An Evaluation Of The Fitting Success Rate Of Senofilcon A Soft Contact Lenses In Three Designs.
Phase: NA
Conditions: Myopia
Sponsor: Graeme Young

V I S I O N C A R E  R E S E A R C H  
 PROTOCOL 
VERSION 1.0 
AN EVALUATION OF THE FITTING SUCCESS 
RATE OF SENOFILCON A SOFT CONTACT 
LENSES IN THREE DESIGNS 
 
STUDY NUMBER: 
TRTN-501 
 
DATE: 
25 August 2017 
 
PROPOSED START DATE: 
October. 2017 
 
AUTHORS: 
F. Louise Nicklin 
 
 
Graeme Young.  
 
Visioncare Research Ltd 
Craven House 
West Street 
Farnham 
Surrey GU9 7EN 
UK 
 
 

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An Evaluation of the Fitting Success Rate of Senofilcon A Soft Contact Lenses 
(TRTN-501) 
TABLE OF CONTENTS 
 
 
 
Page 
PERSONNEL AND FACILITIES 
5 
SYNOPSIS 
6 
1 
INTRODUCTION 
8 
2 
STUDY OBJECTIVES 
8 
2.1 
Hypotheses 
8 
3 
STUDY DESIGN & RATIONALE 
8 
3.1 
Randomisation 
9 
3.2 
Masking 
9 
4 
INVESTIGATIONAL SITES 
9 
4.1 
Number of Sites 
9 
4.2 
Investigator Recruitment 
9 
5 
STUDY POPULATION 
9 
5.1 
Number of Subjects 
9 
5.2 
Inclusion Criteria 
10 
5.3 
Exclusion Criteria 
10 
5.4 
Subject Identification 
10 
5.5 
Study Withdrawal Criteria 
10 
5.6 
Subject Replacement 
11 
5.7 
Subject Compliance 
11 
6 
MATERIALS 
11 
6.1 
Study Lenses 
11 
6.2 
Trial Lens Fitting Sets 
11 
6.3 
Lens Care Products and Other Study Products 
11 
6.4 
Lens Preparation 
11 
6.5 
Lens Replacement Schedule 
12 
6.6 
Product Accountability 
12 
6.7 
Study Document and Case Report Forms (CRFs) 
12 
7 
TREATMENT 
12 
7.1 
Study Product Formulations 
12 
7.2 
Device Administration 
12 
8 
METHODS AND ASSESSMENTS 
12 
8.1 
Subject Recruitment 
12 
8.2 
Study Visits 
13 
8.2.1 
Visit Schedule 
13 
8.2.2 
Screening and Enrolment 
13 
8.2.3 
Baseline Assessment 
14 
8.2.4 
1st Pair Study Lens Assessment 
14 
8.2.5 
2nd Pair Study Lens Assessment 
15 
8.2.6 
3rd Pair Study Lens Assessment 
15 
8.2.7 
Study Exit 
15 
8.2.8 
Clinical Variables 
16 
8.3 
Subject Discontinuation 
16 

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8.4 
Post-Study Follow-up 
17 
9 
ADVERSE EVENTS 
17 
9.1 
Adverse Event Categorisation 
17 
9.2 
Adverse Event Reporting 
17 
9.3 
Device-Related Adverse Event Documentation 
18 
9.4 
Adverse Event Follow-up 
18 
9.5 
Study Completion 
18 
10 
DATA MANAGEMENT 
18 
10.1 
Data Quality Assurance 
18 
10.2 
Data Entry and Storage 
19 
11 
SAMPLE SIZE AND STATISTICAL METHODS 
19 
11.1 
Sample Size Rationale 
19 
11.2 
Level of Statistical Significance 
19 
11.3 
Analysis Population 
19 
11.4 
Summary Tables 
19 
11.5 
Statistical Analysis 
20 
11.5.1 
Success Rates – Two Designs versus One Design 
20 
11.5.2 
Success Rates – Actual versus Theoretical 
20 
11.5.3 
Fitting Characteristics – Actual versus Theoretical 
20 
11.5.4 
Supplementary Analysis 
20 
11.6 
Interim Analysis 
20 
12 
POTENTIAL RISKS AND BENEFITS 
20 
13 
GENERAL STUDY MANAGEMENT 
21 
13.1 
Relevant Standards 
21 
13.2 
Ethics Review 
21 
13.3 
Protocol Deviations 
21 
13.4 
Premature Termination of the Study 
21 
13.5 
Source Documentation 
21 
13.6 
Monitoring 
22 
13.7 
Audits 
22 
13.8 
Records Retention 
22 
13.9 
Confidentiality and Publication 
22 
14 
REFERENCES 
22 
APPENDIX 1     Template Adverse Event Form 
23 
APPENDIX 2     Template Sample Enrolment and Randomisation Logs 
26 
APPENDIX 3     Template Product Accountability Log 
29 
APPENDIX 4     Template Product Dispensing Foil Log 
31 
APPENDIX 5     Grading Scales & Measurement Instructions 
33 
 

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An Evaluation of the Fitting Success Rate of Senofilcon A Soft Contact Lenses  
(TRTN-501) 
PERSONNEL AND FACILITIES 
 
 
PRINCIPAL INVESTIGATOR: 
Graeme Young PhD MPhil FCOptom DCLP 
 
CO-INVESTIGATORS:  
F. Louise Nicklin BSc MCOptom  
Maana K. Aujla BSc  
 
STUDY LOCATION: 
Visioncare Research Clinic have  
Craven House 
West Street 
Farnham 
Surrey GU9 7EN, UK 
Tel:  +44 1252 718719 
Fax:  +44 1252 718720 
Aston University Optometry Clinic  
Aston Triangle 
Birmingham, B4 7ET. 
Tel: 0121 204 4121 
 
MEDICAL MONITOR: 
James Wolffsohn PhD BSc FCOptom  
Aston University Optometry Clinic 
Aston Triangle 
Birmingham, B4 7ET. 
Tel: 0121 204 4121 
BIOSTATISTICIAN: 
Chris Hunt MSc 
Visioncare Research Ltd  
Tel:  01252 718719 x 211 
Email: c.hunt@visioncare.co.uk 
 
 
 

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An Evaluation of the Fitting Success Rate of Senofilcon A Soft Contact Lenses 
(TRTN-501) 
SYNOPSIS 
 
TITLE:  
An evaluation of the fitting success rate of senofilcon A soft contact 
lenses. 
STUDY OBJECTIVES:   
1. 
To compare the lens fitting success rates for three combinations 
of senofilcon A lens pairs when fitted to a population skewed to 
larger corneas. 
2. To compare the actual fitting success rates of senofilcon A lenses 
with theoretical values from the Young model. 
3. To compare the fitting characteristics of senofilcon A lenses 
(tightness, corneal overlap) with theoretical values from the Young 
model. 
STUDY DESIGN: 
This will be an approx. 40-60 subject, one-day, double-masked, 
randomised, repeated measures study.  Each subject will wear the 
three lens types bilaterally in random succession (Acuvue® OASYS® 
with Hydraclear PlusTM in two base curves and Acuvue® 1·Day Oasys 
with HydraLuxeTM in one base curve).  A total of six lenses will 
therefore be worn by each subject (3 per eye).  
HYPOTHESES: 
i. 
The fitting success rate for a combination of two senofilcon A 
designs is greater than for a single design when fitted to a 
population skewed to larger corneas. 
ii. 
The fitting success rates for senofilcon A designs are equivalent 
to those predicted by the Young model. 
iii. The fitting characteristics (tightness, corneal overlap) for 
senofilcon A designs are equivalent to those predicted by the 
Young model. 
TEST PRODUCTS: 
Both lens types are manufactured by JJVC, in senofilcon A material 
with 38% water content and a shrinkage factor (20→34ºC) of 0.997.  
Both are available in powers -1.00 to -6.00D and are CE marked. 
 
Acuvue® 1·Day Oasys with HydraLuxeTM (8.50/14.3) 
 
Acuvue® OASYS® with Hydraclear PlusTM (8.40/14.0, 8.80/14.0) 
LENS CARE PRODUCTS:  
Unpreserved saline for rinsing, e.g. Sauflon saline.  
NO. SUBJECTS: 
Approximately 40-60 subjects. An attempt will be made to include 
~50% subjects who have an HVID >11.75mm or corneal diameter 
>13.75mm.   
STUDY POPULATION: 
Volunteer subjects will be enrolled if they meet the baseline screening 
criteria and the inclusion and exclusion listed below.  Ideally at least 
half of the eyes will fall within the top quartile of average corneal 
diameters ie >HVID 11.75mm or corneal diameter >13.75mm or will 
have demonstrated loose / tight fitting contact lenses in previous 
studies.   

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Inclusion Criteria: 
i. 
Age 18-70 years.  
ii. 
Able to read, comprehend and sign an informed consent.  
iii. Willing to comply with the wear and study assessment schedule. 
iv. Spherical distance prescription between -0.50 and -6.00 (inc.). 
v. Astigmatism, if present,≤1.50DC in both eyes.  
vi. Have normal eyes with no evidence of any ocular abnormality or 
disease.  For the purposes of this study a normal eye is defined 
as one having: 
 A clear central cornea   
 No anterior segment disorders  
 No clinically significant slit lamp findings (i.e. corneal 
oedema, significant staining, central scarring, infiltrates, 
active neovascularisation)  
 No other active ocular disease (including pterygia) 
Exclusion Criteria:  
i. 
Previous anterior ocular surgery 
ii. 
Any active corneal infection, injury or inflammation 
iii. Large pinguecula likely to affect soft lens fit 
iv. Systemic or ocular disease or medication which might interfere 
with CL wear 
v. Pregnancy or breastfeeding 
vi. Participation in any concurrent trial  
NO. SITES: 
Two sites in UK: Visioncare Research Ltd, Farnham; Aston Research 
Clinic, Birmingham 
END POINTS: 
Completion of assessment of three pairs of lenses or discontinuation. 
VISITS/SCHEDULE: 
One visit 
PROCEDURE: 
Lenses will be inserted and each pair assessed after ~30 minutes. 
CLINICAL VARIABLES: 
Primary variables: 
Lens fit:  horizontal* & vertical* centration (mm), post-blink movement 
in primary gaze* (mm), version lag (mm), edge tightness (0-4), 
tightness (push-up %), horizontal corneal overlap (mm)*, diameter 
acceptance (mm), overall fit acceptability (0-5), fit success rate (%).   
Corneal topography:  Sim-K-readings and corneal shape factor 
(Medmont), horizontal HVID* (photo slit lamp) corneal sagittal height, 
corneal diameter (Visante OCT). 
* From photographs / video 
THEORETICAL FIT  
Edge strain (%), corneal overlap (mm), fit success (Yes/No) based on 
VARIABLES: 
following criteria: Edge strain: 0-6%, Horizontal corneal overlap:  0.2-
1.2mm.   
 
 

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1 
INTRODUCTION 
Since ocular topographies vary within the population,1 it is important that contact lens designs 
are selected that comfortably and successfully fit a wide range of eyes. Multiple designs 
generally give a wider coverage of the population than single designs. Because soft contact 
lenses are generally not available in a wide range of parameters, it is difficult to evaluate the 
effectiveness of design combinations.  However, senofilcon A lenses have recently become 
available in multiple diameters, which offers the opportunity to explore the utility of various 
design combinations.  
Computer modelling provides useful insights into the relationship between lens design and fit 
and allows an estimation of the fitting success rate for a given lens design on a given population. 
2,3  Recent calculations suggest that a combination of multiple diameter designs is likely to be 
more successful than multiple base curves of identical lens diameter.4  
The main purpose of this study is to evaluate the fitting success of various combinations of 
senofilcon A lens designs. A secondary purpose will be to evaluate the validity of the Young 
soft contact lens fit model.2  
2 
STUDY OBJECTIVES 
i. 
To compare the lens fitting success rates for three combinations of senofilcon A lens pairs 
when fitted to a population skewed to larger corneas. 
ii. 
To compare the actual fitting success rates of senofilcon A lenses with theoretical values 
from the Young model. 2 
iii. To compare the fitting characteristics of senofilcon A lenses (tightness, corneal overlap) 
with theoretical values from the Young model.  
2.1 
Hypotheses 
The following hypotheses will be tested: 
i. 
The fitting success rate for a combination of two senofilcon A designs is greater than for a 
single design when fitted to a population skewed to larger corneas. 
ii. 
The fitting success rates for senofilcon A designs are equivalent to those predicted by the 
Young model. 
iii. The fitting characteristics (tightness, corneal overlap) for senofilcon A designs are 
equivalent to those predicted by the Young model. 
3 
STUDY DESIGN & RATIONALE 
This will be a one-day, double-masked, randomised, repeated measures study.  Each subject 
will wear the three lens types (Acuvue® OASYS® with Hydraclear PlusTM in two base curves and 
1·Day Oasys with HydraLuxeTM   in one base curve).  A total of six lenses will therefore be worn 
by each subject (3 per eye). 
An attempt will be made to include subjects who have large corneas or have previously 
demonstrated loose / tight fitting contact lenses since eyes with larger corneas tend to be less 
successful in contact lens fitting.  

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3.1 
Randomisation 
Subjects will wear each of the three lens types bilaterally in random succession. A random 
number generator (Microsoft Excel) will determine the randomisation of lenses to subjects, 
which is then incorporated into the Randomisation Log.  
The randomised assignment of subjects will be performed at the first assessment prior to the 
first randomised lens fitting. The following must be ensured prior to randomisation: 
 
Informed consent has been obtained 
 
Subjects meet all inclusion / exclusion criteria 
 
Subject history and baseline information have been collected 
Subjects who are discontinued may be replaced in order to achieve the targeted minimum 
number of cohort subjects, but the ID number will not be reused. 
3.2 
Masking 
To prevent bias, subjects will be masked to lens type and lens codes, and investigators will be 
masked to lens code.  An unmasked individual at Visioncare Research will be responsible for 
preparing the lenses by over-labelling with the appropriate code.  The lenses will be coded (A, 
B or C) to facilitate masking.   
4 
INVESTIGATIONAL SITES 
4.1 
Number of Sites 
Two investigational sites in the UK: Visioncare Research Clinic, Farnham:  Aston University 
Research Clinic, Birmingham 
4.2 
Investigator Recruitment  
The Investigators will be required to fulfil the following criteria:  
 
General Optical Council (GOC) registered optometrist 
 
At least two years post-registration contact lens fitting experience 
 
Experienced investigators trained in Good Clinical Practice (GCP) 
 
Willingness to follow the study protocol and to co-operate with the study monitors 
5 
STUDY POPULATION 
5.1 
Number of Subjects 
Approx. 50 subjects (40-60 subjects) who fulfil the inclusion criteria will be fitted with study 
contact lenses.   
In order to fully explore the hypothesis an attempt will be made to include subjects who have 
an HVID of >11.75mm, Corneal Diameter of >13.75mm, or who have exhibited ‘loose’ or ‘tight’ 
lens fittings in previous studies. 
 
 

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5.2 
Inclusion Criteria 
All subjects must satisfy the following conditions prior to enrolling in the study: 
i. 
Age 18-70 years.  
ii. 
Able to read, comprehend and sign an informed consent.  
iii. 
Willing to comply with the wear and study assessment schedule. 
iv. 
Spherical distance contact lens requirement between -0.50 and -6.00 (inclusive). 
v. 
Astigmatism, if present, <1.50DC in both eyes. 
vi. 
Have normal eyes with no evidence of any ocular abnormality or disease.  For the 
purposes of this study a normal eye is defined as one having: 
 
A clear central cornea   
 
No anterior segment disorders  
 
No clinically significant slit lamp findings (i.e. corneal oedema, staining, central 
scarring, infiltrates, active neovascularisation)  
 
No other active ocular disease (including pterygia) 
5.3 
Exclusion Criteria 
Any of the following will render a subject ineligible for inclusion: 
vii. 
Previous anterior ocular surgery 
viii. 
Any active corneal infection, injury or inflammation 
ix. 
Large pinguecula likely to affect soft lens fit 
x. 
Systemic or ocular disease or medication which might interfere with CL wear 
xi. 
Pregnancy or breastfeeding 
xii. 
Participation in any concurrent trial     
5.4 
Subject Identification 
Subjects will be identified by a six-digit code made up of the site identifier (XX), the two-digit 
subject enrolment number (XX), and subject initials (XX).  Enrolment numbers 01-30 will be 
assigned to Site 1, and numbers 31-60 will be assigned to Site 2.   
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 01 will be 01/01, 
the second 01/02 and so forth.  The first subject to be enrolled at Site 2 will be 02/31, the second 
02/32 and so on. 
5.5 
Study Withdrawal Criteria 
Due to the nature and duration of the study, no circumstances are foreseen whereby this study 
would be prematurely terminated.  However, if during the study it becomes evident to the 
Investigator that the study contact lenses pose a threat to subject well-being, the study will be 
terminated.  The Research Ethics Committee (REC) will be advised of the reason for 
termination.   

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5.6 
Subject Replacement 
Subject IDs will not be reused should a subject drop-out or be discontinued from the study.  If 
subjects are discontinued or drop out of the study, new subjects may be enrolled to ensure 
adequate subject numbers complete the study.   
5.7 
Subject Compliance 
This is a one-day study and, therefore, there is little scope for subject non-compliance. 
However, subjects will be questioned at the follow-up assessments to check whether they have 
removed the lenses or failed to follow the instructions for any reason.   
6 
MATERIALS 
6.1 
Study Lenses 
Table 1: 
Lens Details  
 
Acuvue® 1·Day 
Oasys with 
HydraLuxe TM 
Acuvue® OASYS® 
with Hydraclear 
Plus TM 
Manufacturer 
JJVC 
JJVC 
Material/ water  
senofilcon A 
senofilcon A 
Water content 
38% 
38% 
Shrinkage factor 
(20→34ºC) 
0.997 
0.997 
Base curve (mm) 
8.50 
8.40, 8.80 
Diameter (mm) 
14.3 
14.0 
Powers (D) 
-1.00 to -6.00  
 
CE marked 
6.2 
Trial Lens Fitting Sets  
Lenses will be provided by the Investigator sites.  
6.3 
Lens Care Products and Other Study Products 
Unpreserved saline for rinsing away fluorescein or for rinsing contact lenses, e.g. Sauflon 
saline.  
6.4 
Lens Preparation  
An unmasked individual at Visioncare Research will be responsible for preparing the lenses by 
over-labelling with the appropriate code: A, B or C.   

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6.5 
Lens Replacement Schedule  
Subjects will wear a new pair of lenses for the duration of each 30-minute section of the study. 
Therefore, there is no requirement for subjects to replace their lenses. If subjects experience 
any complications with the study lenses, they should speak to the Investigator. 
6.6 
Product Accountability 
Product Accountability and Dispensing Foil Logs will be kept by each site (Appendix 3 and 4).  
Number of lenses received (listed by power and lot number) and number of lenses used (even 
if not dispensed) will be recorded on these logs.   
6.7 
Study Document and Case Report Forms (CRFs) 
The following forms will be completed where appropriate: 
Investigator CRF Booklet: 
A) 
Baseline form  
B) 
Lens Assignment Form 
C) 
Follow Up Assessment form (including any Unscheduled Visits) 
D) 
Study Exit Form 
Additional Forms 
A) 
Statement of Informed Consent 
B) 
Participant Information Sheet 
C) 
Eligibility Checklist (in Baseline CRF) 
D) 
Enrolment Log 
E) 
Randomisation Log 
F) 
Adverse Event Form 
G) 
Product Accountability Log 
H) 
Product Dispensing Foil Log 
7 
TREATMENT 
7.1 
Study Product Formulations 
The contact lenses are CE marked and supplied sterile in single use blister packs containing 
buffered saline solution.  
7.2 
Device Administration 
The single use devices will be used on a daily wear basis and disposed of after fitting and 
assessment on same study day. 
8 
METHODS AND ASSESSMENTS 
8.1 
Subject Recruitment 
Recruitment materials (adverts, letters, etc.) must be approved by the Research Ethics 
Committee.  The Investigator will provide an approved advert and letter for the recruitment 
purposes.  Any changes to these must be submitted back to the ethics committee. 

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The procedures listed below will be conducted on all subjects.  Variables must be collected in 
the order they are listed on the Case Report Form (CRF).   
To participate in this clinical study, the Investigator will explain the Statement of Informed 
Consent to the subject, ensure each subject understands the Participant Information Guide 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 Participant Information 
Guide. 
A subject is considered enrolled when he or she signs the Statement of Informed Consent.   
8.2 
Study Visits 
8.2.1 
Visit Schedule 
This will be a non-dispensing study. Each subject will be required to attend one scheduled study 
visit over a period of approximately 3.5 hours in a single day. They will be examined at three 
different time-points.  
First Time-point: 
 
 
Screening and Enrolment: 
 
 
Baseline Assessment:  
 
1st Pair Study Lens Assessment: 
Insert 1st pair of study lenses, assess fit after 30 
minutes then discard lenses 
Second Time-point: 
 
 
2nd Pair Study Lens Assessment: 
Insert 2nd pair of study lenses, assess fit after 
30 minutes then discard lenses  
Third Time-point: 
 
 
3rd Pair Study Lens Assessment: 
Insert 3rd pair of study lenses, assess fit after 30 
minutes then discard lenses and exit 
Subjects may discontinue or be discontinued from the study at any time, and the Exit Visit CRF 
will be completed.  
8.2.2 
Screening and Enrolment 
The following procedures will be conducted on all subjects:   
i. 
Allow the subject to read the Patient Information Sheet and Informed Consent Form 
(ICF) and explain the nature, purpose, risks of the study, etc.  If they are agreeable, 
ask the subject to print their initials against each declaration on the last page, print their 
name, and then sign and date in the relevant section.  The person explaining the 
consent and Investigator should also print their name, and then sign and date the 
consent form.  Provide the subject with a copy of both forms, and keep the original ICF 
in the subject’s CRF Booklet.  
ii. 
The Investigator or a clinical assistant will review instructions and warnings for lens 
wear.  Participants who appear unable or unwilling to follow instructions will not be 
enrolled onto the study.   

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iii. 
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, and onto the subjects Source Document Record (see Section 13.5 for further 
details). 
iv. 
Full ocular health will be established. 
8.2.3 
Baseline Assessment 
The following baseline measurements and assessments will be recorded: 
i. 
Subject demographics, age, sex, medications, allergies 
ii. 
Monocular sphero-cylindrical refraction (sphere, cylinder and axis) 
iii. 
Monocular and binocular high contrast (HC) distance visual acuity (logMAR) with best 
sphero-cyl spectacle refraction [D] 
iv. 
Baseline Biometry measurements 
 
Corneal topography: Sim-K-readings and corneal shape factor (Medmont) 
 
HVID* (photo slit lamp)  
 
Palpebral Aperture (mm) 
 
Corneal sagittal height, corneal diameter (CD) (Visante OCT). 
*  From photographs 
v. 
Slit lamp biomicroscopy  
 Limbal Hyperaemia (0-4) 
 Bulbar Hyperaemia (0-4) 
 Palpebral Hyperaemia (0-4) and roughness (0-4) 
 Corneal staining (0-4) 
 Conjunctival fluorescein staining (0-4) 
 Other findings (0-4). 
See Appendix 6 for Grading Scales and measurement instructions. 
Rinse away fluorescein with non-preserved saline (e.g. Sauflon saline) and allow at 
least 2 minutes for tear film to reform. 
vi. 
Complete the eligibility checklist. 
The subject’s eligibility will be assessed for the study ensuring that the subject meets all of the 
inclusion/exclusion criteria, and full ocular health must be established.  If the subject is eligible, 
then they can be fitted with the study lenses, if not eligible, then the reason should be noted on 
the Enrolment Log and the Exit CRF should be completed before the subject exits from the 
study.   
Enter the subject number on to the next line of the Randomisation Log to identify the first pair 
of study lenses.   
8.2.4 
1st Pair Study Lens Assessment  
i. 
Complete the Product Dispensing Foil Log. 
ii. 
Record the parameters of the lenses on the 1st Pair Study Lens Assessment CRF (lens 
code, lens power). Lenses powers should be chosen as close as possible to the 
subject’s spherical refraction based upon habitual contact lens information and 
refraction. 

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iii. 
Confirm lens is undamaged (Y/N).  If yes, replace and complete Product Dispensing Foil 
Log. 
iv. 
Insert 1st pair of study contact lenses. 
v. 
Confirm subjects comfort and vision is satisfactory (Y/N).  If no, then remove, replace 
and complete Product Dispensing Foil Log, and then repeat section v.   
vi. 
If yes, allow approximately 30-45 minutes settling period.   
vii. 
After settling, record the following on the 1st Pair Study Lens Assessment CRF: 
Lens Fit 
 Horizontal* & vertical* centration / overlap (mm) 
 Post-blink movement in primary gaze (mm)*  
 Version lag (mm) 
 Edge tightness (0-4) 
 Tightness on push-up (%) 
 Diameter acceptance (mm) 
 Overall fit acceptability (0-5) and reason if Grade 2 or less 
* From photographs / video 
viii. 
Remove 1st Pair Study Lenses and discard. 
ix. 
See Appendix 6 for grading scales and measurement instructions.   
8.2.5 
2nd Pair Study Lens Assessment 
Repeat the procedure listed in 8.2.4 using the Product Dispensing Foil Log and 2nd Pair Study 
Lens Assessment CRF to record the clinical test variables for the second pair of study lenses. 
8.2.6 
3rd Pair Study Lens Assessment 
Repeat the procedure listed in 8.2.4 using the Product Dispensing Foil Log and 3rd Pair Study 
Lens Assessment CRF to record the clinical test variables for the third pair of study lenses. 
8.2.7 
Study Exit 
The Study Exit Form must be completed for all subjects, who have signed the informed consent, 
to exit the study.  This will occur either at study completion, i.e. after 3rd Study Lens 
Assessment, or when a subject is discontinued from the study.  The exit date should also be 
recorded on the subjects named patient notes i.e. the Source Document Record. 
Post-study follow-up visits will be scheduled if the Investigator judges this is necessary, but the 
Exit CRF must not be completed until any such visits have been completed.   
At the study Exit Visit the following measurements are taken: 
i. 
Monocular sphero-cylindrical refraction (sphere, cylinder and axis) 
ii. 
Monocular distance visual acuity with sphero-cylindrical refraction (Snellen or logMAR).  
iii. Slit lamp examination  
 Limbal Hyperaemia (0-4) 
 Bulbar Hyperaemia (0-4) 
 Palpebral Hyperaemia (0-4) and Roughness (0-4) 
 Corneal staining (0-4) 

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 Conjunctival fluorescein staining (0-4) 
 Other findings (0-4). 
See Appendix 5 for grading scales and measurement instructions. 
Rinse away fluorescein with non-preserved saline (e.g. Sauflon saline).   
iv. Post-study follow-up requirement (Y/N).  If yes, the reason and date of the follow-visit must also 
be recorded.   
If the subject is being exited due to discontinuation, further details need to be recorded on the 
exit form. This is described in Section 8.3 below. 
8.2.8 
Clinical Variables  
The following table summarises the clinical measurements to be taken at each stage of the 
study: 
Table 2: Summary of clinical assessments by visit 
Procedure 
Screening/ 
baseline 
Pair 1 lens 
assess-
ment 
Pair 2 lens 
assess-
ment 
Pair 3 lens 
assess-
ment 
Exit 
Subject demographics 
✓ 
 
 
 
 
Subject eligibility 
✓ 
 
 
 
 
Monocular sphero-
cylindrical refraction 
✓ 
 
 
 
✓ 
Monocular HCVA 
✓ 
 
 
 
✓ 
Biometry- Medmont 
✓ 
 
 
 
 
Biometry- Visante OCT  
✓ 
 
 
 
 
Slit lamp biomicroscopy 
✓ 
 
 
 
✓ 
Lens fit and comfort 
assessment 
 
✓ 
✓ 
✓ 
 
 
8.3 
Subject Discontinuation 
Subjects may be discontinued from the study at the discretion of the Investigator or the subject. 
In the event of discontinuation, the Study Exit Form must be completed and the study exit date 
recorded on the Source Document Record.  The Investigator will indicate the primary reason 
for discontinuation by ticking one of the boxes provided on the bottom half of the Exit Form. 
Further details can be provided in the ‘comments’ section if necessary. 

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8.4 
Post-Study Follow-up 
A post-study follow-up visit must be scheduled if the subject exhibits any slit lamp findings which 
are clinically different from baseline upon discontinuation or completion of the study, unless the 
Investigator judges that no follow-up is warranted. 
Post-study follow-up visits will be recorded on the Unscheduled Visit CRF.  All variables listed 
on the forms must be completed unless the subject exhibits a condition that prohibits their 
completion.  If this is the case, a written explanation is required in the comments section. 
The study Exit form should not be completed until all post study follow-up visits have been 
completed. 
9 
ADVERSE EVENTS 
An Adverse Event (AE) is defined as any unfavourable or unintended sign (including an 
abnormal finding), symptom or disease temporarily associated with the use of a study device 
whether or not related to the study device.  All AEs, both ocular and non-ocular (but related to 
the test or control lens or to the study procedures), will be monitored.  
The Investigator will be required to judge whether or not an AE is device-related.  In the case 
where more than one diagnostic finding is associated with an AE, 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 device-related AEs to the REC.  The seriousness 
of an AE is categorized as being either serious, significant, or non-significant:   
 
Serious – 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.   
 
Significant – Symptomatic and warrant discontinuation of contact lens wear (temporary 
or permanent).  
 
Non-Significant – 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.   
For additional information, questions, or assistance in recording potential AEs, the Investigator 
should refer to VCR Standard Operating Procedure for Good Clinical Practice (SOP-GCP-161). 
9.1 
Adverse Event Categorisation 
The Investigator will be required to rate the likelihood of an event being lens-related (Possible, 
Probable, Highly Probable) or non-lens-related (No, Doubtful) in their adverse event evaluation.   
9.2 
Adverse Event Reporting 
Upon discovery of an AE, the Investigator will complete an Adverse Event Form (AE form) to 
capture the event.   
If applicable, the Investigator will notify the REC as per the REC requirements.   

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9.3 
Device-Related Adverse Event Documentation 
Investigators are required to document and follow-up all adverse events. 
All adverse events are documented on an AE Form (Appendix 1) upon event discovery.  For all 
ocular AEs, one AE form is used per eye.  For AEs which are non-ocular but related to the study 
device (test or control) or to the study procedures, only one AE Form needs to be completed 
per AE.   
Procedure: 
The Investigator has the responsibility to: 
1. Complete as much information as possible on the AE Form upon event discovery.  This 
includes: 
 
A detailed description of the adverse event and a diagnosis, including a probable 
cause.   
 
Detailed drawings that detail size, location and depth, or photographs (if necessary).   
 
Likelihood of the adverse event being device-related.   
2. If appropriate, report the AE to the Research Ethics Committee within the specified 
timelines (see Reporting of Adverse Events section 9.2). 
3. Follow study subject until resolution recording all information on an unscheduled visit CRF, 
including VA, symptoms and slit lamp findings, resolution and permanent sequelae if any.  
4. Complete all remaining information as required on the AE Form.  If follow-up of the adverse 
event is required, the resolution of the AE can only be completed when all follow-up visits 
are done.  The following additional information will also be completed on the AE resolution 
form:  
 
Outcome, ocular sequelae if any 
 
Whether the patient is discontinued from the study as a result of the AE 
9.4 
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 Unscheduled Visit CRFs and on the AE Form. 
9.5 
Study Completion 
The study is completed when all subjects have completed the third pair study lens assessment 
or have been discontinued. 
10 
DATA MANAGEMENT 
10.1 
Data Quality Assurance 
Before the final closing of the database, the data will be checked and any subsequent omissions 
and discrepancies resolved before analysis as per VCR SOPs.   

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10.2 
Data Entry and Storage 
Data shall be completed on the CRFs and hand entered into a database using DACs software 
and then exported to an Excel database (Microsoft).  The statistical analyses will be completed 
using SAS software. 
11 
SAMPLE SIZE AND STATISTICAL METHODS 
11.1 
Sample Size Rationale  
A sample size of 60 subjects showing a 90% success rate would give an 80% confidence 
interval of ± 5.0%.  This would statistically differentiate success rates of 85% and 95%.   
A sample size of 60 is sufficient to detect a mean difference of 5 (0-100) in tightness, or 0.2 mm 
in corneal overlap assuming the standard deviation of the mean differences in Table 2 below 
and assuming =0.05 with a power of 95%.   
Table 2:  Sample Size Justification: 
 
Sample Size  
Tightness (0-100) 
Corneal overlap 
(mm) 
Mean of paired difference 
5 
0.2 
SD of paired difference 
10 
0.4 
Minimum sample size per 
group 
42 
42 
11.2 
Level of Statistical Significance 
The overall type I error rate will be preserved at 5%.  To preserve type I error control, the study 
hypotheses will be evaluated using a sequential gate-keeping strategy.  All tests will be 
two-sided.  The three co-primary hypotheses will be simultaneously evaluated using α=0.05, all 
of which must be met in order to satisfy the primary objective of this study. 
11.3 
Analysis Population 
The primary hypotheses will be analysed on all randomized subjects who have successfully 
completed the study without a protocol deviation that is deemed to impact the assessment of 
the primary hypotheses (i.e. the per-protocol population). 
11.4 
Summary Tables 
Summary tables (descriptive statistics and/or frequency tables) will be provided for all variables 
as appropriate.  Continuous variables will be summarized with descriptive statistics (n, mean, 
standard deviation (SD), median, minimum, and maximum).  Frequency count and percentage 
of subjects or eyes within each category will be provided for categorical data.   

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11.5 
Statistical Analysis 
11.5.1 Success Rates – Two Designs versus One Design 
Fit acceptance (0=Unacceptable, 1=Acceptable) will be analysed using a generalized linear 
mixed model with a binary distribution and a logit link function.  Lens type will be included as a 
fixed effect and subject will be included as a random effect.   
If the incidence rate is too low or there are problems with the convergence of the above model, 
the method of Wilson5 will be used to evaluate the confidence intervals. 
11.5.2 Success Rates – Actual versus Theoretical 
Fit acceptance (0=Unacceptable, 1=Acceptable) will be analysed using a generalized linear 
mixed model with a binary distribution and a logit link function.  Lens type, period, and the lens 
by period interaction will be included as fixed effects and subject will be included as a random 
effect.  The proportion of eyes with acceptable lens fit with each lens type will be calculated 
with 95% confidence intervals.  These confidence intervals will be compared to the theoretical 
success rates. 
If the incidence rate is too low or there are problems with the convergence of the above model, 
the method of Wilson5 will be used to evaluate the confidence intervals. 
11.5.3 Fitting Characteristics – Actual versus Theoretical 
The fitting characteristics will be analysed separately for tightness and corneal overlap using 
linear mixed models.  The regression models will include the experimental design factors: lens 
type, period, and the lens by period interaction as fixed effects, and subject as a random effect.  
Comparisons will be carried out using 95% confidence intervals constructed of least-square 
means (LSM) from the linear mixed models.   
11.5.4 Supplementary Analysis 
Appropriate additional post hoc analyses may be undertaken. 
11.6 
Interim Analysis 
There will be no interim analyses and, therefore, there are no criteria for early termination of 
the study on statistical grounds. 
12 
POTENTIAL RISKS AND BENEFITS 
There might not be direct benefits to the participants in this study.  However, participation in a 
study may contribute to scientific research information that may be used in the development of 
new contact lens products.   
This study is considered to be a non-significant risk study based on International Standards 
Organization (ISO) guidelines due to the relatively short duration of wear (30mins) of a 
marketed lens in the study.    
The risks to participants in this study are similar to those associated with normal daily wear of 
soft contact lenses. 

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13 
GENERAL STUDY MANAGEMENT 
13.1 
Relevant Standards 
This protocol has been developed in accordance with the following:   
 
ISO 14155-1:2011 Clinical Investigation of Medical Devices for Human Subjects 
 
ISO 11980:2012 contact lenses and contact lens care products – Guidance for clinical 
investigations. 
 
ICH Harmonised Tripartite Guideline for Good Clinical Practice (GCP) 
 
Declaration of Helsinki 
The study will also be carried out in accordance with the Visioncare Research Quality 
Management System (ISO 9001:2008).   
13.2 
Ethics Review 
The study Protocol, Informed Consent Form and Participant Information Sheet will be submitted 
to the Research Ethics Committee - National Research Ethics Service (NRES) and to Aston 
University REC. A favourable opinion will be received prior to undertaking the study. The 
approval letter should clearly mention the approval/favourable opinion of the Protocol, Informed 
Consent Form and Participant Information Guide, 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. 
13.3 
Protocol Deviations 
The Investigators will not deviate from the protocol without written approval from NRES and 
Aston University REC and will require a protocol amendment. However, in medical 
emergencies, the Investigator will use their judgement and remove the subject from immediate 
hazard.   
If an unexpected deviation from the protocol occurs, the Investigator will document their findings 
until resolution on a follow-up assessment form.   
13.4 
Premature Termination of the Study 
The Investigator reserves the right to terminate the study at any time for any reason, including 
adverse effects.  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 NRES.   
13.5 
Source Documentation 
Unless otherwise documented, the CRFs will be considered the source document and will be 
completed to comply with GCP guidelines.  A permanent record will be made within the patient’s 
notes to document the subject’s involvement in a clinical research study and will include:   
 
 
Study number and Subject ID 
 
Confirmation that subject met eligibility criteria 
 
Confirmation that subject signed the informed consent 

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 
Confirmation that subject received a signed and dated copy of informed consent 
 
Date enrolled 
 
General notes 
 
Reportable protocol deviations 
 
Adverse events 
 
Exit date 
 
Whether subject completed the study or discontinued 
 
Investigator’s signature 
13.6 
Monitoring 
Since this is an investigator initiated study, there will be no external monitoring, although all 
activities will comply with ISO14155 and ISO 11980.   
13.7 
Audits 
The Investigator shall permit the NRES to inspect its facilities, equipment, and study-related 
records, data and other documents upon reasonable notice.  In addition, the NRES may 
conduct such inspections as they deem necessary at any time whether or not advanced notice 
is given by them. If such notice is in writing, a copy with any attachments thereto shall be added 
to the study documents.  
13.8 
Records Retention 
The study lens material is already on the market; therefore, the study documents should be 
kept for a minimum of two years after the end of the study according to the ICH GCP guidelines.   
13.9 
Confidentiality and Publication 
By signing the Informed Consent Form, the subject authorises the Investigator to access their 
optometric clinical records.  The authorisation will be indefinite; however, subjects will have the 
right to reverse this authorisation at any time. 
Any electronic records will also be handled in accordance with the UK Data Protection Act 
(1998). 
14 
REFERENCES 
1. 
Hall L, Hunt C, Young G, Wolffsohn J.  Factors affecting corneoscleral topography. Invest 
Ophthal Vis Opt 2013; 54:3691-3701. 
2. 
Young G.  Mathematical model for evaluating soft contact lens fit. Optom Vis Sci 2014; 
91:167-76. 
3. 
Young G, Hall L, Sulley A, Osborn-Lorenz K, Wolffsohn J. The inter-relationship of soft 
contact lens diameter, base curve radius and fit. Optom Vis Sci 2017; 94:458-65. 
4. 
Sulley A, Young G, Hunt C. Retention rates in new contact lens wearers. Eye Cont Lens 
2017 In press. 
5. 
Wilson, E. B. Probable inference, the law of succession, and statistical inference, J Am 
Stat Assoc, 1927; 22:209-12. 
 

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APPENDIX 1 
 
 
 
 
Template Adverse Event Form 

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Page 1 (of 2) 
Study No: TRTN-501 
AD V E R S E  E V E NT  FO RM  
(Immediate Notification) 
Please notify Visioncare Research of this event IMMEDIATELY in the following way: 
complete and fax page 1 or telephone to relay the information 
Tel: 01252 718719    Fax:  01252 718720  
If required, Visioncare Research will advise how to notify the appropriate research ethics committee. 
Subject ID: ___ / ____ / _____ 
Date of visit when event discovered: ___ / __ / ___  
Visit when event discovered:   1st assessment     2nd assessment     3rdassessment     Exit 
G e n e r a l  I n f o r m a t i o n  
Data entered by eye (only one eye per form) 
Eye: (tick one box only) 
 Right 
 Left 
Lens code: 
 
 
Wearing schedule at time of AE: 
 Daily Wear 
Spectacle refraction: 
_________ / _________ x _________ 
Best corrected distance VA: 
 
 
Date event began: 
____ / ___ / ___  
Date subject entered the study: 
____ / ___ / ___  
D i a g n o s i s  
see Adverse Event section in protocol 
Symptoms and history:   
 
 
 
 
 
Significant slit lamp findings relating to AE:  
 
 
 
 
 
Diagnosis: 
 
 
 
Event seriousness: (tick one box only) 
 Serious 
 Significant 
 Non-significant 
Do you consider the event device related:   Highly Probably    Probable  Possible     No 
Event severity: (tick one box only) 
 Mild 
 Moderate 
 Severe 
Is corneal infection suspected? 
 Yes 
 
 No 
Possible cause: (If not known tick box)    
 
 
 
 
 
 

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Page 2 (of 2) 
Study No: TRTN-501  
(Action, Follow-up & Resolution) 
AD V E R S E  E V E NT  FO RM  
 
 
Subject ID: __ / ____ / ____ 
Eye: R / L  
Date discovered: ___/___/ ___  
T r e a t m e n t  /  A c t i o n  
Medication prescribed:   
 
 
 
 
 
 
 
 
 
Initial treatment (including referral if required):   
 
 
 
 
 
 
 
 
 
F o l l ow - u p  
If no follow-up required tick box:  
otherwise provide follow-up dates below, and at each visit record details on an Unscheduled Visit Form 
Follow-up dates: 
___ / __ /___  
___ / __ /___  
___ / __ / ___  
 
AE resolved at this visit? 
AE resolved at this visit? 
AE resolved at this visit? 
 
 Yes    No 
 Yes    No 
 Yes    No 
O u t c o m e  
O nly complete this section when event has resolved 
Total number of days out of lens wear: 
__________ days 
Spectacle refraction and best corrected 
distance VA (at resolution): 
________ / ________ x ________       _________ 
Permanent sequelae to eye following event? 
 Yes 
 No 
If Yes describe: 
 
 
 
 
 
Discontinued from study due to event? 
 Yes 
 No 
If Yes, date of discontinuation: 
___ / __ / 2014 
 
 
 

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APPENDIX 2 
 
 
 
 
Template Sample Enrolment and Randomisation Logs 
 
 

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TRTN-501 
SAMPLE ENROLMENT LOG 
A maximum of 20 subjects may be enrolled.  All subjects must be enrolled sequentially. 
Subject ID 
Site /Sub/Initials 
Subject Name 
Enrolment Date 
(Consent signed) 
(dd/mm/yy) 
Subject 
Eligible 
Large 
HVID / 
CD 
Reason if not eligible 
01 / 01 / JS 
John SMITH 
10 / 01 / 14 
Y 
Y 
 
01 / 01 /    
 
/         / 
Y / N 
Y / N 
 
01 / 02 /   
 
/         / 
Y / N 
Y / N 
 
01 / 03 /   
 
/         / 
Y / N 
Y / N 
 
01 / 04 /   
 
/         / 
Y / N 
Y / N 
 
01 / 05 /   
 
/         / 
Y / N 
Y / N 
 
01 / 06 /   
 
/         / 
Y / N 
Y / N 
 
01 / 07 /   
 
/         / 
Y / N 
Y / N 
 
01 / 08 /   
 
/         / 
Y / N 
Y / N 
 
01 / 09 /   
 
/         / 
Y / N 
Y / N 
 
01 / 10 /   
 
/         / 
Y / N 
Y / N 
 
01 / 11 /   
 
/         / 
Y / N 
Y / N 
 
01 / 12 /   
 
/         / 
Y / N 
Y / N 
 
01 / 13 /   
 
/         / 
Y / N 
Y / N 
 
01 / 14 /   
 
/         / 
Y / N 
Y / N 
 
01 / 15 /   
 
/         / 
Y / N 
Y / N 
 
01 / 16 /   
 
/         / 
Y / N 
Y / N 
 
01 / 17 /   
 
/         / 
Y / N 
Y / N 
 
01 / 18 /   
 
/         / 
Y / N 
Y / N 
 
01 / 19 /   
 
/         / 
Y / N 
Y / N 
 
01 / 20 /   
 
/         / 
Y / N 
Y / N 
 
 
 
 

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TRTN-501 
SAMPLE RANDOMISATION LOG 
Subjects should only be entered onto the Randomisation Log once they have been found to be 
eligible for the study. 
 
Subject ID 
Site /Sub/Initials 
Randomisation Date 
(dd/mm/yy) 
Pair 1 
Pair 2 
Pair 3 
01 / 01 / JS 
10/08/17 
A 
B 
C 
01 / 01 /    
 
A 
C 
B 
01 / 02 /   
 
B 
A 
C 
01 / 03 /   
 
A 
C 
B 
01 / 04 /   
 
B 
C 
A 
01 / 05 /   
 
A 
B 
C 
01 / 06 /   
 
C 
B 
A 
01 / 07 /   
 
          C 
B 
A 
01 / 08 /   
 
A 
C 
B 
01 / 09 /   
 
B 
C 
A 
01 / 10 /   
 
B 
A 
C 
01 / 11 /   
 
A 
C 
B 
01 / 12 /   
 
C 
B 
A 
01 / 13 /   
 
A 
B 
C 
01 / 14 /   
 
B 
A 
C 
01 / 15 /   
 
C 
A 
B 
01 / 16 /   
 
B 
C 
A 
01 / 17 /   
 
A 
B 
C 
01 / 18 /   
 
C 
A 
B 
01 / 19 /   
 
B 
C 
A 
01 / 20 /   
 
A 
B 
C 
 
 
 
 

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APPENDIX 3 
 
 
 
 
Template Product Accountability Log  
(1 Page sample only) 
 
 

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TRTN-501  
PRODUCT ACCOUNTABILITY LOG 
  
SITE NUMBER ____ 
1. 
When product is received, record power (if applicable), base curve (if applicable), expiry date (if applicable), 
lot numbers, date of receipt and number received. 
2. 
Tally (tick mark) under "No. Dispensed" column when product is dispensed or given to a subject. 
3. 
Insert the number of unused product, this should equal the “No. Received” minus “No. Dispensed”. 
4. 
Please sign, date and return this sheet with the product when all subjects have been exited. 
Power 
Base 
Curve 
Expiry 
Date 
Lot # 
Date 
Rec’d at 
Site 
No. 
Rec’d 
No. 
Dispensed 
No. 
Returned to 
Site 
No. unused 
to be 
returned 
OFFICE USE 
ONLY 
No. 
Destroyed 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TOTALS 
 
 
 
 
 
Investigator’s signature: _____________________________ 
Date: _____/_____/_____ 
 
 
 

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APPENDIX 4 
 
 
 
 
Template Product Dispensing Foil Log  
(1 Page sample only) 
 
 

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TRTN-501  
PRODUCT DISPENSING FOIL LOG 
   Date/Page:  ________/__        Investigator’s Initials: _______                    Subject ID:  __ / ____ / ____ 
 
Please affix the OD and OS foil from the dispensed study lenses to the table below and record the 
applicable information. After each lens foil is affixed to the page the site staff member dispensing the 
lenses should initial and date the entry in the space provided in the middle column. 
 
OD  Foil 
Visit Information 
OS Foil 
 
Lens Code ________ 
 
Are Additional lenses Needed: □ Yes   □ No 
If yes please affix foils below. 
 
 
OD  Foil 
Visit Information 
OS Foil 
 
Lens Code ________ 
 
Are Additional lenses Needed: □ Yes   □ No 
If yes please affix foils below. 
 
 
OD  Foil 
Visit Information 
OS Foil 
 
Lens Code ________ 
 
Are Additional lenses Needed: □ Yes   □ No 
If yes please affix foils below. 
 
 
OD  Foil 
Visit Information 
OS Foil 
 
Lens Code ________ 
 
Are Additional lenses Needed: □ Yes   □ No 
If yes please continue on next page of log. 
 
 
 
 
 

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APPENDIX 5 
 
 
 
 
Grading Scales & Measurement Instructions 
 
 

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GRADING & MEASUREMENT SYSTEM (TRTN-501) 
 
VARIABLE 
ASSESSMENT METHOD 
GRADING/MEASUREMENT SYSTEM 
Vision 
Distance VA – High 
contrast 
Assessed using computer generated 
logMAR chart. 
logMAR visual acuity (VA) to nearest 
letter. 
 
                  Biometry 
 
Corneal Topography 
Sim-K 
Assessed using Medmont Corneal 
Topographer.   
To nearest 0.01 mm 
Corneal Topography 
Corneal Shape Factor 
(P-value) 
Assessed using Medmont Corneal 
Topographer.   
To nearest 0.01 mm 
Iris Diameter 
Assessed using photographs from 
photo slit lamp (10x or 30x 
magnification), at primary gaze and 
using the eyepiece graticule.   
To nearest 0.1 mm 
Palpebral Aperture 
Assessed using slit lamp in 10x or 
30x magnification, at primary gaze 
and using the eyepiece graticule.   
To nearest 0.1 mm 
Corneal Sagittal Height 
Assessed using Visante OCT.   
To nearest 0.01 mm 
Corneal Diameter 
Assessed using Visante OCT.   
To nearest 0.01 mm 
Lens Fit 
- assessed using photo / video slit lamp (10x or 30x magnification) 
Horizontal and Vertical 
Centration / overlap  
Assessed using photographs / video, 
primary gaze and eyepiece graticule.   
Lens centration will be recorded by 
degree and direction in the primary 
position. 
To nearest 0.1mm 
For Superior or Nasal record +ve value 
For Inferior or Temporal record -ve value 
Post-Blink Movement in 
Primary Gaze  
Assessed using photographs / video, 
primary gaze and using the eyepiece 
graticule immediately after the blink - 
lower lid to be depressed only if 
necessary for observation. 
To nearest 0.1mm 
Version Lag 
Assessed on D / L gaze.   
To nearest 0.1mm 

V I S I O N C A R E  R E S E A R C H  
PRO TRTN-501v1/25Augl17  
35 - 
 PROTOCOL TRTN-501 v1.0 
VARIABLE 
ASSESSMENT METHOD 
GRADING/MEASUREMENT SYSTEM 
Edge Tightness  
Assessed using primary gaze and 
eyepiece graticule. 
Grade 0-4 where:   
0     Gross edge stand-off/fluting 
1     Loose, occasional edge lifting 
2     Optimum 
3     Tight, mild vessel compression 
4 
Conjunctival 
indentation 
and/or  
compression against immobile lens 
Tightness / Push-up  
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.   
Grade 0%-100% continuous scale where:  
100% No movement 
50% 
Optimum 
0% Falls from cornea without lid support 
Diameter Acceptance  
Assessed using primary gaze and the 
eyepiece graticule.   
To nearest 0.1mm 
Overall Fit Acceptance  
Assessed by the Investigator based 
on lens fit alone (i.e. not comfort or 
vision). 
Grade 0-5 & add reason if Grade 2 or less:   
0 
Should not be worn 
1 
Should not be dispensed although no 
immediate danger  
2 
Borderline but unacceptable 
3 
Min. acceptable, early review 
4 
Not perfect but OK to dispense 
5  
Perfect  
Comfort 
Subjective Comfort 
Ask the subject the following:  
“Using a 0-10 scale, please rate the 
lens comfort as it is now (10=Can’t 
feel the lenses, 0=painful).”  
0-10 scale 
Biomicroscopy 
Limbal Hyperaemia 
Assessed using white light and low-
medium magnification.   
 
Grade 0-4:   
0 
NONE:  No hyperaemia 
1 
TRACE: Slight limbal hyperaemia 
(mild segmented)  
2 
MILD: Mild limbal hyperaemia (mild 
circumcorneal)  
3 
MODERATE: Significant limbal 
hyperaemia (marked segmented)  
4 
SEVERE: Severe limbal hyperaemia 
(marked circumcorneal) 

V I S I O N C A R E  R E S E A R C H  
PRO TRTN-501v1/25Augl17  
36 - 
 PROTOCOL TRTN-501 v1.0 
VARIABLE 
ASSESSMENT METHOD 
GRADING/MEASUREMENT SYSTEM 
Bulbar Hyperaemia 
Assessed using white light and low-
medium magnification. 
 
Grade 0-4:   
0 
NONE:  No hyperaemia  
1 
TRACE: Slight regional hyperaemia 
2 
MILD:  Diffuse hyperaemia 
3 
MODERATE:  Marked regional or 
diffuse hyperaemia 
4 
SEVERE:  Diffuse episcleral or scleral 
hyperaemia 
Palpebral Roughness 
Assessed using white light, low-
medium magnification and CCLRU 
images for reference.   
Grade 0-4:   
0 
Uniform satin appearance off 
conjunctiva 
1 
Trace, slight loss of smoothness 
2 
Mild, or scattered papillae/ follicles, 
less than 1mm in diameter. 
3 
Moderate, significant papillae / 
follicles, less than 1mm in diameter. 
4      Severe, localised or generalised     
papillae / follicles 1mm or more in 
diameter  
 
Corneal Staining Grade 
Assessed using fluorescein, blue 
light, yellow filter and full beam with 
medium magnification. 
 
0 
NONE:  No staining 
1 
TRACE:  Minimal superficial diffuse 
staining or stippling, or trace abrasion 
or foreign body tracks 
2 
MILD:  Regional or diffuse punctate 
staining, or mild abrasion or foreign 
body tracks 
3 
MODERATE:  Significant dense 
coalesced staining, corneal abrasion 
or foreign body tracks 
4 
SEVERE:  Confluent abrasions 
greater than 2mm diameter, 
ulcerations, epithelial loss, or full 
thickness abrasion 
Conjunctival Staining 
Assessed using fluorescein, blue 
light, yellow filter and full beam with 
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 
 
 

V I S I O N C A R E  R E S E A R C H  
PRO TRTN-501v1/25Augl17  
37 - 
 PROTOCOL TRTN-501 v1.0 
 
M E A S U R E M E N T  I N S T R U C T I O N S  
CORNEAL STAINING 
Materials Needed:   Soduim fluorescein impregnated strips and Yellow filter.   
The type (severity) of corneal staining will be evaluated with the slit-lamp using blue light and a yellow 
filter (e.g. #12 Wratten).  Both eyes will be evaluated.  The fluorescein used throughout the study will 
be standard fluorescein sodium ophthalmic strips (e.g. Chauvin Fluorets). 
i. 
Wet a fluorescein strip using non-preserved sterile saline. 
ii. 
Instil one drop of fluorescein onto either: a) the upper bulbar conjunctiva of the right eye with the 
upper lid retracted and the patient looking downwards; or b) the lower lid margin with the patient 
looking upwards.   
iii. 
Instruct the subject to blink a few times, and wait 1-2 minutes before examining the eye.  Note 
that excess fluorescein in the tear film can mask corneal staining.   
iv. 
Examine for staining through a biomicroscope, using blue light and a yellow filter.  The 
magnification should be medium and the illumination high. 
v. 
Grade and record the type of corneal staining using the scales below.   
vi. 
N.B.  Do not record staining secondary to debris, dimple veiling, or pooling.  If a region has 
more than one type (severity) of staining, grade and record the most severe staining.  
vii. 
Repeat the assessment for the left eye. 
 
 
Grade of Corneal Staining (Severity):                                                      
0 
NONE:  No staining.   
1 
TRACE:  Minimal superficial diffuse staining or stippling, or trace 
abrasion or foreign body tracks.   
2 
MILD:  Regional or diffuse punctate staining, or mild abrasion or 
foreign body tracks.   
3 
MODERATE:  Significant dense coalesced staining, corneal 
abrasion or foreign body tracks. 
4 
SEVERE:  Confluent abrasions greater than 2mm diameter, 
ulcerations, epithelial loss, or full thickness abrasion.