Late Night Study 2: End-of-Day Assessment of Asymptomatic and Symptomatic Soft Lens Wearers
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Protocol Title
Late Night Study 2: End-of-Day Assessment of Asymptomatic and Symptomatic Soft Lens 
Wearers
Protocol CR-6290
Version: 6.0 Amendment 5
Date: 23 September 2020
Investigational Products: Dailies AquaComfort Plus, Acuvue Oasys 1-Day
Key Words: asymptomatic, symptomatic, comfort, end-of-day, Dailies AquaComfort Plus 
(nelfilcon A), Acuvue Oasys 1-Day (senofilcon A), daily wear, daily disposable, dispensing,
osmolarity, non-invasive break up time, tear meniscus height, lid margin staining, confocal 
microscopy
Statement of Compliance to protocol, GCP and applicable regulatory guidelines:
This trial will be conducted in compliance with the protocol, ISO 14155,1 the International 
Conference on Harmonization Good Clinical Practice E6 (ICH-GCP),2 the Declaration of 
Helsinki,3 and all applicable regulatory requirements.
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc.  The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc.  Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document.
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TABLE OF CONTENTS
PROTOCOL TITLE, NUMBER, VERSION........................................................................... 7
SPONSOR NAME AND ADDRESS....................................................................................... 7
MEDICAL MONITOR............................................................................................................. 7
AUTHORIZED SIGNATURES............................................................................................... 8
CHANGE HISTORY................................................................................................................ 9
SYNOPSIS.............................................................................................................................. 11
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS .................... 17
1.
INTRODUCTION AND BACKGROUND ................................................................... 19
1.1.
Name and Descriptions of Investigational Products ................................................ 19
1.2.
Intended Use of Investigational Products................................................................. 19
1.3.
Summary of Findings from Nonclinical Studies...................................................... 19
1.4.
Summary of Known Risks and Benefits to Human Subjects................................... 19
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 20
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 20
2.1.
Objectives................................................................................................................. 20
2.2.
Endpoints.................................................................................................................. 21
2.3.
Hypotheses ............................................................................................................... 23
3.
TARGETED STUDY POPULATION........................................................................... 24
3.1.
General Characteristics ............................................................................................ 24
3.2.
Inclusion Criteria...................................................................................................... 24
3.3.
Exclusion Criteria..................................................................................................... 26
3.4.
Enrollment Strategy.................................................................................................. 27
4.
STUDY DESIGN AND RATIONALE.......................................................................... 27
4.1.
Description of Study Design .................................................................................... 27
4.2.
Study Design Rationale............................................................................................ 27
4.3.
Enrollment Target and Study Duration.................................................................... 28
5.
TEST ARTICLE ALLOCATION AND MASKING..................................................... 28
5.1.
Test Article Allocation............................................................................................. 28
5.2.
Masking.................................................................................................................... 28
5.3.
Procedures for Maintaining and Breaking the Masking........................................... 28
6.
STUDY INTERVENTION............................................................................................. 29
6.1.
Identity of Test Articles............................................................................................ 29
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6.2.
Ancillary Supplies/Products..................................................................................... 30
6.3.
Administration of Test Articles................................................................................ 30
6.4.
Packaging and Labeling ........................................................................................... 30
6.5.
Storage Conditions................................................................................................... 30
6.6.
Collection and Storage of Samples .......................................................................... 30
6.7.
Accountability of Test Articles ................................................................................ 31
7.
STUDY EVALUATIONS.............................................................................................. 31
7.1.
Time and Event Schedule......................................................................................... 31
7.2.
Detailed Study Procedures ....................................................................................... 35
PART 1, VISIT 1 ............................................................................................................ 35
PART 1, VISIT 2 ............................................................................................................ 38
PART 1, VISIT 3 ............................................................................................................ 40
PART 1, VISIT 4 ............................................................................................................ 44
PART 2, VISIT 5 ............................................................................................................ 47
PART 2, VISIT 6 ............................................................................................................ 49
PART 2, VISIT 7 ............................................................................................................ 51
PART 2, VISIT 8 ............................................................................................................ 55
FINAL EVALUATION.................................................................................................. 59
7.3.
Unscheduled Visits................................................................................................... 60
7.4.
Laboratory Procedures ............................................................................................. 61
8.
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 61
8.1.
Completion Criteria.................................................................................................. 61
8.2.
Withdrawal/Discontinuation from the Study ........................................................... 61
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 62
10.
DEVIATIONS FROM THE PROTOCOL.................................................................. 62
11.
STUDY TERMINATION ........................................................................................... 63
12.
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS.............. 63
13.
ADVERSE EVENTS................................................................................................... 64
13.1.
Definitions and Classifications............................................................................. 64
13.2.
Assessing Adverse Events.................................................................................... 67
13.2.1.Causality Assessment ........................................................................................... 67
13.2.2.Severity Assessment............................................................................................. 67
13.3.
Documentation and Follow-Up of Adverse Events.............................................. 68
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13.4.
Reporting Adverse Events.................................................................................... 69
13.4.1.Reporting Adverse Events to Sponsor.................................................................. 69
13.4.2.Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities. 70
13.4.3.Event of Special Interest....................................................................................... 70
13.5.
Reporting of Pregnancy........................................................................................ 70
14.
STATISTICAL METHODS........................................................................................ 70
14.1.
General Considerations......................................................................................... 70
14.2.
Sample Size Justification...................................................................................... 71
14.3.
Analysis Populations ............................................................................................ 75
14.4.
Level of Statistical Significance........................................................................... 75
14.5.
Primary Analysis (For Part 1)............................................................................... 75
14.6.
Secondary Analysis (For Part 1 and Part 2) ......................................................... 78
14.7.
Other Hypotheses ................................................................................................. 79
14.8.
Interim Analysis ................................................................................................... 81
14.9.
Procedure for Handling Missing Data and Drop-Outs ......................................... 81
14.10.
Procedure for Reporting Deviations from Statistical Plan ................................... 81
15.
DATA HANDLING AND RECORD KEEPING/ARCHIVING................................ 81
15.1.
Electronic Case Report Form/Data Collection ..................................................... 81
15.2.
Subject Record...................................................................................................... 82
16.
DATA MANAGEMENT............................................................................................. 82
16.1.
Access to Source Data/Document ........................................................................ 82
16.2.
Confidentiality of Information.............................................................................. 83
16.3.
Data Quality Assurance........................................................................................ 83
17.
MONITORING............................................................................................................ 83
18.
ETHICAL AND REGULATORY ASPECTS ............................................................ 84
18.1.
Study-Specific Design Considerations ................................................................. 84
18.2.
Investigator Responsibility................................................................................... 84
18.3.
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 84
18.4.
Informed Consent ................................................................................................. 85
18.5.
Privacy of Personal Data ...................................................................................... 86
19.
STUDY RECORD RETENTION................................................................................ 87
20.
FINANCIAL CONSIDERATIONS ............................................................................ 88
21.
PUBLICATION........................................................................................................... 88
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22.
REFERENCES ............................................................................................................ 89
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)..... 90
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 97
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)......................................... 98
APPENDIX D: 
.................................... 129
SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS....................... 130
, PATIENT REPORTED OUTCOMES .............................................................. 132
APPENDIX E:  EUROLENS RESEARCH SOP #12A, THE SET UP, MEASUREMENT OF 
VISUAL ACUITY AND PROCEDURES FOR CARRYING OUT AN OVER REFRACTION 
USING THE EUROLENS COMPUTERISED LOGMAR VA CHART ............................ 134
APPENDIX F: EUROLENS RESEARCH SOP #16, MEDMONT E300 
(TOPOGRAPHY 
AND TEAR FILM ANALYSIS).......................................................................................... 146
APPENDIX G: EUROLENS RESEARCH SOP #13, EXAMINATION OF THE ANTERIOR 
SEGMENT USING SLIT LAMP BIOMICROSCOPY....................................................... 151
APPENDIX H: EUROLENS RESEARCH GRADING SCALE (LENS FIT AND SURFACE 
ASSESSMENT).................................................................................................................... 156
APPENDIX I: EUROLENS RESEARCH SOP #53, IN-VIVO CONFOCAL MICROSCOPY
............................................................................................................................................... 159
APPENDIX J: EUROLENS RESEARCH SOP #58, MEASURING TEAR MENISCUS 
HEIGHT 
AND 
CROSS-SECTIONAL 
AREA 
USING 
OPTICAL 
COHERENCE 
TOMOGRAPHY .................................................................................................................. 168
APPENDIX K: EUROLENS RESEARCH SOP #52, TEARLAB™.................................. 175
APPENDIX L: EUROLENS RESEARCH SOP #57, TEAR FLUID SAMPLING USING THE 
MICROCAPILLARY TUBE METHOD ............................................................................. 181
APPENDIX M: EUROLENS RESEARCH SOP #41, LID MARGIN STAINING 
ASSESSMENT..................................................................................................................... 187
APPENDIX N: EUROLENS RESEARCH SOP #24 OBJECTIVE CONTACT LENS 
MEASURES ......................................................................................................................... 194
APPENDIX O:
 Guidelines for COVID-19 Risk Mitigation .............................. 206
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 216
 
TABLE OF CONTENTS
Figure 1: Study Flowchart ...................................................................................................... 16
TABLE OF CONTENTS
Table 1: Test Articles.............................................................................................................. 29
Table 2: Ancillary Supplies .................................................................................................... 30
Table 3: Time and Events ....................................................................................................... 31
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Table 4: Historical Studies Included....................................................................................... 71
Table 5: Lid Margin Staining – Completed Per-Protocol Population 
................. 72
Table 6: Non-Invasive Tear Break-Up Time (NITBUT in Seconds) – Completed Per-Protocol 
Population 
............................................................................................................. 72
Table 7: Tear Meniscus Height (TMH) – Completed Per-Protocol Population
.... 72
Table 8: Tear Film Osmolarity (mOsm/L) – Completed Per-Protocol Population 
................................................................................................................................................. 72
Table 9: Mean White Bloods Cell (WBC) Count (Confocal Microscopy) – Completed Per-
Protocol Population 
.............................................................................................. 73
Table 10: Power Calculations of LMS for N=54.................................................................... 73
Table 11: Power Calculations of NIBUT for N=54................................................................ 74
Table 12: Power Calculations of TMH for N=54................................................................... 74
Table 13: Power Calculations of TOSM for N=54................................................................. 74
Table 14: Power Calculations of WBC for N=54................................................................... 74
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PROTOCOL TITLE, NUMBER, VERSION 
Title: Late Night Study 2: End-of-Day Assessment of Asymptomatic and Symptomatic Soft 
Lens Wearers
Protocol Number: CR-6290
Version: 6.0 Amendment 5
Date: 23 September 2020
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care (JJVC)
7500 Centurion Parkway 
Jacksonville, FL 32256
MEDICAL MONITOR 
Name:  
Title:
Address:
Email: 
Fax#:
The Medical Monitor must be notified by the clinical institution/site by e-mail, fax, or 
telephone within 24 hours of learning of a Serious Adverse Event. The Medical Monitor may 
be contacted during business hours for adverse event questions. General study related questions 
should be directed towards your assigned clinical research associate.
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File.
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5.0
To enable recruitment of the targeted 
number of symptomatic subjects, the 
total number of subjects which can be 
enrolled was increased.
Study responsible clinician at JJVC 
changed to 
.
Clarified numbering of visits in Part 2.
30 October 2019
6.0
Updated pregnancy language in 
section 13.5
Updated to v10 of protocol template
Updated biostatistician and reviewer
Added COVID language to Protocol 
Compliance Signature Page 
Added Appendix O –
23 September 
2020
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SYNOPSIS  
Protocol Title
Late night study 2: End-of-Day Assessment of Asymptomatic and 
Symptomatic Soft Lens Wearers
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Development phase, Phase 0
Trial 
Registration
This study will be registered on ClinicalTrials.gov by the Sponsor
Test Article(s)
Investigational Products:
Dailies AquaComfort Plus daily disposable contact lenses
Acuvue Oasys 1-Day daily disposable contact lenses
Wear and 
Replacement 
Schedules
Wear Schedule: daily wear
Replacement Schedule: daily disposable
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Objectives
Primary Objectives:
Part 1: to investigate if there are statistically significant differences in the 
following clinical measures between asymptomatic and symptomatic
contact lens wearers:
1. Upper and lower lid margin lissamine green staining (14 hours)
2. Non-invasive tear break-up time (NIBUT) (14 hours)
3. Tear meniscus height (TMH) (14 hours)
4. Tear film osmolarity (14 hours)
5. Density of white blood cells in the eyelid margins using confocal 
microscopy (6 hours)
These will be referred to as the ‘five clinical measures’
Secondary Objectives:
Part 1 and 2: To investigate any possible relationship between subjective 
scores of contact lens comfort and the five clinical measures.
Other Objectives:
1. Part 2: to investigate differences in the five clinical measures 
between asymptomatic and symptomatic contact lens wearers.
2. Part 1 and 2: To investigate if end-of day comfort following lens 
removal returns to pre-lens wear comfort levels.
3. Part 1 and 2: To provide frozen samples of tear film for further 
laboratory analysis which will be outlined in separate laboratory 
protocols.
4. To investigate the relationship between difference in CLDEQ-8
score between Part 1 and 2 and the difference in the five clinical 
measures between Part 1 and 2.
5. To investigate the relationship between difference in CLDEQ-8
score between Part 1 and 2 and the difference in the (follow-up
minus baseline) and (follow-up minus fitting) values between Part 
1 and Part 2 for all clinical measures except density of white blood 
cells.
6. Part 1 and 2: To investigate the change from baseline and fitting 
in all the clinical measures except density of white blood cells in 
the eyelid margins for asymptomatic and symptomatic subjects.
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Study 
Endpoints
Primary endpoints: Lid margin staining grade, NIBUT, TMH, tear film 
osmolarity, mean density of white blood cells
Secondary endpoints: VAS comfort scores 
Other endpoints: Change from baseline, change from fitting, CLDEQ-8
and change in CLDEQ-8
Study Design
This is a 2-Part, 8-Visit, single-center, open-label, bilateral and dispensing 
clinical study. In Part 1 (Visits 1-4) all subjects will be dispensed Dailies 
AquaComfort Plus, in Part 2 (Visits 5-8) all subjects will be dispensed 
Acuvue Oasys 1-Day.
Part 1
Approximately 210-240 subjects will be recruited and fitted with Dailies 
AquaComfort Plus over approximately a two-week period in order to 
identify ~27 asymptomatic (CLDEQ-8 score less or equal to 10) and ~27
symptomatic (CLDEQ-8 score more than or equal to 20). Only those 
subjects classified as asymptomatic or symptomatic at the end of Visit 2 
(~54 subjects) will be asked to continue. Visits 3 and 4 will take place in 
the early morning and after 14 ± 2 hours respectively, on a single study 
day.
Part 2
Subjects who complete Part 1 (~ 54 subjects) will continue onto Part 2.
The visit procedures will be the same as for Part 1 but subjects will use 
the Acuvue Oasys 1-Day lens.
See the flow chart at the end of the synopsis table for the schematic of the 
study visits and procedures of main observations (Figure 1)
Sample Size
Part 1, Visits 1 & 2: ~210-240 subjects
Part 1, Visits 3 & 4: ~54 subjects
Part 2: ~54 subjects
Study Duration
The study will last approximately 18 months and will include a 9-month 
recruitment period.
Anticipated 
Study 
Population
Habitual soft contact lens wearers aged 18-45 years will be stratified into 
asymptomatic and symptomatic lens wearers based on their CLDEQ-8
score.
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Eligibility 
Criteria
Potential subjects must satisfy all of the criteria listed in Section 3.2 to be 
enrolled in the study.
Inclusion Criteria after Screening
1. They are 18-45 years of age (inclusive).
2. They understand their rights as a research subject and are willing 
and able to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They agree not to participate in other clinical research while 
enrolled on this study.
5. They currently use daily disposable soft daily wear contact lenses 
(worn bilaterally) (within the last six months) which may be 
spherical, toric or multifocal.
6. They agree to wear their lenses for at least 12-14 hours per day.
7. They own a wearable pair of spectacles (by self report).
Inclusion Criteria after Baseline
8. They have a spherical contact lens prescription in the range +6.00 
to -10.00 DS (based on the calculated ocular refraction).
9. They have up to a maximum of 1.00 DC of refractive astigmatism 
(based on the calculated ocular refraction).
10. They have best corrected distance visual acuity of at least 0.20 
binocularly.  
Potential subjects who meet any of the following criteria will be excluded 
from participating in the study: 
Exclusion Criteria after Screening:
1. They have an ocular disorder which would normally contra-
indicate contact lens wear.
2. They have a systemic disorder which would normally contra-
indicate contact lens wear.
3. No ocular topical medications (including comfort drops) from 24 
hours prior to study visits or during the wear of any study lenses.
4. They are regularly using anti-inflammatory or pain medications 
(i.e. medication routinely used more than twice per week).
5. They have had cataract surgery.
6. They have had corneal refractive surgery.
7. They are pregnant or breast-feeding.
8. They have any infectious disease (e.g. hepatitis) or any 
immunosuppressive disease (e.g. HIV) or a history of anaphylaxis 
or severe allergic reactions.
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9. They are an employee or immediate family member of an 
employee of the clinical site (e.g. Investigator, Coordinator, 
Technician).
10. They have taken part in any other clinical trial or research within 
two weeks prior to starting this study.
11. History of allergy to sodium fluorescein or lissamine green.  
Exclusion Criteria after Baseline:
12. They have any corneal distortion e.g. as a result of previous rigid 
lens wear or have keratoconus.
13. They have any slit lamp findings of Efron Grade 3 or greater (e.g. 
corneal oedema, corneal neovascularization, tarsal abnormalities, 
conjunctival injection) or findings of < Grade 3 which in the 
investigator’s opinion would contraindicate contact lens wear.
Disallowed 
Medications/Int
erventions 
No ocular topical medications (including comfort drops) from 24 hours 
prior to study visits or during the wear of any study lenses.
No systemic medications that in the view of the investigator may affect 
the ocular surface or contact lens wear from 24 hours prior to study visits.
No regular use of anti-inflammatory or pain medications (i.e.
medication routinely used more than twice per week).
Measurements 
and Procedures
Lid margin staining, NIBUT, TMH, tear film osmolarity, VAS comfort 
score, logMAR VA, lens fitting measurements, white blood cells using 
confocal microscopy.
Microbiology 
or Other 
Laboratory 
Testing
Tear film cytokine investigations
Study 
Termination
The occurrence of one or more Unanticipated Adverse Device Effect 
(UADE), or any SAE where relationship to study agent cannot be ruled 
out, will result in stopping further dispensing of investigational product.  
Ancillary 
Supplies/ 
Study-Specific 
Materials
Any Sponsor-approved saline pods
Principal 
Investigator(s) 
and Study 
Institution(s)/Si
te(s)
A full list of Principal Investigators, clinical sites, and institutions is kept 
separately from the Study Protocol and is included in the study Trial 
Master File.  
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COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS 
ADD
Plus Power Required For Near Use
ADE
Adverse Device Effect
AE
Adverse Event/Adverse Experience
BCVA
Best Corrected Visual Acuity
BSCVA
Best Spectacle Corrected Visual Acuity
CFR
Code of Federal Regulations
CLUE
Contact Lens User Experience
COAS
Complete Ophthalmic Analysis System
COM
Clinical Operations Manager
CRA
Clinical Research Associate
CRF
Case Report Form
CRO
Contract Research Organization
CT
Center Thickness
D
Diopter
DMC
Data Monitoring Committee
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
ETDRS
Early Treatment Diabetic Retinopathy Study
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act
IB
Investigator’s Brochure
ICF
Informed Consent Form
ICH
International Conference on Harmonization
IDE
Investigational Device Exemption
IEC
Independent Ethics Committee
IRB
Institutional Review Board
ISO
International Organization for Standardization
ITT
Intent-to-Treat
JJVC
Johnson & Johnson Vision Care, Inc.
LC
Limbus Center
LogMAR
Logarithm of Minimal Angle of Resolution
MedDRA©
Medical Dictionary for Regulatory Activities
MOP
Manual of Procedures
NIBUT
Non-invasive tear break up time
NIH
National Institutes of Health
OD
Right Eye
OHRP
Office for Human Research Protections
OHSR
Office for Human Subjects Research
OS
Left Eye
OU
Both Eyes
PD
Protocol Deviation
PHI
Protected Health Information
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PI
Principal Investigator
PIG
Patient Instruction Guide
PQC
Product Quality Complaint
PRO
Patient Reported Outcome
QA
Quality Assurance
QC
Quality Control
SAE
Serious Adverse Event/Serious Adverse Experience
SAP
Statistical Analysis Plan
SAS
Statistical Analysis System
SD
Standard Deviation
SOP
Standard Operating Procedure
TMH
Tear meniscus height
UADE
Unanticipated Adverse Device Effect
USADE
Unanticipated Serious Adverse Device Effect
VA
Visual Acuity
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1.
INTRODUCTION AND BACKGROUND 
The study design and the objectives were based on the results obtained through previous 
clinical work (
5 and 
6) which showed that clinical parameters such as lid 
margin staining, tear film osmolarity, NIBUT, tear meniscus height (TMH) and the appearance 
of white blood cells in the lid margin are different in asymptomatic and symptomatic soft lens 
wearers. This study aims to confirm the results obtained and attempts to replicate the previous 
findings with Dailies AquaComfort Plus (DACP) and then to explore the potential impact on 
the findings using the same methodology with Acuvue Oasys 1-Day (O1D).  Utilizing this 
approach will allow us to identify the best endpoints to predict end-of-day contact lens 
discomfort.    
1.1.
Name and Descriptions of Investigational Products  
The products used in this clinical study are:
Dailies AquaComfort Plus (Alcon) daily disposable contact lenses
Acuvue Oasys 1-Day (JJVC) daily disposable contact lenses
Both lenses are CE marked. Further details about the test articles are found in Section 6 of this 
protocol.
1.2.
Intended Use of Investigational Products 
The lenses will be used as indicated i.e. for daily wear, daily disposable use. Each lens type 
will be worn bilaterally for a two-week period and then followed up with an additional single 
study day. Subjects will be encouraged to wear the lenses for 12-14 hours during the two-week 
wear period and then for 14 ± 2 hours on the ensuing study single visit day.
Only subjects who are classified as asymptomatic or symptomatic will go on to wear the second 
lens type (O1D). Asymptomatic subjects are defined as those with a CLDEQ-8 score less or 
equal to 10 and symptomatic subjects are defined as those with a CLDEQ-8 score of more than 
or equal to 20.
1.3.
Summary of Findings from Nonclinical Studies 
Not Applicable – marketed products only.
1.4.
Summary of Known Risks and Benefits to Human Subjects 
This study will use approved marketed products. The following risks/adverse events can be 
associated with the use of any marketed contact lens:

Discomfort, pain, watering or unusual secretions of the eyes

Redness of the eyes

Reduced vision and sensitivity to light

In very rare instances corneal infection, scarring or permanent loss of vision may occur
The key invasive procedures in this work and their associated risks are outlined below:
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Confocal microscopy

Some temporary discomfort on manipulation of the eyelids

Some temporary discomfort during the procedure itself
Staining of the ocular surface with sodium fluorescein

Some temporary discomfort on application

Very rarely, anaphylaxis with topical application
Staining of the lid margins with lissamine green

Some temporary discomfort on application

No known cases of anaphylaxis with topical application
There is no direct benefit to the subjects enrolled other than being able to try a lens or lenses 
that they have not had the opportunity to try before.  The information obtained from this study 
may aid in the development of improved contact lenses in the future.
In order to minimise the likelihood of adverse events, subjects will undergo an ocular 
examination before and after the clinical investigations. Subjects will also be trained on what 
to do if they develop ocular discomfort, redness or reduced vision and what to do if they need 
to be seen outside of the Eurolens Research clinic opening hours. 
For the most comprehensive risk and benefit information regarding DACP and O1D refer to 
the latest version of the package insert of the marketed products (Appendix C).
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
All lenses being investigated in this work are CE marked/approved and marketed products. 
(APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT).
Two previously completed JJVC clinical study reports:
Navascues-Cornago M. 
 Clinical study report version 1.0: End-of-Day clinical 
assessment of asymptomatic and symptomatic soft contact lens wearers. April 6, 2018.
Morgan PB. 
 Clinical study report version 1.0: Confocal microscopy of the eyelid 
margin as a surrogate for contact lens discomfort. June 12, 2018.
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1.
Objectives  
Primary Objectives
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To investigate if there are statistically significant differences in the following clinical measures 
between asymptomatic and symptomatic lens wearers:
1. Upper and lower lid margin lissamine staining (14 hours)
2. NIBUT (14 hours)
3. TMH (14 hours)
4. Tear film osmolarity (14 hours)
5. Density of white blood cells in the eyelid margins using confocal microscopy (6 hours)
These will be referred to as the five clinical measures.
Secondary Objective(s)
Part 1 and 2: to investigate any possible relationship between subjective scores of contact lens 
comfort and the five clinical measures.
Other Objectives 
1. Part 2: to investigate differences in the five clinical measures between asymptomatic 
and symptomatic contact lens wearers 
2. Part 1 and 2: to investigate if end-of day comfort following lens removal returns to pre-
lens wear comfort levels.
3. Part 1 and 2: to provide frozen samples of tear film for further laboratory analysis which 
will be outlined in separate laboratory protocols.
4. To investigate the relationship between difference in CLDEQ-8 score between Part 1 
and 2 and the difference in the five clinical measures between Part 1 and 2.
5. To investigate the relationship between difference in CLDEQ-8 score between Part 1 
and 2 and the difference in the (followup – baseline) and (followup – fitting) values
between Part 1 and Part 2 for all the clinical measures except density of white blood 
cells.
6. Part 1 and 2: to investigate the change from baseline and fitting in all the clinical 
measures except density of white blood cells in the eyelid margins for asymptomatic 
and symptomatic subjects.
2.2.
Endpoints  
Primary Endpoint(s)
The primary endpoints in this study are lid margin lissamine green staining grade, NIBUT, 
TMH, tear film osmolarity at the beginning and the end of a lens-wearing day (after 14 hours). 
Additionally, the number of white blood cells in the lid margins after 6 hours of lens wear will 
be investigated.
Lid margin staining
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Lid margin staining of the upper and lower eyelids will be performed in the left eye (OS) only
using lissamine green. The staining will be graded both subjectively at the time of the clinic 
visit and also objectively using automated image analysis software from photographs. Images 
should be collected as soon as possible for best image quality, and grading can be conducted 
using a slit lamp or from the images.
For the subjective grading the following will be graded for each eyelid:
Horizontal length of staining
Sagittal width of staining
Average staining grade – this is the average of the horizontal and sagittal grades for each eyelid
A final grade will be calculated which is the average of each eyelid’s average staining grade.
For the objective image analysis three metrics of staining will be evaluated; (1) Staining Area, 
(2) Staining Intensity and (3) Staining thickness
Non-invasive Break-up Time (seconds)
NIBUT will be measured using the Medmont topographer for the right eye (OD) only. Three 
measurements will be undertaken.
Tear Meniscus Height (mm) 
The lower tear meniscus in the right eye (OD) only will be imaged using optical coherence 
tomography (OCT). Three images will be taken. 
Tear Film Osmolarity 
Tear film osmolarity will be collected in the right eye (OD) only using the Tearlab (Tearlab
Corp.)  Two measurements will be collected. 
White Blood Cells (mean density of cells) 
Images, using Confocal Microscopy will be taken in both eyes for both the upper and lower 
eyelid in the central lid area. These images will be used to determine the density of
inflammatory white blood cells. 
Secondary Endpoints
Contact lens comfort will be assessed at the beginning and at the end of day (14 ± 2 hours post
lens insertion) using a visual analogue scale (VAS) ranging from 0 – 100, where 0 is 
uncomfortable and 100 is comfortable. 
Other Endpoints
Change from baseline and 14 hours and change from fitting and 14 hours (where appropriate) 
for the following clinical measures: 
- upper and lower lid margin staining 
- NIBUT
- TMH
- tear film osmolarity
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CLDEQ-8 score and change in CLDEQ-8 score
2.3.
Hypotheses 
Primary Hypotheses
For Part 1:
1. Symptomatic subjects will have, on average, statistically significantly, greater upper and 
lower lid margin staining compared to asymptomatic subjects after 14 hours of lens wear.
2. Symptomatic subjects will have, on average, statistically significantly, shorter NIBUT 
compared to asymptomatic subjects after 14 hours of lens wear.
3. Symptomatic subjects will have, on average, statistically significantly, lower TMH 
compared to asymptomatic subjects after 14 hours of lens wear.
4. Symptomatic subjects will have, on average, statistically significantly, greater tear film 
osmolarity compared to asymptomatic subjects after 14 hours of lens wear.
5. Symptomatic subjects will have, on average, statistically significantly, greater density
of white blood cells (visualized by confocal microscopy) in both the upper and lower lid 
margins compared to asymptomatic subjects after 6 hours of lens wear. 
Secondary Hypotheses:
For Part 1 and 2 
1. There is a statistically significant relationship with at least one of the five clinical 
measures (lid margin staining, NIBUT, TMH, tear film osmolarity and density of white
blood cells) and subjective comfort measured using VAS grading scales at 14 hours (6 
hours for white cells).
Other Hypotheses:
For Part 2:
1. Symptomatic subjects will have, on average, statistically significantly, greater 
upper and lower lid margin staining compared to asymptomatic subjects after 14 
hours of lens wear.
2. Symptomatic subjects will have, on average, statistically significantly, shorter 
NIBUT compared to asymptomatic subjects after 14 hours of lens wear.
3. Symptomatic subjects will have, on average, statistically significantly, lower TMH 
compared to asymptomatic subjects after 14 hours of lens wear.
4. Symptomatic subjects will have, on average, statistically significantly, greater tear 
film osmolarity compared to asymptomatic subjects after 14 hours of lens wear.
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5. Symptomatic subjects will have, on average, statistically significantly, greater 
density of white blood cells (visualized by confocal microscopy) in both the upper 
and lower lid margins compared to asymptomatic subjects after 6 hours of lens 
wear. 
For Part 1 and 2: 
1. The measured end of day discomfort score, following lens removal, will not be 
statistically significantly different than the pre-lens wear discomfort score.  
2. There will be a statistically significant relationship between change in CLDEQ score 
between Part 1 and Part 2 and a change in the five clinical parameters investigated
between Part 1 and Part 2.
3. There will be a statistically significant relationship between change in CLDEQ score 
between Part 1 and Part 2 and the difference in the (follow-up – baseline) and (follow-
up – fitting) values between Part 1 and Part 2 for all clinical measures except density 
of white blood cells.
4. For Part 1 and 2: at 14 hours, symptomatic subjects will have a statistically 
significantly, greater change from baseline in all the clinical measures except density 
of white blood cells in the eyelid margins.
Other exploratory analyses may be conducted at the discretion of the study responsible 
clinician.
3.
TARGETED STUDY POPULATION 
3.1.
General Characteristics  
The study population will be healthy contact lens wearers aged 18-45 years of age from a single 
site in the United Kingdom (UK). Two groups will be recruited: asymptomatic lens wearers 
reporting a low score on the CLDEQ-8 scale and symptomatic wearers reporting a high score 
on the same scale.  Specific details are provided below.
3.2.
Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Inclusion Criteria after Screening
1. They are 18-45 years of age (inclusive).
2. They understand their rights as a research subject and are willing and able to sign a 
Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They agree not to participate in other clinical research while enrolled on this study.
5. They currently use daily disposable soft daily wear contact lenses (worn bilaterally) 
(within the last six months) which may be spherical, toric or multifocal.
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6. They agree to wear their lenses for at least 12-14 hours per day.
7. They own a wearable pair of spectacles (by self report).
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Inclusion Criteria after Baseline
8. They have a spherical contact lens prescription in the range +6.00 to -10.00 DS (based 
on the calculated ocular refraction).
9. They have up to a maximum of 1.00 DC of refractive astigmatism (based on the 
calculated ocular refraction).
10. They have best corrected distance visual acuity of at least 0.20 binocularly.  
3.3.
Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study: 
Exclusion Criteria after Screening:
1. They have an ocular disorder which would normally contra-indicate contact lens 
wear.
2. They have a systemic disorder which would normally contra-indicate contact lens 
wear.
3. No ocular topical medications (including comfort drops) from 24 hours prior to study 
visits or during the wear of any study lenses.
4. They are regularly using anti-inflammatory or pain medications (i.e. medication 
routinely used more than twice per week).
5. They have had cataract surgery.
6. They have had corneal refractive surgery.
7. They are pregnant or breast-feeding.
8. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease 
(e.g. HIV) or a history of anaphylaxis or severe allergic reactions.
9. They are an employee or immediate family member of an employee of the clinical 
site (e.g. Investigator, Coordinator, Technician).
10. They have taken part in any other clinical trial or research within two weeks prior to 
starting this study.
11. History of allergy to sodium fluorescein or lissamine green.  
Exclusion Criteria after Baseline
12. They have any corneal distortion e.g. as a result of previous rigid lens wear or have 
keratoconus.
13. They have any slit lamp findings of Efron Grade 3 or greater (e.g. corneal oedema, 
corneal neovascularization, tarsal abnormalities, conjunctival injection) or findings 
of < Grade 3 which in the investigator’s opinion would contraindicate contact lens 
wear.
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3.4.
Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials. 
4.
STUDY DESIGN AND RATIONALE 
4.1.
Description of Study Design 
PART 1: VISITS 1 AND 2
A single-arm, non-randomised, open-label, bilateral dispensing clinical investigation in which 
each subject’s asymptomatic or symptomatic status will be confirmed based on their CLDEQ-8
after two-weeks of wear of the DACP lens. Subjects with a CLDEQ-8 score less or equal to 
10 (classified as asymptomatic) or more than or equal to 20 (classified as symptomatic) will 
continue. Recruitment will stop when approximately 27 asymptomatic and 27 symptomatic 
subjects are enrolled onto Part 1, Visit 3 and beyond. 
PART 1: VISITS 3 AND 4
This is a single arm study with two different population groups (asymptomatic vs. symptomatic 
depending on their CLDEQ-8 score) and is a non-randomized, open-label, bilateral dispensing 
clinical investigation. 
All subjects will wear the same lens type (DACP) and will be aware of the lens they are 
receiving; however, subjects and investigators will be masked to whether participants have 
been assigned to the asymptomatic or symptomatic group. As far as is logistically possible, 
each group (asymptomatic and symptomatic) will have a similar ratio of gender distribution 
among male and female volunteers.  
PART 2: VISITS 5 AND 6
This will be a repeat of Part 1, Visits 1 and 2 but will use the O1D lens.  Regardless of subjects’ 
classification by the CLDEQ-8, all subjects will move on to Part 2, Visits 7 and 8.
PART 2: VISITS 7 AND 8
This will be a repeat of Part 1, Visits 3 and 4 using the O1D lens. CLDEQ-8 classification with 
O1D does not affect participation in Part 2. 
N.B. If a subject changes their habitual lens type during the study this will not affect their 
participation in subsequent visits.
4.2.
Study Design Rationale 
The study utilizes a similar design to what was employed in 
. The purpose of 
designing the two studies similarly was to allow for a meta-analysis to be performed at a later 
date. 
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4.3.
Enrollment Target and Study Duration 
x
The overall target is for 54 subjects to complete Part 2 of the study.  Approximately
210-240 eligible subjects will be enrolled for Part 1 (Visits 1 and 2).  It will be 
determined based on Visit 2 results whether subjects are suitable to continue in the 
study. Once the Informed Consent Form signed the subject will be considered enrolled.
A replacement will be enrolled if a subject discontinues from the study before 
completion. 
x
Approximately 54 subjects (consisting of approximately 27 asymptomatic and 27
symptomatic subjects) will continue to Part 1, Visit 3 to complete all remaining visits.
x
The work will be conducted at a single study site and enrollment is expected to take in 
the region of 12 months.  Each subject will attend either a) two visits (Part 1, Visits 1 
and 2) if they are not classified as asymptomatic or symptomatic at the end of Part 1, 
Visit 2 or b) eight visits (all visits in Parts 1 and 2) if they are successfully classified as 
asymptomatic or symptomatic at the end of Part 1, Visit 2.
The study is expected to last for 18 months in total.
5.
TEST ARTICLE ALLOCATION AND MASKING 
5.1.
Test Article Allocation  
This is a non-randomized study. All subjects will receive the same lens type to be worn 
bilaterally in both Part 1 (Dailies AquaComfort Plus) and Part 2 (Acuvue Oasys 1-Day).
5.2.
Masking 
This is an open label study where the identity of the lenses used is known to all. However, both 
subjects and investigators involved with data collection will be masked as to which group 
(asymptomatic or symptomatic) they have been assigned to following Part 1, Visit 2.
Under normal circumstances, the mask should not be broken until all subjects have completed 
the study and the database is finalized. Otherwise, the mask should be broken only if specific 
emergency treatment/course of action would be dictated by knowing the treatment status of the 
subject. In such cases, the Investigator may, in an emergency, contact the medical monitor.  In 
the event the mask is broken, the Sponsor must be informed as soon as possible. The date, 
time, and reason for the unmasking must be documented in the subject record. The Investigator 
is also advised not to reveal the study treatment assignment to the clinical site or Sponsor 
personnel. 
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations.  Subjects who are discontinued will be replaced.
5.3.
Procedures for Maintaining and Breaking the Masking 
Masking of test articles is not applicable.
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PART 2, VISITS 7 AND 8
Lenses from the fitting bank will be used.
6.2.
Ancillary Supplies/Products  
Table 2: Ancillary Supplies
Product
Saline pods
Fluorescein Strips
Lissamine Green
Manufacturer
Any 
sponsor-
approved 
manufacturer 
of 
sterile, preservative 
free, single use saline 
(0.9%w/v 
sodium 
chloride solution)
Any 
sponsor 
approved product
Contacare 
Ophthalmics 
and 
Diagnostics 
(or 
alternative Sponsor-
approved product)
Preservative
None
None
None
Other 
distinguishing 
items 
(dye, 
packaging, 
approval status, etc.
N/A
6.3.
Administration of Test Articles 
Test articles will be dispensed to subject meeting all eligibility requirements, including any 
dispensing requirements set forth in this clinical protocol. Subjects will be dispensed an 
adequate supply of test articles to complete the study. Lost or damaged test articles may be 
replaced at the discretion of the Investigator and/or the Sponsor.
6.4.
Packaging and Labeling 
The test articles will be packaged in blisters as the primary packaging. The test articles will be 
in in plastic bags as the secondary packaging form. In this open label study, no additional 
primary label is required. 
6.5.
Storage Conditions 
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions.
6.6.
Collection and Storage of Samples 
When possible, any lens or test article associated with an Adverse Events and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending 
directions from the sponsor for potential return back to JJVC.
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Tear samples will be frozen for subsequent analysis. Samples will initially be stored at -20 oC
but will be transferred (using dry ice) to a -80oC freezer within three working days.
6.7.
Accountability of Test Articles 
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation.  The Investigator is asked to retain all lens shipment documentation 
for the test article accountability records. 
Test article must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study site 
personnel listed on the Site Delegation Log.  All test articles must be accounted.  This includes:
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued 
for the subject to replace appropriately between visits 
2. What was returned to the Investigator unused
3. The number and reason for unplanned replacements
The Investigator will collect all unused test articles from the subjects at the end of the subject’s 
participation. Subject returned unused test articles must be separated from the clinical study 
inventory of un-dispensed test articles, and must be labeled with the subject number and date 
of return.  Following final reconciliation of test articles by the monitor, the Investigator or 
monitor will destroy all unused test articles unless the Sponsor requires another course of 
action.
If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately.
Reference 
:  Site Instructions for Test Article Receipt and Test Article 
Accountability for additional information.
7.
STUDY EVALUATIONS  
7.1.
Time and Event Schedule 
Table 3: Time and Events
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x
Subject not compliant with study lens wear schedule 
x
Subject not successfully dispensed due to lack of efficacy and safety including poor 
vision, poor comfort or unacceptable fit
For discontinued subjects, the Investigator will:
x
Complete the current visit (scheduled or unscheduled)
x
Complete the Final Evaluation, indicating the reason that the subject was discontinued 
from the study
x
Record the spherocylindrical refraction with best corrected distance visual acuity 
x
Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in section 7.2.
x
Collect all unused test article(s) from the subject
An additional subject will be enrolled if a subject discontinues from the study prematurely.
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal. The measures taken to follow 
up must be documented including two written attempts and a certified letter (or equivalent) as 
the final attempt. 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION 
Concomitant medications will be documented during screening and updated during the study. 
Disallowed medications for this study include: any ocular topical medications (including 
comfort drops) and any systemic medications that in the view of the investigator may affect 
the ocular surface or contact lens wear from 24 hours prior to study visits.
Concomitant therapies that are disallowed include: any that the investigator feels may 
significantly affect contact lens wear.
10. DEVIATIONS FROM THE PROTOCOL 
Investigator will notify study sponsor upon identification of a protocol deviation. Major 
protocol deviations must be reported to the sponsor within 24 hours after discovery of the 
protocol deviation. The Investigator will report deviations per IRB/IEC requirements.  All 
deviations will be tracked and corrective actions implemented as appropriate. 
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB. 
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11. STUDY TERMINATION 
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article. In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled.
The Sponsor will determine when a study will be stopped.  The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised.
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.   
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated, as soon as possible.
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements.
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use. 
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints:
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO)”
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site
x
Lens replacements that occur due to drops/fall-outs
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
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is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred. 
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include:
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness)
x
Who received the complaint
x
Study number
x
Clinical site information (contact name, site ID, telephone number)
x
Lot number(s)
x
Unique Subject Identifier(s)
x
Indication of who first observed complaint (site personnel or subject)
x
OD/OS indication, along with whether the lens was inserted
x
Any related AE number if applicable
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.)
x
Eye Care Provider objective (slit lamp) findings if applicable
x
Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return (Refer to Form Control No.
for test article return instructions)
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also applies and will be executed in parallel.  
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”. Justification for ILB must be
documented.
13. ADVERSE EVENTS 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device. 
Note 1 to entry: This definition includes events related to the investigational medical device 
or the comparator.
Note 2 to entry: This definition includes events related to the procedures involved.
Note 3 to entry: For users or other persons, this definition is restricted to events related to 
investigational medical devices.”1
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An AE includes any condition (including a pre-existing condition) that:
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study 
2. Was present prior to the study, but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states 
3. Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event
Serious Adverse Event (SAE) – An SAE is any untoward medical occurrence that:
x
Results in death
x
Is life threatening
x
Requires in-patient hospitalization or prolongation of existing hospitalization
x
Results in persistent or significant disability/incapacity (e.g., a sight threatening event, 
a significant persistent or permanent change, impairment, damage, or disruption to the 
subject’s body)
x
Is a congenital anomaly/birth defect, or
x
Requires intervention to prevent permanent damage (the use of the test article resulting 
in a condition which requires medical or surgical intervention to preclude permanent
impairment of the body structure or a body function). Important medical events that 
may not result in death, be life-threatening, or require hospitalization may be 
considered an SAE when, based upon appropriate medical judgment, they may 
jeopardize the patient or subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in the above definition
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis
x
Hypopyon
x
Hyphemia
x
Penetration of Bowman’s Membrane
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – Those events that are usually symptomatic and warrant 
discontinuation (temporary or permanent) of the test article (excluding Serious Adverse 
Events). 
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Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU)
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of > 2 Lines of BSCVA
x
Other grade 3 or higher corneal findings, such as abrasions or edema
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks
Non-Significant Adverse Events – Those conditions that are usually asymptomatic and 
usually do not warrant discontinuation (temporary or permanent) of the test article.  However, 
the Investigator may choose to treat as a precautionary measure. 
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.
Note 1 to entry: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device.
Note 2 to entry: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device.”1
Unanticipated Adverse Device Effect (UADE) – Any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, the test article, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan, Investigator’s Brochure or protocol, or any other 
unanticipated serious problem associated with the test article that relates to the rights, safety 
and welfare of subjects.
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13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include:
x
Seriousness/Classifications (see definition in Section 13.1)
x
Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related; unlikely related; possibly
related; related - see definition in Section 13.2.1)
x
Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild; moderate; severe for all events - see definition in 
Section 13.2.2)
x
Outcome – not recovered or not resolved; recovering or resolving; recovered or 
resolved with sequelae; recovered or resolved; death related to adverse event; unknown
x
Actions Taken – none; temporarily discontinued; permanently discontinued; other
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations:
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures
x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely
x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive. The relationship in time is 
reasonable. Therefore, the causal relationship cannot be excluded
x
Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
concomitant treatment of concomitant disease(s).  The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge
13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale:
x
Mild – Event is noticeable to the subject, but is easily tolerated and does not interfere 
with the subject’s daily activities
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities
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13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) begins when the 
subjects are exposed to the test article, study treatment or study procedure. Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator.
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs. He/she will complete the Adverse Event /eCRF. 
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship. 
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following:
x
Adverse event (diagnosis not symptom)
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.) 
x
Date the clinical site was notified 
x
Date and time of onset
x
Date and time of resolution
x
Adverse event classification, severity, and relationship to test articles, as applicable
x
Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements
x
Any referral to another health care provider if needed
x
Outcome, ocular damage (if any)
x
Likely etiology
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded. 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
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Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up.
13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event.  In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (Section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures.
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail, fax, or telephone, but no later than 24 
hours following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported.
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles.
In the event of a serious/significant adverse event, the Investigator must:
x
Notify the Sponsor immediately
x
Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations
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Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect.
Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery.
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities.
The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines. 
13.4.3. Event of Special Interest 
None
13.5. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus.
14. STATISTICAL METHODS 
14.1. General Considerations 
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below. More details will be included in the stand-alone Statistical Analysis Plan (SAP). The 
SAP will be developed and finalized prior to database lock.
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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.  
Unscheduled visits will be summarized separately and will be excluded from the statistical 
analysis.
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety 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.
14.2. Sample Size Justification 
The sample size was not determined by any empirical power calculation. The plan is to enroll 
approximately 210-240 subjects with a completion target of 27 subjects per strata 
(Symptomatic and Asymptomatic). Assuming a sample of size 27 subjects per strata, the 
statistical power was calculated using SAS procedure PROC POWER. The goal is to show 
Symptomatic subjects have, on average, lower Non-invasive tear Breaks up Time (NIBUT) 
and Tear Meniscus Height (TMH); and greater Lid Margin Staining (LMS), Tear Film 
Osmolarity (OSM), and White Blood Cell (WBC) count compared to Asymptomatic subjects. 
Table 4 contains the information of two previous studies and their corresponding subject 
disposition. Tables 5 to Table 9 below summarizes the primary endpoints from the studies
and 
that are corresponded to the current study and therefore used to 
compute the power. 
Table 4: Historical Studies Included 
Study
Study Design
Endpoints 
Collected 
No. of
Enrolled
No. of
Completed -
Asymptomatic
No. of
Completed -
Symptomatic
Cross-sectional 
study of 
subjects 
wearing 
Dailies 
AquaComfort 
Plus
Lid Margin 
Staining, 
NIBUT, 
TMH, Tear 
film
osmolarity,  
42
25
16
Cross-sectional 
study of 
subjects 
Lid Margin 
Staining, 
74
27
15
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wearing their 
habitual lenses
White blood 
Cell Count 
Table 5: Lid Margin Staining – Completed Per-Protocol Population
LMS (Mean 
[STD]) **
Eyelid 
Strata
Asymptomatic
N=50
Symptomatic
N=32
Baseline
Lower 
0.98 (0.95) 
1.15 (0.75)
Upper 
0.79 (0.75) 
0.68 (0.58) 
14-Hours Post 
Lens Insertion
Lower 
1.34 (0.77) 
1.47 (0.72) 
Upper 
0.74 (0.89) 
1.31 (0.87) 
N=Number of eyes. 
Table 6: Non-Invasive Tear Break-Up Time (NITBUT in Seconds) – Completed Per-Protocol 
Population 
NIBUT (Mean [STD]) **
Strata
Asymptomatic N=25
Symptomatic N=16
Post Lens Insertion 
13.19 (8.917)
11.47 (7.035)
14-Hours Post Lens Insertion 
9.46 (4.608)
8.34 (4.660)
N=Number of Subjects
**Averaged across three measurements
Table 7: Tear Meniscus Height (TMH) – Completed Per-Protocol Population
TMH (Mean 
[STD]) **
Eyelid 
Strata
Asymptomatic
N=50
Symptomatic
N=16
Baseline 
Lower 
0.21 (0.054) 
0.21 (0.059) 
Upper 
0.16 (0.036) 
0.017 (0.034) 
Post Lens 
Insertion 
Lower 
0.20 (0.056)
0.19 (0.048)
Upper 
0.16 (0.041)
0.15 (0.036)
14-Hours Post 
Lens Insertion 
Lower 
0.18 (0.065) 
0.14 (0.067) 
Upper 
0.14 (0.044) 
0.12 (0.030) 
N=Number of eyes. 
**Averaged across three measurements
Table 8: Tear Film Osmolarity (mOsm/L) – Completed Per-Protocol Population
TOSM (Mean [STD]) **
Strata
Asymptomatic N=25
Symptomatic N=16
Post Lens Insertion 
319.52 (75.538)
297.47 (10.899)
14-Hours Post Lens Insertion 
301.38 (34.473)
288.41 (58.943)
N=Number of Subjects
**Averaged across two measurements
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Table 9: Mean White Bloods Cell (WBC) Count (Confocal Microscopy) – Completed Per-
Protocol Population
Mean[STD]
Eyelid
Strata/Eye
Asymptomatic N=27
Symptomatic N=15
Left
Right
Left
Right
Visit 2 (2-14
Days after 
Visit 1)
Lower
3.044
(2.7755)
4.062
(4.8873)
6.175
(5.8041)
6.533
(4.1495)
Upper
3.006
(3.1092)
4.130
(3.9155) 
6.277
(6.8528) 
5.633
(5.5359) 
Visit 3 (2-14
Days after 
Visit 2)
Lower
2.957
(2.8150)
3.790
(4.7627) 
4.444
(4.7879) 
6.555
(6.6327) 
Upper
3.197
(3.8542) 
4.253
(4.0071) 
8.267
(10.5946) 
9.301
(10.8690) 
N=Number of Subjects
The power calculation of LMS, NIBUT, TMH, and TOSM were conducted for the combination 
of the different effect sizes (Δ = Symptomatic – Asymptomatic) and the different common 
variances (ߪ). The power calculation of WBC was conducted for the combination of the 
different mean ratios (߶ൌSymptomatic/Asymptomatic) and the different common coefficient 
of variances (CV). CV, also known as the relative standard deviation, is the ratio of the standard 
deviation to the mean.
The parameters ȟǡ ߪǡ ߶ǡ and ܥܸwere estimated from the data of 
and 
.
Historical data suggest that increasing the effect sizes or the mean ratios and decreasing the 
standard deviation or the coefficient of variations increases the power. For the fixed number 
of 27 subjects per strata, the criteria that need to be satisfied in order to obtain ~80% power 
corresponding to the primary hypotheses are presented below in Table 10 to Table 14: 
1. Hypothesis 1: Symptomatic subjects will have, on average, greater upper and lower lid 
margin staining (LMS) compared to asymptomatic subjects after 14 hours of lens wear.
Table 10: Power Calculations of LMS for N=54
Common standard deviation (σ)
Effect size (Δ)
0.5
0.7
0.9
0.30
70%
46%
33%
0.35
81%
57%
41%
0.40
90%
67%
49%
The sample size is sufficiently large to demonstrate greater LMS with ~80% power to 
Symptomatic subjects if  ȟ ൒ͲǤ͵ͷandߪ൑ͲǤͷ.
2. Hypothesis 2: Symptomatic subjects will have, on average, shorter NIBUT compared 
to asymptomatic subjects after 14 hours of lens wear.
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Table 11: Power Calculations of NIBUT for N=54
Common standard deviation (σ)
Effect size (Δ)
3
4
5
-2.1
81%
60%
45%
-1.1
38%
26%
20%
0.0
5%
5%
5%
The sample size is sufficiently large to demonstrate lower NIBUT with ~80% power to 
Symptomatic subjects if  ȟ ൑െʹǤͳandߪ൑͵.
3. Hypothesis 3: Symptomatic subjects will have, on average, lower TMH compared to 
asymptomatic subjects after 14 hours of lens wear.
Table 12: Power Calculations of TMH for N=54
Common standard deviation (σ)
Effect size (Δ)
0.04
0.06
0.08
-0.04
98%
78%
56%
-0.03
86%
57%
39%
-0.01
23%
15%
12%
The sample size is sufficiently large to demonstrate lower TMH with ~80% power to 
Symptomatic subjects if  ȟ ൑െͲǤͲ͵andߪ൏ͲǤͲ͸.
4. Hypothesis 4: Symptomatic subjects will have, on average, greater tear film osmolarity 
(TOSM) compared to asymptomatic subjects after 14 hours of lens wear.
Table 13: Power Calculations of TOSM for N=54
Common standard deviation (σ)
Effect size (Δ)
20
25
30
10
57%
42%
33%
12
70%
54%
42%
14
81%
65%
52%
The sample size is sufficiently large to demonstrate greater TOSM with ~80% power to 
Symptomatic subjects if  ȟ ൒ͳͶandߪ൑ʹͲ.
5. Hypothesis 5: Symptomatic subjects will have, on average, greater mean number of 
white blood cells (WBC) (visualized by confocal microscopy) in both the upper and 
lower lid margins compared to asymptomatic subjects after 6 hours of lens wear. 
Table 14: Power Calculations of WBC for N=54
Common coefficient of variances (CV)
Mean ratio (Ԅ)
0.65
1.0
1.3
1.0
5%
5%
5%
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1.5
80%
55%
43%
2.0
100%
92%
81%
The sample size is sufficiently large to demonstrate greater WBC with ~80% power to 
Symptomatic subjects if Ԅ ൒ͳǤͷand ൑ͲǤ͸ͷ; and Ԅ ൒ʹand ൑ͳǤ͵Ǥ
14.3. Analysis Populations 
Safety Population:
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded.
Per-Protocol Population: 
All subjects who have successfully completed all visits and did not substantially deviate from 
the protocol as determined by the trial cohort review committee prior to database hard lock 
(Per-Protocol Population). Justification of excluding subjects with protocol deviations in the 
per-protocol population set will be documented in a memo to file.
Intent-to-Treat (ITT) Population:
All randomized subjects regardless of actual treatment and subsequent withdrawal from study 
or deviation from protocol. At least one observation should be recorded.
14.4. Level of Statistical Significance 
Each pre-planned primary and secondary hypothesis will be analyzed with a two-sided type I 
error rate of 5%. 
14.5. Primary Analysis (For Part 1)  
Lid Margin Staining (LMS)
Model-1: Upper and lower eyelids’ average LMS (average of Horizontal and sagittal grades)
after 14-hours follow-up will be analyzed using a linear mixed model by adjusting the baseline 
LMS as a covariate.
Model-2: Final eyelid’s average (average of the upper and lower lid average) LMS after 14-
hours follow-up will be analyzed using a linear model by adjusting the baseline LMS as a 
covariate.
Both the models will include subject strata (asymptomatic/symptomatic) as fixed effect,
however, only model-1 will include subject as random effect (G-side). Other characteristics 
such as age, gender, and race will be included as fixed covariates when appropriate. For only 
model-1, different covariance structures will be considered to model the residual errors
between the lower and upper eyelids’ average LMS from the same subject (R-side). The 
covariance structure will be selected based on the finite-sample corrected Akaike’s Information 
Criterion10. The following covariate structures will be considered:
x
Unstructured Covariance Structure (UN)
x
Homogenous Compound symmetry (CS)
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Comparisons between subject strata for LMS will be carried out using a one-sided 95% CI of 
least-square means differences (symptomatic - asymptomatic) at 14-hour follow-up for the 
hypothesis given below:
ܪ଴ǣ ߤௌെߤ஺൑Ͳ
ܪ஺ǣ ߤௌെߤ஺൐Ͳǡ
where S=Symptomatic and A=Asymptomatic. For only model-1, adjustments for multiple 
comparisons across lower and upper eyelids’ will be performed using a simulation method 
with alpha equal to 0.05 (Edwards and Berry, 1987)13.A statistically greater upper and lower 
LMS, on average, for symptomatic subjects compared to asymptomatic subjects after 14 hours 
of lens wear will be concluded if the lower limit of the 95% confidence intervals for the least-
squares means is greater than 0.
Non-invasive tear break-up time (NIBUT) and Tear Meniscus Height (TMH)
NIBUT and TMH will be analyzed using a linear mixed model separately by adjusting the 
baseline as a covariate. The model will include subject strata (asymptomatic/symptomatic), 
time event (i.e., fitting and 14-hours follow-up), and strata by time event interaction as fixed 
effects; subject will be included as random effects (G-side). Other characteristics such as age, 
gender, and race will be included as fixed covariates when appropriate. Different covariance 
structures will be considered to model the residual errors between the repeated measurements 
within time event from the same subject (R-side). The covariance structure will be selected 
based on the finite-sample corrected Akaike’s Information Criterion10. The following covariate 
structures will be considered:
x
Unstructured Covariance Structure (UN)
x
Homogenous Compound symmetry (CS)
x
Heterogeneous Compound Symmetry (CSH)
x
Spatial Power (SP[POW])
For SP(POW) covariance structure, subject and time event within subject will be included as 
random effects. For the remaining structures, only subject will be included as a random effect. 
The structure that returns the lowest Akaike Information Criteria Corrected (AICC) will be 
selected as the structure that best fit the data. Heterogeneous covariance structures across strata 
may be considered if necessary. The Kenward and Roger method (Kenward and Roger, 1997)11
will be used for the denominator degree of freedom.
Comparisons between subject strata for NIBUT and TMH will be carried out using a one-sided 
95% CI of least-square means differences (symptomatic - asymptomatic) at 14-hour follow-up
for the hypothesis given below:
ܪ଴ǣ ߤௌെߤ஺൒Ͳ
ܪ஺ǣ ߤௌെߤ஺൏ͲǤ
where S=Symptomatic and A=Asymptomatic. No multiple adjustment will be necessary since 
the hypothesis test will be conducted based on only 14-hour follow-up. A statistically shorter 
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NIBUT or lower TMH, on average, for symptomatic subjects compared to asymptomatic 
subjects after 14 hours of lens wear will be concluded if the upper limit of the 95% confidence 
intervals for the Least-squares means is less than 0.
Tear Film Osmolarity (TOSM) 
TOSM will be analyzed using a linear mixed model by adjusting the baseline TOSM as a 
covariate. The model will include subject strata (asymptomatic/symptomatic), time event (i.e.,
fitting and 14-hours follow-up), and strata by time event interaction as fixed effects; subject 
will be included as random effects (G-side). Other characteristics such as age, gender, and race 
will be included as fixed covariates when appropriate. Different covariance structures will be 
considered to model the residual errors between the repeated measurements within time event 
from the same subject (R-side). The covariance structure will be selected based on the finite-
sample corrected Akaike’s Information Criterion10. The following covariate structures will be 
considered:
x
Unstructured Covariance Structure (UN)
x
Homogenous Compound symmetry (CS)
The structure that returns the lowest Akaike Information Criteria Corrected (AICC) will be 
selected as the structure that best fit the data. Heterogeneous covariance structures across strata 
may be considered if necessary. The Kenward and Roger method (Kenward and Roger, 1997)11
will be used for the denominator degree of freedom.
Comparisons between subject groups for TOSM will be carried out using a one-sided 95% CI 
of least-square means differences (symptomatic - asymptomatic) at 14-hour follow-up for the 
hypothesis given below:
ܪ଴ǣ ߤௌെߤ஺൑Ͳ
ܪ஺ǣ ߤௌെߤ஺൐Ͳǡ
where S=Symptomatic and A=Asymptomatic. No multiple adjustment will be necessary since 
the hypothesis test will be conducted based on only 14-hour follow-up. A statistically greater 
TOSM, on average, for symptomatic subjects compared to asymptomatic subjects after 14 
hours of lens wear will be concluded if the lower limit of the 95% confidence intervals for the 
Least-squares means is greater than 0.
Number of White Blood Cells (WBC)
The number of white blood cells (visualized by confocal microscopy) after 6-hour follow up 
will be analyzed using a generalized linear mixed model with Poisson distribution and log link 
function. The model will include subject strata (asymptomatic/symptomatic) as fixed effects;
subject will be included as random effects (G-side). Other characteristics such as age, gender, 
and race will be included as fixed covariates when appropriate. Different covariance structures
will be considered to model the residual errors between the lower and upper lid margin 
measurements within eye from the same subject (R-side). The covariance structure will be 
selected based on the finite-sample corrected Akaike’s Information Criterion10. The following 
covariate structures will be considered:
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x
Unstructured Covariance Structure (UN)
x
Homogenous Compound symmetry (CS)
The structure that returns the lowest Akaike Information Criteria Corrected (AICC) will be 
selected as the structure that best fit the data. Heterogeneous covariance structures across strata 
may be considered if necessary. The Kenward and Roger method (Kenward and Roger, 1997)11
will be used for the denominator degree of freedom.
The Comparison between the symptomatic and the asymptomatic strata will be carried out 
using one-sided 95% confidence intervals for the Least-squares means risk ratio (symptomatic 
over asymptomatic) at 6-hour follow up for the hypothesis given below:
ܪ଴ǣ ߤௌȀߤ஺൑ͳ
ܪ஺ǣ ߤௌȀߤ஺൐ͳǡ
where S=Symptomatic and A=Asymptomatic. Adjustments for multiple comparisons across 
lower and upper lid margins will be performed using a simulation method with alpha equal to 
0.05 (Edwards and Berry, 1987)13. A statistically significantly greater density of WBC, on 
average, in both the upper and lower lid margins for symptomatic subjects compared to 
asymptomatic subjects after 6 hours of lens wear will be concluded if the multiple adjusted 
lower limit of the 95% confidence intervals for the Least-squares means risk ratio is above 1.0.
Remark: For all the above models, the Kenward and Roger method implemented with the kr2
option12 in SAS will be used for the calculation of the denominator degrees of freedom. 
Heterogenous models across subject strata may be considered. The log-likelihood ratio test 
will be used to test for homogeneity between the two strata. Convergence limitations will be 
taken into account as necessary. If convergence is problematic, then reduced versions of the 
corresponding model will be considered. When the normality assumption does not hold for an 
endpoint, the analysis will be conducted on transformed data; generalized linear models or 
generalized linear mixed models with appropriate distributions will also be considered on the 
original data. 
14.6. Secondary Analysis (For Part 1 and Part 2) 
Relationship between Comfort Scores and Clinical Measures
Correlation analysis will be conducted between subjective comfort scores (VAS scale) and 
primary endpoints. Pearson product-moment correlation coefficient will be provided for 
continuous endpoints and Kendall's tau coefficient will be provided for ordinal endpoints. For 
each of the primary endpoints, when there is more than one measurement taken for each subject
(eye for WBC), the mean will be used in the analysis and a test based on the corresponding 
correlation coefficient will be conducted separately. 
Tests for the relationship between the comfort scores and each of the primary endpoints will 
be conducted separately using two-sided 95% confidence intervals constructed for the 
corresponding correlation coefficient. The relationship between comfort scores and a primary 
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endpoint will be concluded to be significant if 0 does not fall within confidence limits of the 
corresponding coefficient. The directional statistical relationship will be determined using the 
upper or lower limit of the 95% confidence interval. Upper limit below zero or lower limit 
above zero of the 95% confidence will determine negative or positive relationship, 
respectively, between the clinical measure and the VAS score. Further analysis based on a 
linear model or a generalized linear model depending on the distribution of the VAS scale may 
be undertaken if necessary when the relationship between comfort scores and any one of 
primary endpoints is significant.
14.7. Other Hypotheses  
For Part 2:
The analysis procedure will follow the exact steps for analyzing these hypotheses as described 
in the primary analysis section for LMS, NIBUT, TMH, TOSM, and WBC.
For Part 1 and 2:
1. For Part 1 and 2: End of day discomfort will return to pre-lens wear comfort levels 
following lens removal.
Within each stratum and overall post VAS score for both eyes will be analyzed separately 
using a linear mixed model by adjusting the baseline VAS score (pre-VAS) as covariate. The
model will include subject strata (asymptomatic/symptomatic) as fixed effect. Other 
characteristics such as, age, gender, and race will be included as fixed covariates when 
appropriate. Unstructured (UN) and Homogenous Compound symmetry (CS) Covariances will 
be considered to model the residual errors between the eyes from the same subject (R-side). A
two-sided 95% CI for the coefficient of the model intercept will be constructed for the 
hypothesis given below:
ܪ଴ǣ ߚ௜௡௧ൌͲ
ܪ஺ǣ ߚ௜௡௧്Ͳǡ
where ߚ௜௡௧ൌmodel intercept. End of day discomfort returned to pre-lens wear comfort will be 
concluded if the 95% confidence intervals contains 0. Otherwise, statistical difference between 
end of day comfort and pre-lens comfort will be concluded. The direction will be determined 
using the upper or lower limit of the 95% confidence interval. Upper limit below zero or lower 
limit above zero of the 95% confidence will determine negative or positive change, in other 
words, lower or higher post VAS score compared to pre-VAS score, respectively.
2. There will be a relationship between change in CLDEQ score between Part 1 and Part 2 
and change in the five clinical parameters investigated between Part 1 and Part 2.
Correlation analysis will be conducted for the change in CLDEQ score and the change in the 
five clinical parameters between Part 1 and Part 2. Pearson product-moment correlation 
coefficient will be provided for continuous endpoints, and Kendall's tau coefficient will be 
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provided for ordinal endpoints. For each of the primary endpoints, when there is more than one 
measurement taken for each subject (eye for WBC), the mean will be used in the analysis and 
a test based on the corresponding correlation coefficient will be conducted for each of the
endpoints separately using two-sided 95% confidence intervals. The relationship of the 
endpoints will be concluded to be significant if 0 does not fall within confidence limits of the 
corresponding coefficient. The directional statistical relationship will be determined using the 
upper or lower limit of the 95% confidence interval. Upper limit below zero or lower limit 
above zero of the 95% confidence will determine negative or positive relationship, 
respectively, between the clinical measures.
3. There will be a relationship between change in CLDEQ score between Part 1 and Part 2 
and the difference in the (follow-up – baseline) and (follow-up – fitting) values between 
Part 1 and Part 2 for all clinical measures except density of white blood cells.
Correlation analysis will be conducted for the change in CLDEQ score and the difference in 
the (follow-up – baseline) and (follow-up – fitting) values of all clinical measures except 
density of white blood cells between Part 1 and Part 2. Pearson product-moment correlation
coefficient will be provided for continuous endpoints. For each of the primary endpoints, when 
there is more than one measurement taken for each subject, the mean will be used in the 
analysis and a test based on the corresponding correlation coefficient will be conducted 
separately. Tests for the relationship each of the endpoints will be conducted separately using 
two-sided 95% confidence intervals constructed for the corresponding correlation coefficient. 
The relationship of the endpoints will be concluded to be significant if 0 does not fall within 
confidence limits of the corresponding coefficient. The directional statistical relationship will 
be determined using the upper or lower limit of the 95% confidence interval. Upper limit below 
zero or lower limit above zero of the 95% confidence will determine negative or positive 
relationship, respectively, between the clinical measures.
4. For Part 1 and 2: at 14 hours, symptomatic subjects will have a greater change from 
baseline in all the clinical measures except density of white blood cells in the eyelid 
margins.
The analysis procedure will follow the exact steps for analyzing the change from baseline in 
mean as described in the primary analysis section for LMS, NIBUT, TMH, and TOSM except 
the response variable will be the change of LMS, NIBUT, TMH, and TOSM from the
corresponding baseline and the covariate baseline LMS, NIBUT, TMH, and TOSM will be 
excluded from the model. Comparisons between subject strata will be carried out using a one-
sided 95% CI of least-square means differences (symptomatic - asymptomatic) for the change 
form bassline for the hypothesis given below:
ܪ଴ǣ ߤௌെߤ஺൑Ͳ
ܪ஺ǣ ߤௌെߤ஺൐Ͳǡ
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where S=Symptomatic and A=Asymptomatic. A statistically greater change, on average, for 
symptomatic subjects compared to asymptomatic subjects will be concluded if the lower limit 
of the 95% confidence intervals for the Least-squares means is greater than 0.
Other observations will be presented in a separate laboratory protocol and will be analyzed in 
a separate report.
14.8. Interim Analysis 
There will not be an interim read performed on this study. 
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using 
multiple imputation methods if the proportion of subject dropout is greater than the 15%. The 
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a parametric 
regression method used to make at least 50 imputations.
14.10. Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change.
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using an EDC 
system (Bioclinica). An authorized data originator will enter study data into the eCRFs using 
the EDC system. Data collected on equipment that is not captured in EDC will be formatted to 
the specification of the JJVC database manager and sent to JJVC for analysis. Data generated 
from post hoc measurements (e.g. tear meniscus height, lid wiper image analysis, tear film 
cytokines, etc.) will be collected on specific Microsoft Office Excel format worksheets at the 
clinical site and at the completion of the analysis transferred to JJVC biostatistician for data 
analysis in such format.
The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit. Once completed, the eCRFs will be reviewed for accuracy and 
completeness and signed by the Investigator. The sponsor or sponsor’s representatives will be 
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authorized to gain access to the subject recordation for the purposes of monitoring and auditing 
the study. 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study. 
The content and structure of the eCRFs are compliant with ISO14155:2011.1
15.2. Subject Record 
At a minimum, subject record should be available for the following: 
x
subject identification
x
eligibility
x
study identification
x
study discussion
x
provision of and date of informed consent
x
visit dates
x
results of safety and efficacy parameters as required by the protocol
x
a record of all adverse events
x
follow-up of adverse events
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record.
Adverse event notes must be reviewed and initialed by the Investigator.
16. DATA MANAGEMENT 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours.
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16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor.
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article.
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate.
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities.
17. MONITORING 
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol, any 
subsequent amendments, and regulatory requirements are maintained
x
Ensuring the rights and wellbeing of subjects are protected
x
Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel
x
Ensuring that protocol deviations are documented with corrective action plans, as 
applicable
x
Ensuring that the clinical site has sufficient test article and supplies
x
Clarifying questions regarding the study
x
Resolving study issues or problems that may arise
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x
Reviewing of study records and source documentation verification in accordance with 
the monitoring plan
18. ETHICAL AND REGULATORY ASPECTS 
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Only subjects who are fully able to understand the 
risks, benefits, and potential adverse events of the study, and provide their consent voluntarily 
will be enrolled.
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements.
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable):
x
Final protocol and, if applicable, amendments
x
Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects)
x
Investigator’s Brochure (or equivalent information) and amendments
x
Sponsor-approved subject recruitment materials
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB)
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects
x
Any other documents that the IEC/IRB requests to fulfill its obligation
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This study will be undertaken only after IEC/IRB has given full approval of the final protocol, 
amendments (if any), the informed consent form, applicable recruiting materials, and subject 
compensation programs, and the Sponsor has received a copy of this approval. This approval
letter must be dated and must clearly identify the documents being approved.
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate:
x
Protocol amendments
x
Revision(s) to informed consent form and any other written materials to be provided to 
subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s Brochure amendments or new edition(s)
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB)
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements
x
New information that may adversely affect the safety of the subjects or the conduct of 
the study
x
Major protocol deviations as required by the IEC/IRB
x
Report of deaths of subjects under the Investigator's care
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB
For protocol amendments that increase subject risk, the amendment and applicable informed 
consent form revisions must be submitted promptly to the IEC/IRB for review and approval 
before implementation of the change(s).
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing.
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable.
18.4. Informed Consent 
Each subject must give written consent according to local requirements after the nature of the 
study has been fully explained. The consent form must be signed before performance of any 
study-related activity. The consent form that is used must be approved by both the Sponsor 
and by the reviewing IEC/IRB. The informed consent is in accordance with principles that 
originated in the Declaration of Helsinki,3 current ICH2 and ISO 141551 guidelines, applicable 
regulatory requirements, and Sponsor Policy.
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Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study, and any discomfort it may entail. Subjects will be informed 
that their participation is voluntary and that they may withdraw consent to participate at any 
time. 
The subject will be given sufficient time to read the informed consent form and the opportunity 
to ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the 
consent, a copy of the informed consent form must be given to the subject.
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the General Data Protection Regulation7, UK Data Protection Act 20188 and 
other applicable personal data protection and security laws and regulations.  Appropriate 
measures will be employed to safeguard these data, to maintain the confidentiality of the
person’s related health and medical information, to properly inform the concerned persons 
about the collection and processing of their personal data, to grant them reasonable access to 
their personal data and to prevent access by unauthorized persons.
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records.
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study.
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations.
The Sponsor ensures that the personal data will be:
x
processed fairly and lawfully
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes
x
adequate, relevant, and not excessive in relation to said purposes
x
accurate and, where necessary, kept current
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Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries.
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations.
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential.
19. STUDY RECORD RETENTION 
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents.
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained.
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor.
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
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20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation.
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as:
x
Continuing an ineligible subject in the study
x
Scheduling a study visit outside the subject’s acceptable visit range
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as:
x
Query resolution
x
Case Report Form signature
x
Completion of any follow-up action items 
21. PUBLICATION 
This study will be registered on ClinicalTrials.gov by the study sponsor.
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22. REFERENCES 
1. ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects —
Good Clinical Practice. Available at: https://www.iso.org/standard/45557.html
2. International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR
5. Navascues-Cornago M. 
 Clinical study report version 1.0: End-of-Day 
clinical assessment of asymptomatic and symptomatic soft contact lens wearers.
April 6, 2018.
6. Morgan PB. 
 Clinical study report version 1.0: Confocal microscopy of the 
eyelid margin as a surrogate for contact lens discomfort. June 12, 2018.
7. General Data Protection Regulation. Available at: https://www.eugdpr.org/
8. Data Protection Act. Available at:
http://www.legislation.gov.uk/ukpga/2018/12/contents/enacted
9. http://www.legislation.gov.uk/ukpga/2018/12/contents/enacted
10. Keselman H, Algina J, Kowalchuk RK, Wolfinger RD. A comparison of two 
approaches for selecting covariance structures in the analysis of repeated 
measurements. Communications in Statistics-Simulation and computation. 
1998;27(3):591-604.
11. Kenward MG, Roger JH. Small sample inference for fixed effects from restricted 
maximum likelihood. Biometrics. 1997:983-997.
12. Kenward MG, Roger JH. An improved approximation to the precision of fixed effects 
from restricted maximum likelihood. Computational Statistics & Data Analysis.
2009;53(7):2583-2595.
13. Edwards D, Berry JJ. The efficiency of simulation-based multiple 
comparisons. Biometrics. 1987:913-928.
 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
 
 
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
The Patient Instruction Guide will be provided separately.
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
Dailies AquaComfort Plus
Acuvue Oasys 1-Day
 
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DESCRIPTION
ACUVUE OASYS® Brand Contact Lenses 1-Day and ACUVUE OASYS® 
Brand Contact Lenses 1-Day for ASTIGMATISM are soft (hydrophilic) 
contact lenses made with HydraLuxe™ Technology. They are available as 
spherical or toric lenses respectively. 
These lenses are made of a silicone hydrogel material containing an internal 
wetting agent, visibility tint, and UV absorbing monomer and are tinted blue 
using Reactive Blue Dye #4 to make the lenses more visible for handling.
A benzotriazole UV absorbing monomer is used to block UV radiation. The 
transmittance characteristics for these lenses are less than 1% in the UVB 
range of 280 nm to 315 nm and less than 10% in the UVA range of 316 nm 
to 380 nm for the entire power range.
Lens Properties:
The physical/optical properties of the lens are:
• Speciﬁ c Gravity (calculated):
0.98 - 1.12
• Refractive Index:
1.42
• Light Transmission: 
85% minimum
• Surface Character:
Hydrophilic
• Water Content:
38%
• Oxygen Permeability:
VALUE
METHOD
122 x 10-11 (cm2/sec) 
(ml O2/ml x mm Hg) at 35°C
Fatt (boundary corrected, non-
edge corrected)
103 x 10-11 (cm2/sec) 
(ml O2/ml x mm Hg) at 35°C
Fatt (boundary corrected, edge 
corrected)
Lens Parameters:
• Diameter Range:
12.0 mm to 15.0 mm
• Center Thickness:
varies with power
• Base Curve Range:
7.85 mm to 10.00 mm
• Spherical Power Range:
-20.00D to +20.00D
• Cylinder Power Range:
-0.25D to -10.00D
• Axis Range:
2.5° to 180°
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AVAILABLE LENS PARAMETERS
ACUVUE OASYS® Brand 1-Day with HydraLuxe™ Technology are 
hemispherical shells of the following dimensions:
Diameter:
14.3 mm
Center Thickness:
0.085 mm to 0.221 mm (varies with power)
Base Curve:
8.5 mm, 9.0 mm
Powers:
-0.50D to -6.00D (in 0.25D increments)
-6.50D to -12.00D (in 0.50D increments)
+0.50D to +6.00D (in 0.25D increments)
+6.50D to +8.00D (in 0.50D increments)
ACUVUE OASYS® Brand 1-Day with HydraLuxe™ Technology for 
ASTIGMATISM are hemitoric shells of the following dimensions:
Diameter:
14.3 mm
Center Thickness:
0.075 mm to 0.172 mm (varies with power)
Base Curve:
8.5 mm
Powers:
+0.00D to -6.00D (in 0.25D increments)
Cylinders: -0.75D, -1.25D, -1.75D, -2.25D*
Axis: 10° to 180° in 10° increments
*-2.25D cylinder is availble in 10°, 20°, 70°, 80°, 90°, 100°, 110°, 
160°, 170°, 180° axes only.
+0.25D to +4.00D (in 0.25D increments)
-6.50D to -9.00D (in 0.50D increments)
Cylinders: -0.75D, -1.25D, -1.75D
Axis: 10°, 20°, 70°, 80°, 90°, 100°, 110°, 160°, 
170°, 180°
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TRANSMITTANCE CURVES
ACUVUE OASYS® 1-Day with HydraLuxe™ Technology (senoﬁ lcon A) 
Visibility Tinted with UV Blocker vs. 24 yr. old human cornea and 25 yr. old 
human crystalline lens. 
……. 
ACUVUE OASYS®  
1-Day with 
HydraLuxe™ 
Technology 
(senoﬁ lcon A)*
_____
24 YR. OLD HUMAN 
CORNEA1
- - - - - 
25 YR. OLD HUMAN 
CRYSTALLINE LENS2
* The data was obtained from measurements taken through the central 3-5 mm portion for 
the thinnest marketed lens (-9.00D lens, 0.075 mm center thickness).
1Lerman, S., Radiant Energy and the Eye, MacMillan, New York, 1980, p. 58, ﬁ gure 2-21
2Waxler, M., Hitchins, V.M., Optical Radiation and Visual Health, CRC Press, Boca Raton, Florida, 
1986, p. 19, ﬁ gure 5 
WARNING: UV absorbing contact lenses are NOT substitutes for 
protective UV absorbing eyewear, such as UV absorbing goggles 
or sunglasses because they do not completely cover the eye and 
surrounding area. The patient should continue to use UV absorbing 
eyewear as directed.
ACTIONS
In its hydrated state, the contact lens, when placed on the cornea, acts as 
a refracting medium to focus light rays onto the retina.
The transmittance characteristics for these lenses are less than 1% in the 
UVB range of 280 nm to 315 nm and less than 10% in the UVA range of 
316 nm to 380 nm for the entire power range.
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NOTE:  Long-term exposure to UV radiation is one of the risk 
factors associated with cataracts.  Exposure is based on a number 
of factors such as environmental conditions (altitude, geography, 
cloud cover) and personal factors (extent and nature of outdoor 
activities).  UV-Blocking contact lenses help provide protection 
against harmful UV radiation. However, clinical studies have not 
been done to demonstrate that wearing UV-Blocking contact 
lenses reduces the risk of developing cataracts or other eye 
disorders. The Eye Care Professional should be consulted for more 
information.
INDICATIONS (USES)
ACUVUE OASYS® Brand Contact Lenses 1-Day with HydraLuxe™ 
Technology are indicated for daily disposable wear for the optical 
correction of refractive ametropia (myopia and hyperopia) in phakic or 
aphakic persons with non-diseased eyes who may have 1.00D or less of 
astigmatism.
ACUVUE OASYS® Brand Contact Lenses 1-Day with HydraLuxe™ Tech-
nology for ASTIGMATISM are indicated for daily disposable wear for the 
optical correction of refractive ametropia (myopia and hyperopia) in phakic 
or aphakic persons with non-diseased eyes who may have 0.50D to 3.00D 
of astigmatism.
These lenses contain a UV Blocker to help protect against transmission of 
harmful UV radiation to the cornea and into the eye.
CONTRAINDICATIONS (REASONS NOT TO USE) 
DO NOT USE these contact lenses when any of the following 
conditions exist:
• Acute or subacute inﬂ ammation or infection of the anterior chamber 
of the eye.
• Any eye disease, injury or abnormality that affects the cornea, 
conjunctiva, or eyelids.
• Severe insufﬁ ciency of lacrimal secretion (dry eye).
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• Corneal hypoesthesia (reduced corneal sensitivity).
• Any systemic disease that may affect the eye or be exaggerated by 
wearing contact lenses.
• Allergic reactions of ocular surfaces or adnexa that may be induced 
or exaggerated by wearing contact lenses or use of contact lens 
solutions.
• Ocular irritation due to allergic reactions which may be caused by 
use of contact lens solutions (i.e., rewetting drops) that contain 
chemicals or preservatives (such as mercury, Thimerosal, etc.) to 
which some people may develop an allergic response.
• Any active corneal infection (bacterial, fungal, protozoal, or viral).
• If eyes become red or irritated.
WARNINGS
Patients should be advised of the following warnings pertaining to 
contact lens wear:
EYE PROBLEMS, INCLUDING CORNEAL ULCERS, CAN DEVELOP 
RAPIDLY AND LEAD TO LOSS OF VISION; IF THE PATIENT EXPE-
RIENCES:
• Eye Discomfort,
• Excessive Tearing,
• Vision Changes,
• Loss of Vision,
• Eye Redness,
• Or Other Eye Problems, 
THE PATIENT SHOULD BE INSTRUCTED TO IMMEDIATELY RE-
MOVE THE LENSES AND PROMPTLY CONTACT THE EYE CARE 
PROFESSIONAL.
• When prescribed for daily wear, patients should be instructed not 
to wear lenses while sleeping. Clinical studies have shown that 
the risk of serious adverse reactions is increased when lenses are 
worn overnight, and that the risk of ulcerative keratitis is greater for 
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extended wear contact lens users than for daily wear users.3
• Studies have shown that contact lens wearers who are smokers 
have a higher incidence of adverse reactions than nonsmokers.
• Problems with contact lenses or lens care products could result in 
serious injury to the eye. Patients should be cautioned that proper 
use and care of contact lenses and lens care products are essential 
for the safe use of these products.
• The overall risk of ulcerative keratitis may be reduced by carefully 
following directions for lens care.
3 New England Journal of Medicine, September 21, 1989; 321 (12), pp. 773-783
Speciﬁ c Instructions for Use and Warnings:
• Water Activity
Instructions for Use
Do not expose contact lenses to water while wearing them.
WARNING:
Water can harbor microorganisms that can lead to severe infection, 
vision loss or blindness. If lenses have been submersed in water 
when participating in water sports or swimming in pools, hot tubs, 
lakes, or oceans, the patient should be instructed to discard them 
and replace them with a new pair. The Eye Care Professional should 
be consulted for recommendations regarding wearing lenses during 
any activity involving water.
PRECAUTIONS
Special Precautions for Eye Care Professionals:
• Due to the small number of patients enrolled in clinical investiga-
tion of lenses, all refractive powers, design conﬁ gurations, or lens 
parameters available in the lens material are not evaluated in signif-
icant numbers. Consequently, when selecting an appropriate lens 
design and parameters, the Eye Care Professional should consider 
all characteristics of the lens that can affect lens performance and 
ocular health, including oxygen permeability, wettability, central and 
peripheral thickness, and optic zone diameter.
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• The potential impact of these factors on the patient’s ocular health 
should be carefully weighed against the patient’s need for refractive 
correction; therefore, the continuing ocular health of the patient and 
lens performance on the eye should be carefully monitored by the 
prescribing Eye Care Professional.
• Patients who wear these lenses to correct presbyopia using mono-
vision may not achieve the best corrected visual acuity for either 
far or near vision. Visual requirements vary with the individual and 
should be considered when selecting the most appropriate type of 
lens for each patient.
• Fluorescein, a yellow dye, should not be used while the lenses are 
on the eyes. The lenses absorb this dye and become discolored. 
Whenever ﬂ uorescein is used in eyes, the eyes should be ﬂ ushed 
with a sterile saline solution that is recommended for in-eye use.
• Eye Care Professionals should instruct the patient to remove the 
lenses immediately if the eyes become red or irritated. 
Eye Care Professionals should carefully instruct patients about the 
following care regimen and safety precautions.
Handling Precautions:
• Before leaving the Eye Care Professional’s ofﬁ ce, the patient should 
be able to promptly remove the lenses or should have someone 
else available who can remove the lenses for him or her. 
• DO NOT use if the sterile blister package is opened or damaged. 
• Always wash and rinse hands before handling lenses. Do not get 
cosmetics, lotions, soaps, creams, deodorants, or sprays in the 
eyes or on the lenses. It is best to put on lenses before putting on 
makeup. Water-based cosmetics are less likely to damage lenses 
than oil-based products. 
• DO NOT touch contact lenses with the ﬁ ngers or hands if the 
hands are not free of foreign materials, as microscopic scratches 
of the lenses may occur, causing distorted vision and/or injury to 
the eye.
• Carefully follow the handling, insertion, removal, and wearing 
instructions in the “Patient Instruction Guide” for the prescribed 
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wearing schedule and those prescribed by the Eye Care 
Professional.
• Always handle lenses carefully and avoid dropping them.
• Never use tweezers or other tools to remove lenses from the lens 
container unless speciﬁ cally indicated for that use. Slide the lens up 
the side of the bowl until it is free of the container. 
• Do not touch the lens with ﬁ ngernails. 
Lens Wearing Precautions:
• If the lens sticks (stops moving) on the eye, follow the recom-
mended directions in “Care for a Sticking (Non-Moving) Lens." The 
lens should move freely on the eye for the continued health of the 
eye. If non-movement of the lens continues, the patient should be 
instructed to immediately consult his or her Eye Care Professional.
• Never wear lenses beyond the period recommended by the Eye 
Care Professional.
• The patient should be advised to never allow anyone else to wear 
their lenses. They have been prescribed to ﬁ t their eyes and to 
correct their vision to the degree necessary. Sharing lenses greatly 
increases the chance of eye infections.
• If aerosol products, such as hair spray, are used while wearing 
lenses, exercise caution and keep eyes closed until the spray has 
settled.
• Avoid all harmful or irritating vapors and fumes while wearing 
lenses. 
• Always discard lenses worn as prescribed by the Eye Care 
Professional. 
Lens Care Precautions:  
• The patient should be informed that no cleaning or disinfection is 
needed when lenses are worn for daily disposable wear.  Patients 
should always dispose of lenses when removed and have spare 
lenses or spectacles available.
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Other Topics to Discuss with Patients:
• Always contact the Eye Care Professional before using any medi-
cine in the eyes. 
• Certain medications, such as antihistamines, decongestants, 
diuretics, muscle relaxants, tranquilizers, and those for motion 
sickness may cause dryness of the eye, increased lens awareness, 
or blurred vision. Should such conditions exist, proper remedial 
measures should be prescribed. Depending on the severity, this 
could include the use of lubricating drops that are indicated for use 
with soft contact lenses or the temporary discontinuance of contact 
lens wear while such medication is being used. 
• Oral contraceptive users could develop visual changes or changes 
in lens tolerance when using contact lenses. Patients should be 
cautioned accordingly. 
• As with any contact lens, follow-up visits are necessary to assure 
the continuing health of the patient’s eyes. The patient should be 
instructed as to a recommended follow-up schedule. 
Who Should Know That the Patient is Wearing Contact Lenses?
• Patients should inform all doctors (Health Care Professionals) about 
being a contact lens wearer. 
• Patients should always inform their employer of being a contact 
lens wearer. Some jobs may require use of eye protection equip-
ment or may require that the patient not wear contact lenses. 
ADVERSE REACTIONS
The patient should be informed that the following problems may 
occur when wearing contact lenses:
• The eye may burn, sting, and/or itch.
• There may be less comfort than when the lens was ﬁ rst placed on 
the eye.
• There may be a feeling of something in the eye (foreign body, 
scratched area).
• There may be the potential for some temporary impairment due to 
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peripheral inﬁ ltrates, peripheral corneal ulcers, or corneal erosion. 
There may be the potential for other physiological observations, 
such as local or generalized edema, corneal neovascularization, 
corneal staining, injection, tarsal abnormalities, iritis, and conjuncti-
vitis; some of which are clinically acceptable in low amounts.
• There may be excessive watering, unusual eye secretions, or 
redness of the eye.
• Poor visual acuity, blurred vision, rainbows, or halos around 
objects, photophobia, or dry eyes may also occur if the lenses are 
worn continuously or for too long a time.
The patient should be instructed to conduct a simple 3-part self-examina-
tion at least once a day. They should ask themselves:
• How do the lenses feel on my eyes?
• How do my eyes look?
• Have I noticed a change in my vision? 
If the patient reports any problems, he or she should be instructed to 
IMMEDIATELY REMOVE THE LENS. If the problem or discomfort stops, 
the patient should discard the lens and place a new fresh lens on the eye.
If after inserting the new lens, the problem continues, the patient should be 
directed to IMMEDIATELY REMOVE THE LENS AND CONTACT HIS OR 
HER EYE CARE PROFESSIONAL.
The patient should be instructed NOT to use a new lens as self-treatment 
for the problem.
The patient should be advised that when any of the above symptoms oc-
cur, a serious condition such as infection, corneal ulcer, neovascularization, 
or iritis may be present. He or she should be instructed to seek immediate 
professional identiﬁ cation of the problem and prompt treatment to avoid 
serious eye damage.
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• ACUVUE OASYS® 1-Day: 8.5 mm/14.3 mm
• ACUVUE OASYS® 1-Day for ASTIGMATISM: 8.5 mm/14.3 mm
The trial lens should be placed on each of the patient's eyes and evaluated 
after the patient has adjusted to the lenses.  
1. Criteria of a Properly Fit Lens 
A properly ﬁ t lens will center and completely cover the cornea (i.e., no 
limbal exposure), have sufﬁ cient movement to provide tear exchange 
under the contact lens with the blink, and be comfortable. The lens 
should move freely when manipulated digitally with the lower lid, and 
then return to its properly centered position when released.
2. Criteria of a Flat Fitting Lens 
A ﬂ at ﬁ tting lens may exhibit one or more of the following characteris-
tics: decentration, incomplete corneal coverage (i.e., limbal exposure), 
excessive movement with the blink, and/or edge standoff. If the lens is 
judged to be ﬂ at ﬁ tting, it should not be dispensed to the patient.
3. Criteria of a Steep Fitting Lens 
A steep ﬁ tting lens may exhibit one or more of the following charac-
teristics: insufﬁ cient movement with the blink, conjunctival indentation, 
and resistance when pushing the lens up digitally with the lower lid. 
If the lens is judged to be steep ﬁ tting, it should not be dispensed to 
the patient.
If the initial trial base curve is judged to be ﬂ at or steep ﬁ tting, the alternate 
base curve, if available, should be trial ﬁ t and evaluated after the patient 
has adjusted to the lens. The lens should move freely when manipulated 
digitally with the lower lid, and then return to a properly centered position 
when released. If resistance is encountered when pushing the lens up, the 
lens is ﬁ tting tightly and should not be dispensed to the patient.
E. Final Lens Power (Spherical)
A spherical over-refraction should be performed to determine the ﬁ nal lens 
power after the lens ﬁ t is judged acceptable. The spherical over-refraction 
should be combined with the trial lens power to determine the ﬁ nal lens 
prescription. The patient should experience good visual acuity with the 
correct lens power unless there is
ve residual astigmatism.
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Example 1
Diagnostic lens:
-2.00D
Spherical over-refraction: 
-0.25D
Final lens power: 
-2.25D
Example 2
Diagnostic lens:
-2.00D
Spherical over-refraction: 
+0.25D
Final lens power: 
-1.75D
If vision is acceptable, perform a slit lamp examination to assess adequate 
ﬁ t (centration and movement). If the ﬁ t is acceptable, dispense the lenses 
and instruct the patient to return in one week for reassessment (see 
dispensing and follow up information in PATIENT MANAGEMENT).
All patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com.
TORIC FITTING GUIDELINES
Although most aspects of the ﬁ tting procedure are identical for all types 
of soft contact lenses, including toric lenses, there are some additional 
steps and/or rules to follow to assure the proper ﬁ t of toric lenses.
The only new steps you must follow in prescribing ACUVUE OASYS® 
1-Day for ASTIGMATISM are that you must determine the stability, 
repeatability, and drift angle of the lens axis so that you can prescribe the 
correct lens axis for the patient.
A. How to Determine Lens Cylinder and Axis Orientation 
1. Locate the Orientation Marks
To help determine the proper orientation of the toric lens, you’ll 
ﬁ nd two primary marks approximately 1 mm from the lens edge 
representing the vertical position on opposite ends of the lens at 
6 and 12 o’clock (Fig. 1). Because of the lens’ ballasting system, 
either mark can represent the vertical position – there is no “top” 
and “bottom” as in a prism-ballasted lens. You don’t need to view 
both marks to assess orientation; simply look for the 6 o’clock 
mark as you would with a prism-ballasted lens.
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Figure 1
You’ll need a slit lamp biomicroscope with a 1 to 2 mm 
parallelepiped beam to highlight the marks when the lens is ﬁ tted 
to the eye. There are a number of techniques you can use to 
improve the visibility of the 6 o’clock mark. Using a parallelepiped 
beam and medium magniﬁ cation (10x or 15x), slowly pan 
down the lens, looking just below the direct illumination at the 
retroilluminated area. Backlighting the mark this way should make 
it more visible. Sometimes manipulating the lower lid may be 
necessary to uncover the mark.
2. Observe Lens Rotation and Stability
Observe the position and stability of the “bottom” mark. It usually 
stabilizes at the 6 o’clock position. If it does, calculation of the 
lens power will be straightforward. The 6 o’clock position is not a 
“must”; however, the absolute requirement is that the axis position 
be stable and repeatable.
The mark may stabilize somewhat left or right (drift) of the vertical 
meridian and still enable you to ﬁ t a toric lens for that eye, as 
long as the lens always returns to the same “drift axis” position 
after settling. The deviation can be compensated for in the ﬁ nal 
prescription. Your objective is to ensure that whatever position the 
initial lens assumes near 6 o’clock, this position must be stable 
and repeatable. With full eye movement or heavy blink, you may 
see the marks swing away, but they must return quickly to the 
original stable position. If the lens does not return quickly, you may 
need to select a different lens.
3. Assessing Rotation
Imagine the eye as a clock dial and every hour represents a 
30° interval. If the orientation mark of the initial lens stabilizes 
somewhat left or right of the vertical position, the ﬁ nal lens will 
orient on the eye with the same deviation. You can use an axis 
reticule in the slit lamp or use a line-scribed lens in a spectacle trial 
frame to measure or estimate the “drift angle” of the cylinder axis.
To compensate for this “drift”, measure or estimate the “drift”, then 
add or subtract it from the refractive axis to determine the correct 
cylinder axis. Use the LARS (Left Add, Right Subtract) method to 
determine which direction to compensate.
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B. Final Lens Power 
When the diagnostic lens has its axis aligned in the same meridian 
as the patient’s refractive axis, a spherocylindrical over-refraction may 
be performed and visual acuity determined. However, in the case 
of crossed axes, such as when the diagnostic lens axis is different 
from the spectacle cylinder axis, it is not advisable to perform a full 
spherocylindrical over-refraction because of the difﬁ culty in computing 
the resultant power. A spherical over-refraction without cylinder 
refraction may be performed. 
If the required cylinder correction falls between two available cylinder 
powers, it is recommended to prescribe the lower cylinder power 
lens. See below for instructions on how to determine the ﬁ nal lens 
power.
1. For the Sphere
If sphere alone or combined sphere and cylinder Rx > ±4.00D, 
compensate for vertex distance. If sphere alone or combined 
sphere and cylinder Rx ≤ ±4.00D, vertex compensation is not 
necessary.
2. For the Cylinder
Adjust the axis by the drift angle using the LARS method. Choose 
a cylinder that is ≤ 0.50D from the refractive cylinder.
3. Case Examples
Example 1
Manifest (spectacle) refraction:
O.D. -2.50D / -1.25D x 180° 20/20
O.S. -2.00D / -1.00D x 180° 20/20
Choose a diagnostic lens for each eye with axis 180°. Place 
the lens on each eye and allow a minimum of 3 minutes for it to 
equilibrate, based on the patient’s initial response to the lens. If the 
lens has not yet stabilized, recheck until stable.
Check the orientation of the axis mark. If the bottom axis mark 
is in the 6 o’clock position on both eyes, choose the appropriate 
cylinder as listed previously. If the lens has not yet stabilized, 
recheck until stable.
Here is the Rx Prescribed:
O.D. -2.50D / -1.25D x 180°
O.S. -2.00D / -0.75D x 180°
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Example 2
Manifest (spectacle) refraction:
O.D. -3.00D / -1.00D x 90° 20/20
O.S. -4.75D / -2.00D x 90° 20/20
Choose diagnostic lenses of -3.00D / -0.75D x 90° for the right 
eye and -4.50D / -1.75D x 90° for the left eye, the nearest lenses 
available to the spherical power, cylinder power, and axis needed. 
For the left eye, since the manifest refraction called for -4.75D, 
compensating for vertex distance the sphere is reduced by 0.25D 
to -4.50D. The cylinder power will be -1.75D. Place the lens on 
each eye and allow a minimum of 3 minutes for it to equilibrate, 
based on the patient's initial response to the lens. If the lens has 
not yet stabilized, recheck until stable. 
Right Eye
The orientation mark on the right lens rotates left from the 6 
o’clock position by 10° and remains stable in this position. 
Compensation for this rotation should be done as follows: 
Compensate the 10° axis drift by adding it to the manifest 
refraction axis.
Here is the Rx Prescribed:
O.D. -3.00D / -0.75D x 100°
Left Eye
The orientation mark on the left lens rotates right from the 6 
o’clock position by 10° and remains stable in this position. 
Compensate for the 10° axis drift by subtracting it from the 
manifest refraction axis. 
Here is the Rx Prescribed: 
O.S. -4.50D / -1.75D x 80°
If vision is acceptable, perform a slit lamp examination to assess 
adequate ﬁ t (centration and movement). If ﬁ t is acceptable, 
dispense the lenses instructing the patient to return in one week 
for reassessment (see dispensing and follow-up information in 
PATIENT MANAGEMENT).
All patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com.
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MONOVISION FITTING GUIDELINES
A. Patient Selection
1. Monovision Needs Assessment
For a good prognosis, the patient should have adequately 
corrected distance and near visual acuity in each eye. The 
amblyopic patient or the patient with signiﬁ cant astigmatism 
(greater than 1.00D) in one eye may not be a good candidate for 
monovision correction with these lenses.
Occupational and environmental visual demands should be 
considered. If the patient requires critical vision (visual acuity and 
stereopsis), it should be determined by trial whether this patient 
can function adequately with monovision correction. Monovision 
contact lens wear may not be optimal for activities such as:
• visually demanding situations such as operating potentially 
dangerous machinery or performing other potentially hazardous 
activities; and
• driving automobiles (e.g., driving at night). Patients who cannot 
meet state driver's licensing requirements with monovision 
correction should be advised to not drive with this correction, 
OR may require that additional over-correction be prescribed.
2. Patient Education
All patients do not function equally well with monovision correc-
tion. Patients may not perform as well for certain tasks with this 
correction as they have with spectacles (multifocal, bifocal, trifocal, 
readers, progressives). Each patient should understand that 
monovision, as well as other presbyopic alternatives, can create 
a vision compromise that may reduce visual acuity and depth 
perception for distance and near tasks. Therefore, caution should 
be exercised when the patient is wearing the correction for the ﬁ rst 
time until they are familiar with the vision provided in visually chal-
lenging environments (e.g., reading a menu in a dim restaurant, 
driving at night in rainy/foggy conditions, etc.). During the ﬁ tting 
process, it is necessary for the patient to realize the disadvantages 
as well as the advantages of clear near vision and straight ahead 
and upward gaze that monovision contact lenses provide.
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B. Eye Selection
1. Ocular Preference Determination Methods
Generally, the non-dominant eye is corrected for near vision. The 
following two methods for eye dominance can be used.
Method 1:  Determine which eye is the “sighting eye.” Have the 
patient point to an object at the far end of the room. 
Cover one eye. If the patient is still pointing directly at the 
object, the eye being used is the dominant (sighting) eye.
Method 2:  Determine which eye will accept the added power with 
the least reduction in vision. Place a hand-held trial lens 
equal to the spectacle near ADD in front of one eye 
and then the other while the distance refractive error 
correction is in place for both eyes. Determine whether 
the patient functions best with the near ADD lens over 
the right or left eye.
2. Other Eye Selection Methods
Other methods include the "Refractive Error Method" and the 
"Visual Demands Method."
Refractive Error Method
For anisometropic correction, it is generally best to ﬁ t the more 
hyperopic (less myopic) eye for distance and the more myopic 
(less hyperopic) eye for near.
Visual Demands Method
Consider the patient’s occupation during the eye selection process 
to determine the critical vision requirements. If a patient’s gaze for 
near tasks is usually in one direction, correct the eye on that side 
for near.
Example: A secretary who places copy to the left side of the desk 
will function best with the near lens on the left eye.
C. Special Fitting Characteristics
1. Unilateral Vision Correction
There are circumstances where only one contact lens is required. 
As an example, an emmetropic patient would only require a near 
lens, whereas a bilateral myope would require corrective lenses on 
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both eyes.
Examples: 
A presbyopic emmetropic patient who requires a +1.75D ADD 
would have a +1.75D lens on the near eye and the other eye left 
without correction. 
A presbyopic patient requiring a +1.50D ADD who is -2.50D 
myopic in the right eye and -1.50D myopic in the left eye may 
have the right eye corrected for distance and the left uncorrected 
for near.
2. Near ADD Determination
Always prescribe the lens power for the near eye that provides 
optimal near acuity at the midpoint of the patient’s habitual reading 
distance. However, when more than one power provides optimal 
reading performance, prescribe the least plus (most minus) of the 
powers.
3. Trial Lens Fitting
A trial ﬁ tting is performed in the ofﬁ ce to allow the patient to 
experience monovision correction. Lenses are ﬁ t according to 
the GENERAL FITTING GUIDELINES for base curve selection 
described in this Package Insert.
Case history and standard clinical evaluation procedure should 
be used to determine the prognosis. Determine the distance 
correction and the near correction. Next determine the near ADD. 
With trial lenses of the proper power in place, observe the reaction 
to this mode of correction.
Allow the lenses to settle for about 20 minutes with the correct 
power lenses in place. Walk across the room and have the patient 
look at you. Assess the patient’s reaction to distance vision under 
these circumstances. Then have the patient look at familiar near 
objects such as a watch face or ﬁ ngernails. Again assess the 
reaction. As the patient continues to look around the room at both 
near and distance objects, observe the reactions. Only after these 
vision tests are completed should the patient be asked to read 
print. Evaluate the patient’s reaction to large print (e.g., typewritten 
copy) at ﬁ rst and then graduate to newsprint and ﬁ nally smaller 
type sizes.
After the patient’s performance under the above conditions 
is completed, tests of visual acuity and reading ability under 
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conditions of moderately dim illumination should be attempted.
An initial unfavorable response in the ofﬁ ce, while indicative of 
a guarded prognosis, should not immediately rule out a more 
extensive trial under the usual conditions in which a patient 
functions.
4. Adaptation
Visually demanding situations should be avoided during the 
initial wearing period. A patient may at ﬁ rst experience some 
mild blurred vision, dizziness, headaches, and a feeling of slight 
imbalance. You should explain the adaptational symptoms to 
the patient. These symptoms may last for a brief minute or for 
several weeks. The longer these symptoms persist, the poorer the 
prognosis for successful adaptation.
To help in the adaptation process, the patient can be advised to 
ﬁ rst use the lenses in a comfortable familiar environment such as 
in the home.
Some patients feel that automobile driving performance may not 
be optimal during the adaptation process. This is particularly true 
when driving at night. Before driving a motor vehicle, it may be 
recommended that the patient be a passenger ﬁ rst to make sure 
that their vision is satisfactory for operating an automobile. During 
the ﬁ rst several weeks of wear (when adaptation is occurring), it 
may be advisable for the patient to only drive during optimal driving 
conditions. After adaptation and success with these activities, the 
patient should be able to drive under other conditions with caution.
D. Other Suggestions
The success of the monovision technique may be further improved by 
having the patient follow the suggestions below:
• Have a third contact lens (distance power) to use when critical 
distance viewing is needed.
• Have a third contact lens (near power) to use when critical near 
viewing is needed.
• Having supplemental spectacles to wear over the monovision 
contact lenses for speciﬁ c visual tasks may improve the success 
of monovision correction. This is particularly applicable for those 
patients who cannot meet state driver's licensing requirements 
with monovision correction.
• Make use of proper illumination when carrying out visual tasks.
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Monovision ﬁ tting success can be improved by the following 
suggestions:
• Reverse the distance and near eyes if a patient is having trouble 
adapting.
• Reﬁ ne the lens powers if there is trouble with adaptation. 
Accurate lens power is critical for presbyopic patients.
• Emphasize the beneﬁ ts of clear near vision and straight ahead 
and upward gaze with monovision.
The decision to ﬁ t a patient with monovision correction is most 
appropriately left to the Eye Care Professional in conjunction with the 
patient after carefully considering the patient’s needs.
All patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com.
PATIENT MANAGEMENT
Dispensing Visit
Each sterile lens is supplied in a foil-sealed plastic package containing 
buffered saline solution with methyl ether cellulose. To remove the lens 
from the container, peel back the foil seal, place a ﬁ nger on the lens, and 
slide the lens up the side of the bowl of the lens package until it is free of 
the container.
• Evaluate the physical ﬁ t and visual acuity of the lens on each eye.
• Teach the patient how to apply and remove his or her lenses.
• Explain daily disposable lens wear and schedule a follow-up 
examination.
• Provide the patient with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available 
for download at www.acuvue.com.
REVIEW THESE INSTRUCTIONS WITH THE PATIENT SO THAT HE 
OR SHE CLEARLY UNDERSTANDS THE PRESCRIBED WEARING 
AND REPLACEMENT SCHEDULES.
Follow-Up Examinations
Follow-up care (necessary to ensure continued successful contact lens 
wear) should include routine periodic progress examinations, management 
of speciﬁ c problems, if any, and a review with the patient of the wear 
schedule, daily disposable modality  and proper lens handling procedures. 
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the criteria for successful ﬁ t are not satisﬁ ed during any follow-up 
examinations, repeat the patient’s trial ﬁ tting procedure and reﬁ t 
the patient.
WEARING SCHEDULE
The wearing schedule should be determined by the Eye Care Professional.  
Regular checkups, as determined by the Eye Care Professional, are also 
extremely important.
Patients tend to overwear the lenses initially. The Eye Care Professional 
should emphasize the importance of adhering to the initial maximum wear-
ing schedule.  Maximum wearing time should be determined by the Eye 
Care Professional based upon the patient’s physiological eye condition, 
because individual response to contact lenses varies.
The maximum suggested wearing time for these lenses is:
Day
Hours
1
6-8
2
8-10
3
10-12
4
12-14
5 and after
all waking hours
REPLACEMENT SCHEDULE
These lenses are indicated for daily disposable wear and should be 
discarded upon removal.
LENS CARE DIRECTIONS
When lenses are prescribed for daily disposable wear, the Eye Care 
Professional should provide the patient with appropriate and adequate 
warnings and instructions for daily disposable lens wear at the time they 
are dispensed. 
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The Eye Care Professional should review with patients that no cleaning 
or disinfection is needed with daily disposable lenses. Patients should 
always dispose of lenses when they are removed and have spare lenses or 
spectacles available.
Basic Instructions
• Always wash, rinse, and dry hands before handling contact lenses.
• Do not use saliva or anything other than the recommended solutions 
for lubricating or rewetting lenses. Do not put lenses in the mouth.
• Eye Care Professionals may recommend a lubricating/rewetting 
solution which can be used to wet (lubricate) lenses while they are 
being worn to make them more comfortable. 
Care for a Sticking (Non-Moving) Lens
If the lens sticks (stops moving), the patient should be instructed to apply 
a few drops of the recommended lubricating or rewetting solution directly 
to the eye and wait until the lens begins to move freely on the eye before 
removing it. If non-movement of the lens continues after a few minutes, the 
patient should immediately consult the Eye Care Professional.
EMERGENCIES
The patient should be informed that if chemicals of any kind (household 
products, gardening solutions, laboratory chemicals, etc.) are splashed 
into the eyes, the patient should: FLUSH EYES IMMEDIATELY WITH TAP 
WATER AND IMMEDIATELY CONTACT THE EYE CARE PROFESSIONAL 
OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY. 
HOW SUPPLIED
Each UV-blocking sterile lens is supplied in a foil-sealed plastic package 
containing buffered saline solution with methyl ether cellulose. The plastic 
package is marked with the following: 
• ACUVUE OASYS® 1-Day: base curve, power, diameter, lot number, 
and expiration date
• ACUVUE OASYS® 1-Day for ASTIGMATISM: base curve, power, 
diameter, cylinder, axis, lot number, and expiration date
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REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions observed in 
patients wearing these lenses or experienced with these lenses should be 
reported to:
Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway
Jacksonville, FL 32256
USA
Tel: 1-800-843-2020
www.acuvue.com
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX D: 
 
 
x
, Subject Reported Ocular Symptoms/Problems
x
, Patient Reported Outcomes
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
, SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS 
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
, PATIENT REPORTED OUTCOMES 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX E:  EUROLENS RESEARCH SOP #12A, THE SET UP, MEASUREMENT 
OF VISUAL ACUITY AND PROCEDURES FOR CARRYING OUT AN OVER 
REFRACTION USING THE EUROLENS COMPUTERISED LOGMAR VA CHART 
 
 
 
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12a 
 
 
 
 
 
 
 
 
Eurolens Research 
 
Clinical 
Standard Operating Procedure 
 
 
 
 
 
The set up, measurement of visual acuity and 
procedures for carrying out an over refraction 
using the Eurolens computerised logMAR  
VA chart  
 
 
 
 
 
Neil Chatterjee 
Research Optometrist 
 
 
First issued: v0; July 8, 2009 
Reviewed (with changes): v1; February 7, 2014 
Reviewed (no changes): v1; February 2, 2016 
Reviewed (with changes): v2; December 19, 2017 
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Eurolens Research 
Computer logMAR VA chart (v2) 
December 19, 2017 
4 
Confidential 
 
Microsoft Excel software.  The chart is displayed through an external monitor 
connected to the Apple Mac via its monitor socket and appropriate cable. 
2. The Eurolens chart is similar in design to the traditional Bailey-Lovie logMAR chart, 
however it uses a reversed Sloan font as the optotype.  The need for the reversed 
font is due to the chart being viewed indirectly in a mirror in a 3m consulting room.  
The chart is mounted on an adjustable mount, above the subject’s head. 
3. The indirect viewing makes the effective distance of the chart 6m from the subject.  
This 6m distance is the standard testing distance in optometric practice. 
4. High (100%) and low (10%) contrast VA measurements can be taken with the chart. 
5. The VA measurement from the Eurolens chart is intended to be equivalent to that 
obtained from the traditional Bailey-Lovie logMAR charts at 6m.  The Eurolens chart 
has two advantages over the Bailey-Lovie.  The Eurolens chart does not fade or 
discolour (which reduces legibility).  Further, unlike the fixed Bailey-Lovie chart, the 
letters can be randomised on the Eurolens chart, which reduces the effect of memory 
influencing the subject’s VA score. 
 
Initial computer set up 
1. 
The Apple Macintosh should have the following installed:  
a. Reversed Sloan font (otf file, which should be copied to the Macintosh 
HD/Library/Fonts/ folder) 
b. Microsoft Office 2011 or later 
c. Eurolens chart v5 software 
2. 
The external monitor should be connected to the Mac.  It will require the use of an 
appropriate adaptor and cable. 
3. 
The additional monitor should be recognised automatically by the Mac.  The Mac 
should configure the monitor as a second desktop.  To verify this, move the mouse 
pointer across the screen.  It should be possible to move the mouse pointer off the 
edge of the main screen and it should appear on the external monitor. 
4. 
The Eurolens Chart software is an Excel file called Eurolens Research chart.xls.  
This, for convenience, is located on the desktop. 
5. 
To run the chart, open the Excel file.  Click on “enable macros”. 
6. 
The chart should be displayed on the external monitor and the chart’s control panel 
should appear on the Mac’s main screen (Figure 1). 
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Eurolens Research 
Computer logMAR VA chart (v2) 
December 19, 2017 
5 
Confidential 
 
 
Figure 1.  Chart control panel 
 
7. 
If the letter chart appears on the Mac’s main screen, it will need to be “dragged” onto 
the external monitor.  To do this the chart control box must be closed.  The main 
chart can now be dragged onto the second screen and maximised. 
8. 
To restart the control panel, click on the Excel icon in the dock.  Then in Excel’s 
menu, select.: Tools -> Macro-> Macros.  A macro box should appear, select the 
macro entitled ‘showform’ and click on run.  The chart’s control panel can be 
reopened if closed (e.g. accidentally) by repeating this step. 
 
Chart calibration procedure 
1. 
It is important the charts are calibrated before first use, to ensure the optotypes are 
of the correct size and contrast.  Minute adjustments of monitor contrast or 
brightness can affect the contrast of the letters (especially low). 
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Eurolens Research 
Computer logMAR VA chart (v2) 
December 19, 2017 
6 
Confidential 
 
2. 
If the chart distance is set to 6m, the 0.8 letter on the computer chart should be the 
same height as that on the Bailey-Lovie chart, measuring just under 55mm high. 
3. 
The chart distance should then be set to the distance of the subject’s head to the 
chart. 
4. 
The monitor should be inclined downwards at an angle of approximately five 
degrees from the vertical.  The reason being the contrast of an LCD monitor can 
vary with tilt.  At five degrees of inclination, the monitor will be ‘straight on’ for the 
subject sat on the chair below. (see Appendix A) 
5. 
The monitor should then be calibrated using a Datacolor Spyder 4. Whilst 
calibrating, the room lights should be on full illumination and the monitor set to 
factory default values (all setting “standard”).  The corresponding monitor profile file 
generated should be saved and then used as the profile for the external monitor. 
6. 
The contrast of the low contrast chart should be measured.  The test spreadsheet 
(low contrast grey test.xlsx) should be displayed on the monitor with room lights on.  
Measurements of the luminance of the grey and white halves are taken with the 
spyder.  The luminance measurements are then averaged.  The contrast of the grey 
to white backgrounds is calculated as follows: 
 
% contrast = 
 
white lum – grey lum  x 100 
 
 
 
 
white lum  
7. 
The RGB vales of the grey background should be altered until the contrast is 
calculated to be approximately 10%.  This value is usually between 240 and 245 
units. 
8. 
Acuity measurements on the freshly calibrated chart should then be compared to 
those taken with two already calibrated charts.  This is done by measuring high and 
low contrast visual acuity with all three charts (in a randomised order on around 
eight subjects).  The acuity measurements of the three charts should all agree within 
two letters (0.04 logMAR) for high and low contrast acuity. 
9. 
If the high contrast acuity on the test chart does not agree with that of the control 
charts, then the “chart distance” value should be altered on the test chart, until it is in 
agreement with the controls. 
10. Once the high contrast acuity values are in agreement, the test chart’s low contrast 
acuity should be in agreement with the control.  If not then the “LC grey” value 
should be altered on the test chart until agreement is reached. 
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Eurolens Research 
Computer logMAR VA chart (v2) 
December 19, 2017 
7 
Confidential 
 
11. Final settings for each monitor on 11 October 2017 are contained in Appendix B. 
 
Measurement of VA using the Eurolens chart 
General instructions 
 
1. 
The subject should be seated in the chair 3m from the mirror.  This will place the 
chart at a 6m testing distance. 
2. 
The default test chart for standard testing should be a 7-line chart ranging from 0.4 
to -0.2 (Figure 1). 
3. 
The subject’s acuity can be tested monocularly and/or binocularly according to the 
study protocol. 
4. 
If the subject cannot read the top line then increase letter size in 0.1 steps until the 
subject can see the top line.   
5. 
Adjusting the “number of lines” box can alter the number of rows of letters displayed 
on the chart.  Please note to display larger letters (over 0.4), then only one or three 
rows should be selected.  
6. 
Letters can be increased in size by 0.1 steps, by clicking on the “+0.1” box.  Letters 
can be increased in size to a maximum of 1.0. 
7. 
Letters can be decreased in size by clicking on “-0.1”. 
8. 
The control panel displays information on the optotypes currently displayed on the 
chart and their size in logMAR. 
9. 
The VA score is calculated using the same method as a traditional Bailey-Lovie 
chart, with each letter scoring 0.02 units and each complete line scoring 0.1 (see 
below). 
10. To display the high contrast chart select “high contrast”, similarly to display the low 
contrast chart select “low contrast”.  This will display letters of 100% and 10% 
contrast respectively 
11. The Mac generates the sequence of letters used in the chart randomly.  Clicking on 
“shuffle letters” can change the sequence of letters. 
12. Letters should be shuffled after each VA measurement to avoid the subject learning 
the chart. 
13. As the chart is at 6m, any over-refraction performed can be considered to be 
equivalent to that performed on a 6m Snellen chart i.e. at infinity. 
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Eurolens Research 
Computer logMAR VA chart (v2) 
December 19, 2017 
8 
Confidential 
 
14. The 6m testing distance should also be taken into account when comparing logMAR 
scores obtained with the Bailey-Lovie chart at 3m.  The Bailey-Lovie scores should 
differ by -0.3. 
 
Subject instructions (standard chart display) 
After positioning the subject at the desired test distance, initiate the testing as follows: 
1. 
Ask the subject to read the smallest line where they feel they can easily read all the 
letters.  If the subject reads all the letters on the initial line, encourage them to 
continue reading the smaller lines until three or more letters on a 5- letter line are 
incorrectly identified. 
2. 
If the subject identifies one letter incorrectly on the initial line, ask them to read the 
line(s) above until one complete line has been identified correctly. Then encourage 
the subject to continue reading the smaller lines/letters until three or more letters on 
a 5-letter line are incorrectly identified. Note: The subject is to be encouraged to 
read and even guess at the letters until three or more letters are incorrectly 
identified. 
Scoring 
To determine the VA unit score for a given line: Take the maximum VA for the last line 
read (i.e. the line on which three or more letters were missed) and add +0.02 for every 
letter missed on the chart. 
For example: 
i) 
 0.00 line 
3 letters missed 
logMAR score +0.06 
 
ii) 
+0.20 line 
0 letters missed 
+0.10 line 
2 letters missed 
  
 0.00 line 
3 letters missed 
logMAR score +0.10 
 
iii) 
-0.20 line 
0 letters missed 
-0.30 line 
2 letter missed 
-0.40 line 
4 letters missed 
logMAR score –0.28 
 
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Eurolens Research 
Computer logMAR VA chart (v2) 
December 19, 2017 
9 
Confidential 
 
Over-refraction 
Unless the clinical study protocol states otherwise the following procedures should be 
carried out: 
1. 
Visual acuity using the Eurolens chart will be measured with no over-refraction in 
place.  The study protocol may require that this be carried out monocularly or 
binocularly. 
2. 
A binocular over-refraction should be carried out using the chart at 6m.  This 
procedure will control accommodation and allow accurate assessment of the 
subject’s visual status.  These results will allow the Investigator to judge whether or 
not the contact lens BVP is acceptable. 
Bailey Lovie chart 
LogMAR visual acuity can also be measured on a card-based Bailey-Lovie chart.  The 
use of this chart is covered in more detail in the relevant SOP1.  In summary the 
differences are: 
1. 
Unless specified the Bailey-Lovie chart is used at a testing distance of 3m as it is 
viewed directly. 
2. 
The font used (5x5 sans-serif font)2 is that defined in the British Standard: BS 4274.  
3. 
If the Bailey-Lovie is used at 3m, then it should not be used as a target to determine 
over-refraction.  Instead an alternative chart (e.g. Snellen) positioned at 6m should 
be used. 
 
References 
1. 
Eurolens Research Standard Operating Procedure.  Assessment of visual 
performance using the Bailey-Lovie logMAR visual acuity test chart and procedures 
for carrying out an over-refraction. 
2. 
BS 4274-1:2003.  Visual acuity test types. Test charts for clinical determination of 
distance visual acuity – Specification.   
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Eurolens Research 
Computer logMAR VA chart (v2) 
December 19, 2017 
10 
Confidential 
 
 
Appendix A.  Screen inclination calculation 
 
To calculate chart inclination 
 
Tan (angle of chart inclination) = Subject’s distance below chart 
 
 
 
     Subject to chart distance (parallel to floor) 
Room 
1.015  
1.014  
1.013 
1.012 
Subject’s 
distance below 
chart (eye to top 
of monitor) (cm)* 
50 
65 
 
65 
65 
Subject to chart 
distance (parallel 
to floor) (cm) 
600 
605 
610 
600 
Calculated chart 
inclination 
(degrees) 
4.7 
6.1 
6.1 
6.2 
Table 2: Eurolens clinic room screen inclination. 
 
* Subject with Eurolens ID 2023 of  average UK male height (175cm, ONS data) was 
used 
 
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Eurolens Research 
Computer logMAR VA chart (v2) 
December 19, 2017 
11 
Confidential 
 
Appendix B.  Example of chart settings (11 October 2017) 
 
Clinic room 
1.012 
1.013 
1.014 
1.015 
1.018 
Monitor number  4 
5 
3 
1 
2 
Chart distance 
(m) 
6.0 
6.1 
6.05 
6.0 
6.1 
LC grey 
240 
240 
243 
240 
237 
 
Table 3: Eurolens clinic room chart settings 
All monitors calibrated were a BenQ G2255 displaying the chart at native resolution 
(1920x1080). 
 
Appendix C.  Revisions to chart software 
2008 
Initial clinic version of computer chart software 
 
01/02/2013 v5 
2013 version of chart software was rewritten for compatibility with Office 2011 and Mac 
OSX10.8.  Contains the following amendments: 
 - Colours of the control box have been altered for better legibility with office 2011 
 - Chart letter display was updated for 16:9 monitors 
 - Letter size is calculated correctly for chart distance 
 - Low contrast letters contrast adjustable from chart control panel.  
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX F: EUROLENS RESEARCH SOP #16, MEDMONT E300 
(TOPOGRAPHY AND TEAR FILM ANALYSIS) 
 
 
CR-6290, v 6.0 
 
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16 
 
 
 
 
 
Eurolens Research 
 
Clinical 
Standard Operating Procedure 
 
 
 
Medmont E300 
(topography and tear film analysis) 
 
 
 
 
 
 
Sarah Smith 
Research Optometrist 
 
 
First issued: v0; July 30, 2002 
Reviewed (with changes): v1; January 23, 2004 
Reviewed (with changes): v2; May 4, 2012 
Reviewed (with changes): v3; March 28, 2014 
Reviewed (no changes): v3; April 15, 2016 
Reviewed (no changes): v3; July 3, 2018 
Reviewed (with changes): v4; October 25, 2018 
 
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Eurolens Research 
Medmont E300 (v4) 
 October 25, 2018 
 3 
Summary 
This document describes the procedures when using the Medmont E300 to obtain non-
invasive ocular measurements including: 
• 
Topography 
• 
Tear film analysis 
 
Responsibilities 
Clinical investigators or trained personnel would normally carry out these non-invasive 
procedures.  
 
Equipment Required 
• 
Medmont E300 (Medmont International Pty Ltd Victoria, Australia) 
• 
Medmont Studio software (v6.2.3 or above) 
• 
Calibration object 
• 
Antimicrobial disposable wipes to sanitise the headrest and chinrest 
• 
Medmont manual 
 
Procedures 
Performing Examinations 
1. Search or add subject details using Medmont studio software. 
2. Confirm subject details before starting examination. 
3. Position the subject correctly. 
4. Select exam type (topography or tear film analysis). 
5. Detailed guidance on the action required is provided on screen. 
 
Notes: 
Topography images are graded out of 100 based on centring, focusing and eye 
movement. A good score for a normal eye is over 75, and images should exceed this 
when being saved. 
 
Full details can be found on pages 22-37 of v2.7 manual. 
 
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Eurolens Research 
Medmont E300 (v4) 
 October 25, 2018 
 4 
Back up of data 
1. Data for all examinations are stored on the computer’s hard drive in the directory: 
C:\Program Data\Medmont\Medmont Studio 6\Data. 
2. To ensure these data are protected against hard drive failure, the computer’s hard drive 
(including this directory) is automatically backed up to an external hard drive once a 
week using the Window 7 back-up wizard which is built into the computer’s Windows XP 
operating system. 
3. The Medmont software does have it’s own backup facility (refer to Medmont 
Administrator Tool).  This process is initiated manually and may be done on an ad-hoc 
basis.  
 
Calibration 
It is recommended to calibrate the E300 after installation or moving.  The E300 will be calibrated 
annually where practicable. The calibration object itself should be verified and re-calibrated 
every two years. 
1. Navigate to Configure > E300 > Instrument Setup.  
2. From the E300 Instrument window, click on the installed instrument and click Calibrate to 
run the Calibration Wizard, which allows you to check the current calibration and 
optionally recalibrate the instrument. 
3. Follow the on screen instructions. 
 
Full details regarding calibration can be found on pages 80-84 of v2.7 manual. 
 
References 
Medmont E300  user manual v2.7 Sep 2015 
https://www.medmont.com/files/ms6/manuals/E300.pdf 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX G: EUROLENS RESEARCH SOP #13, EXAMINATION OF THE 
ANTERIOR SEGMENT USING SLIT LAMP BIOMICROSCOPY 
 
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Eurolens Research 
 
 
 
 
Clinical 
Standard Operating Procedure 
 
 
 
 
Examination of the anterior segment 
using slit lamp biomicroscopy 
 
 
Carole Maldonado-Codina 
Associate Director 
 
 
First issued: v0; May 20, 2002 
Reviewed (with changes): v2; June 26, 2009 
Reviewed (no changes): v2; October 14, 2011 
Reviewed (with changes): v3; March 4, 2014 
Reviewed (with changes): v4; February 2, 2016 
Reviewed (no changes): v4; February 5, 2018 
 
 
 
 
 
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Eurolens Research                     Slit lamp biomicroscopy (v4) 
   February 2, 2016 
 
 
 
                                           
          
 Confidential 
3 
Summary 
The slit lamp biomicroscope is a high quality illuminating observation system which 
allows the external and internal ocular structures to be assessed in detail. The Efron 
Grading Scales for Contact Lens Complications1 will be used to quantify most of the 
observations made.  If an alternative grading scale is to be used this will be detailed in 
the study protocol. 
 
Definitions 
External ocular structures in this procedure refer to the following structures: conjunctiva, 
sclera, limbus and associated blood vessels, cornea, lids, lashes and tear film.  
Internal ocular structures in this procedure refer to the anterior chamber. 
Wratten 12 filter – A yellow filter which enhances the contrast of fluorescein staining 
when viewed using cobalt blue light. 
 
Procedure 
1. Using the recommended settings for slit width, magnification and filter, examine 
the external and internal ocular structures2. The following primary signs should 
be graded using the Efron Grading Scales: conjunctival redness, limbal redness, 
corneal neovascularisation, epithelial microcysts, corneal oedema and corneal 
infiltrates. The following secondary signs are also usually graded using the Efron 
Grading Scales: blepharitis and meibomian gland dysfunction. The number of 
mucin balls present are counted and recorded. 
2. Instil sodium fluorescein (using a fluorescein ophthalmic strip wetted with saline) 
in both eyes and using cobalt blue light and a Wratten 12 filter or similar yellow 
filter, examine and grade the following: corneal and conjunctival staining.  The 
location and ‘type’ of any staining is also usually recorded. Corneal staining type 
is usually divided into the following categories: no staining, toxicity, SEAL, foreign 
body/abrasion, inferior dehydration and non-specific. 
3. The upper eyelid should then be everted and examined both with cobalt blue light 
(with the yellow filter in place) and with white light (no filter in place).  The grading 
of upper palpebral conjunctivitis should then be made with the Efron Grading 
Scales.   
4. If a soft contact lens needs to be applied after the examination, irrigate the eye 
with unpreserved sterile saline once the examination has been completed in 
order to remove excess sodium fluorescein. 
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APPENDIX H: EUROLENS RESEARCH GRADING SCALE (LENS FIT AND 
SURFACE ASSESSMENT) 
 
 
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Eurolens Research                      Version 1
             September 2004
Confidential
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Eurolens Research                      Version 2
             September 2004
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APPENDIX I: 
EUROLENS 
RESEARCH 
SOP 
#53, 
IN-VIVO 
CONFOCAL 
MICROSCOPY 
 
 
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53 
 
 
 
 
 
 
Eurolens Research 
 
 
Clinical 
Standard Operating Procedure 
 
 
 
 
In-vivo Confocal Microscopy 
 
 
 
 
 
Neil Chatterjee 
Research Optometrist 
 
 
First issued: v1; January 16, 2017 
Reviewed (with changes): v2; March 1, 2018  
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In-vivo Confocal Microscopy v2 
March 1, 2018 
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Confidential 
Summary 
In-vivo confocal microscopy is a non-invasive technique that visualises living tissue under 
high magnification, in healthy and pathological states. For the cornea, this instrument is 
able to capture cellular thickness of 1.3 to 2.1 μm; thus individual corneal layers can be 
examined.  
 
The laser scanning confocal microcope described in this SOP is the Heidelberg Retina 
Tomograph III (HRT III) with the Rostock Corneal Module (RCM) attached.  
 
Responsibilities 
All users of the instrument, usually clinical investigators. 
 
Definitions/Acronyms  
• 
Viscotears (0.2% carbomer 980; Novartis UK) will be used as a coupling agent 
between the microscope and the TomoCap. 
• 
Oxybuprocaine (minims 0.4% benoxinate hydrochloride) may be used to numb the 
eye during the examination. 
• 
TomoCap (disposable Perspex applanating cap) 
• 
HRT III - Heidelberg Retina Tomograph III 
• 
RCM – Rostock Corneal module.  This sits on the front of the HRT III and enables it to 
function as a confocal microscope. 
• 
CCD – charge-coupled device 
• 
HEYEX - Heidelberg Eye Explorer 
• 
fps - frames per second 
• 
FOV – field of view 
 
Procedure 
Preparation of the Camera 
1. 
Power on the laptop and the HRT III. 
2. 
The refraction of the HRT III’s scanning camera (inside it’s objective tube) should be 
set to to +12 dioptres.  
3. 
Attach the RCM to the front of the HRT III’s objective tube. 
4. 
Move the RCM lens posteriorly by rotating the RCM wheel anticlockwise.  
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5. 
Apply a large homogenous, bubble-free amount of the ocular gel (Viscotears) on the 
RCM  lens tip.  
6. 
Remove a Tomocap from its sterile container and mount it over the lens tip. Be 
careful not to touch the front surface of the Tomocap at all time.  
 
Creat subject file  
1. 
Double click on the Heidelberg Eye Explorer (HEYEX) icon  
. 
2. 
Insert subject data and click OK. 
3. 
The “Examination Data” dialog box is now displayed.  
a. In the “Device” field, select the device type in the drop-down list. 
b. In the “Operator” field, enter the operator’s name or select an existing entry from 
the drop-down list. 
c. In the “Study” field, enter a study or select an existing entry from the drop-down 
list.  
4. 
In the “Diagnosis” tab, enter the subject diagnosis. 
5. 
Click OK to confirm.  “Corneal Module Settings” should now be displayed. 
6. 
In the “Field Lens” field, select the appropiate field lens from the drop-down list. 
7. 
Then click OK to confirm.  The acquisition window should appear.  
 
Camera adjustment and scan depth calibration 
1. 
The acquisition window will display two live camera feeds.  The confocal camera is 
displayed on the left and charge-coupled device (CCD) camera on the right.  
2. 
Prior to acquiring confocal images, the focal plane of the instrument should be set to 
the anterior surface of the TomoCap. 
3. 
Move the RCM lens anteriorly (by rotating the RCM collar clockwise) until the first 
bright image appears. This image represents the inner surface of the TomoCap. 
4. 
Continue rotating the RCM collar until the second bright image appears. The depth 
value shown in the focus position display should now be between -150 μm and +150 
μm.  This second bright image represents the outer surface of the TomoCap. 
5. 
Then reset the depth to 0 by clicking on the “Reset” button.  
 
Subject preparation 
1. 
Depending on the structure to be examined, it may be necessary to instil anaesthetic 
(Oxybuprocaine) and ocular gel (Viscotears) to the subject’s eye, to aid comfort. 
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2. 
Clean the chin rest and forehead bar using a wet disinfecting tissue. 
3. 
The subject should be seated comfortably, with the chin on the chin rest and 
forehead resting firmly against the forehead bar. 
 
Examining the subject 
A) Cornea 
1. 
Anaesthetic and ocular gel should be instilled into the subject’s eye for corneal 
examination. 
2. 
The subject should be instructed to fixate the HRT III’s outer fixation light with the eye 
not being examined.  
3. 
The  CCD camera should be positioned perpendicular to the optical axis of the laser 
scanning camera. 
4. 
The camera should be on the subject’s right side when imaging the right eye and vice 
versa.  
5. 
At this point, the investigator should see the front surface of the TomoCap in the 
centre of the CCD camera live image. 
6. 
The mode of acquisition should be selected according to research/study purposes. 
The are three acquisition modes available for this instrument: 
a. Section: One single image is acquired and stored each time the foot switch 
is depressed. 
b. Sequence:  A sequence of up to 100 images is acquired with an adjustable 
frame rate.  A frame rate between 30 frames and 1 frame per second (fps) 
can be chosen and a movie with a duration of 3 to 100 seconds can be 
acquired. 
c. Volume: A series of 40 images is taken at consecutive focal planes. A total 
depth of 85 μm can be scanned with the "FOV 300 μm"  and "FOV 400 
μm" field lens. The focal distance between two consecutive images will be 
approximately 1.3 μm and 2.1 μm respectively. 
7. 
Move the TomoCap towards the subject’s cornea until it is approximately 5 to 10 mm 
away.  
8. 
The RCM can be moved up/down or left/right using the black knobs on the HRT 
table.   These should be adjusted until the TomoCap is in-line with the centre of the 
subject's cornea.  
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9. 
The subject’s cornea and reflection of the red laser beam can be observed on the 
CCD camera window.  Once the TomoCap is correctly aligned, the laser reflection 
should be in the centre of the cornea.  If not, fine adjustments can be performed.  
10. The subject should be instructed to open his/her eye as wide as possible.  The RCM 
should be slowly moved forwards, until the Tomocap is in minimal contact with the 
subject’s cornea.  
11. Live confocal images of the cornea should now be observed.  The foot pedal can be 
used to capture the live images.  
12. If repositioning of the RCM is required, the TomoCap should be first moved away 
from the subject’s cornea, the RCM repositioned, then the TomoCap can be replaced 
on the subject’s cornea, and confocal imaging resumed. 
13. When examining the cornea, it is important to not exert too much pressure on the 
subject’s cornea, only a light touch is required.  If too much pressure is placed on the 
cornea by the TomoCap, lines will appear in the live confocal image.  If this occurs 
the TomoCap should be moved slightly backwards, to reduce pressure on the cornea 
(Tavakoli and Malik, 2011). 
 
B) Bulbar conjunctiva 
1. 
Anaesthetic and ocular gel should be instilled into the subject’s eye for bulbar 
conjunctival examination. 
2. 
The subject should be instructed to direct their gaze to the extreme opposite direction 
of the bulbar region to be scanned.  For example, if the temporal bulbar conjunctiva of 
the right eye is to be scanned, the subject should be instructed to direct their gaze 
extremely to the left.  
3. 
The subject should be asked to not change their fixation (where possible) throughout 
the examination.  
4. 
An appropriate acquisition mode should be selected (explained in the Cornea 
section) 
5. 
Move the RCM forward until the TomoCap is just in contact with the bulbar 
conjunctiva, and start scanning.  
6. 
The foot pedal can be used to capture images during scanning.  
 
C) Lid wiper and Palperbral conjunctiva 
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1. 
Both upper and lower lid wipers and nearby palpebal conjunctiva can be scanned 
with the RCM.  No anaesthetic or ocular gel are required for this.  
2. 
To examine the upper lid, the subject should be instructed to lower their gaze.  The 
upper lid can then be everted with a cotton bud, and the lid margin taped against the 
subject’s brow with surgical tape.  Multiple pieces of tape may be required.   
3. 
To examine the lower lid, the subject should be instructed to direct their gaze 
upwards, and the examiner’s thumb used to gently to evert the lower lid.  This should 
expose the lower lid wiper area.  
4. 
The subject should be instructed to not change fixation throughout the examination.  
5. 
The acquisition mode of the scan can now be selected (explained in the Cornea 
section) 
6. 
Move the RCM module forward until The TomoCap is just in contact with the lid wiper 
area, and start scanning.  
7. 
Use the foot pedal to capture images during the scan. 
 
Post-examination procedures 
1. 
After the examination is complete, turn the camera off by clicking the camera power 
button in the acquisition window.  
2. 
If anaesthetic was used, the subject should be instructed to not rub their eyes until 
the local anesthesia has worn off.  As a precaution, you may wish to perform a slit 
lamp examination of the subject's cornea after the examination. 
3. 
The TomoCap should be changed between subjects and/or ocular surface examined 
(cornea, bulbar and lid wiper area) to avoid cross infection.  
4. 
Remove the TomoCap from the RCM and dispose of it in the bio bin and then clean 
the RCM lens with a dry tissue. 
 
Cleaning of confocal lens 
Dried viscotears may crystalise and accumulate inside the RCM in-between the RCM 
lens at the metal collar.  To prevent the build up of dried viscotears affecting operation of 
the instrument, the confocal lens and collar should be cleaned as required. 
1. To perform the cleaning process the RCM must be part-dismantled and the metal 
collar and RCM lens removed.  A specific spanner for this disassembly is kept in the 
wooden box with the spare RCM field lens. 
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2. The spanner is used to loosen the metal collar, it can then be uscrewed by hand.  
The RCM lens can then be untightened and removed by hand. 
3. Using a moist tissue, any crystalised viscotears can be wiped off the side of the RCM 
lens.  The inside of the metal collar can also be cleaned by this method. 
4. Once dry the RCM can be reassambled.  The sequence of reassembly is the reverse 
of disassembly.  
 
References 
TAVAKOLI, M. & MALIK, R. A. 2011. Corneal confocal microscopy: a novel non-invasive 
technique to quantify small fibre pathology in peripheral neuropathies. J Vis Exp. 
 
 
  
 
 
 
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APPENDIX J: EUROLENS RESEARCH SOP #58, MEASURING TEAR MENISCUS 
HEIGHT AND CROSS-SECTIONAL AREA USING OPTICAL COHERENCE 
TOMOGRAPHY 
 
 
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58  
 
 
 
 
 
 
 
Eurolens Research 
 
 
Clinical 
Standard Operating Procedure 
 
 
 
 
Measuring tear meniscus height and cross-
sectional area using Optical Coherence 
Tomography 
 
 
 
 
 
Research Associate 
Maria Navascues-Cornago 
 
 
First issued: v0; May 24, 2016 
Reviewed (with changes): v1; September 9, 2016 
Reviewed (with changes): v1.1; August 30, 2018
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OCT Tear meniscus v1.1  
August 30, 2018 
 
 3 
Confidential 
Summary 
This document describes a non-invasive method for the imaging and measurement of 
the height and cross-sectional area of upper and lower tear menisci using Optical 
Coherence Tomography (OCT).  
 
Responsibilities 
Clinical investigators or trained personnel would normally carry out this non-invasive 
procedure. 
 
Equipment required 
Topcon 3D-OCT 2000 (Topcon, Tokyo, Japan) 
Computer 
 
Procedures 
Set-up 
1. Switch on the computer and Topcon OCT instrument. 
2. Remove dust cover and lens cap. 
3. Clean the forehead-rest unit and chin-rest unit. 
4. Mount the attachment for anterior segment onto the forehead rest. 
5. Double-click the [3D OCT] icon on the desktop. 
6. For a new subject, click the [Register New Patient] button. Enter the subject 
information in the dialogue box (ID) and click [Register]. The format of the ID will 
be study specific and the use of indefinable data should be considered.  
7. For an existing subject, select the subject from the subject list or type the 
subject’s details into the [Patient Search] panel and click the [Search] button.  
8. Select subject from list and click the [Capture] button from the toolbar.  
9. Operator should now look to the monitor screen on the OCT instrument. 
10. Click on [set up] to confirm settings. [Anterior] tab and [Line Anterior Seg. 
3.0mm].  
a. Scan Resolution [1024V] 
b. Color Photo: [OFF] 
c. Over Scan Count [Not]. 
d. OCT Focus Position: [Cornea],  
11. Exit the set up screen. 
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OCT Tear meniscus v1.1  
August 30, 2018 
 
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instrument body. 
f. When imaging the lower tear meniscus an “V” shaped image should be 
sought (the angle between the lower lid and the inferior cornea) 
g. Make sure that the eyelashes are kept out of the picture. 
h. After the subject blinks, adjust the focus briefly if needed, then press the 
joystick button to trigger image capture. 
i. Three successful images (i.e. area of tear meniscus clearly defined) should 
be captured in this manner. 
j. The images are automatically saved. 
2. Upper tear meniscus 
a. The subject is asked to look slightly upwards. 
b. Using the joystick, adjust the height of the instrument, so the green dotted 
vertical line crosses the upper tear meniscus at corneal 12 o'clock position. 
c. Using the joystick, move towards/away from the eye until a cross-section is 
observed on the OCT live image window. The tear meniscus should be 
displayed within the ‘Optimal display position frame’. 
d. The focusing and image quality should be adjusted by moving the 
instrument body. 
e. Make sure that the eyelashes are kept out of the picture. 
k. When imaging the upper tear meniscus an “V” shaped image should be 
sought (the angle between the upper lid and the superior cornea) 
l. After the subject blinks, adjust the focus briefly if needed, then press the 
joystick button to trigger image capture. 
f. Three successful images should be captured. 
g. The images are automatically saved. 
 
Exporting an image 
1. Select [View] on the toolbar. 
2. Images should be exported in JPEG format. Select [Tools], [Options] and the 
[Export] tab. Select ‘JPEG Files’ from the [Export File Type] drop-down list and 
click [OK]. 
3. Select the image to be exported. 
4. Click [Export] on the toolbar and select [B-Scan]. 
5. Enter the filename and click [Save]. 
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Analysing an image 
Image processing software such as ImageJ or customised MATLAB software can be 
used to process the images captured and measure the tear meniscus height and cross-
sectional area.  
 
Calculation of tear meniscus volume 
If required, the upper tear meniscus volume (UTMV) and lower tear meniscus volume 
(LTMV) can be calculated as suggested by Palakuru et al. (2007): 
 
UTMV = 25 mm of upper lid length X mm2 of upper meniscus area X 1.294 
LTMV = 25 mm of lower lid length X mm2 of lower meniscus area X 1.294 
 
References 
1. TOPCON 3D-OCT 2000 USER MANUAL (Volume for instrument body). 3D 
OPTICAL COHERENCE TOMOGRAPHY. Version 8.2X (132 pages)* 
2. TOPCON 3D-OCT 2000 USER’S MANUAL. 3D OPTICAL COHERENCE 
TOMOGRAPHY. PC SOFTWARE EDITION. Version 8.2X (264 pages)* 
*Copies of these Manuals (electronic only) can be found on the Server.  
3. Palakuru JR, Wang J and Aquavella JV 2007. Effect of blinking on tear 
dynamics. Invest Ophthalmol Vis Sci: 48; 3032-7. 
 
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APPENDIX K: EUROLENS RESEARCH SOP #52, TEARLAB™ 
 
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Eurolens Research 
 
Clinical 
Standard Operating Procedure 
 
 
 
 
 
TearLab™ 
 
 
 
 
 
Gillian Howarth 
 
 
 
Research Optometrist 
 
 
First issued: v0; October 20, 2015 
Current revision: v0; October 20, 2015 
Reviewed (no changes): v0; July 3, 2018 
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TearLab™ SOP v0 
October 20, 2015 
3 
Confidential 
Summary 
Tears fulfill an essential role in maintaining ocular surface integrity, protecting against 
microbial challenge and preserving visual acuity.1  Hyperosmolarity has been described 
in the literature as a primary marker of tear film integrity.2  When either the quantity or 
quality of secreted tears is compromised, the total osmolarity of the tear film is increased 
due to increased evaporation.  As a result, basal tear equilibrium is shifted to a saltier 
solution, which places stress on the corneal epithelia and conjunctiva. 
 
The TearLab™ osmolarity system provides a quick and simple method for determining 
tear osmolarity using nanolitre volumes of tear fluid collected directly from the ocular 
surface. 
 
Responsibilities 
Clinical investigators or designated staff may use the TearLab™ osmolarity system. 
 
Equipment 
 
 
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Procedure 
 
Subject Testing Procedure 
1. Turn the TearLab reader on.  
2. Remove either pen from the reader.  The LCD display will say “Ready”. 
NB do not collect tear samples if the display does not say “Ready” 
3. Remove a test card from its package. 
4. Attach a test card by sliding the wings of the test card onto the TearLab pen.  The 
pen will light up and beep when the card is attached properly.  The green light will 
stay on until you collect tears or the pen times out (after 2 minutes). 
IMPORTANT: Any test card that does not contain a protective sheath should not be 
used for subject testing. 
5. Note the numeric code on the top of the test card. 
6. Just before tear collection, whilst holding the test card wings, remove the protective 
sheath from the test card. 
NB ONLY collect tears if the green light is on.  NEVER collect tears when the green 
light is off. 
 
Tear Collection Procedure 
1. Seat the subject with their chin tilted upward and eyes directed towards the ceiling. 
2. Place one hand on the face for stabilisation.  Do not pull the eyelid down or away 
from the eye. 
3. Posiiton the tip of the pen above the lower eyelid. 
4. Gently lower the pen until the bottom of the tip touches the thin line of moisture 
between the eyelid and the eye.  It is not necessary to press inward towards the eye. 
5. If the pen doesn’t beep immediately, withdraw the pen, ask the subject to blink, and 
restart the process. 
6. The pen will beep and the green light turn off after a successsful tear collection. 
7. Dock the pen into the reader within 40 seconds.  Do not remove the test card from 
the pen before docking or all data will be lost. 
8. Immediately press the RECALL key (it has a ‘U’ shaped arrow on it) below the up or 
down arrows to select the test card code (located on the top of the test card). 
NB it is important to select the code within 8 seconds  to obtain an accurate result. 
9. Press OK or wait 8 seconds for the reader to accept the code. 
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10. The reader will display the osmolarity result in a few seconds. This is then recorded 
by the investigator. 
11. Remove the test card by pressing your thumb forward on top of the test card.  Do not 
pull from the wings.  Dispose in a biohazard container. 
 
Quality Control 
The blue electronic check card should be tested on each pen before each day of subject 
testing to ensure the system is performing within manufactured calibration specification. 
 
To ensure the test cards are working and the test is being performed correctly a normal 
and high osmolarity control solution should be tested once with each lot number of test 
card or when a new shipment is received. 
 
References 
1. Schaumberg, DA, Sullivan, DA, Dana, MR et al, Lacrimal Gland, Tear Film, and 
Dry Eye Syndromes 2: Basic Science and Clinical Relevance. Advances in 
Experimental Medicine and Biology. 1998; 438. 
2. Definition and Classification of Dry Eye. Report of the Diagnosis and 
Classification Subcommittee of the Dry Eye Workshop (DEWS). The Ocular 
Surface. 2007;5(2):75-92. 
 
TearLab™ Osmolarity System  User Manual 
 
Appendix A  
 
TearLab™ Osmolarity System Quick Reference Guide (attached) 
TearLab™ Osmolarity System Clinical Utility Guide (attached) 
 
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APPENDIX L: EUROLENS RESEARCH SOP #57, TEAR FLUID SAMPLING USING 
THE MICROCAPILLARY TUBE METHOD 
 
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Clinical 
Standard Operating Procedure 
 
 
 
 
 
Tear Fluid Sampling Using the Microcapillary 
Tube Method 
 
 
 
 
 
 
Noor Haziq Saliman 
PhD student 
 
 
First issued: v0; October 20, 2015 
Current revision: v0; October 20, 2015 
Reviewed (no changes): v0; November 20, 2017
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 Tear Fluid Sampling SOP v0 
 
October 20, 2015 
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Summary 
Tear fluid collection can be obtained using a fine microcapillary tube for the biological 
investigation of tear content. Posa et al. (2013) reported that a microcapillary tube could 
sample higer number of proteins compared to a semi-invasive technique such as the 
Schirmer strip.  
 
Collection of tear samples are useful to assess ocular surface disorder (OSD) by 
studying the proteins and other inflammatory biomarkers present in cases like dry eyes.  
 
These guidelines describe the technique in which tear samples are collected using a 
microcapillary tube. 
 
Equipment 
  
Single-use, disposable, sterile, smoothly-polished, fine glass 
microcapillary tubes and bulb assembly to dispense collected 
tears into a LoBind protein microcentrifuge tube. 
 
e.g. Wiretrol-Micropipettes, Drummond Scientific Co., Broomall, 
PA, USA. VWR cat # 53440-023 and 53507-268. 
 
 
 
 
 
 
 
LoBind protein microcentrifuge tube to store tears. 
 
e.g.Eppendorf™, North AmericaHauppauge, NY USA. VWR 
cat # 80077-232. 
 
 
 
 
 
 
 
 
 
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Procedure 
1. 
A fluoroscein-free assessment of the eyes is first made using a slit lamp 
biomicroscope to ensure that there are no contraindications to conducting the 
procedure. 
2. 
Tear collection should be performed without corneal anaesthesia. 
3. 
Take a sterile capillary tube from its container for tear collection see Figure 1 (tubes 
are available in 2 μL, 5 μL and 10 μL). 
 
Figure 1. Microcapillary tube 
 
4. 
Ask the subject to sit in a chair. 
5. 
Ask the subject to blink a few times, and then look away from the tear collector and 
the microcapillary tube. 
6. 
Submerge the microcapillary tip at the lateral inferior tear meniscus, holding the 
microcapillary tube perpendicular to the lower lid margin as shown in Figure 2. This 
creates a suction which facilitates the flow of tears into the micropipette. 
 
 
Figure 2. Tear collection 
 
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7. 
Care should be taken to ensure that the corneal surface is not touched during the 
tear collection procedure. 
8. 
To avoid reflex tearing, touch the pipette tip in and out of the tear prism. 
9. 
Subjects can blink and close their eyes for a few seconds during the tear collection 
procedure. 
10. The time taken for drawing 4-5μL of the tear sample from each subject should be 
within 45 minutes.  (The volume required may vary per protocol). 
11. Following collection from the first eye, the entire volume should be carefully 
transferred/ejected into a labeled LoBind protein microcentrifuge tube using the bulb 
assembly.  Ensure the whole droplet is at the bottom of the tube and the lid remains 
closed at all time.   
12. Keep the microcentrifudge tube in a freezer at a temperature of -80°C until required 
for analysis. 
13. Dispose of all used microcapillary tubes in the appropriate sharps container.  
 
References 
POSA, A., BRAUER, L., SCHICHT, M., GARREIS, F., BEILEKE, S. & PAULSEN, F. 
2013. Schirmer strip vs. capillary tube method: non-invasive methods of obtaining 
proteins from tear fluid. Ann Anat, 195, 137-42. 
 
 
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APPENDIX M: EUROLENS RESEARCH SOP #41, LID MARGIN STAINING 
ASSESSMENT 
 
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Eurolens Research 
 
 
Clinical  
Standard Operating Procedure 
 
 
 
 
 
Lid margin staining assessment 
 
 
 
 
Maria Navascues-Cornago 
Optometric Research Associate 
 
 
First issued: v0; September 20, 2011 
Reviewed (with changes): v1; February 28, 2014 
 Reviewed (no changes): v1; September 2, 2016 
Reviewed (with changes): v2; March 2, 2017
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Summary 
The lid wiper is defined as that portion of the marginal conjunctiva of the eyelid that 
wipes the ocular surface during blinking.  It has been shown that staining of this region of 
the upper eyelid has high specificity on defining non- and contact lens wearers with 
ocular discomfort.1-3  It has also been shown that staining of the lower lid wiper is also 
present at similar levels in a symptomatic population.4 
 
Responsibilities 
Lid wiper epitheliopathy may form part of a typical biomicroscopic assessment routine 
and be performed by clinical investigators. 
 
Definitions/Acronyms  
Lid Wiper Epitheliopathy is often abbreviated as LWE or ULMS (Upper Lid Marginal 
Staining). 
 
Procedure 
Lid wiper epitheliopathy will be assessed at each lid margin: upper and lower, and in 
both eyes. Fluorescein and LIssamine Green staining will be assessed following the 
instillation routine detailed: 
1. Apply one moistened fluorescein/lissamine green strip to the lower fornix of each  
eye. 
2. After five minutes a second identical application should be instilled. 
3. Examination of the upper and lower lid margins should be performed after a 
further minute. 
 
How to grade 
Lid wiper epitheliopathy will appear as depicted in Figure 1.  Any staining present will 
then be graded according to the horizontal length and sagittal width of the total staining 
area.3  These scales are depicted in  
Table 1.    
In the case of Figure 1 below, the horizontal length is over 9mm and would be graded 3.  
The sagittal width in Figure 1 is approximately 90% of the lid wiper and would also be 
graded 3.  Therefore, on the CRF the grades for the right upper lid margin would be 
recorded as 3 and 3 respectively. 
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Automated grading 
Lissamine green staining can also be graded by automated or semi-automated analysis. 
Photographs of the upper and lower lid margins will be captured using a high quality 
digital camera (e.g. Canon EOS 7D or similar) mounted to a slit-lamp. Consistent 
camera exposure and illumination settings will be maintained during the study (typical 
camera settings are f-stop = 16, exposure = 1/250, ISO = 640 with an illumination setting 
of manual = 1/32). Polarising filters are typically used to minimise reflections in the 
images.  
 
Images will be processed using custom-designed software developed in MATLAB. After 
manual delination of the lid margin, images will undergo image thresholding and 
binarisation in order to automatically detect lissamine green staining. The image analysis 
routine will extract the following variables: 
• 
Area of lissamine green staining 
• 
Intensity of lissamine green staining 
• 
Overall staining index (area*intensity) 
 
References 
1. 
Korb, D. R. et al. Lid-wiper epitheliopathy and dry-eye symptoms in contact 
lens wearers. The CLAO journal : official publication of the Contact Lens 
Association of Ophthalmologists, Inc 28, 211-216 (2002). 
2. 
Korb, D. R. et al. Lid wiper epitheliopathy and dry eye symptoms. Eye & 
contact lens 31, 2-8 (2005). 
3. 
Korb, D. et al. Prevalence of lid wiper epitheliopathy in subjects with dry eye 
signs and symptoms. Cornea 29, 377 (2010). 
4. 
Guillon, M. & Maissa, C. Assessment of Contact Lens Wearers' Lid Margins 
With Lissamine Green. ARVO Meeting Abstracts 50, 6343 (2009). 
 
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APPENDIX N: EUROLENS RESEARCH SOP #24 OBJECTIVE CONTACT LENS 
MEASURES 
 
 
 
 
 
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24 
 
 
 
 
 
 
 
Eurolens Research 
 
Clinical 
Standard Operating Procedure 
 
 
 
 
 
Objective Contact Lens Measures 
 
 
 
 
 
Neil Chatterjee 
Research Optometrist 
 
 
First issued: v0; March 1, 2006 
Reviewed (with changes): v1; December 6, 2011 
Reviewed (with changes): v2; March 11, 2014 
Reviewed (with changes): v2.1; October 11, 2016 
Reviewed (with changes): v3; October 22, 2018 
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Summary 
Using this technique, the investigator can objectively measure contact lens fitting 
characteristics, such as movement and centration. 
 
Equipment required: 
• 
Slit lamp 
• 
0.2mm calibrated graticule eyepiece 
 
Responsibilities 
Objective contact lens measures may form part of a contact lens assessment and are 
performed by clinical investigators. 
 
Definitions 
Primary gaze movement: The change in position of the lens edge after a blink, while the 
subject is fixating in the primary gaze. 
Upgaze movement: The change in position of the lens edge after a blink, while the subject 
is fixating in an upward gaze. 
Primary gaze lag: The change in vertical position of the inferior lens edge from the resting 
primary gaze position, when the lower lid is pulled down. 
Upgaze lag: The inferior decentration of the lens resulting from the subject changing fixation 
from primary to upward gaze. 
Temporal gaze lag: The nasal decentration of the lens resulting from the subject changing 
fixation from primary to temporal gaze. 
Nasal gaze lag: The temporal decentration of the lens resulting from the subject changing 
fixation from primary to nasal gaze. 
Coverage: In a soft contact lens, the distance from the lens edge to the limbus. This can be 
defined both horizontally and vertically.  Coverage may also be referred to as overlap. 
Centration: For a soft lens, the optimum fitting position is about the centre of the cornea.  
Centration can be defined both horizontally and vertically. 
 
Procedure 
Setting up 
1. Seat the subject comfortably at the slit lamp. 
2. Ideally place the graticule eyepiece in the biomicroscope ocular which corresponds with 
the observer’s dominant eye. 
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3. Focus the graticule eyepiece to the appropriate power. 
4. Adjust magnification. Typically the magnification is set to 10x or 8x.  However this will 
depend on the combination of graticule and slit lamp being used to ensure an observed 
measure corresponds to the same value in millimetres. 
5. Diffuse illumination should be used when taking measurements. 
6. It is important to instruct the subject to “look straight ahead”, when taking primary gaze 
movements.  Any misalignment in fixation by the subject will cause the lens to decentre 
due to lag, which may affect measures. 
7. All measurements should be made to the nearest 0.1mm. 
 
Lens movement 
Primary gaze movement 
1. Instruct the subject to look straight ahead (eyes in the primary gaze position) and to 
continue blinking normally. 
2. Turn the graticule vertically, the ball bearing should be in line with the lower edge of the 
scale.  Align a mark on the scale with the lower edge of the lens. 
3. If the lower lens edge is not visible, the bottom lid may be lowered slightly (without 
affecting the position of the lens), until the lower lens edge is visible.  The primary gaze 
movement can then be measured by using the inferior lens edge. 
4. During normal unforced blinking, measure the difference between the original lens edge 
position and the maximum displacement of the lens.  This difference is the primary gaze 
movement of the lens. 
Upgaze movement 
1. Instruct the subject to look up and blink normally. 
2. Align any mark on the graticule with the lower lens edge. 
3. Observe the lens displacement occurring during normal unforced blinking.  The maximum 
displacement noted is the measure of upgaze movement.   
4. The lens may move both inferior and superior to the original position.  The difference 
between these extreme positions is the measure of upgaze movement. 
 
Lens lag 
Primary gaze Lag 
1. The subject is instructed to look straight ahead and not to blink. 
2. Align any mark on the scale with the lower edge of the lens. 
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3. If the lower lens edge is not visible, the lowest visible edge of the lens should be 
observed. 
4. The subject’s lower eyelid is gently pulled down, so it is not supporting the contact lens.  
The lens will move slightly inferiorly, as it is no longer supported by the lower lid. 
5. The difference between the lens in its primary position and the position of the lens with 
the lower lid pulled down is calculated.  This is the primary gaze lag. 
Upgaze Lag 
1. Instruct the subject to look straight ahead (eyes in the primary gaze position) and not to 
blink. 
2. The distance from the lower lens edge to the lower limbus is measured (inferior overlap 
primary gaze). 
3. If the lower lens edge is not visible, the lower lid may be lowered slightly (without affecting 
the position of the lens), until the lower lens edge is visible. 
4.  The subject is then instructed to look up and not to blink.  The distance from the lower 
limbus to the inferior lens edge is measured in upgaze (inferior overlap upgaze). 
5. The change in eye position from primary to upgaze causes lens to decentre inferiorly, this 
decentration is the upgaze lag. 
6. The upgaze lag can be calculated by: 
Upgaze lag = inferior overlap in upgaze – inferior overlap in primary gaze 
Temporal gaze lag 
1. Instruct the subject to look straight ahead (eyes in the primary gaze position) and not to 
blink. 
2. The distance from the nasal lens edge to the nasal limbus is measured (nasal overlap 
primary gaze). 
3. The subject is then instructed to look temporally and not to blink.  The distance from the 
nasal limbus to the nasal lens edge is measured in temporal gaze (nasal overlap 
temporal gaze). 
4. The change in eye position from primary to temporal gaze causes the lens to decentre 
nasally.  This decentration is the temporal gaze lag. 
5. The temporal gaze lag can be calculated by: 
Temporal gaze lag = nasal overlap in temporal gaze – nasal overlap in primary gaze 
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Nasal Gaze Lag 
1. Instruct the subject to look straight ahead (eyes in the primary gaze position) and not to 
blink. 
2. The distance from the temporal lens edge to the temporal limbus is measured (temporal 
overlap primary gaze). 
3. The subject is then instructed to look nasally and not to blink.  The distance from the 
temporal limbus to the temporal lens edge is measured in nasal gaze (temporal overlap 
nasal gaze). 
4. The change in eye position from primary to nasal gaze causes the lens to decentre 
temporally.  This decentration is the nasal gaze lag. 
5. The nasal gaze lag can be calculated by: 
 Nasal gaze lag = temporal overlap in nasal gaze – temporal overlap in primary gaze 
 
Lens Position 
Horizontal (x) coverage and centration 
Nasal overlap  
 
ON 
Temporal overlap 
 
OT 
 
1. Instruct the subject to look straight ahead (eyes in the primary gaze position). 
2. Turn the graticule horizontally.  The scale should be almost bisecting the pupil 
horizontally. 
3. At the vertical midpoint of the cornea, measure the horizontal distance from the lens edge 
to the limbus nasally.  This value is the nasal overlap (or nasal coverage).  
4. Reposition the graticule and measure the horizontal distance from the lens edge to the 
limbus temporally. This value is the temporal overlap (or temporal coverage). 
5. Subtraction of the nasal value from the temporal value and dividing by 2 gives the 
horizontal decentration (Appendix B).  If the temporal overlap is greater than the nasal 
overlap, the value is positive.  If the nasal overlap is greater than the temporal overlap, 
the value is negative.  If the amount of overlap is equal nasally and temporally, the 
horizontal decentration is zero. 
Horizontal decentration= (OT - ON)/2 
 
Vertical (y) coverage and centration 
Superior overlap 
 
OS 
Inferior overlap 
 
OI 
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1. Instruct the subject to look straight ahead (eyes in the primary gaze position). 
2. With the graticule placed vertically, measure the distance from the lens edge to the 
limbus superiorly on the 90° meridian.  This value is the superior overlap (superior 
coverage). 
3. Reposition the graticule and measure from the limbus to the lens edge inferiorly on the 
90° meridian.  This value is the inferior overlap (inferior coverage). 
4. Subtraction of the inferior value from the superior value and dividing by 2 gives the 
vertical decentration of the lens.  If the lens overlaps the limbus more superiorly than 
inferiorly, the value is positive.  If the lens overlaps more inferiorly than superiorly, the 
value is negative.  If the amount of overlap is equal superiorly and inferiorly, then the lens 
vertical decentration is zero. 
Vertical decentration= (OS – OI)/2 
 
In many cases the upper and/or lower lens edges may not be visible when the subject’s 
eyes are in the primary gaze position.  In such cases, the lower lid may be lowered slightly 
(without affecting the position of the lens), until the lower lens edge is visible. 
 
The superior measurement should be taken with the subject looking down slightly and the 
upper lid gently lifted to reveal the lens edge without altering the lens position. 
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Horizontal decentration =  1.0(T )  0.3(N )
2
 =  + 0.35mm 
2. To aid the investigator in recording these measurements, a crib sheet is available for 
most studies (see Appendix A).  The spaces between the concentric circles record the 
distance between lens edge and limbus. 
3. To aid the investigator, the clinical database can calculate lag and any decentration from 
these measurements. 
 
Appendix A 
Example of a lens fitting measurement sheet (see page 10).  Note that the required 
measurements to be taken may vary between studies. 
 
Appendix B 
Calculation of decentration (see page 11).
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APPENDIX O: 
 GUIDELINES FOR COVID-19 RISK MITIGATION 
 
 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6290 Late Night Study 2: End-of-Day Assessment of Asymptomatic 
and Symptomatic Soft Lens Wearers
Version and Date: v6.0 Amendment 5, 23 September 2020
I have read and understand the protocol specified above and agree on its content.  
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the Declaration of 
Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the pertinent individual country 
laws/regulations and to comply with its obligations, subject to ethical and safety considerations. The 
Principal Investigator is responsible for ensuring that all clinical site personnel, including Sub-
Investigators adhere to all ICH2 regulations and GCP guidelines regarding clinical trials during and 
after study completion.
I will assure that no deviation from, or changes to the protocol will take place without prior agreement 
from the Sponsor and documented approval from the Institutional Review Board (IRB), except where 
necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere to all 
ICH2 regulations and GCP guidelines regarding clinical trials during and after study completion.
All clinical site personnel involved in the conduct of this study have completed Human Subjects 
Protection Training. 
I agree to ensure that all clinical site personnel involved in the conduct of this study are informed about 
their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from this study 
without written authorization.
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation, 
(COVID-19 Work Instruction in the Appendix of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks.
Principal Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
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