Evaluating the Initial Lens Handling Experience of Neophyte Contact Lens Wearers Fitted With Precision1 and 1-Day Acuvue Moist Contact Lenses
Phase: NA
Conditions: Myopia
Sponsor: University of Waterloo



SALUKI Protocol 02Dec2019 
 
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Study Personnel 
 
Principal investigator: 
 
Lyndon Jones PhD FCOptom  
Director, Centre for Ocular Research and Education 
 
Head of Clinical Research: 
Jill Woods BSc(Hons) MCOptom 
 
Project developers 
Lyndon Jones 
Jill Woods 
 
 
 
Protocol author: 
 
 
 
Quality Control: 
 
Alcon (funding source) contacts: 
 
 
 
 
 
 
 
 
 

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DOCUMENT CHANGE HISTORY 
 
Version 
date 
Author 
Description of change(s) 
21Nov2019 
 
Original protocol 
02Dec2019 
 
After feedback from ethics: clarification of Visit 1 
and Visit 1B-R, updated Table of contents. 
 
 

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Table of contents 
Document change history ............................................................................................................ 3 
1 
Introduction .......................................................................................................................... 8 
2 
Objectives ............................................................................................................................ 8 
3 
Rationale ............................................................................................................................. 9 
4 
Hypothesis ........................................................................................................................... 9 
5 
Materials and methods ........................................................................................................ 9 
5.1 
Study design ................................................................................................................. 9 
5.1.1 
Overall design ........................................................................................................ 9 
5.1.2 
Randomization ....................................................................................................... 9 
5.1.3 
Masking.................................................................................................................. 9 
5.2 
Study population ......................................................................................................... 10 
5.2.1 
Sample size calculation ........................................................................................ 10 
5.2.2 
Number of participants ......................................................................................... 10 
5.2.3 
Inclusion and exclusion criteria ............................................................................. 10 
5.2.4 
Repeated screenings ........................................................................................... 11 
5.3 
Study materials ........................................................................................................... 11 
5.3.1 
Lenses ................................................................................................................. 12 
5.3.2 
Lens care system ................................................................................................. 12 
5.3.3 
Rewetting drops ................................................................................................... 12 
5.3.4 
Ordering consumables ......................................................................................... 12 
5.3.5 
Disposing of consumables ................................................................................... 12 
5.3.6 
Product accountability .......................................................................................... 12 
5.4 
Scheduled and unscheduled visits .............................................................................. 12 
5.4.1 
ScreeninG ............................................................................................................ 13 
5.4.2 
Study visits ........................................................................................................... 13 

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5.4.3 
Unscheduled visits ............................................................................................... 16 
5.5 
Study procedures ........................................................................................................ 16 
5.5.1 
Case history ......................................................................................................... 17 
5.5.2 
subjective ratings ................................................................................................. 17 
5.5.3 
Visual acuity ......................................................................................................... 18 
5.5.4 
Autorefraction ....................................................................................................... 18 
5.5.5 
Subjective refraction ............................................................................................. 18 
5.5.6 
Lens performance ................................................................................................ 18 
5.5.7 
Slit lamp biomicroscopy ........................................................................................ 19 
6 
Monitoring protocol adherence .......................................................................................... 19 
7 
Potential Risks and Benefits to Human participants ........................................................... 19 
8 
Adverse events .................................................................................................................. 20 
9 
Discontinuation from the study ........................................................................................... 21 
10 
Study completion and remuneration .................................................................................. 22 
11 
Statistical analysis and data management ......................................................................... 22 
11.1 
Statistical analysis ................................................................................................... 22 
11.2 
Data management ................................................................................................... 22 
11.3 
Comments on source documents ............................................................................ 23 
12 
Protocol training ................................................................................................................. 23 
13 
Study monitoring ................................................................................................................ 23 
14 
Study management............................................................................................................ 23 
14.1 
Statement of compliance ......................................................................................... 23 
14.2 
Ethics review ........................................................................................................... 24 
14.3 
Clinical trial registration ............................................................................................ 24 
14.4 
Protocol deviations .................................................................................................. 24 
14.4.1 
Major protocol deviations ..................................................................................... 24 

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14.4.2 
Minor protocol deviations ..................................................................................... 25 
14.4.3 
Reporting and documenting protcol deviations ..................................................... 25 
14.5 
Premature termination of the study .......................................................................... 25 
14.6 
Study participant records ......................................................................................... 25 
14.7 
Retention of study records and data ........................................................................ 26 
15 
Report................................................................................................................................ 26 
16 
References ........................................................................................................................ 26 
 
 

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

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1 
INTRODUCTION 
Contact lens (CL) dropout is a problem for established CL wearers but also in new wearers 
(neophytes).1 A recent retrospective study on neophytes showed that 1 in 4 patients 
discontinued lens wear within the first 12 months with the primary reasons being vision (41%), 
comfort (36%) and lens handling problems (25%).2 
Alcon has recently launched a new daily disposable contact lens (Precision1) and in this study the 
initial subjective handling experience of neophyte CL wearers will be determined. The handling 
experience with this new lens will be compared to a daily disposable lens which has been on the 
market for numerous years already (1-Day ACUVUE Moist). 
2 
OBJECTIVES 
The objectives of the study are: 
 
Subjective ratings of lens handling for insertion and removal as determined during the 
handling training component of Visit 1 (Or Visit 1B-R) (i.e. the first exposure of the 
participants to handling contact lenses; 0 to 100 scale) for each lens. 
 
Additional “general” handling questions to be evaluated may include “Ease of opening 
package”, “Ease of removing lens from package”, “Ease of telling whether lens is 
inside/out” or “Stability on finger”. These questions will be evaluated after training session 
(Visit 1 and Visit 1B-R)) and after 1 week of wear (Visit 2), using 0 – 100 ratings.  
Primary Endpoint:  
• 
Subjective ratings of lens handling for insertion and removal as determined during the 
handling training component during Visit 1 (and Visit 1B-R) (i.e. the first exposure of the 
participants to handling contact lenses; 0 to 100 scale) 
Other Endpoints: 
• 
Subjective ratings of comfort and handling after 1 week of wear, considering a “typical 
day” (0 to 100 scale) 
• 
Lens preference after 1 week of wear for Handling for Insertion & Handling for Removal 
(Likert scale; including strongly prefer Lens1, slightly prefer Lens1, no preference, slightly 
prefer Lens2, strongly prefer Lens2) 
• 
Subjective ratings (0 – 100 scale) of “general” handling questions, to be evaluated at Visit 
1 and Visit 1B-R (based on initial training) & at Visit 2 (after 1 week of wear), including 

SALUKI Protocol 02Dec2019 
 
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“Ease of opening package”, “Ease of removing lens from package”, “Ease of telling 
whether lens is inside/out” and “Stability on finger”. 
3 
RATIONALE 
Although CL handling is an important factor to the success of CL use in neophytes, the handling 
experience of Precision 1 compared to a hydrogel daily CL is unknown.  
4 
HYPOTHESIS 
Neophyte participants will have a superior handling experience for insertion, removal, overall 
handling and handling preference with Precision1 DD CLs when compared to 1-Day ACUVUE 
Moist DD CLs.  
5 
MATERIALS AND METHODS 
5.1 STUDY DESIGN 
5.1.1 OVERALL DESIGN 
This is a prospective, double-masked, contralateral wear, dispensing, single-site study with 2 
study visits over the course of 1 week. Eligible participants will wear the two study lens types (L1 
& L2) contralaterally for approximately 1 week (6-10 days) at least 5 days and at least 6 
hours/day. 
5.1.2 RANDOMIZATION 
A randomization schedule will be generated using a web-based program: (for example 
www.randomization.com) by CORE’s Data management team, and provided to the research 
assistants for the study. The schedule will determine which lens type (L1 or L2) will be worn on 
which eye for each participant. In addition, start eye for insertion/removal training will also be 
randomized to prevent any potential bias due to handedness/dexterity. Study investigators and 
participants will remain masked to the lens randomization schedule until the study is completed 
and the database has been locked.  
5.1.3 MASKING 
Participants and Investigators will be masked to which lens type (brand) the participants will be 
wearing in each eye during the study in order to reduce bias towards or against any of the 
products. Lens packages/ blister will be overlabeled. 

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5.2 STUDY POPULATION 
5.2.1 SAMPLE SIZE CALCULATION 
The sample size required for a 2-tailed matched paired t-test to detect a change of 5 points in 
subjective ratings of handling for insertion and removal, with α=0.05, power = 0.90, and an effect 
size of 0.60 is 32 to complete the study and be eligible for data analysis (a sample size of 32 
participants excluding possible dropouts and screen failures). 
Up to 60 participants may be randomized to and dispensed with 1-Day ACUVUE Moist and 
Precision1 DD CLs, to account for potential drop-out in neophytes e.g. due to adaptation/ 
handling issues.  
5.2.2 NUMBER OF PARTICIPANTS 
Up to 60 participants may be recruited using CORE records and advertising approved by the 
UW Office of Research Ethics. Up to 60 participants may be randomized to and dispensed with 
study products, with a target of number of 32 participants completing the study. Informed 
consent will be obtained for all participants prior to their enrolment in the study (Appendix 1). 
5.2.3 INCLUSION AND EXCLUSION CRITERIA 
A person is eligible for inclusion in the study if he/she: 
1. Is between 18 and 40 years of age inclusively 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. Is a neophyte who has no history of any previous contact lens handling experience; 
5. Has a refraction cyl ≤1.00DC in either eye (after vertexing to corneal plane); 
6. Has visual acuity ≤0.20 logMAR each eye with study lenses; 
7. Demonstrates acceptable fit with study lenses; 
8. Demonstrates the ability to successfully insert and remove the study lenses 3 times for 
each eye (contralateral CL handling, so that each lens type inserted and removed 3x on 
same eye); 
9. Is willing to wear study CLs at least 5 days per week and 6 hours per day throughout the 
study 
A person will be excluded from the study if he/she: 
1. Is participating in any concurrent clinical or research study; 

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2. Has any known active* ocular disease and/or infection; 
3. Has a systemic condition that in the opinion of the investigator may affect a study 
outcome variable; 
4. Is using any systemic or topical medications that in the opinion of the investigator may 
affect a study outcome variable; 
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report); 
7. Is aphakic; 
8. Has undergone refractive error surgery; 
9. Has taken part in another clinical research study within the last 14 days; 
10. Any ocular and/or systemic conditions or concomitant medication to contraindicate 
contact lens wear or be expected to interfere with the primary outcome variables. 
* 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. 
5.2.4 REPEATED SCREENINGS 
In some circumstances a repeated screening (Visit 1R) may need to be scheduled. Examples 
include, but are not limited to: 
1. Incomplete information available at time of screening to determine eligibility (e.g. 
incomplete information about medical history.) 
2. Study procedures unable to be completed in time scheduled for visit; 
3. Study products not available at the time of the screening visit; 
4. A transient health condition which may affect the eye(s) (e.g. a common cold, active 
allergies, fatigue etc;) 
5. The short term use of medications (e.g. antibiotics, antihistamines etc.) 
6. Reassessment of baseline ocular conditions (e.g. corneal and/or conjunctival staining, 
scars etc.) 
The maximum total number of screenings permitted (per subject) will be 3. 
 
5.3 STUDY MATERIALS 

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o Power optimization if applicable; 
o Lens fit assessment (Overall Lens Fit acceptance (0-4, 0.5 steps), Lens 
Wettability (0-4, 0.25 steps), Lens Tightness (0-100, 1 step), Lens Centration (0-
3, 1 step) 
o  
 
Confirmation of eligibility to continue to Visit 1 Part B. 
 
Visit 1 – Part B – Handling training, questionnaires and lens dispensing (1hr)  
 
Randomization: Eye for contralateral handling: 
o Start eye for insertion/removal training will be randomized to prevent any potential 
bias due to handedness/dexterity 
o Participant opens the lens blister packs and practices insertion & removal;  
o Insertion & removal with each lens needs to be successful 3x to be allowed to 
leave site with CLs 
 
Confirmation of eligibility – capable of insertion/removal of CLs; participants who are 
NOT able to remove/insert the study lenses 3x will be offered to attend a re-training 
session (Visit 1B-R), at which the training will be repeated. Only those participants able 
to insert/remove lenses at Visit 1 (or Visit 1B-R) will continue in the study. 
 
 
PRIMARY OUTCOME VARIABLE (only if participants have passed the CL handling 
training): subjective post-handling training ratings (0-100 scale, where 100 means better 
handling) for each eye individually. Separate ratings and comments for: 
o Ease of insertion 
o Ease of removal 
o General handling questions (not primary outcome variable) 
 
LogMAR HIHC VA for OD, OS and OU (If returning for Re-training: habitual spectacles, if 
lenses are dispensed today: study CL) 
 
Lens wear instructions (only after a successful training) 
 
Booking of Follow-up visit(only after a successful training) 
 
Lens dispense (equal number of pairs as there are days until next visit day, plus 3 spare 
pairs in case of handling issues); each px will keep the same lens type (L1 or L2) for 
each eye as randomized to for handling training (e.g. if Precision1 was used on OD for 
training, Precision1 will be worn on OD for 1 week of wear) (only after a successful 
training) 
 
Visit 1B-R: Handling Re-Training (optional) (1hr) 
 
Those participants who did not pass the handling training at Visit 1 will repeat this 
training, following the same randomization schedule as determined during Visit 1. If a 
participant passes the handling training (i.e. they successfully inserted and removed 
each lens 3x), the remaining steps from Visit 1, starting at “PRIMARY OUTCOME 
VARIABLE”, will be completed. 

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 
PRIMARY OUTCOME VARIABLE (only if participants have passed the CL handling 
training): subjective post-handling training ratings (0-100 scale, where 100 means better 
handling) for each eye individually. Separate ratings and comments for: 
o Ease of insertion 
o Ease of removal 
o General handling questions (not primary outcome variable) 
 
LogMAR HIHC VA for OD, OS and OU (If returning for Re-training: habitual spectacles, if 
lenses are dispensed today: study CL) 
 
Lens wear instructions (only after a successful training) 
 
Booking of Follow-up visit(only after a successful training) 
 
Lens dispense (equal number of pairs as there are days until next visit day, plus 3 spare 
pairs in case of handling issues); each px will keep the same lens type (L1 or L2) for 
each eye as randomized to for handling training (e.g. if Precision1 was used on OD for 
training, Precision1 will be worn on OD for 1 week of wear) (only after a successful 
training) 
 
Participants who were unable to successfully complete the insertion/removal training will 
exit the study now. 
 
Visit 2: 1-week follow-up and study exit, day 6-10 days after Visit 1 or Visit 1B-R 
Participant to attend visit after 2 hours or more of contralateral study lens wear. 
 
Collect unused study CLs;  
 
Changes in medical history/medications; 
 
LogMAR HIHC VA for OD, OS and OU with study lenses 
 
Compliance (# of CL wear days; total and comfortable hours of wear); 
 
Subjective ratings for wear experience with both CLs  (0-100 scale, where 100 means 
better performance; integer steps, ratings for each eye individually for a typical day 
in the last week); 
o Comfort (at insertion and just before removal) 
o Handling (insertion & removal) 
o General handling questions 
 
Preference ratings between study lenses: 
o Comfort 
o Handling for insertion 
o Handling for removal 
o Overall 
o Willingness to purchase 
 
Lens fit assessment (Overall Lens Fit acceptance (0-4, 0.5 steps), Lens Wettability (0-4, 
0.25 steps), Lens Tightness (0-100, 1 step), Lens Centration (0-3, 1 step) 
 
Lens removal 
Study Exit:  
 
Biomicroscopy examination (Efron scale) - SAFETY 
o External adnexa anomalies 
o Cornea & anterior eye assessment for scars, infiltrates 

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HCVA (logMAR) (Contact lenses) 
X 
X 
X 
Lens wear instructions and lens dispense 
X 
X 
 
Confirm eligibility 
X 
X 
 
Collection of unused study lenses 
 
 
X 
Compliance questions 
 
 
X 
Subjective ratings for wear experience and 
preference ratings 
 
 
X 
Lens removal 
 
 
X 
Study exit documentation 
 
 
X 
 
5.5.1 CASE HISTORY 
Demographics: 
Demographic information from the participant will be obtained, including age and sex. 
Medical History: 
At screening, information will be obtained from participants about the current medication, allergies, 
and any medical conditions. At visits 1B-R and Visit 2 participants will be asked about changes in 
their medication or health. 
5.5.2 SUBJECTIVE RATINGS 
Subjective ratings: 
After a successful insertion/ removal training at Visit 1 or Visit 1B-R, participants will complete 
subjective post-handling training ratings (0-100 scale, where 100 means better handling) for 
each eye individually. Separate ratings and comments for: 
o Ease of insertion 
o Ease of removal 
A Visit 2, participants will be provided with subjective rating questionnaires for wear experience 
with both CLs (0-100 scale, where 100 means better performance; integer steps, ratings for 
each eye individually for a typical day in the last week); 
o Comfort (at insertion and just before removal) 
o Handling (insertion & removal) 
 
General” handling questions, to be evaluated at Visit 1 (based on initial training) & at Visit 
2 (after 1 week of wear), including  

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o “Ease of opening package”,  
o “Ease of removing lens from package”,  
o “Ease of telling whether lens is inside/out” 
o “Stability on finger”  
 
Preference ratings between study lenses: (Likert scale; including strongly prefer L1, 
slightly prefer L1, no preference, slightly prefer L2, strongly prefer L2) 
o Comfort 
o Handling for insertion 
o Handling for removal 
o Overall 
o Willingness to purchase 
 
5.5.3 VISUAL ACUITY 
Visual acuity will be measured using high contrast computer-generated acuity charts. 
Participants will be asked to read letters that progressively decrease in size on a computer 
screen located at a distance of 6 meters. Measurements will be taken during the subjective 
refraction, with study lenses and habitual spectacles. 
5.5.4 AUTOREFRACTION 
Participants will be asked to focus on a target while seated at an instrument that measures their 
approximate spectacle prescription and corneal shape. 
5.5.5 SUBJECTIVE REFRACTION 
Participants will be asked to read a letter chart from a distance through lenses placed in front of 
their eyes. They will also be asked to compare clarity of your vision between different lenses 
placed in front of your eyes. This procedure aids to determine their spectacle and/or contact lens 
prescription. 
5.5.6 LENS PERFORMANCE 
Contact lens fit: 
Overall Lens Fit acceptance will be assessed to ensure acceptable lens fit with the study lenses 
using a 0-4 scale (0.5 step, 0= perfect lens fit), in addition, Lens Tightness (0-100, 1 step – 100 
= no movement) and Lens Centration (0-3, 1 step, 0= optimally centred) will be collected. 
Contact lens wettability: 
Contact lens wettability will be graded using e.g. 32x magnification, on a 0-4 scale, 0 = excellent 
wettability, 0= no deposits (0.25step). 

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5.5.7 SLIT LAMP BIOMICROSCOPY 
The participant will be seated behind a slit lamp and the following will be assessed: 
Cornea:  
Any current or past corneal observations (such as infiltrates, old scars, etc) will be documented 
at each visit.  
Corneal and conjunctival staining:  
A sodium fluorescein strip, wetted with a few drops of saline, will be applied to the superior 
bulbar conjunctiva of both eyes. Staining will be graded using the Efron grading scale (0 to 4, 0 = 
normal) in 0.1 scale increments, while viewing with cobalt blue light through a Wratten no. 12 
barrier filter.  
Bulbar and limbal hyperemia: 
Ocular redness will be assessed for the bulbar and limbal conjunctiva using the EFRON grading 
scale (0 to 4, 0 = normal; 0.1 increments). Redness will also objectively be assessed using an 
imaging technique provided by the Oculus K5M. 
Palpebral conjunctival hyperemia and roughness: 
The redness and roughness of the upper and lower eyelids (tarsal plate zone 2) will be assessed 
using the Efron grading scale (0 to 4, 0 = normal/ uniform satin appearance). 
6 
MONITORING PROTOCOL ADHERENCE 
All personnel involved in this study will be listed on a delegation log and their training will be 
documented. Consent documentation will be reviewed by personnel not involved in the consent 
process. Visit windows will be reviewed when determining the analysis cohort. All adverse 
events and protocol deviations will be reviewed by the Lead Investigator. Serious adverse 
events and major protocol deviations will be reviewed by the Principal Investigator. 
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 wear (and daily disposable) basis. Adverse 
events and/ or complications in daily wear of soft contact lenses can occur (e.g. inflammation and 
infection). Complications that may occur during the wearing of contact lenses include discomfort, 

SALUKI Protocol 02Dec2019 
 
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dryness, aching or itching eyes, excessive tearing, discharge, hyperemia and variable or blurred 
vision. More serious risks may include photophobia, iritis, corneal edema or eye infection. 
Although contact lens-related infections are very infrequent, the possibility does exist. The 
incidence of infection due to daily-wear soft lenses is 0.035%. Almost always an infection will occur 
only in one eye. Thirty five million Americans who currently wear contact lenses assume this risk.  
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. 
A dye (fluorescein) normally used for eye exams is being used in this study. Although rare, it is 
possible that participants may have an allergic reaction to the dye. This could cause discomfort to 
their eye.   
Participants are advised to inform the investigator of any sensitivities to any ophthalmic drops or 
study products. 
Additionally, it is possible that participants may experience temporary discomfort associated with 
the study procedures /products including: burning and stinging, blurred vision, sandiness or 
grittiness, light sensitivity, dryness, itching, crusty eyes and foreign body sensation.  
Participants will have the opportunity to try two different types of soft contact lenses at no cost to 
them. They will be trained on lens handling for lens insertion and removal and will be provided 
with instructions to safely wear daily disposable contact lenses.  
Participation in this study may contribute to scientific research information that may be used in 
the development of new contact lens products. Information from this study may help researchers 
and the funding company to better understand if the use of specific daily disposable lens types 
in neophyte lens wearers. 
8 
ADVERSE EVENTS 
See CORE SOP012_v02 for a description of all adverse events, including management and 
reporting. 
Any observations taking place prior to determining that a subject meets all inclusion/ exclusion 
criteria for the study and which are not related to the performed study procedures are not 
considered an AE. An AE can be any unfavourable and unintended sign, symptom, or disease 
temporarily associated with a study procedure, whether there is a causal relationship or not. 

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9 
DISCONTINUATION FROM THE STUDY 
Participants may be discontinued at the discretion of the investigator in consideration of 
participant safety or protocol compliance, or at discretion of the participant. Participants 
discontinued from a study will be reimbursed $20 per hour for their active involvement in the 
study (including the initial screening visit). Upon discontinuing, a participant will be offered the 
option of their data being withdrawn from future statistical analysis. The following is a list of 
possible reasons for discontinuation from the study: 
 
Screening failure: Participants will be discontinued if they do not meet the inclusion and 
exclusion criteria outlined in section 5.2.3. 
 
Unacceptable performance with products to be used in study: Participants may be 
discontinued if they are unable to achieve acceptable comfort and /or vision with the 
study products. 
 
Positive slit lamp finding: Participants may be permanently discontinued from the study 
depending on the severity of the condition and on the judgement of the investigator.   
 
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 may be discontinued if they elect 
to use a topical ocular medication during the study;  
 
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 CORE or the Office of Research Ethics at the 
University of Waterloo. 

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A discontinuation form (ADMIN 3), stating the reason for discontinuation will be completed, 
which requires the signatures of both the participant and the investigator except where the 
participant is lost to follow-up in which case only the signature of the investigator is required.   
All discontinuations including their reasons will be included in the final report. 
10 STUDY COMPLETION AND REMUNERATION 
At the last scheduled protocol visit a study completion form (ADMIN 2) will be completed, which 
requires the signatures of both the participant and the investigator.   
Once their involvement in the study is complete, participants will be informed about receiving 
feedback following study completion in the Letter of Appreciation (ADMIN 1). 
Participant remuneration will be $55 for completing the study. If participants attended an 
additional visit for lens handling training (Visit 1B-R), they receive an additional $20 for their 
involvement in the study for a maximum of $75 for completing the study. 
11 STATISTICAL ANALYSIS AND DATA MANAGEMENT 
11.1 STATISTICAL ANALYSIS 
All data will be analyzed by CORE at the University of Waterloo.  Descriptive statistics will be 
provided on information regarding baseline variables (e.g. age, gender). Differences between 
lenses and differences over time will be compared using either Paired t-tests or Wilcoxon 
matched pairs, or using ANOVA, as applicable; statistical significance will be set at 5%. The 
appropriate tests will be selected based on tests of normality - non-parametric tests will be used 
for data not showing a normal distribution. For assessments conducted for each eye separately, 
the right eye will be used for analysis. 
Subjective ratings for lens handling with Precision1 and 1-Day ACUVUE Moist as determined at 
study Visit 1 (or Visit 1B-R) (after successfully completing the lens handling training) will also be 
compared using superiority testing, with a margin of 5 points on a 100-point scale. 
11.2 DATA MANAGEMENT 
All study data will be recorded on paper CRFs. Data from this study will be entered in an 
electronic database and 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.  

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At the completion of the study CORE may provide a copy of the study data to the funding 
company. 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. Using this method means that data files are only stored on University of 
Waterloo servers during the transfer.  
11.3 COMMENTS ON SOURCE DOCUMENTS 
Data analysis will not be conducted on comments which have been recorded in the source 
documents. Only relevant and applicable comments will be included in the final report as 
deemed necessary by the lead investigator.  
12 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. 
13 STUDY MONITORING 
Study monitoring will be conducted throughout the study. In addition study records may be 
inspected at CORE by 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. 
Study monitoring will include, but may not be limited to: 
 
The number of participants screened, enrolled, and randomized (i.e. assigned a study ID 
number), discontinued and completed; 
 
Consent documentation; 
 
Details of adverse events and protocol deviations; 
 
Reports of unintended events. 
14 STUDY MANAGEMENT 
14.1 STATEMENT OF COMPLIANCE 

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This clinical study is designed to be in compliance with the ethical principles in the Declaration of 
Helsinki, with the ICH guidelines for Good Clinical Practice (GCP), with the University of 
Waterloo’s Guidelines for Research with Human Participants and with the Tri-Council Policy 
Statement: Ethical Conduct for Research Involving Humans, 2nd Edition. 
 
Declaration of Helsinki 
 
ICH E6 - International 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/ 
14.2 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. 
14.3 CLINICAL TRIAL REGISTRATION 
CORE will register this study with clinicaltrials.gov.  
14.4 PROTOCOL DEVIATIONS 
Protocol deviations are unanticipated or unintentional changes to a study after it has received 
ethics clearance. Protocol deviations can be major or minor.  
14.4.1 MAJOR PROTOCOL DEVIATIONS 
Major protocol deviations may impact the research protocol, information consent document or 
other study materials, usually cannot be anticipated ahead of time and are often necessary to 
ensure the safety and welfare of the participants. 
The following are examples of protocol deviations that must be reported to the ORE: 
 
Changes in procedures initiated to eliminate immediate risks/hazards to participants; 
 
Enrollment of participants outside the protocol inclusion/exclusion criteria; 
 
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; 

SALUKI Protocol 02Dec2019 
 
25 
 
Information consent documentation violations: no documentation of informed consent; 
incorrect version of, or incomplete, informed consent documentation used. 
14.4.2 MINOR PROTOCOL DEVIATIONS 
Protocol deviations caused by or which originate with research participants are considered 
minor, and normally are not reported to the ORE unless these result in increased risk to the 
participant(s). The following are examples of protocol deviations that are considered minor and 
do not require reporting to the ORE: 
 
Logistical or administrative aspects of the study (e.g., study participant missed 
appointment, change in appointment date); 
 
Inadvertent deviation in specific research intervention procedures or timing of the 
research intervention which would not impact upon the safety or efficacy of the study-
related intervention or upon the experimental design (i.e., missing a measurement during 
a session that is not considered critical for the study).  
14.4.3 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. 
14.5 PREMATURE TERMINATION OF THE STUDY 
CORE or the Office of Research Ethics at the University of Waterloo may terminate the study at 
any time for any reason. 
14.6 STUDY PARTICIPANT RECORDS 
Study participant records will be completed to comply with GCP guidelines. Records will contain: 
 
Unique study acronym and/or code; 
 
Participant ID; 
 
Date enrolled; 
 
Confirmation by investigator that participant met eligibility criteria; 

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26 
 
Confirmation that participant received a signed and dated copy of informed consent; 
 
Exit date; 
 
Investigator’s signature confirming study exit. 
14.7 RETENTION OF STUDY RECORDS AND DATA 
Records and data from this study will be retained for a minimum of 25 years. Details regarding 
storage procedures are given in CORE SOP014_v02_Clinical data management.  
15 REPORT 
A report will be completed after data collection has been completed. 
16 REFERENCES 
1. Sulley A, Young G, Hunt C, et al. Retention rates in new contact lens wearers. Eye & Contact 
Lens. 2018;44:S273-S282 
2. Eric B. Papas, Lisa Keay, Blanka Golebiowski; Estimating a Just-Noticeable Difference for Ocular 
Comfort in Contact Lens Wearers. Invest. Ophthalmol. Vis. Sci. 2011;52(7):4390-4394. doi: 
10.1167/iovs.10-7051. 
3. Alcon press release; accessible at https://www.alcon.com/media-release/alcon-launch-precision1-
daily-disposable-contact-lenses-it-continues-deliver-vision. Last accessed on 26-Aug-2019.