Short-Term Clinical Comparison of Two Silicone Hydrogel Daily Disposable Contact Lenses
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

 
 
Johnson & Johnson Vision Care, Inc. 
 
Clinical Study Protocol 
 
Short-Term Clinical Comparison of Two Silicone Hydrogel Daily Disposable Contact 
Lenses 
 
Protocol CR-5932 
Version:  2.0, Amendment 1.0 
Date: 14-March-2017 
Investigational Products:  ACUVUE OASYS® 1·Day and 1·DAY ACUVUE® TruEye®, 
in flat and steep base curves  
Key Words: Senofilcon A, narafilcon A, ACUVUE OASYS® 1·Day and 1·DAY 
ACUVUE® TruEye®, base curve, daily wear, non-dispensing  
 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines: 
This trial will be conducted in compliance with the protocol, the International Conference 
on Harmonisation Good Clinical Practice E6 (ICH-GCP), ISO 14155, the Declaration of 
Helsinki, 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. 
 
 
 
 
 
 
 
CR-5932, v2.0
       Page 1 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
TABLE OF CONTENTS  
PROTOCOL TITLE, NUMBER, VERSION ......................................................................6 
SPONSOR NAME AND ADDRESS ..................................................................................6 
MEDICAL MONITOR ........................................................................................................6 
AUTHORISED SIGNATURES ..........................................................................................7 
CHANGE HISTORY...........................................................................................................8 
SYNOPSIS ...........................................................................................................................9 
Figure 1: Study Flowchart ..............................................................................................12 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS ...............13 
1. INTRODUCTION AND BACKGROUND ................................................................14 
1.1. 
Name and Descriptions of Investigational Products ............................................14 
1.2. 
Intended Use of Investigational Products .............................................................14 
1.3. 
Summary of Findings from Nonclinical Studies ..................................................14 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ...............................14 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study .......................................................................................................14 
2. STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................14 
2.1. 
Objectives .............................................................................................................14 
2.2. 
Endpoints ..............................................................................................................14 
2.3. 
Hypotheses ...........................................................................................................16 
3. TARGETED STUDY POPULATION ........................................................................16 
3.1. 
General Characteristics .........................................................................................16 
3.2. 
Inclusion Criteria ..................................................................................................16 
3.3. 
Exclusion Criteria .................................................................................................17 
3.4. 
Enrolment Strategy ...............................................................................................18 
4. STUDY DESIGN AND RATIONALE .......................................................................18 
4.1. 
Description of Study Design ................................................................................18 
4.2. 
Study Design Rationale ........................................................................................18 
4.3. 
Enrolment Target and Study Duration .................................................................18 
5. TEST ARTICLE ALLOCATION AND MASKING ..................................................18 
5.1. 
Test Article Allocation .........................................................................................18 
5.2. 
Masking ................................................................................................................19 
5.3. 
Procedures for Maintaining and Breaking Randomisation Codes .......................19 
6. STUDY INTERVENTION ..........................................................................................20 
6.1. 
Identity of Test Articles ........................................................................................20 
Table 1: Test Articles ......................................................................................................20 
CR-5932, v2.0
        Page 2 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
6.2. 
Ancillary Supplies/Products .................................................................................21 
Table 2: Ancillary Supplies ............................................................................................21 
6.3. 
Administration of Test Articles ............................................................................21 
6.4. 
Packaging and Labelling ......................................................................................21 
6.5. 
Storage Conditions ...............................................................................................22 
6.6. 
Collection and Storage of Samples ......................................................................22 
6.7. 
Accountability of Test Articles ............................................................................22 
7. STUDY EVALUATIONS ...........................................................................................23 
7.1. 
Time and Event Schedule .....................................................................................23 
Table 3: Time and Events ...............................................................................................23 
7.2. 
Detailed Study Procedures ...................................................................................23 
VISIT 1 ...................................................................................................................... 23 
FINAL EVALUATION ............................................................................................ 26 
7.3. 
Unscheduled Visits ...............................................................................................27 
7.4. 
Laboratory Procedures .........................................................................................28 
8. SUBJECTS COMPLETION/WITHDRAWAL...........................................................28 
8.1. 
Completion Criteria ..............................................................................................28 
8.2. 
Withdrawal/Discontinuation from the Study .......................................................28 
9. PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ..............29 
10. DEVIATIONS FROM THE PROTOCOL ..................................................................29 
11. STUDY TERMINATION ...........................................................................................29 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS ..............30 
13. ADVERSE EVENTS ...................................................................................................31 
13.1. Definitions and Classifications .............................................................................31 
13.2. Assessing Adverse Events ....................................................................................33 
13.2.1 Causality Assessment .................................................................................... 33 
13.2.2 Severity Assessment ...................................................................................... 34 
13.3. Documentation and Follow-Up of Adverse Events .............................................34 
13.4. Reporting Adverse Events ....................................................................................35 
13.4.1 Reporting Adverse Events to Sponsor ........................................................... 36 
13.4.2 Reporting Adverse Events to the Responsible IEC/IRB and Health 
Authorities ................................................................................................................. 36 
13.5. Event of Special Interest .......................................................................................37 
13.6. Reporting of Pregnancy ........................................................................................37 
14. STATISTICAL METHODS ........................................................................................37 
14.1. General Considerations ........................................................................................37 
14.2. Sample Size Justification ......................................................................................37 
CR-5932, v2.0
        Page 3 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
14.3. Analysis Populations ............................................................................................38 
14.4. Level of Statistical Significance ...........................................................................38 
14.5. Primary Analysis ..................................................................................................38 
14.6. Secondary Analysis ..............................................................................................39 
14.7. Other Exploratory Analyses .................................................................................40 
14.8. Interim Analysis ...................................................................................................40 
14.9. Procedure for Handling Missing Data and Drop-Outs .........................................40 
14.10. Procedure for Reporting Deviations from Statistical Plan ...................................41 
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................41 
15.1. Electronic Case Report Form/Data Collection .....................................................41 
15.2. Subject Record .....................................................................................................41 
16. DATA MANAGEMENT.............................................................................................42 
16.1. Access to Source Data/Document ........................................................................42 
16.2. Confidentiality of Information .............................................................................42 
16.3. Data Quality Assurance ........................................................................................42 
17. MONITORING ............................................................................................................43 
18. ETHICAL AND REGULATORY ASPECTS ............................................................43 
18.1. Study-Specific Design Considerations .................................................................43 
18.2. Investigator Responsibility ...................................................................................43 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) ..........43 
18.4. Informed Consent .................................................................................................45 
18.5. Privacy of Personal Data ......................................................................................45 
19. STUDY RECORD RETENTION................................................................................46 
20. FINANCIAL CONSIDERATIONS ............................................................................47 
21. PUBLICATION ...........................................................................................................47 
22. REFERENCES ............................................................................................................48 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 49 
APPENDIX B: PATIENT INSTRUCTION GUIDE ........................................................55 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ....................................56 
APPENDIX D: GRADING & MEASUREMENT SYSTEM ...........................................61 
APPENDIXE
DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS ................................................................................................................65 
APPENDIX F: 
 BIOMICROSCOPY SCALE .................................................72 
APPENDIXG: 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION
 
………………………………………………………………………………………..78 
APPENDIX H: TOPOGRAPHY MEASUREMENT USING MEDMONT E300 
CORNEAL TOPOGRAPHER ..........................................................................................83 
CR-5932, v2.0
        Page 4 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
APPENDIX I: MEASURING THE OCULAR TOPOGRAPHY BY VISANTE OCT ....89 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE .....................92 
 
LISTING OF TABLES  
Table 1: Test Articles ......................................................................................................... 20 
Table 2: Ancillary Supplies ............................................................................................... 21 
Table 3: Time and Events .................................................................................................. 23 
 
LISTING OF FIGURES 
Figure 1: Study Flowchart ................................................................................................. 12 
CR-5932, v2.0
        Page 5 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
PROTOCOL TITLE, NUMBER, VERSION  
Title: Short-Term Clinical Comparison of Two Silicone Hydrogel Daily Disposable 
Contact Lenses 
Protocol Number: CR-5932 
Version: 2.0, Amendment 1.0 
Date: 14-March-2017 
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care, Inc. (JJVC) 
7500 Centurion Parkway,  
Jacksonville, FL 32256 
MEDICAL MONITOR 
Name:  
 
Title:  Associate Director, Global Strategic Medical Affairs for EMA and Regional GMA 
Team Lead 
Address: Johnson & Johnson Medical Ltd., Pinewood Campus, Nine Mile Ride, 
Wokingham RG40 3EW. 
  
Email: asulley1@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. 
 
 
CR-5932, v2.0
       Page 6 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
SYNOPSIS  
 
Protocol Title 
Short-Term Clinical Comparison of Two Silicone Hydrogel 
Daily Disposable Contact Lenses 
Sponsor 
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256 
Clinical Phase 
Post Marketing (Marketing claims), Phase 4  
Trial Registration 
This study will be registered on ClinicalTrials.gov by the 
Sponsor  
Test Article(s) 
Investigational Products:  Senofilcon A contact lens in flat 
and steep base curves. 
Control Products:  Narafilcon A contact lens in flat and 
steep base curves. 
Wear and Replacement 
Schedules 
Wear Schedule:  Daily wear 
Replacement Schedule:  Not applicable 
Objectives  
When introducing an updated version of an existing contact 
lens, it is helpful to compare it against the existing product 
in order to ensure it provides comparable, if not better, 
comfort, vision, and lens fit.  It also gives insights into the 
ease of transition from one lens to the other.  The main 
purpose of this study is to compare the performance of a 
new daily disposable silicone hydrogel lens (ACUVUE 
OASYS® 1·Day) with that of an existing similar lens: 
1·DAY ACUVUE® TruEye® 
Study Endpoints 
Primary Endpoints:  
The primary endpoints are overall lens fit acceptability and 
lens power requirement. 
Secondary Endpoints: 
The secondary endpoints are subjective ratings of comfort, 
vision, quality and handling as well as high contrast visual 
acuity. 
Study Design 
This will be a 2 period one-day, double-masked, 
randomised, repeated measures, non-dispensing, cross-over 
study.  Each subject will wear the steeper base curve of each 
design in one eye while the flatter base curve of each will be 
worn in the other.  The two base curves of a given lens type 
will be worn simultaneously (i.e. contralaterally).  A total of 
four lenses will therefore be worn by each subject (2 per 
eye).  Lenses will be evaluated after 30-45 minutes settling. 
See the flow chart at the end of the synopsis table for the 
schematic of the study assessments and procedures of main 
observations. 
CR-5932, v2.0
        Page 9 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
Sample Size 
45 to 60 eligible subjects will be enrolled and randomised 
into the study.  A replacement subject may be enrolled if a 
subject discontinues from the study prematurely; the 
decision whether to enrol replacement subjects will be made 
by the joint agreement of the Investigator and Sponsor. 
Study Duration 
Approximately 8 weeks 
Anticipated Study 
Population 
Habitual soft contact lens users, myopes and hyperopes with 
astigmatism less than or equal to 1.00 D.  Age range: 18-55 
years. 
Eligibility Criteria 
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study: 
1. The subject must read and sign the Informed Consent 
form. 
2. The subject must appear able and willing to adhere to 
the instructions set forth in this clinical protocol. 
3. Healthy adult males or females aged 18-55 years. 
4. The subject’s spherical contact lens requirement in the 
range +2.00 D to +4.00 D or -1.00 D to -6.00 D. 
5. The subject’s refractive cylinder must be ≤1.00 D in 
each eye. 
6. The subject must have visual acuity best correctable to 
6/9 (20/30) or better for each eye. 
7. The subject is a current soft contact lens wearer 
(defined as a minimum of 6 hours of DW per day, at 
least 5 days per week, for a minimum of 1 month prior 
to the study). 
8. The subject must have normal eyes (i.e., no ocular 
medications or infections of any type). 
Potential subjects who meet any of the following criteria 
will be excluded from participating in the study:  
1. Currently pregnant or lactating 
2. Any systemic disease (e.g., Sjögren’s Syndrome), 
allergies, 
infectious 
disease 
(e.g., 
hepatitis, 
tuberculosis), contagious immunosuppressive diseases 
(e.g., HIV), autoimmune disease (e.g. rheumatoid 
arthritis), or other diseases, by self-report, which are 
known to interfere with contact lens wear and/or 
participation in the study. 
3. Use of systemic medications (e.g., chronic steroid use) 
that are known to interfere with contact lens wear. 
4. 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  
CR-5932, v2.0
        Page 10 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
5. Extended wear contact lens correction. 
6. Any current use of ocular medication. 
7. Any previous, or planned (during the course of the 
study) ocular surgery (e.g., radial keratotomy, PRK, 
LASIK, etc.) 
8. Any greater than Grade 2 slit lamp findings (e.g., 
oedema, corneal neovascularisation, corneal staining, 
tarsal abnormalities, conjunctival injection) on the FDA 
classification scale or any other ocular abnormality that 
may contraindicate contact lens wear. 
9. Any contact lens-related history or signs of a corneal 
inflammatory event, or any other ocular abnormality 
that would contraindicate contact lens wear. 
10. Participation in any contact lens or lens care product 
clinical trial within 14 days prior to study enrolment. 
11. Employee, relative or friends of employees of any 
ophthalmic company, or investigational clinic (e.g., 
Investigator, Coordinator, Technician). 
Disallowed 
Medications/Interventions  
See above 
Measurements and 
Procedures 
Vision:  High and low contrast visual acuity with CLs and 
spherical over-refraction (logMAR), vision quality (0-100). 
Comfort:  On insertion and on settling (0-10, 11-point 
scale). 
Handling – subject graded (0-10) 
Lens fit:  Horizontal & vertical centration, post-blink 
movement in primary gaze and up-gaze, version lag, edge 
tightness, tightness (push-up), diameter acceptance. 
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 
Saline for rinsing   
Principal Investigator(s) 
and Study 
Institution(s)/Site(s) 
Visioncare Research 
, Aston University 
 
CR-5932, v2.0
        Page 11 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS 
AE 
Adverse Event/Adverse Experience 
BSCVA 
Best Spectacle Corrected Visual Acuity 
BVS 
Best Vision Sphere 
CFR 
Code of Federal Regulations 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CRO 
Contract Research Organisation 
CT 
Center Thickness 
CTP 
Clinical Technical Procedure 
D 
Diopter 
DMC 
Data Monitoring Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
ISO 
International Organisation for Standardisation 
ITT 
Intent-to-Treat 
JJVC 
Johnson & Johnson Vision Care, Inc. 
LogMAR 
Logarithm of Minimal Angle of Resolution 
OD 
Right Eye 
OS 
Left Eye 
OU 
Both Eyes 
PD 
Protocol Deviation 
PI 
Principal Investigator 
PIG 
Patient Instruction Guide 
PQC 
Product Quality Complaint 
QA 
Quality Assurance 
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 
CR-5932, v2.0
        Page 13 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
1. 
INTRODUCTION AND BACKGROUND 
When introducing an updated version of an existing contact lens, it is helpful to compare 
it against the existing product in order to ensure it provides comparable, if not better, 
comfort, vision, and lens fit.3 It also gives insights into the ease of transition from one 
lens to the other.  The main purpose of this study is to compare the performance of a new 
daily disposable silicone hydrogel lens (ACUVUE OASYS® 1·Day) with that of an 
existing similar lens: 1·DAY ACUVUE® TruEye®.  This will provide useful information 
regarding the ease of refitting existing wearers of the existing lens into the new lens. 
1.1. 
Name and Descriptions of Investigational Products  
This study will compare two daily disposable lens designs in two different materials: 
ACUVUE OASYS® 1·Day (senofilcon A), 1·Day ACUVUE® TruEye® (narafilcon A). 
1.2. 
Intended Use of Investigational Products 
The study products are indicated for the correction of myopia and hyperopia.  During the 
study, each test article will be worn for 30-45 minutes. 
1.3. 
Summary of Findings from Nonclinical Studies 
Not Applicable – Marketed product only. 
1.4. 
Summary of Known Risks and Benefits to Human Subjects 
For the most comprehensive clinical information, refer to the latest version of the relevant 
package inserts. 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical Study 
Refer to relevant package inserts. 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1. 
Objectives  
The main purpose of this study is to compare the performance of a new daily disposable 
silicone hydrogel lens (ACUVUE OASYS® 1·Day) with that of an existing similar lens: 
1·DAY ACUVUE® TruEye®. 
Primary Objective(s) 
The primary objective is to compare the performance of a new daily disposable silicone 
hydrogel lens (ACUVUE OASYS® 1·Day) with that of 1·DAY ACUVUE® TruEye®. 
2.2. 
Endpoints  
Primary Efficacy Endpoints 
The primary endpoints are overall lens fit acceptability and lens power requirement. 
CR-5932, v2.0
        Page 14 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
Overall lens fit acceptability will be graded by the investigator on a 0-5 scale (VCR 
grading scale, where 5 indicates a perfect fit) and will be based on fitting characteristics 
such as centration and movement (not comfort or vision). 
The proportion of subjects with similar (±0.00 D and ±0.25 D) lens power requirements 
for each lens type will be calculated.  The lens requirements will be calculated from the 
lens power and spherical over-refraction by summing the lens power and the over-
refraction. 
Secondary Endpoints 
The secondary endpoints are subjective ratings of comfort, vision quality and handling as 
well as high contrast visual acuity. 
Comfort and handling will be scored by the subject on an 11-point scale (0-10).   
Vision quality will be scored by the subject on a 0-100 scale.   
High contrast visual acuity will be recorded with contact lenses only using logMAR 
charts. 
CR-5932, v2.0
        Page 15 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
3. Healthy adult males or females aged 18-55 years 
4. The subject’s spherical contact lens requirement in the range +2.00 D to +4.00 
D or -1.00 D to -6.00 D 
5. The subject’s refractive cylinder must be ≤1.00D in each eye 
6. The subject must have visual acuity best correctable to 0.20 logMAR (6/9, 
20/30) or better for each eye 
7. The subject is a current soft contact lens wearer (defined as a minimum of 6 
hours of DW per day, at least 5 days per week, for a minimum of 1 month prior 
to the study) 
8. The subject must have normal eyes (ie, no ocular medications or infections of 
any type). 
3.3. 
Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from 
participating in the study:  
1. Currently pregnant or lactating 
2. Any systemic disease (e.g., Sjögren’s Syndrome), allergies, infectious disease 
(e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., 
HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-
report, which are known to interfere with contact lens wear and/or participation 
in the study 
3. Use of systemic medications (e.g., chronic steroid use) that are known to 
interfere with contact lens wear. 
4. 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  
5. Extended wear contact lens correction. 
6. Any current use of ocular medication. 
7. Any previous, or planned (during the course of the study) ocular surgery (e.g., 
radial keratotomy, PRK, LASIK, etc.) 
8. Any greater than Grade 2 slit lamp findings (e.g., oedema, corneal 
neovascularisation, corneal staining, tarsal abnormalities, conjunctival 
injection) on the FDA classification scale or any other ocular abnormality that 
may contraindicate contact lens wear. 
9. Any contact lens-related history or signs of a corneal inflammatory event, or 
any other ocular abnormality that would contraindicate contact lens wear. 
10. Participation in any contact lens or lens care product clinical trial within 14 
days prior to study enrolment. 
11. Employee, relative or friends of employees of any ophthalmic company, or 
investigational clinic (e.g., Investigator, Coordinator, Technician). 
CR-5932, v2.0
        Page 17 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
3.4. 
Enrolment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or utilising 
Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved materials.  
4. STUDY DESIGN AND RATIONALE 
4.1. 
Description of Study Design 
This will be a one-day, double-masked, randomised, repeated measures, and 
non-dispensing cross-over study.  Each subject will wear the steeper base curve of each 
design in one eye while the flatter base curve of each will be worn in the other.  The two 
base curves of a given lens type will be worn simultaneously (i.e. contralaterally).  A total 
of four lenses will therefore be worn by each subject (2 per eye).  
Lenses will be evaluated after 30-45 minutes settling.  There will be no washout period 
between study lenses. 
4.2. 
Study Design Rationale 
Since the main purpose of the study is to compare lens fit and lens power requirements, a 
one-day repeated measures study allows meaningful comparisons with relatively short 
periods between comparisons.  
A limitation of this design is that the subjective endpoints (comfort, vision quality) are 
assessed after a relatively short wearing time.  However, since these are secondary 
endpoints, this limitation is felt to be outweighed by the advantage of the close 
comparisons for the primary endpoints. 
The main comparison between the relatively new daily disposable lens (ACUVUE 
OASYS® 1·Day) with that of the existing similar lens (1·DAY ACUVUE® TruEye®) 
will provide useful information regarding the ease of refitting existing wearers into the 
new lens.   
4.3. 
Enrolment Target and Study Duration 
Approximately 45-60 subjects will be enrolled across two sites (15-30 subjects per site) to 
ensure that at least 43 subjects will complete the study.  Enrolled subjects will be habitual 
wearers of spherical contact lenses.  All subjects will be between 18 and 55 years of age.  
Subjects will be considered enrolled after signing the informed consent.  Subjects will 
wear the Test and Control contact lenses for approximately 45 minutes each for a total 
study duration of approximately 3 hours per subject. 
5. TEST ARTICLE ALLOCATION AND MASKING 
5.1. 
Test Article Allocation  
This will be a one-day, double-masked, randomised, repeated measures study.  Each 
subject will wear three pairs of lenses each in two base curves.  The order of the Test and 
Control lenses worn and the assignment of the steeper BC to right or left eyes will be 
randomised. 
CR-5932, v2.0
        Page 18 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
The randomisation scheme was created using a random number generating computer 
program (SAS version 9.4 or higher, SAS Institute, Cary, NC) with a blocking system of 
four subjects stratified by site.  Each subject will be randomly assigned to wear one of 
two lens sequences with the steeper base curve randomly assigned to the left or right eye 
giving a total of four potential sequences: 
i. 
T/C steeper lens in right eye 
ii. 
T/C steeper lens in left eye 
iii. 
C/T steeper lens in right eye 
iv. 
C/T steeper lens in left eye 
The study site must follow the randomisation scheme provided and complete enrolment 
according to the randomisation list and not pre-select or assign subjects.  The randomised 
assignment of subjects will be performed prior to the first fitting. The following must 
have occurred prior to randomisation: 
• 
Informed consent has been obtained 
• 
Subject meets all the inclusion / exclusion criteria 
• 
Subject history and baseline information has been collected 
Randomly-permuted block randomisation will be used to avoid bias in the assignment of 
subjects to treatment, and to enhance the validity of statistical comparisons across 
treatment groups.  
5.2. 
Masking 
Both the investigator and the subjects are masked to the identity of the study lenses in 
order to reduce potential bias.  To ensure lens masking, lenses will be over-labelled and 
coded to mask the lens foil.  Over-labelling will be carried out by the study sponsor 
following specific SOPs (see ICH GCP guidelines Section 5.13).  
Masking will be used to reduce potential bias. Subjects will be unaware of the identity of 
the investigational product.  Investigators and clinical site personnel involved in the data 
collection will be masked as to the identity of the investigational product. 
Under normal circumstances, the mask should not be broken until all subjects have 
completed the study and the database is finalised. Otherwise, the mask should be broken 
only if specific emergency treatment/course of action would be dictated by knowing the 
treatment status of the subject. In such cases, the Investigator may, in an emergency, 
contact the medical monitor.  In the event the mask is broken, the Sponsor must be 
informed as soon as possible. The date, time, and reason for the unmasking must be 
documented in the subject record. The Investigator is also advised not to reveal the study 
treatment assignment to the clinical site or Sponsor personnel.  
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations.  Subjects who are discontinued may be replaced. 
5.3. 
Procedures for Maintaining and Breaking Randomisation Codes 
The test articles mask shall not be broken unless information concerning the lens type is 
necessary for the urgent medical treatment of a subject.  The Sponsor must be notified 
before the mask is broken. 
CR-5932, v2.0
        Page 19 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
• Complete the Final Evaluation, indicating the reason that the subject was 
discontinued from the study 
• Record the spherocylindrical refraction with best corrected distance visual 
acuity  
• Collect used test article(s) (worn or brought to the visit) from the subject and 
discard them, unless otherwise stated in Section 7.2 
• Collect all unused test article(s) from the subject 
An additional subject may 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: use of medications that 
contraindicate contact lens wear.   
Concomitant therapies that are disallowed include: therapies in which contact lens wear is 
contraindicated. 
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. 
CR-5932, v2.0
        Page 29 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
The Sponsor will determine when a study will be stopped.  The Principal Investigator 
always has the discretion to initiate stopping the study based on patient safety or if 
information indicates the study’s results are compromised. 
JJVC reserves the right to terminate the study at any time for any reason.  Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined.  The study 
can be terminated by the Principal Investigator at the individual clinical site due to specific 
clinical observations, if in their opinion, after a discussion with JJVC, it is determined that it 
would be unwise to continue at the clinical site.    
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events.  If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part of 
the investigation presenting the risk, will be terminated, as soon as possible. 
Should the study be terminated (either prematurely or as scheduled), the Investigator will notify 
the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral 
communication that alleges deficiencies related to the identity, quality, durability, 
reliability, safety, effectiveness or performance of test articles after they have been 
released for clinical trial use.   
Potential complaints may come from a variety of sources including but not limited to 
subjects, clinical research associates (CRA), clinical operations managers (COM), 
medical monitors, and site personnel, etc. The following are not considered product 
quality complaints: 
• Subject satisfaction inquiries reported via “Subjective Questionnaires” and 
“Patient Reported Outcomes (PRO)”. 
• Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site. 
• Lens replacements that occur due to drops/fall-outs. 
• 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:  
• Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness) 
• Who received the complaint 
CR-5932, v2.0
        Page 30 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
• Study number 
• Clinical site information (contact name, site ID, telephone number) 
• Lot number(s) 
• Unique Subject Identifier(s) 
• Indication of who first observed complaint (site personnel or subject) 
• OD/OS indication, along with whether or not the lens was inserted 
• Any related AE number if applicable 
• Detailed complaint description (scheduled/unscheduled visit, wear time, 
symptoms, resolution of symptoms, etc.) 
• Eye Care Provider objective (slit lamp) findings if applicable 
• Confirmation of product availability for return (and tracking information, if 
available), or rationale if product is not available for return 
 
 
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 (unwanted) medical occurrence in a 
patient or clinical investigation subject administered a test article, study treatment or 
study procedure whether or not caused by the test article, study treatment or procedure.  
An AE can therefore be any unfavorable or unintended sign (including an abnormal 
finding), symptom, or disease temporally associated with the use of the test article, study 
treatment, or study procedure whether or not related to the test article, study treatment, or 
study procedure. 
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: 
• Results in death 
• Is life threatening 
• Requires in-patient hospitalisation or prolongation of existing hospitalisation 
CR-5932, v2.0
        Page 31 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
• 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) 
• Is a congenital anomaly/birth defect, or 
• 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 hospitalisation may be considered an SAE when, based upon 
appropriate medical judgment, they may jeopardise 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: 
• Microbial Keratitis (MK) 
• Iritis (including cells in the anterior chamber) 
• Permanent decrease in best spectacle corrected visual acuity equivalent to 2 
acuity lines or greater 
• Central Corneal Opacity 
• Central Corneal Neovascularisation 
• Uveitis 
• Endophthalmitis 
• Hypopyon 
• Hyphema 
• Penetration of Bowman’s Membrane 
• Persistent Epithelial Defect 
• Limbal cell Damage leading to Conjunctivalisation 
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: 
• Contact Lens Induced Peripheral Ulcer (CLPU) 
• Significant Infiltrative Events (SIE) 
• Superior Epithelial Arcuate Lesions (SEALs) 
• Any Temporary Loss of > 2 Lines of BSCVA 
• Other grade 3 or higher corneal findings, such as abrasions or edema 
• Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis 
(EKC) 
• Asymptomatic Corneal Scar 
• Any corneal event which necessitates temporary lens discontinuation > 2 
weeks 
Non-Significant Adverse Events – Those conditions that are usually asymptomatic and 
usually do not warrant discontinuation (temporary or permanent) of the test article.  
However, the Investigator may choose to treat as a precautionary measure.   
CR-5932, v2.0
        Page 32 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events 
include, but not limited to the following: 
• Non-significant Infiltrative Event (NSIE) 
• Contact Lens Papillary Conjunctivitis (CLPC) 
• Superficial Punctate Keratitis (SPK) 
• Conjunctivitis: Bacterial, Viral, Allergic 
• Blepharitis 
• Meibomianitis 
• Contact Dermatitis 
• Localised Allergic Reactions 
• Any corneal event not explicitly defined as serious or significant adverse 
event, which necessitates temporary lens discontinuation < 2 weeks 
Adverse Device Effect (ADE) – A sub-set of AEs, and include only those adverse events 
that are cause by or related to the investigational device. 
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 categorised correctly.  Elements of categorisation will include: 
• Seriousness/Classifications (see definition in Section 13.1) 
• Causality or Relatedness – i.e. the relationship between the test article, study 
treatment or study procedures and the adverse event (not related; doubtful; 
possible; probable; very likely - see definition in Section 13.2.1) 
• 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).   
• Outcome – Not Recovered or Not Resolved; Recovering or Resolving; Recovered 
or Resolved with Sequelae; Recovered or Resolved; Death Related to Adverse 
Event; Unknown 
• Actions Taken – None; temporarily discontinued; permanently discontinued; other 
action taken 
13.2.1 
Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event 
and the test article, study treatment, or study procedure. The test article, study treatment 
or study procedure relationship for each adverse event shall be determined by the 
Investigator using these explanations: 
• Not Related- An adverse event that is not related to the use of the test article, 
study treatment or study procedures. 
CR-5932, v2.0
        Page 33 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
• 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. 
• 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. 
• 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: 
• Mild – Event is noticeable to the subject, but is easily tolerated and does not 
interfere with the subject’s daily activities 
• Moderate – Event is bothersome, possible requiring additional therapy, and 
may interfere with the subject’s daily activities 
• 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.   
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: 
CR-5932, v2.0
        Page 34 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
• Adverse event (diagnosis not symptom) 
• Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.)  
• Date the clinical site was notified  
• Date and time of onset 
• Date and time of resolution 
• Adverse event classification, severity, and relationship to test articles, as 
applicable 
• Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements 
• Any referral to another health care provider if needed 
• Outcome, ocular damage (if any) 
• Likely etiology 
• 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 utilised 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 
characterised 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, stabilised, 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 or not 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. 
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 or not the adverse event was considered to be related to the test article, study 
treatment or study procedures. 
CR-5932, v2.0
        Page 35 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
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 randomisation 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: 
• 
Notify the Sponsor immediately 
• 
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 
• 
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 
• 
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. 
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.  
CR-5932, v2.0
        Page 36 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
 
Difference in Proportion 
Number of Subjects needed 
by study arms 
10% 
88 
12% 
70 
14% 
53 
15% 
47 
 
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 assessments 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. 
14.4. Level of Statistical Significance 
All planned analysis for this study will be conducted with an overall type I error rate of 
5%. No adjustment for multiple comparisons will be conducted unless specified 
otherwise.  
14.5. Primary Analysis  
All analyses will be conducted on the analysis population (defined above).  If the 
difference between the analysis and safety populations is higher than 15% then a 
sensitivity analysis will be conducted on all available data.  
Primary Endpoints – Overall Fit Acceptance:  Overall lens fit acceptability will be 
analysed using a generalised linear mixed model with a multinomial distribution and a 
cumulative logit link function.  Sequence of lens wear, base curve, period, lens type, site, 
and the two-way interactions between lens type and base curve and between lens type and 
period will be included in each model as fixed effects.  An appropriate covariance 
structure will be used to model the residual errors between measurements within same 
subject across study periods.  The covariance structure will be selected based on the 
finite-sample corrected Akaike’s Information Criterion.  Covariance structures considered 
include: 
o Unstructured Covariance Structure (UN) 
o Homogenous Compound symmetry (CS) 
The Kenward and Roger method4 will be used for the denominator degree of freedom.  If 
convergence is problematic, then reduced versions of the above model may be 
considered. 
CR-5932, v2.0
        Page 38 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
Comparisons between the Test lens and the control lens will be carried out using two-
sided 95% confidence intervals constructed for odds ratio (Test/Control) by base curve.  
The lower limits of the 95% confidence intervals will be compared to 1.6 and 1 to Test 
for non-inferiority and superiority, respectively.  Non-inferiority of the Test lens relative 
to the control will be concluded if the upper limit is below 1.6.  The superiority will be 
established if the upper limit is below 1. 
Primary Endpoints – Lens Power Requirement:  The difference in lens power 
requirement between the Test and Control lenses will be calculated by base curve for the 
purpose of the analyses.  The proportions, and the corresponding 95% confidence 
intervals, of eyes with no difference in lens power requirement and with a difference 
within ±0.25 D will be calculated.  The 95% two-sided confidence intervals of the 
proportions will be calculated using the method of Wilson.3  The lower limits of the 
confidence intervals will be compared to 70% and 80%.  Equivalence will be established 
if the lower limit of the proportion with no differences is above 70% and if the lower limit 
of the proportion within ±0.25 D is above 80%. 
14.6. Secondary Analysis 
Secondary Endpoints – Comfort and Handling:  The subjective ratings of comfort and 
handle ability will be analysed using a linear mixed model.  Sequence of lens wear, base 
curve, period, lens type, site, and the two-way interactions between lens type and base 
curve and between lens type and period will be included in each model as fixed effects.  
An appropriate covariance structure will be used to model the residual errors between 
measurements within same subject across study periods.  The covariance structure will be 
selected based on the finite-sample corrected Akaike’s Information Criterion.  Covariance 
structures considered include: 
o Unstructured Covariance Structure (UN) 
o Homogenous Compound symmetry (CS) 
The Kenward and Roger method4 will be used for the denominator degree of freedom.  If 
convergence is problematic, then reduced versions of the above model may be 
considered. 
Comparisons between the Test lens and the Control lens will be carried out using two-
sided 95% confidence intervals constructed for least-square mean differences (Test minus 
Control) separately for each base curve.  The lower limits of the 95% confidence intervals 
will be compared to -1 and 0 to Test for non-inferiority and superiority, respectively.  
Non-inferiority of the Test lens relative to the Control will be concluded if the lower limit 
is above -1.  The superiority will be established if the lower limit is above 0. 
Secondary Endpoints – Vision Quality:  The subjective rating of vision quality will be 
analysed using a linear mixed model.  Sequence of lens wear, base curve, period, lens 
type, site, and the two-way interactions between lens type and base curve and between 
lens type and period will be included in each model as fixed effects.  An appropriate 
covariance structure will be used to model the residual errors between measurements 
within same subject across study periods.  The covariance structure will be selected based 
on the finite-sample corrected Akaike’s Information Criterion.  Covariance structures 
considered include: 
o Unstructured Covariance Structure (UN) 
CR-5932, v2.0
        Page 39 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
o Homogenous Compound symmetry (CS) 
The Kenward and Roger method4 will be used for the denominator degree of freedom.  If 
convergence is problematic, then reduced versions of the above model may be 
considered. 
Comparisons between the Test lens and the Control lens will be carried out using two-
sided 95% confidence intervals constructed for least-square mean differences (Test minus 
Control) separately for each base curve.  The lower limits of the 95% confidence intervals 
will be compared to -10 and 0 to Test for non-inferiority and superiority, respectively.  
Non-inferiority of the Test lens relative to the Control will be concluded if the lower limit 
is above -10.  The superiority will be established if the lower limit is above 0. 
Secondary Endpoints – High Contrast Visual Acuity:  Monocular high contrast VA 
scores will be analysed using a linear mixed model.  Sequence of lens wear, base curve, 
period, lens type, site, and the two-way interactions between lens type and base curve and 
between lens type and period will be included in each model as fixed effects.  An 
appropriate covariance structure will be used to model the residual errors between 
measurements within same subject eye across study periods.  The covariance structure 
will be selected based on the finite-sample corrected Akaike’s Information Criterion.  
Covariance structures considered include: 
o Unstructured Covariance Structure (UN) 
o Homogenous Compound symmetry (CS) 
The Kenward and Roger method4 will be used for the denominator degree of freedom.  If 
convergence is problematic, then reduced versions of the above model may be 
considered. 
Comparisons between the Test lens and the Control lens will be carried out using two-
sided 95% confidence intervals constructed for least-square mean differences (Test minus 
Control) separately for each base curve.  The upper limits of the 95% confidence intervals 
will be compared to 0.1 and 0 logMAR to Test for non-inferiority and superiority, 
respectively.  Non-inferiority of the Test lens relative to the Control will be concluded if 
the upper limit is below 0.10 logMAR.  The superiority will be established if the upper 
limit is below 0.00 logMAR. 
14.7. Other Exploratory Analyses 
Further exploratory analysis can be undertaken if necessary at the discretion of the Study 
Responsible Clinician. 
14.8. Interim Analysis 
There will be no interim analysis. 
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.  
CR-5932, v2.0
        Page 40 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
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 authorised 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. 
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 authorised 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. 
15.2. Subject Record 
At a minimum, subject record should be available for the following:  
• subject identification 
• eligibility 
• study identification 
• study discussion 
• provision of and date of informed consent 
• visit dates 
• results of safety and efficacy parameters as required by the protocol 
• a record of all adverse events 
• follow-up of adverse events 
• medical history and concomitant medication 
• test article receipt/dispensing/return records 
• date of study completion 
CR-5932, v2.0
        Page 41 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
• 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 initialled by the Investigator. 
16. DATA MANAGEMENT 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review 
and regulatory inspection(s) by providing direct access to source data/documents.  Should 
the clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC 
must be contacted and notified in writing within 24 hours. 
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. 
CR-5932, v2.0
        Page 42 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
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: 
• Ensuring that the investigation is being conducted according to the protocol, any 
subsequent amendments, and regulatory requirements are maintained 
• Ensuring the rights and wellbeing of subjects are protected 
• Ensuring adequate resources, including facilities, laboratories, equipment, and  
qualified clinical site personnel 
• Ensuring that protocol deviations are documented with corrective action plans, as 
applicable 
• Ensuring that the clinical site has sufficient test article and supplies 
• Clarifying questions regarding the study 
• Resolving study issues or problems that may arise 
• 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), 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 2013 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), 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): 
CR-5932, v2.0
        Page 43 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
• Final protocol and, if applicable, amendments 
• Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects) 
• Investigator’s Brochure (or equivalent information) and amendments 
• Sponsor-approved subject recruitment materials 
• Information on compensation for study-related injuries or payment to subjects 
for participation in the study 
• Investigator’s curriculum vitae, clinical licenses, or equivalent information 
(unless not required, as documented by IEC/IRB) 
• Information regarding funding, name of the Sponsor, institutional affiliations, 
other potential conflicts of interest, and incentives for subjects 
• Any other documents that the IEC/IRB requests to fulfil its obligation 
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: 
• Protocol amendments 
• Revision(s) to informed consent form and any other written materials to be 
provided to subjects 
• If applicable, new or revised subject recruitment materials approved by the 
Sponsor 
• Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study 
• Investigator’s Brochure amendments or new edition(s) 
• Summaries of the status of the study (at least annually or at intervals stipulated 
in guidelines of the IEC/IRB) 
• Reports of adverse events that are serious, unanticipated, and associated with 
the test articles, according to the IRB’s requirements 
• New information that may adversely affect the safety of the subjects or the 
conduct of the study 
• Major protocol deviations as required by the IEC/IRB 
• Report of deaths of subjects under the Investigator's care 
• Notification if a new Investigator is responsible for the study at the clinical site 
• 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. 
CR-5932, v2.0
        Page 44 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
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, current ICH and GCP guidelines, 
applicable regulatory requirements, and Sponsor policy. 
Before entry into the study, the Investigator or an authorised 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 Data Protection Act of 1998 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 unauthorised 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 organisations 
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. 
CR-5932, v2.0
        Page 45 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
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: 
• processed fairly and lawfully 
• collected for specified, explicit, and legitimate purposes and not further 
processed in a way incompatible with these purposes 
• adequate, relevant, and not excessive in relation to said purposes 
• accurate and, where necessary, kept current 
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 organisational measures to protect the personal data against 
unauthorised 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, 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/GCP Section 8, Essential Documents for the 
Conduct of a Clinical Trial, 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 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 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. 
CR-5932, v2.0
        Page 46 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
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 
Investigator’s Research Agreement.  The Research Agreement will be signed by the 
Principal Investigator and a JJVC management representative prior to study initiation. 
Case Report Forms will be completed in real time according to the study procedures 
specified in the study protocol.  Case Report Forms should be completed and reviewed 
and signed as applicable by the Investigator within 3 days of visit completion.  Data 
queries must be addressed with complete responses within 3 days of generation.  JJVC 
reserves the right to withhold remuneration until these activities are addressed. 
JJVC reserves the right to withhold remuneration for costs associated with protocol 
violations such as: 
• Continuing an ineligible subject in the study 
21. PUBLICATION 
This study will be registered on ClinicalTrials.gov by the Sponsor.   
 
 
 
 
 
 
 
 
 
 
CR-5932, v2.0
        Page 47 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
22. REFERENCES 
1. Young G, Schnider C, Hunt C, Efron S. Corneal topography and soft contact lens 
fit.  Optom Vis Sci. 2010; 87:358-366. 
2. Stroup, W.W. Generalized Linear Mixed Models, Modern Concepts, Methods and 
Applications 2013.467-497 
3. Wilson EB. Probable inference, the law of succession, and statistical inference. J 
Am Stat Assoc. 1927;22:309-312. 
4. Kenward MG, Roger JH, Small sample inference for fixed effects from restricted 
maximum likelihood. Biometrics 1997; 53: 983-997 
 
5. International Conference on Harmonization Guideline for Good Clinical Practice 
E6(R1) (ICH-GCP). Available at: 
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficac 
y/E6/E6_R1_Guideline.pdf 
 
6. ISO 14155:2011: Clinical investigation of medical devices for human subjects – 
Good clinical practice. 
 
7. Declaration of Helsinki – Ethical principles for Medical Research Involving 
Human Subjects. Available 
at:http://www.wma.net/en/30publications/10policies/b3/index.html 
 
 
 
CR-5932, v2.0
        Page 48 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
 
 
CR-5932, v2.0
        Page 49 of 92
JJVC CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2017-02-22
Protocol 5932                 Johnson & Johnson Vision Care, Inc.                  Confidential
1
CR-5932, v2.0
        Page 50 of 92
JJVC CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2017-02-22
Protocol 5932                 Johnson & Johnson Vision Care, Inc.                  Confidential
2
CR-5932, v2.0
        Page 51 of 92
JJVC CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2017-02-22
Protocol 5932                 Johnson & Johnson Vision Care, Inc.                  Confidential
3
CR-5932, v2.0
        Page 52 of 92
JJVC CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2017-02-22
Protocol 5932                 Johnson & Johnson Vision Care, Inc.                  Confidential
4
CR-5932, v2.0
        Page 53 of 92
JJVC CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2017-02-22
Protocol 5932                 Johnson & Johnson Vision Care, Inc.                  Confidential
5
CR-5932, v2.0
        Page 54 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
A patient instruction guide will be provided separately 
 
 
CR-5932, v2.0
        Page 55 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
 
• Investigational Products:  Senofilcon A contact lens in flat and steep base 
curves. 
• Control Products:  Narafilcon A contact lens in flat and steep base curves  
CR-5932, v2.0
        Page 56 of 92
JJVC CONFIDENTIAL

IMPORTANT: Please read carefully and keep this 
information for future use.
This Package Insert and Fitting Guide is intended for the 
Eye Care Professional, but should be made available to 
patients upon request. The Eye Care Professional should 
provide the patient with the patient instructions that 
pertain to the patient’s prescribed lens.
1-DAY ACUVUE® TruEye® Brand Contact Lenses 
with HYDRACLEAR® 1 Technology
(narafilcon A) 
Visibility Tinted with UV Blocker 
for Daily Wear Single Use Only
 
PATIENT MANAGEMENT
Dispensing Visit 
• PROVIDE THE PATIENT WITH A COPY OF THE 1-DAY ACUVUE® TruEye® Brand Contact  
	 Lenses PATIENT INSTRUCTION GUIDE. REVIEW THESE INSTRUCTIONS WITH THE PATIENT 
	 SO THAT HE OR SHE CLEARLY UNDERSTANDS THE PRESCRIBED WEARING SCHEDULE. 
• Schedule a follow-up examination.
Follow-up Examinations
• Follow-up care (necessary to ensure continued successful contact lens wear) should include  
	 routine periodic progress examinations, management of specific problems, if any, and a review  
	 with the patient of the wear schedule and handling procedures. 
• Recommended Follow-up Examination Schedule for 1-DAY ACUVUE® TruEye® Brand Contact  
	 Lenses (complications and specific 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 
• 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 fitting 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 fluorescein (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 fitting 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 measurements.
If any observations are abnormal, use professional judgment to alleviate the problem 
and restore the eye to optimal conditions. If the criteria for successful fit are not satisfied 
during any follow-up examinations, repeat the patient’s trial fitting procedure and refit 
the patient.
 
WEARING SCHEDULE
The wearing schedule should be determined by the Eye Care Professional. 
Patients tend to over wear the lenses initially. The Eye Care Professional should 
emphasize the importance of adhering to the initial maximum wearing schedule. 
Regular checkups, as determined by the Eye Care Professional, are also extremely 
important.
Daily Wear (less than 24 hours, while awake) 
For Daily Disposable Wear, JJVCI recommends that the 1-DAY ACUVUE® TruEye® 
Brand Contact Lenses be discarded upon removal.
Maximum wearing time should be determined by the Eye Care Professional based 
on the patient’s physiological eye condition, because individual response to contact 
lenses varies. However, JJCVI recommended maximum wearing time for these 
lenses is:
 DAYS
HOURS
1
6-8
2
8-10
3
10-12
4
12-14
5 and after
all waking hours
Studies have not been completed to show that the lens is safe to wear during 
sleeping. 
 
LENS CARE DIRECTIONS: 
When lenses are dispensed, the Eye Care Professional should provide the patient 
with appropriate and adequate warnings and instructions in accordance with the 
individual patient’s lens type and wearing schedule. 
For 1-DAY ACUVUE® TruEye® Brand Contact Lenses: The Eye Care Professional 
should review with patients that no cleaning or disinfection is needed. Patients 
should always dispose of lenses when they are removed and have replacement 
lenses or spectacles available. 
Care for sticking (non-moving) lenses 
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 im-
mediately 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 sterile lens is supplied in a foil-sealed plastic package containing buffered 
saline solution with methyl ether cellulose.  The plastic package is marked with base 
curve, diameter, diopter power, lot number and expiration date. 
 
REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions observed in patients wearing 
or experienced with the 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
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 first to make sure that their vision is satisfactory for operating 
an automobile. During the first 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. 
Other Suggestions
The success of the monovision technique may be further improved by having your 
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 specific  
	
visual tasks may improve the success of monovision correction. This is particularly  
	
applicable for those patients who cannot meet state licensing requirements with a  
	
monovision correction.
•  Make use of proper illumination when carrying out visual tasks.
Monovision fitting success can be improved by the following suggestions:
• Reverse the distance and near eyes if a patient is having trouble adapting.
• Refine the lens powers if there is trouble with adaptation. Accurate lens power is critical  
	 for presbyopic patients.
• Emphasize the benefits of clear near vision and straight ahead and upward gaze  
	 with monovision.
The decision to fit a patient with a 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 “1-DAY ACUVUE® TruEye® 
Brand Contact Lenses Patient Instruction Guide”.
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 fitting is performed in the office to allow the patient to experience monovi-
sion correction. Lenses are fit according to the General Fitting Instructions for 
base curve selection 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 fingernails. 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 first and then graduate to 
newsprint and finally smaller type sizes. 
After the patient’s performance under the above conditions is completed, 
tests of visual acuity and reading ability under conditions of moderately dim 
illumination should be attempted. 
An initial unfavorable response in the office, 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 first experience some mild blurred vision, dizziness, 
headaches and a feeling of slight imbalance. You should explain the adaptation 
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 first use the lenses in a comfortable familiar environment such as in 
©JJVCI 2013
Printed in U.S.A.
Revision date: 1/11/13
Revision number: AS011303
ACUVUE®,1-DAY ACUVUE® TruEye® and HYDRACLEAR® are trademarks of  
Johnson & Johnson Vision Care, Inc. (JJVCI)
Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway
Jacksonville, FL 32256
USA
Tel: 1-800-843-2020
www.acuvue.com
If vision is acceptable, perform a slit lamp examination to assess adequate fit 
(centration and movement). If fit is acceptable, dispense the lenses instructing the 
patient to return in one week for reassessment (see dispensing and follow up 
information in PATIENT MANAGEMENT).
III.	MONOVISION (SPHERICAL) FITTING GUIDELINES
A.	 Patient Selection
Monovision Needs Assessment 
For a good prognosis, the patient should have adequately corrected distance and 
near visual acuity in each eye. The amblyopic patient with significant astigmatism 
(greater than 1.00D) in one eye may not be a good candidate for monovision cor-
rection with the 1-DAY ACUVUE® TruEye® Brand Contact 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 such activities as:
	
(a) visually demanding situations such as operating potentially dangerous  
	
	
machinery or performing other potentially hazardous activities; and
	
(b) driving automobiles (e.g., driving at night). Patients who cannot pass their  
	
	
state drivers license requirements with monovision correction should be  
	
	
advised to not drive with this correction, OR may require that additional  
	
	
over-correction be prescribed.
Patient Education
All patients do not function equally well with monovision correction. 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 first time until they are familiar with the vision provided in 
visually challenging environments (e.g., reading a menu in a dim restaurant, driving 
at night in rainy/foggy conditions, etc.). During the fitting 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.
B.	 Eye Selection
Generally, the non-dominant eye is corrected for near vision. The following two 
methods for eye dominance can be used.
1.	 Ocular Preference Determination Methods 
	
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.
	
Other methods include the Refractive Error Method and the visual demands method.
2.	 Refractive Error Method 
For anisometropic correction, it is generally best to fit the more hyperopic (less myopic) eye for 
distance and the more myopic (less hyperopic) eye for near.
3.	 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 Lens Correction 
There are circumstances where only one contact lens is required. As an 
example, an emmetropic patient would only require a near lens while a bilateral 
myope may only require a distance lens.
Example: 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 a lens. 
	
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.
20400875
CR-5932, v2.0
        Page 59 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
APPENDIX E: 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS 
 
 
 
 
CR-5932, v2.0
        Page 65 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
APPENDIX F: 
 BIOMICROSCOPY SCALE  
 
 
 
CR-5932, v2.0
        Page 72 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
APPENDIX G: 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
 
 
 
CR-5932, v2.0
        Page 78 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
APPENDIX H: TOPOGRAPHY MEASUREMENT USING MEDMONT E300 CORNEAL 
TOPOGRAPHER  
 
1.0 OBJECTIVES 
Acquire and save corneal topography maps. 
 
2.0 MATERIALS 
The Medmont E300 Corneal Topographer is a computerized Videokeratometer using 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 E300 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.    
Primary source data are the image files and the Medmont’s internal database.  Secondary 
source data are the output files for the selected map (.axl, .tgl, .dst, .hgt) and the pupil 
decentration vector (r, theta) which is recorded in the Case Report Form. 
 
4.0 PROCEDURES 
CALIBRATION 
Medmont corneal topographer will be calibrated using the standard calibration object 
provided by the manufacturer following the steps described in the user manual.  
 
CAPTURING AND SAVING TOPOGRAPHY 
The following sections describe the steps to performing an examination with the 
Medmont E300 instrument. 
 
PATIENT SELECTION 
The recommended practise is to have a patient selected before starting to capture and 
analyse an exam. Figure 1 shows the Medmont Studio initial display with a patient 
selected in the explorer pane. 
CR-5932, v2.0
        Page 83 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
 
 
POSITIONING THE PATIENT 
In order to capture good quality and accurate images some precautions should be 
followed in positioning the patient correctly. 
The patient should sit comfortably in the chair. Ask the patient to put her chin onto the 
chinrest and put her forehead firmly against the forehead rest. She should then push her 
chin forward on the chinrest. If the patient has deep-set eyes instruct her to move her head 
back from the headrest. This rotates the eye away from the eyebrow and eyelashes and 
produces better coverage and fewer interruptions of rings on the upper cornea. Adjust the 
eye height to the level marks on the chinrest. 
Ask the patient to look into the centre of the green fixation target and keep her gaze on 
this target. The target centre point together with the centre of the ring pattern on the eye 
defines the Video-Keratoscope axis (VK-axis), the reference axis to which the axial 
radius/power is calculated (the values for tangential radius/power are less affected by the 
fixation).  
When an image is taken with the patient not fixated on the target, the videokeratoscope 
axis may not be reproducible in future exams.  Axial power maps are identical for fixated 
eyes.  The tangential power for both images should have their centre in the same position 
relative to the pupil centre.  If there are differences between maps and you suspect 
fixation errors, re-instruct the subject where to fixate, then re-capture the image and 
compare the old maps with the new maps to decide which ones correspond to good 
fixation.  Ask the patient to open her eyelid as much as possible and close the other eye if 
necessary.  
 
CR-5932, v2.0
        Page 84 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
CAPTURING PATIENT EXAMS 
Click on the button or the File > New > E300 Patient Exam menu to display the E300 
Capture View (see Figure 3). The red illumination rings inside the E300 cone should turn 
on. Ensure the Normal radio button is selected in Capture Control window (Figure 2). 
         
      
Figure 2. Selecting Normal (single frames) or Video capture control. 
 
      
 
Figure 3. E300 Initial Capture Screen. 
 
Select the eye to be examined in the Exam Details box (the right eye is the default). 
The focussing window shows live video from the E300. The green and red target overlaid 
on the focussing window provides three-dimensional centring and focussing information. 
The green crosshair indicates the keratoscope axis. The red bar moving along a three-
dimensional runway indicates the distance of the eye from the optimal focussing plane. 
The “view” is from the camera’s perspective, so if the red bar is at the top or narrowest 
part of the runway then the patient is still too far away. 
The E300 joystick allows positioning in three dimensions. Move the joystick in the 
desired direction for movement left and right and for closer to or further away. Rotate the 
joystick knob for movement up and down, clockwise to raise, anti-clockwise to lower. 
       
CR-5932, v2.0
        Page 85 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
      
 
 Figure 4. Focus examples showing Too Far, In Focus, and Too Near. 
     
Using the joystick, position the E300 relative to the patient’s eye so that the reflection of 
the Placido rings is centred on the green crosshair, and the red bar is over the horizontal 
green line. Once this is achieved, the software automatically captures the best set of 
images and displays them in the image windows along the top of the View pane, with the 
best images to the right. Images for automatic capturing are selected according to best 
centring, focussing and least eye movement. Figure 8 shows a typical capture screen 
display. It may not be possible to align the red focussing bar over the horizontal cross bar 
for patients with deep set eyes, because of contact between the bridge of the nose and the 
instrument. In this case, centre the Placido rings on the green crosshair and bring the red 
focussing bar as close to the horizontal green line as possible without causing patient 
discomfort. Provided that the red bar is somewhere within the focussing range (i.e. not at 
the very end) the software will automatically compensate for the focussing error.     
 
                        Figure 5. E300 Image Capture View. 
 
CR-5932, v2.0
        Page 86 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
 
SAVING THE BEST IMAGE 
Each image captured is awarded a score out of 100 based on centring, focus and 
movement. The score is displayed as a large white number above each captured image. A 
good score for a normal eye will be over 75. Calibration balls can achieve scores of up to 
100. Select the best image from those automatically captured. Typically this will be the 
right-most image. Click on an individual image’s Expand/Collapse Testing a Patient 
button to expand the image to full-screen. You should consider the following factors 
when assessing images: 
• Patient Fixation– choose images where the pupil is better centred with respect to the 
Placido rings. 
• Eyelid Position – choose images where the patient’s eyelid does not obscure large 
portions of the cornea or cause large eyelash shadows. 
• Central Ring Clarity – choose images where the central Placido ring reflection is clearly 
visible. For some patients with extreme conditions, this may require shifting their fixation 
to get the central Placido ring area over an area with less surface irregularity. Click on an 
image’s save button to save it. You can also save the set of images from the File > Save 
All Exams menu. Alternatively you may decide to analyse the image before saving. If this 
is the case then use File > Save from the analysis window. A Patient Exam item is added 
to the Explorer pane under the current patient. You can save more than one exam if you 
wish. To view the Exam Results, select the Exam in the Data pane and the View Mode 
(see Analyzing and Viewing Exam Results page 22 of the instruction manual). 
   
EXPORTING THE ANALYSIS 
For the selected map, record the pupil offset or decentration of the pupil center from the 
videokeratoscope axis as the pupil decentration vector (r, theta) from the screen.  
 
The E300 software provides the facility to export raw topography data for the selected 
exam to a set of text files. This data can then be imported and manipulated by external 
software and tools. First select the exam analysis to export. Then select the button or the 
Analysis > Export menu and specify the “root” name and location of the files to create. 
Typically the file name is based on the study name, subject number, visit number, 
condition and eye (eg. 5032_001_V1bare_OD. The following files are created: 
Filename.axl – axial curvature data (in mm) 
Filename.tgl – tangential curvature data (in mm) 
Filename.hgt – corneal height data (in mm) 
Filename.dst – radial distance data (in mm) 
 
 
CR-5932, v2.0
        Page 87 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
 
 
5.0 
PHOTODOCUMENTATION 
 
Not applicable 
 
6.0 
ADDITIONAL INFORMATION 
 
Not applicable 
 
7.0 
TRAINING REQUIREMENTS 
 
Read only 
 
 
CR-5932, v2.0
        Page 88 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
   
 
  
 
 
 
  
 
 
     
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
     
 
 
 
 
CR-5932, v2.0
        Page 90 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CR-5932, v2.0
        Page 91 of 92
JJVC CONFIDENTIAL

 
 
 
 
 
 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-5932 Short-Term Clinical Comparison of Two Silicone 
Hydrogel Daily Disposable Contact Lenses 
 
Version and Date: _V2.0 ,14-March-2017______________________________________ 
 
I have read and understand the protocol specified above and agree on its content.   
 
I agree to conduct this study according to GCP and ICH guidelines, the Declaration of 
Helsinki, ISO 14155, United States (US) Code of Federal Regulations (CFR), 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 ICH 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 ICH 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 authorisation. 
 
Principal 
Investigator: 
 
 
  
 
Signature 
 
 
 Date 
 
Name and Professional Position (Printed) 
  
 
Institution/Site: 
 
  
 
Institution/Site Name 
 
 
  
 
Institution/Site Address 
  
 
CR-5932, v2.0
        Page 92 of 92
JJVC CONFIDENTIAL