ACUVUE® OASYS With Transitions™ Light Intelligent Technology™ Clinical Performance Registry
Conditions: Vision Satisfaction in Bright Light
Sponsor: Johnson & Johnson Vision Care, Inc.

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Johnson & Johnson Vision Care, Inc. 
Clinical Study Protocol 
ACUVUE OASYS with Transitions Light Intelligent Technology Clinical Performance 
Registry 
 
Protocol CR-6334 
Version: 4.0 
Date: 24 November 2020 
 
 
Test Articles: ACUVUE OASYS with Transitions Light Intelligent Technology™ 
 
Key Words: senofilcon A, Photosol 7-1911, ACUVUE OASYS with Transitions Light 
Intelligent Technology™, daily wear reusable, dispensing, physiological responses, subjective 
responses 
 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines: 
This trial will be conducted in compliance with the protocol, ISO 141551, the International 
Conference on Harmonization Good Clinical Practice E6 (ICH-GCP),2 the Declaration of 
Helsinki,3 and all applicable regulatory requirements. 
 
Confidentiality Statement: 
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc. The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc. Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document. 

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TABLE OF CONTENTS 
SPONSOR NAME AND ADDRESS ....................................................................................... 6 
MEDICAL MONITOR ............................................................................................................. 6 
AUTHORIZED SIGNATURES ............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS ................................................................................................................................ 9 
ABBREVIATIONS AND DEFINITIONS OF TERMS ........................................................ 14 
1. 
INTRODUCTION AND BACKGROUND ............................................................ 15 
1.1. 
Name and Descriptions of Investigational Products ................................................ 15 
1.2. 
Intended Use of Investigational Products ................................................................. 15 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 15 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 16 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study ........................................................................................................................ 16 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ............................... 16 
2.1. 
Objectives ................................................................................................................. 16 
2.2. 
Endpoints .................................................................................................................. 16 
2.3. 
Hypotheses ............................................................................................................... 17 
3. 
TARGETED STUDY POPULATION .................................................................... 18 
3.1. 
General Characteristics ............................................................................................ 18 
3.2. 
Inclusion Criteria ...................................................................................................... 18 
3.3. 
Exclusion Criteria ..................................................................................................... 18 
3.4. 
Enrollment Strategy .................................................................................................. 18 
4. 
STUDY DESIGN AND RATIONALE ................................................................... 19 
4.1. 
Description of Study Design .................................................................................... 19 
4.2. 
Study Design Rationale ............................................................................................ 20 
4.3. 
Subject Numbers ...................................................................................................... 20 
4.4. 
Study Duration ......................................................................................................... 20 
5. 
TEST ARTICLE ALLOCATION AND MASKING .............................................. 21 
5.1. 
Test Article Allocation ............................................................................................. 21 
5.2. 
Masking .................................................................................................................... 21 
6. 
STUDY INTERVENTION ...................................................................................... 22 
6.1. 
Identity of Test Articles ............................................................................................ 22 
6.2. 
Ancillary Supplies/Products ..................................................................................... 22 
6.3. 
Administration of Test Articles ................................................................................ 22 
6.4. 
Packaging and Labeling ........................................................................................... 23 
6.5. 
Storage Conditions ................................................................................................... 23 

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6.6. 
Collection and Storage of Samples .......................................................................... 23 
6.7. 
Accountability of Test Articles ................................................................................ 23 
7. 
STUDY EVALUATIONS ....................................................................................... 24 
7.1. 
Time and Event Schedule ......................................................................................... 24 
7.2. 
Detailed Study Procedures ....................................................................................... 24 
VISIT 1 ........................................................................................................................... 25 
7.3. 
Unscheduled Visits ................................................................................................... 27 
7.4. 
Laboratory Procedures ............................................................................................. 27 
8. 
SUBJECTS COMPLETION/WITHDRAWAL....................................................... 27 
8.1. 
Completion Criteria .................................................................................................. 27 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 27 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION .......... 28 
10. 
DEVIATIONS FROM THE PROTOCOL .............................................................. 28 
11. 
STUDY TERMINATION ....................................................................................... 28 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .......... 28 
13. 
ADVERSE EVENTS ............................................................................................... 28 
13.1. Definitions and Classifications................................................................................. 29 
13.2. Assessing Adverse Events ........................................................................................ 31 
13.2.1. 
Causality Assessment .................................................................................... 31 
13.2.2. 
Severity Assessment ...................................................................................... 31 
13.3. Documentation and Follow-Up of Adverse Events ................................................. 32 
13.4. Reporting Adverse Events ........................................................................................ 32 
13.5. Event of Special Interest .......................................................................................... 32 
13.6. Reporting of Pregnancy ............................................................................................ 32 
14. 
STATISTICAL METHODS .................................................................................... 33 
14.1. General Considerations ............................................................................................ 33 
14.2. Sample Size Justification ......................................................................................... 33 
14.3. Analysis Populations ................................................................................................ 34 
14.4. Level of Statistical Significance ............................................................................... 35 
14.5. Primary Analysis ...................................................................................................... 35 
14.6. Secondary Analysis .................................................................................................. 36 
14.7. Other Exploratory Analyses ..................................................................................... 36 
14.8. Interim Analysis ....................................................................................................... 37 
14.9. Procedure for Handling Missing Data and Drop-Outs ............................................. 37 
14.10. Procedure for Reporting Deviations from Statistical Plan ....................................... 37 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ............................ 37 

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15.1. Case Report Form/Data Collection .......................................................................... 37 
15.2. Subject Record ......................................................................................................... 38 
16. 
DATA MANAGEMENT ......................................................................................... 38 
16.1. Access to Source Data/Document ............................................................................ 38 
16.2. Confidentiality of Information ................................................................................. 38 
16.3. Data Quality Assurance ............................................................................................ 38 
17. 
MONITORING ........................................................................................................ 39 
18. 
ETHICAL AND REGULATORY ASPECTS......................................................... 39 
18.1. Study-Specific Design Considerations ..................................................................... 39 
18.2. Investigator Responsibility ....................................................................................... 39 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) .............. 39 
18.4. Informed Consent ..................................................................................................... 40 
18.5. Privacy of Personal Data .......................................................................................... 41 
19. 
STUDY RECORD RETENTION ............................................................................ 42 
20. 
FINANCIAL CONSIDERATIONS ........................................................................ 43 
21. 
PUBLICATION ....................................................................................................... 43 
22. 
REFERENCES ........................................................................................................ 43 
APPENDIX A: PATIENT REPORTED OUTCOMES FORM SPECIFICATIONS ............ 45 
APPENDIX B: ECP REGISTRATION FORM ..................................................................... 63 
APPENDIX C: IRIS COLOR SCALE ................................................................................... 66 
APPENDIX D: 
PATIENT REPORTED OUTCOMES ........................................ 67 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE .......................... 69 
TABLE OF CONTENTS 
Figure 1: Study Flowchart ...................................................................................................... 13 

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SYNOPSIS 
 
Protocol Title 
ACUVUE OASYS with Transitions Light Intelligent 
Technology™ Clinical Performance Registry 
Sponsor 
Johnson and Johnson Vision Care, Inc. (JJVC), 7500 
Centurion Parkway, Jacksonville, FL 32256 
Clinical Phase 
Post Marketing (Registry) phase 4 
Trial Registration 
This study will be registered on ClinicalTrials.gov by the 
Sponsor 
Test Article(s) 
Investigational Products: JJVC spherical senofilcon A with 
photochromic additive (ACUVUE® OASYS with 
Transitions™ contact lenses) 
Control Products: spherical non-photochromic reusable 
marketed silicone hydrogel contact lenses. 
Wear and Replacement 
Schedules 
Wear schedule: Daily wear 
Recommended replacement schedule: 2-weekly or as 
determined by the prescribing eyecare practitioner. 
Objectives 
Evaluate the performance of JJVC senofilcon A with 
photochromic 
additive 
(ACUVUE® 
OASYS 
with 
Transitions™ contact lenses) compared to non-photochromic 
reusable contact lenses over a period of one year in the 
following areas: 
x Vision satisfaction in bright lighting 
x Overall quality of vision 
x Subjective assessment of Pulfrich Effect 
x Overall comfort 
x Reported serious or significant adverse events 

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Study Endpoints 
Primary endpoint: 
1. Vision satisfaction in bright lighting 
 
Secondary endpoints: 
1. Overall quality of vision 
2. Subjective assessment of Pulfrich Effect 
3. Overall comfort 
4. Reported serious or significant adverse events 
 
Other endpoints: 
1. Overall satisfaction 
2. Cosmetic appearance assessment 
3. Lens storage compliance 
4. Reasons for discontinuation 
5. Other subjective assessments (indoor performance, 
overall opinion, average wear time, etc.) 
Study Design 
This registry study is a one-year, one-visit, observational, 
prospective, open-label, two-arm, multi-center, multi-
national, post-market study of approximately 300 patients 
who have recently been fitted with the ACUVUE® OASYS 
with Transitions™ and approximately 300 patients who have 
recently been fitted with spherical non- photochromic 
reusable marketed silicone hydrogel contact lenses (of any 
brand). 
Visit 1 is conducted in-person at the eyecare practitioner 
(ECP) office. Assessments 2-4 are online surveys, 
conducted remotely. 
x Visit 1: Registration visit 
x Assessment 2: 2-week questionnaire 
x Assessment 3: 4-month questionnaire 
x Assessment 4: 12-month questionnaire 
The documentation of adverse events in the registered 
wearer’s clinical record will reflect routine clinical practices 
that are outside the scope of this protocol. Medical records 
from any subject who reports having experienced “a problem 
with their eyes while wearing lenses that required you to visit 
an eyecare practitioner or hospital” will be obtained from the 
treating facility after they are reported via the 2-week, 4- 
month or 12-month questionnaires. 
See the flowchart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1). 
 

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Sample Size 
Approximately 600 eligible subjects will be enrolled (~300 
subjects per arm) with a target of 480 to complete the study 
(~240 subjects per arm). 
Study Duration 
The study will start within 6 months of launch in a given 
country and will observe the clinical performance of the Test 
and Control lenses for approximately one year in that 
country. 
Anticipated Study 
Population 
x Patient age: minimum 18 years old, no maximum age 
x Patients with no known history that would contradict 
contact lens wear. 
x Neophyte patients or those refit from habitual contact 
lenses 
Eligibility Criteria 
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study: 
1. Contact lens neophytes or those who have recently 
(i.e. within last 2 months) begun the use of a new 
reusable silicone hydrogel lens type and have 
purchased a supply of lenses. 
2. A minimum age of 18 years, with no maximum age. 
3. The registrant must read and sign the Informed 
Consent form. 
4. The registrant must appear able and willing to adhere 
to the instructions set forth in this clinical protocol. 
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study: 
1. Current participant in another research study. 
2. Employee or relative of site, or family member of 
Recruiting Practitioner or Johnson & Johnson. 
3. Non-spherical contact lens wearers, i.e. toric or 
multifocal lenses. 
Disallowed 
Medications/Interventions 
Pre-study and concomitant medications are not being tracked 
in this Registry. Concomitant and incident therapy noted in 
the medical source record will be considered as part of the 
adjudicated diagnosis in subjects who experience events in 
the study. 
Measurements and 
Procedures 
x Physiological responses 
x Subjective questionnaires 
Study Termination 
Since all of the products associated with the study are 
marketed products, there are no anticipated circumstances in 
which the study would be prematurely terminated. 
 

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~600 Subjects 
Neophytes, or those refit into a new brand, that have received a prescription for and 
purchased a supply of either Test of Control lens 
Germany Site(s) 
Na60-70 Test 
Na60-70 Control 
Netherlands Site(s) 
Na60-70 Test 
Na60-70 Control 
Spain Site(s) 
Na60-70 Test 
Na60-70 Control 
UK Site(s) 
Na100 Test 
Na100 Control 
Visit 1 
Registry participation explained 
Registrant completes Informed Consent (IC) 
ECP completes paper ECP Registration Questionnaire (ERQ) for given Registrant 
Registrant completes Patient Registration Questionnaire (PRQ) 
2-Week Questionnaire 
(~2 weeks after Visit 1) 
Registrant receives an email reminder 
2-week questionnaire is completed online similar to baseline for Registrant 
Payment for Registration and 2-week questionnaire is made to the Registrant 
Follow-up of Events reported at the 2-week questionnaire by CRO & PI 
12-Month Questionnaire 
(~12 months after Visit 1) 
 
Registrant receives an email reminder 
12-month questionnaire is completed online similar to baseline for Registrant 
Payment for 12-month questionnaire is made to the Registrant 
Follow-up on Events reported at the 12-month questionnaire by CRO & PI 
Study completed the study on completion of the 12-month questionnaire 
Figure 1: Study Flowchart 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4-Month Questionnaire 
(~4 months after Visit 1) 
 
Registrant receives an email reminder 
4-month questionnaire is completed online similar to baseline for Registrant 
Payment for 4-month questionnaire is made to the Registrant 
Follow-up on Events reported at the 4-month questionnaire by CRO & PI 

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ABBREVIATIONS AND DEFINITIONS OF TERMS 
ADE 
Adverse Device Effect 
AE 
Adverse Event/Adverse Experience 
CL 
Contact Lens 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
DMC 
Data Monitoring Committee 
eCRF 
Electronic Case Report Form 
ECP 
Eye Care Practitioner 
EDC 
Electronic Data Capture 
ERQ 
ECP Registration Questionnaire 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HEV 
High Energy Visible 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
JJVC 
Johnson & Johnson Vision Care, Inc. 
PI 
Principal Investigator 
PQC 
Product Quality Complaint 
PRO 
Patient Reported Outcome 
PRQ 
Patient Registration Questionnaire 
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 
UK 
United Kingdom 
UV 
Ultraviolet 
VCR 
Visioncare Research Ltd 

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1. 
INTRODUCTION AND BACKGROUND 
In April 2018, the U.S. Food and Drug Administration (FDA) cleared the first contact lens to 
incorporate a photochromic additive that automatically darkens the lens in the presence of 
ultraviolet (UV) and high energy visible (HEV) light and lightens in its absence. The 
ACUVUE OASYS with Transitions Light Intelligent Technology™ are soft contact lenses 
indicated for daily use to correct the vision and to reduce the effect of bright light. The intended 
users are people with non-diseased eyes who are nearsighted (myopia) or farsighted 
(hyperopia). They can also be used by people with certain degrees of astigmatism. The global 
roll-out of the lens began in the spring of 2019, with countries being added over forthcoming 
years. 
 
The goal of this registry study is to provide real world data on the effectiveness of ACUVUE 
OASYS with Transitions in the general population of spherical contact lens wearers and 
under general clinical practice. Vision satisfaction in bright lighting and overall quality of 
vision will be assessed using a longitudinal survey questionnaire over a period of one year. 
Pulfrich effect and reported serious and significant ocular adverse events will also be 
evaluated. This a non-randomized study and the sponsor, Johnson and Johnson Vision Care, 
Inc. (JJVC), has no control of the treatment assignment and minimal input on the study targeted 
population. 
 
The sponsor has contracted with Visioncare Research (VCR) to monitor the study. 
 
This Clinical Investigation Plan is to be used in conjunction with JJVC standard operating 
procedures (SOPs) (except for as outlined in this plan) as a project-specific working plan by 
VCR and designees during the conduct of the study. The following plan provides the minimum 
acceptable criteria for this study. This plan does not replace an understanding or adherence to 
the requirements contained in the study protocol, applicable regulations and ICH/GCP 
guidelines. 
 
1.1. Name and Descriptions of Investigational Products 
All products are approved and marketed within the countries participating in this Registry 
study. ACUVUE OASYS with Transitions will serve as the Test lens. Other reusable 
spherical silicone hydrogel lenses will serve as the Control lenses. Further details about the 
Test lenses are found in Section 6 of this protocol. 
 
1.2. Intended Use of Investigational Products 
The intended use of the Test product is for correcting ametropia and the attenuation of bright 
light. During the study, the Test article will be worn bilaterally in a daily wear, reusable, 2-
weekly modality, or as determined by the prescribing eyecare practitioner (ECP). 
 
1.3. Summary of Findings from Nonclinical Studies 
Not Applicable – Marketed product only. 

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1.4. Summary of Known Risks and Benefits to Human Subjects 
The risks of wearing soft contact lenses are well known and are described in the relevant 
Package Insert. 
 
1.5. Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
Refer to relevant Package Insert. 
 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
 
2.1. Objectives 
The objective of this study is to evaluate the performance of JJVC senofilcon A with 
photochromic additive (ACUVUE® OASYS with Transitions™ contact lenses) compared to 
non-photochromic reusable contact lenses over a period of one year in the following areas: 
x Vision satisfaction in bright lighting 
x Overall quality of vision 
x Subjective assessment of Pulfrich Effect 
x Overall comfort 
x Reported serious or significant adverse events 
2.2. Endpoints 
All of the primary and secondary endpoints will be assessed using the follow-up questionnaire 
administered at 2-weeks, 4-months and 12-months after the enrollment visit (Visit 1). 
 
Primary endpoints 
Vision Satisfaction in Bright Lighting 
Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level 
of agreement with the statement “I was satisfied with the quality of my vision in bright lighting 
with these contact lenses” using a 5-point agreement Likert scale (1: Strongly Disagree, 2: 
Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree). 
 
Secondary endpoints 
Overall quality of vision 
This will be assessed subjectively using the item “I am satisfied with the overall quality of my 
vision with these contact lenses”. The item uses a 5-point agreement scale (1: Strongly 
Disagree to 5: Strongly Agree) 
 
Pulfrich Effect 
This will be assessed subjectively using the item “While wearing these lenses, my depth 
perception of moving objects has NOT been impacted”. Subjects who disagree or strongly 
disagree with the statement will be considered to have experienced the Pulfrich effect. 

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Overall comfort 
This will be assessed using the item “How would you rate the overall comfort of these contact 
lenses?”. The item uses the 5-point satisfaction scale, 1: Excellent, 2: Very Good, 3: Good, 4: 
Fair and 5: Poor. 
 
Reported serious and significant ocular adverse events: 
Incidence rate serious and significant ocular adverse events during the study period will be 
calculated (in 100 patient-year) using all available data from the entire study. 
 
Other endpoint(s): 
1. Overall satisfaction 
2. Cosmetic appearance assessment 
3. Lens storage compliance 
4. Reasons for discontinuations 
5. All reported ocular and non-ocular adverse events 
6. Other subjective assessments (indoor performance, overall opinion, average wear time, 
etc.) 
 
2.3. Hypotheses 
Primary Hypotheses 
Subjects wearing JJVC senofilcon A contact lenses with photochromic additive (ACUVUE® 
OASYS with Transitions™ contact lenses) will have superior vision satisfaction in bright lighting 
compared to subjects wearing non-photochromic reusable silicone hydrogel contact lenses over a 
period of one year. 
 
Secondary Hypotheses 
1. Subjects wearing JJVC senofilcon A contact lenses with photochromic additive 
(ACUVUE® OASYS with Transitions™ contact lenses) will have superior vision 
satisfaction compared to subjects wearing non-photochromic reusable silicone hydrogel 
contact lenses at 12-month evaluation. This hypothesis will also be tested at 2-week and 4- 
month evaluation periods. 
2. Subjects wearing JJVC senofilcon A contact lenses with photochromic additive 
(ACUVUE® OASYS with Transitions™ contact lenses) will have superior overall quality 
of vision compared to subjects wearing non-photochromic reusable silicone hydrogel 
contact lenses over a period of one year. This hypothesis will also be tested at each 
evaluation period. 
3. Subjects wearing JJVC senofilcon A contact lenses with photochromic additive 
(ACUVUE® OASYS with Transitions™ contact lenses) will have superior overall comfort 
compared to subjects wearing non-photochromic reusable silicone hydrogel contact lenses 
over a period of one year. This hypothesis will also be tested at each evaluation period. 
 
No hypotheses are formulated about Pulfrich effect or, serious and significant ocular adverse 
events (AEs). The following will be calculated by arm: 
1. Proportion of subjects who experienced the Pulfrich effect at each evaluation period. 
2. Incidence rate of serious and significant ocular AEs (in patient-year) 

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3. Proportion of subjects with at least one reported serious or significant ocular AE at each 
evaluation period. 
4. Proportion of eyes with a least one reported serious or significant ocular AE at each 
evaluation period. 
5. Proportion of all reported serious and significant ocular AEs at each evaluation period. 
 
3. 
TARGETED STUDY POPULATION 
 
3.1. General Characteristics 
Subjects may be of any race, nationality, and ethnicity that meet the following inclusion and 
exclusion criteria. Subjects will not be fitted with contact lenses specifically for the purposes 
of this study. Instead, patients recently fitted or refitted with contact lenses will be invited to 
take part in this observational study. 
 
3.2. Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 
 
Inclusion Criteria after Screening: 
1. Contact lens neophytes or those who have recently (i.e. within last 2 months) begun the 
use of a new reusable silicone hydrogel lens type and have purchased a supply of lenses. 
2. A minimum age of 18 years, with no maximum age. 
3. The registrant must read and sign the Informed Consent form. 
4. The registrant must appear able and willing to adhere to the instructions set forth in this 
clinical protocol. 
 
For clarification, non-neophyte subjects may include previous wearers of any type of soft 
contact lens (e.g. daily disposable), however, the new lens type must be a reusable silicone 
hydrogel. Also, non-neophyte subjects may have previously worn soft contact lenses at any 
point in time; in other words, it is not necessary for recently refitted subjects to have 
transitioned from their old to new lenses without a break in wear. 
 
3.3. Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study: 
 
Exclusion Criteria after Screening: 
1. Current participant in another research study. 
2. Employee or relative of site, or family member of Recruiting Practitioner or Johnson & 
Johnson. 
3. Non-spherical contact lens wearers, i.e. toric or multifocal lenses. 
 
3.4. Enrollment Strategy 
Study subjects will be recruited from the clinical site’s subject database and/or utilizing 
Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved materials. 

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Site recruitment based on actively prescribing a new device is a method that has been used in 
two prior post-market surveillance studies for FDA.5,6 Proposed regions include but are not 
limited to areas within the United Kingdom (UK), Spain, Netherlands and Germany. Regions 
will be replaced or supplemented if there is inadequate response to invitations to participate. 
 
The Principal Investigator and CRO will recruit sub-investigators, referred to as ‘Recruiting 
Practitioners’ throughout this document at clinical sites. Clinical sites in the selected regions 
that are actively prescribing the ACUVUE® OASYS with Transitions™ lenses will be invited 
to participate as Recruiting Practitioners. Recruiting Practitioners will be allowed a maximum 
of 50 registered wearers per site, so that no one site will contribute more than 25% of the 
sample population in a given country. The study anticipates unequal enrollment across the 
sites, as their rate of prescribing ACUVUE® OASYS with Transitions™ will vary considerably. 
Unequal enrollment should reflect the population exposures to the Test lens and follows the 
tenets of surveillance. A convenience, rather than random, sample is necessary for the study 
because ACUVUE® OASYS with Transitions™ contact lenses have not yet been widely 
launched and are only available to some eye care practitioners. Thus, active prescribers of 
ACUVUE® OASYS with Transitions™ lenses will be invited to participate within each region 
in order to provide a large enough sample size for the study. 
 
Within sites, wearers of ACUVUE® OASYS with Transitions™ lenses will be invited to 
participate without regard to any demographic or other ocular features. Wearers will be 
registered after they have recently (i.e. within last 2 months) received a prescription for and a 
supply of ACUVUE® OASYS with Transitions™ lenses. 
 
The study design also allows an unconstrained relative proportion of ACUVUE® OASYS with 
Transitions™ lenses within a site in order to reflect the exposure profile present in that site. 
When the study has enrolled 300 Test lens subjects, enrollment will be actively curtailed but 
leaving the enrollment open to the other lens type until complete (or vice versa). 
 
4. 
STUDY DESIGN AND RATIONALE 
 
4.1. Description of Study Design 
This registry study is a one-year, one-visit, observational, prospective, open-label, two-arm, 
multi-center, multi-national, post-market study. Approximately 300 patients who have 
recently been fitted with the ACUVUE® OASYS with Transitions™ (Test) and approximately 
300 patients who have recently been fitted with spherical non-photochromic reusable marketed 
silicone hydrogel contact lenses (of any brand) (Control) will be enrolled in the study, a total 
of 600 subjects. The goal is for a sample size of 480 subjects (~240/arm) after subjects who 
withdraw or are lost-to-follow-up. 
 
At Visit 1, each subject will be first consented to participate in the study. The ECP will then 
complete the paper ECP Registration Questionnaire (ERQ) for the given consented subject and 
collect his/her demographics and baseline information. Participants who meet eligibility 
criteria, will be asked to complete the Patient Registration Questionnaire (PRQ). At the end 
of the visit, registrants will be instructed to complete the survey follow-up questionnaire online 
at 2-weeks (day 10-30), 4-months (day 110-150) and 12-months (day 345-395) from Visit 1 

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(day 0). The registrants will receive an email reminder and link to the online questionnaire 
(Kiosk) prior to each evaluation period. Follow-up on events reported at each evaluation 
period will be completed by the Recruiting Practitioner/PI. 
 
Country specific Good Clinical Practice (GCP) standards, laws, and applicable regulations 
were reviewed in designing the clinical study protocol to ensure compliance in the management 
of the clinical trial and to protect the rights and interest of subjects. 
 
4.2. Study Design Rationale 
The study is designed as an observational, prospective, non-interventional, multi-center, multi- 
national post-market study to evaluate the effectiveness of ACUVUE® OASYS with 
Transitions™ over a period of one year in the general population of spherical contact lens 
wearers and under general clinical practice. By allowing wide subject eligibility criteria, wide 
age range and different clinical practices from different countries, the study is ideal for 
obtaining real world data to assesses the effectiveness of this new technology. 
 
This a non-randomized study and the sponsor has no control of the treatment assignment. The 
Test and Control groups may have large differences on their baseline characteristics, and these 
differences can lead to biased estimates of treatment effects. Appropriate statistical methods 
will be used to reduce the bias (see Section 14 for more details). 
 
4.3. Subject Numbers 
The study will enroll approximately 300 (maximum: 330) subjects in each arm with the intent 
of completing at least 240 in each arm. Thus, the study will enroll approximately 600 subjects 
with a maximum of 660 (Figure 1). 
 
Multiple sites in the UK, Netherlands, Spain, and Germany will participate with other countries 
a possibility. Each site will enroll approximately similar numbers of test and control subjects. 
 
4.4. Study Duration 
Study enrollment occurs with execution of the study-related forms and informed consent. 
Study completion occurs with completion of the 12-month survey. 
 
Once the Test lens is launched in the study-participating country, the first subject registration 
will occur within six (6) months. 
 
The enrolment period should not exceed twelve (12) months in any country without prior 
authorization from the Sponsor. 
 
Subjects will present to the investigational site for Visit 1. Follow-up assessments are 
performed online at approximately 2-weeks, 4-months, and 12-months following Visit 1. 
Therefore, each subject is enrolled in the study for approximately 12 months. With the 12-
month enrollment period, the study will last approximately two (2) years per country. 

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5. 
TEST ARTICLE ALLOCATION AND MASKING 
 
5.1. Test Article Allocation 
This is a non-randomized observational study. Subjects receiving a new lens brand as part of 
the routine practice at the investigational site will be asked to participate: 
x Subjects receiving an ACUVUE® OASYS with Transitions™ contact lens on both eyes 
will comprise the Test group. 
x Subjects receiving any other spherical silicone hydrogel lens to be worn as daily wear 
and frequent replacement (2-weekly or monthly) will comprise the Control group. 
x The Test/Control allocation per site is approximately 1:1. Sites should not recruit a 
larger number of control subjects than test subjects. 
 
5.2. Masking 
This is an open label registry study. The identity of the lenses is known to all. Given this, there 
are no procedures for maintaining and breaking the masking. 

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6.4. Packaging and Labeling 
The test products will be packaged in sterile blister packs as the primary packaging. A sample 
Test lens label and packaging are shown below: 
 
 
6.5. Storage Conditions 
Any test lenses stored at the clinical site should be maintained at ambient temperatures and out 
of direct sunlight. 
 
6.6. Collection and Storage of Samples 
No samples will be collected as part of the study procedures. 
 
6.7. Accountability of Test Articles 
Not applicable. 

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x Subject not compliant to protocol 
x Subject lost to follow-up, i.e. misses two consecutive follow-up questionnaires. 
x Subject death during the study period 
x Subject develops significant or serious adverse events causing discontinuation of study 
lens wear 
x Investigator’s clinical judgment regarding for subject safety reasons (that it is in the 
subject’s best interest to stop contact lens use) 
 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION 
Concomitant medications will not be documented during the study. 
 
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. 
 
11. STUDY TERMINATION 
Since all of the products associated with the study are marketed products, there are no 
anticipated circumstances in which the study would be prematurely terminated. 
 
The Sponsor will determine if and when the study will be stopped. JJVC reserves the right to 
terminate the study at any time for any reason. Additionally, the IEC/IRB may reserve the 
right to terminate the study if an unreasonable risk is determined. 
 
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. 
 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
Given the nature of the study, and since the subjects will be using normally marketed product, 
the monitoring of Product Quality Complaints (PQCs) is out of the scope of this study. 
 
If the subject reports ‘poor’ overall comfort during a follow-up questionnaire, the subject will 
automatically be advised as part of the online questionnaire to consult their ECP. 
 
13. ADVERSE EVENTS 
This study is only concerned with ocular adverse events or adverse events related to the study 
lenses (test & control). 
 
Investigators will not automatically report any adverse event. Instead, these will be captured 
by a question in the follow-up questionnaire regarding ‘a problem with their eyes while 
wearing lenses that required them to visit an eyecare practitioner or hospital’. If subjects 
answer ‘Yes’ to this question the ECP investigator will be asked to complete a paper adverse 

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event form, detailing the problem. In the event of the subject having been seen by another 
clinic (e.g. emergency room) copies of the medical records will be requested. 
 
The records of any adverse event will be reviewed by a Data Monitoring Committee (DMC) 
who will adjudicate the diagnosis, severity and causality of any adverse events. 
 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device. 
NOTES: 
Note 1 to entry: This definition includes events related to the investigational medical device or the 
comparator. 
Note 2 to entry: This definition includes events related to the procedures involved. 
Note 3 to entry: For users or other persons, this definition is restricted to events related to 
investigational medical devices.”1 
 
In this study, monitored AEs will be confined to ocular AEs or non-ocular AEs related to the 
study lenses (e.g. injury sustained through poor vision). 
 
Serious Adverse Event (SAE) – An SAE is any untoward medical occurrence that: 
x Is potentially sight-threatening 
x Requires in-patient hospitalization or prolongation of existing hospitalization 
x Results in persistent or significant disability/incapacity (e.g., a sight threatening event, 
a significant persistent or permanent change, impairment, damage, or disruption to the 
subject’s body) 
x Requires intervention to prevent permanent damage (the use of the test article resulting 
in a condition which requires medical or surgical intervention to preclude permanent 
impairment of the body structure or a body function). Important medical events that 
may not result in death, be life-threatening, or require hospitalization may be 
considered an SAE when, based upon appropriate medical judgment, they may 
jeopardize the patient or subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in the above definition 
 
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to: 
x Microbial Keratitis (MK) 
x Iritis (including cells in the anterior chamber) 
x Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater 
x Central Corneal Opacity 
x Central Corneal Neovascularization 
x Uveitis 
x Endophthalmitis 
x Hypopyon 

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x Hyphema 
x Penetration of Bowman’s Membrane 
x Persistent Epithelial Defect 
x Limbal cell Damage 
 
Significant Adverse Events – Those events that are usually symptomatic and warrant 
discontinuation (temporary or permanent) of the test article (excluding Serious Adverse 
Events). 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following: 
x Contact Lens Induced Peripheral Ulcer (CLPU) 
x Significant Infiltrative Events (SIE) 
x Superior Epithelial Arcuate Lesions (SEALs) 
x Any Temporary Loss of >2 Lines of BSCVA 
x Other grade 3 or higher corneal findings, such as abrasions or edema 
x Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 
x Asymptomatic Corneal Scar 
x Any corneal event which necessitates temporary lens discontinuation > 2 weeks 
 
Non-Significant Adverse Events – Those conditions that are usually asymptomatic and 
usually do not warrant discontinuation (temporary or permanent) of the test article. However, 
the Investigator may choose to treat as a precautionary measure. 
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following: 
x Non-significant Infiltrative Event (NSIE) 
x Contact Lens Papillary Conjunctivitis (CLPC) 
x Superficial Punctate Keratitis (SPK) 
x Conjunctivitis: Bacterial, Viral, Allergic 
x Blepharitis 
x Meibomianitis 
x Contact Dermatitis 
x Localized Allergic Reactions 
x Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks 
 
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device. 
NOTES: 
Note 1 to entry: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction of the 
investigational medical device. 
Note 2 to entry: This definition includes any event resulting from use error or from intentional misuse 
of the investigational medical device.”1 
 
Unanticipated Serious Adverse Device Effect (USADE) – Any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, the test 

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article, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan, Investigator’s Brochure or protocol, or any 
other unanticipated serious problem associated with the test article that relates to the rights, 
safety and welfare of subjects. 
 
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include: 
x Seriousness/Classifications (see definition in Section 13.1) 
x Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related; unlikely related; possibly 
related; related - see definition in Section 13.2.1) 
x Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild; moderate; severe for all events - see definition in 
Section 13.2.2) 
x Outcome – not recovered or not resolved; recovering or resolving; recovered or 
resolved with sequelae; recovered or resolved; death related to adverse event; unknown 
x Actions Taken – none; temporarily discontinued; permanently discontinued; other. 
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations: 
x Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures 
x Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely 
x Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive. The relationship in time is 
reasonable. Therefore, the causal relationship cannot be excluded 
x Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge. 
 
13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale: 
x Mild – Event is noticeable to the subject, but is easily tolerated and does not interfere 
with the subject’s daily activities 

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x Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities 
x Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities. 
 
13.3. Documentation and Follow-Up of Adverse Events 
If a subject reports through the follow-up questionnaire ‘a problem with their eyes while 
wearing lenses that required them to visit an eyecare practitioner or hospital’, this will be 
followed-up with the treating facility. If this is the ECP investigator, they will be asked to 
complete a paper adverse event form and to supply copies of any other relevant records. In the 
event of the subject having been seen by another clinic (e.g. emergency room) copies of the 
medical records will be requested. 
 
Investigators are recommended to include the following in the patients records: 
x Adverse event (diagnosis not symptom) 
x Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.) 
x Date the clinical site was notified 
x Date and time of onset 
x Date and time of resolution 
x Adverse event classification, severity, and relationship to test articles, as applicable 
x Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements 
x Any referral to another health care provider if needed 
x Outcome, ocular damage (if any) 
x Likely etiology 
x Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event. 
 
13.4. Reporting Adverse Events 
In addition, a written report will be submitted by the Principal Investigator to the IEC/IRB 
according to their requirements. The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures. 
 
13.5. Event of Special Interest 
None 
 
13.6. Reporting of Pregnancy 
 
Not applicable for this study. 

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14. STATISTICAL METHODS 
 
14.1. General Considerations 
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below. More details will be included in the stand-alone Statistical Analysis Plan (SAP). The 
SAP will be finalized prior to database lock. 
 
All data summaries and statistical analyses will be performed using the SAS software 9.4 or 
higher (SAS Institute, Cary, NC).7 Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization and statistical analysis. 
 
Summary tables (descriptive statistics and/or frequency tables) will be provided by arm for all 
baseline variables, ECP registration questionnaire (ERQ), Patient registration questionnaire 
(PRQ), and 2-week, 4-month and 12-month survey questionnaires. Continuous variables will 
be summarized with descriptive statistics (n, mean, standard deviation (SD), median, minimum 
and maximum). Frequency count and percentage of subjects or eyes within each category will 
be provided for categorical data. 
 
14.2. Sample Size Justification 
This study was designed and powered to show superiority of JJVC senofilcon A contact lenses 
with photochromic additive (Test) compared to non-photochromic reusable silicone hydrogel 
contact lenses (Control) with respect to vision satisfaction in bright lighting over a period of 
one year. 
The sample size calculation was based on historical data from six Johnson & Johnson Vision 
Care sponsored randomized clinical trials
 
In all of the studies, the Test lens and ACUVUE OASYS were worn as a 
daily wear for approximately 2 weeks each. Table 3 summarizes the percentage of patients 
with vision satisfaction in bright lighting (agree/strongly agree) pooled from all studies. When 
the trial is a crossover design, only data from the first period were considered. 
 
Table 3: Summary of vision satisfaction in bright lighting at 2-week follow-up 
 
Study Lens 
Number of Patients 
Vision satisfaction in bright 
lighting (%) 
ACUVUE OASYS® 
397 
77.1% 
ACUVUE OASYS with 
Transitions
395 
86.6% 

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The sample size was estimated from the formula given by Diggle et al.14 for clustered binary 
data: 
 
  
 2 
[ܼߙξ2݌ݍ  + ܼߚξ݌ܥ ݍܥ + ݌ܶ ݍܶ ] 
(1 + (݊ െͳሻߩ 
ܰ = 
 
 
݊(݌ܶ െ ݌ܥሻ2 
Where ݌ܥ: Response proportion in the Control group, ݍܥ ൌ ͳ െ ݌ܥ, ݌ܶ: Response proportion 
in the Test group, ݍܶ ൌ ͳ െ ݌ܶ, ݌ҧ = (݌ܥ + ݌ܶ)/2, ݍҧ ൌ ͳ െ ݌ҧ, n: number of observations per 
subject (i.e. n = 3) and ߩ  is the common correlation across n observations. The terms  ܼߙ   and 
ܼߚ    are the Z scores that correspond to the pre-specified type I error ߙ  and power 1 െ ߚ 
repectively. 
 
Based on the historical data reported in Table 3, we calculated the sample size for different 
possible scenarios of correlation ߩ, ݌ܥ and ݌ܶ. Here we assume the response proportions will 
be the same over time. The results are summarized in Table 4 below 
 
Table 4: Required sample size per arm for different scenarios of ࣋, ࢖࡯ and ࢖ࢀ 
 
࢖࡯ 
࢖ࢀ 
Difference 
(࢖ࢀ  െ ࢖࡯ሻ 
࣋ 
0.3 
0.5 
0.7 
0.50 
0.62 
0.12 
143 
178 
213 
0.65 
0.77 
0.12 
119 
149 
178 
0.70 
0.80 
0.10 
156 
195 
234 
0.75 
0.85 
0.10 
133 
167 
200 
0.77 
0.86 
0.09 
145 
194 
242 
 
As shown in Table 4, a sample size of 240 subjects per arm is considered sufficiently large to 
test for superiority under different scenarios of ݌ܥ and ݌ܶ and with a minimum power of 80% 
and a two-sided type I error of 0.05. 
 
The plan is to enroll 300 subjects per arm with a target completion of 240 subjects per arm. 
During the enrollment period, the subject’s dropouts will be monitored. If the dropout rate is 
over 20% in certain arms, the targeted total enrollment number will be increased accordingly 
to ensure a minimum of 240 subjects per group to complete the study. 
 
14.3. Analysis Populations 
Per-Protocol Population: 
All eligible subjects who have completed at least two follow-up questionnaires including the 
12-month questionnaire 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. 

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Full Analysis Population: 
All enrolled subjects (signed consent form) regardless of subsequent withdrawal from study or 
deviation from protocol. At least one observation should be recorded. 
 
Both primary and secondary analysis will be conducted on full analysis set. A sensitivity 
analysis will be conducted on the per-protocol population. To evaluate the impact of missing 
data, sensitivity analysis will be conducted using multiple imputation. 
 
14.4. Level of Statistical Significance 
All planned analysis for this study will be conducted with an overall type I error rate of 5%. 
The secondary analysis will be adjusted for multiple comparisons between the Test and the 
Control groups across the evaluation periods using a simulated-based approach (Edward and 
Berry).15 
14.5. Primary Analysis 
Vision Satisfaction in Bright Lighting 
Subjects’ responses will first be categorized into a binary outcome of 1 if the response is 
positive (Agree or Strongly Agree) or 0 otherwise (Neither Agree Nor Disagree, Disagree or 
Strongly Disagree). The outcome will then be analyzed using a generalized linear mixed model 
for correlated binary data. The model will include treatment group (Test, Control), evaluation 
period (2-week, 4-month and 12-month) and group by evaluation period as fixed factors, and 
site as random effect (G-side). The model will be adjusted for baseline values, country, age, 
gender and race as fixed covariates when appropriate. The correlation between responses from 
the same subjects across evaluation periods will be modeled using an unstructured (UN) 
covariance matrix (R-side). If problem of convergence encountered, a Compound Symmetry 
(CS) covariance structure will be considered. 
 
The null and alternative hypotheses for the primary hypothesis are as follows: 
 
ܪ0: ܱܴ  ൑ 1 
ܪܣ   ܱܴ  > 1; 
 
where ܱܴ is the overall odds ratio of having a positive rating of vision satisfaction in bright 
lighting (Test over Control). The superiority test will be based on the OR and corresponding 
95% confidence interval calculated using the final selected model. The lower bound of the 
95% confidence interval will be compared to 1. If the lower bound is above 1, the Test lens 
will be considered superior to the Control lenses with respect to vision satisfaction in bright 
lighting. The odds ratio at 2-week, 4-month and 12-month evaluation periods will be calculated 
with their corresponding adjusted 95% confidence intervals to test the secondary hypothesis 
#1. 
 
This is an observational study and the treatment assignment is not randomized. The Test and 
Control groups may have large differences on their baseline characteristics, and these 
differences can lead to biased estimates of treatment effects. Instead of adjusting the model to 
all covariates including interactions with treatment group and higher order terms, the 
propensity score will be used. The propensity score, defined as the conditional probability of 

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being in Test or Control group given the covariates, will be used to balance the covariates in 
the two groups, and therefore reduce this bias. The propensity will be calculated using a logistic 
regression model. 
 
A generalized linear mixed model for correlated ordinal data may be considered if the 
proportion of subjects with positive response is low. Cumulative odds ratio will be used for 
hypothesis tests. 
 
14.6. Secondary Analysis 
Overall Quality of Vision and Overall Comfort 
Overall quality of vision and overall comfort ratings will be analyzed separately using the same 
statistical method described in the primary analysis. The hypothesis tests will be conducted 
using adjusted 95% confidence intervals of odds ratios. 
 
Pulfrich Effect 
The proportion of subjects who experienced the Pulfrich effect will be calculated as the 
proportion of subjects who disagree or strongly disagree with the statement “While wearing 
these lenses, my depth perception of moving objects has NOT been impacted”. The Pulfrich 
effect will be evaluated over time at 2-week, 4-month and 12-month evaluation periods. The 
proportion of subjects who experienced the Pulfrich effect at least once will also be calculated. 
 
Serious and Significant Ocular AEs 
No statistical hypothesis will be tested. The following will be calculated: 
1. Incidence rate of serious and significant ocular AEs (in patient-year) will be 
calculated as follow: 
 
ܫܴ = 
ܰݑܾ݉݁ݎ ݋݂ ݏݑܾ݆݁ܿݐݏ ݓ݅ݐ݄ ܽ݊ ݁ݒ݁݊ݐ 
 
 
(ܵݑ݉ ݋݂ ݏݑܾ݆݁ܿݐݏԢ݁ݔ݌݋ݏݑݎ݁ ݐ݅݉݁ݏሻȀ͵͸ͷǤʹͷ 
Where each subject’s exposure time is defined as number of days in the study after 
the enrollment, censored only by events such as first serious or significant ocular 
AE, dropouts, death or the end of the study. 
2. Proportion of subjects with at least one reported serious or significant ocular AE at 
each evaluation period. 
3. Proportion of eyes with a least one reported serious or significant ocular AE at each 
evaluation period. 
4. Proportion of all reported serious and significant ocular AEs at each evaluation 
period. 
 
14.7. Other Exploratory Analyses 
Subgroup analysis of the primary and secondary endpoints will be conducted by country, age 
group and lens material. Other subgroup analysis may be considered by factors showing 
interaction effects with the treatment. The control group will be categorized by lens materials 
and/or wear modality for further comparisons with the Test lens. 

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Further analysis using a generalized linear mixed model using Poison or negative binomial 
distribution will be considered to test for statistical difference in incidence rates between Test 
and Control groups. Non-ocular lens related AEs will be evaluated. 
 
14.8. Interim Analysis 
There will be three interim analyses once 50% of enrolled subjects have completed the 2-week, 
4-month and 12-month questionnaires. The interim data will be summarized using descriptive 
statistics. Reasons for dropouts and ocular adverse events will be monitored. An interim 
statistical analysis plan (ISAP) may be considered, if necessary, for further analysis prior to 
the database lock. 
 
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
Subject dropout is expected to be one of the main reasons of missing data in this registry study. 
Past clinical trials do not provide the evidence that subject dropout is systematic or not-at- 
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using 
multiple imputation. The SAS/STAT procedures PROC MI and PROC MIANALYZE will be 
utilized with a parametric regression method used to make at least 50 imputations. 
 
14.10. Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change. 
 
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
 
15.1. Case Report Form/Data Collection 
The data collected by the investigators for this study will be captured on paper case report 
forms (CRFs). These will be returned to the CRO and then entered into an electronic data 
collection (EDC) system. 
 
Once completed, the eCRFs will be reviewed for accuracy and completeness. The sponsor or 
sponsor’s representatives will be authorized to gain access to the subject recordation for the 
purposes of monitoring and auditing the study. 
 
The questionnaire data will be entered by the subjects into an EDC system. Edit checks, 
electronic queries, and audit trails are built into the system to ensure accurate and complete 
data collection. Electronic data will be transmitted to a secure central database as forms are 
completed or updated, ensuring information accuracy, security, and confidentiality. 
 
The content and structure of the eCRFs are compliant with ISO14155:2011.1 

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15.2. Subject Record 
At a minimum, the subject record should be available for the following: 
x subject identification 
x eligibility 
x study identification 
x provision of and date of informed consent 
x a record of all adverse events 
x follow-up of adverse events 
 
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. 
 
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. 

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Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
 
17. MONITORING 
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include: 
x Ensuring that the investigation is being conducted according to the protocol, any 
subsequent amendments, and regulatory requirements are maintained 
x Ensuring the rights and wellbeing of subjects are protected 
x Ensuring that protocol deviations are documented with corrective action plans, as 
applicable 
x Clarifying questions regarding the study 
x Resolving study issues or problems that may arise 
x Reviewing of informed consent forms 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 requirements of the study. 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 have provided their consent voluntarily will be enrolled. 
 
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 20133 and that the 
clinical study data are credible. The Investigator must maintain clinical study files in 
accordance with Section 8 of the ICH E6 guidelines on Good Clinical Practice (GCP),2 and 
applicable regulatory requirements. 
 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
x Final protocol and, if applicable, amendments 

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x Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects) 
x Sponsor-approved subject recruitment materials 
x Information on compensation to subjects for participation in the study 
x Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB) 
x Any other documents that the IEC/IRB requests to fulfill 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: 
x Protocol amendments 
x Revision(s) to informed consent form and any other written materials to be provided to 
subjects 
x If applicable, new or revised subject recruitment materials approved by the Sponsor 
x Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study 
x Summaries of the status of the study (at intervals stipulated in guidelines of the 
IEC/IRB) 
x Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements 
x Major protocol deviations as required by the IEC/IRB 
x Any other requirements of the IEC/IRB 
 
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing. 
 
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable. 
 
18.4. Informed Consent 
Each subject must give written consent according to local requirements after the nature of the 
study has been fully explained. The consent form must be signed before performance of any 
study-related activity. The consent form that is used must be approved by both the Sponsor 
and by the reviewing IEC/IRB. The informed consent is in accordance with principles that 
originated in the Declaration of Helsinki,3 current ICH2 and ISO 141551 guidelines, applicable 
regulatory requirements, and Sponsor Policy. 
 
Before entry into the study, the Investigator or an authorized member of the clinical site 
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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. 
 
The subjects will be informed that choosing not to participate will not affect the care they will 
receive. Finally, they will be told that the Investigator will maintain a subject identification 
register for the purposes of long-term follow-up if needed and that their records may be 
accessed by health authorities and authorized Sponsor personnel without violating the 
confidentiality of the subject, to the extent permitted by the applicable law(s) or regulations. 
By signing the Informed Consent Form the subject is authorizing such access and agrees to be 
contacted after study completion by health authorities and authorized Sponsor personnel for 
the purpose of obtaining consent for additional safety evaluations if needed. 
 
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 in the United Kingdom16 and other applicable 
personal data protection and security laws and regulations. Appropriate measures will be 
employed to safeguard these data, to maintain the confidentiality of the person’s related health 
and medical information, to properly inform the concerned persons about the collection and 
processing of their personal data, to grant them reasonable access to their personal data and to 
prevent access by unauthorized persons. 
 
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records. 
 
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study. 
 
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. 
 
The Sponsor ensures that the personal data will be: 
x processed fairly and lawfully 

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x collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes 
x adequate, relevant, and not excessive in relation to said purposes 
x accurate and, where necessary, kept current 
 
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries. 
 
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
 
19. STUDY RECORD RETENTION 
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents. 
 
Essential documents must be retained for at least two (2) years after study completion. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports. 
 
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC. 

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20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation. 
JJVC reserves the right to withhold remuneration for costs associated with protocol violations, 
such as, registering an ineligible subject. 
 
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as: i) query resolution, ii) completion of any follow-up action items. 
 
21. PUBLICATION 
This study will be registered on ClinicalTrials.gov by the Sponsor. 
 
22. REFERENCES 
1. 
ISO14155:2011: Clinical investigation of Medical Devices for Human Subjects- 
Good Clinical Practice. Available at: https://www.iso.org/standard/45557.html 
2. 
International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP) 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy- 
guidelines.html 
3. 
Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of- 
helsinki-ethical-principles-for-medical-research-involving-human-subjects/ 
 
 
4. 
United States (US) Code of Federal Regulations (CFR) Available at : 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR 
5. 
Gleason. W, Albright RC. Menicon Z 30-day continuous wear lenses: a clinical 
comparison to ACUVUE 7-day extended wear lenses. . Eye & contact lens. 
2003;S1:S149-152. 
6. 
Schein OD, McNally JJ, Katz J, et al. The Incidence of Microbial Keratitis Among 
Wearers of 30-day Silicone Hydrogel Extended-Wear Contact Lenses. 
Ophthalmology. 2005;112(12):2172-2179. 
7. 
SAS Institute Inc: SAS® 9.4 Statements: Reference, Third Edition. Cary, NC: SAS 
Institute Inc; 2014. 
8. 
Buch J. Clinical Study Report 
 Long-term Evaluation of 
Investigational lenses containing new UV- Blocker 2017. 
9. 
Buch J. Clinical Study Report 
 Confirmation of ECL100 
pilot line clinical performance. 2018. 
10. 
Buch J. Clinical Study Report 
 Long-term Evaluation of 
Investigational Lenses containing new UV-Blocker 2017. 
11. 
Buch J. Clinical Study Protocol 
Evaluation of 
Approved and Investigational Contact Lenses 2018. 
12. 
Buch J. Clinical Study Report 
 Initial Evaluation of 
Investigational Lenses Manufactured on a New Production Line.2018. 

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13. 
Buch J. Clinical Study Report
 Design Validation of 
senofilcon A with New UV Blocking Additive.2018. 
14. 
Diggle PJ, Heagerty P, Liang K-Y, Zeger SL. Analysis of Longitudinal Data, Second 
Edition. Oxford2002. 
15. 
Edwards D, Berry JJ. The efficiency of simulation-based multiple comparisons. 
Biometrics. 1987;43(4):913-928. 
16. 
Data Protection Act. Available at: 
http://www.legislation.gov.uk/ukpga/1998/29/contents 

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APPENDIX A: PATIENT REPORTED OUTCOMES FORM SPECIFICATIONS 

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APPENDIX B: ECP REGISTRATION FORM 

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V  I S  I O N C A  R E    R E  S E A  R C H 

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V I S I O N C A R E   R E S E A R C H 

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APPENDIX C: IRIS COLOR SCALE 
 
 

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APPENDIX D: 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6334 ACUVUE OASYS with Transitions Light Intelligent 
Technology Clinical Performance Registry 
 
Version and Date: v4.0, 24 November 2020 
 
I have read and understand the protocol specified above and agree on its content. 
 
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the 
Declaration of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the 
pertinent individual country laws/regulations and to comply with its obligations, subject to 
ethical and safety considerations. The Principal Investigator is responsible for ensuring that all 
clinical site personnel, including Sub-Investigators adhere to all ICH 2 regulations and GCP 
guidelines regarding clinical trials during and after study completion. 
 
I will assure that no deviation from, or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants. 
 
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere 
to all ICH2 regulations and GCP guidelines regarding clinical trials during and after study 
completion. 
 
All clinical site personnel involved in the conduct of this study have completed Human 
Subjects Protection Training. 
 
I agree to ensure that all clinical site personnel involved in the conduct of this study are 
informed about their obligations in meeting the above commitments. 
 
I shall not disclose the information contained in this protocol or any results obtained from this 
study without written authorization. 
 
Principal 
Investigator: 
  
 
 
 
Signature 
 
Date 
 
 
Name and Professional Position (Printed) 
 
Institution/Site: 
  
 
Institution/Site Name 
 
 
Institution/Site Address