One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System
Phase: NA
Conditions: Myopia, Hyperopia
Sponsor: OTE North America

 
 
FINAL PROTOCOL 
VERSION 3.0  
 
One-month Clinical Evaluation of Oté Sensation 
Multi-Purpose Solution Care System 
 
SPONSOR: 
OTE North America 
 
STUDY NUMBER: 
OTES-3301 
 
DATE: 
10 July 2017 
 
PROPOSED START DATE: 
August 2017 
 
AUTHORS:  
Graeme Young 
 
 
Thomas Boyes  
VISIONCARE RESEARCH Ltd 
Craven House 
West Street 
Farnham 
Surrey GU9 7EN 
UK 
 
Visioncare Research Ltd. 
Author: Thomas Boyes 
Title: Senior CRA 
  
Signature: ___________________ 
Date: _____________ 
 
OTÉ North America 
Reviewed and approved:  
Name: Eric Sharvelle 
Title: V.P. Of Sales  
 
Signature: ___________________ 
Date: _____________ 
 
 
This copy is issued to: __________________________________ 

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CONFIDENTIAL 
DOCUMENT CHANGE HISTORY 
Revision 
Originator 
Description of Change(s) 
Date 
1.0 
Graeme Young 
Thomas Boyes 
Original Protocol 
31 May 2017 
2.0 
Thomas Boyes 
Section 5.3 amended 
21 June 2017 
3.0  
Thomas Boyes 
Sections  3.2, 5.3, 7.5 and 8.4 amended 
10 July 2017 
 
 
 

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One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System 
OTES-3301 
TABLE OF CONTENTS 
 
 
Page 
PERSONNEL AND FACILITIES 
5 
SYNOPSIS 
6 
1 
INTRODUCTION 
8 
2 
STUDY OBJECTIVES 
8 
2.1 
Primary Hypotheses 
8 
2.1.1 
Efficacy Hypotheses 
8 
2.1.2 
Safety Hypotheses 
8 
3 
STUDY DESIGN & RATIONALE 
9 
3.1 
Masking 
9 
3.2 
Randomization 
9 
4 
STUDY POPULATION 
10 
4.1 
Number of Sites 
10 
4.1.1 
Investigator Recruitment 
10 
4.2 
Number of Subjects 
10 
4.3 
Inclusion Criteria 
11 
4.4 
Exclusion Criteria 
11 
4.5 
Subject Identification 
12 
4.6 
Study Withdrawal Criteria 
12 
4.7 
Subject Replacement 
12 
4.8 
Subject Compliance 
12 
5 
MATERIALS 
12 
5.1 
Study Solutions 
12 
5.2 
Concomitant Care Products and Medications 
13 
5.3 
Study Contact Lenses 
14 
5.4 
Care Product Accountability 
15 
5.5 
Study Document and Case Report Forms 
15 
6 
TREATMENT 
15 
6.1 
Study Product Formulations 
15 
6.2 
Device Administration 
15 
7 
METHODS AND ASSESSMENTS 
16 
7.1 
Subject Recruitment 
16 
7.2 
Study Visits 
16 
7.2.1 
Visit Schedule 
16 
7.3 
Questionnaire 
17 
7.4 
Visit 1a: Baseline 
17 
7.5 
Visit 1b:  Lens Fitting and Dispensing 
18 
7.5.1 
Study Contact Lens Care Products 
19 
7.5.2 
Visit 2: 1-week Follow-up 
20 
7.5.3 
Visit 3: 1-month Follow-up 
21 
7.5.4 
Study Exit 
21 
7.5.5 
Study Lens Accountability 
21 
7.5.6 
Clinical Variables 
22 

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7.6 
Subject Discontinuation 
22 
7.7 
Unscheduled Visits 
23 
7.8 
Study Completion 
23 
7.9 
Site Training and Visits 
23 
8 
ADVERSE EVENTS 
23 
8.1 
Adverse Event Categorization 
24 
8.2 
Adverse Event Reporting 
25 
8.3 
Device-Related Adverse Event Documentation 
25 
8.4 
Adverse Event Follow-up 
26 
8.4.1 
Sponsor Safety Responsibilities 
26 
9 
DATA MANAGEMENT 
26 
9.1 
Electronic Case Report Forms/Data Collection 
26 
9.2 
Data Quality Assurance 
27 
9.3 
Data Entry and Storage 
27 
10 
SAMPLE SIZE AND STATISTICAL METHODS 
27 
10.1 
Sample Size Rationale 
27 
10.2 
Statistical Analysis Plan 
27 
10.3 
Interim Analysis 
29 
11 
GENERAL STUDY MANAGEMENT 
29 
11.1 
Relevant Standards 
29 
11.2 
Ethical Review 
29 
11.3 
Protocol Deviations 
29 
11.4 
Premature Termination of the Study 
30 
11.5 
Source Documentation 
30 
11.6 
Monitoring 
30 
11.7 
Audits 
31 
11.8 
Records Retention 
31 
11.9 
Confidentiality and Publication 
31 
12 
REFERENCES 
32 
13 
ABBREVIATIONS 
33 
APPENDIX 1   Template Enrolment Log (Sample) 
34 
APPENDIX 2  Template Kit-Box Accountability Form (Sample) 
35 
APPENDIX 3  Template Source Document Record (Sample) 
36 
APPENDIX 4  Grading Scales & Measurement Instructions 
37 
 
 

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One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System 
OTES-3301 
PERSONNEL AND FACILITIES 
SPONSOR: 
OTE North America,  
40 Bayview Ave,  
Inwood NY 11096 
USA  
Tel: +1 516 620 2857 
PROJECT CO-ORDINATOR: 
Eric Sharvelle  
OTE North America,  
Email: eric@oteamerica.com 
INVESTIGATORS:  
UK and US contact lens practitioners (listed 
separately) 
STUDY LOCATION: 
Approximately 10 sites in the UK and US (3-5 UK 
and 5-6 US) - listed separately 
CLINICAL RESEARCH ORGANISATION: 
Visioncare Research Ltd 
 
Craven House 
West Street 
Farnham 
Surrey GU9 7EN 
UK 
Tel:  +44 1252 718719 
Fax: +44 1252 718720 
MEDICAL MONITOR: 
Graeme Young MPhil PhD FCOptom DCLP FAAO 
Visioncare Research Ltd 
Tel: +44 1252 718719  
24-hour Tel:  +44 7887 564320 
Email: g.young@visioncare.co.uk 
BIOSTATISTICIAN: 
Chris Hunt MSc 
Visioncare Research Ltd  
Tel:  +44 1252 718719 
Email: c.hunt@visioncare.co.uk 
DATA MANAGER: 
Gordon Adnams 
Visioncare Research Ltd  
Tel:  +44 1252 718719  
Email: g.adnams@visioncare.co.uk  
 
 

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One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System 
OTES-3301 
SYNOPSIS 
OBJECTIVES: 
To test whether the Oté Sensation multi-purpose solution is 
substantially equivalent to another multi-purpose solution (Bausch & 
Lomb BioTrue® multipurpose solution). 
STUDY DESIGN: 
One-month, 
approximately 
200-subject, 
double-masked 
(care 
product), bilateral, randomized, comparative study.  Subjects will be 
randomly assigned to use either the test or control solution. 
TEST PRODUCT: 
Oté Sensation multi-purpose solution care system and Oté storage 
case (Oté Pharma, Uden, Nederland)  
Constituents:   PHMB 0.00002%, Polyquaternium-2 0.0001%, Sodium 
hyaluronate  
The user instructions will include a rub and rinse step. 
CONTROL PRODUCT: 
Bausch & Lomb BioTrue multipurpose solution and B&L storage case. 
A sterile, isotonic solution that contains hyaluronan, sulfobetaine, 
poloxamine, boric acid, sodium borate, edetate disodium and sodium 
chloride 
and 
preserved 
with 
a 
dual 
disinfection 
system: 
polyaminopropyl biguanide 0.00013% and polyquaternium 0.0001%. 
This will be used with a rub and rinse step. 
CONTACT LENSES: 
The following six lens types will be used to represent a cross-section 
of lenses in use:  ACUVUE® 2, ACUVUE® VITA® (Johnson & Johnson 
Vision Care), Air OPTIX® (Alcon), Biofinity®, Clariti (CooperVision), 
PureVision® (Bausch & Lomb) 
Approximately 33 subjects will be allocated to use each lens type: 22 
using the test MPS product and 11 using the control product. Each site 
will use four lens types. 
NO. OF SITES: 
Approx. 10 (3-5 UK and 5-6 US) sites.  Each site will enroll approx. 20 
subjects.  
NO. OF SUBJECTS: 
Total approx. 200 subjects (400 eyes), approx. 20 subjects/site. The 
aim is for at least 180 subjects to complete the study; 30 in each lens 
group (20 using the test solution and 10 using the control solution). 
 
 
Test Group 
Control Group 
Total 
Subjects 
Site 1 to 10 
~14 
~7 
~20 
Total 
133 
67 
200 
 

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STUDY POPULATION: 
Volunteer subjects will be currently adapted soft contact lens wearers 
(>1 month of lens wear), be at least 18 years of age with contact lens 
sphere power requirement in the range +4.00 to -8.00D and refractive 
astigmatism of less than or equal to 0.75D in each eye.  
VARIABLES: 
Comfort (0-10)  
Average wearing time (WT), comfortable WT (hrs.) 
Visual acuity (Snellen/logMAR) 
Slit lamp findings, including corneal edema, limbal and bulbar 
hyperemia, vascularization, palpebral hyperemia and roughness, 
corneal staining, conjunctival staining, etc. (0-4) 
Lens surface wettability (0-4) 
Lens surface deposits (0-4, no. of spots) 
Adverse events 
IN VITRO MEASUREMENTS: Deposit analysis in dark field illumination using a modified version of 
the method of Lowther et al (ICLC 1991;18:219-26) on approx. 60 
lenses. 
VISITS/SCHEDULE: 
There will be four scheduled visits (visit 1a and 1b may be conducted 
on the same day): 
Visit 1a: Baseline 
Visit 1b: Lens issue 
Visit 2: 1 week follow-up (7 days ±3 days) – WT 1-3 hours 
Visit 3:  1 month follow-up (30 days ±4 days) 
STUDY END POINTS 
a)  Safety Endpoints: Non-inferiority of slit lamp findings: limbal 
hyperemia, bulbar hyperemia, and corneal staining. 
 
b)  Efficacy Endpoints: Non-inferiority of comfort, visual acuity, 
surface wettability, lens deposits. 
 
 
 

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1 
INTRODUCTION 
The contact lens (CL) care product Oté Sensation is a multi-purpose soft contact lens solution 
applicable to all soft contact lenses and is intended for cleaning, disinfection, rinsing and 
storage of lenses.   
The product is CE-marked and has been marketed in Europe since January 2011.  The product 
contains constituents already used in FDA-approved multipurpose solutions.  The disinfecting 
agents are polyheximethylene biguanide (PHMB) and polyquaternium which are widely used in 
other multi-purpose solutions, including BioTrue® (Bausch & Lomb). 
There has been extensive pre-clinical testing to demonstrate sufficient safety and efficacy of 
the test solution, and scientific justification for conducting this clinical study (see Investigator 
Brochure). 
The purpose of this study is to evaluate the clinical performance of the contact lens care product 
Oté Sensation in a representative population of soft contact lens wearers.  For comparison, the 
widely used soft lens multipurpose solution, BioTrue (Bausch & Lomb) will be used as a control.  
This control product has been tested in previous clinical trials.2-4 
2 
STUDY OBJECTIVES 
To test whether the Oté Sensation multi-purpose solution is substantially equivalent to another 
multi-purpose solution (Bausch & Lomb BioTrue). 
2.1 
Primary Hypotheses 
2.1.1 
Efficacy Hypotheses 
The Oté Sensation multi-purpose solution will be non-inferior to the Bausch & Lomb BioTrue 
solution in terms of: 
Comfort (0-10), a non-inferior bound of 1.0 will be used. 
Visual acuity (logMAR VA), a non-inferiority bound of 0.05 will be used 
Wettability (0-4), a non-inferior bound of 0.5 will be used. 
Deposits (in situ 0-4), a non-inferior bound of 0.5 will be used. 
2.1.2 
Safety Hypotheses 
The Oté Sensation multi-purpose solution will be non-inferior to the Bausch & Lomb BioTrue 
solution in terms of: 
Corneal staining – type (mean grade, 0-4), a non-inferior bound of 0.5 will be used. 
Limbal hyperemia (grade, 0-4), a non-inferior bound of 0.5 will be used. 
Bulbar hyperemia (grade, 0-4), a non-inferior bound of 0.5 will be used. 

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3 
STUDY DESIGN & RATIONALE 
This will be a 1-month, 200-subject, double-masked (care product), bilateral, randomized, 
comparative study.  Subjects will be clinically evaluated at the initial baseline visit (Visit 1), then 
after 1 week and 1 month of lens wear having been randomly assigned to use one of six lens 
types and either the test or control solution. 
The risks and benefits to the subjects taking part in this study are detailed in the Informed 
Consent Form. 
3.1 
Masking  
To prevent bias, several steps will be taken to keep the investigators and subjects masked to 
the identity of the assigned solution: 
 
Subjects will be identified by subject numbers, which are unrelated to study solution 
assignments. 
 
Solution bottles will be over-labelled (‘A’, ‘B’ or ‘C’) and packaged in kit-boxes so that the 
identity of the study solution is not revealed.  Therefore, investigators must only dispense 
solutions for the study that have been provided by the sponsor or clinical research 
organisation (CRO). 
 
If for any reason the investigator needs to be unmasked to the solution type that the study 
subject is using, they should follow the decoding procedures which will be present in the 
investigator study binder. 
If required, for purposes of a subject’s safe clinical management, the investigators will be able 
to learn the identity of the solution being used by contacting the study Clinical Research 
Associate (CRA). 
3.2 
Randomization 
Subjects will be randomly assigned to use either the test or control solution. Two codes will be 
used for the test product and one code for the control so there are equal numbers of bottles of 
each code (‘A’, ‘B’ or ‘C’). Subjects will also be randomly assigned to a lens type. 
A random number generator (Microsoft Excel) will be used to determine the randomization of 
solutions and lens types.  Each eligible subject will randomly be assigned to one of the lens 
care products and lens types using a blocking method and stratified by site. All sites will use 
both the test and control solutions. Each site will only use four of the six study lens types.   
The randomization will be performed in stages.  Firstly, the sites will be randomly assigned to 
four of the six study lens types.  Secondly, subjects will be randomly allocated, by site, to one 
of the four lens types in blocks of four subjects.  Thirdly, subjects within each site and lens type 
will be randomly allocated to one of the three solution codes (2 x Test, 1 x Control) in blocks of 
three subjects.   
Subject ID numbers will be assigned consecutively to maintain randomization. 

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4 
STUDY POPULATION 
4.1 
Number of Sites 
Approximately ten sites located in the UK and the US each recruiting approximately 20 
subjects/site (up to a maximum of 24 subjects/site).  Investigators will be contact lens 
practitioners with at least three years’ post-registration experience of contact lens practice. 
4.1.1 
Investigator Recruitment 
Investigational sites will be identified by Visioncare Research.  The Investigators will be required 
to fulfil the following criteria: 
 Appropriately licensed eye care practitioner or contact lens optician 
 At least three years, post-registration contact lens fitting experience. 
 In-office email. 
 Willingness to follow the study protocol and to co-operate with the study monitors. 
 Experienced investigators trained in Good Clinical Practice (GCP) and the study protocol 
prior to commencing the study.  
 Computers available to complete CRFs using electronic data capture (EDC). 
 
All of the investigational sites will be trained and evaluated by on-line training modules before 
enrolling subjects.  
This clinical study is designed to be in conformance with the ethical principles in the Declaration 
of Helsinki, with the ICH guidelines for GCP and all applicable local regulations. 
4.2 
Number of Subjects 
Approximately 200 subjects will be enrolled in the study.  Of these, approximately 133 subjects 
will use the test solution (Oté Sensation) and 67 subjects will use the control solution (Bausch 
& Lomb BioTrue). 
Each subject will be required to attend up to four scheduled study visits over a period of 
approximately 1 month.  
Subjects will be currently adapted soft contact lens wearers and will be recruited from the sites’ 
existing patient database or via REC/IRB approved recruitment material. The anticipated 
enrolment period for the study is approximately 5 weeks. 
The study population has been chosen to represent the range of patients that may use this 
multipurpose solution type. 

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4.3 
Inclusion Criteria 
Subjects must satisfy the following conditions prior to inclusion in the study: 
i. 
Be a currently adapted soft contact lens wearer (>1 month of lens wear). 
ii. 
Be at least 18 years of age. 
iii. 
Refractive astigmatism <0.75D in both eyes. 
iv. 
Have clear corneas and be free of any anterior segment disorders. 
v. 
Be correctable through spherocylindrical refraction to 6/12 (20/40) (0.30 LogMAR) or 
better in each eye. 
vi. 
Contact lens sphere requirement between +4.00D and -8.00D (inclusive).  
vii. 
Require visual correction in both eyes (monovision allowed, no monofit). 
viii. 
Have normal eyes with no evidence of abnormality or disease.  For the purposes of this 
study a normal eye is defined as one having: 
a. No amblyopia 
b. No strabismus 
c. No evidence of lid abnormality or infection 
d. No conjunctival abnormality or infection that would contraindicate contact lens wear 
e. No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, 
staining, scarring, vascularization, infiltrates or abnormal opacities) 
f. 
No other active ocular disease. 
4.4 
Exclusion Criteria 
Any of the following will render a subject ineligible for inclusion: 
i. 
Require toric or multifocal contact lenses. 
ii. 
Previously shown a sensitivity to any of the study solution components. 
iii. 
Any systemic or ocular disease or allergies affecting ocular health. 
iv. 
Using systemic or topical medications that will in the investigator’s opinion affect ocular 
physiology or lens performance. 
v. 
Clinically significant (>Grade 3) corneal staining, corneal stromal edema, corneal 
vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other 
abnormality of the cornea that would contraindicate contact lens wear. 
vi. 
Any corneal infiltrates or any corneal scarring or neovascularization within the central 
5mm of the cornea. 
vii. 
Keratoconus or other corneal irregularity. 
viii. 
Aphakia or amblyopia. 
ix. 
Have undergone corneal refractive surgery or any anterior segment surgery. 

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x. 
Abnormal lacrimal secretions. 
xi. 
Has diabetes. 
xii. 
Known/reported 
infectious 
disease 
(e.g., 
hepatitis, 
tuberculosis) 
or 
an 
immunosuppressive disease (e.g., HIV). 
xiii. 
History of chronic eye disease (e.g. glaucoma). 
xiv. 
Pregnant or lactating or planning a pregnancy at the time of enrolment. 
xv. 
Participation in any concurrent clinical trial or in last 30 days. 
4.5 
Subject Identification 
Subjects will be identified by a four-digit code made up of the site number and their enrolment 
number. 
The enrolment ID must be assigned to the subjects sequentially. Enrolment numbers will be in 
ascending order for each site. Thus, the first subject to be enrolled at Site 1 will be 01/01, the 
second 01/02 and so forth.  The first subject to be enrolled at Site 2 will be 02/01, the second 
02/02 and so on.  No ID can be used more than once and enrolment is recorded on the 
Enrolment Log (Appendix 1).   
4.6 
Study Withdrawal Criteria 
If during the study it becomes evident to either the Sponsor or the Clinical Research 
Organisation (Visioncare Research) that the study test solution (Oté Sensation) poses a threat 
to subject well-being, the study will be terminated.  The REC/IRB will be advised of the reason 
for termination.   
4.7 
Subject Replacement 
Subjects that are discontinued or drop out of the study will not be replaced. 
4.8 
Subject Compliance 
To track compliance, subjects will be questioned at each of the follow-up visits about: their lens 
cleaning regimen, average contact lens wearing times (typical insertion and removal times), 
average number of days lenses are worn per week and their contact lens solution usage.   
Subjects will also be asked to return their remaining solution at the end of the study. 
5 
MATERIALS 
5.1 
Study Solutions 
The contact lens care systems that will be used in this study are recorded in Table 1. The 
solutions will be over-labelled and secured in kit-boxes.  

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Table 1:   Care Product Details  
 
Test  
Control  
Brand 
Oté Sensation 
Bausch & Lomb BioTrue® 
Manufacturer 
Oté Pharma,  
Vluchtoord 38  
5406 XP Uden 
Nederland 
Bausch & Lomb U.K., Ltd. 
106 London Road 
Kingston-Upon-Thames 
Surrey KT2 6TN  
UK 
Disinfectant 
polyaminopropyl biguanide 
0.00002%, 
polyquaternium-2 0.0001% 
polyaminopropyl biguanide 
0.00013%, 
polyquaternium-1  0.0001% 
Wetting and 
other agents 
sodium hyaluronate 
hyaluronan,  
sulfobetaine, poloxamine, 
boric acid, sodium borate, 
EDTA 
Bottle size 
300 or 360 ml 
Lens case 
Oté lens case 
 B&L lens case 
CE Mark 
Yes 
Yes 
Subjects will be given a leaflet explaining the care system regimen and instructions.  A rub and 
rinse step is included in the required regimen for both the test and control multipurpose 
solutions. 
The solution bottles will be over-labelled and the subjects and investigators will be masked to 
the solution type. 
Both solutions will be provided to the sites in sealed kit-boxes by the sponsor’s representative 
(Visioncare Research) and all boxes containing the study care solutions must be fully 
accounted for. 
5.2 
Concomitant Care Products and Medications 
Subjects must only use the care products issued by the Investigator.  Subjects will be instructed 
to use no other lens care products (e.g. daily cleaner solution or protein remover), unless 
absolutely necessary.  If rewetting drops are required, investigators should dispense 
preservative-free, unit dose wetting drops (e.g. AMO Blink™ Contacts Vials). All unused 
solutions (empty, unopened or partially used bottles) will be returned to the investigator during 
Visit 3.   
All medications (prescription and over the counter) that the subjects are taking at enrolment will 
be documented on the eCRF at baseline, including supplements such as vitamins and minerals, 
and/or herbs taken by the participant.  

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5.3 
Study Contact Lenses 
Subjects will be randomly allocated to use one of six lens types (Table 2). Approximately 33 
subjects will be allocated to use each lens type: approximately 22 using the test MPS product 
and 11 using the control product.  
Each investigational site will use four of the six lens types (e.g. Types 1,2,3,4 or Types 1,2,5,6 
or Types 3,4,5,6). Each site will utilise a stock of lenses so that, where possible, subjects may 
be dispensed lenses at the first visit.  However, if the appropriate lenses are not immediately 
available, a second visit (Visit 1b) will be scheduled. 
One of the lenses (Acuvue 2) is recommended for 2-weekly replacement.  For these subjects, 
spare lenses will be issued during the Baseline visit with instructions for replacement. 
In the event of lens loss or damage, replacement lens(es) will be issued at an unscheduled 
visit. 
Table 2:   Contact Lens Details  
 
Type 1 
Type 2 
Type 3 
Type 4 
Type 5 
Type 6 
Brand 
ACUVUE® 2 
PureVision® 
Clariti 
ACUVUE® 
VITA® 
Air OPTIX® 
Biofinity® 
Manufacturer 
Johnson & 
Johnson 
Vision Care 
Bausch & 
Lomb 
CooperVision 
Johnson & 
Johnson 
Vision Care  
Alcon 
CooperVision 
Material type 
Conventional 
hydrogel 
SH ionic, 
plasma 
oxidation 
surface 
treatment 
SH non-ionic, 
not surface 
treated, high 
water 
Silicone 
hydrogel 
(SH) non-
ionic, not 
surface 
treated; 
contains PVP 
SH non-ionic, 
surface 
modification 
by plasma 
polymerization 
SH non-ionic, 
not surface 
treated; 
contains 
monomer n-
vinyl 
pyrrolidone 
Material  
etafilcon A 
balafilcon A  
somofilcon 
A   
senofilcon 
C  
lotrafilcon B 
comfilcon A 
Water 
content 
58% 
36% 
56% 
41% 
33% 
48% 
FDA Group  
Group 4  
Group 5A  
Group 5B 
Group 5Cr 
Group 5Cm 
Group 5C 
Base curve / 
Diameter 
(mm) 
8.30, 8.70 / 
14.0 
8.60 / 14.0 
8.40 / 14.1 
8.40 / 14.0 
8.60 / 14.2 
8.60 / 14.0 
Replacement 
period 
2-weekly 
Monthly 
Monthly 
Monthly 
Monthly 
Monthly 
Powers (D) 
+4.00 to -8.00 
 

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5.4 
Care Product Accountability 
Kit-box (containing study care product) Accountability forms and Lens Foil Logs will be kept by 
each site.  A sample Kit-box Accountability form is shown in Appendix 2. 
To monitor care product usage, any remaining unused study solution will be returned to the 
investigator at Visit 3 (empty, unopened or partially used).  The returned kit-boxes will be 
recorded on the Kit-box Accountability Logs.  
5.5 
Study Document and Case Report Forms 
The following forms will be completed where appropriate: 
eCRFs: 
 
Baseline Visit 
 
Eligibility Checklist 
 
Dispensing Visit  
 
Follow-up Visit  (1 week, 1 month) 
 
Unscheduled Visit 
 
Adverse Event Form 
 
Study Exit Form 
Additional Forms 
 
Statement of Informed Consent 
 
Participant Information Sheet 
 
Enrolment Log 
 
Participant Information Guide 
 
Kit-box Accountability Log 
 
Source Document Record Label 
Any corrections that need to be made to the essential study documents should be neatly 
crossed through such that the original entry can still be seen, the new entry written in, and the 
correction initialed and dated. 
6 
TREATMENT 
6.1 
Study Product Formulations 
The study solutions are to be used in place of habitual contact lens care solutions and will be 
randomly assigned to the study subjects in labelled kit-boxes.    
6.2 
Device Administration 
The lenses will be used on a daily wear re-usable, monthly or 2-weekly replacement basis, i.e. 
lenses worn during the day, removed at night and cleaned and stored with appropriate contact 
lens care products.   
The care systems will be used according to the Patient Information Guide. 

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7 
METHODS AND ASSESSMENTS 
7.1 
Subject Recruitment 
Recruitment materials (adverts, letters, etc.) must be approved by the Research Ethics 
Committee (REC) or Investigational Review Board (IRB).  VCR will provide an approved 
advertisement, letter and telephone script for recruitment purposes.  Any changes to these must 
be submitted back to the REC/IRB via VCR. 
The procedures listed below will be conducted on all subjects.  Variables must be collected in 
the order they are listed on the eCRF.   
To participate in this clinical study, the Investigator will explain the Statement of Informed 
Consent to the subject, ensure each subject understands the subject instructions and determine 
subject eligibility.  
The Investigator is required to answer any questions the subject has concerning the study or 
the information contained in the Statement of Informed Consent and Patient Information Sheet. 
A subject is considered enrolled when he or she signs the Statement of Informed Consent.  
Other study-related may not be activities undertaken prior to obtaining informed consent. 
All subjects enrolled should be accounted for, even if they are not dispensed lenses or study 
product.  A signed Statement of Informed Consent constitutes enrolment.  After enrolment, a 
subject is considered active and should be accounted for at every visit until the completion of 
or discontinuation from the study. 
Each site will be expected to enroll approximately 20 subjects, up to a maximum of 24 subjects.   
7.2 
Study Visits 
7.2.1 
Visit Schedule 
There will be a maximum of four scheduled visits as follows: 
Visit 1a: Baseline 
Visit 1b: Lens issue (may be combined with Visit 1a) 
Visit 2: 
1 week follow-up (7 days ±3 days) – WT 1-3 hours 
Visit 3:  1 month follow-up (30 days ±4 days) 
A visit schedule form will be supplied to all sites which will list the visit windows and this can 
assist in arranging visits within the acceptable visit window. 
The investigator should confirm with the subject that they are able to attend the follow-up visits 
within the visit window before enrolling them in the study.  If, in extreme situations (sickness, 
unforeseen circumstances), the subject can only attend outside the visit window, the 
investigator should discuss with the CRA whether this visit can be considered a scheduled visit.  

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The 1-week, and 1-month follow-up visits may only take place when the subject attends wearing 
their lenses.  If this is not the case and the subject is not experiencing any problems with their 
lenses or the study solutions, the appointment will be rescheduled, ideally within the visit 
window unless they are experiencing difficulty. 
7.3 
Questionnaire 
At the 1 month visit, subjects will be asked a small number of questions about their experience 
with the study care product.  The responses will be entered by the investigator into the eCRF. 
7.4 
Visit 1a: Baseline 
The subjects should attend the first visit wearing their habitual lenses.  
If they are not wearing their lenses, reschedule the visit. 
The following procedures will be conducted on all subjects: 
i. 
Allow the subject to read the Participant Information Sheet and Informed Consent and 
explain the nature, purpose, risks of the study etc.  If he/she is agreeable, ask the 
subject to sign the Informed Consent Form and initial where appropriate. The 
investigator (or person taking the consent) should also sign the consent form.  Provide 
the subject with a copy and retain the original. 
ii. 
The subject is assigned with a Subject ID number according to the Enrolment Log. 
Subjects must be enrolled sequentially.  Enter details on Enrolment Log as outlined on 
the form. 
Baseline Measurements and Eligibility:  
The following baseline measurements will be recorded on the Baseline eCRF: 
i. 
Subject demographics (age, sex, medications and associated medical history, 
allergies) 
ii. 
Habitual lens comfort (on insertion, during the day and prior to removal, 0-10)  
iii. 
Symptoms, problems and complaints 
iv. 
Vision 
 
Subjective vision quality: distance (0-10 scale) 
 
Monocular high contrast (HC) visual acuity (VA) with CLs ( Snellen/logMAR to the 
nearest letter) 
 
Spherical over-refraction (SOR) 
 
Monocular and binocular HC DVA with SOR 
v. 
Wearing times – habitual lenses: 
 Wearing time at visit 
 Typical insertion time 
 Typical removal time 
 Typical time CL comfort deteriorates 
 Maximum wearing time in last month (hrs.) 
 Days worn per week 
vi. 
Details of habitual lenses and care system: 
 Lens brand 
 Care system brand 

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vii. 
Rewetting drop usage (type and frequency),  
viii. 
Lens surface characteristics - habitual lenses 
 Lens surface wetting (0-4) 
 Lens deposits (film: 0-4; no. of white spots) 
ix. 
Lens fit - habitual lenses 
 Centration (0-2) 
 Corneal coverage (Y/N) 
 Post-blink movement (0-4) 
 Tightness on push-up (0-4) 
 Overall fit acceptance (0-4) and reason if Grade 2 or less. 
x. 
Remove habitual lenses  
xi. 
Full ocular health 
xii. 
Monocular sphero-cylindrical refraction and monocular HC distance VAs (logMAR or 
Snellen to the nearest letter)  
xiii. 
Biometry:  Horizontal visible iris diameter (HVID), palpebral aperture (PA), 
keratometry (D/mm) 
xiv. 
Slit lamp examination  
 Limbal hyperemia (0-4) 
 Bulbar hyperemia (0-4) 
 Stromal edema (0-4) 
 Vascularization (0-4) 
 Palpebral conjunctival hyperemia (0-4) 
 Upper palpebral roughness (0-4) 
 Corneal staining by sector (type 0-4) 
 Conjunctival fluorescein staining by quadrant (0-4) 
 Other findings (0-4) 
See Appendix 4 for grading scales and measurement instructions. 
xv. 
Complete the eligibility checklist 
If at this point the subject is found to be ineligible, then complete an Exit eCRF and exit the 
subject from the study. 
If eligible, the subject will be assigned to one of the four lens types allocated to the site and 
assigned to one of the study solutions.  
7.5 
Visit 1b:  Lens Fitting and Dispensing  
The subjects will undergo a trial fit with the randomly allocated study lens type.  If the 
appropriate study lenses are not available, a dispensing visit will be scheduled for another day.   
i. 
Slit lamp – confirm continued eligibility if on a different day 
ii. 
Record the parameters of the lenses on the Dispensing eCRF (lens type / lot number, 
lens parameters, etc.). 
The performance of the lenses should be assessed after 10-15 minutes settling time and the 
following variables will be assessed:   
iii. 
Subjective comfort (0-10) 

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iv. 
Vision 
 
Monocular HC DVA (with CL) 
 
Spherical over-refraction (SOR) 
 
Monocular HC DVA with SOR 
 
Binocular distance VA with CLs (Snellen/logMAR  to the nearest letter) 
v. 
Surface characteristics 
 
Lens surface wetting (0-4) and reason if Grade 1 or less.  
vi. 
Lens fit 
 
Centration (0-2) 
 
Corneal coverage (Y/N) 
 
Post-blink movement (0-4) 
 
Tightness on push-up (0-4) 
 
Overall fit acceptance (0-4) and reason if Grade 2 or less. 
To be successfully dispensed, subjects must show >Grade 2 lens fit acceptance with the trial 
lens and must be correctable to 6/12 (20/40) (0.30 LogMAR) or better in each eye. Trial lenses 
must also show >Grade 1 wettability.  
Modifications to optimize the lens power will be allowed. 
If the lens fit is acceptable, the investigator will issue the care system (Kit-box containing 
solution, lens case and instructions) that the subject was randomized to, and complete the Kit-
box Accountability Log.  All kit-boxes must be accounted for, even if they are not dispensed.  
vii. 
The subject will be instructed to wear the lenses on a daily wear basis (at least 8 hours 
a day, 6 days per week) until the 1-week follow-up appointment, unless they experience 
a problem which warrants lens removal. In this case the subject should contact the 
investigator. 
viii. 
The investigator or a clinical assistant will review the Participant Information Guide with 
the subject, which describes the procedures for contact lens wear, lens care, handling, 
cleaning and disinfecting.  Any subject, who does not follow instructions to a degree 
that, in the Sponsor or Investigator's opinion, jeopardizes the subject's wellbeing or the 
validity of the study, will be discontinued. 
ix. 
The investigator will complete the Source Document Record (Appendix 3).  
7.5.1 
Study Contact Lens Care Products 
Eligible subjects will receive a kit-box containing either the test or control multi-purpose solution 
as indicated during Randomization. The kit-boxes allocated to each subject must be recorded 
on the Kit-box Accountability Log. 
If a subject proves intolerant to any of the products, then the subject will be discontinued and 
an Exit form will be completed. 

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7.5.2 
Visit 2: 1-week Follow-up  
The 1-week follow-up visit will be scheduled 1 week (7 days ±3 days) from the lens dispensing 
date.  The subject should wear the lenses 1 to 3 hours prior to the appointment.  This has been 
shown to be the time period when solution-induced corneal staining is most evident.5   If the 
subject attends without lenses or with more than 3 hours of lens wear on that day and they are 
not having any problems with their lenses or the study solution, the visit should be rescheduled, 
if possible within the visit window. 
The following clinical test variables will be recorded on the Follow-Up Visit eCRF: 
i. 
Wearing times: 
 
Days worn since last visit 
 
Typical insertion time 
 
Typical removal time 
 
Typical time CL comfort deteriorates 
 
Maximum wearing time since last visit (hrs.) 
 
Wearing time today (hrs.) 
ii. 
Rewetting drop usage (type and frequency) 
iii. 
Symptoms, problems and complaints 
iv. 
Subjective assessments 
 Overall comfort on insertion, during the day and prior to removal (0-10) 
v. 
Vision 
 Subjective vision quality: distance (0-10 scale). 
 Monocular VA (CL, Snellen/logMAR to the nearest letter) 
 Spherical over-refraction (SOR) 
 Monocular HC DVA with SOR 
 Binocular distance VA with CLs  
vi. 
Lens surface characteristics 
 Lens surface wetting (0-4) 
 Lens deposits (film: 0-4, no. of white spots) 
vii. 
Lens fit 
 Centration (0-2) 
 Corneal coverage (Y/N) 
 Post-blink movement (0-4) 
 Tightness on push-up (0-4) 
 Overall fit acceptance (0-4) and reason if Grade 2 or less 
viii. 
Remove lenses and store in sterile saline 
ix. 
Slit lamp examination  
 Limbal hyperemia (0-4) 
 Bulbar hyperemia (0-4) 
 Stromal edema (0-4) 
 Vascularization (0-4) 
 Palpebral conjunctival hyperemia (0-4) 
 Upper palpebral roughness (0-4) 
 Corneal staining (type 0-4) 
 Conjunctival fluorescein staining by quadrant (0-4) 
 Other findings (0-4) 
See Appendix 4 for grading scales and measurement instructions. 

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Rinse away fluorescein with non-preserved saline.  
Re-insert study lenses. 
7.5.3 
Visit 3: 1-month Follow-up  
The 1-month follow-up visit will be scheduled 4 weeks (30 + 4 days) from the dispensing date. 
The subjects should wear the lenses for a minimum of 2 hours prior to the appointment. If the 
subject attends without lenses or with less than 2 hours of lens wear on that day and they are 
not having any problems with their lenses or the study solution, the visit should be rescheduled, 
if possible within the visit window.  
The subject will be asked a small number of questions relating to the study care solution.  
The same assessments will be followed as at the 1-week visit and will be recorded on the 
Follow-Up Visit eCRF.  At the UK sites (if requested) worn lenses will be retrieved for return to 
Visioncare Research for in vitro analysis. 
The kit-boxes containing any remaining study solution will be collected from the subjects.  The 
Kit-box accountability log will be completed and the kit-boxes returned to Visioncare Research 
at the end of the study. 
7.5.4 
Study Exit 
The Study Exit Form must be completed when a subject exits the study.  This will occur either 
at study completion, i.e. at the 1-month visit, or if the subject is discontinued from the study at 
another time.  A Study Exit eCRF must be completed for all subjects who have signed a consent 
form.  The exit date should also be recorded on the subjects named patient notes i.e. the Source 
Document Record.   
At the study Exit Visit the following measurements are taken: 
i. 
Monocular sphero-cylindrical refraction. 
ii. 
Monocular distance high contrast visual acuity (Snellen/logMAR) with sphero-
cylindrical refraction. If VA is 2 or more lines worse than at Baseline, the reason will be 
recorded on the Study Exit eCRF. 
If the subject is being exited without completing the full study schedule, further details need to 
be recorded on the exit form.  This is described in Section 7.6 below. 
7.5.5 
Study Lens Accountability 
At the end of the study, worn study lenses will be returned to Visioncare Research (UK sites 
only) in cases labelled with the subject ID number and date of retrieval.  Any remaining care 
solutions will be returned in the kit-boxes along with the completed Kit-box accountability form. 
Accountability of kit-boxes, and lenses ordered, received, dispensed or otherwise disposed of 
will be conducted at the end of the trial.  

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7.5.6 
Clinical Variables 
A full assessment of ocular health will be performed at the Baseline Visit. 
Table 3 summarizes the clinical measurements to be taken at each visit: 
Table 3: 
Summary of clinical measurements 
 
Baseline 
Dispensing 
Follow-up 
(1-week, 
1-month) 
Exit 
 
Visit 1a 
Visit 1b 
Visits 2 & 3 
 
Sphero-cylindrical refraction 




Best corrected (sphero-cyl) 
Monocular VA  

 
 

Keratometry/ Topography 

 
 

Wearing time 

 

 
Comfort (on insertion, during the 
day, prior to removal) 

 

 
Symptoms, problems & complaints 
 
 

 
Vision quality 

 

 
Subjective assessments  
 
 

 
Monocular HC DVA  
 


 
Spherical over-refraction (SOR) 



 
Monocular HC DVA with SOR 
 


 
Binocular distance VA with CLs 
 


 
Lens fit assessments 
 


 
Lens surface (wetting, deposits) 
 
 

 
Slit lamp findings 

if required 

 
7.6 
Subject Discontinuation 
Subjects will be discontinued from the study in the event of any of the following occurring: 
i. 
Unacceptable subjective discomfort (i.e. lens cannot be tolerated or worn) 
ii. 
Unacceptable slit lamp findings (i.e. clinically significant, Grade 3 or 4) 
iii. 
Unacceptable fit (i.e. lens too tight or too loose) 
iv. 
At the discretion of the investigator or the subject 
In the event of discontinuation, the Study Exit eCRF must be completed and the study exit date 
recorded on the source document record.  The investigator will indicate the primary reason for 
discontinuation by selecting one of the boxes provided on the Exit eCRF.  Further details can 
be provided in the ‘comments’ section if necessary. 

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7.7 
Unscheduled Visits 
An unscheduled visit is defined as any follow-up that occurs outside the visit window of the 
scheduled visit.  A visit is also classified as unscheduled if the subject is seen a second time 
within the scheduled visit window. 
Investigators should try as far as possible to schedule follow-up visits within the window.  If this 
is not possible, and the visit falls outside the window, a protocol deviation eCRF will be 
completed to document. The investigator might also judge that a follow-up visit is in the best 
interest of the subject and schedule two visits within the same window, e.g. follow-up of an 
adverse event.  Unscheduled visits are also made available anytime at the subject’s request.  
Unscheduled visits will be recorded on the follow-up eCRF.  All variables listed on the 
Unscheduled Visit must be completed unless the subject exhibits a condition that prohibits the 
completion of a full visit.  If this is the case, a written explanation is required in the comments 
section (e.g. not using solution due to discomfort after use). 
Presenting VA and slit lamp variables must always be completed and the reason for the visit 
and any actions taken must be indicated in the ‘comments’ section. 
7.8 
Study Completion 
The study is completed when all subjects have finished the 1-month Visit or have been 
discontinued. 
Worn study lenses will be retrieved from the subjects and, if requested, returned to Visioncare 
Research in appropriately labelled cases.  Lenses to be returned will be stored in saline and 
refrigerated until shipping.  Similarly, any remaining care solutions will be returned in the kit-
boxes along with the completed Kit-box Accountability Form. 
7.9 
Site Training and Visits 
A site evaluation will take place during a visit to the site (with the exception for sites that have 
a valid onsite Site Evaluation Visit conducted within the past two years).  Additional clinical 
training will be conducted by online training which will include an audio PowerPoint presentation 
and multiple-choice questions.   
Monitoring visits will be documented in the Monitoring Plan which is a separate document.  
8 
ADVERSE EVENTS 
An adverse event (AE) is defined as an undesirable clinical occurrence whether it is considered 
to be device-related or not.  All adverse events regardless of whether device-related or not, will 
be monitored and reported on throughout the study.  Possible adverse events are summarized 
in Table 4 below. 
The investigator will be required to judge whether or not an adverse event is device-related.  
Reoccurring device-related events from the same subject are usually tabulated as separate 
events.  In the case where more than one diagnostic finding is associated with an adverse 

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event, the event will be counted as one event and categorized under the most significant of the 
findings. 
The investigator will be required to report all adverse events to the study CRO and all care 
product related adverse events to the REC/IRB. The seriousness of an adverse event is 
categorized as serious, significant, or non-significant (see Table 4).   
Table 4: 
Adverse Events by Severity 
Serious 
Significant 
Non-significant 
Result in, or have the potential 
to cause either permanent 
impairment of a body function or 
damage to a body structure and 
may necessitate medical or 
surgical intervention. They 
include but are not limited to: 
Symptomatic and warrant 
discontinuation of contact lens 
wear (temporary or permanent). 
They include but are not limited 
to: 
Usually asymptomatic and           
do not warrant discontinuation 
of contact lens wear 
(temporary or permanent). 
However, as a precautionary 
measure the Investigator may 
decide to take action. They 
include but are not limited to: 
MK – Microbial keratitis 
Permanent reduction in best 
spectacle corrected visual acuity 
( 2 lines) 
Central (4mm) corneal opacity  
Central corneal 
neovascularization 
Iritis 
Hypopyon 
Hyphema 
Penetration of Bowman’s 
membrane 
Any untoward medical 
occurrence that results in death, 
is life-threatening, requires 
hospitalization or prolongation of 
existing hospitalization, results 
in persistent or significant 
disability/incapacity or is a 
congenital anomaly/birth defect 
CLPU – Contact lens peripheral 
ulcer 
CLARE – Contact lens 
associated red eye 
Significant Infiltrative Event 
(S.I.E) 
SEAL – Superior epithelial 
arcuate lesion  
Corneal warpage 
SLK – Superior limbic 
keratoconjunctivitis  
Other significant Grade 3 
corneal findings (e.g. edema or 
abrasions) 
Any corneal event which 
necessitates lens wear 
discontinuation of > 2 weeks 
Non-CL related anterior 
segment events e.g. EKC –
epidemic keratoconjunctivitis  
Temporary loss of  2 lines of 
Best Spectacle Corrected Visual 
Acuity 
New corneal scar without 
positive history 
CLPC – Contact lens 
associated papillary 
conjunctivitis 
SPK – Superficial Punctate 
Keratitis  
Non-significant infiltrative event 
Blepharitis 
Meibomitis 
Contact dermatitis 
Localized allergic reactions, 
including solution-related 
ocular toxicity 
Conjunctivitis: Bacterial, Viral, 
Allergic 
Keratoconjunctivitis 
Any corneal event not explicitly 
defined as a serious or 
significant event which 
necessitates lens wear 
discontinuation <2 weeks 
Other slit lamp findings 
requiring treatment 
 
For additional information, questions or assistance in recording potential adverse events, 
contact Visioncare Research.   
8.1 
Adverse Event Categorization 
The investigator will be required to rate the likelihood of an event being device-related 
(Possible, Probable, Highly Probable) or non-device-related (No) in their adverse event 
evaluation.   
All device-related adverse events will be tabulated and reported in the final report. 

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8.2 
Adverse Event Reporting 
On finding an adverse event the investigator will complete an Adverse Event Form (AE eCRF) 
to document the condition.  
The Investigator must notify Visioncare Research of any type of AE, so that they are able to 
provide advice and support to the Investigator on how to proceed. 
The Investigator must do this by providing the information on the AE eCRF to Visioncare 
Research by eCRF, email, fax or telephone as soon as possible and no later than: 
o 
24 hours from discovery if event is Serious 
o 
2 working days from discovery if event is Significant or Non-Significant 
Visioncare Research will advise the investigator to notify the REC/IRB no later than: 
 
Sterling IRB (US) reporting requirements, within 10 working days from the date of 
discovery. 
 
NRES REC (UK) reporting requirements, 15 working days from the date discovery. 
Visioncare Research may notify the REC/IRB on behalf of the investigator. 
To report to the REC/IRB send a covering letter with details as per the REC/IRB requirements. 
This usually includes the subject identifier and a brief description of how the AE was discovered, 
the subject’s condition and any follow-up anticipated. The AE Form is also sent to the REC/IRB. 
These documents can be sent by fax or email depending on the individual REC/IRB facilities. 
The investigator must also notify Visioncare Research in writing that the AE has been reported 
to the REC/IRB. 
8.3 
Device-Related Adverse Event Documentation 
Investigators are required to document and follow-up all AEs. 
All AEs are documented on an AE eCRF upon event discovery.  One AE eCRF is used per 
eye.   
Procedure: 
The investigator has the responsibility to: 
1. Complete as much information as possible on the AE eCRF upon event discovery.  This 
includes: 
 
A detailed description of the AE and a diagnosis, including a probable cause   
 
Detailed drawings that detail size, location and depth or photographs (if necessary) 
 
Likelihood of the AE being device-related and whether lens or care product-related. 
2. If serious, collect any contact lenses worn, solutions, and the lens case used at the time. 
3. Report the AE to the sponsor (via CRO, i.e. Visioncare Research) and the REC/IRB within 
the specified timelines (see Adverse Events section 8.2). 
4. Follow study subject until resolution recording all information on an unscheduled visit eCRF, 
including VA, symptoms and slit lamp findings, resolution and permanent sequelae if any.   

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5. Complete all remaining information as required by the AE eCRF.  If follow-up of the AE is 
required, the follow-up section can only be completed when all follow-up visits are done.  
Additional information that will be completed on the AE eCRF include: 
 
Outcome, ocular sequelae if any 
 
Whether the patient is discontinued from the study as a result of the AE 
8.4 
Adverse Event Follow-up 
The Investigator will conduct follow-up examinations until the condition has either: 
 
Returned to pre-event status,  
 
Stabilized, or   
 
Been satisfactorily explained. 
If the subject is referred for medical attention, they will be tracked by the investigator until the 
aforementioned conditions are met. 
Follow-up data will be collected on Follow-up Visit eCRFs (marked as unscheduled visit) and 
on the AE eCRF. 
If Corneal Staining is present of Grade 3 or more, another follow up visit should be scheduled 
within 24 hours. 
The investigator should use his/her clinical judgement as to whether or not the subject reporting 
with an adverse event should continue in the study. 
8.4.1 
Sponsor Safety Responsibilities 
The sponsor will ensure that all participating investigators are promptly informed of significant 
new safety information with respect to the device being studied as per regulatory bodies’ 
requirements. 
To comply with this, the sponsor is responsible for promptly advising (in writing, via Visioncare 
Research) all investigators conducting clinical studies using an investigational device, of any 
incidents of serious or unexpected adverse events/unanticipated adverse device effects 
reported for the devices/products involved in those studies. 
9 
DATA MANAGEMENT 
9.1 
Electronic Case Report Forms/Data Collection 
The data for this study will be collected on electronic report forms (eCRFs) using an electronic 
data collection (EDC) system.  Designated study site personnel will enter study data into the 
electronic CRFs (eCRFs) using the Medrio EDC system.  Medrio is compliant with all relevant 
aspects of ICH/Good Clinical Practices and 21 CFR Part 11 (Electronic Records & Electronic 
Signatures) regulations. 

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9.2 
Data Quality Assurance 
When eCRFs are reviewed at Visioncare Research, they will be subjected to error checking 
and data queries will be raised electronically via the EDC system for resolution of omissions 
and discrepancies by the investigator.   
Before the final closing of the database, the data will be checked and approved for analysis as 
per Visioncare Research SOPs.  This includes checking for missing or erroneous data entries  
9.3 
Data Entry and Storage 
All study data shall be entered into the study eCRFs.  The statistical analyses will be completed 
by the CRO using SAS software (SAS Institute Inc., Version 9.4). 
10 
SAMPLE SIZE AND STATISTICAL METHODS 
10.1 
Sample Size Rationale 
The sample size was selected to be in agreement with ISO 11980:2012.  The sample size 
assumes a drop-out rate of <10% and was rounded up to allow for equal subject numbers and 
even enrolment at each site. 
10.2 
Statistical Analysis Plan 
General considerations:  All data summaries and statistical analyses will be performed using 
the SAS software Version 9.4 or higher (SAS Institute, Cary, NC).  Throughout the analysis of 
data, the results for each subject/eye will be used when available for summarization and 
statistical analysis.  Missing data will be excluded from the analysis.  Unscheduled visits will be 
excluded from the statistical analysis. 
Descriptive statistics will be reported by solution type at baseline, dispensing, and each follow-
up visit according to ISO 11980:2012.  Continuous variables will be summarized using sample 
size (N), mean, standard deviation (SD), minimum and maximum, and categorical data 
variables will be summarized using the sample size, frequency distribution (count and 
percentage of subjects or eyes in each category), mean, median and SD. 
Analysis Population: Statistical Analysis for hypothesis testing will be performed on all 
evaluable subjects.  All inference will be carried out with an overall type I error rate controlled 
at 0.05. 
Analysis of comfort: Results will be analyzed using a linear mixed model including the 
experimental design factors: solution type, visit and their interaction will be included as fixed 
effect factors and site and subject as random effects. 
Comparisons between the test and control solutions will be carried out using pairwise one-sided 
confidence intervals constructed for least-square mean differences (mean difference calculated 
as Test minus Control).  Non-inferiority will be concluded if the lower confidence limit is greater 
than -1.0. 

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Analysis of visual acuity: Results will be analyzed using a linear mixed model including the 
experimental design factors: solution type, visit and their interaction will be included as fixed 
effect factors and site and subject as random effects. 
Comparisons between the test and control solutions will be carried out using pairwise one-sided 
confidence intervals constructed for least-square mean differences (mean difference calculated 
as Test minus Control).  Non-inferiority will be concluded if the upper confidence limit is less 
than +0.05 logMAR. 
Analysis of wettability: Results will be analyzed using a linear mixed model including the 
experimental design factors: solution type, visit and their interaction will be included as fixed 
effect factors and site and subject as random effects. 
Comparisons between the test and control solutions will be carried out using pairwise one-sided 
confidence intervals constructed for least-square mean differences (mean difference calculated 
as Test minus Control).  Non-inferiority will be concluded if the lower confidence limit is greater 
than -0.5. 
Analysis of deposits: Results will be analyzed using a linear mixed model including the 
experimental design factors: solution type, visit and their interaction will be included as fixed 
effect factors and site and subject as random effects. 
Comparisons between the test and control solutions will be carried out using pairwise one-sided 
confidence intervals constructed for least-square mean differences (mean difference calculated 
as Test minus Control).  Non-inferiority will be concluded if the upper confidence limit is less 
than +0.5. 
Analysis of slit lamp findings:  First the results will be averaged across each sector.  Average 
results will be analyzed using a linear mixed model including the experimental design factors: 
solution type, visit and their interaction will be included as fixed effect factors and site and 
subject as random effects. 
Comparisons between the test and control solutions will be carried out using pairwise one-sided 
confidence intervals constructed for least-square mean differences (mean difference calculated 
as Test minus Control).  Non-inferiority will be concluded if the upper confidence limit is less 
than +0.5. 
Additional analyses:   
 
Overall occurrence of slit lamp findings of Grade 2 or higher 
 
Overall occurrence of lens VA findings worse than 6/12 (20/40) 
 
Overall occurrence of clinically significant lens surface deposits (>Grade 1) 
 
Ocular adverse events. 
Any deviations from the above analysis will be documented in the report. 

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10.3 
Interim Analysis 
There will be no interim analyses and, therefore, there are no criteria for early termination of 
the clinical investigation on statistical grounds. 
11 
GENERAL STUDY MANAGEMENT 
11.1 
Relevant Standards 
This protocol has been developed in accordance with the following:   
 
ISO 14155:2011 Clinical Investigation of Medical Devices for Human Subjects 
 
ISO 11980:2012 Ophthalmic Optics - Contact lenses and contact lens care products  
 
ICH Harmonised Tripartite Guideline for Good Clinical Practice 
 
Declaration of Helsinki 
The study will also be carried out in accordance with the Visioncare Research Quality 
Management System (ISO 9001:2008, ISO 13485:2012) 
11.2 
Ethical Review 
The study protocol, patient instruction sheet, questionnaire and Informed Consent Form will be 
submitted to the REC/IRB (UK – NRES, US - STERLING). A favorable opinion will be received 
prior to undertaking the study. The approval letter should clearly mention the approval/favorable 
opinion of the protocol, the patient information sheet and informed consent form, including 
respective version dates. 
If significant protocol changes which require the preparation of an amendment are necessary, 
written approval will be obtained prior to implementation. 
11.3 
Protocol Deviations 
The investigators will not deviate from the protocol without written approval from Visioncare 
Research.   
Any serious breaches of GCP that are likely to effect to a significant degree the safety, physical 
or mental integrity of the trial subjects or scientific value of the trial must be immediately notified 
to the Sponsor (and Visioncare, if reported by the investigator) to permit notification to the 
REC/IRB within 10 days after becoming aware of the breach.  
In medical emergencies, the investigator will use their judgement and remove the subject from 
immediate hazard.  Any significant changes or deviations in the protocol will be the subject of 
a protocol amendment and must be pre-approved by the REC/IRB.  
If an unexpected deviation from the protocol occurs, the investigator must notify Visioncare 
Research immediately and the deviation from the protocol will be documented and resolved on 
a Protocol Deviation eCRF. 

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11.4 
Premature Termination of the Study 
The sponsor reserves the right to terminate the study at any time for any reason including 
adverse effects.  The applicable authorities also have the right to terminate the study.  If it is 
determined that an unanticipated adverse device effect presents an unreasonable risk, then 
the entire investigation or part of the investigation presenting the risk shall be terminated as 
soon as possible. A written statement fully documenting the reasons for such termination will 
be provided to the REC/IRB. 
11.5 
Source Documentation 
The eCRFs will be considered the source document, unless otherwise documented.  The 
sponsor’s representatives (Visioncare Research) will be authorized to gain access to the source 
documentation for the purposes of monitoring and auditing the study (see sections 11.6 and 
11.7). 
The Source Document Record must be completed to comply with GCP guidelines.  It is a 
permanent record within the patient’s records/notes that documents the subject’s involvement 
in a clinical research study. 
Contents of the source document record: 
 
Study number 
 
Subject ID 
 
Confirmation that subject met eligibility criteria 
 
Confirmation that subject signed the informed consent 
 
Confirmation that subject received a signed and dated copy of informed consent 
 
Date enrolled 
 
Details of Solution (code) assigned  
 
Details of lenses worn on study 
 
General notes 
 
Adverse events 
 
Exit date 
 
Whether subject completed the study or discontinued 
 
Investigator’s signature 
The Source Document Record will be completed for each subject upon enrolment and then 
updated when required, e.g. when subject exits the study. 
11.6 
Monitoring 
Investigational site monitoring will be performed by a qualified study monitor identified by the 
Sponsor or Visioncare Research. On-site visits will be completed at each site. The frequency 
and procedure of the monitoring visits will be documented in the monitoring plan which is in a 
separate document. The investigator will allow the study monitor and sponsor representatives 
or REC/IRB to observe procedures and inspect study records and subjects’ medical records 
throughout the study to verify protocol compliance, case report completeness and 
investigational material accountability.  Should the investigator be found to be non-compliant 
and unwilling or unable to convert non-compliant practices, Visioncare Research in consultation 
with the Sponsor will terminate the investigator's role in the investigation and the REC/IRB will 
be notified. 

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11.7 
Audits 
The Investigator shall permit Visioncare Research, the Sponsor, the REC/IRB and the 
appropriate regulatory authorities to inspect its facilities, equipment, and study-related records, 
data and other documents upon reasonable notice.  In addition, the regulatory authorities or 
the REC/IRB may conduct such inspections as they deem necessary at any time whether or 
not advanced notice is given by them.  The Investigator agrees to notify the Sponsor or 
Visioncare Research within 24 hours (or as soon as reasonably practicable) of the start of any 
unannounced inspection by the REC/IRB or the regulatory authorities or of the receipt from the 
REC/IRB or the regulatory authorities of a notice of inspection whether given in writing or orally.  
If such notice is in writing, a copy with any attachments thereto shall be provided to Visioncare 
Research or the Sponsor. 
11.8 
Records Retention 
Investigators will be required to retain all records and the study file for a period of at least 10 
years unless otherwise authorized by the Sponsor. As the clinical research organisation 
supervising the study, Visioncare Research will also retain the written records for the same 
period of time. 
11.9 
Confidentiality and Publication 
By signing the Informed Consent form the subject authorizes the sponsor and the sponsor’s 
representatives (Visioncare Research) to access their optometric clinical records.  The 
authorization will be indefinite; however, subjects will have the right to reverse this authorization 
at any time. 
All patient information will have the patient name (or any information that can identify the 
patient) removed before leaving the principal investigator’s site. 
In accordance with the VCR Confidentiality Policy, the data, information, and reports arising 
from this project are the property of the sponsor.  VCR will not release to a third party any 
information arising from this study unless required to do so by a legal or regulatory body.  The 
electronic records will also be handled in accordance with the UK Data Protection Act (1998). 
The investigators will not be permitted to publish or present at scientific meetings results 
obtained from the clinical study without prior written consent from the sponsor. 

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12 
REFERENCES 
1. 
Szczotka-Flynn LB, Pearlman E, Ghannoum M. Microbial contamination of contact 
lenses, lens care solutions, and their accessories: A literature review. Eye Cont Lens 
2010; 35:116-129. 
2. 
Rah MJ, Merchea MM, Doktor MQ. Reducing dropout of contact lens wear with Biotrue 
multipurpose solution. Clin Ophthalmol. 2014; 24;8:293-9.  
3. 
Reindel W, Merchea MM, Rah MJ, Zhang L. Meta-analysis of the ocular 
biocompatibility of a new multipurpose lens care system. Clin Ophthalmol. 
2013;7:2051-6.  
4. 
González-Méijome JM, da Silva AC, Neves H, Lopes-Ferreira D, Queirós A, Jorge J. 
Clinical performance and "ex vivo" dehydration of silicone hydrogel contact lenses with 
two new multipurpose solutions. Cont Lens Anterior Eye. 2013;36:86-92. 
5. 
Garofalo RJ, Dassanayake N, Carey C, Stein J, Stone R, David R. Corneal staining 
and subjective symptoms with multipurpose solutions as a function of time. Eye Contact 
Lens 2005;31:166-74. 

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13 
ABBREVIATIONS 
 
AE 
Adverse event 
CL 
CRA 
Contact lens 
Clinical Research Associate  
CRF 
Case report form 
CRO 
Clinical Research Organisation 
D 
Diopter 
eCRF 
Electronic case report form 
EDC 
Electronic data collection 
EDTA 
ethylenediaminetetraacetic acid 
GCP 
Good Clinical Practice  
HC 
ICH 
High Contrast 
International Conference on Harmonization 
IRB 
Investigational Review Board 
logMAR 
Log of Minimum Angle of Resolution 
MPS 
Multipurpose solution 
NRES 
National Research Ethics Service 
PHMB 
polyheximethylene biguanide 
REC 
Research Ethics Committee 
SH 
Silicone hydrogel 
SOP 
Standard Operating Procedure 
SOR 
Spherical over-refraction 
UK 
United Kingdom 
US 
United States 
VA 
Visual acuity  
VCR 
Visioncare Research 
WT 
Wearing time 

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APPENDIX 1  
 
Template Enrolment Log (Sample) 
 
 

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APPENDIX 2 
 
Template Kit-Box Accountability Form (Sample) 
 
 
 
 
 
 

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APPENDIX 3 
 
Template Source Document Record (Sample) 
 
 
 

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APPENDIX 4 
 
Grading Scales & Measurement Instructions 
Variable 
Assessment Method 
Grading/Measurement System 
Wearing Times 
Average Wearing 
Time 
Typical time of day when lenses 
inserted and removed. 
Time of day to nearest half hour 
Comfortable Wearing 
Time 
Typical time of day when subject first 
experiences lens awareness or 
irritation. 
Time of day to nearest half hour when first 
aware of lenses 
OR   ‘Always comfortable’ (tick-box) 
Maximum Wearing 
Time 
Maximum WT on a given day since 
last visit. 
Hours to nearest half hour 
Subjective Assessments 
Comfort 
Assessed by subject.  
0 to 10 scale  
       10 = cannot be felt 
Vision 
Distance VA – High 
contrast 
Measured using Snellen (or logMAR) 
chart. 
Visual acuity (VA) to nearest letter 
Vision Quality 
Assessed by subject 
0 to 10 scale 
       10 = perfect 
Lens Fit 
- assessed using slit lamp 
Lens Centration 
Lens centration will be recorded by 
degree and direction in the primary 
position. 
0 
Centered - optimal 
1 
Decentered slightly  
2 
Substantially decentered  (>0.5mm) 
If decentered, direction(s) will be recorded 
as: Superior, Inferior, Nasal, Temporal 
Corneal Coverage 
Assessed in primary gaze. 
Y 
Yes, full corneal coverage at all times 
N 
No, incomplete corneal coverage 
Post-Blink Movement  
Assessed immediately after the blink 
- lower lid to be depressed only if 
necessary for observation. 
0 
Insufficient, unacceptable movement 
1 
Minimal, but acceptable movement 
2 
Optimal movement 
3 
Moderate, but acceptable movement 
4  
Excessive, unacceptable movement 
Lens Tightness – 
Push-up test 
Assessed by digital push-up test 
(gentle push of the lens upward using 
the lower lid) with eye in primary gaze 
position and observing ease of push-
up and speed of return to original 
position. 
0 
Insufficient, unacceptable movement 
1 
Minimal, but acceptable movement 
2 
Optimal movement 
3 
Moderate, but acceptable movement 
4       Excessive, unacceptable movement 

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Variable 
Assessment Method 
Grading/Measurement System 
Overall Fit 
Acceptance 
Assessed by the investigator based 
on lens fit alone (i.e. not comfort or 
vision). 
0 
Should not be worn 
1 
Borderline but unacceptable  
2 
Min. acceptable, early review  
3 
Not perfect but OK to dispense  
4 
Perfect  
Biomicroscopy 
Stromal Edema 
Assessed with indirect white light, 
medium-high magnification and 
observing any corneal haze against 
the pupil.  More significant changes 
(e.g.  striae, folds) can be observed 
with direct illumination. 
0  
NONE:  No corneal haze, normal 
transparency 
1  
TRACE:  Just detectable haze 
2  
MILD:  Faint corneal striae (2 or 
fewer) 
3  
MODERATE:  Pronounced corneal 
striae (3) 
4  
SEVERE:  Folds in Descemet’s 
membrane and >4 striae 
Limbal & Bulbar  
Hyperemia 
Assessed using slit lamp with white 
light, low-medium magnification 
 
0 
NONE:  No injection present 
1 
TRACE: Slight limbal (mild 
segmented), bulbar (mild regional), 
and/or palpebral injection 
2 
MILD: Mild limbal (mild 
circumcorneal), bulbar (mild diffuse) 
injection 
3 
MODERATE: Significant limbal 
(marked segmented), bulbar (marked 
regional or diffuse) injection 
4 
SEVERE: Severe limbal (marked 
circumcorneal), bulbar (diffuse 
episcleral or scleral) injection 
Corneal 
Vascularization 
Assessed using slit lamp with diffuse 
white light, low-medium 
magnification. 
The depth and location of any 
vascularization should also be 
recorded. 
0 
NONE:  No vascular changes 
1 
TRACE:  Vessel penetration <1.0mm 
2 
MILD:  Penetration of limbal vessels 
<1.5mm 
3 
MODERATE:  Penetration >1.5mm to 
2.0mm 
4 
 SEVERE:  Penetration more than 
2.0mm inside the limbus 
Upper Palpebral 
Conjunctival 
Roughness 
Assessed using slit lamp with white 
light, low-medium magnification.   
0 
NONE:  Uniform satin appearance of 
conjunctiva 
1 
TRACE:  Slight conjunctival injection 
without loss of texture 
2 
MILD:  Mild or scattered 
papillae/follicles less than 1mm in 
diameter 
3 
MODERATE:  Significant papillae/ 
follicles less than 1mm in diameter 
and/or marked conjunctival injection 
4 
SEVERE:  Localized or generalized 
papillae/ follicles 1mm or more in 
diameter 
Palpebral 
Conjunctival 
Hyperemia 
Assessed with diffuse white light, low-
medium magnification using CCLRU 
images for reference 
0 
None 
1 
Slight injection of conjunctival vessels 
2 
Mild injection  
3 
Moderate injection 
4 
Severe injection 

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Variable 
Assessment Method 
Grading/Measurement System 
Corneal Staining Type 
Assessed by sector with fluorescein, 
blue light, yellow filter and full beam 
using medium magnification. 
Cornea will be assessed by sector (C, 
N, T, I, S)  
 
0 
NONE:  No staining 
1 
Micropunctate – Superficial, 
minute/fine/pinpoint punctate staining, 
includes superficial stippling 
2 
Macropunctate – Focal, ball-like 
punctate staining, includes moderate 
stipple staining 
3 
Coalesced macropunctate 
4 
Patch (> 1 mm) 
Conjunctival Staining 
Assessed by quadrant using 
fluorescein, blue light, yellow filter, 
low-medium magnification.   
Ignore conjunctival indentation with 
no staining. 
0 
None 
1 
Minimal diffuse punctate 
2 
Coalescent punctate 
3 
Confluent 
4 
Widespread confluent 
Other Significant 
Findings 
Describe finding and grade severity 
0  
NONE 
1 
TRACE 
2 
MILD 
3 
MODERATE 
4 
SEVERE 
Lens Surface Characteristics 
Lens Surface Wetting 
 
Lens surface wettability rated on the 
appearance of the lens surface and 
the drying time viewed with a slit lamp 
under low magnification. 
 
0 
VERY POOR:  Immediately displaying 
non-wetting areas on lens surface. 
1 
POOR:  Irregular surface appearance; 
drying time <interblink period. 
2 
ACCEPTABLE: Smooth surface 
appearance immediately after the blink 
becoming irregular with time; drying 
time  interblink period. 
3 
GOOD:  Typical lens appearance with 
long drying time. 
4 
EXCELLENT: Appearance of a healthy 
cornea with very long drying time. 
Film Deposits 
 
Any film deposits (protein/lipid) 
attached to the front surface of the 
lens.  Scan the entire lens surface 
(10- 20X) for the presence of 
deposits. 
0 
No film. 
1 
Slight 
film 
visible 
only 
under 
magnification. 
2 
Moderate film only under magnification. 
3 
Moderate film visible to the naked eye 
4 
Heavy film visible to the naked eye 
White Spot Deposits 
 
Assessed using slit lamp with white 
light, low-medium magnification 
Number of white spot deposits 
 
 
 

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M E A S U R E M E N T  I N S T R U C T I O N S  
DISTANCE VISUAL ACUITY 
Measure Visual Acuity (VA) to the nearest letter.   
If the subject reads more than half of the letters on a given line, ask them to attempt the next line.  
Then if the subject is able to read letters on the next line assume that the previous line was correctly 
read for the purposes of recording VA. 
EXAMPLE 1: If all six of the letters on the 6/9 line were correctly identified and the subject then 
correctly identified all but one of the six letters on the 6/7.5 line, record the acuity as: 
6 / 7.5 - 1 
EXAMPLE 2: If the subject correctly identified four of the six letters on the 6/6 line and two of 
the six letters on the 6/5 line were correctly identified, record the acuity as: 
6 / 6 + 2 
If necessary, VA can also be recorded on the eCRF in logMAR