Clariti 1-Day Multifocal Study - 'Real World' Subjective Acceptance Study (HARP)
Phase: NA
Conditions: Presbyopia
Sponsor: CooperVision, Inc.

 
Centre for Ocular Research & Education (CORE), 
School of Optometry & Vision Science | University of Waterloo, 200 University Avenue West | Waterloo, ON, Canada N2L 3G1 
+1 (519) 888-4742 | CORE.uwaterloo.ca 
Protocol 
CLARITI 1-DAY MULTIFOCAL STUDY – 
‘REAL WORLD’ SUBJECTIVE 
ACCEPTANCE STUDY (HARP) 
 
This protocol remains the exclusive property of CORE until it is commissioned by the sponsors. 
 
Reviewed and approved (sign) 
Date 
DD/MMM/YYYY 
 
 
 
  
 
 
 
 
  
 
 
 
 
  
 
 
 
 
  
 
 
 
  
 
Sponsor Company 
CooperVision, Inc. 
Sponsor Study number: 
EX-MKTG-81 
 
 
 
 
 
 
 
 
 
 
 
 
Document Type: 
Study protocol 
Core Clinical Site: 
1) CORE, University of Waterloo 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of contents 
1 
Introduction ........................................................................................................................ 10 
2 
Objectives .......................................................................................................................... 10 
3 
Hypothesis ......................................................................................................................... 11 
4 
Materials and methods ...................................................................................................... 11 
4.1 
Study design ............................................................................................................ 11 
 
Overall design and study visits ............................................................................. 11 
 
Masking................................................................................................................ 13 
5 
Study population ................................................................................................................ 13 
 
Number of participants ......................................................................................... 13 
 
Inclusion and exclusion criteria ............................................................................. 13 
 
Repeated screenings ........................................................................................... 15 
5.2 
Study materials ........................................................................................................ 15 
 
Lenses ................................................................................................................. 15 
 
Rewetting drops ................................................................................................... 15 
 
Contact lens dispensing ....................................................................................... 16 
 
Ordering consumables ......................................................................................... 16 
 
Disposing of consumables ................................................................................... 16 
 
Product accountability .......................................................................................... 16 
5.3 
Scheduled and unscheduled visits ........................................................................... 16 
 
Scheduled visits ................................................................................................... 16 
 
Unscheduled visits ............................................................................................... 17 
 
Study visit codes .................................................................................................. 17 
 
Screening & evaluation of habitual contact lenses, Visit 1 .................................... 18 
 
Fit and dispense, and evaluation of test lens, Visit 2 ............................................ 19 
 
Review of lens powers & Dispense revised lens powers if needed, Visit 3 ........... 21 
 
Follow-up assessment of test lens, Visit 4 ............................................................ 22 

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Unscheduled visits ............................................................................................... 24 
5.4 
Summary of Study procedures ................................................................................. 24 
5.5 
Recording Findings of Interest ................................................................................ 25 
6 
Monitoring protocol adherence .......................................................................................... 26 
7 
Potential Risks and Benefits to Human participants ........................................................... 26 
8 
Adverse events .................................................................................................................. 27 
8.1 
Normal or adaptive symptoms ................................................................................. 29 
8.2 
Procedures for Adverse Events ............................................................................... 29 
8.3 
Reporting Adverse Events ....................................................................................... 29 
9 
Discontinuation from the study ........................................................................................... 30 
10 
Device Malfunctions ........................................................................................................... 31 
11 
Study completion and remuneration .................................................................................. 31 
12 
Statistical analysis and data management ......................................................................... 32 
12.1 
Sample size calculation ........................................................................................... 32 
12.2 
Statistical analysis ................................................................................................... 32 
12.3 
Data management ................................................................................................... 33 
12.4 
Comments on source documents ............................................................................ 34 
13 
Protocol training ................................................................................................................. 34 
14 
Study monitoring ................................................................................................................ 34 
15 
Study management............................................................................................................ 34 
15.1 
Statement of compliance ......................................................................................... 34 
15.2 
Ethics review ........................................................................................................... 35 
15.3 
Protocol deviations .................................................................................................. 35 
 
Major protocol deviations ..................................................................................... 35 
 
Minor protocol deviations ..................................................................................... 35 
 
Reporting and documenting protcol deviations ..................................................... 36 
15.4 
Premature termination of the study .......................................................................... 36 

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15.5 
Study participant records ......................................................................................... 36 
15.6 
Retention of study records and data ........................................................................ 36 
16 
Report................................................................................................................................ 36 
17 
Appendices ........................................................................................................................ 37 
 
 
 

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 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 in a 
regulatory submission. 
 
 
 

Protocol: CLARITI 1-DAY MULTIFOCAL STUDY – ‘REAL WORLD’ SUBJECTIVE ACCEPTANCE STUDY v4.0 04jun2018 
 
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1 
INTRODUCTION 
The average American spends approximately 87% of their time indoor (Journal of Exposure 
Analysis and Environmental Epidemiology (2001) 11, 231-252). As the use of digital devices 
increases in daily routine, both near and intermediate vision play an increasing role in our daily 
vision requirements.  
CooperVision’s, clariti 1 day multifocal has a design with a center near, surrounded by two 
staggered power intermediate zones and then a distance focus towards the lens periphery. The 
optical design that encompasses two staggered power intermediate zones is unique to clariti 1 day 
multifocal and is not shared by other one day multifocal lenses in the marketplace.  A study to 
explore the acceptance of this lens design is of particular interest to gather data to support the 
changing vision requirements of today’s lifestyle where majority of our time is spent indoor and in 
particular where near and intermediate vision quality plays an important role in people’s satisfaction 
with their multifocal lenses.   
2 
OBJECTIVES 
The objective of the study is to evaluate the performance of clariti 1 day multifocal when worn on a 
daily disposable wear modality over a period of up to 3 weeks.  
Primary outcome variable: The primary outcome variable is Vision clarity during the day – distance 
vision.  
The primary outcome variable, and other secondary outcome variables will be collected at the 
screening visit for habitual contact lenses, and at the final visit for the study contact lens i.e. clariti 1 
day multifocal. The secondary outcome variables include: 
• 
Vision clarity and vision satisfaction (subjective ratings) for the following tasks at various 
distances: 
o Driving at night – distance vision 
o TV viewing - distance vision 
o Desktop computer – long intermediate  vision 
o Laptop/tablet –short intermediate vision 
o Reading on cell phone – near vision 
o Reading hand-held printed materials– near vision 
• 
Comfort (subjective ratings) 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 

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• 
Visual acuity (logMAR) 
• 
Lens centration and mobility 
• 
Bulbar and conjunctival redness 
• 
Corneal and conjunctival staining 
• 
Satisfaction with lens package and lens handling (subjective ratings) 
• 
Satisfaction with visual demand tasks with speed of changing focus.  
• 
Subjective preference between study and habitual contact lenses for a range of 
requirements and tasks.  
• 
Subjective preference between study and habitual contact lenses to lifestyle related 
questions.  
3 
HYPOTHESIS 
The study hypothesis is that the clariti 1-day multifocal will perform as well or better clinically than 
the habitual multifocal lenses.  
4 
MATERIALS AND METHODS 
4.1 STUDY DESIGN 
 
OVERALL DESIGN AND STUDY VISITS 
The study is a prospective bilateral wear, participant masked, dispensing study evaluating, among 
other things, vision clarity, vision satisfaction and comfort with clariti 1-day multifocal (i.e. test lens) 
for tasks performed indoors and outdoors, and for vision activities related to distance (≥3 m), long-
intermediate (1-2 m approx), short-intermediate (0.5-1 m approx), and near vision (30 - 50 cms). 
Each participant who is a habitual multifocal lens wearer will be refit into the clariti 1-day multifocal 
lens. They will use subjective ratings to report their satisfaction with their habitual contact lenses 
and with clariti 1-day multifocal lens. It is anticipated that this study will involve up to 4 scheduled 
visits: 
Visit 1 (1.5 hrs): Screening - includes consent, screening and evaluation of satisfaction with 
habitual contact lenses.  
Visit 2 (1.5 hrs): Baseline - Fit and dispense test lens, assessments of test lens at dispense, and 
subjective ratings with test lens.  
Visit 3 (1.5 hrs) Day 3 - 10 after visit 2:  
• 
Part A: Review prescription of study lenses, and subjective ratings;  

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A person is eligible for inclusion in the study if he/she: 
1. Is at least 17 years of age 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. Has had a self-reported oculo-visual examination in the last two years. 
5. Currently wears multifocal soft contact lenses, and have worn multifocal contact lenses 
for at least one month; 
6. Presently wears lenses for minimum wear 4 days/week and 10 hours/day 
7. Participant has an anticipated ability to wear test lenses for minimum 5 days/week and 
10 hours/day.  
8. Can be fit with the available test contact lens power range to achieve satisfactory vision 
i.e. 0.18 logMar (20/30) binocular distance acuity with the test lenses.  
9. Current refraction indicates a reading addition of +1.50 or higher 
10. Uses a digital device (computer/laptop/tablet etc.) for at least 5hrs/day 
11. Spends 10hrs or more indoors at least 5 days/week 
12. Possesses a smartphone and is willing to download the MetricWire app to receive and 
respond to surveys 
A person will be excluded from the study if he/she: 
1. Is presently wearing Clariti 1 day multifocal lenses 
2. Has astigmatism greater than -0.75 DCyl as determined with subjective refraction 
3. Is participating in any concurrent clinical or research study; 
4. Has any known active* ocular disease and/or infection; 
5. Has a systemic condition that in the opinion of the investigator may affect a study 
outcome variable; 
6. Is using any systemic or topical medications that in the opinion of the investigator may 
affect a study outcome variable;  
7. Has known sensitivity to fluorescein dye or products to be used in the study; 
8. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal 
confirmation at the screening visit); 
9. Is aphakic; 
10. Has undergone refractive error surgery; 
11. Is an employee of CORE or external clinical site. 
* 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 

Protocol: CLARITI 1-DAY MULTIFOCAL STUDY – ‘REAL WORLD’ SUBJECTIVE ACCEPTANCE STUDY v4.0 04jun2018 
 
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recorded at the follow-up visit.  In the event of an adverse event, rewetting drops may be given to 
participants.  
 
CONTACT LENS DISPENSING 
The lenses will be provided to the participant after being transferred, complete with blister pack 
solution, to a contact lens cup; this will maintain participant masking. The use of saline for rinsing 
the contact lens prior to insertion is permitted if necessary. Saline will not be dispensed during the 
study.  
 
ORDERING CONSUMABLES 
The clariti 1 day multifocal lenses will be supplied by the sponsor. If they have difficulty sourcing 
product in good time then lenses may instead be purchased by CORE through a commercial route. 
If necessary, the lenses may be shipped between sites.  
The investigators/clinical sites must maintain an accurate accounting of the study product during 
the study. A detailed inventory must be completed for study supplies at each clinical site.  
 
DISPOSING OF CONSUMABLES 
This study provides consumables (lenses) to participants for use during the study. Participants will 
be instructed to dispose of worn lenses daily, but retain the foils of all used lens packs and return 
them together with any unworn lenses, at their next study visit. Lenses worn for the scheduled 
visits will be collected from the participants. Worn lenses and unworn lenses collected at the 
external clinical site will be returned to COREat the end of the study, where they will be disposed of 
according to UW guidelines. Worn lenses associated with adverse events may be retained either at 
CORE or returned to CooperVision. Typical analysis in these cases relates to inspection for 
damage and/ or bacterial contamination. Upon completion of the study, all worn lenses will be 
destroyed, unless otherwise directed by the study Sponsor. 
 
PRODUCT ACCOUNTABILITY 
Accountability logs will be kept to include the number of lenses and lens care system bottles 
received, dispensed, unused and returned to sponsor (where relevant). All products dispensed to 
participants will be recorded in the study binder. 
5.3 SCHEDULED AND UNSCHEDULED VISITS 
 
SCHEDULED VISITS 
This study has a total of 4 scheduled visits, including:  

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Visit 4 
V4 
Follow-up assessment of test lens and Study exit 
 
 
SCREENING & EVALUATION OF HABITUAL CONTACT LENSES, VISIT 1 
All participants who sign the informed consent letter will be assigned a study ID number.The 
investigator will determine participant eligibility using the inclusion and exclusion criteria. Ineligible 
participants will be discontinued from the study. The procedures to be performed are outlined 
below: 
• 
The participant is expected to attend the screening visit wearing their habitual contact lens 
products. 
• 
The participant will be required to read and sign an Informed Consent Form prior to 
enrollment. When the participant has signed the consent form, the participant will be 
considered to be enrolled in to the study (and ID # is assigned). 
• 
Participant demographics and medical history (age, sex, medical conditions, medications, 
allergies) obtained. 
• 
Contact lens history (own lens information, and wear time) 
• 
Use of digital devices and distance of device when in regular use (information request to be 
sent ahead of visit so that participant can measure) 
• 
The participant will score their subjective responses (on 3-point Likert scale) for the habitual 
lens by reflecting on a typical day, and rate the following: 
o Subjective ratings of vision quality/clarity, for different everyday-life tasks performed 
at various distances such as: 
▪ 
Driving, at day & after sunset  
▪ 
TV viewing  
▪ 
Desk computer  viewing  
▪ 
Laptop/tablet viewing  
▪ 
Reading on cell phone  
▪ 
Reading printed materials  
o Overall comfort, 
 
 
 with habitual lens (typical day experience)  
o Subjective satisfaction with lens handling (ease of insertion and removal) with 
habitual lens  
o Subjective satisfaction with changing focus speeds for in-office tasks with habitual 
lens  
• 
Measure habitual reading distance for printed material and for smartphone 
• 
Habitual lens high contrast visual acuity (logMAR) with high room illumination:  

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o distance; right eye, left eye & binocular  
o distance (binocular) 
 
 
 
 
o near; right eye, left eye & binocular 
 
 
• 
Assessment of habitual lens fit.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
o Lens centration (optimal; acceptable decentration; unacceptable decentration)  
o Corneal & Limbal coverage in primary gaze (Yes or No) 
o Post-blink lens movement in primary gaze (0-4, 1 steps) 
 
  
 
 
 
  
 
• 
The lenses will be removed 
• 
Slit lamp biomicroscopy will be assessed according to the CVI approved study 
biomicroscopy CRF (Appendix 7). 
 
 
 
 
 
• 
 
 
, monocular & binocular distance and near visual acuity 
(high contrast) (logMAR) 
• 
Best corrected high contrast high illumination VA (distance and near) 
 
 
 
 
 
• 
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.  
 
 
FIT AND DISPENSE, AND EVALUATION OF TEST LENS, VISIT 2 
Lenses will be provided to participants in a manner which does not unmask the participant, as 
described in Section 5.2.3.  
The test lens will be fit following the manufacturer’s guidelines. The following procedures will be 
performed following: 
• 
Baseline high contrast visual acuity (logMAR) with high room illumination:  
o distance;  right eye, left eye & binocular  
o distance (binocular) 
 
 
 
o near; right eye, left eye & binocular 
 
 
• 
Assessment of test lens fit.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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o Lens centration (optimal; acceptable decentration; unacceptable decentration)  
o Corneal & Limbal coverage in primary gaze (Yes or No) 
o Post-blink lens movement in primary gaze (0-4, 1 steps) 
 
  
 
 
 
  
 
• 
The participant will download the 
 
 on their phone for completing subjective 
questionnaires starting the morning after the dispensing visit, to reflect their lens wear 
experience at the time of rating (in real-time). Participants will be given careful explanation 
of how and when to complete them.  
• 
Subjective ratings  
 
 
 are completed on next day 
 
 
 
 
 
 
 
 
 and just before lens removal. 
 
 
 
 
 
 
 
 
 The time of lens insertion will be recorded. Subjective 
ratings include: 
o Comfort  
 
  
o Visual clarity  
o Overall satisfaction  
• 
Vision clarity/quality  for the following tasks at various distances: 
o Driving, at day & after sunset  
o TV viewing  
o Desk computer  viewing  
o Laptop/tablet viewing  
o Reading on cell phone  
o Reading printed materials  
o Subjective satisfaction with changing focus distance 
• 
On day 1 after V2 (i.e. day after the dispensing visit) the participant will be asked to complete 
various subjective ratings (Appendix 6) 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 The time of 
lens insertion and removal will be recorded. The participant will also submit the following 
through the 
 
 
o Hours spent on desktop computer 
 
  
 
 
 
 
o Hours spent on laptop or tablet computer 
 
  
 
 
 
 
o Hours spent reading smart phone 
 
  
 
 
 
 
o Hours spent reading written material 
 
  
 
 
 
 
o Any unusual symptoms with the contact lenses (No, Yes; if yes details) 

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The participant will be asked to wear the study lenses for at least 10 hours per day and 5 days 
per week. 
Participant will be provided with sufficient contact lens supply.  
The participant will be discharged and reminded to return for Visit 3 (Follow-up visit of test lens) 
and to bring back all lens package foils. 
 
REVIEW OF LENS POWERS & DISPENSE REVISED LENS POWERS IF 
NEEDED, VISIT 3 
The review assessment of the lens power dispensed at visit 2, will occur between day 3 and day 
10. The following variables will be measured with the first test lens power (Appendix 3B). 
 VISIT 3 – PART A 
The participant will score their subjective responses (on 3-point Likert scale) for the test lens by 
reflecting on a typical day during the previous days of lens wear, and rate the following (Appendix 
4): 
• 
Subjective ratings of vision clarity, for different everyday-life tasks performed at various 
distances such as: 
o Driving, at day & after sunset  
o TV viewing  
o Desk computer  viewing  
o Laptop/tablet viewing  
o Reading on cell phone  
o Reading printed materials  
• 
Overall comfort  
 
 
 with test lens (typical day experience)  
• 
Subjective satisfaction with lens handling (ease of insertion and removal) with test lens  
• 
Subjective satisfaction with changing focus speeds for in-office tasks with test lens  
• 
Wearing time on visit day will be recorded 
• 
Baseline high contrast visual acuity (logMAR) with high room illumination:  
o distance;  right eye, left eye & binocular  
o distance (binocular) 
 
 
 
o near; right eye, left eye & binocular 
 
  
If visual acuity is optimal, a lens change is not necessary.  

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• 
The participant will be asked to wear the study lenses for at least 10 hours per day and 5 days 
per week. 
• 
Participant will be provided with sufficient contact lens supply.  
• 
The participant will be discharged and reminded to return for Visit 4 (Follow-up visit of test lens) 
and to bring back all worn lens package foils and any remaining unworn lenses. 
 VISIT 3 – PART B 
If lens change is deemed necessary during Visit 3- Part A, then the new power lenses will be 
dispensed. If the revised power lenses are to be ordered, this visit will be scheduled on a different 
date. 
The following will be recorded after allowing the lens to settle: 
• 
Subjective ratings on lens insertion (Appendix 5).  
• 
Baseline high contrast visual acuity (logMAR) with high room illumination (Appendix 3):  
o distance;  right eye, left eye & binocular  
o distance (binocular) 
 
 
 
o near; right eye, left eye & binocular 
 
 
• 
Assessment of test lens fit (Appendix 3b): 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
o Lens centration (optimal; acceptable decentration; unacceptable decentration)  
o Corneal & Limbal coverage in primary gaze (Yes or No) 
o Post-blink lens movement in primary gaze 
  
 
 
  
 
 
 
  
 
• 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 The time of lens insertion and removal will be 
recorded. Participant will be provided with sufficient contact lens supply.  
• 
The participant will be discharged and reminded to return for Visit 4 (Follow-up visit of test 
lens) and to bring back all lens package foils. 
 
FOLLOW-UP ASSESSMENT OF TEST LENS, VISIT 4 
 

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The follow-up visit of test lens will occur between day 9-14 after Visit 3. The following procedures 
will be performed: 
The participant will score their subjective responses (on 3-point Likert scale) for the test lens by 
reflecting on a typical day during the previous 9 - 14 days of lens wear, and rate the following: 
• 
Subjective ratings of vision clarity, for different everyday-life tasks performed at various 
distances such as: 
o Driving, at day & after sunset  
o TV viewing  
o Desk computer  viewing  
o Laptop/tablet viewing  
o Reading on cell phone  
o Reading printed materials  
• 
Overall comfort, 
 
 
 with test lens (typical day experience)  
• 
Subjective satisfaction with lens handling (ease of insertion and removal) with test lens  
• 
Subjective satisfaction with changing focus speeds for in-office tasks with test lens  
• 
Subjective preference between study and habitual CLs for a range of requirements and tasks. 
These include: 
o Overall comfort preference 
o Visual clarity preference  
o Overall lens preference 
• 
Life-style related questions will be completed by the participants.  
Other variables collected include: 
• 
Wearing time on visit day 
• 
Baseline high contrast visual acuity (logMAR) with high room illumination:  
o distance;  right eye, left eye & binocular  
o distance (binocular) 
 
 
 
o near; right eye, left eye & binocular 
 
  
• 
Assessment of test lens fit.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
o Lens centration (optimal; acceptable decentration; unacceptable decentration)  
o Corneal & Limbal coverage in primary gaze (Yes or No) 

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o Post-blink lens movement in primary gaze 
  
 
 
  
 
 
 
  
 
• 
The lenses will be removed 
• 
Slit lamp biomicroscopy will be assessed according to the CVI approved study biomicroscopy 
CRF (Appendix 7). 
• 
Exit visual acuity will be performed.  
• 
Participants will be expected to uninstall the MetricWire app from their phone at the final exit 
visit. 
• 
The study exit form will be completed when a participant exits the study. This will occur either 
at study completion, or if the participant is discontinued from the study at another time. A study 
exit form must be completed for all participants who have taken a study ID number. If in the 
opinion of the investigator post-study follow-up visits are required, the exit form will be 
completed after the last follow-up visit.  
• 
The participant will be discharged and will sign the study completion forms and receive 
remuneration for participating in the study. 
 
UNSCHEDULED VISITS 
An unscheduled visit is defined as an interim visit requested by the participant or investigator due 
to an unanticipated problem. Data recorded at these visits will be entered into the database. Only 
relevant and applicable unscheduled visit information will be included in the final report as deemed 
necessary by the lead investigator.  
 
5.4 SUMMARY OF STUDY PROCEDURES 
Table 4 summarizes the visits and procedures for the study. 
Table 4: Summary of procedures to be conducted at scheduled visits 
 
 
Visit 1 
Screening & 
evaluation of 
habitual contact 
lenses 
 
Visit 2 
Fitting & 
evaluation of test 
lens 
 
Visit 3a 
Review 
assessment of test 
lens power and 
Visit 3b 
dispense of revised 
lens powers if 
needed 
Visit 4 
Follow-up visit of 
test lens 
Informed consent (screening) 
√ 
 
 
 
Confirmation of 
inclusion/exclusion criteria 
√ 
 
 
 
Ocular & medical history  
√ 
 
 
 

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Visit 1 
Screening & 
evaluation of 
habitual contact 
lenses 
 
Visit 2 
Fitting & 
evaluation of test 
lens 
 
Visit 3a 
Review 
assessment of test 
lens power and 
Visit 3b 
dispense of revised 
lens powers if 
needed 
Visit 4 
Follow-up visit of 
test lens 
Demographics 
√ 
 
 
 
VA with study lenses / and 
refraction 
√ 
√ 
√ 
 
Auto-refraction & keratometry 
√ 
 
 
 
Sphero-cylindrical refraction 
√ 
 
√ 
 
Best corrected (sphero-cyl) VA 
monocular and binocular 
(distance and near) 
√ 
 
 
 
Biomicroscopy 
√ 
√ 
√ 
√ 
Trial fitting of study lenses 
(if applicable) 
 
√ 
√ 
 
Wearing time on visit day 
and rating day 
 
 
√ 
√ 
Symptoms & problems 
enquiry 
√ 
√ 
√ 
√ 
Dispense new lenses (if 
applicable) 
 
√ 
√ 
 
Participant ratings 
completed 
√ 
√ 
√ 
√ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Lens fit assessments 
√ 
√ 
√ 
√ 
 
 
 
 
 
 
 
VA with contact lenses 
√ 
√ 
√ 
√ 
Assessment of adverse events 
(if applicable) 
√ 
√ 
√  
√ 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
Return questionnaires (if 
applicable) 
 
 
 
√ 
Exit Study 
 
 
 
√ 
 
5.5 RECORDING FINDINGS OF INTEREST 
The following variables may be recorded using a digital slit lamp system (video and still images): 
• 
Lens fits not considered to be clinically acceptable or associated with symptoms 

Protocol: CLARITI 1-DAY MULTIFOCAL STUDY – ‘REAL WORLD’ SUBJECTIVE ACCEPTANCE STUDY v4.0 04jun2018 
 
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• 
Relevant corneal and conjunctival staining 
 
Abnormalities of lens performance (e.g. poor fit) 
 
 
 
 
 
 
 
 
• 
Additional videos (e.g. 
 
 
 
 
 
 
 lens 
movement, etc.) may also be recorded in order to better understand on-eye lens 
performance and to help communicate this information to the sponsor. 
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 internally by the investigators. Deviations 
from the windows described in the protocol will be reported in the weekly progress reports and the 
final study report.  
7 
POTENTIAL RISKS AND BENEFITS TO HUMAN PARTICIPANTS 
This is a minimal risk study because of the use of marketed products and standard optometric 
assessments. 
Contact lenses in this study will be worn on a daily disposable wear basis. Adverse events and/ or 
complications in daily disposable wear of soft contact lenses can occur (eg: inflammation and 
infection). 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.  
The most common adverse events to contact lens wear are infiltrates (small lesions in the cornea -- 
or the clear portion of the front of the eye, resulting from inflammation). Over a period of one year, 
infiltrates occur in one to two people per population of 100 who wear soft contact lenses on a daily 
basis, and in four to eight people per population of 100 who wear soft contact lenses on an 
extended wear basis. Participants may also experience an allergic reaction to the sodium 
fluorescein dye used to evaluate the ocular surface.  
In rare instances more serious complications may occur, including corneal ulcers (a sight 
threatening eye infection) which can result in corneal scarring, temporarily or permanently 
decreased vision and in some cases blindness. Infections relating to contact lens wear occur in 
approximately four people in a population of 10,000 who wear soft lenses on a daily wear basis 
and in approximately two people in a population of 1,000 who wear soft contact lenses on an 
extended wear basis. All risk values listed in the above paragraph relate to annual risk.  

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22 
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; ORE 
reporting as per 
requirements 
23 
Asymptomatic corneal infiltrative events 
24 
Any sign and/or symptom for which temporary lens discontinuation for > 1 day 
is recommended (if not already classified) 
20 
Other sign and/or symptom warranting classification as a non-significant 
adverse event 
 
8.1 NORMAL OR ADAPTIVE SYMPTOMS 
Transient symptoms such as end-of-day dryness, lens awareness, itching or burning or other 
discomfort may occur with contact lens wear and may occasionally reduce wearing time. These 
transient symptoms and symptoms of temporary discomfort associated with the study procedures 
(mentioned in Section 7) are not reported as adverse events unless in the investigator’s opinion 
they are unexpected in nature, severe or have a high rate of occurrence.  
8.2 PROCEDURES FOR ADVERSE EVENTS 
Treatment of an adverse event will depend on its nature and severity. Based on the clinical 
judgment of the investigator the participant may be referred to an appropriate health care 
professional 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 18) 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 the Principal Investigator and the sponsor within 24 
hours of the investigator becoming aware of the event. The Investigator will report Serious Adverse 
Events to the ORE within 24 hours of the investigator becoming aware of the event and as per 

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30 
ORE requirements (by fax, mail/delivery, phone, or email). All fatal or life threatening events will be 
reported immediately to the ORE. 
Significant and Non-Significant Adverse Events will be reported to the sponsor as soon as 
possible, but no later than 5 working days after the occurrence. The Investigator will report the 
event to the ORE as per ORE requirements (by fax, mail/delivery, phone, or email). 
 
 
 
  
  
 
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
 
  
 
 
 
9 
DISCONTINUATION FROM THE STUDY 
Participants discontinued from a study will be reimbursed $20 per hour for their active involvement 
in the study (including the initial screening visit).  Participants may be discontinued at the discretion 
of the investigator or sponsor in consideration of their safety or their compliance with study 
instructions, or by the participant themself. 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 5.1.2. 
• 
Unacceptable performance with products to be used in study: Participants may be 
discontinued if they are unable to achieve acceptable comfort and /or vision with the study 
products. 
• 
Positive slit lamp finding:  Participants may be permanently discontinued from the study 
depending on the severity of the condition and on the judgement of the investigator.   
• 
Adverse event: If a participant experiences an adverse event during the study they may be 
discontinued based on the clinical judgement of the investigator. 
• 
Symptoms: If the participant has persistent symptoms they may be discontinued based on 
the clinical judgement of the investigator. 
• 
Disinterest, relocation or illness: The participant may choose to discontinue due to reasons 
within or beyond their control. 
• 
Violation of protocol or non-compliance:  The participant will be discontinued if they are 
unable or unwilling to follow the protocol specified visit schedules and/or study procedures. 

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• 
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. 
• 
Premature termination of the study by the sponsor, CORE or the Office of Research Ethics 
at the University of Waterloo. 
A discontinuation form (Appendix 12) will be completed stating the reason for discontinuation, 
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.   
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 the Principal Investigator and the sponsor within 24 hours of 
the investigator becoming aware of the malfunction. The ORE would also be notified within 24 
hours of any device malfunction that may contribute to a Serious Adverse Event. 
Other defective lenses should be reported to the Sponsor as soon as possible (usually in weekly 
study updates to the Sponsor). 
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 (Appendix 21) will be completed, which 
requires the signatures of both the participant and the investigator.  The participants will also be 
provided with a letter of appreciation (Appendix 22).    

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redness, corneal and 
conjunctival staining 
Effect of treatment on outcome variable within 
subjects (comparison between study days) 
RMANOVA  
Paired t-test 
     * For non-parametric data only 
The critical alpha level for statistical significance will be set at p  0.05, with no adjustments for 
multiple comparisons. 
All participants who were evaluated 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. 
12.3 DATA MANAGEMENT 
Data will be entered on paper CRFs or in MetricWire app. The clinical investigators will be 
responsible for data integrity and the completeness of data entry for each visit. Investigators at 
both sites will make an attempt to provide the CORE data team with the completed CRFs within 
ONE BUSINESS DAY of the visit date. For the external site the CRFs will be scanned and emailed 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
  
 
 
 
 
 
 
  
 
 
  
 
CORE personnel will review all CRFs for integrity and completeness and communicate data 
queries back to the investigator as necessary. Investigators should make an attempt to answer all 
data queries within TWO business days of receipt.  
After the study is closed, the external site will send the original CRFs and other study documents 
and products as requested to CORE. 
Data from this study will be retained by CORE for a minimum of 25 years on a password-protected 
server. After 25 years, data will be disposed of in accordance with the guidelines laid out by the 
University of Waterloo.  
At the completion of the study CORE will provide a copy of the study data to the sponsor when 
requested. Data will typically be sent using a secure file share system operated by the University of 
Waterloo called Sendit which uses 128bit (or 256bit) SSL encryption.  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.  

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12.4 COMMENTS ON SOURCE DOCUMENTS 
Data analysis will not be conducted on comments which have been recorded in the source 
documents. Only highlighted comments will be entered into the study database. Only relevant and 
applicable comments will be included in the final report as deemed necessary by the lead 
investigator.  
13 PROTOCOL TRAINING 
All study personnel will be required to complete training prior to their involvement in the study. 
Records of training will be kept at CORE. 
14 STUDY MONITORING 
Status reports will be provided to the study sponsor by email on a regular basis.  
Status reports will include: 
• 
The number of participants screened, enrolled, and randomized (i.e. assigned a study ID 
number), discontinued and completed. 
• 
Details of protocol deviations. 
• 
Reports of unintended events. 
Study 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 
CORE and the external site by the sponsor, the sponsor's designate, the Office of Research Ethics 
at the University of Waterloo, and by regulatory authorities in Canada and the United States, 
namely Health Canada and the United States Food and Drug Administration (FDA); however, no 
records containing identifiable/personal information will be permitted to leave the custody of CORE. 
 
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. 

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• 
Declaration of Helsinki 
• 
ICH E6 - International Conference on Harmonisation; Good Clinical Practice 
• 
http://iris.uwaterloo.ca/ethics/human/guidelines/index.htm 
• 
http://iris.uwaterloo.ca/ethics/human/ethicsReview/UWStatement.htm 
• 
http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/ 
 
15.2 ETHICS REVIEW 
This protocol will be submitted to and reviewed through the Office of Research Ethics (ORE) at the 
University of Waterloo. Notification of ethics clearance of the application is required prior to the 
commencement of the study. 
15.3 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 
Major protocol deviations may impact the research protocol, information consent document or other 
study materials, usually cannot be anticipated ahead of time and are often necessary to ensure the 
safety and welfare of the participants. 
The following are examples of protocol deviations that must be reported to the ORE: 
• 
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. 
 
MINOR PROTOCOL DEVIATIONS 
Protocol deviations caused by or which originate with research participants are considered minor, 
and normally are not reported to the ORE 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: 

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• 
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).  
 
REPORTING AND DOCUMENTING PROTCOL DEVIATIONS 
Major protocol deviations must be reported to the ORE within 7 days of the deviation occurring (or 
its discovery) using the Protocol Deviation Report Form 107 (PDRF).  Information from the PDRF is 
provided to the Clinical Research Ethics Committee (CREC) at the next monthly meeting. 
All protocol deviations (major and minor) occurring during the study will be documented and 
included in the final report. 
15.4 PREMATURE TERMINATION OF THE STUDY 
The sponsor, CORE or the Office of Research Ethics at the University of Waterloo may terminate 
the study at any time for any reason. 
15.5 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 lead investigator that participant met eligibility criteria; 
• 
Confirmation that participant received a signed and dated copy of informed consent; 
• 
Exit date; 
• 
Investigators signature confirming study exit. 
15.6 RETENTION OF STUDY RECORDS AND DATA 
Records and data from this study will be retained for a minimum of 25 years.  
16 REPORT 
A report will be sent to the sponsors according to terms described in the study contract. 

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17 APPENDICES 
 
  
 
 
 
  
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
  
 
 
 
  
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 

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