Clinical Evaluation of Proclear Toric and Biofinity Toric
Phase: NA
Conditions: Astigmatism
Sponsor: CooperVision, Inc.



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DOCUMENT CHANGE HISTORY 
 
Version 
date 
Author 
Description of change(s) 
05apr2024 
Marc Schulze 
Original protocol 
1may2024 
Marc Schulze 
Correction of typos. 
Added Komal Kumar to study Personnel list (page 2) 
Section 4.2.5: Increased total number of screenings to 3; 
Section 4.3.2: Updated process of ordering study lenses; 
Section 4.4.1: Updated and clarified screening procedures, 
removed duplicate steps; 
Section 13.1: Added ISO14155 to Statement of 
Compliance; 
 
 
 

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Table of contents 
Document change history ............................................................................................................ 3 
1 
Introduction .......................................................................................................................... 8 
2 
Objectives ............................................................................................................................ 8 
3 
Hypothesis ........................................................................................................................... 8 
4 
Materials and methods ........................................................................................................ 8 
4.1 
Study design ................................................................................................................. 9 
4.1.1 
Overall design ........................................................................................................ 9 
4.1.2 
Randomization ....................................................................................................... 9 
4.1.3 
Masking.................................................................................................................. 9 
4.2 
Study population ........................................................................................................... 9 
4.2.1 
Sample size calculation .......................................................................................... 9 
4.2.2 
Number of participants ......................................................................................... 11 
4.2.3 
Inclusion and exclusion criteria ............................................................................. 11 
4.2.4 
Vulnerable population........................................................................................... 12 
4.2.5 
Repeated screenings ........................................................................................... 12 
4.3 
Study materials ........................................................................................................... 13 
4.3.1 
Lenses ................................................................................................................. 13 
4.3.2 
Ordering consumables ......................................................................................... 13 
4.3.3 
Disposing of consumables ................................................................................... 13 
4.3.4 
Product accountability .......................................................................................... 13 
4.4 
Scheduled and unscheduled visits .............................................................................. 13 
4.4.1 
Screening (V1) ..................................................................................................... 14 
4.4.2 
Study visits (V2 & V3) ........................................................................................... 15 
4.4.3 
Study exit ............................................................................................................. 17 
4.4.4 
Unscheduled visits ............................................................................................... 18 

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4.5 
Study procedures ........................................................................................................ 18 
4.6 
Details of procedures .................................................................................................. 19 
4.6.1 
Case history ......................................................................................................... 19 
 
 
 
 
 
 
4.6.5 
Lens fit assessments ............................................................................................ 20 
 
 
 
 
5 
Monitoring protocol adherence .......................................................................................... 21 
6 
Potential risks and benefits to human participants ............................................................. 21 
7 
Adverse events .................................................................................................................. 22 
7.1 
Normal or adaptive symptoms ..................................................................................... 24 
7.2 
Procedures for adverse events .................................................................................... 24 
7.3 
Reporting adverse events ........................................................................................... 25 
8 
Discontinuation from the study ........................................................................................... 25 
9 
Study completion and remuneration .................................................................................. 26 
10 
Statistical analysis and data management ......................................................................... 27 
10.1 
Statistical analysis ................................................................................................... 27 
10.2 
Data management ................................................................................................... 28 
10.3 
Comments on source documents ............................................................................ 29 
11 
Protocol training ................................................................................................................. 29 
12 
Study monitoring ................................................................................................................ 29 
13 
Study management............................................................................................................ 30 
13.1 
Statement of compliance ......................................................................................... 30 
13.2 
Ethics review ........................................................................................................... 30 

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13.3 
Clinical trial registration ............................................................................................ 30 
13.4 
Protocol deviations .................................................................................................. 30 
13.4.1 
Major protocol deviations ..................................................................................... 31 
13.4.2 
Minor protocol deviations ..................................................................................... 31 
13.4.3 
Reporting and documenting protcol deviations ..................................................... 31 
13.5 
Premature termination of the study .......................................................................... 32 
13.6 
Study participant records ......................................................................................... 32 
13.7 
Retention of study records and data ........................................................................ 32 
14 
Report................................................................................................................................ 32 
15 
References ........................................................................................................................ 32 
 
 

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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. 
 
 
 

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1 
INTRODUCTION 
Toric soft contact lenses work best for people with astigmatism and other refractive errors (e.g., 
nearsightedness, farsightedness). The use of toric soft contact lenses has increased significantly 
in recent years. Recently released data on prescription habits with soft toric lenses ranged from 
13% to 59%. Soft toric contact lens wearers demand two things from their contact lenses, great 
comfort and excellent vision. 
Contact lens manufacturers are continuously innovating in this area, with increased availability of 
soft toric contact lenses with novel designs in a range of replacement frequencies, from daily 
disposables to monthly replacement, and different materials, including silicone hydrogels. 
Therefore, CooperVision is interested in comparing the short-term clinical performance and 
subjective acceptance of Proclear toric contact lenses (Lens A; Control) with Biofinity toric (Lens 
B; Test) silicone hydrogel lenses in a short-term, non-dispensing fitting study. 
2 
OBJECTIVES 
To evaluate and compare the performance of Proclear toric (control) and Biofinity toric (test) 
contact lenses in existing soft toric lens (CL) wearers in a short term (15 minutes wear) study. 
The primary outcome variable for this study is: 
• 
Overall fit acceptance  
 
 
 
 
 
 
 
  
 
 
3 
HYPOTHESIS 
Null Hypothesis (H0) There is no difference in overall fit acceptance between the study lenses. 
Alternative Hypothesis (H1) There is a difference in overall fit acceptance between the study 
lenses. 
4 
MATERIALS AND METHODS 

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4.1 STUDY DESIGN 
4.1.1 OVERALL DESIGN 
This is a prospective, participant masked, bilateral eye, non-dispensing cross-over study with 3 
study visits that will be conducted on 2 separate days. The consent, screening and lens fitting 
assessments will be done on study day 1 (Visit 1) to determine eligibility and confirm optimal 
contact lens powers. The performance of both lens types during bilateral wear will be assessed 
on study day 2, with a cross-over from Lens A (Visit 2) to Lens B (Visit 3). Participants will exit 
the study at the end of V3.  
4.1.2 RANDOMIZATION 
There is no randomization in this study. Each participant will wear each of the two lens types for 
approximately 15 minutes during the assessment visits. Each participant will wear the Proclear 
toric lens first (Visit 2) and the Biofinity toric lens (Visit 3) second. 
4.1.3 MASKING 
The order of contact lens wear will be masked to the study participants only. The lenses will be 
removed from their blister pack by an assistant and transferred to an unmarked lens case to 
maintain participant masking of the study lenses. Participants will then be instructed to remove 
the lenses from the lens case and insert them onto their eyes. It is not possible for the study 
investigators to be masked because of the plan for a fixed lens order. 
4.2 STUDY POPULATION 
4.2.1 SAMPLE SIZE CALCULATION 
 
 

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Figure 1 shows the sample size determination for a paired t-test, with alpha=0.05 and a power of 
84%. In order to detect a difference of 0.42 points between lenses on the 0 to 4 fit acceptance 
rating scale, a sample size of 37 completed participants is needed.  
 
 

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Figure 1: Sample size calculation (Minitab 20.2. Statistics software) 
 
 
 
4.2.2 NUMBER OF PARTICIPANTS 
Participants will be recruited using CORE records and advertising approved by the UW Office of 
Research Ethics. To account for potential dropouts, up to 40 participants may be dispensed with 
the study lenses on visit day 2, with the goal to have 37 participants complete the study. 
Informed consent will be obtained for all participants prior to their enrolment in the study. 
4.2.3 INCLUSION AND EXCLUSION CRITERIA 
A person is eligible for inclusion in the study if they: 
1. Are at least 17 years of age and has full legal capacity to volunteer; 
2. Have understood and signed an information consent letter; 
3. Are willing and able to follow instructions and maintain the appointment schedule; 
4. Are an adapted soft toric contact lens wearer; 
5. Do not habitually wear either of the two study lens types; 
6. Have a vertex-corrected contact lens prescription with a spherical component of +4.00D 
to -9.00D in combination with astigmatism of no less than -0.75D and no more than ‐
2.25D in each eye; 
7. Can achieve best corrected distance visual acuity of +0.10 logMAR (subjective 
refraction) or better in each eye; 
8. Can be fitted with and achieve a distance visual acuity of +0.18 logMAR or better in each 
eye with the study contact lenses; 
A person will be excluded from the study if they: 
1. Are participating in any concurrent clinical or research study; 

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2. Have any known active* ocular disease and/or infection or slit lamp findings that would 
contraindicate contact lens use; 
3. Have a systemic condition that in the opinion of the investigator may affect a study 
outcome variable; 
4. Are using any systemic or topical medications that in the opinion of the investigator may 
affect a study outcome variable; 
5. Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;  
6. Have a history of not achieving comfortable CL use (5 days per week; > 8 hours/day) 
7. Are an employee of the Centre for Ocular Research & Education directly involved in the 
study (i.e. on the delegation log). 
* 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 mild 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. 
4.2.4 VULNERABLE POPULATION 
This study will not be conducted in vulnerable populations. 
4.2.5 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 will be 3 (1 screening and up to two 
repeated screenings). 

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8. Allow 5 minutes settling time. 
9. 
 
10. Measure lens fitting characteristics (
 
overall fit acceptance). 
11. Participant to remove LENS A and to insert trial toric LENS B 
. 
12. Allow 5 minutes settling time. 
13. 
 
14. Measure lens fitting characteristics 
 
overall fit acceptance). 
15. Participant to remove LENS B. 
16. 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. 
17. Instructions. The participant will be advised:  
 To attend V2 with their habitual spectacles. 
 That they are permitted to wear their habitual CLs every day from now on (end of 
screening visit) until the day of V2 (i.e. no habitual CL wear on day of V2 visit). 
18. Confirmation of final lens powers for LENS A & B. If final lenses for either lens type are 
not in stock, lenses will be ordered. 
 
 
 
 
 
4.4.2 STUDY VISITS (V2 & V3) 
Study visits 2 and 3 to be conducted on the same day, with both study lens types in the final lens 
power as determined during the screening visit required to be available on site. Participants will 
attend this visit wearing their spectacles and not having worn their habitual CLs on the day 
of this visit. 
Visit 2 (LENS A) – Visit Procedures: 

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1. Changes in health & medications 
2. Lens insertion 
Part A – post-insertion measurements 
3. 
  
 
  
 
 
 
 
 
5. Lens fit assessment 
 
 
 
 
 
  
 
 
 
 Overall fit acceptance (0 – 4) and reason if Grade 2 or less.  
Part B – 15 minutes-post insertion measurements 
6. 
  
 
 
 
 
 
 
 
 
 
 
8. Lens fit assessment 
 
 
 
 
 
  
 
 
 
 Overall fit acceptance (0 – 4) and reason if Grade 2 or less.  
9. Lens removal 
10.
  
 
  
 
Visit 3 (LENS B) – Visit Procedures: 

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1. Lens insertion 
Part A – post-insertion measurements 
2. 
  
 
  
 
 
 
 
 
4. Lens fit assessment 
 
 
 
 
 
  
 
 
 
 Overall fit acceptance (0 – 4) and reason if Grade 2 or less.  
Part B – 15 minutes-post insertion measurements 
5. 
  
 
 
 
 
 
 
 
 
 
 
7. Lens fit assessment 
 
 
 
 
 
  
 
 
 
 Overall fit acceptance (0 – 4) and reason if Grade 2 or less.  
8. Lens removal 
9. 
  
 
  
 
 
10. 
 
11. 
  
4.4.3 STUDY EXIT 

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4.6 DETAILS OF PROCEDURES 
4.6.1 CASE HISTORY 
Demographics: 
Demographic information from the participant will be obtained, including age and sex. 
Medical History: 
At screening, information will be obtained from the participant about the current medication, 
allergies, and any medical conditions.  At the beginning of the Follow-up visits, the participant 
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), replacement frequency, contact lens care solution (if applicable), typical 
number of lens wear days per week, typical lens wear time per day (total and comfortable). 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 

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5 
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. 
6 
POTENTIAL RISKS AND BENEFITS TO HUMAN PARTICIPANTS 
This is a minimal risk study because of the use of marketed products and standard optometric 
assessments or investigational lens /products/device. 
Contact lenses in this study will be worn on a daily wear basis, for approximately 15-30 minutes, 
on a single day only. Adverse events and/ or complications in daily wear of soft contact lenses 

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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. 
Fluorescein is used in this study to assess the ocular surface. Although rare, it is possible that 
participants may have an allergic reaction to the dye.  They will be advised of the fluorescein use 
in the consent document and will be instructed to advise the investigator if they have a known 
allergy to fluorescein. 
Additionally, it is possible that participants may experience temporary discomfort associated with 
the study procedures /products including: light sensitivity, dryness, and foreign body sensation.  
Some measurements will be conducted at close distance with the investigator (within 2m for 
some assessments). To reduce the risk of airborne illness (including COVID-19), CORE has 
implemented a series of on-site safety procedures, including maintaining physical distancing as 
much as possible, frequent handwashing, optional face masks, frequent room and equipment 
hygiene, and air filtration equivalent to medical examination rooms. 
Participants will not benefit directly from taking part in this study. This study may help the study 
sponsor to better understand the performance of the products being used in this study. 
7 
ADVERSE EVENTS 
See CORE SOP012 AE Reporting for a description of the reporting of adverse events. 
Any observations taking place prior to determining that a participant 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. 
Adverse events (AE) may be classified as ‘unanticipated adverse device effects,’ ‘serious 
adverse events,’ ‘significant adverse events,’ or ‘non-significant adverse events,’ as defined 
below, Table 4.   
A number of conditions may result in temporary suspension until resolution. These include 
corneal infiltrates, corneal staining, limbal injection, bulbar injection or tarsal conjunctival 
abnormalities.   
Table 4: Classification of types of adverse event 

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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. 
7.3 REPORTING ADVERSE EVENTS 
All potential Significant, Serious and Unanticipated Adverse Device Effects that are related or 
possibly related to participant’s participation will be reported to the Principal Investigator and the 
sponsor within 24 hours of the investigator becoming aware of the event.  The Investigator will 
report the event to the ORE as per 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). 
Sponsor contact details are:  
  
  
 
 
 
 
  
  
 
 
 
 
 
Details of all adverse events will be included in the study report. 
8 
DISCONTINUATION FROM THE STUDY 
Participants may be discontinued at the discretion of the investigator or sponsor in consideration 
of participant safety or protocol compliance, or at discretion of the participant.  
 
 
  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: 

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10 STATISTICAL ANALYSIS AND DATA MANAGEMENT 
10.1 STATISTICAL ANALYSIS 
All data will be analysed by CORE at the University of Waterloo.  Unmasked data analysis will 
be conducted using Statistica and / or SPSS, or other appropriate software.  Descriptive 
statistics will be provided on information regarding baseline variables (age, sex, etc.). Table 6 
lists the primary outcome variables and anticipated statistical procedures. 
 
 
. The OD data will be analysed for certain assessments that are conducted for 
each eye separately, for example 
lens fit. 
 
 
 

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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 during the transfer.  
10.3 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.  
11 PROTOCOL TRAINING 
All study personnel will be required to complete training prior to their involvement in the study. A 
series of training modules will be developed for the study and records of training will be kept at 
CORE. 
12 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 will be conducted by CORE personnel. Consent documentation will be 
reviewed by a person not involved in the consent process. To improve data integrity, data entry 
will be conducted by one person and a second person will visually compare the data entry to the 
source documents. All adverse events and protocol deviations will be reviewed by the Lead 
Investigator. All significant and serious adverse events and all major protocol deviations will be 
reviewed by the Head of Clinical Research and the Principle Investigator and reported to the 

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sponsor and the Office of Research Ethics at the University of Waterloo according to reporting 
requirements.. 
In addition study records may be inspected at CORE 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. 
13 STUDY MANAGEMENT 
13.1 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) (ICH E6 R2), with ISO 
14155:2020 Clinical Investigation of Medical Devices for Human Subjects, 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 Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use Guidelines for Good Clinical Practice 
• 
ISO 14155:2020 - International Organization for Standardization Clinical investigation of 
medical devices for human subjects – Good clinical practice 
• 
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 
(2022) 
• 
https://uwaterloo.ca/research/office-research-ethics/research-human-participants 
 
13.2 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. 
13.3 CLINICAL TRIAL REGISTRATION 
The sponsor will register this study with clinicaltrials.gov.  
13.4 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.  

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13.4.1 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 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. 
13.4.2 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).  
13.4.3 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 Board (CREB) at the next monthly meeting. 

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All protocol deviations (major and minor) occurring during the study will be documented and 
included in the final report. 
13.5 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. 
13.6 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. 
13.7 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 Clinical data management.  
 
14 REPORT 
A report will be sent to the sponsors according to terms described in the study contract. 
 
15 REFERENCES 
1. Navascues-Corago M, et al. Determination of the minimal clinically important difference 
(MCID) for contact lens-related subjective responses. BCLA Clinical Conference. 
Manchester 2023.