Comparing Habitual Daily Disposable Silicone Hydrogel (DDSH) Contact Lens Wearers to Habitual Daily Disposable Hydrogel (DDH) Contact Lens Wearers and Non-lens Wearers
Phase: NA
Conditions: Myopia
Sponsor: CooperVision, Inc.



                                                                                                                                                                                                                         
 
Centre for Ocular Research & Education (CORE), 
School of Optometry & Vision Science | University of Waterloo, 200 University Avenue West | Waterloo, ON, Canada N2L 3G1 
+1 (519) 888-4742 | CORE.uwaterloo.ca 
Protocol 
Comparing habitual daily disposable silicone 
hydrogel (DDSH) contact lens wearers to  
habitual daily disposable hydrogel (DDH) contact 
lens wearers and non-lens wearers (BAGPIPES) 
This protocol remains the exclusive property of CORE until it is commissioned by the sponsors. 
 
Sponsor Company 
CooperVision, Inc. 
Sponsor Study number: 
EX-MKTG-89 
CORE Study number: 
 
Version Number: 
2.0 
Document Date: 
28nov2020 
Document Type: 
Study protocol 
Clinical Sites: 
CORE, University of Waterloo 
Eurolens Research, Manchester, UK 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    2 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    3 
 
DOCUMENT CHANGE HISTORY 
 
Version # 
Originator/s 
Description of change(s) 
Date 
1.0 
Amir Moezzi  
 
Original protocol 
27 Feb 2018 
1.1 
Amir Moezzi 
Reviewer edits in general 
Removed reference to a Pilot Study 
Changed primary objective & primary 
variable 
Revised contact lens wear history inclusion 
criteria 
Contact lens details specified 
04 Apr 2018 
1.2 
 
Page 10, Re matching ethnicity in study 
Groups: Added ”this is due to possible 
differences in physiological response to 
corneal hypoxia in Asian and non-Asian 
participants”. 
 
Page 14, inclusion criterion #6: Changed 
“BVS” to “vertexed spherical equivalent”  
 
Page 15, inclusion #10: Clarified that this 
criterion is not-applicable to participants in 
group 3. 
 
Page 15: Added “topical anesthetic” to 
exclusion # 6. 
 
Page 16: Added “due to potential ocular 
physiological changes, such as changes in 
the corneal shape and cell types” in the end 
of exclusion #9.  
 
Page 17, 4.7.2 Contact lens care system: 
Added The study lens will inserted directly 
from sterile saline in the standard lens vial 
(sealed by the manufacturer).  
 
Page 17, 4.7.3 Rewetting drops & saline, 
Added: Worn lenses will be collected from 
the participants’ lens-wearing eye at the end 
of the 3-hour wearing period (or on 
discontinuation/exit from the study) and will 
be disposed as described section 4.7.6 of 
the protocol. 
 
Page 18, Table 2: V1 has been changed to 
V0 for day 1. 
  
28 May 2018 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    4 
Version # 
Originator/s 
Description of change(s) 
Date 
Page 24, Potential risks: Equalized 
denominators of rates of AEs by revising to 
“in approximately twenty people in a 
population of 10,000 who wear soft contact 
lenses on an extended wear basis”. 
 
Page 25, Potential risks: Added “In rare 
situations, some individuals may experience 
vaso-vagal syncope (or similar symptoms) 
with the use of topical anesthetic or ocular 
examination procedures” 
 
Page 25, Potential risks: Reference to “An 
examination of the front part of their eyes” 
has been removed as a benefit to the 
participant. 
 
1.3 
Amir Moezzi 
Page 10-11, study group inclusion criteria 
description: changed to DD CL wear for the 
past (minimum) 6 months and CL wear in 
the same material category in the past 
(minimum) 3 years. Removed maximum of  
7 years CL wear experience. Added no 
previous history of PMMA CL wear. 
 
Page 14-15, study inclusion criteria: revised 
to reflect the above-mentioned changes in 
the inclusion criteria. 
 
29Nov2018 
1.4 
Amir Moezzi 
Changed the study design to multi-site and 
reflected this minor change throughout the 
protocol.  
12Jul2019 
1.5 
Amir Moezzi 
 Section 4.8.1. Added CE marking in Table 
1. 
 
Section 4.9.3. Changed ‘required to remain 
within CORE’s premises’, to “required to 
remain in the study site”. 
 
Section 7. Changed “UW SOP012” to 
“Adverse Event Standard Operating 
Procedures (SOP) document for the relevant 
study site”. Typo (Appendix 16) has been 
removed from the end of the sentence. 
 
 
Section 10. Clarified that Eurolens Research 
will follow their local standard procedures 
and forms for study completion and any 
required feedback to participants. 
 
04Oct2019 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    5 
Version # 
Originator/s 
Description of change(s) 
Date 
Section 12.5. Added retention period of 20 
years for Eurolens Research. 
 
Section 15.1.3. Provided clarification that 
Eurolens Research study site will follow their 
local ethics committee requirements for 
reporting protocol deviations to the 
respective ethics committee. 
 
1.6 
Amir Moezzi 
Section 4.8.3. Typo corrected from 4.7.6. to 
4.8.6. 
 
Section 4.8.5. Clarification provided for 
ordering consumables.  
 
Corrected name of “Eurolens Research” site 
throughout the protocol. 
 
Section 8. Clarified reimbursement rate as 
“$20 per hour in CORE and it will be based 
on the rate approved by the respective 
ethics committee for Eurolens Research 
study site. 
 
Section 10. Added participant remuneration 
provided by Eurolens Research will be 
based on the amount approved by the 
respective ethics committee. 
 
Section 12.1. Re study updates, changed to 
“regular study updates from each site to the 
sponsor” instead of “regular study updates 
from CORE to the sponsor”  
  
 
08Oct2019 
1.7 
Amir Moezzi 
4.1.1 Clarified that trial fitting of study lenses 
is done in day 1. 
 
Section 4.6: Clarified that Eurolens 
Research may use a different terminology 
for the ICL (for example, ICF or PIS). 
 
Section 4.7.2: Replaced “CORE” with “study 
site in exclusion criterion#2”  
 
Section 8: added flat fees for participant 
discontinuation at Eurolens. 
 
Section 4.9.2: Changed the order of 
subjective and objective redness 
measurements.  
 
10Oct2019 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    6 
Version # 
Originator/s 
Description of change(s) 
Date 
Section 4.9.2: Clarified that trial fitting of the 
study lens (randomized eye) will be 
conducted in groups 1 and 2 (Cl wearers) 
only. 
 
1.8 
Amir Moezzi 
Section 4.1.1. Study visits: Clarified washout 
period of at least 1 day (24 hours) before to 
the 2nd study day and that the second study 
day should occur within maximum of 30 days 
from the first study day 
 
Section 4.9.3. Study Day 2: Clarified 
washout period of at least 1 day before the 
2nd study day and that the second study day 
should occur within maximum of 30 days 
from the first study day. 
 
Section 4.10. Moved CL fitting to after 
confocal microscopy in the summary of 
procedures for clarification. 
02Mar2020 
1.9 
Amir Moezzi 
Sections 4.1.1, 4.9.1 Table 2, 4.9.2 and 4.10 
(throughout the protocol) Removed trial 
fitting of the study lenses from V0. This is a 
COVID-19 consideration to reduce the time 
in close proximity with participants. 
 
Sections 4.1.1, 4.7.2, 4.8.4 and 4.9.3 
(throughout the protocol) Clarified that 
inclusion criterion #12 for acceptable lens fit 
and comfort will be evaluated after fitting 
study lenses in V1 (Study Day2). 
 
Section 4.7.1. Changed maximum number of 
participants to 26 in each group. 
 
Section 4.8.1. Removed Health Canada 
license# for study lenses from Table1. Also, 
clarified that study lens is no longer licensed 
by Health Canada or marketed in Canada 
and that an investigational testing 
authorization from Health Canada will be 
obtained prior to recruitment.  
27Aug2020 
2.0 
Amir Moezzi 
Section 4.7.1. Clarified that Groups 1 and 2 
will be recruited at both CORE (Canada) and 
Eurolens (UK). These participants will be 
exposed to the study contact lens on the 
second day of the study. There will be 
competitive recruitment between the two 
sites. 
Section 4.7.1. Clarified that Group 3, the 
non-lens wearing group, will all be recruited 
at CORE (Canada). These participants will 
28Nov2020 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    7 
Version # 
Originator/s 
Description of change(s) 
Date 
only attend the first study visit and will not be 
exposed to the study contact lens. 
 
 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    8 
 
Table of contents 
1 
Introduction & background ................................................................................................. 12 
2 
Objectives .......................................................................................................................... 12 
3 
Hypothesis ......................................................................................................................... 13 
4 
Materials and methods ...................................................................................................... 13 
4.1 
Study design ............................................................................................................... 13 
4.1.1 
Overall design ...................................................................................................... 13 
4.1.2 
Randomization ..................................................................................................... 15 
4.1.3 
Masking................................................................................................................ 16 
4.2 
Statement of compliance ............................................................................................. 16 
4.3 
Study sites .................................................................................................................. 16 
4.4 
Ethics review ............................................................................................................... 16 
4.5 
Clinical Trial Registration ............................................................................................. 16 
4.6 
Informed Consent ........................................................................................................ 17 
4.7 
Study population ......................................................................................................... 17 
4.7.1 
Number of participants ......................................................................................... 17 
4.7.2 
Inclusion and exclusion criteria ............................................................................. 17 
4.8 
Study materials ........................................................................................................... 20 
4.8.1 
Lenses ................................................................................................................. 20 
4.8.2 
Contact Lens care system .................................................................................... 20 
4.8.3 
Rewetting drops & saline ...................................................................................... 20 
4.8.4 
Contact lens fit and wear ...................................................................................... 21 
4.8.5 
Ordering consumables ......................................................................................... 21 
4.8.6 
Disposing of consumables ................................................................................... 21 
4.8.7 
Product accountability .......................................................................................... 22 
4.9 
Scheduled and unscheduled visits .............................................................................. 22 
4.9.1 
Study visit codes .................................................................................................. 22 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    9 
4.9.2 
Study Day 1 (Visit 0) ............................................................................................ 22 
4.9.3 
Study Day 2 (Visits 1 to 6) & study exit ................................................................. 24 
4.9.4 
Unscheduled visits ............................................................................................... 25 
4.10 
Summary of Study procedures ................................................................................. 25 
4.11 
Recording Findings of Interest ................................................................................ 27 
5 
Monitoring protocol adherence .......................................................................................... 27 
6 
Potential Risks and Benefits to Human participants ........................................................... 27 
7 
Adverse events .................................................................................................................. 29 
7.1 
Adverse Event Definitions ........................................................................................... 29 
7.2 
Normal or adaptive symptoms ..................................................................................... 30 
7.3 
Procedures for Adverse Events ................................................................................... 31 
7.4 
Reporting Adverse Events ........................................................................................... 31 
8 
Discontinuation from the study ........................................................................................... 32 
9 
Device Malfunctions ........................................................................................................... 33 
10 
Study completion and remuneration .................................................................................. 33 
11 
Statistical analysis and data management ......................................................................... 33 
11.1 
Sample size calculation ........................................................................................... 33 
11.2 
Statistical analysis ................................................................................................... 34 
12 
Data Quality Assurance ..................................................................................................... 35 
12.1 
Study monitoring ...................................................................................................... 35 
12.2 
Sponsor Responsibilities .......................................................................................... 36 
12.3 
Investigator Responsibilities .................................................................................... 36 
12.4 
Record keeping ....................................................................................................... 36 
12.5 
Retention of study records and data ........................................................................ 37 
12.6 
Data entry / Data management ................................................................................ 37 
13 
Protocol training ................................................................................................................. 37 
14 
Study monitoring ................................................................................................................ 37 
15 
Study management............................................................................................................ 38 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    10 
15.1 
Protocol deviations .................................................................................................. 38 
15.1.1 
Major protocol deviations ..................................................................................... 38 
15.1.2 
Minor protocol deviations ..................................................................................... 38 
15.1.3 
Reporting and documenting protocol deviations ................................................... 39 
15.2 
Premature termination of the study .......................................................................... 39 
15.3 
Study participant records ......................................................................................... 39 
15.4 
Retention of study records and data ........................................................................ 40 
16 
Confidentiality .................................................................................................................... 40 
 
 
 
 
 
 
 
 
 
 
 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    11 
 
 
 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 and is not intended to be used to support safety 
and efficacy in a regulatory submission. 
 
 
 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    12 
1 
INTRODUCTION & BACKGROUND 
Current contact lenses are available in either silicone hydrogel (SH) or hydrogel (H) materials. 
Silicone hydrogel lenses are far more transmissible to oxygen (they have higher Dk/t) and this is 
believed to be beneficial for maintaining healthy corneal metabolism. Several publications 
highlight this by showing less redness around the cornea (less limbal redness with SH compared 
to H) and the eye in general (less bulbar redness with SH compared to H). 1-3 The severity of 
corneal infections has also been reported to be reduced with SH lenses compared to H lenses. 4, 
5 
Napping and sleeping in contact lenses has been reported as a common occurrence,6, 7  It is 
known that, even with no contact lens wear, the limbus may become redder and the cornea 
swells when the eye is closed 8, 9 due to the uptake of water as a result of anaerobic corneal 
metabolism with eye closure, and deswells upon eye opening. It is of interest to understand 
whether habitual wear of hydrogel contact lenses modifies this redness and/or the swelling or 
deswelling response due to the lower level of oxygen through the lens during habitual lens wear.  
This non-dispensing, randomised study is designed to evaluate differences in ocular 
physiological responses to a 3-hour period of monocular closed eye lens wear of a low Dk/t 
hydrogel (HEMA) lens, between habitual Daily Disposable Silicone Hydrogel (DDSH) lens 
wearers and habitual Daily Disposable Hydrogel (DDH) lens wearers. 
Daily disposable wearers will be used because this replacement modality is being fit more often 
than re-useable lenses in many countries around the world. A 3-hour period has been chosen in 
this study because this length of time is anticipated to be sufficient to induce limbal redness and 
will induce a sufficient corneal swelling response to measure a change in corneal thickness from 
baseline,10, 11 meaning that we do not require the participants to wear the lenses overnight. The 
reduction in redness and deswelling of the cornea will be followed for 3-hours. This should be 
sufficient time for the average corneal thickness to return to levels that are very close to baseline 
values. 12 Limbal redness and corneal thickness will fully recover to baseline values and there 
will be no permanent changes as a result of this study. 12-15  
   
2 
OBJECTIVES 
The primary objectives of this study are: 
To compare baseline data between 3 groups - habitual wearers of DDSH / habitual wearers of 
DDH / non-lens wearers - in terms of: 
• 
Limbal & bulbar redness  

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    13 
• 
Corneal vessel ingrowth 
And to compare data post closed eye lens wear in 2 groups - habitual wearers of DDSH / 
habitual wearers of DDH - in terms of: 
• 
Limbal & bulbar redness 
The primary study measures are: 
• 
Limbal & bulbar redness (Oculus Keratograph 5) 
• 
Corneal vessel ingrowth (slit-lamp photography & image analysis) 
3 
HYPOTHESIS 
The study main hypotheses are: 
1) There will be greater corneal vessel ingrowth in habitual wearers of DDH than DDSH and 
non-lens wearers at baseline. 
2) There will be greater limbal & bulbar hyperemia response following 3 hours of wearing a 
low Dk HEMA CL in habitual wearers of DDH than DDSH and non-lens wearers. 
4 
MATERIALS AND METHODS 
4.1 STUDY DESIGN 
4.1.1 OVERALL DESIGN 
This study is a multi-site, prospective, randomized, non-masked, unilateral, non-dispensing 
study. The first part of the study (Day 1) involves collecting measures from three groups of 
participants (see group descriptions below). The second part (Day 2) only involves the two 
contact lens wearing groups (Group 1 & Group 2) and involves comparing between habitual 
wearers of DDSH and DDH for corneal swelling response & recovery following wearing a low Dk 
HEMA CL in a randomized eye under eye closure conditions for 3 hours. The contralateral 
control eyes with no lens wear will remain open during the test period. 
Study Group inclusion criteria description: 
The following 3 groups with age (within ± 5 years), ethnicity (being Asian vs. non-Asian, this is 
due to possible differences in physiological response to corneal hypoxia in Asian and non-Asian 
participants), and spherical contact lens power (within ± 2.00D) matched will be involved in this 
study: 
GROUP 1: 
For the past (minimum) 6 months has ONLY worn spherical DDSH lenses AND 
prior to wearing this lens they only wore SH material lenses in the past (minimum) 3 total years.   

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    14 
GROUP 2: 
For the past (minimum) 6 months has ONLY worn spherical DDH lenses AND 
prior to wearing this lens they only wore H material lenses in the past (minimum) 3 total years.  
GROUP 3: 
No previous experience of contact lens wear (no need to match Rx of this group). 
Additional criteria: 
For groups 1 & 2, currently and for at least the previous 6 months has had habitual daily 
disposable wear schedule of at least 8 hrs a day, 5 days a week in only one material category - 
either silicone hydrogel or hydrogel material.  
For groups 1 & 2, no previous history of overnight wear or PMMA (polymethylmethacrylate) lens 
wear. 
For groups 1 & 2, a minimum of 3 years of lens wear experience.  
For group 3, no previous history of contact lens wear. 
Study visits: 
It is anticipated that this study will involve 2 days with at least 1 day in-between with no lens 
wear and no use of any rewetting drops (if applicable) as the washout period. The second study 
day should occur within maximum of 30 days from the first study day. The required minimum 
study washout period will be at least 1 day of no lens wear and no use of any rewetting drops (if 
applicable) on the day (24 hours) before the second study day. This study has up to a total of 7 
scheduled visits: 
Study Day 1  
The first study day will be observational in nature for collecting comparison data across all 3 
participant groups described above. There will be only one study visit on day 1. 
Visit 0:  This visit includes screening, confirmation of CL history, measurements of 
 
, slit-lamp biomicroscopy, 
 
 
 Then Day1 exit slit-lamp biomicroscopy 
 
  
Study Day 2  
Only the study groups 1 & 2 will be involved in the second day of study. They will attend the 
study visit 1 on day 2 at 3 ± 0.5 hours after waking and eye opening in the morning, and wearing 
their habitual spectacles. 
  

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    15 
 
 
 
 
 
 
 
Visit 2:  
 
 
 
 
 
 
 
 
Visit 4: 1hr after CL removal  
 
 
 
 
 
Visit 6: 3hr after CL removal 
 the objective ocular 
redness measurement OU 
 
Exit Visit:  
 
Biomicroscopy including corneal staining, OU 
Study exit 
 
Exit the study. 
 
4.1.2 RANDOMIZATION 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    16 
A randomization schedule will be generated using SAS or a web-based program: 
(www.randomization.com). The final study randomization schedule will be generated by CORE’s 
Data Management Team, and provided to the research assistants and clinical investigators at 
each study site for use during the study.  
4.1.3 MASKING 
There will be no masking in this study. Masking of the Study investigators is not possible as they 
need to measure the study main variables in the predetermined randomized eye. 
4.2 STATEMENT OF COMPLIANCE 
This protocol document has been developed in accordance with the following:  
• 
ISO 14155 Clinical Investigation of Medical Devices for Human Subjects, Parts 1 & 2 
• 
ICH Harmonized Tripartite Guideline for Good Clinical Practice 
• 
The University of Waterloo’s Guidelines for Research with Human Participants 
• 
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd 
Edition. http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/ 
• 
Declaration of Helsinki 
4.3 STUDY SITES 
 
This study will be conducted at the following study sites: 
• 
CORE, University of Waterloo, Canada 
• 
Eurolens Research, University of Manchester, UK 
4.4 ETHICS REVIEW 
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. 
This protocol will be submitted to and reviewed through the Office of Research Ethics (ORE) at 
the University of Waterloo, Canada and to the respective ORE at the University of Manchester, 
UK. Notification of ethics clearance of the application is required prior to the commencement of 
the study at each site. The conduct of this study will be given clearance by the Clinical Research 
Ethics Committee at the University of Waterloo, Canada, and the respective Research Ethics 
Committee at the University of Manchester, UK.  
4.5 CLINICAL TRIAL REGISTRATION 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    17 
This study will be registered in the clinical trials registry (https://clinicaltrials.gov/) by the study 
sponsor.  
4.6 INFORMED CONSENT 
Informed consent shall be obtained in writing from all participants prior to their enrolment in the 
study, and before any procedure specific to the clinical investigation is carried out. Based on 
local research ethics requirements, Eurolens Research may use a different terminology for the 
information consent letter/ICL (participant information sheet (PIS) and informed consent form/ 
ICF). 
4.7 STUDY POPULATION 
4.7.1 NUMBER OF PARTICIPANTS 
Up to a maximum of 26 participants in each study group will be randomized, with a target of 
completing 17 in each of the three groups.  
Groups 1 and 2 will be recruited at both CORE (Canada) and Eurolens (UK). These participants 
will be exposed to the study contact lens on the second day of the study. There will be 
competitive recruitment between the two sites and though unlikely, depending on recruitment 
progress, it is possible that all the subjects will be seen only at CORE (Canada) or only at 
Eurolens (UK). This means that a maximum of 52 and a minimum of 0 participants will be 
exposed to the study contact lens at each site. 
Group 3, the non-lens wearing group, will all be recruited at CORE (Canada). These participants 
will only attend the first study visit/day and will not be exposed to the study contact lens. 
Participants will be recruited using the study site records and advertising approved by the 
respective Office of Research Ethics (ORE). Each participant will be given a unique study 
specific ID number. Additionally, all participants must meet all the study inclusion and none of 
the exclusion criteria listed below.  
4.7.2 INCLUSION AND EXCLUSION CRITERIA 
A person is eligible for inclusion in the study if he/she: 
1. Is between 17 and 60 years of age inclusive (age matching required between all 3 study 
groups), and has full legal capacity to volunteer; 
2. Has had a self-reported oculo-visual examination in the last two years.  
3. Has read and signed an information consent letter; 
4. Is willing and able to follow instructions and maintain the appointment schedule; 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    18 
5. No previous history of overnight contact lens wear or PMMA (polymethylmethacrylate) 
lens wear. 
6. Auto-refraction vertexed spherical equivalent between +4.00 and -8.00 (prescription 
matching required between groups 1 & 2). This criterion is non-applicable to participants 
in group 3. 
7. Is found to be in one of the study groups matched by age (±5 years), ethnicity (Asian vs. 
non-Asian) and CL Rx (±2.00 D) according using the following criteria: 
GROUP 1: 
For the past (minimum) 6 months has ONLY worn spherical DDSH lenses AND 
prior to wearing this lens they only wore SH material lenses in the past (minimum) 3 total years.   
GROUP 2: 
For the past (minimum) 6 months has ONLY worn spherical DDH lenses AND 
prior to wearing this lens they only wore H material lenses in the past (minimum) 3 total years.  
GROUP 3: 
No previous experience of contact lens wear (no need to match Rx of this group). 
8. For groups 1 & 2, currently and for at least the previous 6 months has had habitual daily 
disposable wear schedule of at least 8 hrs a day, 5 days a week in only one material 
category - either silicone hydrogel or hydrogel material. This criterion is not-applicable to 
participants in group 3. 
9. Is willing to wear the study contact lens in the randomized eye for 3 hours of eye closure 
on the second study day. This criterion is not-applicable to participants in group 3.  
10. Has clear and healthy corneas and anterior eye and no active* ocular disease; 
11. Can achieve monocular HCVA of logMAR 0.10 or better in each eye with subjective 
refraction or pinhole. 
12. Can achieve acceptable fit and comfort in the randomized eye with the study lens. This 
criterion will be confirmed at the baseline visit (V1). This criterion is not-applicable to 
participants in group 3.  
13. Has a wearable pair of spectacles. 
A person will be excluded from the study if he/she: 
1. Is participating in any concurrent clinical trial; 
2. Is unable/unwilling to provide permission for the study site to seek CL history from 
their eye care practitioner 
3. Has any known active* ocular disease and/or infection; 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    19 
4. Has a systemic condition that in the opinion of the investigator may affect a study 
measure or interfere with contact lens wear; this may include, but not be limited to, 
diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren’s syndromes, 
xerophthalmia, acne rosacea, Stevens-Johnson syndromes, and systemic connective 
tissue disorders e.g. rheumatoid arthritis. 
5. Is using any systemic or topical medications that in the opinion of the investigator 
may affect a study measure; 
6. Has known sensitivity to fluorescein dye, topical anesthetic, or products to be used in 
the study; 
7. Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency 
of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;  
8. Appears to have any signs of corneal inflammation or previous infection or corneal 
opacity/scar;  
9. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal 
confirmation at the screening visit), due to potential ocular physiological changes, 
such as changes in the corneal shape and cell types; 
10. Is aphakic; 
11. Has undergone refractive error surgery, or has a history of any ocular surgery or 
injury.  
12. Is a toric or multifocal contact lens wearer. 
* 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.  
Repeated screenings 
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; 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    20 
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 i.e. 2 repeated screenings are 
allowed. 
4.8 STUDY MATERIALS 
4.8.1 LENSES 
Details of study lenses are show in Table 1.  
Table 1: Lens parameters to be used in this study 
Manufacturer 
CooperVision 
Lens Name 
PREFERENCE STANDARD 
Material 
tetrafilcon A 
EWC (%) 
43% 
Centre thickness (mm) @ +6.00 D 
0.26 
Dk 
9.3 
Dk/t (+6.00D) 
3.6 
BOZR (mm) 
8.3 
Diameter (mm) 
14.0 
Sphere power (D) 
+6.00 D 
CE marking on the label 
Yes 
 
The study lens is no longer licensed by Health Canada or marketed in Canada.  The 
investigational testing authorization for this study will be obtained from Health Canada by the 
study sponsor. 
4.8.2 CONTACT LENS CARE SYSTEM 
No contact lens care systems will be used in this study. The study lens will inserted directly from 
sterile saline in the standard lens vial (sealed by the manufacturer). 
4.8.3 REWETTING DROPS & SALINE 
No rewetting drops will be used in this study. In the event of lens binding a few drops of sterile 
saline solution may be instilled into the eye to loosen the lens and therefore facilitate safe lens 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    21 
removal.  A log of whether saline was used to aid lens removal will be maintained.  Saline 
solution may also be used to rinse residual sodium fluorescein from the eyes after corneal 
staining assessment. Worn lenses will be collected from the participants’ lens-wearing eye at the 
end of the 3-hour wearing period (or on discontinuation/exit from the study) and will be disposed 
as described section 4.8.6 of the protocol. 
4.8.4 CONTACT LENS FIT AND WEAR 
This is not a dispensing study. The fit of study contact lens will be evaluated on the randomly 
determined study eye during the baseline visit (Visit 1, Study Day 2) to ensure acceptable lens 
parameters and fit. After placing the study lens on the randomized eye, slit lamp examination will 
be conducted to confirm acceptable lens fit and comfort, and the absence of debris underneath 
the lens. Only participants with acceptable lens fit and comfort in the randomized eye will be 
eligible to continue in the study. The study lens will then remain on that eye for 3-hours and the 
eye will be lightly covered to keep it completely closed. Complete eye closure will be attained 
through the use of gauze and surgical tape, covered by a loosely-fitting ophthalmic eye patch 
which does not create excess pressure on the eye. The contralateral (no-lens) eye will remain 
open during the 3 hour period.  
4.8.5 ORDERING CONSUMABLES 
A stock of study lenses will be provided by the Sponsor to CORE. CORE will distribute the 
lenses to any other study site.  
Each study site must maintain an accurate accounting of the study product during the study. A 
detailed inventory must be completed for study contact lenses for the study product 
accountability. Unused lenses will be disposed of after discussion with CORE. 
The disposable covers for confocal microscopy will be purchased by each study site. CORE will 
reimburse Eurolens Research for consumables, and CORE will be reimbursed by the study 
sponsor. 
4.8.6 DISPOSING OF CONSUMABLES 
This study will not provide any consumables (lenses and/or lens care solution) to participants for 
use during the study. Worn lenses will be collected from the participants’ lens-wearing eye at the 
end of the 3 hour wearing period (or on discontinuation/exit from the study) and at the end of the 
study they will be disposed of according to UW/study site guidelines, unless otherwise directed 
by the study Sponsor. Worn lenses specifically associated with adverse events/product 
observations may be retained either at the study site or returned to CooperVision. Typical 
analysis in these cases relates to inspection for damage and/ or bacterial contamination. 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    22 
4.8.7 PRODUCT ACCOUNTABILITY 
Accountability logs will be kept to include the number of lenses received, dispensed, unused, 
and returned to vendor (where relevant). All lenses dispensed to participants will be recorded in 
the lens accountability log.  
4.9 SCHEDULED AND UNSCHEDULED VISITS 
 
4.9.2 STUDY DAY 1 (VISIT 0) 
The first study day will be observational in nature for collecting comparison data across all 3 
participant groups described above. There will be only one study visit (visit 0) in day 1. 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    23 
Visit 0 (2.75 hours):  This visit includes screening, confirmation of CL history, measurements of 
 slit-lamp biomicroscopy, 
 
 
 
At the screening, all participants who sign the informed consent letter will be assigned a study ID 
number. The investigator will determine participant eligibility using the inclusion and exclusion 
criteria. Ineligible participants will be discontinued from the study. The procedures to be 
performed in visit 0 are outlined below: 
• 
The participant is expected to attend the screening visit 6-8 hours after waking. The 
participants in groups 1 and 2 (CL wearers) will attend, having inserted their CLs 0.5 
hours after waking that day. Participants in group 3 will attend this visit with habitual 
spectacles, if any. 
• 
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 to be enrolled in the study. 
• 
Participant demographics and medical history (age, sex, medical conditions, 
medications, allergies). 
• 
Contact lens history (habitual lens information and wearing habits) (N/A in group 3). 
• 
Participants will be asked to review and sign a permission request to seek CL history 
from their eye care practitioner. 
• 
Contact lens removal (N/A in group 3).  
• 
 
• 
n Slit lamp 
biomicroscopy. 
• 
 
 
• 
Slit lamp biomicroscopy 
 
 
• 
Confirmation of study eligibility and continuation 
• 
 
 
• 
 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    24 
• 
 
 
• 
 
• 
  
• 
 
 
 
• 
Day1 exit Slit lamp biomicroscopy assessments including corneal & conjunctival staining 
(safety measure). 
• 
 
4.9.3 STUDY DAY 2 (VISITS 1 TO 6) & STUDY EXIT  
Only the study groups 1 & 2 will be involved in the second day of study. There will be a washout 
period of at least 1 day between study days 1 and 2 with no lens wear and no use of any 
rewetting drops (if applicable) on the day before the second study day as a minimum washout. 
The second study day should occur within maximum 30 days from the first study day.   
Participants will attend the study visit 1 on day 2 at 3 ± 0.5 hours after waking and eye opening 
in the morning, and wearing their habitual spectacles.  They are required to remain in the study 
site in-between visits during Day 2. The following study visits will occur in Day 2 (please refer to 
the Table 3 for the required study assessments for each visit in Day 2 : 
 
 
 
Visit 2 (0.5 hours): Study assessments immediately after CL removal 
 
Study assessments.  
 
Visit 3 (0.5 hours): 0.5hr after CL removal study assessments 
 
Visit 4 (0.75 hours): 1hr after CL removal study assessments  
 
Visit 5 (0.5 hours): 2hr after CL removal study assessments 
 
Visit 6 (1.25 hours): 3hr after CL removal study assessments and the study exit 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    25 
 
Study Exit: 
• 
After completing the study exit assessments, 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.  
• 
The participant will be discharged and will sign the study completion forms and receive 
remuneration for participating in the study. 
4.9.4 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 by the lead investigator.  
4.10 SUMMARY OF STUDY PROCEDURES 
Table 3 summarizes the visits and procedures for the study. 
Table 3: Summary of visits and procedures for the study. 
 
Day 1 
Attend V0 
after 6-8 hrs 
of waking 
Day 2 
Attend V1 at 3 ± 0.5 hours after waking and eye opening in the morning, 
and wearing habitual spectacles. 
 
V0   
Screen &  
Observational 
data 
collection 
V1  
Baseline 
& CL 
insertion 
V2 
Immediately 
after CL 
removal 
V3  
  0.5 hr 
after CL 
removal 
 
V4  
1hr 
after CL 
removal 
V5  
2hr 
after CL 
removal 
V6  
3hr 
after CL 
removal 
V-
Exit 
Consent process 
x 
 
 
 
 
 
 
 
CL history and wear 
schedule 
x 
x 
 
 
 
 
 
 
Health & 
medication 
x 
x 
 
 
 
 
 
 
Permission for CL 
History from eye 
care practitioner 
x 
 
 
 
 
 
 
 
Habitual contact 
lens removal 
 
x 
 
 
 
 
 
 
 
 
 
x 
 
 
 
 
 
 
 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    26 
 
Day 1 
Attend V0 
after 6-8 hrs 
of waking 
Day 2 
Attend V1 at 3 ± 0.5 hours after waking and eye opening in the morning, 
and wearing habitual spectacles. 
 
V0   
Screen &  
Observational 
data 
collection 
V1  
Baseline 
& CL 
insertion 
V2 
Immediately 
after CL 
removal 
V3  
  0.5 hr 
after CL 
removal 
 
V4  
1hr 
after CL 
removal 
V5  
2hr 
after CL 
removal 
V6  
3hr 
after CL 
removal 
V-
Exit 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
x 
 
 
 
 
 
 
 
Slit lamp 
biomicroscopy 
(with staining) 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
x 
 
 
 
 
 
 
Exit Slit lamp (with 
staining) 
x 
 
 
 
 
 
 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
x 
 
 
 
 
 
 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    27 
 
Day 1 
Attend V0 
after 6-8 hrs 
of waking 
Day 2 
Attend V1 at 3 ± 0.5 hours after waking and eye opening in the morning, 
and wearing habitual spectacles. 
 
V0   
Screen &  
Observational 
data 
collection 
V1  
Baseline 
& CL 
insertion 
V2 
Immediately 
after CL 
removal 
V3  
  0.5 hr 
after CL 
removal 
 
V4  
1hr 
after CL 
removal 
V5  
2hr 
after CL 
removal 
V6  
3hr 
after CL 
removal 
V-
Exit 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
x 
 
x 
x 
x 
x 
x 
 
Study completion 
and Exit 
 
 
 
 
 
 
 
x 
 
* Additional lenses may be dispensed at scheduled or U/S visits if there is lens defect, or lens damage.  
** Not required if visit concurrent with previous one. 
4.11 RECORDING FINDINGS OF INTEREST 
The following variables may be recorded using a digital slit lamp system (video and still images): 
• 
 
• 
Relevant corneal and conjunctival staining and/or other relevant findings in slit-lamp 
bomicroscopy 
• 
 
 
5 
MONITORING PROTOCOL ADHERENCE 
Adherence to study visit windows, lens wearing schedule, and time windows around other data 
collection points (i.e. subjective ratings) will be monitored internally by the study site. Deviations 
from the windows described in the protocol will be reported in the study report. Major protocol 
deviations will be reported to the Sponsor and the respective Office of Research Ethics (ORE) 
within 7 days of becoming aware of them (as per ORE’s guidelines). 
6 
POTENTIAL RISKS AND BENEFITS TO HUMAN PARTICIPANTS 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    28 
This is considered a minimal risk study because the study soft CL will be worn under closed eye 
conditions for only one single 3-hour period, for participants in groups 1 and 2 only. Group 3 will 
not wear a contact lens at all. The exact risks associated with this short period of closed eye 
contact lens wear is not reported in the literature, however the risks associated with daily wear 
(removal for eye closure) and with extended wear (repeated and successive overnight lens 
wear),) have been studied and are reported below. 
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 photophobia, iritis, corneal edema, or eye infection. In rare 
instances more serious complications may occur, including corneal ulcers (a sight threatening 
eye infection) which can result in corneal scarring, temporarily or permanently decreased vision 
and in some cases blindness. Although contact lens-related infections are very infrequent, the 
possibility does exist. The annual risk of Infections relating to contact lens wear occur in 
approximately four people in a population of 10,000 who wear soft lenses on a daily wear basis 
and in approximately twenty people in a population of 10,000 who wear soft contact lenses on 
an extended wear 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 (repeated overnights in succession), there is a significantly increased risk of an adverse 
reaction compared with wearing contact lenses on a daily wear basis. Over a period of one year, 
infiltrates occur in one to two people per population of 100 who wear soft contact lenses on a 
daily basis, and in four to eight people per population of 100 who wear soft contact lenses on an 
extended wear basis. 
Additionally, it is possible that participants may experience mild and temporary discomfort 
associated with the study procedures /products/devices/eye drops (sodium fluorescein) 
including: burning and stinging, blurred vision, sandiness or grittiness, light sensitivity, dryness, 
itching, crusty eyes, foreign body sensation, and eye redness. The use of topical numbing 
(anesthesia) eye drops may also cause transient stinging and burning or, in rare occasions, an 
allergic reaction.  In rare situations, some individuals may experience vaso-vagal syncope (or 
similar symptoms) with the use of topical anesthetic or ocular examination procedures. 
There will be no direct benefits to the participants in this study. However, participation in this 
study may contribute to scientific research information that may be used in the development of 
new contact lens products. This study may help the study sponsor to better understand possible 
corneal structural/physiological differences among the study 3 groups. 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    29 
7 
ADVERSE EVENTS 
7.1 ADVERSE EVENT DEFINITIONS 
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.  
A number of conditions may result in temporary discontinuation until resolution. These include 
corneal infiltrates, corneal staining, limbal injection, bulbar injection or bulbar and tarsal 
conjunctival abnormalities.  
See Adverse Event Standard Operating Procedures (SOP) document for the relevant study site 
for a description of adverse events, including management and reporting.  
 
AE classification, coding (for reporting to the sponsor) and examples are provided in the 
following table of Contact Lens Adverse Event Classification and Reporting table: 
Code 
Condition 
Reporting 
Serious Adverse Events 
01 
Presumed infectious keratitis or infectious corneal ulcer 
For all serious 
AEs:  
02 
Permanent loss of ≥ 2 lines of best spectacle corrected visual acuity (BSCVA) 
Classification 
Definition 
Serious Adverse 
Event 
Those events that are life-threatening, or result in permanent impairment of a body 
function, or permanent damage to a body structure or necessitate medical 
(therapeutic) or surgical intervention to preclude permanent impairment of a body 
function or permanent damage to a body structure. 
Significant 
Adverse Event 
Those non-serious adverse events that occur with contact lens usage that are not 
sight-threatening but are usually symptomatic and may warrant therapeutic 
management and /or temporary or permanent discontinuation of contact lens wear. 
Non-Significant 
Adverse Events 
Those less severe non-serious adverse events that occur with contact lens usage that 
are not sight-threatening, may or may not be symptomatic and may warrant palliative 
management, such as ocular lubricants or temporary interruption of contact lens wear. 
Unanticipated 
Adverse Device 
Effect 
Adverse events in a study that were not previously identified in the protocol in terms of 
nature, severity, or degree of incidence. An Unanticipated Serious Adverse Device 
Effect is an unanticipated adverse event that is serious in nature and caused by or 
associated with the device and is considered reportable. 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    30 
03 
Corneal injury that results in permanent opacification within central cornea 
(6mm) 
 
Notify sponsor as 
soon as possible, 
within 24 hours;  
 
ORE reporting 
will be within 24 
hours as per 
requirements 
04 
Uveitis or Iritis (e.g. presence of anterior segment inflammation as described 
in ISO 11980, Annex B) 
05 
Endophthalmitis 
06 
Hyphema 
07 
Hypopyon 
08 
Neovascularization within the central 6mm of cornea 
00 
Other serious event 
Significant Adverse Events 
11 
Peripheral (outside central 6mm), non-progressive, non-infectious ulcer 
Notify sponsor as 
soon as possible, 
within 5 working 
days; ORE 
reporting as per 
requirements 
12 
Symptomatic corneal infiltrative event 
13 
Superior epithelial arcuate lesions (SEALs) involving epithelial split 
14 
Corneal staining ≥ dense coalescent staining up to 2mm in diameter (e.g. 
moderate, ISO 11980 grade 3) 
15 
Corneal neovascularization ≥ 1.0mm vessel penetration  
(e.g. ≥ ISO 111980 Grade 2), if 2 grade change from baseline 
16 
Any temporary loss of ≥ 2 lines BSCVA for ≥ 2wks 
17 
Any sign and/or symptom for which participant is administered therapeutic 
treatment or which necessitates discontinuation of lens wear for ≥ 2 weeks 
10 
Other significant event 
Non-significant Adverse Events 
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 
 
7.2 NORMAL OR ADAPTIVE SYMPTOMS 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    31 
Mild ocular symptoms such as dryness, itching or burning or other mild discomfort, and/or mild 
level signs of ocular redness, corneal/conjunctival staining, corneal endothelial blebs, stromal 
striae and folds, and central corneal epithelial clouding may occur with contact lens wear and 
eye closure. These are transient in nature and not reported as adverse events unless in the 
investigator’s opinion they are unexpected in nature, and/or severity.  
7.3 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 referred to an ophthalmologist 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 (Appendix 17) 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 deemed necessary as a result of study participation will 
be paid by the study site on behalf of the sponsor (bills and prescription receipts must be 
provided). 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. 
7.4 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 the Principal Investigator and the sponsor 
within 24 hours of the investigator becoming aware of the event. The Investigator will report 
Serious Adverse Events to the respective ORE within 24 hours of the investigator becoming 
aware of the event and as per ORE requirements (by fax, mail/delivery, phone, or email). All 
fatal or life threatening events will be reported immediately to the respective ORE. 
Significant and Non-Significant Adverse Events will be reported to the sponsor as soon as 
possible, but no later than 5 working days after the occurrence. The Investigator will report the 
event to the ORE as per ORE requirements (by fax, mail/delivery, phone, or email). 
  
  
 
  
 
 
 
  
  
 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    32 
8 
DISCONTINUATION FROM THE STUDY 
Participants discontinued from the study will be reimbursed $20 per hour at CORE for their 
active involvement in the study (including the initial screening visit). Participants discontinued 
from a study at Eurolens Research study site will be reimbursed based on the rate approved by 
their respective ethics committee. A participant’s study participation may be discontinued at any 
time if, in the opinion of the sponsor or the investigator it is in the best interest of the participant. 
All discontinuations will be fully documented on the appropriate study forms and the 
Discontinuation Form will be completed. The following is a list of possible reasons for 
discontinuation from the study: 
• 
Screening failure: Participants will be discontinued if they do not meet the inclusion and 
exclusion criteria outlined in section 4.7.2. 
• 
Unacceptable performance with products to be used in study: Participants may be 
discontinued if they are unable to achieve acceptable comfort with the study products. 
• 
Positive slit lamp finding: Participants may be temporarily or permanently discontinued 
from the study depending on the severity of the condition and on the judgement of the 
investigator.  
• 
Adverse event: If a participant experiences an adverse event during the study they may 
be discontinued based on the clinical judgement of the investigator. 
• 
Symptoms: If the participant has persistent symptoms they may be discontinued based 
on the clinical judgement of the investigator. 
• 
Disinterest, relocation or illness: The participant may choose to discontinue due to 
reasons within or beyond their control. 
• 
Violation of protocol or non-compliance: The participant will be discontinued if they are 
unable or unwilling to follow the protocol specified visit schedules and/or study 
procedures. 
• 
Instillation of topical ocular medication: The participant will be discontinued if they elect to 
use a topical ocular medication during the study unless that topical ocular medication is 
prescribed for a limited duration (less than two weeks) to treat a transient condition; in 
this case the participant may remain an active participant (at the discretion of the 
investigator) after stopping topical ocular medication following resolution of the ocular 
condition). 
• 
Lost to follow-up: The participant will be discontinued if they cannot be contacted and do 
not return for a final exit visit, and if the investigator has made a reasonable effort to 
contact the participant for a final study visit. 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    33 
• 
Premature termination of the study by the sponsor, study site or the respective Office of 
Research Ethics. 
A discontinuation form (Appendix 10) 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.  
9 
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 the Principal Investigator and the sponsor within 
24 hours of the investigator becoming aware of the malfunction. The respective ORE would also 
be notified within 24 hours of any device malfunction that may contribute to a Serious Adverse 
Event. 
Other defective lenses should be reported to the Sponsor as soon as possible (usually in weekly 
study updates to the Sponsor). 
10 STUDY COMPLETION AND REMUNERATION 
At the last scheduled protocol visit at CORE a study completion form will be completed, which 
requires the signatures of both the participant and the investigator. The participants will also be 
provided with a letter of appreciation. 
Once their involvement in the study is complete at CORE, participants will be informed about 
receiving feedback following study completion in the Letter of Appreciation.  
Participant remuneration will be $20 per scheduled protocol visit hour at CORE (including the 
initial screening visit and the periods between measurements on day 2), as specified in the 
information consent letter for CORE. 
At Eurolens Research, participants will be remunerated based on the approved amount by the 
respective ethics committee as specified in the information consent letter for Eurolens Research.  
Eurolens Research will follow their local standard procedures and forms for study completion 
and any required feedback to participants. 
11 STATISTICAL ANALYSIS AND DATA MANAGEMENT 
11.1 SAMPLE SIZE CALCULATION 
Two previous studies 10, 11 assessed differences in corneal response to 3-hour closed eye CL 
wear between low Dk/t HEMA and PMMA lenses in a group of neophytes. However, there is no 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    34 
data from similar methodology and participant groups on which to calculate the sample size in 
the current study. A guide to the minimum sample size for Visit 2 bulbar and limbal hyperemia 
measures has been calculated from hyperemia data reported in a recent publication reporting  
objective bulbar and limbal hyperemia (using Oculus Keratograph) while wearing DDH contact 
lenses in habitual silicone hydrogel lens wearers.16 This data indicates that to detect an effect 
size of 1.2 (or 0.5 grade difference) in either bulbar or limbal hyperemia with power of 0.9 and 
alpha level 0.05, a minimum total sample size of 32 participants should be studied for the 2 
study groups in Day 2 (Figure 1).  
In this initial study to evaluate the response differences between groups it is proposed that 17 
participants in each group (shown in randomized side of the graph) are studied to evaluate the 
size of the differences in bulbar and limbal hyperemia between groups found following lens 
removal and across the recovery period at each time point. If the data shows a trend of finding a 
difference between groups, this data can be used to plan a larger study which is powered 
  
11.2 STATISTICAL ANALYSIS 
All data will be analyzed by CORE at the University of Waterloo. Data analysis will be conducted 
using Statistica, SPSS or SAS. Descriptive statistics will be provided on information regarding 
baseline variables (age, gender, refractive error distribution, etc.). Analysis of variables will be 
conducted separately on each eye, and data will not be pooled. For assessments conducted for 
each eye separately, the right eye will be used for analysis if there is no difference between 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    35 
eyes. If a general difference is found (e.g. for paired t-test / Wilcoxon matched pairs) between 
OD and OS, a comment will be provided. 
The critical alpha level for statistical significance will be set at p  0.05, with no adjustments for 
multiple comparisons. 
All participants who were evaluated and complete all scheduled study visits will be included in 
the analysis cohort. In the event of missing data, individual data points will be excluded from the 
analysis and not extrapolated from the collected data. 
12 DATA QUALITY ASSURANCE 
12.1  STUDY MONITORING 
Site qualification of the investigative site has been completed to ensure that the site facility is 
adequate, personnel are qualified and resources are satisfactory to conduct clinical studies for 
the Sponsor. The protocol will be reviewed by the investigators prior to enrollment of the first 
participant. This review will be led by the lead investigator at each site and will involve an 
overview of the protocol, which includes information on study objectives, inclusion and exclusion 
criteria, study visits and adverse event reporting. Data collection forms will also be reviewed and 
this will provide an opportunity to discuss any questions.  
Central study monitoring will involve regular study updates from each site to the sponsor. The 
updates will include the number of participants enrolled, the number eligible, the number 
completed and whether there have been any unscheduled visits, discontinuations, significant or 
serious adverse events or major protocol deviations. These updates will be provided weekly.  

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    36 
Prior to final data lock, a close-out visit/discussion may be warranted to check for accuracy and 
completeness of records. The sponsor or sponsor’s representatives will be authorized to gain 
access to the source documentation for the purposes of monitoring and auditing the study. 
12.2 SPONSOR RESPONSIBILITIES 
The Sponsor has the ultimate responsibility for monitoring. The Sponsor is to supply and keep 
an up-to-date signed protocol and protocol amendments, and provide devices which are the 
subject of the clinical investigation. 
The sponsor should ensure: appropriate information is provided to the Investigators to conduct 
the study; that deviations are reviewed with the Investigator as needed and included in the final 
report. Adverse events are reported by the Investigator, and the sponsor in turn will then notify 
their applicable regulatory authorities, and other investigators as appropriate. The Sponsor is to 
maintain Sponsor-specific study documentation as required by the regulatory authorities and to 
ensure the Investigator is aware of their record keeping responsibilities. 
12.3 INVESTIGATOR RESPONSIBILITIES 
The Investigator is responsible for ensuring participant safety and data quality by: protocol 
compliance, adherence to GCP and local regulatory requirements, and the Declaration of 
Helsinki. The Investigator should be appropriately qualified and legally entitled to practice, and 
be trained in the proper method of obtaining informed consent.  
The Investigator must have the appropriate resources to conduct the study, be familiar with the 
protocol and agree to adhere to it, support monitoring and auditing activities, communicate with 
the Sponsor regarding any study issues or need for protocol modifications, make the necessary 
arrangements to ensure proper conduct and completion of the study, and ensure the protection 
and welfare of the participant, including arranging any emergency treatment as needed. 
The Investigator must ensure written ORE approval for the study site is received prior to the start 
of the study, that the respective ORE and Sponsor is kept informed of the study progress, 
including adverse events and deviations as required by them, and that any changes to the 
protocol are notified to the ORE and review written approval prior to implementation. 
12.4 RECORD KEEPING 
Detailed records of all study visits will be made using the Case Report Forms (CRFs). Each 
subject will be identified on the CRFs with a study ID number which will not contain any 
identifying information such as initials and date of birth. All data recorded on forms will be in ink. 
Any corrections to the forms will be initialed and dated at the time they are modified. 

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12.5 RETENTION OF STUDY RECORDS AND DATA 
Following study completion, data will be available in electronic and/or paper format for audit, 
sponsor use, or subsequent analysis. The original clinical raw data (including completed CRFs 
and Informed Consent forms) will be retained according to guidelines set forth in the general 
work agreement with the site. The CRFs in the external study site will be scanned and 
electronically transferred via the University of Waterloo Secure File Transfer Service to CORE 
for data entry. The Sponsor will be notified and consulted if ever the files are to be destroyed. 
Copies of raw data will be forwarded to the sponsor at completion of the final report.  
Records and data from this study will be retained for a minimum of 25 years at CORE and the 
relevant part of the study data will be retained for a minimum of 20 years at Eurolens Research 
study site.  
12.6 DATA ENTRY / DATA MANAGEMENT 
Data will be entered into an electronic spreadsheet at CORE. Study staff will only be able to 
modify the data file via password entry. The investigators will be responsible for the data 
integrity, and complete data entry for each visit in the CRFs and other relevant forms. At the 
completion of the study CORE will send the data collected to the study sponsor within 
approximately 5 business days after the study report is finalized.  
Data analysis will not be conducted on comments which have been recorded in the source 
documents. Only pre-defined comments will be entered into the study database. Only relevant 
and applicable comments will be included in the final report as deemed necessary by the lead 
investigator.  
13 PROTOCOL TRAINING 
All study personnel will be required to complete training prior to their involvement in the study. 
Records of training will be kept at the study site. 
14 STUDY MONITORING 
Status reports will be provided to the study sponsor by email on a regular basis.  
Status reports will include: 
• 
The number of participants screened, enrolled, and randomized (i.e. assigned a study ID 
number), discontinued and completed. 
• 
Details of protocol deviations. 
• 
Reports of unintended events. 

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Study monitoring visits may be conducted throughout the study and, if so, would be scheduled 
by the study sponsor in conjunction with the site. In addition study records may be inspected at 
the study site by the sponsor, the sponsor's designate, the Office of Research Ethics at the 
University of Waterloo, and by regulatory authorities in Canada and the United States, namely 
Health Canada and the United States Food and Drug Administration (FDA); however, no records 
containing identifiable/personal information will be permitted to leave the custody of the study 
site. 
Each study site will conduct internal monitoring of proper consent documentation and reporting 
of protocol deviations and adverse events. 
15 STUDY MANAGEMENT 
15.1 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.  
15.1.1 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 respective Office 
of Research Ethics (ORE) at each site: 
• 
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; 
• 
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. 
15.1.2 MINOR PROTOCOL DEVIATIONS 
Protocol deviations caused by or which originate with research participants are considered 
minor, and normally are not reported to the ORE nor to the Sponsor (other than within the study 
report) unless these result in increased risk to the participant(s) or potentially affect data 

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integrity. The following are examples of protocol deviations that are considered minor and do not 
require reporting to the ORE: 
• 
Logistical or administrative aspects of the study (e.g., study participant missed 
appointment, change in appointment date); 
• 
Inadvertent deviation in specific research intervention procedures or timing of the 
research intervention which would not impact upon the safety or efficacy of the study-
related intervention or upon the experimental design (i.e., missing a measurement during 
a session that is not considered critical for the study).  
15.1.3 REPORTING AND DOCUMENTING PROTOCOL DEVIATIONS 
Major protocol deviations which require changes to the research protocol or informed consent 
process/document or other corrective actions to protect the safety, welfare, or rights of 
participants or others must be reported to the Sponsor and to the respective ORE within 7 days 
for CORE (or as per guidelines of the respective ORE for each study site), using the ORE 
Protocol Deviation Report Form  (PDRF). Information from the PDRF is provided to the Clinical 
Research Ethics Committee (CREC) at the next monthly meeting. The PDRF requirements 
indicated above are only applicable to CORE. Eurolens Research study site will follow their local 
ethics committee requirements for reporting protocol deviations to the respective ethics 
committee. 
All protocol deviations (major and minor) occurring during the study will be documented and 
included in the final report. 
15.2 PREMATURE TERMINATION OF THE STUDY 
The sponsor, study sites or the Office of Research Ethics for the study site may terminate the 
study at any time for any reason. 
15.3 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 each participant’s study exit. 

15.4 RETENTION OF STUDY RECORDS AND DATA 
Records and data from this study will be retained for a minimum of 25 years at CORE and 20 
years at Eurolens Research, respectively. Details regarding storage procedures are given in 
SOPs of the respective site.  
16 CONFIDENTIALITY 
This study is confidential in nature. All information gathered during this study is proprietary and 
should be made available only to those directly involved in the study. Information and reports 
arising from this project are the property of the sponsor.  
17 PUBLICATION 
Due to the confidential and proprietary nature of the clinical study, any presentation and/or 
publication including but not limited to those made at scientific meetings, in peer-review journals, 
professional publications, etc. need to be approved by the sponsor.  
18 STUDY COSTS  
The sponsor will compensate the clinical site and the participants for their time and participation 
in this voluntary study. 
Expenses incurred for medical treatment required as a consequence of study participation will 
be paid to the participant by the study site, which will then claim from the sponsor (bills and 
prescription receipts provided). The participant must be followed until resolution and a written 
report completed indicating the subsequent treatment and resolution of the condition.  
19 REPORT 
A report will be sent to the sponsors according to terms described in the study contract. 

EX-MKTG-89 BAGPIPES Protocol v2.0_28nov2020                                                                                                    41