Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type
Phase: NA
Conditions: Dry Eye
Sponsor: University of Waterloo



CORGI Protocol 12Jul2019 
 
1 
 
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 
 
REFITTING DAILY DISPOSABLE CONTACT 
LENS WEARERS WITH DRY EYE DISEASE 
WITH A DIFFERENT DAILY DISPOSABLE LENS 
TYPE (CORGI) 
Funding source: ALCON (IIT) 
 
Funding study number: IIT Proposal
 
CORE protocol number: P/678/19/L 
Protocol authors: 
 
 
Principal investigator: Lyndon Jones 
 
This protocol remains the exclusive property of CORE. 
Role & printed name 
Reviewed and approved  
(sign) 
Date 
DD/MMM/YYYY 
Principal investigator
 
Lead investigator: 
 
Protocol author: 
 
Quality assurance: 
 

CORGI Protocol 12Jul2019 
 
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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: 
 
 
 
Lead investigator: 
 
Quality Control: 
 
Alcon (funding source) contact: 
 
 
 
 
 
 
 

CORGI Protocol 12Jul2019 
 
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DOCUMENT CHANGE HISTORY 
 
Version 
date 
Author 
Description of change(s) 
12Jul2019 
 
Original protocol 
 
 
 

CORGI Protocol 12Jul2019 
 
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Table of contents 
Document change history ............................................................................................................ 3 
1 
Introduction .......................................................................................................................... 8 
2 
Objectives ............................................................................................................................ 8 
3 
Rationale ............................................................................................................................. 8 
4 
Hypothesis ........................................................................................................................... 8 
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 ........................................................................................................... 9 
5.2.1 
Sample size calculation .......................................................................................... 9 
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 ................................................................................................................. 11 
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 

CORGI Protocol 12Jul2019 
 
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5.4.3 
Unscheduled visits ............................................................................................... 15 
5.5 
Study procedures ........................................................................................................ 15 
5.5.1 
Case history ......................................................................................................... 17 
5.5.2 
Questionnaires and subjective ratings .................................................................. 17 
5.5.3 
Visual acuity ......................................................................................................... 18 
5.5.4 
Autorefraction ....................................................................................................... 18 
5.5.5 
Subjective refraction ............................................................................................. 18 
5.5.6 
Non-invasive break-up time .................................................................................. 18 
5.5.7 
Tear meniscus height ........................................................................................... 18 
5.5.8 
Tear osmometry ................................................................................................... 18 
5.5.9 
Lens performance ................................................................................................ 19 
5.5.10 
Slit lamp biomicroscopy ........................................................................................ 19 
5.5.11 
Meibomian Gland Expressibility ........................................................................... 20 
6 
Monitoring protocol adherence .......................................................................................... 20 
7 
Potential Risks and Benefits to Human participants ........................................................... 20 
8 
Adverse events .................................................................................................................. 21 
9 
Discontinuation from the study ........................................................................................... 21 
10 
Study completion and remuneration .................................................................................. 23 
11 
Statistical analysis and data management ......................................................................... 23 
11.1 
Statistical analysis ................................................................................................... 23 
11.2 
Data management ................................................................................................... 24 
11.3 
Comments on source documents ............................................................................ 24 
12 
Protocol training ................................................................................................................. 24 
13 
Study monitoring ................................................................................................................ 25 
14 
Study management............................................................................................................ 25 
14.1 
Statement of compliance ......................................................................................... 25 

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14.2 
Ethics review ........................................................................................................... 25 
14.3 
Clinical trial registration ............................................................................................ 25 
14.4 
Protocol deviations .................................................................................................. 26 
14.4.1 
Major protocol deviations ..................................................................................... 26 
14.4.2 
Minor protocol deviations ..................................................................................... 26 
14.4.3 
Reporting and documenting protcol deviations ..................................................... 26 
14.5 
Premature termination of the study .......................................................................... 27 
14.6 
Study participant records ......................................................................................... 27 
14.7 
Retention of study records and data ........................................................................ 27 
15 
Report................................................................................................................................ 27 
16 
References ........................................................................................................................ 27 
 
 

CORGI Protocol 12Jul2019 
 
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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. 
 
 
 

CORGI Protocol 12Jul2019 
 
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1 
INTRODUCTION 
Contact lens (CL) discomfort affects up to 50% of contact lens wearers.1 Patients with signs and 
symptoms of dry eye disease (DED) have significantly increased odds of dropping out of CL 
wear.1 It is likely that symptomatic CL wearers also have DED, either due to evaporative causes, 
aqueous deficiency or, most often, a combination of both.  
To date, there are no CL studies characterizing dry eye in CL wearers using the TFOS DEWS II 
guidelines.2 
2 
OBJECTIVES 
The objectives of the study are: 
 
To examine and classify DED subtypes in a group of symptomatic CL wearers who are 
already wearers of daily disposable (DD) CLs (excluding Dailies Total1 (DT1)). 
 
To assess subjective ratings, cumulative comfort scores, average wear time and 
comfortable wear time while symptomatic CL wearers use their habitual DD CLs. 
 
To refit participants with DT1 CLs and assess subjective ratings, cumulative comfort 
scores, average wear time and comfortable wear time after wearing DT1 for one month. 
Primary Endpoint:  
• 
Subjective ratings of end-of-day comfort and dryness (with CLs; 0 to 100 scale) 
• 
Average wear time (hours) 
• 
Comfortable wear time (hours) 
3 
RATIONALE 
Refitting symptomatic CL-wearing patients into daily disposable (DD) CLs is one problem-solving 
strategy that has been frequently reported.  
To explore if the unique ‘water gradient’ material of DT1 allows symptomatic daily disposable 
contact lens wearers to comfortably wear these contact lenses for a longer period than possible 
in their habitual DD lenses. 
4 
HYPOTHESIS 
DT1 CLs will provide equivalent or better end-of-day comfort and longer comfortable wear time 
for DD CL wearers who suffer from DED compared to their habitual lenses. 

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5.2.2 NUMBER OF PARTICIPANTS 
Up to 60 participants may be screened using CORE records and advertising approved by the 
UW Office of Research Ethics. Approximately 43 participants will be dispensed / randomized 
with study products, with a target of number of 39 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 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. As per TFOS DEWS II2, have dry eye symptoms (without CL wear) as determined by an 
OSDI score of ≥13 and at least one of the following: 
a. Tear osmolarity ≥ 308mOsm/L or interocular difference >8 mOsm/L 
b. Non-invasive tear breakup time of < 10 seconds in at least one eye 
c. More than 5 spots of corneal staining OR > 9 conjunctival spots in at least one 
eye 
5. Reports dryness while wearing DD CLs with CLDEQ-8 score ≥ 12 and ≤ 203 
6. Habitually wears soft spherical DD CLs with a power between +6.00D and -10.00D 
7. Manifest spectacle cyl ≤1.00DC in either eye 
8. BCVA ≤0.20 log MAR each eye with habitual & DT1 
9. Acceptable fit with habitual & DT1 
10. Willing to wear DT1 CLs at least 3 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; 
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); 

CORGI Protocol 12Jul2019 
 
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7. Is aphakic; 
8. Has undergone refractive error surgery; 
9. Has taken part in another clinical research study within the last 14 days; 
10. Current habitual wearer of DT1 
11. 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 may need to be scheduled. Examples include, but 
are not limited to: 
1. Incomplete information available at time of screening to determine eligibility (e.g. current 
lens brands worn, history from current eye care practitioner etc.) 
2. Study procedures unable to be completed in time scheduled for visit; 
3. Study products not available at the time of the screening visit; 
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 
5.3.1 LENSES 
Details on the lens type used in this study are listed in Table 1. 

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 
Participants will attend this visit wearing their habitual spectacles. They will be asked to 
stop lens wear for ≥ 12 hours prior to the visit and will be asked to bring a new pair of 
their habitual lenses with them.  
 
The purpose of this visit is to determine participant eligibility and to classify the type of 
DED exhibited by the participant, using TFOS DEWS II guidelines. These tests will 
include: 
o OSDI questionnaire (with participant reflecting on their ocular symptoms without 
CL wear); 
o Tear osmolarity (TearLab); 
o Non-invasive tear break-up time (using the Oculus K5M); 
o Tear meniscus height assessment (using the Oculus K5M); 
o Meibomian gland assessment (to calculate a meibomian gland score) using the 
meibomian gland evaluator (Johnson & Johnson Vision);  
o Ocular surface staining assessment and lid wiper staining; 
 
To minimize disruption of the ocular surface, these tests will be conducted in the 
order of the least invasive, through to the most invasive. 
 
 
Participants will complete a CLDEQ-8 questionnaire to review their experience with their 
habitual lenses over the past two weeks.  
 
A full slit lamp biomicroscopy examination will also be performed to determine ocular 
health, including ocular hyperemia and surface staining with fluorescein. 
 
Participants will undergo a subjective refraction (Distance High Contrast High Illumination 
[HIHC] visual acuity, OD, OS & OU) and will be fit with DT1 to confirm acceptable visual 
acuity and lens fit.  
 
Participants will be asked to insert their habitual lenses to confirm acceptable visual 
acuity and lens fit. 
o Distance HCHI visual acuity with habitual lenses, OD, OS & OU 
 
If the participant meets all inclusion / exclusion criteria, the participant will be instructed to 
wear their habitual DD CLs as usual until their next scheduled visit.  
 
Participants will be provided with a subjective rating questionnaire (related to comfort, 
dryness, handling, onset time of discomfort, total wear times and reasons for lens 
removal) to be completed at home on Days 1, 3 and 5. Participants will be instructed that 
they must wear the lenses on the days where they are required to complete the ratings, 
and will be scheduled to return for their next visit between 6 and 14 days after the 
screening visit. 
 
Visit 2 (Day 0 for DT1): Review habitual DD lenses and dispense DT1, 6-14 days after V1 
(1.0 hour)  
 
Participants will attend this visit wearing their habitual DD CLs for ≥ 2 hours prior to the 
visit. 
 
The subjective ratings completed at home will be reviewed.  
 
In-office subjective ratings of a typical day for comfort, dryness, vision and handling (with 
CLs; 0 to 100 scale), plus total wear time and comfortable wear time (onset time of 
discomfort) per day over the last month. 

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 
The following assessment of the habitual lenses will be made: 
o Distance HCHI visual acuity, OD, OS & OU; 
o Lens surface characteristics: wettability and deposition; 
o Lens fit. 
 
After lens removal, a slit lamp biomicroscopy examination (including assessments for 
ocular surface staining and hyperemia) will be performed. 
 
DT1 will be dispensed and the following assessments will be made:  
o Distance HCHI visual acuity, OD, OS & OU; 
o Lens surface characteristics: wettability and deposition; 
o Lens fit. 
 
Participants will be provided with a 1 month supply of overlabeled DT1 CLs (for masking) 
and instructed to wear the lenses at least 3 days per week and 6 hours per day 
throughout the study. 
 
Participants will be provided with a subjective rating questionnaire (related to comfort, 
dryness, handling wear times and reasons for lens removal) to complete at home on 
Days 1, 3, 5, 7, 21, 28. Participants will be instructed that they must wear the study 
lenses on the days where they are required to complete the ratings, and will be 
scheduled to return for their next visit between 29 and 34 days after V2. 
 
Visit 3: Review DT1 and study exit, day 29-34 days after V2 
 
Participants will attend this visit wearing the study CLs for ≥ 2 hours prior to the visit. 
 
Participants will be asked to complete a CLDEQ-8 questionnaire to review their 
experience with the DT1 study lenses.  
 
The subjective ratings completed at home will be reviewed.  
 
In-office subjective ratings of comfort, dryness, vision and handling (with CLs; 0 to 100 
scale), total wear time and comfortable wear time (onset time of discomfort) over the last 
month. 
 
The following assessment of the study lenses will be made: 
o Distance HCHI visual acuity, OD, OS & OU; 
o Lens surface characteristics: wettability and deposition; 
o Lens fit. 
 
Slit lamp biomicroscopy examination (including assessments for ocular surface staining 
and hyperemia). 
 
Study exit documentation & reimbursement.  
 
5.4.3 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.  
5.5 STUDY PROCEDURES 

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5.5.1 CASE HISTORY 
Demographics: 
Demographic information from the participant will be obtained, including age, sex and ethnicity. 
Medical History: 
At screening, information will be obtained from participants about the current medication, allergies, 
and any medical conditions. At visits 2 and 3 participants will be asked about changes in their 
medication or health. 
Contact Lens History: 
Information will be obtained from the participant about the current contact lens type (lens name, 
brand), lens power, lens wear days and use of artificial tears. Participants will be asked how many 
years of lens wear experience they have and how long they have been wearing DD lenses. 
 
5.5.2 QUESTIONNAIRES AND SUBJECTIVE RATINGS 
Questionnaires: 
At the screening visit (Visit 1), participants will complete the OSDI questionnaire to reflect their 
dry eye symptoms. 
At visits 1 and 3, participants will complete the CLDEQ-8 questionnaire, reporting their 
experience with their habitual and study contact lenses, respectively, over the past 2 weeks. 
Subjective ratings: 
Participants will be provided with subjective rating 0-100 questionnaires related to comfort, 
dryness, vision, lens handling and will be asked for times of lens insertion and removal and 
reasons for lens removal as well as onset of discomfort on that day and reason for lens removal. 
This questionnaire will be completed at home on Days 1, 3, 5 after visit 1 and on Days 1, 3, 5, 7, 
21, 28 after visit 2. Participants will be instructed that they must wear the study lenses on the 
days where they are required to complete the ratings, and will be scheduled to return for their 
next visit. 

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The same questionnaire will be provided to the participants during visit 1 and 3 to reflect their 
overall ‘typical day’ experience over the previous month. 
 
 
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 habitual lenses, 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 NON-INVASIVE BREAK-UP TIME  
The participant will be seated in front of a device (OCULUS Keratograph (K5M) that will project 
rings of light (Placido discs) onto the tear film. The participant will be asked to keep their eyes 
open for as long as they can and the time until the rings first begin to distort or break will be 
recorded. Three measurements will be taken for each eye to obtain an average value. 
5.5.7 TEAR MENISCUS HEIGHT 
The participant will be seated in front of the OCULUS Keratograph (K5M) with their chin on the 
chin rest and head against the forehead rest. The investigator will select the Tear meniscus 
height feature and will take images of the ocular surface of each eye. 
5.5.8 TEAR OSMOMETRY 
The participant will be asked to lean their head back and gaze towards the ceiling. The 
TearLab™ pens are loaded with sterile test cards. The pen will be used to gather ~50nL of tears 

CORGI Protocol 12Jul2019 
 
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from one eye at a time, from the lower lateral tear meniscus without making direct contact with 
the eye. The pen will be docked to the base instrument to determine tear osmolarity. 
 
 
5.5.9 LENS PERFORMANCE 
Contact lens fit: 
Lens fit will be assessed to ensure acceptable lens fit with a participant’s habitual and study 
lenses using a 0-4 scale, (0= perfect lens fit). 
Contact lens wettability and deposits: 
Contact lens wettability and deposits will be graded with participant’s habitual and study lenses 
using e.g. 32x magnification, on a 0-4 scale, 0 = excellent wettability, 0= no deposits. 
5.5.10 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). 

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5.5.11 MEIBOMIAN GLAND EXPRESSIBILITY 
Meibomian gland dysfunction results in stagnation of the meibum (oil) within the glands. The 
ease of expression of the gland and the quality of the expressed contents therefore provides an 
indication of the functional capabilities of the glands. The MG Evaluator (TearScience/J&J) will 
be used to apply a pressure of 1.2g/mm2 to the lower eyelid just inferior to the lid margin in three 
areas – nasal, central and temporal. Five consecutive glands in each area will be assessed for 
expressibility. Glands will be graded as follows: 0: blocked, 1: inspissated (toothpaste), 2: cloudy 
with debris, 3: clear, the results for each location will be summed (Meibomian gland score). 
5.5.12 MEIBOGRAPHY 
While seated at the Lipiview II instrument the participant will be asked to place their chin on the 
chin rest and head against the forehead rest. The lower lid will be everted and infrared images 
will be taken of the exposed palpebral surface. This will be repeated for the superior eyelid. The 
grading of meibomian gland dropout will be conducted on the images after all participants are 
completed. The grading scale used will be the one described by Arita et al. 4  the Meiboscore, 
where: Grade 0: no dropout, Grade 1: < 1/3 total area dropout, Grade 2: 1/3 to 2/3 total area 
dropout, Grade 3: > 2/3 total area dropout. 
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, 
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 

CORGI Protocol 12Jul2019 
 
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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.  
The study lens may provide fewer signs and symptoms of dry eye during wear, however, there is 
no guarantee that participants will benefit from participating in this study. In addition, participants 
will have the opportunity to try a different type of soft contact lenses at no cost to them.  
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 lens wearers with dry eye disease. 
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. 
9 
DISCONTINUATION FROM THE STUDY 

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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 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. 

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23 
 
Premature termination of the study by CORE or the Office of Research Ethics at the 
University of Waterloo. 
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 $90 for completing the study this includes $70 for active time 
and $20 for completing the at-home questionnaires. 
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. 
The following statistical tests will be performed for the listed comparisons after 1 month of DT1 
wear vs habitual DD CL wear (Table 4).  
Table 4: Statistical procedures 
Comparison 
Statistical test 
CLDEQ-8 ratings between lenses (habitual DD vs. DT1) 
2-sided paired t-test 
Subjective ratings between lenses (habitual DD vs. DT1) 
2-sided paired t-test 

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Subjective ratings over time (from home ratings) for DT1 
Repeated Measures 
ANOVA 
Comparisons as above, but on groups stratified by DED subtype 
(evaporative/aqueous deficient/mixed disease) 
2-sided paired t-test 
 
In addition, equivalence and superiority for the test lens (DT1) vs the habitual lens will be 
evaluated for the primary outcome variables, with a change in subjective ratings of 5 points and 
a difference of 0.5 hours in average and comfortable wear time being considered as a clinically 
relevant difference. 
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.  
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. 

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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 
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.  

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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; 
 
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 

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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; 
 
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. 
Dumbleton K, Caffery B, Dogru M, et al. The TFOS International Workshop on Contact 
Lens Discomfort: report of the subcommittee on epidemiology. Invest Ophthalmol Vis Sci. 
2013;54(11):TFOS20-36. 
2. 
Wolffsohn JS, Arita R, Chalmers R, et al. TFOS DEWS II Diagnostic Methodology report. 
Ocul Surf. 2017;15(3):539-574. 

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3. 
Chalmers RL, Young G, Kern J, Napier L, Hunt C. Soft Contact Lens-Related Symptoms 
in North America and the United Kingdom. Optom Vis Sci. 2016;93(8):836-847. 
4. 
Arita R, Suehiro J, Haraguchi T, Shirakawa R, Tokoro H, Amano S. Objective image 
analysis of the meibomian gland area. Br J Ophthalmol. 2014;98(6):746-755.