Ocular Characteristics in Contact Lens and Spectacle Wear
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Johnson & Johnson Vision Care, Inc.
Clinical Study Protocol
Ocular Characteristics in Contact Lens and Spectacle Wear
Protocol: CR-6332
Version: 4.0, Amendment 3.0
Date: 16 April 2019
Investigational Products: ACUVUE OASYS®1-Day with HydraLuxe™ Technology
(senofilcon A) 
Key Words: Senofilcon A, ACUVUE OASYS® 1-Day with HydraLuxe™ Technology,
daily disposable, daily wear, dispensing, symptomatic, characterization, CLDEQ-8, DEQ-5, 
Spectacle, Sensitivity Questionnaire (Highly Sensitive Person-HSP Scale), Meibomian Gland
Expressibility, Meibomian Gland Evaluator (MGE), blink patterns, tear film stability
(NIBUT/NIKBUT), lid wiper epitheliopathy, conjunctival staining
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........................................................................... 6 
SPONSOR NAME AND ADDRESS....................................................................................... 6 
MEDICAL MONITOR............................................................................................................. 6 
AUTHORIZED SIGNATURES............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS .................... 15 
1. INTRODUCTION AND BACKGROUND ....................................................................... 16 
1.1. 
Name and Descriptions of Investigational Products ................................................ 16 
1.2. 
Intended Use of Investigational Products................................................................. 16 
1.3. 
Summary of Findings from Nonclinical Studies...................................................... 16 
1.4. 
Summary of Known Risks and Benefits to Human Subjects................................... 17 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study...................................................................................................................... 17 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 17 
2.1. 
Objectives................................................................................................................. 17 
2.2. 
Endpoints.................................................................................................................. 18 
2.3. 
Hypotheses ............................................................................................................... 19 
3. 
TARGETED STUDY POPULATION........................................................................... 19 
3.1. 
General Characteristics ............................................................................................ 19 
3.2. 
Inclusion Criteria...................................................................................................... 20 
3.3. 
Exclusion Criteria..................................................................................................... 20 
3.4. 
Enrollment Strategy.................................................................................................. 21 
4. 
STUDY DESIGN AND RATIONALE.......................................................................... 21 
4.1. 
Description of Study Design .................................................................................... 21 
4.2. 
Study Design Rationale............................................................................................ 22 
4.3. 
Enrollment Target and Study Duration .................................................................... 22 
5. 
TEST ARTICLE ALLOCATION AND MASKING..................................................... 22 
5.1. 
Test Article Allocation............................................................................................. 22 
5.2. 
Masking.................................................................................................................... 23 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 23 
6. 
STUDY INTERVENTION............................................................................................. 23 
6.1. 
Identity of Test Articles............................................................................................ 23 
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6.2. 
Ancillary Supplies/Products..................................................................................... 24 
Supplies............................................................................................................................... 24 
6.3. 
Administration of Test Articles................................................................................ 25 
6.4. 
Packaging and Labeling ........................................................................................... 25 
6.5. 
Storage Conditions................................................................................................... 25 
6.6. 
Collection and Storage of Samples .......................................................................... 25 
6.7. 
Accountability of Test Articles ................................................................................ 26 
7. 
STUDY EVALUATIONS.............................................................................................. 26 
7.1. 
Time and Event Schedule......................................................................................... 26 
7.2. 
Detailed Study Procedures ....................................................................................... 28 
VISIT 1 ........................................................................................................................... 29 
VISIT 2 ........................................................................................................................... 35 
VISIT 3 ........................................................................................................................... 38 
VISIT 4 ........................................................................................................................... 41 
FINAL EVALUATION.................................................................................................. 43 
7.3. 
Unscheduled Visits................................................................................................... 44 
7.4. 
Laboratory Procedures ............................................................................................. 45 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 45 
8.1. 
Completion Criteria.................................................................................................. 45 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 45 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 46 
10. 
DEVIATIONS FROM THE PROTOCOL.................................................................. 46 
11. 
STUDY TERMINATION ........................................................................................... 46 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS.............. 47 
13. 
ADVERSE EVENTS................................................................................................... 48 
13.1. 
Definitions and Classifications............................................................................. 48 
13.2. 
Assessing Adverse Events.................................................................................... 50 
13.2.1. 
Causality Assessment.................................................................................... 51 
13.2.2. 
Severity Assessment...................................................................................... 51 
13.3. 
Documentation and Follow-Up of Adverse Events.............................................. 51 
13.4. 
Reporting Adverse Events.................................................................................... 53 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 53 
13.4.2. 
Reporting Adverse Events to
the Responsible IEC/IRB and Health 
Authorities....................................................................................................................... 54 
13.4.3. 
Event of Special Interest ............................................................................... 54 
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13.5. 
Reporting of Pregnancy........................................................................................ 54 
14. 
STATISTICAL METHODS........................................................................................ 54 
14.1. 
General Considerations......................................................................................... 54 
14.2. 
Sample Size Justification...................................................................................... 55 
14.3. 
Analysis Populations ............................................................................................ 55 
14.4. 
Level of Statistical Significance........................................................................... 56 
14.5. 
Primary Analysis .................................................................................................. 56 
14.6. 
Secondary Analysis .............................................................................................. 56 
14.7. 
Other Exploratory Analyses ................................................................................. 57 
14.8. 
Interim Analysis ................................................................................................... 57 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 57 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 57 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING................................ 57 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 57 
15.2. 
Subject Record...................................................................................................... 58 
16. 
DATA MANAGEMENT............................................................................................. 58 
16.1. 
Access to Source Data/Document ........................................................................ 58 
16.2. 
Confidentiality of Information.............................................................................. 59 
16.3. 
Data Quality Assurance........................................................................................ 59 
17. 
MONITORING............................................................................................................ 59 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 60 
18.1. 
Study-Specific Design Considerations ................................................................. 60 
18.2. 
Investigator Responsibility................................................................................... 60 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 60 
18.4. 
Informed Consent ................................................................................................. 61 
18.5. 
Privacy of Personal Data ...................................................................................... 62 
19. 
STUDY RECORD RETENTION................................................................................ 63 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 63 
21. 
PUBLICATION........................................................................................................... 64 
22. 
REFERENCES ............................................................................................................ 64 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)..... 65 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 87 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)......................................... 88 
APPENDIX D: 
.................................... 117 
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, DETERMINATION OF NEAR ADDITION .................................................... 118 
 LENS FITTING CHARACTERISTICS............................................................ 126 
, SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS....................... 133 
, FRONT AND BACK SURFACE LENS DEPOSIT GRADING PROCEDURE
............................................................................................................................................... 135 
 
DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS ................................................................................................................... 141 
 BIOMICROSCOPY SCALE ............................................................................. 148 
 CONJUNCTIVAL STAINING.......................................................................... 154 
 KERATOMETRY PROCEDURE..................................................................... 158 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION........................ 160 
 DISTANCE LOGMAR VISUAL ACUITY MEAUSREMENT PROCEDURE
............................................................................................................................................... 165 
 PATIENT REPORTED OUTCOMES .............................................................. 169 
 LENS INSERTION AND REMOVAL ............................................................. 171 
 WHITE LIGHT LENS SURFACE WETTABILITY........................................ 174 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING.............................................................................................................................. 176 
APPENDIX E: NON-INVASIVE BREAK-UP TIME (NIBUT) WORK AID ................... 182 
APPENDIX F: NON-INVASIVE KERATOGRAPHIC BREAK-UP TIME (NIKBUT) 
WORK AID .......................................................................................................................... 188 
APPENDIX G: LIPIVIEW II MANUFACTURER INSTRUCTIONS ............................... 196 
APPENDIX H: LID WIPER EPITHELIOPATHY WORK AID......................................... 244 
APPENDIX I: MEIBOMIAN GLAND EVALUATOR ...................................................... 253 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 255 
 
TABLE OF CONTENTS
Figure 1: Study Flowchart ...................................................................................................... 14 
TABLE OF CONTENTS
Table 1: Subject Enrollment ................................................................................................... 22 
Table 2: Test Lens................................................................................................................... 23 
Table 3: Ancillary Supplies/Equipment.................................................................................. 24 
Table 4: Time and Events ....................................................................................................... 26 
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PROTOCOL TITLE, NUMBER, VERSION 
Title: Ocular Characteristics in Contact Lens and Spectacle Wear
Protocol Number: CR-6332
Version: 4.0, Amendment 3.0
Date:  16 April 2019
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care (JJVC)
7500 Centurion Parkway 
Jacksonville, FL 32256
MEDICAL MONITOR 
Name: Elizabeth Dow, OD, FAAO
Title: Principal Research Optometrist
Address: 7500 Centurion Parkway, Suite 100; Jacksonville, FL 32256
Email: edow1@its.jnj.com
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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AUTHORIZED SIGNATURES 
The signature below constitutes the approval of this protocol and the attachments, and 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and according 
to local legal and regulatory requirements and applicable U.S. federal regulations,4 ICH 
guidelines,2 ISO 14155,1 and the Declaration of Helsinki.3
Author & Study 
Responsible 
Clinician
See Electronic Signature Report
Elizabeth Dow, OD, FAAO
Principal Research Optometrist, R&D
DATE
Clinical Operations 
Manager
See Electronic Signature Report
Clinical Operations Manager, Clinical 
Operations
DATE
Biostatistician
See Electronic Signature Report
Biostatistician, Clinical Sciences, R&D
DATE
Biostatistics 
Reviewer  
See Electronic Signature Report
Sr Biostatistics Manager, R&D
DATE
Data Management
See Electronic Signature Report
Clinical Project Manager –
Data & Systems, Clinical Operations
DATE
Fellow Reviewer
See Electronic Signature Report
Research Fellow, R&D
DATE
Approver
See Electronic Signature Report
Director, 
Sphere-Light 
Management-
Lens Care, JJVC
DATE
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SYNOPSIS  
Protocol Title
Ocular Characteristics in Contact Lens and Spectacle Wear
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Post Marketing (Marketing claims, registry, post marketing 
surveillance), phase 4 
Trial Registration
This study will be registered on ClinicalTrials.gov by the 
Sponsor
Test Article(s)
Investigational Products:
Test: ACUVUE OASYS ® 1-Day with Hydraluxe™ 
Technology
Control: Subject’s own Spectacle
Wear and Replacement 
Schedules
Wear Schedule: Daily Wear
Replacement Schedule: Daily Disposable 
Objectives 
Primary Objective(s):
Compare between Test lens and Spectacles with respect to
non-invasive 
break 
up 
time 
(NIBUT)/ 
non-invasive 
keratography break up time (NIKBUT) among habitual lens 
users.
Secondary Objective(s):
Compare between Test lens and Spectacles with respect to
Meibomian gland expressibility, conjunctival staining, and lid 
wiper epitheliopathy among habitual lens users.
Other Objective(s):
Compare between Test lens and Spectacles among habitual 
lens users with respect to digital device ocular symptoms, 
digital device use, blink characteristics, and subjective 
sensitivity.
The same comparisons presented above will be conducted 
between Spectacles/Test lens for habitual contact lens users 
and Spectacles for habitual spectacle users.     
Study Endpoints
Primary endpoint(s): 
Non-invasive 
break 
up 
time 
(NIBUT)/ 
non-invasive 
keratography break up time (NIKBUT) time in seconds
(Appendix E and Appendix F)
Secondary endpoint(s):
x
Meibomian gland expressibility (Appendix I)
x
Conjunctival staining 
x
Lid wiper epitheliopathy (Appendix H)
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Other exploratory endpoint(s):
x
Dry eye symptoms assessed by time point modified 
CLDEQ-8/DEQ-5
x
Subjective comfort assessed by (0-100) numeric scale
x
Digital device use and the related ocular symptoms 
assessed by digital device use and ocular symptoms 
surveys
x
Blink characteristics
x
Subjective sensitivity measured by Highly Sensitive 
Person-HSP Scale 
Study Design
This is a two-arm study. There will be an observational arm 
and an interventional arm. 
In the observational arm, habitual spectacle wearers will all 
continue to use their habitual optical correction and undergo 
ocular evaluations and questionnaires at 2 separate study 
visits.
The observational arm will have a total of 2 visits:
Visit 1: Screening, baseline evaluation 
Visit 2: Follow up evaluation and final evaluation. 
In the interventional arm, habitual contact lens wearers who 
own spectacles will undergo a bilateral, dispensing, 
randomized, controlled, unmasked, 2×2 cross-over study over 
4 visits.  Each subject will be bilaterally fitted with the one test
article and crossed with their own spectacle in 2 periods. 
The interventional arm will have a total of 4 visits:
Visit 1: Screening, baseline evaluation, randomization to lens 
fit or spectacle wear × 1 week. 
Visit 2: Follow-up evaluation
WASHOUT: 1 week
Visit 3: Lens fit or spectacle wear × 1 week. 
Visit 4: Follow-up evaluation and final evaluation. 
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
Approximately 70 eligible subjects are to be enrolled and 60
subjects are needed to complete
Study Duration
The study is anticipated to last 6 weeks and include a 2 week 
enrollment period.
Anticipated Study 
Population
40 habitual soft contact lens users, and 20 non contact lens
using spectacle wearers, between 18-42 years of age 
(inclusive) 
Eligibility Criteria
Potential subjects must satisfy all of the following criteria to 
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be enrolled in the study:
Inclusion Criteria after Screening
1.
The subject will have completed the pre-screening 
Classification questionnaire.
2.
Subject must have a working cell phone capable of 
sending and receiving text messages.
3.
The subject must read, understand, and sign the 
STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form. 
4.
Appear able and willing to adhere to the instructions 
set forth in this clinical protocol
5.
Between 18 and 42 (inclusive) years of age at the time 
of screening 
6.
Be a current soft contact lens wearer in both eyes with 
a minimum of 5 days/week wear time over the last 1 
month by self-report OR be a full time spectacle 
wearer (7 days/ week) without contact lens wear over 
the last 6 months
7.
Subjects must be willing to adhere to spectacle-only 
refractive correction for approximately 1 week 
Inclusion Criteria after Baseline
8.
Subjects must possess a functional / usable pair of 
spectacles with which they can achieve 20/25 Snellen 
visual acuity or better at distance and near, and bring 
them to the visit 
9.
The subject’s vertex corrected spherical distance 
refraction must be in the range (+/-0.25 D) of -2.00 D 
to -6.00 D (inclusive) in each eye  
10.
The subject’s vertex corrected refractive cylinder must 
be equal or less than -0.75 diopters in each eye  
11.
Contact lens wearers must have spherical best 
corrected visual acuity of 20/25 or better in each eye.
12.
Snellen visual acuity at distance and near must be 
within 1 line between subject’s own spectacle and the 
manifest refraction, distance and near, OD & OS.
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study: 
Exclusion Criteria after Screening:
1.
Currently pregnant or lactating, by self-report 
2.
Any ocular or systemic allergies, disease or use of 
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medication which may interfere with contact lens wear 
and/or participation in the study (at the discretion of 
the investigator). 
3.
Any active ocular abnormalities/conditions that may 
interfere with contact lens wear and/or participation in 
the study (at the discretion of the investigator). 
4.
Any corneal distortion resulting from previous hard or 
rigid gas permeable contact lens wear  
5.
Habitual contact lens wear modality as extended wear 
(≥1 night per month of extended wear) 
6.
Habitual contact lens is rigid gas permeable, toric, 
monovision or multi-focal 
7.
Habitual spectacle contains an add power, 
photochromic or tint.  
8.
Any previous, or planned (during the course of the 
study) ocular surgery (e.g., radial keratotomy, PRK, 
LASIK, etc.) 
9.
Participation in any contact lens or lens care product 
clinical trial within 2 weeks prior to study enrollment.
10.
Employee or employee’s immediate family member of 
clinical site (e.g., Investigator, Coordinator, 
Technician) 
11.
Current habitual use of Restasis, Xiidra, ocular 
steroids, or any medication (RX or OTC) that may 
interfere with contact lens wear and/or participation in 
the study (at the discretion of the investigator)
Exclusion Criteria after Baseline
12.
Any ocular allergies, infections or other ocular 
abnormalities that are known to interfere with contact 
lens wear and/or participation in the study. This may 
include, but not be limited to entropion, ectropion, 
extrusions, chalazia, recurrent styes, glaucoma, history 
of recurrent corneal erosions, aphakia, or corneal 
distortion  
13.
Any Grade 3 or greater biomicroscopy findings (this 
includes, corneal edema, corneal staining, corneal 
vascularization, conjunctival injection, tarsal 
abnormalities, bulbar injection) on the FDA 
classification scale (
.
14.
Accommodative/binocular dysfunction, determined by 
study procedures.
Disallowed 
Medications/Interventions
Restasis, Xiidra, ocular steroids, or any medication (Rx or 
OTC) that may interfere with contact lens wear or 
participation in the study at the discretion of the investigator
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Measurements and 
Procedures
Ocular characteristics: non-invasive break up time (NIBUT)/ 
Non-invasive keratometric break up time (NIKBUT),
Meibomian gland expressibility, blink patterns, conjunctival 
staining, and lid wiper epitheliopathy, Biomicroscopy 
Snellen and logMAR Visual Acuity: Distance 
and Near
Accommodative/binocular testing: Cover test, Global stereo, 
NRA/PRA 
Subjective symptomatology:  Time point modified Dry Eye 
Questionnaire responses 
subjective comfort rating using numeric scale via text 
responses, digital device use and the related ocular 
symptoms surveys
Microbiology or Other 
Laboratory Testing
None
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 
investigational product.  In the event of a UADE or SAE, the 
Sponsor Medical Monitor may unmask the treatment regimen 
of subject(s) and may discuss this with the Principal 
Investigator before any further subjects are enrolled.
Ancillary Supplies/ Study-
Specific Materials (as 
applicable by site)
LogMAR visual acuity charts for distance and near
Live view placedo disc corneal topographer (Medmont or like 
instrument) or Oculus Keratograph 5M
Lipiview II
Korb Meibomian Gland Evaluator (MGE)
Sodium Fluorescein strips
Lissamine Green strips
Lacripure / ScleralFil
Principal Investigator(s) 
and Study 
Institution(s)/Site(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 Break-Up Time
NIKBUT
Non-Invasive Keratography Break-Up Time
NIH
National Institutes of Health
NRA
Negative Relative Accommodation
OD
Right Eye
OHRP
Office for Human Research Protections
OHSR
Office for Human Subjects Research
OS
Left Eye
OU
Both Eyes
PD
Protocol Deviation
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PHI
Protected Health Information
PI
Principal Investigator
PIG
Patient Instruction Guide
PQC
Product Quality Complaint
PRA
Positive Relative Accommodation
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
UADE
Unanticipated Adverse Device Effect
USADE
Unanticipated Serious Adverse Device Effect
VA
Visual Acuity
1. INTRODUCTION AND BACKGROUND 
When exploring differences in characteristics between spectacle and contact lens wear during 
digital device use, controlled clinical studies provide information on objective and subjective 
endpoints. This study will enroll subjects in strata based on a Characterization Questionnaire 
to determine their time of, and symptomatology with typical digital device use. Evaluation 
of characteristics in physiology and symptomatology aim to guide learning into the ocular 
effects of digital device use in study lenses, and subject’s own habitual contact lenses and 
spectacles. The scope of this study will focus on objective metrics found to be associated 
with lens comfort. Subjective comfort metrics will also be collected. Subjects with 
accommodative/binocular dysfunction will be excluded. 
1.1.
Name and Descriptions of Investigational Products  
This study will use a single contact lens type: ACUVUE OASYS® 1-Day with HydraLuxe™
Technology, made of senofilcon A material, an FDA approved product. Further details about 
the test articles are found in Section 6 of this protocol.
The control will be the subject’s own spectacle.
1.2.
Intended Use of Investigational Products 
The intended use of the investigative product is to compensate for ametropia.
During the study, subjects in the interventional arm will bilaterally wear the test lens in daily 
disposable modality for approximately 1 week.
All subjects will wear their own spectacle for approximately 1 week. 
1.3.
Summary of Findings from Nonclinical Studies 
Not Applicable – Marketed product only
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1.4.
Summary of Known Risks and Benefits to Human Subjects 
The following risks/adverse events can be associated with wearing soft contact lenses in
general:
• The eyes may burn, sting and/or itch.
• 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 peripheral
infiltrates, peripheral corneal ulcers and 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 conjunctivitis, 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.
There is no direct benefit to the subject for participating in the study, although they will be
able to try marketed contact lenses. 
For the most comprehensive clinical information regarding ACUVUE OASYS® 1-Day with
HydraLuxe™ Technology (senofilcon A) contact lenses, refer to the latest version of the
package insert.
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
For the most comprehensive clinical information regarding ACUVUE OASYS® 1-Day with
HydraLuxe™ Technology (senofilcon A) contact lenses, refer to the latest version of the
package insert (APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT).
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1.
Objectives  
Primary Objective(s)
Compare between Test lens and Spectacles with respect to non-invasive break up time 
(NIBUT)/ non-invasive keratography break up time (NIKBUT) among habitual lens users.
Secondary Objective(s)
Compare between Test lens and Spectacles with respect to Meibomian gland expressibility, 
conjunctival staining, and lid wiper epitheliopathy among habitual lens users.
Other Objective(s) 
Compare between Test lens and Spectacles among habitual lens users with respect to digital 
device ocular symptoms, digital device use, blink characteristics, and subjective sensitivity.
The same comparisons presented above will be conducted between Spectacles/Test lens for 
habitual lens users and Spectacles for habitual spectacle users.     
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2.2.
Endpoints  
Primary Endpoint(s) 
Non-invasive break up time (NIBUT)/ non-invasive keratography break up time (NIKBUT) 
time in seconds
NIBUT/NIKBUT is measured as the time interval in seconds after the final blink to the first 
appearance of distortion in the reflected rings; or to the time that the participant has to blink 
due to discomfort.
Secondary Endpoint(s) 
Meibomian Gland Expressibility (Appendix I)
Meibomian gland expressiblity is assessed in three regions of the lower eyelid:  temporal, 
central, and nasal. Approximately five glands are expressed per region and evaluated using a 
four-grade scale: 0 = No Secretion, 1 = Inspissated, 2 = Colored/Cloudy Liquid, and 3 = 
Clear Liquid Oil. The total score is calculated as the sum of all grades across the three 
regions and ranges from 0 to 45.   
Conjunctival Staining 
Conjunctival staining is graded and recorded by quadrant (Superior, Inferior, Nasal, and 
Temporal) using the following grading scale: Grade 0 = None, Grade 1 = Trace, Grade 2 = 
Mild, Grade 3 = Moderate, and Grade 4 = Severe. Average grade can be calculated based on 
grades of the four quadrants. 
Lid Wiper Epitheliopathy (Appendix H)
Horizontal lid margin staining and sagittal lid margin staining are graded for each eyelid 
separately. The horizontal and sagittal grades are then averaged for each eyelid to obtain the 
upper lid average grade and lower lid average grade. The final grade is the average of the 
upper and lower lid average grades. Subjects can be classified according to their final grades 
for each eye. The classification is defined as follows: “None” for final grades of 0, “Mild” 
for final grades between 0.25 and 1.00, “Moderate” for final grades between 1.25 and 2.00, 
and “Severe” for final graded between 2.25 and 3.00.
Other Exploratory Endpoint(s) 
Subjective Comfort Assessed by (0-100) Numeric Scale
Subjective comfort will be assessed using a numeric scale which ranges from 0 to 100, where 
100 is defined as “Best comfort imaginable” and 0 as “Worst comfort imaginable”.
Dry Eye Symptoms Measured by CLDEQ-8 and/or DEQ-5
Subject dry eye symptoms will be evaluated using the Contact Lens Dry Eye Questionnaire-8
(CLDEQ-8). The CLDEQ-8 is a validated outcome measure for soft contact lenses wearers.
It has been highly correlated with habitual baseline status and change in overall opinion when
subjects are refit with contact lenses. The sum of the item scores of CLDEQ-8, ranging
from 0 to 37, will be used to assess dry eye symptoms, where higher scores indicate more
serious symptoms.
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Digital Device Ocular Symptoms
Ocular symptoms related to digital device use will be assessed using the digital device ocular 
symptoms questionnaire and MRD items. The digital device ocular symptoms questionnaire 
was modified based on CLDEQ-8. The sum of item scores range from 0 to 37. 
Digital Device Use
Digital device use will be examined using MRD items.  
Subjective sensitivity measured by Highly Sensitive Person-HSP Scale
Subjective sensitivity will be assessed using the Highly Sensitive Person – HSP scale. The 
HSP scale consists of 27 items on the 7-point Likert scale (1 for “Not at all” and 7 for 
“Extremely”). Mean score across the 27 items will be calculated. 
Blink characteristics 
Blink characteristics include blink patterns, total number of blinks, and percent of partial 
blinks over a 20 second measurement duration.
2.3.
Hypotheses 
This is a pilot study and all the hypotheses are exploratory in nature.
Primary Hypotheses
There will be no difference between Test lens and Spectacles with respect to non-invasive
break up time/ non-invasive keratography break up time among habitual contact lens wearers 
(the interventional arm) at 1-Week follow-up.
Secondary Hypotheses
There will be no secondary hypotheses. The following will be estimated for Test lens and 
Spectacles among habitual contact lens wearers at 1-Week follow-up:
x
Total scores of Meibomian gland expressibility 
x
Average grades of conjunctival staining 
x
Proportions of eyes with clinically significant (Grade 3 or 4 of overall classification) 
lid wiper epitheliopathy 
3.
TARGETED STUDY POPULATION 
3.1.
General Characteristics  
Subjects, ages 18-42 are to complete this clinical study. Subjects will be stratified into two 
arms: 20 that are full time spectacle wearers (observational arm), and 40 subjects that are 
current spherical soft contact lens wearers (interventional arm). Within each arm, half of 
subjects will have been classified as symptomatic high digital device users. 
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3.2.
Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Inclusion Criteria after Screening
1.
The subject will have completed the pre-screening Classification questionnaire.
2.
Subject must have a working cell phone capable of sending and receiving text 
messages.
3.
The subject must read, understand, and sign the STATEMENT OF INFORMED 
CONSENT and receive a fully executed copy of the form. 
4.
Appear able and willing to adhere to the instructions set forth in this clinical protocol
5.
Between 18 and 42 (inclusive) years of age at the time of screening 
6.
Be a current soft contact lens wearer in both eyes with a minimum of 5 days/week 
wear time over the last 1 month by self-report OR be a full time spectacle wearer (7 
days/ week) without contact lens wear over the last 6 months
7.
Subjects must be willing to adhere to spectacle-only refractive correction for 
approximately 1 week 
Inclusion Criteria after Baseline
8.
Subjects must possess a functional / usable pair of spectacles with which they can 
achieve 20/25 Snellen visual acuity or better at distance and near, and bring them to 
the visit 
9.
The subject’s vertex corrected spherical distance refraction must be in the range 
(+/-0.25 D) of -2.00 D to -6.00 D (inclusive) in each eye  
10.
The subject’s vertex corrected refractive cylinder must be equal or less than -0.75
diopters in each eye  
11.
Contact lens wearers must have spherical best corrected visual acuity of 20/25 or
better in each eye.
12.
Snellen visual acuity at distance and near must be within 1 line between subject’s 
own spectacle and the manifest refraction, distance and near, OD & OS. 
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.
Currently pregnant or lactating, by self-report 
2.
Any ocular or systemic allergies, disease or use of medication which may interfere 
with contact lens wear and/or participation in the study (at the discretion of the 
investigator). 
3.
Any active ocular abnormalities/conditions that may interfere with contact lens wear 
and/or participation in the study (at the discretion of the investigator). 
4.
Any corneal distortion resulting from previous hard or rigid gas permeable contact 
lens wear  
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5.
Habitual contact lens wear modality as extended wear (≥1 night per month of 
extended wear) 
6.
Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal 
7.
Habitual spectacle contains an add power, photochromic or tint.  
8.
Any previous, or planned (during the course of the study) ocular surgery (e.g., radial 
keratotomy, PRK, LASIK, etc.) 
9.
Participation in any contact lens or lens care product clinical trial within 2 weeks 
prior to study enrollment. 
10.
Employee or employee’s immediate family member of clinical site (e.g., Investigator, 
Coordinator, Technician) 
11.
Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or 
OTC) that may interfere with contact lens wear and/or participation in the study (at 
the discretion of the investigator)
Exclusion Criteria after Baseline
12.
Any ocular allergies, infections or other ocular abnormalities that are known to 
interfere with contact lens wear and/or participation in the study. This may include, 
but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, 
glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion  
13.
Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal 
staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar 
injection) on the FDA classification scale 
14.
Accommodative/binocular dysfunction, determined by study procedures.
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. 
The clinical site will administer a pre-screening on potential subjects before they attend the 
initial study visit utilizing IEC/IRB approved recruitment materials. 
4.
STUDY DESIGN AND RATIONALE 
4.1.
Description of Study Design 
This is two-arm study. There will be an observational arm and an interventional arm. 
In the observational arm, habitual spectacle wearers will all continue to use their habitual 
optical correction and undergo ocular evaluations and questionnaires at 2 separate study 
visits: baseline and 1-week. Since the nature of this arm is observational, it will be 
non-controlled, non-randomized, and unmasked.
In the interventional arm, habitual contact lens wearers who own spectacles will undergo a 
bilateral, 1-week dispensing, randomized, controlled, unmasked, 2×2 cross-over study with a 
1-week washout between periods in which subjects will wear their habitual contact lens.
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Each subject will be bilaterally fitted with the one test article and crossed with their own 
spectacle in 2 periods. 
4.2.
Study Design Rationale 
To investigate the difference in ocular characteristics between contact lens wear and 
spectacle wear among habitual contact lens wearers, a 2-treatment by 2-period cross-over 
design (Spectacle / ACUVUE OASYS 1-Day or ACUVUE OASYS 1-Day /Spectacle) will 
be used with a 1-week washout between the two study periods to eliminate any potential 
carryover effect. Cross-over design is employed because, if the no-carryover assumption is 
met, treatment differences are measured within a subject rather than between subjects which 
makes a more precise measurement. In addition to the interventional arm of habitual contact 
lens wearers, an observational arm will be added to investigate ocular characteristics among 
habitual spectacle wearers which serves as a reference group.
4.3.
Enrollment Target and Study Duration 
The target is to enroll approximately 70 eligible subjects with 60 subjects to complete the 
study. Subjects will be stratified into two arms: 20 subjects that are full time spectacle 
wearers (observational arm), and 40 subjects that are current spherical soft contact lens 
wearers (interventional arm).
Within each arm, subjects will be dichotomized into two 
groups via the Classification Questionnaire. Group 1: half of subjects will have been 
classified as symptomatic high digital device users.
Group 2: half of subjects will be 
classified as having low digital device use and/or asymptomatic with digital device use
The table below provides details of subject enrollment.
Table 1: Subject Enrollment
Habitual Spectacle Wearers
(observational arm)
Habitual Contact Lens Wearers
(interventional arm)
Total
Group 1: 
High use and
Symptomatic
Group 2:
Low use and/or 
Asymptomatic
Group 1:
High use and
Symptomatic 
Group 2:
Low use and/or
Asymptomatic
Randomized
(as 
applicable)
12
12
23
23
70
Complete 
10
10
20
20
60
There will be 2 visits for the observational arm and 4 visits for the interventional arm. The 
study is anticipated to last 6 weeks and include a 2-week enrollment period.
5.
TEST ARTICLE ALLOCATION AND MASKING 
5.1.
Test Article Allocation  
Dispensed contact lenses will be worn in a bilateral fashion. Randomization is applicable in 
this study only in the interventional arm. Study lens and Spectacle will be worn in a bilateral 
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Supplies
Diagnostic
Blink patterns
Non invasive 
keratography 
tear break up 
time / Non 
invasive break 
up time
Meibomian 
Gland 
Expressibility
HLHC
Distance 
(charts HC1, 
HC2) and near 
Retinopathy 
Study 
(ETDRS) 2000 
Series (charts 
1, 2) 
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 article will 
be over-labeled to mask the subject to the identity of the lens. The test articles will be in 
investigational cartons sealed with a tamper evident seal or in plastic bags as the secondary 
packaging form. The sample study label is shown below:
.
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 
Ex-vivo (worn) lenses collected at VRC will be retained dry in vials and frozen in the clinic’s 
freezer, to be collected periodically throughout the study by the sponsor. 
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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: Restasis, Xiidra, ocular steroids, or any 
medication (RX or OTC) that may interfere with contact lens wear (at the discretion of the 
investigator) 
Concomitant therapies that are disallowed include: NA.
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. 
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 
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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 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)
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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
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
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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).  
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
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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.
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
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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
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.  
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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.
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 
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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
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.
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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.  At the Investigator’s discretion, the 
study participant may be followed by the Investigator through delivery. However, this data 
will not be collected as part of the clinical study database. 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.
All data summaries and statistical analyses will be performed using the Statistical Analysis 
System (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.  
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.
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14.2. Sample Size Justification 
The plan is to enroll 70 eligible subjects with a minimum target of 60 subjects to complete 
the study. Of the total 60 subjects, 20 subjects will be habitual spectacle users (the 
observational arm) and 40 subjects will be habitual contact lens users (the interventional 
arm). The sample size was chosen by the project team, given that this study is to gain initial 
insights of the performance of Test lens compared to Spectacles among different users 
(habitual lens users and habitual spectacle users). Therefore, the sample size was not based 
on any empirical sample size calculation. 
The power was calculated for testing the primary hypothesis based on the selected sample 
size of 40 subject in the intervention arm using a 2×2 cross-over design. The calculation was 
performed with a 2-sided type I error of 0.05 assuming the true difference of 2 (seconds) in 
NIBUT between Test lens and Spectacles using a linear mixed model-based power analysis 
method (Stroup, 1999; 2002). Historical data from 
 were used to obtain the overall 
variance of NIBUT. The overall variance of NIBUT was about 34 based on the historical 
data. The intra-class correlation between measurements obtained from the same subject and 
eye across periods was assumed to be 
, and the intra-class correlation 
between measurements obtained from the same subject across eyes and periods was assumed 
to be 
. The SAS procedure PROC GLIMMIX (SAS software Version 9.4) was 
used to perform the calculation. 
Based on the calculation, if the true difference is expected to be 2 seconds in NIBUT, the 
sample size of 40 subjects (80 eyes) using a 2×2 crossover design has a power of 86% to test 
for a significant difference between Test lens and Spectacles with a two-sided type I error of 
0.05.
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.
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14.4. Level of Statistical Significance 
All planned analysis for this study will be conducted with an overall type I error rate of 5%. Type 
I error will be controlled for multiplicity across interim analysis and final analysis.
14.5. Primary Analysis  
Non-Invasive Break-Up Time / Non-Invasive Keratography Break-Up Time (in seconds)
Non-invasive tear break-up time among habitual contact lens wearers (the interventional 
arm) will be analyzed using a linear mixed model to compare between Test lens and 
Spectacles. The model will include lens type (Test lens/Spectacles), sequence of lens wear, 
period, subject group, and subject group by lens type interaction as fixed effects, and site and 
subject as random effects. Other baseline characteristics known of importance such as age 
and gender will be included as fixed covariates when appropriate. The covariance structure 
for the residual errors across different periods from the same subject and eye (R-side) will be 
selected based on the finite sample corrected Akaike’s Information Criterion (Keselman et al. 
1998). Two covariate structures will be considered: Homogenous Compound Symmetry (CS) 
and Unstructured covariance structure (UN). The homogeneity of the covariance structure 
across subject groups will be evaluated using a log-likelihood ratio test.
The null and alternative hypotheses for testing significant difference between Test lens and 
Spectacles among habitual lens users with respect to NIBUT/NIKBUT are presented below:       
,
where 
is the population mean difference (Test - Spectacles) in NIBUT/NIKBUT at 
1-week follow-up.
Comparison on NIBUT/NIKBUT between Test lens and Spectacles will be carried out using 
a two-sided 95% confidence interval (CI) constructed of least-square means (LSM) 
difference from the linear mixed model (Test - Spectacles). A statistically significant 
difference in NIBUT/NIKBUT between Test lens and Spectacles will be concluded if the 
upper confidence limit of the 95% CI is below zero or the lower limit is above zero. 
14.6. Secondary Analysis  
Meibomian Gland Expressibility 
The average of Meibomian gland expressibility Total scores will be calculated and compared 
between Test lens and Spectacles among habitual contact lens users (the interventional arm) 
at 1-week follow-up.
Conjunctival Staining
The average grades of conjunctival staining will be calculated and compared between Test 
lens and Spectacles among habitual contact lens users (the interventional arm) at 1-week 
follow-up.
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Lid Wiper Epitheliopathy
The proportion of eyes with clinically significant (Grade 3 or 4 for overall classification) lid 
wiper epitheliopathy will be calculated and compared between Test lens and Spectacles 
among habitual contact lens users (the interventional arm) at 1-week follow-up.
14.7. Other Exploratory Analyses  
x
Other exploratory endpoints will be analyzed descriptively to compare Test lens and 
Spectacles among habitual lens users (the interventional arm). 
x
Further comparisons will be conducted between Test lens/Spectacles for habitual lens 
users and Spectacles for habitual spectacle users with respect to all endpoints. The first 
period data from habitual lens users (the interventional arm) and all data from habitual 
spectacle users (the observational arm) will be used to analyze these endpoints 
descriptively. 
14.8. Interim Analysis 
No interim analysis is planned for 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%. 
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. 
External Date Sources for this study include: Nightly text messaging comfort scores.  These 
will be analyzed by the sponsor and included in the CSR.    
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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 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 
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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.
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
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x
Clarifying questions regarding the study
x
Resolving study issues or problems that may arise
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 Health Information Portability and Accountability Act (HIPAA) in the 
United States4 /Data Protection Act in the United Kingdom6 /insert applicable country 
specific regulations and add the appropriate reference in Section 22 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.
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.
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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 Sponsor.
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. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html
6. Data Protection Act. Available at: 
http://www.legislation.gov.uk/ukpga/1998/29/contents
7.
8. Stroup, W. W. 1999. Mixed model procedures to assess power, precision, and sample 
sizes. The Design of Experiments 1999 Proceedings of the Biopharmaceutical 
Section. Alexandria, VA: American Statistical Association, pp. 15-24.
9. Stroup, W. W. 2002. Power analysis based on spatial effects mixed models: A tool for 
comparing design and analysis strategies in the presence of spatial variability. Journal 
of Agricultural, Biological, and Environmental Statistics 7, 491-511.
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
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PRO SPECIFICATION Version 2 Final  2019-04-05
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PRO SPECIFICATION Version 2 Final  2019-04-05
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PRO SPECIFICATION Version 2 Final  2019-04-05
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PRO SPECIFICATION Version 2 Final  2019-04-05
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PRO SPECIFICATION Version 2 Final  2019-04-05
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PRO SPECIFICATION Version 2 Final  2019-04-05
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JJVC CONFIDENTIAL

PRO SPECIFICATION Version 2 Final  2019-04-05
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PRO SPECIFICATION Version 2 Final  2019-04-05
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PRO SPECIFICATION Version 2 Final  2019-04-05
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
Patient Instruction Guide (PIG) will be provided separately.
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
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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°
Page 91 of 255

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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• 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
s is increased when lenses are 
worn overnight, and that the risk of ulcerative keratitis is greater for 
P
5

• 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 handlin
n, removal, and wearing 
instructions in the “Patient Instruction Guide” for the prescribed 
Page 97 of 255

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.
Page 98 of 255

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 
Page 99 of 255

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.
Page 100 of 255

GENERAL FITTING GUIDELINES
A. Patient Selection
Patients selected to wear these lenses should be chosen based on: 
• Motivation to wear lenses 
• Ability to follow instructions regarding lens wear care
• General health 
• Ability to adequately handle and care for the lenses 
• Ability to understand the risk and beneﬁ ts of lens wear
Patients who do not meet the above criteria should not be provided with 
contact lenses. 
B. Pre-ﬁ tting Examination
Initial evaluation of the patient should begin with a thorough case history 
to determine if there are any contraindications to contact lens wear. During 
the case history, the patient’s visual needs and expectations should be 
determined as well as an assessment of their overall ocular, physical, and 
mental health. 
Preceding the initial selection of trial contact lenses, a comprehensive 
ocular evaluation should be performed that includes, but is not limited to, 
the measurement of distance and near visual acuity, distance and near 
refractive prescription (including determining the preferred reading distance 
for presbyopes), keratometry, and biomicroscopic evaluation. 
Based on this evaluation, if it is determined that the patient is eligible to 
wear these lenses, the Eye Care Professional should proceed to the lens 
ﬁ tting instructions as outlined below. 
C. Initial Power Determination
A spectacle refraction should be performed to establish the patient’s 
baseline refractive status and to guide in the selection of the appropriate 
lens power. Remember to compensate for vertex distance if the refraction 
is greater than ±4.00D.
D. Base Curve Selection (Trial Lens Fitting)
The following trial lenses should be selected for patients regardless of kera-
tometry readings. However, corneal curvature measurements should be 
performed to establish the patient’s baseline ocular status. 
 
Page 101 of 255

• 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
e good visual acuity with the 
correct lens power unless there is excessive residual astigmatism.
5

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.
Page 104 of 255

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°
Page 105 of 255

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.
Page 106 of 255

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.
Page 107 of 255

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 
 
Page 108 of 255

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 perform
der the above conditions 
is completed, tests of visu
and reading ability under 
Page 109 of 255

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 
when carrying out visual tasks.
55

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
h the patient of the wear 
schedule, daily disposable modality, and proper lens handling procedures. 
P

Recommended Follow-up Examination Schedule (complications 
and speciﬁ c problems should be managed on an individual patient 
basis):
1. One week from the initial lens dispensing to patient
2. One month post-dispensing
3. Every three to six months thereafter 
NOTE: Preferably, at the follow-up visits, lenses should be worn for at least 
six hours.
Recommended Procedures for Follow-up Visits:
1. Solicit and record patient’s symptoms, if any.
2. Measure visual acuity monocularly and binocularly at distance and 
near with the contact lenses.
3. Perform an over-refraction at distance and near to check for residual 
refractive error.
4. With the biomicroscope, judge the lens ﬁ tting characteristics (as 
described in the GENERAL FITTING GUIDELINES) and evaluate 
the lens surface for deposits and damage.
5. Following lens removal, examine the cornea and conjunctiva with 
the biomicroscope and ﬂ uorescein (unless contraindicated).
• The presence of vertical corneal striae in the posterior central 
cornea and/or corneal neovascularization is indicative of 
excessive corneal edema.
• The presence of corneal staining and/or limbal-conjunctival 
hyperemia can be indicative of an unclean lens, a reaction to 
solution preservatives, excessive lens wear and/or a poorly 
ﬁ tting lens.
• Papillary conjunctival changes may be indicative of an unclean 
and/or damaged lens.
6. Periodically perform keratometry and spectacle refractions. The 
values should be recorded and compared to the baseline meas-
urements.
If any observations are abnormal, use professional judgment to 
alleviate the problem and restore the eye to optimal conditions. If 
 
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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 
MATISM: base curve, power, 
diameter, cylinder, axis, lot
and expiration date
Page 114 of 255

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
Page 115 of 255

APPENDIX D: CLINICAL TECHNICAL PROCEDURES 
 
 
Determination of Near Addition
 Lens Fitting Characteristics
 Subject Reported Ocular Symptoms/Problems
 Front and Back Surface Lens Deposit Grading Procedure
 Determination of Distance Spherocylindrical Refractions
 Biomicroscopy Scale
Conjunctival Staining
 Keratometry Procedure
 Distance and Near Visual Acuity Evaluation
 Distance LogMAR Visual Acuity Measurement Procedure 
 Patient Reported Outcomes
 Lens Insertion and Removal
 White Light Lens Surface Wettability
Visual Acuity Chart Luminance and Room Illumination Testing
 
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 DETERMINATION OF NEAR ADDITION 
 
 
 
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 LENS FITTING CHARACTERISTICS 
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 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS 
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FRONT 
AND 
BACK 
SURFACE 
LENS 
DEPOSIT 
GRADING 
PROCEDURE 
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS 
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 BIOMICROSCOPY SCALE 
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 CONJUNCTIVAL STAINING 
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 KERATOMETRY PROCEDURE 
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 DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
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DISTANCE 
LOGMAR 
VISUAL 
ACUITY 
MEAUSREMENT 
PROCEDURE 
 
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Patient Reported Outcomes 
  
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 LENS INSERTION AND REMOVAL 
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 WHITE LIGHT LENS SURFACE WETTABILITY 
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 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING  
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APPENDIX E: NON-INVASIVE BREAK-UP TIME (NIBUT) WORK AID 
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Page 1 of 5
Work Aid: NIBUT Measurement using Medmont E300 Corneal Topographer    
WORK AID: NON-INVASIVE TEAR BREAK-UP TIME (NIBUT)
MEASUREMENT USING THE MEDMONT E300 CORNEAL TOPOGRAPHER
1.0 OBJECTIVES
Tear break-up time is a standard clinical measurement used to indicate the stability of the pre-
ocular tear film.   An individual with an unstable tear film can experience symptoms of visual 
disturbances or discomfort.  The Medmont videokeratoscope is one type of instrument which may
be used to view the regularity of the tear film, since it displays a live video image of a set of 
illuminated rings reflected by the eye surface. Disturbances to the tear film can be visualized as 
disruptions to the reflected ring pattern. This measurement is a form of non-invasive tear break-
up time (NIBUT), since the instrument does not touch the eye and there is no use of topical dyes.
2.0 MATERIALS
The Medmont E300 Corneal Topographer is a computerized videokeratometer which uses
Placido rings to map the surface of the human cornea.
SOFTWARE VERSION
The E300 Software is part of the Medmont Studio integrated software environment.  The 
instructions in this Appendix apply to Medmont Studio 4 software version 4.14.1. Other versions 
of the software are unlikely to have substantial difference in basic function or data integrity.
3.0 DATA MANAGEMENT
The Medmont videokeratoscope consists of a light source made up of a series of concentric rings, 
and a video camera for recording the reflected image of these rings.  For tear break-up time 
measurement, it is not necessary to save the series of images, but this may be done as an optional 
step for proof of performance or if needed for further analysis.  Tear break-up time is measured 
with a stopwatch and the results are recorded on paper CRF forms or an eCRF data entry screen.
4.0 PROCEDURES
MEDMONT SOFTWARE SETUP
If videokeratoscope images are not being saved, it is not necessary to enter a new patient name or 
date of birth. Selecting video data collection mode will ensure that a continuous live video view 
of the participant’s eye is shown on the computer monitor.
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Work Aid: NIBUT Measurement using Medmont E300 Corneal Topographer    
Figure 1. Selecting Normal (single frames) or Video capture control
PARTICIPANT SETUP
While instrument and participant alignment is being set up, the participant should be instructed to 
continue blinking normally.
The patient should sit comfortably in the chair. Ask the participant to put their chin onto the 
chinrest and put their forehead firmly against the forehead rest.  Adjust the chinrest height until 
the eye is approximately level with the mark on the vertical bar of the headrest. The participant 
should push their chin forward slightly on the chinrest. Ask the participant to look into the 
centre of the green central illuminated ring and keep their gaze on this target during the 
measurement. The investigator will use the instrument joystick to move the instrument to the 
correct distance from the eye, and to align the instrument axis (shown as a green cross overlay) 
with the reflection of the central reflected ring.   A red line indicates whether the instrument is too 
close or too far away from the participant’s eye.  
)LJXUH)RFXVH[DPSOHVVKRZLQJ7RR)DU,Q)RFXVDQG7RR1HDU


If it is not possible to move the instrument in to best focus due to obstruction by the eyebrow, 
instruct the participant to move their chin slightly further forward on the chinrest, or their 
forehead slightly back from the headrest. If the instrument is obstructed by the side of the nose, 
ask the participant to turn their head so that their nose moves further away from the instrument.
MEASURING TEAR BREAK-UP TIME
When the examiner is ready to commence the measurement, the participant is instructed to have a
final blink (the blink should be natural, not forceful) and then to stop blinking for as long as 
possible and continue to look straight ahead at the central green ring. NIBUT is measured as the 
time interval in seconds after the final blink to the first appearance of distortion in the reflected 
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Work Aid: NIBUT Measurement using Medmont E300 Corneal Topographer    
rings; or to the time that the participant has to blink due to discomfort. The investigator must 
watch for a change in the appearance of the ring pattern compared to the immediate post-blink 
appearance. Events that are considered distortions and thus endpoints include: debris that causes 
a break in the grid pattern, localized bending or blurring of a section of the ring pattern, or a
distinct doubling of any lines.
The standard measurement of tear film break-up time involves three measurements on each eye.  
Between measurements, ask the participant to sit back from the chinrest for at least 30 seconds 
and to blink naturally. Taking measurements too rapidly without a sufficient rest period can 
result in a gradually worsening (ie. decreasing) tear film break-up time.
)LJXUH$QH[DPSOHRIWKHDSSHDUDQFHRIWHDUEUHDNXS
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Work Aid: NIBUT Measurement using Medmont E300 Corneal Topographer    
SAVING THE SERIES OF IMAGES (OPTIONAL)
The raw images may be saved using “File/Save All Images”.
In order to also save the series of topography maps, click on “File/Analyze All” before “File/Save 
All Images”.

5.0
PHOTODOCUMENTATION
Not applicable
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Work Aid: NIBUT Measurement using Medmont E300 Corneal Topographer    
6.0
ADDITIONAL INFORMATION
Not applicable
7.0
TRAINING REQUIREMENTS
Read only
8.0
CASE REPORT FORM MODULE
The standard Bioclinica eCRF screen will record three measurements of NIBUT (in 
seconds) for each eye.
DOCUMENT CHANGE HISTORY
Originator
Change Description
Effective Date
R. Franklin
New specification.
October 21, 2014
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APPENDIX F: NON-INVASIVE KERATOGRAPHIC BREAK-UP TIME (NIKBUT) 
WORK AID  
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Work Aid: NIKBUT and tear meniscus height measurement with Oculus Keratograph 5M
WORK AID: Measurement of non-invasive tear break up time and tear meniscus 
height with the Oculus Keratograph 5M
1.0 OBJECTIVES
Perform two types of assessment of tear film quality using the Oculus Keratograph 5M 
instrument. Non-invasive keratographic tear break up time (NIKBUT) is an objective way of 
detecting the time period after a blink at which the tear film begins to become unstable, and the 
location of that instability.  Tear meniscus height is a measurement which is used to express the 
relative quantity of tears present in the eye.  Other functions of the Keratograph instrument such 
as corneal topography, meibography and ocular redness are not covered in this document.
2.0 MATERIALS
The Oculus Keratograph 5M multifunction diagnostic instrument is a clinical device 
manufactured by Oculus (Germany).
SOFTWARE VERSION
The instructions in this Appendix apply to software version 6.08r25 for patient data management.
Other versions of the software are unlikely to have substantial difference in basic function or data 
integrity.
3.0 DATA MANAGEMENT
The Oculus Keratograph 5M software generates computer files which are considered source data.  
At a minimum, the Source Data must be saved in a secure location and a backup copy created at 
the end of each study.
Primary source data are the image files, video files and the Oculus Keratograph 5M internal 
database. Secondary source data are output data files (.csv), still image files (.jpg, .png or .bmp),
video files (.mkv) and any on-screen data which are transferred to a paper or electronic Case 
Report Form. Tertiary source data are output data that has been transferred to an Excel sheet for 
further analysis.
4.0 PROCEDURES
CALIBRATION
The instrument does not require recalibration on site.
ROOM SETUP
Perform the examination in a dim or darkened room, and ensure that the area is free from 
sources of light which may reflect from the participant’s eye to the instrument.
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Work Aid: NIKBUT and tear meniscus height measurement with Oculus Keratograph 5M
PATIENT SELECTION
The recommended practice is to enter patient information before starting to capture and analyze
an exam. On the Home Screen (Figure 1), select the icon (indicated as number 1) to add a new 
patient. In a clinical trial, use the Last Name field to record the study name and subject number 
(eg. CR6285-007), use the First Name field to record the visit number and condition (eg. V1-
Bare) and use the Dat. o. B. field to record the date of the examination.
Figure 1: Oculus Keratograph 5M Home Screen
After entering in the Patient Information, choose “Keratograph” (shown as 2 above) to go to the 
Examination screen. To create a new examination, select “Examination” from the tool bar 
(indicated by number 1 in Figure 2). A drop down will appear, select “New.”
SELECTING MEASUREMENT TYPE
Once on the Examination screen, the type of measurement may be selected from the list
of available tests under TF-Scan:
x
Tear Meniscus Height: (indicated as number 2 in the figure below)
x
NIKBUT: (indicated as number 3 in the figure below)
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Work Aid: NIKBUT and tear meniscus height measurement with Oculus Keratograph 5M
Figure 2: Examination Screen
Figure 3: Tear Meniscus Height Illumination Screen
MEASUREMENT PROCEDURE
The patient should sit comfortably in the chair. Ask the patient to put their chin onto the chinrest 
and put their forehead firmly against the forehead rest. Ask the patient to look at the center of the 
fixation target and keep their gaze on this target. For the NIKBUT test, the target will be a red 
light. For tear meniscus height, there will not be a target, so instruct the patient to look straight 
ahead and maintain their gaze. 
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Work Aid: NIKBUT and tear meniscus height measurement with Oculus Keratograph 5M
NIKBUT
After selecting NIKBUT from the test menu, a red cross should appear in the center of 
the red ring that will be bordered by four bars when aligned. Select “IR” lighting in the 
Illumination box on the right side of the screen (indicated as number 4 in Figure 2).
Adjust the camera to the proper focus. The screen will prompt which corrections need to 
be made to reach the proper orientation. Once aligned and focused there will be a prompt 
to instruct the patient to blink 2 times.  Ask the patient to complete 2 full blinks and then 
hold their eye open as wide as they can for as long as they can. The instrument will start 
recording automatically and will stop when the patient blinks, or when there is extreme 
tear break up, or after 25 seconds. After conducting a NIKBUT test, allow approximately 
2 minutes for tear film recovery time before attempting another measurement. If the 
patient accidentally blinks too early or moves causing an incomplete scan, wait 
approximately 2 minutes before repeating the test. Remind the patient to try to hold open 
their eye for as long as they can.
Figure 4. Completed NIKBUT Examination
Tear Meniscus Height Image Capture
After selecting Tear Meniscus Height from the test menu, select 1.0 zoom and “White” 
lighting in the Illumination box on the right side of the screen. Adjust the camera focus so 
that the lower lid tear meniscus is more centrally displayed than it was during the 
NIKBUT test. Adjust the instrument until the tear meniscus is in best focus. Then instruct 
the patient to blink. At approximately 2 seconds after the blink, either select “Image” to 
capture the picture on the screen or press down on the foot pedal. A still image will be 
captured. Multiple images may be collected as specified in the study protocol.
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Work Aid: NIKBUT and tear meniscus height measurement with Oculus Keratograph 5M
Figure 5: Complete Tear Meniscus Height Examination
Measuring Tear Meniscus Height on a captured image
Once the image is taken, a new screen will appear. Measurement of tear meniscus height 
may be performed now, or the image may be reloaded at a later time for analysis.  The 
meniscus height will be measured at the point of the tear film that is straight down from
the center of the pupil. To begin a measurement, use the icon indicated by number 3 in 
Figure 4 to zoom in on the tear film, press the icon 6 times for the proper amount of 
zoom. Next, select the icon indicated by number 2 in Figure 4. Click on the upper most 
part of the tear meniscus, then click where the eyelid margin meets the eye. This will 
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Work Aid: NIKBUT and tear meniscus height measurement with Oculus Keratograph 5M
create a blue marker and provide a numerical measurement of tear meniscus height. If 
the measurement is not aligned or an error occurred, the icon indicated by number 1 in 
Figure 4 will delete the measurement. The measurements save to the computer 
automatically.
EXPORTING THE NIKBUT DATA
Under Patient List select the patient the data is needed for. Choose “Export” towards the bottom 
of the screen. On the Export patient data window, select “Folder” (indicated as number 1 in 
Figure 6) and then select the “…” (indicated as number 2 in Figure 6). A Browse for folder
window will open, the proper folder can be found under This PC (number 1 in Figure 7) then 
Windows (C:) (number 2 in Figure 7). Choose the TOPO folder (number 3 in Figure 7) then the 
study-specific folder (number 4 in Figure 7). Select OK to finish selecting the export location.
The window will close, select Export (indicated as number 3 in Figure 6) to save the data in the 
trial folder. The data may then be copied to a USB data drive for transfer to another computer 
and opened in Excel for further analysis. 
Figure 6. Export Patient Data Window
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Work Aid: NIKBUT and tear meniscus height measurement with Oculus Keratograph 5M
Figure 7. Browse for Folder Window
5.0
PHOTODOCUMENTATION
Not applicable
6.0
ADDITIONAL INFORMATION
Additional information may be found in the user manual for the instrument.
7.0
TRAINING REQUIREMENTS
Read only
8.0
CASE REPORT FORM MODULE
A number of different Bioclinica forms will be required for the recording of different 
types of data, depending on the needs of the study.
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APPENDIX G: LIPIVIEW II MANUFACTURER INSTRUCTIONS 
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012051-US Rev C   
 2016 TearScience, Inc. 
“TearScience” and “LipiView” are registered trademarks of TearScience, Inc. in the United States and other 
jurisdictions.  All other product or company names that may be mentioned in this publication are trade names, 
trademarks or registered trademarks of their respective owners. 
 
 
Revision History 
Revision 
Date 
Description of Changes 
ECR # or PCR # 
A 
19 Nov 2014 
Initial release of Instructions for Use for LipiView 
II/3.x software. 
P1407211 
B 
31 July 2015 
Made updates for software version 3.11.  Replaced 
Figure 6. Fixed minor typographical and formatting 
errors. 
P1502121 
C 
1 February 2016 
Previous revisions of this document were numbered 
012051-ENG. To accommodate the release of varied 
English versions, this document is now numbered as 
012051-US with the following applicable changes: 
Removed phrase "All of these image types can be 
photographically documented and visually 
monitored" from Indications for Use. 
Removed information pertaining to Model LVI-1001.  
Updated phototoxicity warning with ISO 15004-2 
required information.  
Clarified patient contact components and added 
disinfection of Lid Everter to Device Description and 
Warning sections (already described in Cleaning and 
Instructions sections of the manual).  
Added inspection of Lid Everter to Device 
Description and Instructions.  
Added USB mouse and keyboard to Accessory 
Support.  
Updated recording time from 10 to 5 seconds in 
Capture Ocular Images procedure.  
Updated document copyright date to 2016. 
P1601281 
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TearScience® LipiView® II Instructions for Use 
012051-US Rev C 
 2016 TearScience, Inc.
 
 
 
 
 
Page 3 of 47  
Contents
1 INTRODUCTION .........................................................................................................5 
2 IMPORTANT DEVICE INFORMATION ...........................................................................6 
2.1 
Indications for Use ................................................................................................................. 6 
2.2 
Contraindications ................................................................................................................... 6 
2.3 
Precautions ............................................................................................................................... 6 
2.4 
Warnings .................................................................................................................................. 6 
2.5 
Potential Adverse Effects ....................................................................................................... 9 
2.6 
Labeling .................................................................................................................................... 9 
2.7 
Device Description and Overview ..................................................................................... 10 
2.7.1 
Base with Computer System and Electronics ............................................................. 13 
2.7.2 
Forehead and Chin Rest with Fluted Roller ............................................................... 14 
2.7.3 
Motion Stage .................................................................................................................... 14 
2.7.4 
Camera and Attached Lens ........................................................................................... 14 
2.7.5 
Illuminator ........................................................................................................................ 14 
2.7.6 
Pushbutton Controls ...................................................................................................... 14 
2.7.7 
Touchscreen Display with Pivoting Arm .................................................................... 14 
2.7.8 
USB Ports ......................................................................................................................... 15 
2.7.9 
Handheld Near Infrared (IR) Lid Everter .................................................................. 15 
2.7.10 Operating Environment and Specifications ............................................................... 15 
2.7.11 Accessory Support ........................................................................................................... 15 
2.8 
Storage and Transport ......................................................................................................... 16 
2.9 
Installation, Maintenance and Servicing .......................................................................... 16 
2.10 
Cleaning.................................................................................................................................. 16 
2.11 
Disposal .................................................................................................................................. 17 
2.12 
Warranty ................................................................................................................................ 17 
3 INSTRUCTIONS FOR USE ........................................................................................... 18 
3.1 
Startup and Login ................................................................................................................. 18 
3.2 
First Time Device Setup ...................................................................................................... 19 
3.3 
Menu Bar ................................................................................................................................ 20 
3.4 
Enter and Select a Patient and Imaging Mode ................................................................. 21 
3.5 
Capture Tear Film Images (Lipid Imaging Mode) ......................................................... 22 
3.6 
Review Tear Film Images (Lipid Imaging Mode) ........................................................... 24 
3.7 
Capture Gland Images (Gland Imaging Mode) .............................................................. 27 
3.8 
Review Gland Images (Gland Imaging Mode) ................................................................ 31 
3.9 
Capture Ocular Images (Ocular Imaging Mode) ............................................................ 34 
3.10 
Review Ocular Images (Ocular Imaging Mode) .............................................................. 36 
3.11 
Log Out and Power Off ....................................................................................................... 37 
4 TROUBLESHOOTING GUIDE ..................................................................................... 38 
APPENDIX: ELECTROMAGNETIC COMPATIBILITY REQUIREMENTS .................................. 44 
 
 
 
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Figures
Figure 1. Front (Patient) View of LipiView II ..................................................................................... 11 
Figure 2. Rear (User) View of LipiView II ........................................................................................... 12 
Figure 3. Handheld Near Infrared (IR) Lid Everter ........................................................................... 13 
Figure 4. External Connectors on Underside of Base ........................................................................ 13 
Figure 5. Warning Screen ........................................................................................................................ 18 
Figure 6. Initialization Screen ................................................................................................................. 18 
Figure 7. Login Screen .............................................................................................................................. 18 
Figure 8. Patient Records Screen ............................................................................................................ 19 
Figure 9. Main Admin Screen ................................................................................................................. 19 
Figure 10. Menu Bar ................................................................................................................................. 20 
Figure 11. Patient Records Screen ......................................................................................................... 21 
Figure 12. Patient Entry Screen .............................................................................................................. 21 
Figure 13. Capture/View Screen ............................................................................................................ 21 
Figure 14. Lipid Image Capture Screen with Labeled Controls ....................................................... 23 
Figure 15. Export Dialog ......................................................................................................................... 24 
Figure 16. Interferometric Colors .......................................................................................................... 24 
Figure 17. Review Lipid Images Screen with Labeled Controls ....................................................... 25 
Figure 18. Example OD Image – Average Lipid Layer Thickness 39 nm ...................................... 26 
Figure 19. Example OS Image – Average Lipid Layer Thickness 100+ nm .................................. 26 
Figure 20. Everting Lower Eyelid using Handheld Near IR Lid Everter ........................................ 28 
Figure 21. Everting Upper Eyelid using Cotton Swab ....................................................................... 28 
Figure 22. Gland Image Capture Screen with Labeled Controls ..................................................... 29 
Figure 23. Pushbutton Controls (on top of unit) ............................................................................... 30 
Figure 24. Properly Focused Lower Lid Images: Reflected IR and Trans IR ................................. 31 
Figure 25. Gland Example Images:  No Dropout, Medium Dropout, High Dropout ................ 32 
Figure 26. Gland Dilation Example, Lower Lid .................................................................................. 32 
Figure 27. Review Gland Images Screen with Labeled Controls...................................................... 33 
Figure 28. Ocular Image Capture Screen with Labeled Controls .................................................... 35 
Figure 29. Review Ocular Images with Labeled Controls ................................................................. 36 
 
Tables
Table 1: General and Operation Warnings ........................................................................................... 7 
Table 2. Symbols Used on LipiView II Labeling ................................................................................... 9 
Table 3. System and Environmental Specifications ............................................................................ 15 
Table 4: LipiView II Cleaning Information ........................................................................................ 16 
Table 5. Main Admin Functions ........................................................................................................... 20 
Table 6: Troubleshooting Unexpected Events .................................................................................... 38 
Table 7. Operational System Messages and Descriptions.................................................................. 39 
Table 8: Guidance and Manufacturers Declaration-Electromagnetic Emissions ......................... 44 
Table 9: Guidance and Manufacturers Declaration-Electromagnetic Immunity (part 1) .......... 45 
Table 10: Guidance and Manufacturers Declaration-Electromagnetic Immunity (part 2)........ 46 
Table 11: Recommended Separation Distances Between Portable and Mobile RF 
Communications Equipment and LipiView II .......................................................................... 47 
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This manual provides the indications, contraindications, warnings, precautions, potential 
adverse effects and instructions for use for the TearScience® LipiView® II Ocular Surface 
Interferometer.  Carefully read this manual in its entirety before using LipiView II.  Failure 
to follow these instructions may result in improper use of the device. 
This manual provides essential information for safe and proper use of LipiView II.  
x
Section 2 (Important Device Information:  indications, contraindications, warnings, 
precautions, potential adverse effects, device description, storage and transport, service and 
maintenance, cleaning, disposal and warranty) 
x
Section 3 (Instructions for Use for Start-up, First Time Setup, Lipid Imaging, Gland 
Imaging and Ocular Imaging)  
x
Section 4 (Troubleshooting Guide) 
The LipiView II Administrator’s Guide contains information about the setup and 
administration of LipiView II.  
x
Prior to initial use of LipiView II, refer to Section 3.2 of this manual and/or the 
Administrator’s Guide to ensure proper setup (including requirements for operator 
(user) names, passwords, network connections and file storage.) 
NOTE: LipiView II has a firewall and disabled remote access to protect the device and ensure 
privacy of patient records over a network. However, if LipiView II is connected to a non-secure 
wireless network, exported patient data will not be protected from unauthorized access. 
TearScience recommends the LipiView II be connected to a password-protected wireless router 
utilizing the WPA or WPA2 security protocols to ensure protection of the device and patient 
records.  
 
Strong passwords do not contain words that appear in a dictionary, are at least six characters 
long, and consist of a mixture of letters and numbers. TearScience recommends that you choose 
a strong password and change it regularly (for example, every 90 days.) 
Contact TearScience (in North America, at +1 919 459 4891 or by email at 
customerservice@tearscience.com) with any questions about the information contained in this 
manual or for additional information on the safe and proper operation of LipiView II.  
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The LipiView II Ocular Surface Interferometer is an ophthalmic imaging device intended for 
use by a physician in adult patients to capture, archive, manipulate and store digital images of: 
x
Specular (interferometric) observations of the tear film. Using these images, LipiView 
II measures the absolute thickness of the tear film lipid layer. 
x
Meibomian glands under near-infrared (NIR) illumination 
x
The ocular surface and eyelids under white illumination 

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Contraindications are conditions in which the device should not be used because the risk of use 
clearly outweighs any benefit. No contraindications have been identified for LipiView II. 

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The following patient conditions may affect the interferometry assessment of a patient’s tear 
film using LipiView II: 
x
Use of ophthalmic drops such as artificial tear lubricants, ointments, and medications. 
Advise patients not to instill oil-based ophthalmic drops (e.g., Soothe, Restasis, Systane 
Balance) for at least 12 hours prior to device use and not to instill ointments for at least 24 
hours prior to device use. Wait at least 4 hours after instillation of all other ophthalmic 
drops prior to device use. 
x
Soft or rigid contact lens wear. Advise patients to remove contact lenses at least 4 hours 
prior to device use. 
x
Use of oil-based facial cosmetics around the eye.  
x
Eye rubbing.  
x
Recent swimming in a chlorinated pool. Advise patients not to swim for at least 12 hours 
prior to device use. 
x
Any ocular surface condition that affects the stability of the tear film. These conditions 
include disease, dystrophy, trauma, scarring, surgery, or abnormality. 

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Review the warnings in Table 1 prior to using LipiView II. 
 
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6CDNG)GPGTCNCPF1RGTCVKQP9CTPKPIU
 GENERAL WARNINGS
WARNING: No modification of this equipment is allowed. 
Caution: Power Requirements. The LipiView II is a continuous operation device which 
requires a power source of 100-240 Volts AC r 10%, 50/60 Hz single phase, 4 Amps. 
Connection to a power supply other than a supply mains with protective earth may result in 
electric shock. 
Caution: The LipiView II has protection against electric shock of applied part 
classified as Type B. This device is classified as an IEC Class 1 product. 
Caution:  Voltage Protection and Fuse Selection. Contact TearScience to replace a blown 
fuse. TearScience personnel must replace only with a 5 x 20 mm, 4 A, 300 ms, 40 A breaking 
capacity fuse to avoid risk of fire. TearScience personnel must disconnect from power before 
servicing to avoid risk of electrical shock. 
Caution:  Backup Battery Replacement.  Backup battery cannot be replaced.
Caution:  Keep the LipiView II away from strong magnetic fields as it could damage the 
device’s hard drive, but is not a safety hazard to the user or patient. 
Caution:  This equipment is intended for use by healthcare professionals only. This 
equipment may cause radio interference or may disrupt the operation of nearby equipment. 
It may be necessary to take mitigation measures, such as re-orienting or relocating the 
LipiView II or shielding the location. 
Caution:  Portable and mobile RF communications equipment can affect MEDICAL 
ELECTRICAL EQUIPMENT. 
Caution:  The use of ACCESSORIES, transducers and cables other than those specified, 
with the exception of transducers and cables sold by the manufacturer of the EQUIPMENT 
or DEVICE as replacement parts for internal components, may result in increased 
EMISSIONS or decreased IMMUNITY of the EQUIPMENT or DEVICE. 
Caution:  The EQUIPMENT or DEVICE should not be used adjacent to or stacked with 
other equipment and if adjacent or stacked use is necessary, the EQUIPMENT or DEVICE 
should be observed to verify normal operation in the configuration in which it will be used. 
Caution: Degree of protection against harmful ingress of liquid: IPX0. This equipment has 
no protection against ingress of liquids. 
Caution: This device is not suitable for use in the presence of flammable mixtures. 
Caution: This device is not suitable for use in oxygen rich environments. 
Caution: The device monitor and base unit may exceed 41°C. Device will remain within safe 
momentary contact temperature, below 51°C. 
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OPERATION WARNINGS 
Caution: Federal law restricts this device to sale by or on the order of a physician. 
Caution:  The chin and forehead rest surfaces and Handheld Near IR Lid Everter must be 
disinfected with alcohol immediately prior to use and prior to storage.
Caution:  Photo-toxicity hazard. No acute optical radiation hazards have been identified 
for LipiView II under intended use conditions. Since prolonged intense light exposure can 
damage the retina, the use of the device for ocular examination should not be unnecessarily 
prolonged. The retinal exposure dose for a photochemical hazard is a product of the radiance 
and the exposure time. Aphakes and persons with diseased eyes will be at greater risk. The 
risk may also be increased if the person being examined has had any exposure with the same 
instrument or any other ophthalmic instrument using a visible or near-infrared light source 
during the previous 24 hours. 
Caution:  The light emitted from this instrument is potentially hazardous. The longer the 
duration of exposure, the greater the risk of ocular damage. Exposure to light from the 
instrument when operated at maximum intensity will exceed the safety guideline after 8 
hours. 
Caution: To prevent pinching, do not put fingers near illuminator, lens or chin rest during 
focusing. Instruct patient not to place hands on LipiView II during operation, and not to put 
fingers near illuminator, lens or chin rest. 
Caution: If a problem occurs with LipiView II, identify the symptom then attempt to resolve 
the problem as indicated in Section 4, Troubleshooting Guide.  If the problem cannot be 
resolved, stop using the device and contact TearScience.  
Caution: To prevent electric shock or performance alteration, do not attempt to service the 
device or remove the cover. No maintenance is required for LipiView II, and the device and 
all of its associated parts are not serviceable by the user. 
Caution: In order to isolate this equipment from supply mains the equipment must be 
unplugged from the wall.  Do not position the equipment in a location which would prevent 
the unit from being unplugged in an emergency. 
Caution: Do not store this instrument in conditions where the temperature may rise above 
55°C or fall below -10°C. 
Caution: When lifting or handling LipiView II, caution should be taken to prevent injury or 
damage to the device. Prior to moving the device, put the monitor arm into a locked position 
and unplug the power cord from the wall. If an external monitor is attached, disconnect the 
external monitor prior to moving the device.
Caution: Shock hazard. Do not touch patient and device under top cover simultaneously. 
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Key 
1 
Hardwired HDMI connection for external monitor 
2 
Connector for Handheld Near IR Lid Everter 
3 
Connector for Power Cord 
2.7.1
Base with Computer System and Electronics 
The base houses the power connection and computer hardware. The base connects with the 
forehead and chin rest, motion stage and touchscreen display.  The on/off power switch (Figure 
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2) is located on the base opposite the chin rest.  An external monitor connection is hardwired 
into the base, as is a connection point for the Near IR lid everter.   
2.7.2 
Forehead and Chin Rest with Fluted Roller  
The adjustable forehead and chin rest is designed to allow proper positioning of the patient’s 
head to capture images.  To ensure a properly focused image, the patient must place his/her 
forehead and chin firmly against the forehead and chin rests. The chin rest may be raised or 
lowered to accommodate different facial dimensions by spinning the fluted roller.  The chin 
rest has a 2-position adjust (toward the device for Lipid imaging and away from the device for 
Gland and Ocular Imaging.)  
Two canthus alignment marks are located on the left and right sides of the forehead rest. 
Adjusting the chin rest to position the lateral canthus of the patient’s eye at these marks will 
optimize the range of camera motion.  
The forehead and chin rest come in contact with the patient. Disinfect the forehead and chin 
rest surfaces with alcohol immediately prior to use and prior to storage. 
2.7.3 
Motion Stage 
The motion stage contains the camera, illuminator and motor controls used to adjust the 
camera and illuminator. The height of the motion stage is adjusted as part of the image capture 
process, to position the camera correctly. 
2.7.4
Camera and Attached Lens 
The camera is located inside the motion stage and is not visible externally. The height of the 
camera is adjusted as part of the motion stage. The camera can also be adjusted left and right 
and backwards and forwards with separate controls. 
2.7.5 
Illuminator 
The grid-like fixture attached to the motion stage is the illuminator. The height of the 
illuminator is adjusted as part of the motion stage. There are no separate controls for the 
illuminator. 
2.7.6 
Pushbutton Controls  
LipiView II includes a pushbutton control keypad on top of the unit that may be used in all 
modes, to make it easier for the operator to capture images. 
2.7.7
Touchscreen Display with Pivoting Arm 
The touchscreen display is on a pivoting arm, which allows it to be positioned ± 45 degrees or ± 
90 degrees from its location shown in Figure 1.  To reposition the screen, press the button 
under the pivoting arm while moving the arm left or right to the approximate 45 or 90 degree 
location.  Release the button and continue moving the arm until it locks into place.  
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In addition to displaying images and information to the operator, the screen functions as a 
touchscreen user interface to the LipiView II.  The operator touches the screen to operate the 
motion stage and camera controls and capture images.  
2.7.8 
USB Ports 
The lower base of the touchscreen display contains three USB ports, located as shown in Figure 
2.  These ports may be used to connect a printer or storage device.  
2.7.9 
Handheld Near Infrared (IR) Lid Everter  
The Handheld Near Infrared (IR) Lid Everter is both a near-infrared light source and a shaped 
instrument that aids in the proper eversion of the lower eyelid.  The Near IR Lid Everter 
contacts the patient’s lower eyelid. Inspect the Near IR Lid Everter to ensure it is intact prior to 
use.  Disinfect the Near IR Lid Everter with alcohol immediately prior to use and prior to 
storage. Place the Near IR Lid Everter slightly below the lash line and move the instrument 
slightly inward and upward to evert the entire length of the lower eyelid. 
2.7.10 Operating Environment and Specifications 
System and environmental specifications are displayed in Table 3. 
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Input Voltage 
100 – 240 VAC, 50 – 60 Hz 
Product Safety Classification 
Type B Applied Part 
IEC 60601-1— Medical electrical equipment—Part 1: 
General requirements for safety 
 
IEC 60601-1-2 — Medical electrical equipment—Part 1: 
General requirements for safety—Section 2: Collateral 
standard—Electromagnetic compatibility—Requirements 
and tests; 
CISPR 11 (Class A, Group 1) 
Accuracy of lipid layer thickness measurement 
±10 nm 
Operating Temperature 
10°C to 35°C 
Operating Relative Humidity 
Up to 90% non-condensing 
Atmospheric Pressure 
700 hPa to 1060 hPa 
Storage Temperature 
-10°C to 55°C 
Transport Temperature 
5°C to 60°C 
 
2.7.11 Accessory Support 
LipiView II may be used with the following USB accessories that are compatible with Windows 
7 and USB 2.0: 
x
USB printer (Printer Support) 
x
USB external hard drive (External Backup Support) 
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x
USB flash drive (USB / Thumb Drive Support) 
x
USB mouse and keyboard (support for optional alternative to touchscreen controls) 
LipiView II is designed to operate wirelessly with other network devices, such as a printer.  
Placement of LipiView II should be within range of the network, if a network system is used. 
LipiView II may be used with an external monitor. The hardwired connection in the base will 
support HDMI or DVI inputs for an off-the-shelf external monitor, which has at least 1280 x 
1024 resolution and supports 60Hz frame rates. 
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Before storage, ensure the power switch is off, and the chin and forehead rest surfaces, as well as 
the Near  IR Lid Everter, are cleaned according to the instructions in Section 2.10, Cleaning.  
Store LipiView II in a way that prevents contamination and damage between uses.  
 
For transport, ensure power cord is unplugged and secured off the ground. Grip onto metal 
portion of the device in two locations: 1) under the base or under the head containing the 
motion stage; and 2) monitor arm behind the screen. Carefully lift and move the device in an 
upright position. 
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There are no specific installation requirements for LipiView II, other than unpacking the device 
from its carton and connecting power and accessories (the external monitor and Near IR Lid 
Everter.) The device is installed and ready to use safely and correctly if it passes its Power-On 
Self Test with no system errors. 
LipiView II performs a calibration process at startup.  LipiView II does not require preventive 
maintenance or scheduled calibration. If the touchscreen gets out of calibration, refer to the 
LipiView II Administrator’s Guide for instructions on how to recalibrate the touchscreen using 
the built-in utility. 
Expected life of LipiView II is 5 years. Note that no user serviceable components are inside the 
unit.   For Field Service, contact TearScience in North America at +1 919 459 4891 or by email 
at customerservice@tearscience.com.   
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Table 4 identifies the components of LipiView II that require cleaning. For each component, 
the frequency and method of cleaning is provided. 

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Component 
Frequency 
Method 
Chin rest and 
forehead rest 
Immediately prior to 
use and prior to storage 
Alcohol 
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surfaces 
 Handheld Near IR 
Lid Everter 
Immediately prior to 
use and prior to storage 
Alcohol 
Camera lens and 
Illuminator 
Monthly 
Wipe with a lint-free photographic quality 
lens cloth 
Touchscreen 
Display Monitor 
When soiled or as 
needed 
x
Power off the device. 
x
Apply window or glass cleaner to a 
cloth rag and wipe the screen  
x
Do not apply cleaner directly to the 
screen 
x
Do not clean the monitor with 
alcohol, paint thinner, benzene or 
compressed air 
LipiView II 
exterior, including 
keypad 
When soiled or as 
needed 
x
Wipe down exterior of the device with 
a mild soapy cloth 
x
Do not use bleach, chlorine or 
acetone-based solutions to clean any 
part of the chin rest or the system 
enclosure 
External monitor  
Follow manufacturer’s 
cleaning instructions 
Follow manufacturer’s cleaning 
instructions 
 

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LipiView II consists of an ABS plastic enclosure, aluminum chassis, circuit boards, and electrical 
components. In the unlikely event that the device is damaged and cannot be repaired, never 
dispose of the device.  Return LipiView II to TearScience using the contact information on the 
first page of this manual. 

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TearScience, Inc. warrants that each LipiView II:   1) is free from defects in materials and 
workmanship; and 2) conforms to TearScience Inc.’s official specifications.  The warranty 
period for each LipiView II is one year commencing on the date of purchase. Any tampering or 
modifications to the device by the user will void the warranty. 
 
 
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At startup, LipiView II performs a self-test, confirms camera connection, verifies system 
voltages, checks remaining hard drive space, and calibrates camera motors. 
 
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1. Ensure the power cord is plugged into an 
electrical outlet. The power cord connection is 
located underneath the base of the device. 
2. Power on LipiView II by pressing the rocker 
switch on the device base (refer to Figure 2).  
The touchscreen display is initially blank and 
then displays a “Welcome” message and other 
messages related to self-test and initialization.   
3. Press the OK button to acknowledge the 
warning (Figure 5) after ensuring the patient 
and operator are clear of the chinrest area.  The 
motion stage moves during system hardware 
self-test, which takes about 20 seconds. 
4. Touch the screen to continue when Figure 6 is 
displayed indicating that the device is ready for 
use. (Note that the software version displayed 
may differ from Figure 6.) 
5. When the Login screen (Figure 7) is displayed, 
enter the operator name and password using the 
onscreen keyboard. (Operator name and 
password are provided by the Administrator or 
TearScience trainer.)  Press Log In. 
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
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Prior to initial use, ensure that the following instructions are completed by an Administrator.  
Other administrative functions, detailed in LipiView II Administrator’s Guide, can be 
completed at the discretion of the Administrator. LipiView II has been set up with a default  
Operator Name (LIPIVIEW) and Password (LIPIVIEW) that has administrator privileges.   
After initial login, it is recommended but not required that the Administrator reset the 
password. 
 
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
1. Power on the system. 
2. When the Login screen (Figure 7) is 
displayed, enter LIPIVIEW for both the 
Username and Password. (The onscreen 
keyboard only supports uppercase characters.)  
Press Log In. The Patient Records screen 
(Figure 8) is displayed. 
3. Press the Gear icon [
] on Menu bar (Figure 
10) located in the upper right corner of the 
screen.  The Main Admin screen (Figure 9) is 
displayed. 
4. Press Operator Setup. Add additional operator 
usernames and set or change passwords as 
needed. 
Before capturing images, it is also recommended 
that the following items be set up using the 
functions on the Main Admin screen (Table 5).  

 
From Main Admin screen (Figure 9): 
5. Press Practice Info to enter Practice 
Information. 
6. Press System Info, then Press Set Date and 
Time to set System Date and Time.  
7. Press Network to set up network connections. 
8. Press Close to return to the Patient Records 
screen (Figure 8). 
 

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6CDNG/CKP#FOKP(WPEVKQPU
System Info 
System information, including software versions and important utilities 
(Calibrate Touchscreen, Set Date and Time, Set Up System for Packaging, 
Launch Remote Support, Software Update, Save Changes and Shut Down, Save 
as PDF) 
Practice Info 
Enter the name and business information for the medical practice 
System Log 
View the system log, which collects information about key system events and 
errors (useful for troubleshooting and technical support) 
Operator Setup 
Add or delete Operators (users) and/or Administrator
Export Setup 
Select file formats for records export 
Network 
View network information 
Hardware Status 
See comprehensive status information for the hardware and software 
Traceability Log 
View records of all traceable events to ensure data integrity (e.g., users 
added/deleted, treatment records moved from one patient to another) 
System Options
Set the automatic logout timer, choose display options
Modality 
Configuration 
Set options for Lipid Imaging or Gland Imaging modes 
Usage Summary 
View statistics about use, selected by configurable criteria
Data Management 
Delete or move patient records (creates a permanent record in the Traceability 
Log) 
Backup/Restore 
Backs up or restores LipiView II patient and treatment data to networked drive 
or other media 

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The menu bar (Figure 10), shown at the top of the screen, has the following icons. 
 
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Key 
1 
Patients Button – Touch to return to Patient Records screen (Figure 11) 
2 
Drawer Dropdown – Contains information on current patient and active imaging session 
(if any). Pull down to access patient history. 
When on Image Capture screens or Review Image screens, press Capture/View Button on 
menu bar to return to Capture/View screen (Figure 13). 
3 
Admin – Touch to access Administrator screens (requires access privileges) 
4 
Log Out 
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
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After Login, enter a new patient or search for an existing patient.  Select the patient to capture 
new images or view prior images. Then, select an imaging mode.  
 
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1. For a New Patient, select Add Patient on 
Patients Records screen (Figure 11) to display 
Patient Entry screen (Figure 12). 
2. Using onscreen keyboard, enter patient 
information, then press Save.  Patient records 
must include at a minimum: 
1) Patient ID or 
2) Last Name, First Name and Date of Birth 
(enter the month and date as two-digit 
numbers, and the year as a four-digit number: 
MM/DD/YYYY). 
3. For an Existing Patient, enter patient data 
(patient ID or name) in Search field on Patient 
Records screen (Figure 11) to locate the record. 
To edit patient data, press Pencil icon to the 
right of the list. 
4. Select the desired patient record from the 
patient listing table. 
NOTE: The step keys can be used to move 
backwards or forwards through the table.  When 
the list spans multiple pages, sort the table by 
pressing the header field by the desired column. 
Press the same header a second time to sort the 
table in the reverse order. A small triangle in the 
column header indicates the table is being 
displayed by this column. The triangle points 
down or up to specify the sorting direction. 
5. When Capture/View screen (Figure 13) 
displays, select an imaging mode (Lipid 
Imaging, Gland Imaging or Ocular Imaging) to 
capture new images or view prior images for 
that patient. Select All Exams to view all images 
in the patient’s history.
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
&DSWXUH7HDU)LOP,PDJHV/LSLG,PDJLQJ0RGH
1. To image the tear film lipid layer by specular reflection of light, select Lipid Imaging from the 
Capture/View screen (Figure 13) and press New. 
2. Disinfect the forehead and chin rest with alcohol prior to use. 
3. Ensure the chin rest is in closest position toward the device. 
4. Place the patient’s chin fully forward into chin rest and forehead firmly against forehead rest. 
Adjust the height of the chin rest by spinning the fluted roller until the temporal canthus is 
aligned with the marks on the left and right sides of the forehead rest. Instruct the patient to 
look at the orange fixation light. 
CAUTION:  To prevent pinching, do not put fingers near illuminator, lens or chin rest 
during focusing. Instruct patient not to place hands on LipiView II during operation, and 
not to put fingers near illuminator, lens or chin rest. 
5. Select OD (right eye) or OS (left eye) to image by touching the right or left side of the Lipid 
Image Capture screen (Figure 14).   
6. Position the camera using one or a combination of methods:  1) If the pupil is visible on 
screen, press autoposition reticle to automatically center the camera on the pupil.  2) Touch 
the desired location (toward pupil) on screen, which will automatically move the camera and 
center on the location.  3) Press the manual position buttons, as needed, until the pupil 
appears in the center of the screen.  (You may also use the keypad to position the camera.) 
NOTE:  Ensure the lower lid margin is visible to evaluate partial blinking   
7.
Focus the camera using one or a combination of methods: 1) Press autofocus reticle to focus 
(not necessary if reticle was already pressed to position camera); 2) press fine focus buttons to 
adjust the focus until the tear film image is clear.  (You may also use the keypad to focus the 
camera.) 
NOTE:  If the tear film image is not in focus, invalid video data may be saved.  
8. Press Capture button to begin recording approximately 20 seconds of video. The blinking red 
light indicates LipiView II is recording.  Press Capture button again to stop recording prior to 
20 seconds, if desired. 
9. Instruct the patient to blink naturally or to perform a squeezed blink, as desired. 
10. When recording is complete, the illuminator turns off.  Press Notes to add any notes to 
images, if desired. 
11. Review video using onscreen playback button. If image quality is suboptimal, delete video 
using Trashcan icon and recapture another image. 
12. Repeat steps 5 to 11 to capture an image of the other eye, if desired.   
13. Press Analyze to save and process the image(s). 
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Page 23 of 47  
(KIWTG.KRKF+OCIG%CRVWTG5ETGGPYKVJ.CDGNGF%QPVTQNU
 
Key 
1 
Magnify View Icon - OD (right eye) is currently in view. OS (left eye) side is currently 
greyed out. Touch icon to capture images for OS (left eye). 
2 
Capture Video Button – Press to begin recording. Appears as a rectangle during recording; 
press rectangle to stop recording before 20 seconds. 
3 
Select Position/Focus Button – Press to toggle display of manual focusing and positioning 
button controls on or off. 
4 
Autoposition/Autofocus Reticle – Once the pupil is visible on screen, press the reticle to 
automatically center and focus the image. 
5 
Manual Fine Focus Buttons  - Press plus or minus to focus image 
6 
Manual Positioning Buttons – Press to move camera left, right, up or down 
7 
Eye Position Indicator – Indicates the eye being imaged (OD in figure) 
8 
Analyze Button – Press to save, process and analyze captured imagery 
9 
Notes Button – Press to open notes field for text entry 
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Page 26 of 47  
1 Finis D, Pischel N, Schrader S, Geerling G. Evaluation of lipid layer thickness measurement of the tear film as a 
diagnostic tool for Meibomian gland dysfunction.  Cornea. 2013; 32(12):1549-53. 
The first images, labeled as “Example” on the Capture/View screen (Figure 13), are standard 
reference video images of eyes with different lipid layer thickness values, provided for purposes 
of comparison.  These videos allow the physician to observe differences in interference colors 
for a variety of tear films.  As shown in Figure 18, the thin lipid example image is an example of 
an average tear film lipid layer thickness of 39 nm, which is relatively thinner lipid layer with 
very little color appearing mostly gray.  Conversely, the thick lipid example image (Figure 19) is 
an example of an average tear film lipid layer thickness above 100, where brown and blue colors 
are visible indicating a relatively thicker lipid layer.   
 
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(KIWTG'ZCORNG15+OCIGĚ#XGTCIG.KRKF.C[GT6JKEMPGUUPO
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Page 27 of 47  

&DSWXUH*ODQG,PDJHV*ODQG,PDJLQJ0RGH
 
NOTE:  One person can both evert the lids and operate the device, using the pushbutton 
controls on the top panel with an external monitor positioned behind the patient where the 
operator can easily see it. Alternatively, imaging the meibomian glands can be easier to perform 
as a two-person procedure: one person everting the eyelids, and one person operating and 
focusing LipiView II.  
 
1. To image the meibomian glands, select Gland Imaging from the Capture/View screen (Figure 
13) and press New. 
2. Turn the room lights off (or down sharply) prior to imaging to ensure good contrast in the 
image quality. 
3. Disinfect the forehead and chin rest and Handheld Near IR Lid Everter with alcohol prior to 
use. Inspect Handheld Near IR Lid Everter to ensure it is intact prior to use. 
4. Ensure the chin rest is in the extended position away from the device (closer to the patient). 
5. Place the patient’s chin fully forward into chin rest and forehead firmly against forehead rest. 
Adjust the height of the chin rest by spinning the fluted roller until the temporal canthus is 
aligned with the marks on the left and right sides of the forehead rest. 
6. Select the upper or lower eyelid of the OD (right eye) or OS (left eye) to image  by touching 
the magnify view icon in the applicable quadrant on Gland Image Capture screen (Figure 22). 
(You may also use the buttons on the keypad.) 
7. Carefully evert the eyelid and ensure that the full extent of the meibomian glands is visible 
over the entire nasal to temporal length of the eyelid.  
a.
Evert entire length of lower eyelid:  place Handheld Near IR Lid Everter (Figure 20) 
slightly below lash line; while maintaining contact, pull the lid down and then roll 
instrument slightly inward and upward. 
b.
Evert upper lid at the top of the tarsal plate:  use a cotton swab, finger or other handheld 
instrument (Figure 21). Ensure the fingertip or cotton swab is not blocking the inner 
surface of the eyelid before capturing the image. 
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Page 28 of 47  
 

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*CPFJGNF0GCT+4.KF'XGTVGT
 
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8. Position the camera using onscreen or pushbutton controls (Figure 23) on top of the unit to 
center the image of the everted eyelid on the screen. Alternatively, when using the 
touchscreen, touch the desired location to center the image on the screen and the device will 
automatically center the image in that location. 
9. Press the autofocus reticle to focus the image using onscreen or pushbutton controls. If 
needed, press fine focus onscreen controls until the image is clear. (The F3 and F4 buttons on 
the keypad can also be used for fine focus.) 
NOTE: Ensure full extent of the glands is visible over entire nasal to temporal length of the 
eyelid. When imaging lower eyelid, toggle between Reflected IR and Trans IR views (Figure 
24) to ensure both views are of good image quality.  
10. Press Capture button using onscreen or pushbutton controls to capture image. 
11. Review gland image to ensure good image quality, including in both Reflected IR and Trans 
IR views for lower lid images (as shown in Figure 24).  If the image is suboptimal (e.g., blurred 
focus, poor centration, only a partial lid eversion, finger obscuring view, washed out), delete 
image by selecting the Trashcan icon and recapture the image.   Press Notes to add any notes 
to images, if desired. 
12. Repeat steps 6 to 11 to capture the remaining images of other eyelid locations until all four 
eyelid images (i.e., upper and lower eyelid of the right and left eyes) are captured for the 
patient, if desired.   
13. Press Analyze to save the image(s). 
NOTE:  PRESSING ANALYZE IS REQUIRED TO SAVE ALL IMAGES.           
 If Analyze is not pressed before exiting the imaging screen, a message will appear as a 
reminder to save the images. 
 
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Page 29 of 47  
(KIWTG)NCPF+OCIG%CRVWTG5ETGGPYKVJ.CDGNGF%QPVTQNU
Key 
1 
Autofocus Reticle - Press the reticle to automatically focus the image
2 
Select Position/Focus Button – Press to toggle display of manual focusing and positioning 
button controls on or off 
3
Camera Button – Press to capture still image 
4 
Magnify View Icon - OD (right eye) lower lid is currently in view 
Touch to image OD (right eye) upper lid. 
5 
Magnify View Icon - Touch to image OS (left eye) upper lid 
6 
Magnify View Icon - Touch to image OS (left eye) lower lid 
7 
Light Source - Toggle between Reflected IR and Trans IR illumination views to image 
lower lid. Only Reflected IR illumination is used for upper lid.
8 
Review Image Mode - Preview Captured Reflected IR, Trans IR and Merged images (after 
image capture, these small windows are populated with thumbnails of the different images) 
9 
Analyze Button – Press to save captured imagery 
10 Notes Button – Press to open notes field for text entry 
11 Manual Fine Focus Buttons  - Press plus or minus to focus image 
12 Manual Positioning Buttons – Press to move camera left, right, up or down 
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Page 30 of 47  
Gland Image Modes: 
x
Reflected IR view is shown for both upper and lower eyelid gland images. 
x
Trans (Transillumination) IR view is shown only for lower eyelid gland images, if 
images were captured using Handheld Near IR Lid Everter. 
x
Merged view is the combination of the Reflected IR and Trans IR views and is shown 
only for the lower eyelid gland images. 
 
 
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Key  
1 
Function Keys  
F1: In pre-capture view, toggles between Reflected IR and Trans IR mode 
F2: In post-capture review, changes view mode to captured Reflected IR image 
F3: In pre-capture mode, focuses in; post-capture review, changes view mode to captured 
Trans IR image 
F4: In pre-capture mode, focuses out; In post-capture review, changes view mode to 
captured Merged image 
2 
Select Eye/Lid - OD for right eye or OS for left eye and upper or lower lid 
3 
Position/Autofocus Buttons – Press up, down, right and left buttons to center on the 
desired lid. Tap to move in small increments or hold button down to move until released. 
Once lid is positioned, press reticle to autofocus. 
4 
Camera Button – Press to capture an image 
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Page 31 of 47  
 
 
1&.QYGT4GHNGEVGF+48KGY
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
5HYLHZ *ODQG ,PDJHV *ODQG ,PDJLQJ 0RGH
1. To review prior gland images for an existing patient: 
a.
Select the patient from the Patient Records screen (Figure 11).   
b.
On the Capture/View screen (Figure 13), select Gland Imaging to view prior gland 
images or select All Exams to view all prior images.   
c.
A list of prior images is shown on the Capture/View screen (Figure 13).  Drag and drop 
the desired images from the list to the sides of the screen marked “Drop Here”.  Touch 
the image again to display the Review Gland Images screen (Figure 27). 
2. If desired, press the Export icon at the bottom of the Review Gland Images screen (Labeled 4 
in Figure 27) to export or print images or report.  
3. From the Export dialog (Figure 15), press the button to save images or report to an external 
medium or network, or print a report.  Exported images can be displayed with or without 
patient demographics. 
The first images, labeled as “Example” on the Capture/View screen (Figure 13), are standard 
reference images of upper and lower eyelids with different gland findings, provided for purposes 
of comparison.  As shown in Figure 25, the image set labeled high dropout is an example of an 
eye with severely truncated meibomian glands.  The image set labeled as medium dropout is an 
example of an eye with some evidence of gland loss.  The image set labeled as no dropout is an 
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Page 32 of 47  
example of an eye with no signs of gland loss.  In Figure 26, the lower lid image labeled as 
dilation is an example of glands that appear dilated (enlarged), indicating a possible structural 
change or blockage.  
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Page 33 of 47  
(KIWTG4GXKGY)NCPF+OCIGU5ETGGPYKVJ.CDGNGF%QPVTQNU
Key 
1 
Full Screen Mode – Press to view screen in full screen mode 
2 
Image Details – Timestamp date of image collection and Operator name 
3 
Select View Mode:  Press to toggle between views; 
x
Reflected IR view (Light from above icon) 
x
Trans IR view (Light from below icon) – only displayed for lower lid images 
captured using Handheld Near IR Lid Everter 
x
Merged view (Lower Eyelid icon) – only displayed for lower lid images captured 
using Handheld Near IR Lid Everter 
x
Notes (Notepad icon) 
4 
Export Icon – Export saved images or report to external medium or print report 
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
&DSWXUH2FXODU,PDJHV2FXODU,PDJLQJ0RGH
In Ocular Imaging mode, high-resolution images of the surface of the eye or the eyelids can be 
taken.  White-light illumination may be switched on or off. 
1. To image the ocular surface or eyelids, select Ocular Imaging from the Capture/View screen 
(Figure 13) and press New.    
2. Disinfect the forehead and chin rest with alcohol prior to use. 
3. Ensure the chin rest is in the extended position away from the device. 
4. Place the patient’s chin fully forward into chin rest and forehead firmly against forehead rest. 
Adjust the height of the chin rest by spinning the fluted roller until the temporal canthus is 
aligned with the marks on the left and right sides of the forehead rest. Instruct the patient to 
look at the orange fixation light. 
CAUTION:  To prevent pinching, do not put fingers near illuminator, lens or chin rest 
during focusing. Instruct patient not to place hands on LipiView II during operation, and 
not to put fingers near illuminator, lens or chin rest. 
5. Select OD (right eye) or OS (left eye) to image by touching the right or left side of the Ocular 
Image Capture screen (Figure 28).   
6. Select to turn white light illumination on, or turn off to capture images using room 
illumination only. 
7. Position the camera by touching the desired location to be imaged on screen, which will 
automatically move the camera and center on the location. Press the position keys, as needed, 
until the location appears in the center of the screen. 
8. Press the reticle to autofocus, or press the fine focus buttons to adjust the focus until the 
image is clear.  
9. Press Camera icon to capture a still image. Press Capture Video button to begin recording 
approximately 5 seconds of video.  The blinking red light indicates LipiView II is recording 
video. Press Capture Video button again to stop recording prior to 5 seconds, if desired. You 
can capture up to 10 still images and one video per eye. 
10. When recording is complete, the illuminator turns off (if white illumination was turned on 
during imaging). Press Notes to add any notes to images, if desired. 
11. Review still image or video using onscreen playback button. If image quality is suboptimal, 
delete image using Trashcan icon and recapture another image. 
12. Repeat steps 5 to 11 to capture an image of the other eye, if desired.   
13. Press Save to save the video or image(s). 
 
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Page 35 of 47  
(KIWTG1EWNCT+OCIG%CRVWTG5ETGGPYKVJ.CDGNGF%QPVTQNU
 
Key 
1 
Eye Position Indicator – Indicates the eye being imaged (OD in figure) 
2 
Magnify View Icon – OD (right eye) is currently in view. OS (left eye) side is currently 
greyed out. Touch icon to capture images for OS (left eye). 
3 
Capture Video Button – Press to begin recording. Appears as a rectangle during 
recording; press rectangle to stop recording before 10 seconds. 
4 
Camera Button – Press to capture still image 
5 
Full Screen Mode – Press to view screen in full screen mode 
6 
Manual Positioning Buttons – Press to move camera left, right, up or down 
7 
Manual Fine Focus Buttons  - Press plus or minus to focus image 
8 
Autofocus Reticle - Press the reticle to automatically focus the image 
9 
Save Button – Press to save captured imagery 
10 Notes Button – Press to open notes field for text entry 
11 White Light Illumination – Press to toggle illuminator on or off
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Page 36 of 47  

5HYLHZ2FXODU,PDJHV2FXODU,PDJLQJ0RGH
1. To review prior ocular images or video for an existing patient: 
a.
Select the patient from the Patient Records screen (Figure 11).   
b.
On the Capture/View screen (Figure 13), select Ocular Imaging to view prior ocular 
images or select All Exams to view all prior images.   
c.
A list of prior images is shown on the Capture/View screen (Figure 13).  Drag and drop 
the desired images from the list to the sides of the screen marked “Drop Here”.  Touch 
the image again to display the Review Ocular Images screen (Figure 29). 
2. If desired, press the Export icon on the Review Ocular Images screen (Labeled 6 in Figure 29) 
to export or print images or report.  
3. From the Export dialog save, (Figure 15), press the icon to save images, video or report to an 
external medium or network, or print a report.  Exported images can be displayed with or 
without patient demographics. 
 
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Key
1 
Video Playback Controls – Press to play, pause, forward step, reverse step (for captured video 
only) 
2 
Full Screen Mode – Press to view screen in full screen mode 
3 
Video Preview 
4 
Image Preview 
5 
Notes Button – Press to open and view notes field for text entry 
6 
Export Icon – Export saved images, video or report to external medium or print report 
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Page 37 of 47  

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Press the Log Out tab (Labeled 4 in Figure 10) on the menu bar to log out when the device is 
not is use.  
 
Power off LipiView II overnight to allow the device to cool down.  The device does not need to 
be powered off between patient examinations during the day. 
 
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 2016 TearScience, Inc.
 
 
 
 
 
Page 44 of 47  
#RRGPFKZ'NGEVTQOCIPGVKE%QORCVKDKNKV[
4GSWKTGOGPVU
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LipiView II is intended for use in the electromagnetic environment specified below. The customer 
or the user of LipiView II should assure that it is used in such an environment. 
Emissions Test 
Compliance 
Electromagnetic Environment-Guidance 
RF emissions 
CISPR 11 
Group 1 
LipiView II uses RF energy only for its internal 
function. Therefore, its RF emissions are very low and 
are not likely to cause any interference in nearby 
electronic equipment. 
RF emissions 
CISPR 11 
Class A 
NA 
Harmonic emissions 
IEC 61000-3-2 
Class A 
NA 
Voltage fluctuations 
Flicker emissions 
IEC 61000-3-3 
Complies 
LipiView II is suitable for use in all establishments 
other than domestic and those directly connected to 
the public low-voltage power supply network that 
supplies buildings for domestic purposes. 
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Page 45 of 47  
  
6CDNG)WKFCPEGCPF/CPWHCEVWTGTU&GENCTCVKQP'NGEVTQOCIPGVKE
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LipiView II is intended for use in the electromagnetic environment specified below. The customer or the 
user of LipiView II should assure that it is used in such an environment. 
Immunity Test 
IEC 60601  
Test Level 
Compliance Level 
Electromagnetic Environment-
Guidance 
Electrostatic 
discharge (ESD) 
IEC 61000-4-2 
±6 kV contact 
±8 kV air 
±6 kV contact 
±8 kV air 
Floors should be wood, concrete or 
ceramic tile.  If floors are covered with 
synthetic material, the relative humidity 
should be at least 30% 
Electrical fast 
transient/burst 
IEC 61000-4-4 
±2 kV for power 
supply lines 
±1 kV for 
input/output 
lines 
±2 kV for power 
supply lines 
±1 kV for 
input/output lines 
Mains power quality should be that of a 
typical commercial or hospital 
environment 
Surge 
IEC 61000-4-5 
±1 kV 
differential 
mode 
±2 kV common 
mode 
±1 kV differential 
mode 
±2 kV common 
mode 
Mains power quality should be that of a 
typical commercial or hospital 
environment. 
Voltage dips, short 
interruptions and 
voltage variations 
on power supply 
input lines 
IEC 61000-4-11 
<5 % UT 
(>95 % dip in 
UT for 0,5 cycle 
40 % UT 
(60 % dip in UT) 
for 5 cycles 
 
70% UT 
(30% dip in UT) 
 for 25 cycles 
 
<5% UT 
(>95 % dip in 
UT) 
for 5 sec 
<5 % UT 
(>95 % dip in UT for 
0,5 cycle 
40 % UT 
(60 % dip in UT) 
for 5 cycles 
 
70% UT 
(30% dip in UT) 
 for 25 cycles 
 
<5% UT 
(>95 % dip in UT) 
for 5 sec 
Mains power quality should be that of a 
typical commercial or hospital 
environment.  If the user of the 
equipment requires continued operation 
during power mains interruptions, it is 
recommended that the equipment be 
powered from an uninterruptible power 
supply or a battery. 
 
Power frequency 
(50/60 Hz) 
magnetic field 
IEC 61000-4-8 
3 A/m 
3 A/m 
Power frequency magnetic fields should 
be at levels characteristic of a typical 
location in a typical commercial or 
hospital environment. 
*NOTE:  UT is the a.c. mains voltage prior to application of the test level. 

 
 
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TearScience® LipiView® II Instructions for Use 
012051-US Rev C 
 2016 TearScience, Inc.
 
 
 
 
 
Page 46 of 47  
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LipiView II is intended for use in the electromagnetic environment specified below. The customer or 
the user of LipiView II should assure that it is used in such an environment. 
Immunity Test 
IEC 60601 Test 
Level 
Compliance 
Level 
Electromagnetic Environment-Guidance 
 
 
 
 
 
 
 
 
 
Conducted RF 
IEC 61000-4-6 
 
 
 
Conducted RF 
IEC 61000-4-3 
 
 
 
 
 
 
 
 
 
3 Vrms 
150 kHz to 80 
MHz 
 
 
 
3 Vrms 
80 MHz to 2,5 
GHz 
 
 
 
 
 
 
 
 
 
 
10 V  
 
 
 
 
3 V/m  
Portable and mobile RF communications 
equipment should be used no closer to any part 
of the LipiView II, including cables, than the 
recommended separation distance calculated 
from the equation applicable to the frequency of 
the transmitter. 
 
Recommended Separation Distance 
 
d =  [3.5/V1]√ P   
d =  [3.5/E1]√ P  80MHz to 800MHz 
d =  [7.0/E1]√ P  800MHz to 2.5GHz 
 
Where P is the maximum output power rating of 
the transmitter in watts (W) according to the 
transmitter manufacturer and d is the 
recommended separation distance in meters (m). 
Field strengths from fixed RF transmitters, are 
determined by an electromagnetic site survey, a 
should be less than the compliance level in each 
frequency range. b 
Interference may occur in the vicinity of 
equipment marked with the following symbol: 
 
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. 
 
NOTE 2 These guidelines may not apply in all situations.  Electromagnetic propagation is affected by 
absorption and reflection from structures, objects and people. 
a    Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and 
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted 
theoretically with accuracy.  To assess the electromagnetic environment due to fixed RF transmitters, an 
electromagnetic site survey should be considered.  If the measured field strength in the location in which the 
LipiView II is used exceeds the applicable RF compliance level above, the LipiView II should be observed to 
verify normal operation.  If abnormal performance is observed, additional measures may be necessary, such as 
re-orienting or relocating the LipiView II. 
b    Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 
 
 

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TearScience® LipiView® II Instructions for Use 
012051-US Rev C 
 2016 TearScience, Inc.
 
 
 
 
 
Page 47 of 47  
6CDNG4GEQOOGPFGF5GRCTCVKQP&KUVCPEGU$GVYGGP2QTVCDNGCPF
/QDKNG4(%QOOWPKECVKQPU'SWKROGPVCPF.KRK8KGY++
 
 
LipiView II is intended for use in an electromagnetic environment in which radiated RF 
disturbances are controlled. The customer or the user of  LipiView II can help prevent 
electromagnetic interference by maintaining a minimum distance between portable and mobile 
RF communications equipment (transmitters) and LipiView II as recommended below, 
according to the maximum output power of the communications equipment.
  
Separation distance according to frequency of transmitter 
m 
  
Rated maximum 
output power of 
transmitter            
W                      
150 kHz to 80 MHz 
 
d=[3.5/V1]√ P 
80 MHz to 800 MHz 
 
d=[3.5/ E1]√ P    
800 MHz to 2,5 
GHz 
d=[7/E1]√ P 
0,01 
0.12 
0.12 
0.23 
0,1 
0.37 
0.37 
0.74 
1 
1.2 
1.2 
2.3 
10 
3.7 
3.7 
7.4 
100 
12 
12 
23 
For transmitters rated at a maximum output power not listed above, the recommended 
separation distance d in meters (m) can be estimated using the equation applicable to the 
frequency of the transmitter, where P is the maximum output power rating of the transmitter in 
watts (W) according to the transmitter manufacturer. 
 
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range 
applies. 
 
NOTE 2 These guidelines may not apply in all situations.  Electromagnetic propagation is 
affected by absorption and reflection from structures, objects and people.  
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APPENDIX H: LID WIPER EPITHELIOPATHY WORK AID 
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the dyed portion of the strip with the conjunctiva.  The entire dyed length of the strip should contact the 
conjunctiva.  Instill the dye to one of the following locations: 
a.
The inferior cul-de-sac of one eye if bulbar conjunctival staining is to be assessed as part of the 
protocol.  If instilling the dye in this location take care that the lower lid wiper is not touched during 
instillation. 
b.
The superior bulbar conjunctiva if conjunctival staining is not going to be assessed as part of the 
protocol. If instilling the dye in this location take care that the upper lid wiper is not touched during 
instillation. 
5.
With a new dye strip, immediately repeat steps 1-4 for the same eye to complete a second strip dose for the 
first dye instillation. 
6.
Perform the next step after a wait time of 1 minute.    
7.
With two new dye strips, perform a second instillation of lissamine green dye by repeating steps 1 through 
5. Note that four dye strips have been used for one eye.  
8.
Perform the next step after a wait time of 3 minutes.  
9.
Evert the lower eyelid of one eye with care to avoid contact with the lid wiper. 
10. Evaluate the lower lid margin under white light, 10X magnification recommended. 
11. Examine the entire horizontal length of the lid wiper from the punctum to the lateral canthus. Preferred 
method of grading of length in mm is via slit lamp reticle, but slit beam length may also be used if needed.   
Grade the horizontal length of staining observed to the nearest mm as shown in Table 1 on a scale of 0 to 3.  
Note that if there are separate areas of staining along the entire horizontal length of the lid wiper, sum the 
areas together to determine the grade.  Document the horizontal length staining grade. 
 
Table 1:  Horizontal Length of Lid Wiper Grading Scale 
GRADE 
HORIZONTAL LENGTH OF STAINING 
0 
< 2 mm 
1 
2 ≥ to < 4.5 mm 
2 
4.5 ≤ to < 9.5 mm 
3 
≥ 9.5 mm 
 
12. Examine the entire sagittal height (width) of the lid wiper from proximal to the line of Marx to the subtarsal 
fold.  Grade the sagittal height of staining observed based on the percentage of staining over the width of 
the lid wiper, as shown in Table 2 on a scale of 0 to 3.  Note that if there is a range of staining along the 
width of the lid wiper, estimate the average width to determine the grade.  Document the sagittal height 
staining grade.  
 
Table 2:  Sagittal Height (Width) of Lid Wiper Grading Scale 
GRADE 
SAGITTAL HEIGHT (WIDTH) OF STAINING 
0 
< 25% 
1 
25% to < 50% 
2 
50% to < 75% 
3 
≥ 75% 
 
 
13. Repeat steps 9 through 12 on the upper lid.   
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14. If eyelid photography is indicated, follow the steps in Appendix A.  Repeat all of the above steps for the for 
the fellow eye. 
 
Grading: 
 
 
OD 
OS 
Area 
Upper Lid (UL) 
Lower Lid (LL) 
Upper Lid (UL) 
Lower Lid (LL) 
Horizontal 
 
 
 
 
Sagittal 
 
 
 
 
   
Note that there is no averaging of the grading.  There will be 8 LWE grades recorded per subject evaluation.   
For reference, a photographic example of horizontal length and sagittal height grading of the lid wiper under 
lissamine green staining is shown in Figure 2. 
 
The horizontal length of lissamine green staining on the lid wiper is observed in two sections (between the two 
white and two black lines) and when combined the total length is over 10 mm long, which is scored as Grade 3. 
The staining of the sagittal height (width) of the lid wiper shows a range of widths (between the two sets of 
black arrows) that is estimated to be an average of 25% to <50% across all stained areas of the lid wiper and is 
scored as Grade 1.   
 
 
Figure 2:  Photographic Example of LWE Grading 
 
REFERENCES 
1.
Korb DR, Herman JP, Greiner JV, et al. Lid wiper epitheliopathy and dry eye symptoms. Eye & Contact Lens 
2005:31:2-8. 
2.
Efron N, Brennan NA, Morgan PB, et al. Lid wiper epitheliopathy.  Progress in Retinal and Eye Research 
53(2016) 140-174. 
 
 
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10.Magnification 6.3X 
 
 
11.Recommended aperture: 2.  Note 
that lower apertures allow more 
light for photography, but reduce 
the depth of focus. 
 
12.Recommended shutter speed: 4 
(1/60).  Note that a longer shutter 
speed will allow more light for 
photography but may result in a 
motion blurred image. 
13.Recommended sensor rating ISO 
1000.  Note that ISO sensitivity can 
be increased to brighten the image. 
 
14.Remove background light rod and 
insert test rod.  
 
 
 
 
 
 
 
 
 
 
 
 
            Background Light Rod 
 
  Test Rod 
15.Examiners who do not wear glasses: 
Pull the occluders out as far as they 
will go. 
Examiners who do wear glasses: 
Push the occluders in as far as they 
will go. 
 
Each eyepiece should be set 
individually by turning the knurled 
ocular refraction ring. 
 
 
 
Occluder In 
 
 
          Occluder Out 
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entire stain corner to corner is 
visible.  Ensure that the fingers 
are low and flat enough so they 
do not cast a shadow on the lid.   
21. Center the camera optimally 
such that edge to edge of the lid 
is within the field of view (FOV). 
 
Note the difference in field of view 
between eye piece and acquired 
image (acquired image has larger 
FOV horizontally than eye piece).  
 
 
 
 
 
 
 
Circle: The field of 
view of the object observed 
through the microscope's eyepiece. 
Rectangle: Area of photograph. 
22. If using the specular reflection 
reduction cross polarizer system 
is desired, rotate the polarizer 
until the specular reflection is 
minimized. 
                            
 
23. Ensure the entire LWE stain 
from corner to corner is within 
the field of view and is in focus.  
Ensure that the crosshair is also 
in focus.  Capture Image by 
pressing blue bar on base of 
unit. 
 
24. Review the image that is 
presented on the computer 
monitor.  Verify that the field of 
view includes the LWE stain 
from corner to corner and the 
entire stain is in focus.  Acquire 
3 images for the lower lid.  
Repeat above steps and acquire 
3 images for the upper lid.   
 
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APPENDIX I: MEIBOMIAN GLAND EVALUATOR 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6332 Ocular Characteristics in Contact Lens and Spectacle 
Wear
Version and Date: 4.0 16 April 2019
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.
Principal 
Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
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