Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers
Phase: NA
Conditions: Myopia, Hyperopia
Sponsor: CooperVision, Inc.



EX-MKTG-151 ALPACA Protocol v1.4 15Sep2023 
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EX-MKTG-151 ALPACA Protocol v1.4 15Sep2023 
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Study locations 
 
1. Study co-ordination & data management institution (no clinical visits): 
 
 
Lyndon Jones (Director) 
CORE 
 
 
 
School of Optometry & Vision Science 
 
 
 
University of Waterloo 
 
 
 
200 Columbia Street West 
 
 
 
Waterloo, Ontario N2L 3G1 
 
 
 
CANADA 
 
 
2. Clinical research conducted at in-practice study sites: 
 
It is anticipated that between 3 and 4 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. 
 
 
 

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1 
DOCUMENT CHANGE HISTORY 
 
Version 
number 
Version 
date 
Author 
Description of change(s) 
1.0 
27Jul2023 
Doerte Luensmann 
Original protocol. 
1.1 
21Aug2023 
Doerte Luensmann 
Change of study title and primary outcome variable. 
1.2 
07Sep2023 
Doerte Luensmann 
Renaming of subjective ratings, change in section 
5.3.3 inclusion criteria. 
1.3 
08Sep2023 
Doerte Luensmann 
Edits on study hypothesis section 4 and required 
number of clinical research sites section 5.2.1. 
1.4 
15Sep2023 
Doerte Luensmann 
Lens wettability and visible deposit grading added to 
lens assessments. 
 
 

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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 ......................................................................................... 12 
5.3.3 
Inclusion and exclusion criteria ............................................................................. 13 
5.4 
Study materials ........................................................................................................... 14 
5.4.1 
Lenses ................................................................................................................. 15 
5.4.2 
Lens care products ............................................................................................... 15 
5.4.3 
Other products ..................................................................................................... 15 
5.4.4 
Rewetting drops ................................................................................................... 15 
5.4.5 
Disposing of study products ................................................................................. 16 
5.4.6 
Product accountability .......................................................................................... 16 
5.5 
Scheduled and unscheduled visits .............................................................................. 16 
5.5.1 
Visit 0 Screening & fit visit .................................................................................... 17 

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5.5.2 
Repeated screening visits (Visit 0 or Visit 0/R1) ................................................... 19 
5.5.3 
Visit 1-0 Dispense Lens type #1 ........................................................................... 20 
5.5.4 
Visit 2-0, 1-month follow-up Lens type #1, Dispense Lens type #2 ....................... 21 
5.5.5 
Visit 3-0 1-month follow-up Lens type #2 .............................................................. 22 
5.5.6 
Study exit ............................................................................................................. 23 
5.5.7 
Unscheduled visits ............................................................................................... 24 
5.6 
Study procedures ........................................................................................................ 24 
 
 
 
 
 
 
6 
Monitoring protocol adherence .......................................................................................... 26 
7 
Potential risks and benefits to human participants ............................................................. 27 
8 
Adverse events .................................................................................................................. 28 
8.1 
Normal or adaptive symptoms ..................................................................................... 30 
8.2 
Procedures for adverse events .................................................................................... 30 
8.3 
Reporting adverse events ........................................................................................... 30 
9 
Discontinuation from the study ........................................................................................... 31 
10 
Device malfunctions ........................................................................................................... 32 
11 
Study completion and remuneration .................................................................................. 33 
12 
Statistical analysis and data management ......................................................................... 33 
12.1 
Statistical analysis ................................................................................................... 33 
12.2 
Data management ................................................................................................... 34 
12.3 
Comments on source documents ............................................................................ 35 
13 
Protocol & other training .................................................................................................... 35 
14 
Study monitoring ................................................................................................................ 35 
15 
Study management............................................................................................................ 36 

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15.1 
Statement of compliance ......................................................................................... 36 
15.2 
Ethics review ........................................................................................................... 36 
15.3 
Clinical trial registration ............................................................................................ 37 
15.4 
Protocol deviations .................................................................................................. 37 
15.4.1 
Major protocol deviations ..................................................................................... 37 
15.4.2 
Minor protocol deviations ..................................................................................... 38 
15.4.3 
Reporting and documenting protcol deviations ..................................................... 38 
15.5 
Premature termination of the study .......................................................................... 38 
15.6 
Study participant records ......................................................................................... 38 
15.7 
Retention of study records and data ........................................................................ 39 
16 
Report................................................................................................................................ 39 
 
 

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

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2 
INTRODUCTION 
The Avaira Vitality™ (CooperVision Inc. US), also known as Serenity™ (CooperVision Inc. 
Canada) has been on the market for some time, however its performance has not been evaluated 
in comparison to other monthly replacement lenses that have more recently been introduced. The 
goal of this study is to determine the performance of Avaira Vitality™/ Serenity™ (Lens A), a SiHy 
monthly replacement lens from CooperVision Inc., and compare it with TOTAL30® (Lens B), a 
SiHy monthly replacement lens from Alcon Inc.  
3 
OBJECTIVES 
To compare the clinical performance of Avaira Vitality™/ Serenity™ versus TOTAL30® in habitual 
spherical soft lens wearers, when worn for 1-month each in a double-masked, randomized 
crossover study design.  
The primary outcome variable for this study is: 
• 
Lens handling on removal (0-100 scale) collected on Day 27 on the at-home 
diary.   
4 
HYPOTHESIS 
The null hypothesis is that there will be no difference for lens handling rating on removal 
between Lens A compared to Lens B collected on the at-home diaries on day 27.  
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 frequent replacement 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. 

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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 
This study will be double masked i.e. participants and investigators will be masked to the lens 
type dispensed. In order to achieve this, unmasked research assistants will determine the lens 
order according to the randomization schedule (see section 5.1.2) and will over-label the lens 
packages/foils prior to dispense by placing strongly adhesive stickers on the packages/foils to 
mask the participant and investigator to the lens brand. At the fitting visit both lens types will be 
fit, but only the participant will be masked to the lens type during this process. During the lens 
wear phases both investigators and participants will be masked. 
5.2 INVESTIGATIONAL SITES 
5.2.1 NUMBER OF SITES 
This study will be conducted in three to four 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 upload all study visit documents to CORE, ideally the same day* as the 
visit or at most within 2 days of the study visit.  
• 
Is willing to follow the study protocol and to co-operate with the study monitors at 
CORE. 
* Study documents are required as soon as possible because this allows for a timely data 
review, query and entry. 

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5.3 STUDY POPULATION 
5.3.1 SAMPLE SIZE CALCULATION 
The data for subjective responses for ease lens handling for lens removal when reflecting on a 
typical day, collected at the 1-month visits: standard deviation of paired differences was 1.7 (0-
10 scale) was transformed to a standard deviation of 17 on the planned 0-100 scale for this 
study. 90% power is achieved with a minimum sample size of 33 participants. 
In addition, data for subjective responses related to lens comfort on insertion and just prior to 
removal when reflecting on a typical day, collected at the 1-month visits: standard deviation of 
paired differences was 2.2 and 2.3 (0-10 scale) was transformed to a standard deviation of 22 
and 23 on the planned 0-100 scale for this study. 80% power is achieved with a minimum 
sample size of 45 and 44 participants. 
It was therefore decided to move ahead with minimum sample of 45 in order to exceed that 
required for the primary outcome variable, and also provide sufficient sample related to comfort 
variables. To allow for drop-out and possible protocol deviations, up to 52 participants may be 
dispensed with study products.  
 
 
 
 

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Figure 1: Sample size calculation graph (a-c) 
 
5.3.2 NUMBER OF PARTICIPANTS 
Participants will be recruited using site records, databases and advertising materials (e.g., 
posters, email scripts) approved by the ethics review board. All initial individual-targeted 
recruitment activities, such as any direct mailing of recruitment scripts, will be conducted by 
practice staff that are not directly involved in conducting the research. This separation will 
reduce any undue influence of the optometrist-patient relationship. This process will also 
eliminate opportunity for the investigator to access personal health information before any 
consent for disclosure is provided by the potential participant.  

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It is anticipated that up to 80 potential participants may attend a Screening visit and up to 52 
participants may be randomized and dispensed with study products, with a target of at least 45 
completing the study.  
 
5.3.3 INCLUSION AND EXCLUSION CRITERIA 
A person is eligible for inclusion in the study if he/she: 
1. Is at least 18 years of age and no older than 39 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. Has healthy eyes with no health condition or medication that contra-indicate contact lens 
wear, in the opinion of the investigator; 
6. Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week; 
7. Habitually wears spherical soft contact lenses, for the past 3 months minimum: 
It is preferred that all participants are habitual frequent replacement lens wearers. 
However, if this is not possible then no more than 5 participants can be habitual daily 
disposable lens wearers at each site, the rest must be habitual frequent replacement lens 
wearers; 
- 
For the frequent replacement wearers: No more than 3 can be habitual wearers of 
the Avaira Vitality™/ Serenity™ brand (or their equivalent private label brand name) 
and no more than 3 can be habitual wearers of TOTAL30® can be enrolled at each 
site; 
8. Has refractive astigmatism no higher than -0.75DC in each eye; 
9. 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; 
3. Has a systemic or ocular condition that in the opinion of the investigator may affect a 
study outcome variable;  

EX-MKTG-151 ALPACA Protocol v1.4 15Sep2023 
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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 39 years 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 
Each site will be provided with an inventory of Lens A which will be used for fitting and 
dispensing of Lens A.  
For Lens B, the clinical sites will pre-order two commercial 6-packs in each prescription in the 
range -0.25 to -6.00 inclusively in 0.25D steps and one commercial 6-pack in each prescription 
in the range +0.25 to +6.00 inclusively in 0.25D steps for the use in this study. These lenses will 
be used for fitting and dispensing Lens B. Reimbursement to practice sites for study product 
expenses for Lens B will be provided by CooperVision, after 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 
dispensing logs. CORE will train site personnel to complete the forms correctly and provide 
continued support to answer queries on correct form completion. 
 
 

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5.4.5 DISPOSING OF STUDY PRODUCTS 
At the end of the study, all sites will return all unused products to CORE, unless otherwise 
directed. Worn lenses will be disposed of by participants and at the sites according to local 
regulations. 
5.4.6 PRODUCT ACCOUNTABILITY 
Accountability logs are completed to record all study products that were used for each 
participant, which includes products used during the visits and those dispensed to and returned 
by each participant. 
5.5 SCHEDULED AND UNSCHEDULED VISITS 
This study has a minimum of 4 scheduled study visits, including the screening visit. There is an 
option for repeated screening visit if needed. 
A scheduled 1-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 3 summarizes the scheduled study visits and study codes. 

EX-MKTG-151 ALPACA Protocol v1.4 15Sep2023 
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3. Participant demographics and medical history (age, sex, medical conditions, 
medications, allergies). 
4. Contact lens history (habitual lens information and wearing habits).  
5. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 

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• 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
14. 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. 
15. 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; 

EX-MKTG-151 ALPACA Protocol v1.4 15Sep2023 
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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. 
 
 
 
 
 
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: 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 

EX-MKTG-151 ALPACA Protocol v1.4 15Sep2023 
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7. Provide and explain to participant the subjective Home Diary rating forms 
 to 
be completed on Day
 
 The participants need to complete the ratings two times on each of these 
days: 5 minutes after insertion and just before removal. The sites will complete the headers 
on the respective days of the week and dates on these forms to avoid errors. Explain that 
the ratings will include: 
• 
 
  
 
 
 
 
 
 
• 
AFTER LENS REMOVAL: 
a. Time of lens removal, 
b. 0 - 100 ratings for ease of handling for lens removal 
• 
Any comments related to the lens wearing experience.  
8. 
  
 
 
10. Instruct the participant to use their habitual lens care products with the study lenses or if 
applicable as per section 5.4.2, dispense a monthly supply of Optifree Puremoist – the 
correct use of the product will be reviewed with the participant prior to dispense. 
11. Confirm that Visit 2-0 is scheduled 28-32 days after this 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 arrive having worn Lens type #1 for 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. Collect all unworn study lenses. 

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3. 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
10. Continue with the lens dispense for Lens type #2 as described in visit 1-0 starting point 
#3 to #10 
11. Confirm that Visit 3-0 has been scheduled 28-32 days after this Visit 2-0. 
 
5.5.5 VISIT 3-0 1-MONTH FOLLOW-UP LENS TYPE #2  
Participants will be asked to arrive having worn Lens type #2 lenses for at least 2 hours prior to 
the visit. This visit will occur 28-32 days (inclusive) after visit 2-0. 
The study procedures are outlined below: 
1. Confirm participant’s health and medications are unchanged. 
2. Collect all unworn study lenses. 
3. 
 
 
  
 
 
 
 
 

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11. 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 after the last study visit, or if the participant is discontinued from the study at 
another time, complete also an unscheduled visit form. A study exit form must be completed for 
all participants who have taken a study ID number. If in the opinion of the investigator post-study 
follow-up visits are required, the exit form will be completed after the last follow-up visit.  
Exit visual acuity will be recorded with either the participant’s spectacles, refraction or habitual 
contact lenses. An exit biomicroscopy assessment will be conducted if not already completed on 
the same day for a concurrent study visit. 

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6 
MONITORING PROTOCOL ADHERENCE 
Adherence to study visit windows, lens wearing schedule, and time windows around other data 
collection points (i.e. subjective ratings) will be monitored by CORE. Deviations from the study 

EX-MKTG-151 ALPACA Protocol v1.4 15Sep2023 
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plan as described in the protocol will be reported in the study report. As described in Section 13.4, 
major protocol deviations will be reported to the Sponsor and Sterling Institutional Review Board 
within 10 days of becoming aware of them (as per Sterling Institutional Review Board guidelines).  
7 
POTENTIAL RISKS AND BENEFITS TO HUMAN PARTICIPANTS 
There may be no direct benefits to the subjects in this study. Participation in a study may contribute 
to scientific research information that may be used in the development of new contact lens 
products. The subjects will receive an examination of the front part of their eyes and may have the 
opportunity to try a different type of soft contact lenses and/or different lens care products at no 
cost to them. The contact lens materials used in this study are commercially available as daily 
wear. This study will investigate participants’ wearing schedule intended for daily wear (NOT 
extended wear), similar to the average wearing time of 10-16 hours for daily wear lenses.  
All lenses used in this study are IDE exempt under 21 CFR 812.2(c)2. The two study contact lens 
types will be worn as per their approved use; on a daily wear basis with monthly replacement. 
When contact lenses are worn on a daily wear basis there is a small risk of an adverse event 
compared to not wearing contact lenses. When contact lenses are worn on an extended wear 
basis, there is a significantly increased risk of an adverse reaction compared with wearing contact 
lenses on a daily wear basis. 
Adverse events and/ or complications in daily wear of soft contact lenses can occur (e.g. 
inflammation and infection). Complications that may occur during the wearing of contact lenses 
include discomfort, dryness, aching or itching eyes, excessive tearing, discharge, hyperemia and 
variable or blurred vision.  More serious risks may include pain, photophobia, iritis, corneal edema 
or eye infection. Although contact lens-related infections are very infrequent, the possibility does 
exist.  The incidence of infection due to day-wear soft lenses is 0.035%. Almost always an infection 
will occur only in one eye.  This risk is assumed by 35-million Americans who currently wear 
contact lenses and only current soft lens wearers will be recruited for this study.  
A dye (fluorescein) normally used for eye examinations is being used in this study. Although 
rare, it is possible to have an allergic reaction to the dye. Participants will be asked if they have a 
known allergy or sensitivity to fluorescein. 
The assessments conducted in this study are routine clinical procedures and they include auto-
refraction, auto-keratometry, visual acuity, anterior ocular health assessment, and contact lens 
fitting will be used. In addition, high magnification imaging of the lens fit may be made using 35 
mm or digital cameras. Patients will be monitored frequently until the end of the study to reduce 

EX-MKTG-151 ALPACA Protocol v1.4 15Sep2023 
30 
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 ocular adverse events may be managed at the practice, or the 
participant may be 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. 
The site’s Principal Investigator will also report the event to Sterling IRB within 10 days of 
becoming aware of the Serious or Unanticipated event, using the Reportable Events Form. All 
fatal or life-threatening events will be reported immediately to the IRB. 
Significant and Non-Significant Adverse Events will be reported to CORE’s lead study coordinator 
and the sponsor as soon as possible, but no later than 5 working days after becoming aware of 
the occurrence.  
 
 
 

EX-MKTG-151 ALPACA Protocol v1.4 15Sep2023 
31 
 
  
 
  
  
 
 
  
 
 
 
 
  
  
 
  
  
 
 
  
  
 
Details of all adverse events will be included in the study report. 
9 
DISCONTINUATION FROM THE STUDY 
Participants may be discontinued at the discretion of the investigator or sponsor in consideration 
of participant safety or protocol compliance, or at discretion of the participant.  Participants 
discontinued from a study will be reimbursed for their active involvement in the study (including 
the initial screening visit and all lens fitting visits) as per the information on the consent letter.  
Upon discontinuing, a participant will be offered the option of their data being withdrawn from 
future statistical analysis. The following is a list of possible reasons for discontinuation from the 
study: 
• 
Screening failure: Participants will be discontinued if they do not meet the inclusion and 
exclusion criteria outlined in section 5.2.3. 
• 
Unacceptable performance with products to be used in study: Participants may be 
discontinued if they are unable to achieve acceptable comfort and /or vision with the 
study products. 
• 
Positive slit lamp finding: Participants may be permanently discontinued from the study 
depending on the severity of the condition and on the judgement of the investigator.   

EX-MKTG-151 ALPACA Protocol v1.4 15Sep2023 
32 
• 
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 chose to discontinue from the study, they will be given the opportunity to 
withdraw their data from the statistical analysis. This choice will be captured on the discontinuation 
form. 
All discontinuations including their reasons will be included in the final report. 
10 DEVICE MALFUNCTIONS 
A device malfunction means the failure of the device to meet its performance specification or 
otherwise perform as intended. Any defective lens that is likely to cause or contribute to a Serious 
Adverse Event should be reported to CORE and the sponsor within 24 hours of the investigator 

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becoming aware of the malfunction. Sterling IRB would also be notified within 24 hours of any 
device malfunction that may contribute to a Serious Adverse Event. 
Other defective lenses should be reported to CORE as soon as possible. 
This clinical study will also ascertain satisfaction or preference with subjective attributes such as 
comfort, vision, or lens handling. Responses to these subjective questionnaires will not be 
considered as complaints or device malfunctions. 
11 STUDY COMPLETION AND REMUNERATION 
At the last scheduled protocol visit a study completion form will be completed, which requires the 
signatures of both the participant and the investigator.  Participants will also be provided with a 
letter of appreciation.    
Once their involvement in the study is complete, participants will be informed about receiving 
feedback following study completion in the Letter of Appreciation. 
Participant remuneration will be paid as per site contract and approved consent letter. 
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 14.0, Statsoft or other suitable software.  Descriptive statistics will 
be provided on demographic data (age, gender, refractive error distribution, etc.). Table 7  lists 
the primary and other outcome variables and anticipated statistical procedures. 
Visual acuity results will be converted to LogMAR for analysis purposes. 
Comparisons will be made between the study lenses for the variables measured at the 1-month 
visits. Additionally, the subjective ratings completed on days 7, 14 and 27 with each study lens 
will be compared. A binomial test will be used to analyze the results for the count data of 
subjective preferences and experience responses. Where relevant, the number of “no 
preference” responses will be evenly distributed to the two options on the basis they would be 
equally likely to choose either. 
For assessments conducted for each eye separately, the right eye will be used for analysis. If a 
general difference is found (paired t-test / Wilcoxon matched pairs) between OD and OS, a 
comment will be provided. 

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35 
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 Co-ordinator.  
13 PROTOCOL & OTHER TRAINING 
All study personnel will be required to complete training prior to their involvement in the study. 
Records of training will be kept at CORE. This will include training by CORE on the study 
protocol, study procedures, informed consent procedures, and on the randomization and 
participant masking procedures, as well as training for Good Clinical Practice.  
All site Principal Investigators and co-investigators will provide a scan of their curriculum vitae, 
license to practice optometry and evidence of professional indemnity insurance.  
14 STUDY MONITORING 
Each site will provide regular status reports to CORE. Status reports will include: 
• 
The number of participants screened, enrolled, and randomized (i.e. assigned a study ID 
number), discontinued and completed. 
• 
Details of all protocol deviations, adverse events, device malfunctions. 
• 
Reports of unintended events. 
CORE will collate the site updates and regular status reports to the study sponsor. 
Study monitoring visits to the sites may be conducted by CORE, the sponsor, or sponsor’s 
designate, throughout the study and will be scheduled in conjunction with the Principal 
Investigator at each site. In addition, study records may be inspected by the sponsor, the 

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36 
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 
will be reported to the sponsor. All serious adverse events and major protocol deviations will be 
reviewed by the site Principal Investigator and CORE’s Lead Co-ordinator before reporting to the 
sponsor and to Sterling Institutional Review Board as per their policies. 
15 STUDY MANAGEMENT 
15.1 STATEMENT OF COMPLIANCE 
This clinical study is designed to be in compliance with the ethical principles in the Declaration of 
Helsinki, with the ICH guidelines for Good Clinical Practice (GCP), with the University of 
Waterloo’s Guidelines for Research with Human Participants and with the Tri-Council Policy 
Statement: Ethical Conduct for Research Involving Humans, 2nd Edition. 
• 
Declaration of Helsinki 
• 
ICH E6 - International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use Guidelines for Good Clinical Practice 
• 
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 
(2018) 
• 
https://uwaterloo.ca/research/office-research-ethics/research-human-participants  
 
Informed consent shall be obtained in writing from the participant and the process shall be 
documented before any procedure specific to the clinical investigation is carried out. 
15.2 ETHICS REVIEW 
This protocol will be submitted to and reviewed through the Sterling Institutional Review Board. 
Notification of ethics clearance of the application is required prior to the commencement of the 
study. 

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37 
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. All 
protocol deviations must be reported to CORE’s lead study coordinator (see section 8.3). 
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 Sterling IRB: 
• 
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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38 
15.4.2 MINOR PROTOCOL DEVIATIONS 
Protocol deviations caused by or which originate with research participants are considered 
minor, and normally are not reported to Sterling IRB unless these result in increased risk to the 
participant(s). The following are examples of protocol deviations that are considered minor and 
do not require reporting to the ORE: 
• 
Logistical or administrative aspects of the study (e.g., study participant missed 
appointment, change in appointment date); 
• 
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 and the 
sponsor within 10 days of the deviation occurring (or its discovery) using the Reportable Events 
Form. To facilitate timely reporting to the sponsor, all sites must notify CORE (see contact 
details in section 8.3) of a major protocol deviation as soon as possible. 
All protocol deviations (major and minor) occurring during the study will be documented and 
included in the final report. 
15.5 PREMATURE TERMINATION OF THE STUDY 
The sponsor, CORE or Sterling Institutional Review Board may terminate the study at any time 
for any reason. 
15.6 STUDY PARTICIPANT RECORDS 
Study participant records will be completed to comply with GCP guidelines. Records will contain: 
• 
Unique study acronym and/or code; 
• 
Participant ID; 
• 
Date enrolled; 
• 
Confirmation by investigator that participant met eligibility criteria; 
• 
Confirmation that participant received a signed and dated copy of informed consent; 
• 
Exit date; 
• 
Investigator’s signature confirming study exit. 

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39 
An enrolment log will be maintained which will list all participants who attended for a screening 
visit. 
15.7 RETENTION OF STUDY RECORDS AND DATA 
When the study has been completed, all sites will send the original study product accountability 
and dispensing logs, and enrolment logs to CORE. Each site should retain the original consent 
documents and the study data collection forms documentation for ten years following the close 
of the database in case data queries arise during the analysis and report writing stages. CORE 
may request that these originals be sent to them for storage and study data collections forms 
may be sent to the sponsor for storage. 
Records and data from this study will be retained at CORE for a minimum of 25 years. Details 
regarding storage procedures are given in CORE SOP014 Clinical data management.  
16 REPORT 
Data will be analysed at CORE and a report will be sent to the sponsor according to terms 
described in the study contract.