collection forms documentation for ten years following 
the close of the database in case data queries arise during the analysis and report writing stages 
unless instructed otherwise. CORE may request that these originals be sent to them for storage 
and study data collections forms may be sent to the sponsor for storage. 
Records and data from this study will be retained at CORE for a minimum of 25 years. Details 
regarding storage procedures are given in CORE SOP014 Clinical data management.  
16 REPORT 
A report will be sent to the sponsor by CORE according to terms described in the study contract.