Comparison of Daily Disposable Invigor I (Test) and Select 1 Day Lenses
Phase: NA
Conditions: Myopia
Sponsor: CooperVision, Inc.

Centre for 
Contact Lens 
Research 
School of Optometry 
& Vision Science, 
University of Waterloo, 
Waterloo, Ontario, Canada. 
N2L 3G1 
Tel: 519-888-4742 
Fax: 519-888-4303 
http://cclr.uwaterloo.ca
Protocol 
COMPARISON OF DAILY DISPOSABLE 
INVIGOR I (TEST) AND SELECT 1 DAY 
LENSES) (SAGE PHASE-BC1)  
This protocol remains the exclusive property of the CCLR until it is commissioned by the sponsors. 
Reviewed and approved (Name and Signature) 
Date 
DD/MM/YY 
Principal investigator 
Lead investigator 
Protocol author 
Quality assurance 
Sponsor 
CCLR Study number: 
P/564/16/CV 
Sponsor Study Code: 
CV-16-43
Version Number: 
2.0 
Document Date: 
20 Sep, 2017 
Sponsor Company: 
CooperVision, Inc. 

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017 
 2 
Study Personnel 
Principal investigator: 
Clinical Research Manager: 
Protocol author: 
Lead investigator: 
Statistical adviser: 
Sponsor contact: 
Sponsor Management 

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017 
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DOCUMENT CHANGE HISTORY 

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017 
 4 
TABLE OF CONTENTS 
1 
Introduction ............................................................................................................................................. 7 
2 
Study Objective ....................................................................................................................................... 7 
2.1 
Study Hypothesis .............................................................................................................................. 8 
3 
Study Design ........................................................................................................................................... 8 
4 
Ethics Review / Statement of Compliance ............................................................................................ 8 
4.1 
Relevant Standards / Guidelines....................................................................................................... 8 
4.2 
Institutional Review Board ................................................................................................................. 9 
4.3 
Informed Consent .............................................................................................................................. 9 
5 
Clinical Trial Registration ....................................................................................................................... 9 
6 
Potential Risks and Benefits to Human Participants .......................................................................... 9 
7 
Materials and Methods ......................................................................................................................... 10 
7.1 
Randomization ................................................................................................................................ 10 
7.2 
Masking ........................................................................................................................................... 10 
7.3 
Participants ...................................................................................................................................... 11 
7.4 
Study Materials................................................................................................................................ 13 
7.5 
Visit Schedule and Procedures ....................................................................................................... 15 
8 
Monitoring protocol adherence ........................................................................................................... 22 
9 
Adverse Event Reporting ..................................................................................................................... 22 
9.1 
Adverse Event Definitions ............................................................................................................... 22 
9.2 
Procedures for Adverse Events ...................................................................................................... 25 
9.3 
Reporting Adverse Events .............................................................................................................. 25 
9.4 
Discontinuation from the Study ....................................................................................................... 26 
10 
Device Malfunctions ......................................................................................................................... 27 
11 
Statistical Analysis ........................................................................................................................... 27 
11.1 
Sample size ..................................................................................................................................... 27 
11.2 
Sample size determination .............................................................................................................. 27 
11.3 
Statistical analysis ........................................................................................................................... 28 
12 
Data Quality Assurance .................................................................................................................... 29 
12.1 
Study monitoring ............................................................................................................................. 29 
12.2 
Record keeping ............................................................................................................................... 29 
12.3 
Retention of study records and data ............................................................................................... 29 
12.4 
Data Entry / Data Management....................................................................................................... 30 

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017                                                                          5 
 
13 
Protocol training ............................................................................................................................... 30 
14 
Study monitoring .............................................................................................................................. 30 
15 
Protocol Deviations .......................................................................................................................... 31 
15.1 
Reporting and documenting protocol deviations ............................................................................. 31 
16 
Confidentiality ................................................................................................................................... 32 
17 
Publication ......................................................................................................................................... 32 
18 
Study Costs ....................................................................................................................................... 32 
18.1 
Study Completion and Remuneration ............................................................................................. 32 
19 
Study Report ...................................................................................................................................... 32 
20 
Appendices ........................................................................................................................................ 33 
 

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017                                                                          6 
 
  
 
Confidentiality 
This is a private document and the property of the Centre for Contact Lens Research. 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 Contact Lens Research. 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. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017 
 7 
1 
INTRODUCTION 
Small changes in lens design, the process of fabricating contact lenses, and changes to packaging 
solutions can have an impact on their on-eye performance and comfort. CooperVision is 
evaluating the clinical performance of an investigational silicone-hydrogel lens called Invigor I 
(test) when worn on a daily disposable wear modality over 1 week (for each lens) in a randomized, 
bilateral, cross-over, dispensing study. 
 The study 
lenses are specifically designed to be a daily disposable wear silicone hydrogel contact lens, 
replaceable after each use.  
2 
STUDY OBJECTIVE 
The purpose of this study is to investigate the overall clinical performance of the Invigor IA (test) 
daily disposable silicone hydrogel lens compared to the Invigor IB (control) lens that is identical to 
the marketed lens Select 1 Day, and is labelled with an investigational label for the purpose of this 
study. 
This is a study to validate the performance of Invigor 1 (test) lenses when worn on a daily 
disposable wear modality over 1 week (for each lens).  
The primary variables of interest are: 
•
Comfort and preference (subjective ratings)
•
Vision (logMAR, and subjective ratings)
•
Anterior ocular health (corneal staining and conjunctival staining, etc.)
•
Discontinuation rate

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017 
 9 
•
ISO 14155 Clinical Investigation of Medical Devices for Human Subjects
•
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
•
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. 
This protocol will be submitted to and reviewed through the Office of Research Ethics (ORE) at the 
University of Waterloo.  
The conduct of this study has been approved at the Institutional Review Board at University of 
Waterloo, Canada, through ORE file number 21616. 
4.3 INFORMED CONSENT 
Informed consent shall be obtained in writing from the participant prior to their enrollment in the 
study, and before any procedure specific to the clinical investigation is carried out. 
5 
CLINICAL TRIAL REGISTRATION 
This study will be registered in the clinical trials registry (www.ClinicalTrials.gov) by the study 
sponsor.  
6 
POTENTIAL RISKS AND BENEFITS TO HUMAN PARTICIPANTS 
This is a minimal risk study. The investigational contact lenses used in this study are intended for 
daily wear (not extended wear) with usage consistent with typical daily wear.  
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.   
Further, the investigational lens will be tested for sterility and biocompatability prior to release. 
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 and 
infiltrates.  More serious risks may include photophobia, iritis, corneal edema or eye infection. 

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017                                                                          10 
 
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 participant 
(within +/-0.25 of their required contact lens powers). It is possible that some participants may 
experience minimal "eye strain" when focusing through this reduced/extra power which may cause 
headache.  
Routine clinical procedures including auto-refraction, auto-keratometry, visual acuity, anterior 
ocular health assessment, and contact lens fitting will be used. In addition, high magnification 
imaging (including video and still images) of the lens fit may be made using 35 mm or digital 
cameras. 
There might not be direct benefits to the participants 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, participants 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 at no cost to 
them.  
7 
MATERIALS AND METHODS 
7.1 RANDOMIZATION 
A randomization schedule will be generated. The final study randomization schedule will be 
generated by the Head of the CCLR Data Management Team, and provided to the research 
assistants for the study. Study investigators will remain masked to the randomization schedule 
until the study is completed and the database is locked.  
7.2 Masking 
Both participant and investigator will be masked as to lens type and lens assignment (control vs. 
test). The contact lens coding will be masked to both the investigators and participants as much as 
possible. A computer generated randomization scheme (sample randomization in Appendix 14) 
will be used and will be provided to an unmasked member of staff at the study site. Study 
investigators will remain masked to the randomization schedule until the study is completed and 
the database is locked. Lenses dispensed to participants may be over-labelled, however the safety 
information on the outer package label of the contact lens, shall be clearly visible.  

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017 
 11 
Under normal circumstances, the investigator mask will not be broken until all subjects have 
completed the study and the database is finalized, the subject mask will not be broken until their 
involvement in the study is complete. Otherwise, the mask should be broken only if a specific 
emergency treatment or course of action would be dictated by knowing the treatment status of the 
subject. In the event the mask is broken, the sponsor must be informed as soon as possible. The 
date, time, and reason for the unmasking must be documented. 
7.3 Participants 
Up to 40 participants will be successfully enrolled and dispensed/randomized with the study 
products, with a target of 30 participants completing the study. Participants will be recruited using 
CCLR records and advertising approved by the UW Office of Research Ethics (Appendices 2 
&11). Informed consent will be obtained for all participants prior to their enrolment in the study 
(Appendix 1). 
Each participant will be given a unique ID number. Additionally, all participants must meet the 
study inclusion and none of the exclusion criteria listed below. 
7.3.1 INCLUSION CRITERIA 
A person is eligible for inclusion in the study if he/she: 
•
Is at least 17 years of age and has full legal capacity to volunteer;
•
Has had a self-reported oculo-visual examination in the last two years;
•
Has read, understood, and signed the information consent letter;
•
Is willing and able to follow instructions and maintain the appointment schedule;
•
Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or
20/20 best-corrected vision (for binocular distance acuity);
•
Must be able to achieve 20/30 or better (in each eye) with the study lenses;
•
Currently wears soft contact lenses for at least 3 days per week, 8 hours each day;
•
Requires spectacle lens powers between -0.75 and -06.50 diopters sphere (0.25D steps);
•
Has no more than 0.75 diopters of refractive astigmatism;
•
Has clear corneas and no active* ocular disease;
•
Has not worn lenses for at least 12 hours before the examination.
7.3.2 EXCLUSION CRITERIA 
A person will be excluded from the study if he/she: 

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017                                                                          12 
 
• 
Is presently participating in any other clinical or research study including eye related clinical 
or research study;  
• 
Has never worn contact lenses before.  
• 
Has any systemic disease affecting ocular health.  
• 
Has any active* ocular pathology or severe insufficiency of lacrimal secretion (moderate to 
severe dry eyes) that would affect the wearing of contact lenses.  
• 
Is using any systemic or topical medications that will affect a study outcome variable, 
and/or ocular health.  
• 
Has any known sensitivity to fluorescein dye or products to be used in the study. 
• 
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 pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal 
confirmation at the screening visit). 
* 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. 
7.3.3 REPEATED SCREENINGS  
In some circumstances a repeated screening may need to be scheduled. Examples include, but 
are not limited to:  
a) Incomplete information available at time of screening to determine eligibility (e.g. current 
lens brands worn, history from current eye care practitioner etc.)  
b) Study procedures unable to be completed in time scheduled for visit;  
c) Study products not available at the time of the screening visit;  
d) A transient health condition which may affect the eye(s) (e.g. a common cold, active 
allergies, fatigue etc.)  
e) The short term use of medications (e.g. antibiotics, antihistamines etc.)  

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017                                                                          14 
 
7.4.3 CONTACT LENS DISPENSING 
The lenses will be inserted directly from the blister pack. The use of saline for rinsing prior to 
insertion is permitted if necessary. Saline will not be dispensed during the study.  
Participants will not be encouraged to use rewetting drops; however, those who habitually used 
rewetting drops will be allowed to continue using their normal drops. Rewetting drop use will be 
recorded at each visit.  
7.4.4 STORAGE OF LENSES AND LENS CARE SOLUTIONS 
The study materials must be stored in a secured area. All lenses and any lens care solutions used 
to store worn lenses should be stored at controlled room temperature (59-86°F). The lens care 
solution used will be specified in the implementation protocol. 
7.4.5 CLINICAL SUPPLY INVENTORY 
The CCLR must keep an accurate accounting of the study product during the study. A detailed 
inventory (including lenses received, dispensed, unused, and returned to the Sponsor) must be 
completed for study supplies. The study supplies are to be used in accordance with the 
instructions given to participants who are under the direct supervision of an investigator.  
In the event that lenses need to be replaced due to damage/defects before the next scheduled 
visit, only the damaged/defective lenses will be replaced. A log of lens replacement will be 
recorded by the site (CCLR). 
7.4.6 DISPOSAL OF CONSUMABLES 
This study provides consumables (lenses) to participants for use during the study. Participants will 
be instructed to dispose of worn lenses (both test and control lenses) daily, but retain the foils of 
all used lens packs and return them at their next study visit. Lenses worn for the scheduled visits 
will be collected from the participants and they may be either returned to the Sponsor or disposed, 
as detailed in the implementation protocol. Lenses with product observations (e.g. moderate lens 
deposits), product defects, or product quality complaints will be collected and returned to 
CooperVision at the completion of the study. All unworn lenses will be collected from each study 
participant. Any extra lenses not used in the study will be returned to CooperVision.  
7.4.7 MASKING AND CONTROL OF STUDY MATERIALS 
The contact lenses coding will be masked to both the investigator and participant.  If standard 
labelling does not sufficiently mask the study material then over labelling will be performed. However 

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017                                                                          15 
 
the safety information on the outer package label of the contact lens will not be covered and shall 
be clearly visible. 
7.4.8 ORDERING AND ACCOUNTABILITY OF STUDY MATERIALS 
Both the Invigor IA (test) and the Invigor IB study lenses will be provided by the Sponsor.  
The investigator must complete an accurate accounting of the study product at the completion of 
the study. A detailed inventory must be completed for study supplies. All unused and used 
materials will be returned to the Sponsor at the end of the study unless the investigator is 
otherwise directed by the study Sponsor.   
7.5 VISIT SCHEDULE AND PROCEDURES 
Prior to lens insertion, biomicroscopy (including corneal and conjunctival staining) will be 
completed at the screening assessment. When possible, the screening will be combined with the 
baseline assessment.  
The contact lenses will be provided to participants by a research assistant / study coordinator / 
technician or the investigator (lenses will be provided to the investigator without unmasking the 
investigator). 
The investigator should confirm with the participant that they are able to attend the follow-up visits 
within the visit window before enrolling them in the study.  
It is anticipated that this study will involve 3 scheduled visits:  
o Visit 1: Enrollment/ Screening/ Baseline/ Fitting/ Dispensing of lens pair #1 (either test or 
control lens); 
o Visit 2: 1-week follow-up assessment of lens pair #1, & dispense of lens pair #2 (either 
test or control lens), 6-10 days after dispense of lens pair #1; 
o Visit 3: 1-week follow-up assessment of lens pair #2, 6-10 days after lens pair #2 
dispense and exit. 
Visits that fall outside of the specified visit windows may be considered as unscheduled visits.  
The Invigor IA (test) lenses will be worn for one week (6-10 days) and the Invigor IB (control) 
lenses will be worn for one week (6-10 days). Lens assessment visits will occur with each pair of 
lenses with options as described in Table 2.  
At the completion of the one week period of wear with the first pair of lenses there will be a break 
of 10 minutes, followed by a dispense and assessment of the second pair of lenses. At the 
completion of the last visit, participants will exit the study. 

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017                                                                          17 
 
• 
The investigator will confirm that the patient meets the criteria set out in the inclusion 
criteria, and none of the exclusion criteria and is eligible to continue in the study. 
• 
The participant will be assigned a randomization ID and the first pair of contact lenses 
(either test or control) will be selected according to the randomization table. 
• 
Contact lens power and fit may be evaluated at the screening visit or at the baseline visit.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
The contact lenses will be dispensed by a research assistant / study coordinator / 
technician (in a manner which does not unmask the participant and investigator).  
• 
The lenses will be inserted by the participant from the blister pack as described in Section 
7.4.3 of the Protocol. 
• 
The contact lenses will be fitted and allowed to settle (Appendix 3). 
• 
Initial subjective ratings (Appendix 16) include:  
o Initial comfort (0-100 scale) and comments 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
o Vision quality / clarity (0-100 scale) and comments 
 
 
 
 
 
 
 
• 
The lens fit will be assessed for fit acceptance (acceptable or not acceptable) and absence 
of lens defects.  If the fit is acceptable and there are no defects, the participant will be 
allowed to sit for 10 minutes to allow for the lenses to settle.  
• 
Monocular over refraction will be done to determine if a different power is needed. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
• 
Change lens prescription to that noted by over-refraction, if needed. Repeat subjective 
ratings after lens settling. 

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017                                                                          18 
 
• 
Monocular and binocular logMAR visual acuity (4M) will be recorded with high contrast 
letters under high and low room illumination*. 
 
 
 
 
 
 
 
 
 
 
• 
Lens fitting assessment, according to the guidelines in Appendix 3.  
• 
Monocular lens surface and fit will then be assessed and graded according to the CVI 
grading scales (Appendix 5).  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
• 
The participant will be instructed to wear the study lenses for at least 8 hours, and 5 days 
per week. 
• 
Participants will be provided contact lenses for wear till the next scheduled visit. 

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017                                                                          19 
 
• 
At end of visit the participant will be reminded to return for the next scheduled visit of the 
first pair.  
7.5.2 VISIT 2: ASSESSMENT OF PAIR #1 AND DISPENSING PAIR #2 
This visit will occur 6-10 days after dispense of lens pair #1. 
Participants will be asked to wear lenses for at least two hours prior to the visit appointment. 
Participants who attend without wearing lenses for the specified period will be rescheduled. 
• 
The participant will be asked to score their subjective response as detailed in CVI Grading 
scales (Appendix 18D). 
• 
The following will be recorded at the one week visit. 
o Hours of lens wear prior to the appointment  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
o Binocular comfort at insertion, during the day, end of the day, during the last week 
o Overall comfort (0-100 scale), during the last week  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
o Binocular vision quality / clarity of vision during the last week (0-100 scale) 
o Binocular vision quality / clarity of vision at night during the last week if applicable 
(0-100 scale) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
o Comments by participants 
• 
Unscheduled lens replacements (Y/N) OD and / or OS 
• 
Monocular and binocular logMAR visual acuity (4M) will be recorded with high contrast 
letters under high and low room illumination. 
• 
Monocular lens surface and fit will then be assessed and graded according to the CVI 
grading scales. 
 
 
 
 

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017                                                                          20 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
• 
The lenses will be removed and retained in the CCLR (see Section 7.4.6 for disposing 
consumables). 
• 
Slit lamp biomicroscopy will be assessed according to the approved study biomicroscopy 
CRF (Appendix 4). 
• 
There will be a break before insertion of pair 2 (of 10 minutes). 
• 
The same procedures will be followed for pair 2 as mentioned in section 7.5.1.  
• 
The contact lenses will be dispensed by a research assistant / study coordinator / 
technician (in a manner which does not unmask the participant and investigator).  
• 
The lenses will be inserted by the participant from the blister pack as described in Section 
7.4.3.  

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017                                                                          25 
 
9.2 PROCEDURES FOR ADVERSE EVENTS 
Treatment of an adverse event will depend on its nature and severity. Based on the clinical 
judgment of the investigator the participant may be 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 6) 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. 
9.3 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 the Principal Investigator and the sponsor within 24 
hours of the investigator becoming aware of the event. The Investigator will report the event to the 
IRB as per IRB requirements (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. 
Reporting/notification of all adverse events will be made to Clinical Operations, CooperVision 
 
 
 
 
  
 
 
 
 r 
 
 
 
 
 
 
 
 r 
 
 
 
 
 
 
 
 
  
  
            
 
 
 
 
 

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017                                                                          26 
 
9.4 DISCONTINUATION FROM THE STUDY  
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. 
Participants discontinued from a study will be reimbursed $20 per hour for their active involvement 
in the study (including the initial screening visit).  
• 
The 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 7.3. 
• 
Unacceptable performance with products to be used in study: Participants may be 
discontinued if they are unable to achieve acceptable comfort and /or vision and/ or fit 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. 

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017                                                                          29 
 
All participants who were evaluated will be used in the analysis. In the event of missing data, 
individual data points may be excluded in 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 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 the clinical 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.  
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 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. 
 
12.3 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 CCLR SOP014_v01. The Sponsor will 
be notified and consulted if ever the files are to be destroyed. Copies of all original raw data forms 
and completed CRF’s 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.  

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017                                                                          30 
 
 
12.4 DATA ENTRY / DATA MANAGEMENT 
Data will be entered into an electronic spreadsheet. 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 the 
investigator 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 relevant and applicable comments will be included in the final report as deemed 
necessary by the lead investigator.  
 
13 PROTOCOL TRAINING 
All delegated study personnel will be required to complete training prior to their involvement in the 
study. 
 
14 STUDY MONITORING 
Status reports will be provided to the study sponsor by email on a regular basis.  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
Sponsor monitoring visits may be conducted throughout the study and will be scheduled by the 
study sponsor in conjunction with the lead investigator. In addition study records may be inspected 
at the CCLR 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 CCLR. 
 

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15 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.  
Major protocol deviations may impact the research protocol, Informed Consent form 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 IRB: 
1. Changes in procedures initiated to eliminate immediate risks/hazards to participants; 
2. Enrolment of participants outside the protocol inclusion/exclusion criteria; 
3. 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; 
4. Informed Consent documentation violations: no documentation of informed consent; 
incorrect version of, or incomplete, informed consent documentation used. 
Minor protocol deviations are caused by or which originate with research participants and normally 
are not reported to the IRB unless these result in increased risk to the participants. The following 
are examples of protocol deviations that are considered minor and do not require reporting to the 
IRB: 
• 
Logistical or administrative aspects of the study (e.g., study participant missed appointment, 
change in appointment date or time); 
• 
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 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 patients or 
others must be reported to the IRB according to the site’s guidelines.  All protocol deviations (major 
and minor) occurring during the study will be documented and included in the final report and data 
safety monitoring report to the IRB. 
 

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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-house, 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 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.   
18.1 STUDY COMPLETION AND REMUNERATION 
At the last scheduled protocol visit a study completion form (Appendix 9) will be completed, which 
requires the signatures of both the participant and the investigator.  
Once their involvement in the study is complete, participants receive a Letter of Appreciation 
(Appendix 10). 
Participant remuneration will be up to $90 for completing the study. Full details are given in the 
relevant information and consent letter (Appendix 1). 
19 STUDY REPORT  
A report will be sent to the sponsor according to terms described in the study contract. 
 
 
 
 
 

SAGE Phase-BC1_CV-16-43_Protocol (Implementation) 20sep2017                                                                          33 
 
20 APPENDICES 
 
SAGE Appendix 1A ICL-dispensecrossover_31may2017 
SAGE Appendix 2 Advertisements 13jul2016 
SAGE Appendix 3 Screening and fitting form 02aug2016 
SAGE Appendix 4 Biomicroscopy form 03nov2016 
SAGE Appendix 5 Progress evaluation form 02aug2016 
SAGE Appendix 6 -CCLR Adverse Events form 13jan2016 
SAGE Appendix 7 Form106 ORE AE form 
SAGE Appendix 8 Discontinuation form 12jun2016 
SAGE Appendix 9 Study completion form 12jun2016 
SAGE Appendix 10 Letter of Appreciation 02aug2016 
SAGE Appendix 11A Email script (HTML) 31may2017 
SAGE Appendix 12 Study remuneration 12jun2016 
SAGE Appendix 14 Sample Randomization Tables 21jul2016 
SAGE Appendix 15 Emergency Wallet Card 12jun2016 
SAGE Appendix 16E Subjective ratings on lens insertion crossover phases 12jun2016 
SAGE Appendix 18D Subjective ratings at follow-up visits crossover phases 02aug2016 
SAGE Appendix 24 CVI Adverse Event Notification Form 27mar2015 
SAGE Appendix 25 CVI Adverse Event Outcome Form 27mar2015 
SAGE Appendix 26 Medical history form 07nov2014 
SAGE Appendix 27 Protocol Deviation Form 12jun2016 
SAGE Appendix 28 Product Observation Form 02aug2016 
SAGE Appendix 29 Study Exit Form 02aug2016