Clinical Evaluation of CooperVision MyDay Lenses
Phase: NA
Conditions: Myopia
Sponsor: CooperVision, Inc.

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Protocol Version 2.0: JP-MKTG-201709_02 
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Study Implementation document: 
CLINICAL EVALUATION OF MYDAY LENSES 
Sponsor Study Code: 
JP-MKTG-2017_02 
Version Number: 
2.0 
Implementation document Date: 
26 October 2017 
Sponsor Company:  
CooperVision Japan, Inc. 
Document Type: 
Implementation document 
Study Category: 
Design Validation 
Clinical Sites: 

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Implementation document Sponsor: ______________________ 
Date:_______________ 
______________________  
Date:_______________ 
PERSONNEL & FACILITTIES 
STUDY SPONSOR: 
SPONSOR COORDINATOR:
STUDY MONITOR: 

Protocol / Study Number 
Title 
Name of Device(s) and (by 
USAN material) 
lndications for Use 
Study Design 
Purpose 
Study Duration 
Patient Population 
Sample Size 
Clinical Site Destination 
Number of Clinical Sites 
Patient Follow-up 
Primary Endpoints 
Secondary Endpoints 
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Protocol Version 2.0: JP-MKTG-201709_02 
Protocol Synopsis 
JP-MKTG-201709_02 
Clinical Evaluation of CooperVision MyDay® Lenses 
MyDay® (stenfilcon A), 1-DAY ACUVUE® TruEye® 
(narafilcon A) 
Approved for use: 
• stenfilcon A. (Single use daily wear)
• narafilcon A. (Single use daily wear)
lndication for use in this study:
•
3 hours of single use daily wear
3 hours, single masked, randomized, contralateral, single 
use daily wear, non-dispensing study. 
The aim of this non-dispensing study is to evaluate the fitting 
performance of MyDa 
compared it with 1-
DA Y ACUVUE® TruEye 
in a range of 
spherical powers. 
The anticipated timeline for this study is as follows: 
• Patient enrolment: February 2018
•
Visits: V1 (Baseline), V2 (After 3 hours of lens wear/Exit
visit)
Adapted spherical soft contact lens wearers with myopia 
that provide written informed consent and meet protocol 
entry criteria. 
Target enrollment and completion of 40 subjects total. 
Japan 
4 Sites 
Patients enrolled in this study will be followed up: 
• Follow-up: 3 hours of lens wear/Exit visit
Obiective: Lens fitting characteristics, such as Lens 
movement, 
Horizontal 
lens 
centration, 
Vertical 
lens 
centration, Corneal coverage, Lens lag, Overall fitting 
performance, lnvestigator Fit Preference 
Subjective: Subjective rating of wearing comfort, dryness, 
stinging/burning, edge awareness/lens awareness, and 
lens preference 
3 

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TABLE OF CONTENTS 
1 
Introduction ................................................................................................................. 5 
2 
Study Objective ........................................................................................................... 6 
2.1 
Study Hypothesis ........................................................................................................ 6 
3 
Study Design ............................................................................................................... 6 
4 
Ethics Review / Statement of Compliance ................................................................. 6 
4.1 
Relevant Standards / Guidelines ................................................................................ 6 
4.2 
Institutional Review Board .......................................................................................... 7 
4.3 
Informed Consent ....................................................................................................... 7 
5 
Potential Risks and Benefits to Human Subjects ..................................................... 7 
6 
Materials and Methods ................................................................................................ 8 
6.1 
Participants ................................................................................................................. 8 
6.2 
Study Materials ........................................................................................................... 9 
6.3 
Visit Schedule and Procedures ..................................................................................11 
7 
Adverse Event Reporting .......................................................................................... 12 
7.1 
Adverse Event Definitions ..........................................................................................12 
7.2 
Procedures for Adverse Events .................................................................................14 
7.3 
Reporting Adverse Events .........................................................................................14 
7.4 
Discontinuation from the Study ..................................................................................15 
8 
Device Deficiencies ................................................................................................... 15 
9 
Statistical Analysis .................................................................................................... 15 
9.1 
Statistical analysis .....................................................................................................16 
10 
Data Quality Assurance ............................................................................................ 16 
10.1 
Study monitoring ........................................................................................................16 
10.2 
Record keeping .........................................................................................................16 
10.3 
Record retention ........................................................................................................17 
10.4 
Data Entry / Data Management .................................................................................17 
10.5 
Confidentiality ............................................................................................................17 
10.6 
Publication .................................................................................................................17 
11 
Study Costs ............................................................................................................... 17 
 

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1 Introduction 
Cooper Vision Inc. is interesting in evaluating the fitting characteristics of its MyDay lenses in an 
Japanese population. 
2 Study Objective 
 
This is a feasibility study to evaluate the fitting performance of MyDay 
 lens (Test) 
against TruEye 
 (Control) over 3 hour of lens wear in a Japanese population.  
 
The key variables of interest is: 
• 
Lens fit performance 
 
Other variables of interest are: 
• 
Subjective comfort, dryness, stinging/burning, edge awareness/lens awareness and 
preference 
• 
 
 
2.1 Study Hypothesis  
The study primary hypothesis is that there will be no differences between the Test and Control 
lenses in term of fitting characteristics.  
3 Study Design  
This will be a non-dispensing, randomized, contralateral study comparing a test lens against an 
appropriate control lens. Each subject will be randomized to wear the test lens in one eye and the 
control lens in the other eye.  It is anticipated that this study will involve up to 2 visits.  
 
4 Ethics Review / Statement of Compliance 
4.1 Relevant Standards / Guidelines 
This implementation document has been developed in accordance with the following:   

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• 
ISO 14155 Clinical Investigation of Medical Devices for Human Subjects, Parts 1 & 2 
• 
ICH Harmonized Tripartite Guideline for Good Clinical Practice 
• 
Declaration of Helsinki 
 
4.2 Institutional Review Board 
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. 
 
  
 
 
 
4.3 Informed Consent 
Informed consent shall be obtained in writing from the subject and the process shall be 
documented before any procedure specific to the clinical investigation is carried out. 
5 Clinical Trial Registration 
1. 
This study will be registered in www.ClinicalTrials.gov. 
2. 
Prior to the implementation of the study, the contents of the study protocol will be registered with 
masking the key words and numbers to protect the company confidentiality in the publication 
database set up by the Japan Pharmaceutical Information Center and will be updated suitably 
according to the change and progress.  
 
Results of this study will be released with masking the key words and numbers to protect the 
company confidentiality only in the publication database set up by Japan Pharmaceutical 
Information Center after taking necessary measures for the protection of the human rights of 
study subjects and related parties or the rights and profits of researchers, etc. and related 
parties, without delay after the completion of the study. 
 
6 Potential Risks and Benefits to Human Subjects 
There might not be direct benefits to the subjects in this study. However, participation in a study 
may contribute to scientific research information that may be used in the development of new 
contact lens products. In addition, subjects will receive an examination of the front part of their 

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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 investigational contact lenses used in this study are intended for daily wear (NOT extended 
wear) with usage of up to 12 hours only, in contrast to the average wearing time of 10-16 hours for 
daily wear lenses. In addition, this study is a non-dispensing study, meaning the lenses are not 
dispensed to subjects to take home and lens wear will be monitored closely by the investigators.  
This study is considered to be a non-significant risk study based on United State Food and Drug 
administration (FDA) and International Standards Organization (ISO) guidelines due to the daily 
wear nature of the study.   
 
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. 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. 
 
The lenses being used may not have the exact prescription power needed by the subject. The 
prescription closed to the available SKUs without the over minus correction will be made for each 
eye.  This may require that subjects wear their spectacle correction over the study lenses in order 
to see well at distance.  In this case, it is possible that subjects may experience “eye strain” when 
focusing through this extra power which may cause headaches. Routine clinical procedures 
including auto-refraction, auto-keratometry, visual acuity, anterior ocular health assessment, and 
contact lens fitting will be used.  
 
7 Materials and Methods 
7.1 Participants 
Approximately 40 subjects will be enrolled for this study. All subjects will be Japanese. Each 
subject will be given a unique ID number. Additionally, all subjects must meet the study inclusion 
and exclusion criteria listed below. 

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Inclusion criteria 
A person is eligible for inclusion in the study if he/she:  
• 
Is Japanese 
• 
Has had a self-reported oculo-visual examination in the last two years.    
• 
Is at least 18 years of age and has full legal capacity to volunteer.  
• 
Has read and understood the informed consent letter.   
• 
Is willing and able to follow instructions and maintain the appointment schedule.  
• 
Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision 
correction or 20/20 best-corrected.  
• 
Currently wears soft contact lenses.  
• 
Has clear corneas and no active ocular disease. 
 
Exclusion Criteria 
A person will be excluded from the study if he/she: 
• 
Has never worn contact lenses before.  
• 
Has any systemic disease affecting ocular health.  
• 
Is using any systemic or topical medications that will affect ocular health.  
• 
Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe 
dry eyes) that would affect the wearing of contact lenses.  
• 
Has persistent, clinically significant corneal or conjunctival staining using sodium 
fluorescein dye.  
• 
Has any clinically significant lid or conjunctival abnormalities, active neovascularization or 
any central corneal scars.  
• 
Is aphakic.  
• 
Has undergone corneal refractive surgery.  
• 
Is participating in any other type of eye related clinical or research study. 
 
7.2 Study Materials 
7.2.1 Contact lens 
Subjects will be randomized to receive either the Test or Control lens as a matched pair at each 
visit per a predetermined randomization schedule.  The Test lenses used in this study will be 

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Papillary conjunctivitis if ≥ mild scattered papillae/follicles approximately 1mm 
in diameter (e.g. ISO 11890 Grade 2), if 2 grade change from baseline 
Notify sponsor as 
soon as possible, 
within 5 working 
days; IRB 
reporting as per 
requirements 
23 
Asymptomatic corneal infiltrative events 
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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 
 
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. 
 
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 Adverse Events. 
 
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 subject 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 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 subject must be followed until resolution and a written 
report 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 subject participation will be reported to the Principal Investigator and the sponsor within 24 

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hours of the investigator becoming aware of the event. The Principal Investigator will report the 
event to the IRB as soon as possible (by fax, mail/delivery, phone, or email).  All fatal or life 
threatening events will be reported immediately to the IRB. 
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. 
 
 
 
 
 
8.4 Discontinuation from the Study  
A subject’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 subject. All discontinuations will be fully documented 
on the appropriate study forms and the Discontinuation Form will be completed. 
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. 
 
Other defective lenses should be reported to the Sponsor 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. 
 

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10 Statistical Analysis  
10.1 Statistical analysis 
Summary statistics will be produced (e.g. mean, standard deviation). 
 
and subjective scores between study lens types.  χ2 
test will be used to compare the fitting performance between study lens types. The critical alpha 
level for statistical significance will be set at p ≤ 0.05, with adjustment for multiple comparisons. 
 
All participants who were evaluated will be used in the analysis. In the event of missing data, 
individual data points will be excluded in the analysis and not extrapolated from the collected data. 
11 Data Quality Assurance 
11.1  Study monitoring 
Site qualification of the each 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 subject. 
This 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.  
 
Prior to final data freeze, 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. 
 
11.2 Record keeping 
Detailed records of all study visits will be made using the Case Report Forms (CRFs). 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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11.3 Record retention 
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 Sponsor will be notified and consulted if ever the files are to be destroyed.  In the event 
that this implementation document is indicated for design verification and validation purposes, as 
indicated on the title page, all original raw data forms and completed CRF’s will be forwarded to the 
sponsor at completion of the final report. 
11.5 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.  
11.6 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-house, in peer-review 
journals, professional publications, etc. need to be approved by the sponsor. 
12 Study Costs 
The sponsor will compensate the clinical site and the subjects for their time and participation in this 
voluntary study. 
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 and a written 
report completed indicating the subsequent treatment and resolution of the condition.