Orientation Characteristics of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Acuvue Oasys 1-Day for Astigmatism Contact Lenses
Phase: NA
Conditions: Astigmatism
Sponsor: Bausch & Lomb Incorporated

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 1 of 48 
 
 
 
 
Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses 
Compared to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
CLINICAL INVESTIGATIONAL PLAN 
STUDY: ROC2-23-006 
IRB / B+L Reference Code #: AD23-01-00 
PROJECT NAME:  
 
 
Sponsor:  Bausch & Lomb, Incorporated 
 
This study is being conducted in accordance with 21CFR Parts 11, 50, 54, 56 and 812; 42 
USC 282(j); ISO 14155:2020 Clinical investigation of medical devices for human subjects – 
Good Clinical Practice; International Council for Harmonization (ICH) Good Clinical 
Practice (GCP) - Declaration of Helsinki and applicable local regulations. 
 
Revision Chronology: 
Version 1.0 
July 25, 2023 
 
The information in the following document is confidential. The information contained 
herein will not be disclosed to others without written authorization from Bausch & Lomb, 
Incorporated. 
 
 
  
 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 2 of 48 
 
TABLE OF CONTENTS 
LIST OF ABBREVIATIONS/ACRONYMS ......................................................................... 5 
INVESTIGATIONAL SITE AND STUDY PERSONNEL ................................................... 6 
SYNOPSIS .............................................................................................................................. 7 
1.0 INTRODUCTION .......................................................................................................... 11 
2.0 OBJECTIVE ................................................................................................................... 11 
3.0 STUDY DESIGN............................................................................................................ 11 
3.1 Description of Study Design ....................................................................................... 11 
3.2 Selection of Study Population ..................................................................................... 11 
3.2.1 Eligibility ............................................................................................................. 12 
3.2.1.1 Inclusion Criteria .............................................................................................. 12 
3.2.1.2 Exclusion Criteria .......................................................................................... 13 
3.2.2 Point of Enrollment and Randomization .............................................................. 13 
3.2.3 Subject Completion .............................................................................................. 13 
3.2.4 Lost to Follow-up ................................................................................................. 14 
3.3 Investigators ................................................................................................................ 14 
3.4 Study Duration ............................................................................................................ 14 
3.5 Protocol Changes and Amendments ........................................................................... 14 
4.0 STUDY MATERIALS ................................................................................................... 14 
4.1 Description of the Test Lens: ...................................................................................... 14 
4.2 Description of Comparator Lenses ............................................................................. 14 
4.3 Instructions for Use and Administration ..................................................................... 15 
4.3.1 Storage Requirements .......................................................................................... 15 
4.3.2 Subject Instructions .............................................................................................. 15 
4.4 Other Study Materials ................................................................................................. 15 
4.5 Packaging and Labeling .............................................................................................. 16 
4.6 Accountability ............................................................................................................. 16 
4.7 Masking....................................................................................................................... 16 
4.8 Product Replacement .................................................................................................. 17 
4.9 Risk Assessment ......................................................................................................... 17 
4.9.1 Risk Related to Subject ........................................................................................ 17 
4.9.2 Risk Related to Data Management ...................................................................... 17 
4.10 Relevance of Clinical Investigation .......................................................................... 18 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 3 of 48 
 
5.0 STUDY METHODS ....................................................................................................... 18 
5.1 Measurements and Procedures .................................................................................... 18 
5.1.1 Study Visits .......................................................................................................... 18 
5.1.2 Unscheduled Visits .............................................................................................. 19 
5.1.3 Missed Visits ........................................................................................................ 19 
5.1.4 Post-Study Follow-up Visit ................................................................................. 19 
5.2 Study Completion ....................................................................................................... 19 
5.2.1 Study Termination/Suspension ............................................................................ 19 
5.2.2 Study Termination Procedure .............................................................................. 20 
5.3 Concomitant Medications/Therapy ............................................................................. 20 
5.4 Protocol Deviations ..................................................................................................... 20 
6.0 ADVERSE EVENTS (AE) ............................................................................................. 21 
6.1 Adverse Event Definitions .......................................................................................... 21 
6.1.1 Adverse Event (AE) ............................................................................................. 21 
6.1.2 Serious Adverse Event (SAE) .............................................................................. 21 
6.1.3 Serious Adverse Ocular Event ............................................................................. 21 
6.1.4 Significant, Non-Serious Adverse Event ............................................................. 22 
6.1.5 Non-significant, Non-serious Adverse Event ...................................................... 23 
6.1.6 Adverse Device Effect (ADE) ............................................................................. 23 
6.1.6.1 Anticipated Serious Adverse Device Effect (ASADE) ................................. 23 
6.1.6.2 Unanticipated Serious Adverse Device Effect (USADE) .............................. 23 
6.1.7 Device Deficiency ................................................................................................ 23 
6.2 Adverse Event Treatment and Culturing .................................................................... 24 
6.3 Adverse Event Identification and Evaluation ............................................................. 24 
6.4 Adverse Event Collection and Reporting ................................................................... 25 
6.5 Reporting Device Deficiencies ................................................................................... 26 
6.6 Emergency Contact Details for Reporting SAE and ADE ......................................... 27 
7.0 STATISTICAL METHODS ........................................................................................... 27 
7.1 Study Endpoints .......................................................................................................... 27 
7.2 Hypotheses .................................................................................................................. 27 
7.3 Sample Size ................................................................................................................. 27 
7.4 Randomization ............................................................................................................ 27 
7.5 Study Populations ....................................................................................................... 28 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 4 of 48 
 
7.6 Statistical Analysis ...................................................................................................... 28 
7.6.1 Pass/Fail Criteria .................................................................................................. 28 
7.6.2 Interim Analyses .................................................................................................. 28 
7.6.3 Exploratory/Sensitivity Analysis ......................................................................... 28 
7.6.4 Deviations ............................................................................................................ 28 
8.0 DATA QUALITY ASSURANCE .................................................................................. 28 
8.1 Study Monitoring ........................................................................................................ 29 
8.1.1 Monitoring Subject Risk ...................................................................................... 29 
8.1.2 Monitoring Informed Consent Process ................................................................ 29 
8.1.3 Data Verification .................................................................................................. 30 
8.1.3.1 Direct Entry with Verification ....................................................................... 30 
8.1.3.2 Double Entry of Data ..................................................................................... 31 
8.1.3.3 The Data Management Summary (DMS) ...................................................... 31 
8.1.4 Annual Research Clinic Monitoring Plan ............................................................ 31 
8.1.4.1 Monitoring Procedure .................................................................................... 31 
8.1.4.2 Site Performance Evaluation & Monitoring Report ...................................... 32 
8.2 Auditing Procedures.................................................................................................... 32 
8.3 Source Documentation ................................................................................................ 32 
8.4 Maintaining Subject Privacy ....................................................................................... 33 
8.5 Locking the Database .................................................................................................. 33 
8.6 Retention of Documents ............................................................................................. 33 
8.7 Clinical Quality Assurance ......................................................................................... 34 
8.8 Institutional Review Board ......................................................................................... 34 
8.9 Statements of Compliance .......................................................................................... 34 
8.10 Informed Consent Process ........................................................................................ 35 
8.10.1 Vulnerable Population ....................................................................................... 35 
8.11 Publication of Results ............................................................................................... 35 
9.0 REFERENCES ............................................................................................................... 36 
APPENDIX A: METHODS OF CLINICAL EVALUATION ............................................. 37 
APPENDIX B: SUBJECT INSTRUCTIONS FOR USE ..................................................... 41 
 
 
 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 5 of 48 
 
LIST OF ABBREVIATIONS/ACRONYMS 
Abbreviation/Acronym 
Term 
AE 
Adverse Event 
B+L 
Bausch + Lomb 
BSCVA 
Best Spectacle-Corrected Visual Acuity 
CFR 
Code of Federal Regulations 
CRT 
Clinical Research Technician  
CRF/e-CRF 
Case Report Form / Electronic Case Report Form 
EDC 
Electronic Data Capture 
EC 
Ethics Committee 
GCPs 
Good Clinical Practices 
GPRM 
Global Pharmacovigilance and Risk Management 
IB 
Investigator's Brochure 
IDE 
Investigational Device Exemption 
ICF 
Informed Consent Form 
IRB 
Institutional Review Board 
TMF 
Trial Master File 
NOTE:  The first occurrence of some abbreviations is not spelled out in the document (e.g., units of measure). 
 
 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 6 of 48 
 
INVESTIGATIONAL SITE AND STUDY PERSONNEL  
The Investigators are Optometrists employed by Bausch & Lomb, Incorporated (Bausch + 
Lomb) and determined to be suitably qualified by training and experience to conduct this 
study. There are not any external organizations involved in the clinical investigation. Each 
Investigator may participate in all components of study execution. The study is paid for 
entirely by Bausch + Lomb. It will only be conducted at one site.  
 
Sponsor 
Investigational Site 
Bausch & Lomb, Incorporated  
Bausch & Lomb, Incorporated  
1400 North Goodman Street  
1400 North Goodman Street  
Rochester, NY 14609 
Rochester, NY 14609 
 
Principal Investigator 
Sponsor/ Sponsor Representative 
 
 
 
 
  
  
  
  
 
 
 
 
 
 
 
 
 
Clinical Investigator 
Emergency Contact 
 
 
 
 
  
  
  
  
 
 
 
 
 
 
 
 
 
 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 7 of 48 
 
SYNOPSIS 
 
Study Title 
Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact 
Lenses Compared to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
Sponsor 
Bausch & Lomb, Incorporated, 1400 N. Goodman St. Rochester, NY 14609 
Number of Sites One Investigational Site, Bausch & Lomb Incorporated, Rochester, NY 14609 
Clinical Phase  
Device feasibility 
Trial 
Registration  
This study will be registered at clinicaltrials.gov. 
Test Articles 
Test Lens: kalifilcon A Daily Disposable Toric
 (T01: kali A toric) 
 
Comparator Lenses: Commercially available contact lenses 
C01: Acuvue Oasys 1-Day for Astigmatism (C01: AVO1DfA) 
 
Objective 
The objective is to evaluate the contact lens fit characteristics 
 
 of kalifilcon A 
daily disposable toric compared to commercially available Acuvue Oasys 1-Day 
for Astigmatism contact lenses. 
Ethical 
Considerations 
Written approval of the protocol and informed consent will be provided to 
Bausch + Lomb by the IRB prior to initiation of the study. Investigators are 
not to deviate from the study protocol except when necessary for the 
protection of the subject’s health, safety, or welfare. Before any study-specific 
procedures are performed, the Investigator (or designee) will explain the 
purpose of the study, the associated procedures, and any anticipated effects or 
adverse reactions to the subject. The subject will be given sufficient time and 
opportunity to ask questions regarding any aspect of the study and to decide 
whether or not to participate in the study.  Once the Investigator (or designee) 
is assured the subject understands the implications of study participation, the 
subject will be asked to give consent to participate in the study by signing and 
dating the Informed Consent Form (ICF). 
Study Design 
Approximately 30 soft toric contact lens adapted subjects will be enrolled in 
this feasibility, bilateral, randomized, double-masked (subject and 
investigator), repeated measures insertion study. All subjects will be seen for 
a Screening/Dispensing Visit at which informed consent will be obtained and 
eligibility will be assessed. If subjects satisfy all eligibility criteria, subjects 
will be dispensed study lenses according to unique randomization tables that 
will be provided to each Investigator. If study eligibility is met, 
 
 
 
Subjects will be receiving each of the study lens types once, in a randomized 
order. 
 
.   
Study Duration/ 
Follow-up 
There are a total of 2 study lens types. 
 
 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 8 of 48 
 
  
 
Visit 1: Approximately 30 minutes 
 
The clinical investigation will take approximately 1 month to complete.  
Enrollment will take place throughout the duration of the study.  
Treatment and 
Allocation 
Schedule 
There are a total of 2 study lens types. 
 
  
 
Subjects 
Planned 
Approximately 30 experienced soft contact lens wearing subjects (includes 
males and females). Healthy volunteers will be recruited and screened as per 
criteria outlined below. The subjects will all be experienced soft contact lens 
wearers. 
Anticipated 
Study 
Population 
Recruitment for this study will target experienced contact lens wearers that 
have refractive error requiring contact lens correction. Healthy male and 
female volunteers will be recruited and screened as per criteria outlined below. 
Inclusion 
Criteria 
To be eligible for entry into the study, the subject must:  
1. Be 18 years or older on the date the Informed Consent Form (ICF) is 
signed and have capacity to read, understand and provide written 
voluntary informed consent.   
2. Have physiologically normal anterior segments not exhibiting 
clinically significant biomicroscopy findings.  
3. Have no active ocular disease or allergic conjunctivitis.  
4. Not be using any topical ocular medications.  
5. Be willing and able to follow instructions.  
6. Have signed a statement of informed consent 
Exclusion 
Criteria 
The subject is not eligible to participate in the study if the subject is:  
1. Participating in a conflicting study in the opinion of the Investigator.  
2. Considered by the Investigator to not be a suitable candidate for 
participation.  
Disallowed 
Medications/ 
Interventions 
Ocular, systemic or topical medications that, in the Investigator’s 
opinion, could potentially affect ocular physiology or performance are 
prohibited.  
Investigational 
Product, Dosage 
and Mode of 
Administration 
Study lenses will be dispensed to subjects meeting all eligibility requirements 
including any dispensing requirements in this clinical protocol. Study lenses 
will be worn in office only. The investigator or designee will instruct all 
subjects to adhere to subject instructions. 
 
Subjects will be receiving each of the study lens types once, in a randomized 
order. The subject will wear each study contact lens pair for approximately 10 
minutes.  
 
An unmasked designee will be responsible for all study lens accountability, 
including dispensation and collection of study supplies to subjects. Subjects 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
Version 1.0 
  CONFIDENTIAL 
July 25, 2023 
Page 10 of 48 
that the study can be completed within the desired time frame. 
Hypothesis 
No statistical hypotheses were performed for this feasibility study. 
Pass/Fail 
Criteria 
There are no pass/fail criteria for the results of the clinical investigation. 
Interim Analysis No interim analyses are planned. 
Monitoring Risk The risks involved with contact lens wear in this study will be minimized 
because the subjects will be examined frequently and at specified intervals. 
The risks are further minimized by the study eligibility criteria.   
Data Quality 
Assurance 
Edit checks are built into the EDC System to minimize the chance of error.  
Also, data is collected by using either Direct Entry with Verification or Double 
Data Entry.   

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 11 of 48 
 
1.0 INTRODUCTION 
 
The ability of a toric contact lens to orient correctly on-eye and to maintain that 
orientation 
 are important aspects of acceptable on-eye 
performance. Mechanical design features 
 are components of toric 
contact lens designs that are added to provide acceptable movement, orientation, and 
rotational stability needed to correct refractive astigmatism. Study ROC2-23-006 will 
evaluate the 
 kalifilcon A daily disposable toric compared to 
Acuvue Oasys 1-Day for Astigmatism. 
 
2.0 OBJECTIVE 
 
The objective is to evaluate the contact lens fit characteristics 
 
) of kalifilcon A daily disposable toric 
compared to commercially available Acuvue Oasys 1-Day for Astigmatism. 
 
 
3.0 STUDY DESIGN 
 
3.1 Description of Study Design 
 
Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, 
bilateral, randomized, double masked (subject and investigator masked), repeated measures 
insertion study.  All subjects will be seen for a Screening/Dispensing Visit at which 
informed consent will be obtained and eligibility will be assessed. If subjects satisfy all 
eligibility criteria and none of the exclusion criteria, subjects 
 
in random, successive order according to unique randomization schedules that will be 
provided to each Investigator.   
 
 
 
 
 
The target is to have 30 subjects who are experienced contact lens wearers complete each 
study lens type. Further information regarding the target population can be found in the IB. 
 
Visit 1: Approximately 30 minutes 
 
The clinical investigation will take approximately 1 month to complete. 
 
3.2 Selection of Study Population 
 
Written informed consent, enrollment in the study, or dispensing of study products 
cannot begin until the Investigator has received Institutional Review Board (IRB)/Ethics 
Committee (EC) approval to conduct the study. 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 12 of 48 
 
 
To reduce the foreseeable factors that could compromise the outcome of the clinical 
investigation, subjects are targeted who are experienced contact lens wearers. To be eligible 
to participate, subjects must have physiologically normal anterior segments not exhibiting 
clinically significant biomicroscopy findings, no active ocular disease or allergic 
conjunctivitis, not using any topical ocular medications and be willing and able to follow 
instructions. There are no known or foreseeable factors that may compromise the outcome 
of this clinical investigation that are not already controlled for by the Inclusion and 
Exclusion criteria. 
 
Healthy male and female volunteers will be recruited and screened as per criteria outlined 
below. The subjects will all be experienced soft contact lens wearers in both eyes.  
 
Enrollment will take place throughout the duration of the study  
 
Intended Purpose/Use 
The kalifilcon A Daily Disposable 
lenses are intended for the daily wear 
correction of refractive ametropia (myopia, hyperopia and astigmatism). Daily disposable 
lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended 
to be cleaned or disinfected and should be discarded after a single use. 
 
Additional information can be found in IB and in the comparator lens package insert, 
patient instruction booklet, and professional fitting guide1-2. 
 
Investigational and Target Population  
The relationship between the investigative population and the target population is they are 
both contact lens wearers. Daily disposable toric lenses are for use by patients prescribed 
the correction of refractive ametropia (myopia, hyperopia and astigmatism), regardless of 
gender or ethnicity and who do not have contraindications for the device. This study will be 
conducted on adults of at least 18 years of age.  
Recruitment for this study will target experienced soft contact lens wearers that have 
refractive error requiring contact lens correction. Subjects will be targeted that have a toric 
contact lens correction. 
 
Additional information can be found in IB.  
 
3.2.1 Eligibility 
3.2.1.1 Inclusion Criteria 
To be eligible for entry into the study, the subject must:  
1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and 
have capacity to read, understand and provide written voluntary informed consent.  

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 13 of 48 
 
2. Have physiologically normal anterior segments not exhibiting clinically 
significant biomicroscopy findings.  
3. Have no active ocular disease or allergic conjunctivitis.  
4. Not be using any topical ocular medications.  
5. Be willing and able to follow instructions.  
6. Have signed a statement of informed consent.  
 
3.2.1.2 Exclusion Criteria 
The subject is not eligible to participate in the study if the subject is:  
1. Participating in a conflicting study in the opinion of the Investigator.  
2. Considered by the Investigator to not be a suitable candidate for participation.  
 
3.2.2 Point of Enrollment and Randomization 
The study is randomized.  The study investigator and subject will be masked. An unmasked 
designee will be responsible for dispensing study products to the subjects according to the 
randomization schedule. The randomization schedule will be produced prior to study 
enrollment by Bausch + Lomb’s unmasked statistician not otherwise involved in the study. 
 
Randomization will be completed by the unmasked designee. The subjects will be assigned 
randomization numbers sequentially as they are enrolled. The unmasked designee is 
responsible for preparing the clinical trial materials according to the randomization 
schedule. The unmasked designee is also responsible for maintaining study lens inventory, 
randomization schedule and the Product Accountability Log in a masked fashion. 
 
3.2.3 Subject Completion 
The subject will have completed the study when he/she has worn all of the study lens types. 
Subjects who require further follow-up due to an ongoing Adverse Event will be followed 
according to the Adverse Event Section 6.0. 
 
The Investigator may discontinue a subject during the study for any reason if, in his or her 
opinion, it is in the best interest of the subject. Reasons for discontinuation include but are 
not limited to:  
• 
adverse effects  
• 
other ocular complications  
• 
subject non-compliance  
• 
subject request  
• 
subject found to be ineligible during study participation*  
 
*Any subject enrolled in the study, who later is found to have not met any of the eligibility 
criteria at entry, will be discontinued at the Sponsor’s request.  
  
Subject discontinuations will be documented clearly on the applicable case report form.   
Subjects that are discontinued from the study following randomization will not be replaced.  
 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 14 of 48 
 
Exit visits should be completed for early terminated subjects. 
 
The completion of the clinical investigation shall be deemed to coincide with the last visit 
of the last subject and when follow-up is complete. 
 
3.2.4 Lost to Follow-up 
Subjects who do not return for scheduled follow-up visits, as defined by the visit window 
and cannot be contacted, are to be considered lost to follow-up. All attempts to contact the 
subject should be documented and kept with the subject’s source documentation, and the 
applicable CRF/eCRFs will be completed.  
 
3.3 Investigators 
The study will be conducted at one investigative site, the Bausch + Lomb Research Clinic in 
Rochester, NY by Investigators who are employed by Bausch + Lomb. The Investigators 
are qualified by training and experience to conduct this study. All the study procedures will 
be performed by Optometrists who are licensed to fit contact lenses. 
 
The assessments required for the study are routinely performed by Optometrists and are 
standard of care for contact lens wearers. (See Appendix A: Methods of Clinical Evaluation 
for detailed information about study procedures).  
 
3.4 Study Duration 
The clinical investigation will take approximately 1 month to complete. 
 
3.5 Protocol Changes and Amendments 
Changes to the protocol will be approved by the Sponsor. An amendment to the protocol 
may also require submission and approval from the IRB before implementation. The 
Investigator is responsible for the ensuring that staff involved have completed training on 
the changes before implementing with subjects. 
 
4.0 STUDY MATERIALS 
Bausch + Lomb will provide all study materials. Subjects must use only study supplied 
contact lenses during the study visits.  Use of other prescribed contact lenses and solution is 
not permitted during the study visits. 
 
4.1 Description of the Test Lens:  
Test Lens: kalifilcon A Daily Disposable Toric 
(T01: kali A toric) 
 
 
4.2 Description of Comparator Lenses 
Comparator Lenses: Commercially available contact lenses 
C01: Acuvue Oasys 1-Day for Astigmatism (C01: AVO1DfA) 
 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 15 of 48 
 
More information on the commercially available study lenses can be found in the package 
inserts patient instruction booklets and professional fitting guide 1-2. 
 
4.3 Instructions for Use and Administration 
Study lenses will be dispensed to subjects meeting all eligibility requirements including any 
dispensing requirements in this clinical protocol. Subjects will be dispensed an adequate 
supply of study lenses to complete the study. Lost or damaged study lenses may be replaced 
at the discretion of the Investigator. An unmasked designee will be responsible for all study 
lens accountability, including dispensation and collection of study supplies to subjects. 
 
The investigator or designee will instruct all subjects to adhere to the Subject Instructions 
provided with their study contact lenses.  
 
Subjects will be instructed not to use any other contact lenses or lens care products while 
wearing the study lenses. 
 
The subjects will be masked to the study lenses. An unmasked designee at each site will be 
responsible for all study lens accountability, including dispensation and collection of study 
supplies to subjects. 
 
Subjects will be receiving each of the study lens types once, in a randomized order. The 
subject will wear a pair of study contact lenses for approximately 10 minutes. See Appendix 
B for additional Instructions for Use. 
 
4.3.1 Storage Requirements 
All study materials provided by the Sponsor must be stored in a secure location 
accessible only to unmasked study personnel. 
 
4.3.2 Subject Instructions 
Subject Instructions for the use of study lenses are included in Appendix B, which include 
precautions and warnings related to contact lens wear. Subjects must comply with the 
instructions provided to them.  
 
The Investigator or other designee must review, with the subject, the Subject 
Instructions and the precautions and warnings, as appropriate for the study. 
 
Any subject who does not follow instructions to a degree that, in the Sponsor or 
Investigator's opinion, jeopardizes the subject's well-being or the validity of the study, 
should be discontinued. 
 
4.4 Other Study Materials 
Worn and unworn study lenses will be returned after the study is complete. No other study 
materials will be used in this study. 
 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 16 of 48 
 
4.5 Packaging and Labeling 
Test Lens: kalifilcon A Daily Disposable Toric 
 
 
 
 
 
 
 
 
 
 
 
Comparator Lenses: Commercially available contact lenses 
The comparator contact lenses will be packaged with commercial labels.  
C01: Acuvue Oasys 1-Day for Astigmatism (C01: AVO1DfA) 
 
 
4.6 Accountability 
The investigational site is responsible for keeping current and accurate records of the 
amount of study materials received and dispensed, and its disposition. The study lenses 
must be stored under the appropriate conditions in a secure area and are to be dispensed 
only to subjects enrolled in the study, in accordance with the conditions specified in this 
protocol.  
 
All study materials will be accounted for on the Clinical Trial Materials Form and 
Lens/Solution Tracking Form. Subjects must return all remaining study materials to the 
Investigator at the final study visit, or their exit visit if discontinued prior to this visit. 
 
4.7 Masking 
The investigators and subjects will be masked to the study lens types. Unmasked study 
personnel will be responsible for dispensing and collecting study lenses and accountability. 
 
The randomization schedule will be created prior to the start of the study by an unmasked 
statistician not otherwise involved in the study.  
 
In the event that unmasking of a subject’s randomly assigned treatment is required, the 
Investigator (or designee) will reference the subject specific randomization schedule (or 
login to the EDC System) and unmask the subject.  
 
Whether unmasking occurs inadvertently or intentionally, the Investigator must record the 
date, time, and reason for unmasking the study treatment in EDC System.  
 
The contact lenses will be inserted into the subject’s eye. The unmasked designee is not to 
show the study blister packs and foils to the Investigator or the subject. An effort will be 
made to conceal the study lenses from the subject and Investigator throughout the study.  

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 17 of 48 
 
 
4.8 Product Replacement 
Not applicable, as subjects will not leave the office with study lenses for this insertion only 
study. 
 
4.9 Risk Assessment 
Information concerning potential risks associated with the investigational device (as well as 
possible interactions with concomitant medical treatments and risk-to-benefit ratio) can be 
found within the Investigator’s Brochure. Risks are also summarized within the Informed 
Consent Form (ICF) document. The assessments required for the study are routinely 
performed and are standard of care for contact lens wearers. The subjects will be informed 
of any potential study specific risks in the ICF or if new risks become apparent during the 
study. 
 
4.9.1 Risk Related to Subject 
 
With contact lens wear there may be increased risk of corneal edema (swelling of the 
cornea) which may temporarily affect vision or comfort, neovascularization (small blood 
vessels growing into the cornea), giant papillary conjunctivitis (small bumps on the inside 
of the eyelids), iritis (internal inflammation in the eye), corneal infiltrates (corneal 
inflammation) and corneal erosion/abrasion or corneal infection, which if untreated may 
cause ocular problems. 
 
The risks involved in this study will be minimized because the subjects will be examined 
frequently and at specified intervals.  The risks are further minimized by the study 
eligibility criteria.  
 
The subject may not personally benefit from being in this study other than getting the 
opportunity to wear different types of contact lenses.  However, study results may allow a 
new or improved product to be marketed in the future giving benefit to other contact lens 
users.  
No clinical benefit is expected from this feasibility study. 
 
4.9.2 Risk Related to Data Management 
The risks involved in this study related to data management will be minimized because the 
Clinical Research Technician (CRT) will enter the data directly into the Electronic Data 
Capture (EDC) system. The Primary Investigator or Delegate will visually verify the data as 
it is entered, except masked information when applicable.  If data is not entered directly into 
the EDC System, the data will be double entered.  Then, the two sets of data will be 
compared to each other and then checked for discrepancies.  
  
Risk of data management is further minimized by edit checks built into the EDC system to 
minimize the chance of error.  For example, the EDC system does not allow the same study 
material (solution or lens) to be dispensed more than once. Also, the expected ranges of 
values are specified in the EDC system. If data falls outside of the expected range, the CRT 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 18 of 48 
 
will be prompted to answer a query. 
 
4.10 Relevance of Clinical Investigation 
Further information regarding the relevance of this study in the context of state-of-the-art 
clinical practice such as background information, summary of relevant literature, 
mechanism of action, intended clinical performance, and a summary of existing relevant 
clinical data of the investigational device can be found in the Investigator’s Brochure. 
 
5.0 STUDY METHODS 
The clinical procedures in this study are part of normal eye examination. There are not any 
deviations from normal clinical practice. The procedures conducted in the study are outlined 
below and described in Appendix A: Methods of Clinical Evaluation. 
 
Following identification of a potential subject, the Investigator (or designee) will explain 
the purpose of the study, procedures, risks/benefits, and subject responsibilities to the 
potential subject. The subject’s willingness and ability to meet the follow-up requirements 
of the study will be determined. If the subject chooses to participate in the investigation, 
written informed consent will be obtained. The subject and the person obtaining written 
consent will sign and date the IRB-approved ICF. The Investigator must keep the signed ICF 
document. The signed original document should be retained in the subject’s records, and a 
copy should be provided to the subject. In addition, the applicable privacy regulation 
requirements must be met. Additional Informed Consent information is provided in Section 
8.10. 
 
5.1 Measurements and Procedures  
5.1.1 Study Visits 
Visit 1: 
➢ 
 
 
 
 
 
 
 
   
 
 
 
     
 
 
 
   
 
 
 
 
  
 
 
   

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 19 of 48 
 
➢ 
  
 
    
 
 
   
 
 
 
 
5.1.2 Unscheduled Visits 
Additional visits may be scheduled, as necessary, to ensure the safety and well-being of 
subjects. All additional exams should be fully documented on Unscheduled Visit forms as 
appropriate.  
 
5.1.3 Missed Visits 
If a subject misses a Study Visit, the visit is considered missed, and the subject must be 
exited from the study. The Investigator or designee must check the missed visit box on the 
first page of the applicable CRF/e-CRF for that visit. 
 
See Section 3.2.4 Lost to Follow-Up for applicable instructions for subjects who do not 
return for the final visit. 
 
5.1.4 Post-Study Follow-up Visit 
There is no planned follow-up period after the clinical investigation is complete. If a subject 
requires further follow-up upon discontinuation or completion of the study, the 
Investigator must schedule post-study follow-up visits, as necessary. The Investigator is 
required to follow the subject until the condition no longer warrants further follow-up for 
study purposes. A Post-Study Follow-up Visit e-CRF/CRF must be completed for each of 
these visits. 
 
There will not be any routine eye care provided after the clinical investigation is complete. 
Subjects should follow-up with their eye care provider every 1-2 years for comprehensive 
eye care or sooner as recommended by their eye care provider.   
 
5.2 Study Completion 
The subject has completed the study when the subject has completed all of the study lens 
types. Subjects who require further follow-up will be followed according to the Adverse 
Event or Post- Study Follow-Up Section. There is no planned follow-up period after the 
clinical investigation is complete. 
 
The completion of the clinical investigation shall be deemed to coincide with the last visit 
of the last subject and when follow-up is complete. 
 
5.2.1 Study Termination/Suspension  
If during the study it becomes evident that the study should be stopped prematurely or 
placed on hold, appropriate notification will be given to the requestor and IRB/ECs, as 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 20 of 48 
 
applicable. Should the Investigator and/or study requester wish to terminate the study, the 
following Research Clinic procedure will be followed. Any subjects with ongoing Adverse 
Events at the time of premature study termination or hold will be followed by the 
Investigator. 
  
5.2.2 Study Termination Procedure 
The decision to terminate a study will be made by the Director of Clinical Research and/or 
the Principal Investigator (PI). A final slit lamp examination should be performed, and 
adverse events handled accordingly. In the event that this study is suspended or terminated 
early, the Investigator (or designee) will reference the subject specific randomization 
schedule (or login to the EDC System) and unmask the subject. 
 
All investigational materials (lenses, solutions, and / or devices) will be retrieved, all 
subjects will be exited and the Trial Master File will be reconciled.  A clinical report will be 
written and include the reason for study termination.   
 
5.3 Concomitant Medications/Therapy 
Ocular, systemic or topical medications that, in the Investigator’s opinion, 
could potentially affect ocular physiology or lens/solution performance are prohibited. 
 
5.4 Protocol Deviations 
The date of and reason for deviations will be documented in all cases. Significant or 
major protocol deviations impacting the safety of the subject or the integrity of the study 
must be reported by the Investigator to the IRB immediately. Reporting of all other protocol 
deviations must adhere to the requirements of the governing IRB/EC.  
 
Any subject enrolled in the study who later is found to have not met the eligibility criteria 
at entry will be discontinued. Otherwise, unless the protocol deviations put the subject at 
risk or the subject’s condition requires that they be discontinued from the study, subjects 
may continue to participate until the end of the study. 
 
All investigators participating in this study agree to conduct the study in accordance with 
the relevant, current protocol and agree to only make changes in a protocol after being 
notified by the Sponsor, except when necessary to protect the safety, rights, or welfare of 
subjects. Under emergency circumstances investigators may proceed without prior approval 
of the IRB.  These deviations will be documented and reported to the IRB as soon as 
possible. The sponsor will not grant protocol waivers for this study.   
 
Corrective Action plans will be developed and completed as deemed necessary for 
Investigators who deviate from this protocol in a way that adversely affects the rights, 
safety or well-being of the subject(s) and/or the quality or integrity of data. The Corrective 
Action Plan will outline the deviation and the site’s corrective and/or remedial actions. 
Decisions regarding critical deviations that merit investigator disqualification and will be 
documented in the Trial Master File. 
 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 21 of 48 
 
6.0 ADVERSE EVENTS (AE) 
Subjects who experience an adverse event during study participation will be discontinued 
from study participation but will be followed by the Investigator until resolution of the 
adverse event or until the Investigator determines that further improvement is not expected.  
 
6.1 Adverse Event Definitions 
For the purposes of this study, reportable AEs include ocular AEs and non-ocular serious 
adverse events (SAEs). All AEs will be classified first for seriousness and significance and 
then as to whether or not they are device related or non-device related and if device related, 
then, if it is an adverse device effect (ADE), an anticipated serious adverse device effect 
(ASADEs) or an unanticipated serious adverse device effect (USADEs). AEs, ADEs, 
ASADEs, USADEs, SAEs, Significant Non-Serious AEs and Non-Significant Non- 
Serious AEs are defined as follows: 
 
6.1.1 Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects or users, whether or not related to the 
investigational medical device. Adverse events should be categorized as device related or 
non-device related.  
Throughout the course of this study all efforts will be made to remain alert to reportable 
AEs. If an AE occurs, the first concern will be the safety of the subject and appropriate 
medical intervention will be made. 
 
All reportable AEs occurring after signing of informed consent and through the subject’s 
end of participation in the study must be reported. All reportable AEs must be followed 
until the event resolves or stabilizes. 
 
6.1.2 Serious Adverse Event (SAE) 
An adverse event which:  
• Led to death; 
• Led to serious deterioration in the health of the subject, that resulted in: 
o A life-threatening illness or injury; or 
o A permanent impairment of a body structure or a body function (e.g., 
blindness); or  
o Inpatient or prolonged hospitalization; or 
o Medical or surgical intervention to prevent life-threatening illness or  
o Injury or permanent impairment to a body structure or a body function; or 
o Chronic disease 
• Led to fetal distress, fetal death, or a congenital abnormality or birth defect. 
6.1.3 Serious Adverse Ocular Event  
Serious Adverse Ocular Event is a serious adverse event that results in, or has potential to 
cause, either permanent impairment of an ocular function or damage to an ocular structure 
and may necessitate medical or surgical intervention. Serious Adverse Events require 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 22 of 48 
 
expedited reporting. Serious adverse events include any hazardous, sight-threatening 
conditions occurring after exposure to a study lens, including but not limited to the 
following: 
 
• A presumed infectious ulcer (defined as a progressive erosion of the corneal tissue). 
For the purposes of reporting, a corneal ulcer which has any of the following 
characteristics should be considered in this category: 
o Central or paracentral location; 
o Penetration of Bowman’s membrane; 
o Infiltrate ≥2 mm diameter; 
o Associated with iritis;  
o Associated with any increase in intraocular pressure; 
o Culture positive for microorganisms; 
o Increasing size or severity at subsequent visits. 
 
Note: Signs of a presumed infectious ulcer may include irregular focal infiltrates; 
active lesions with raised edges; significant diffuse infiltration; anterior corneal to 
mid-stromal involvement; erosion with overlying staining; conjunctival and lid 
edema; anterior chamber reaction (iritis); severe bulbar and limbal redness. 
Symptoms associated with a presumed infectious ulcer (microbial keratitis) may 
include pain of rapid onset; severe redness; purulent or mucopurulent discharge; 
tearing; photophobia. 
 
• Any central or paracentral (within 6 mm of cornea) corneal event that results in 
permanent opacification (such as corneal scar or vascularization) 
• Any serious adverse ophthalmic events including hypopyon and hyphema. 
• Any neovascularization within the central 6 mm of the cornea. 
• Permanent loss of 2 or more lines (10 letters) of Best Spectacle Corrected Visual 
Acuity (BSCVA). 
• All cases of iritis. 
 
6.1.4 Significant, Non-Serious Adverse Event  
A Significant, Non-Serious Adverse Event is an Adverse Event that does not meet the 
serious criteria, is considered significant, and requires expedited reporting. These events 
include (but are not limited to): 
• Peripheral non-progressive non-infectious corneal ulcer 
• All symptomatic corneal infiltrative events 
• All cases of corneal staining severity greater than or equal to Grade 3 
• A temporary loss of 2 or more lines (10 or more letters) of BSCVA (for greater than 
or equal to 2 weeks) 
• Increase in neovascularization of 1.5mm or greater. 
• Any ocular event that necessitates temporary lens discontinuation of greater than or 
equal to 2 weeks. 
 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 23 of 48 
 
6.1.5 Non-significant, Non-serious Adverse Event 
A Non-Significant Non-Serious Adverse Event may include (but are not limited to) and 
does not require expedited reporting: 
• Asymptomatic, peripheral, corneal infiltrative events. 
• Bacterial Conjunctivitis 
• Viral Conjunctivitis 
• Allergic Conjunctivitis 
• Corneal Edema 
• Contact Lens Related Papillary Conjunctivitis 
 
6.1.6 Adverse Device Effect (ADE) 
An ADE is an Adverse Event that is assessed to be related to the use of an investigational 
medical device. 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. This definition also includes any event 
resulting from use error or from intentional misuse of the investigational medical device. 
 
6.1.6.1 Anticipated Serious Adverse Device Effect (ASADE)  
An ASADE is an ADE that first meets the serious criteria (see definition above for Serious 
Adverse Event) or significant, non-serious criteria (see above definition for significant, non-
serious AE) and which, by its nature, incidence, severity or outcome, has been previously 
identified in the investigational plan or application (including a supplementary plan or 
application) and/or in the risk analysis report. ASADEs include: 
• Corneal Ulcer (infectious or non-infectious) 
• Keratitis 
• Sensitivity to light (photophobia) 
• Excessive eye secretions including mucopurulent discharge 
• Blurred vision, rainbows or halos around objects 
• Poor visual acuity (reduced sharpness of vision) 
• Moderate to severe eye pain not relieved by removing the lens 
 
6.1.6.2 Unanticipated Serious Adverse Device Effect (USADE) 
An USADE is an ADE that first meets the serious criteria (see definition above for Serious 
Adverse Event) or significant, non-serious criteria (see above definition for significant, non-
serious AE) and has an effect on health or safety or any life-threatening problem or death 
caused by, or associated with, a device if that effect, problem or death was not previously 
identified in nature, severity or degree of incidence in the investigational plan or application 
(including a supplementary plan or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects. 
 
6.1.7 Device Deficiency 
Inadequacy of an investigational medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. This includes malfunctions, use errors, 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 24 of 48 
 
inadequate labelling, insufficient or inadequate instructions for use. A Device Deficiency 
can occur with or without the occurrence of an Adverse Event. 
 
6.2 Adverse Event Treatment and Culturing 
With any Adverse Event, treat the subject as appropriate to prevent further complications 
and to potentially resolve the event consistent with the standard of care. 
 
A culture should be obtained in cases of corneal ulcer or suspected  ocular infection, unless 
medically contraindicated. Cultures should be taken from the cul-de-sac, lower eyelid 
margin, and the corneal lesion (if applicable). When a culture is obtained, the contact lenses 
and contact lens cases which were being utilized by the subject at the time of the AE should 
be collected from the subject (if available at the time of the  culture) for culturing and 
processing by the clinical laboratory designated by the Research Clinic. Microbial data 
generated from returned subject supplies (e.g., lenses, lens cases and/or lens case solutions) 
are for  information only. Because microbes may be introduced into subject supplies during 
use, recovery of microbes from returned subject supplies cannot be presumed to indicate 
etiology or direction of organism transmission. The ocular cultures, along with the 
associated contact lenses and contact lens cases, will be sent to the clinical laboratory 
designated by the Research Clinic for analysis. The clinical laboratory will report the 
culture results to both the Investigator and to the Research Clinic, the Investigator will 
record the results in the applicable form. 
 
6.3 Adverse Event Identification and Evaluation  
Throughout the course of a study all efforts will be made to remain alert to Adverse Events 
(AEs). If an AE occurs, the first concern will be the safety of the subject and appropriate 
medical intervention will be made. The associated product should be retained for further 
analysis, if needed. 
 
All AEs occurring after signing the informed consent and through the end of the subject’s 
participation in the study must be recorded and reported, if applicable. All AEs must be 
followed until the event resolves or stabilizes.  
 
Identify potential adverse events during a clinical study by using the following sources: 
• Direct observation by the Investigator 
• Asking the study participant using a non-specific question (i.e. Have you had any 
problems since the last visit?) 
• Unsolicited volunteering of information by the study participant (i.e. Doctor, I have 
had numerous headaches since I started using this lens) 
• Laboratory or test results that meet protocol requirements for classification as an 
adverse event (i.e. IOP over 30mmHg) 
• When evaluating AEs, the Investigator should classify the AE based on the 
following three criteria: Seriousness and/or significance (based on the criteria 
provided in Section 6.1)  
 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 25 of 48 
 
1. Severity: 
• Mild: Subject awareness of a sign or symptom that is easily tolerated, requires 
no treatment, and does not interfere with subject’s daily activities. 
 
• Moderate: Subject awareness of a sign or symptom which may be a low level of 
concern to the subject and may interfere with daily activities but can be relieved 
by simple therapeutic care. 
 
• Severe: A sign or symptom that interrupts the subject’s daily activity and 
requires systemic therapy or other treatment. 
 
2. Relationship of the event to the study device using the following guidelines:   
• Related: There is at least a reasonable possibility that the AE is related to the 
study device (contact lens) and/or solution or rewetting drops. Reasonable 
possibility means that there is evidence to suggest a causal relationship or 
association between the study device and/or solution or rewetting drops and the 
AE. Also referred to as an ADE.  
 
• Not Related: There is little or no reasonable possibility that the AE is related to 
the study device (contact lens) and/or solution or rewetting drops. This 
assessment implies that the AE has no evidence to suggest either a causal 
relationship or association to the study device and/or solution or rewetting drops 
and a more likely or certain alternative etiology exists. 
 
3. Expectedness of the event  
• Unexpected Adverse Event (UAE):  Unexpected Adverse Events must be 
reported to the IRB within 10 calendar days of discovery. 
 
• Expected Adverse Event: An adverse event of which, the nature or severity of 
which is consistent with the current product labeling, investigator brochure, data 
sheet, etc. 
 
6.4 Adverse Event Collection and Reporting 
The Research Clinic will delegate each function’s roles and responsibilities related to 
adverse event reporting. The Director of Clinical Affairs is responsible for ensuring that all 
Research Clinic Staff understand their responsibilities for collecting and assessing adverse 
event information and forwarding applicable adverse event information to the appropriate 
business function. 
 
Research Clinic Staff are responsible for understanding the procedures for adverse event 
collection, evaluation, documentation, and reporting. 
 
• Collect and record information about any identified adverse event (including the 
date of the adverse event, treatment, resolution, assessment of both the seriousness 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 26 of 48 
 
and the relationship to the investigational device and the related procedure) on the 
Adverse Event form. The Adverse Event Form will be completed each time the 
subject is seen during the management of the incident and at resolution of the 
incident.  
• If an adverse event is determined to be serious or significant and non-serious, notify 
the Principal Investigator immediately. 
• Report all serious or significant and non-serious adverse events within twenty-four 
(24) hours to Regulatory Affairs, Global Product Surveillance and/or Global Safety 
Surveillance and Pharmacovigilance as appropriate for the product being evaluated. 
Continue to send follow-up information or provide support to the appropriate 
reporting business function for any serious adverse event as soon as it becomes 
available. 
• Ensure that the subject’s identity is protected and the subject’s identifiers in the 
study are properly documented on the form.   
• Report all unexpected adverse device effects to the reviewing Institutional Review 
Board within 10 business days of discovery.  Continue to send follow-up 
information as soon as it becomes available. 
• Report any adverse event resulting from Intentional Misuse of an investigational 
medical device per the same procedures as above.  
• Report any adverse event resulting from a Device Deficiency per the same 
procedures as above. All Device Deficiencies should be recorded and evaluated for 
the potential to cause a serious adverse event.  
 
• All appropriate measures will be taken to ensure the safety of the subject. Follow the 
subject until the adverse event resolves or until an appropriate endpoint is reached. 
This may imply that follow-up will continue after the subject has left the study.  
• A treatment of an AE will depend on the severity of the adverse event. The Principal 
Investigator will refer the subject to a suitably licensed eye  care professional for 
immediate treatment if necessary. 
• Expenses incurred for study-related medical treatment will be paid by Bausch + 
Lomb. Research Clinic Staff will contact Environmental Health and Safety to 
initiate the medical payment claims process. 
• If it is determined, based on evaluation of any serious adverse event or serious 
adverse event trending, that the study presents an unreasonable risk, the Research 
Clinic may choose to terminate the study. Refer to the Study Termination 
procedures for additional information and relevant periods for terminating a study.  
• All adverse events will be documented in the final study report. Adverse Event 
documentation must be saved in the Trial Master File and in the respective study 
folder in the electronic repository. 
 
6.5 Reporting Device Deficiencies  
• Report to Global Pharmacovigilance and Risk Management (GPRM) and Design 
Quality within 24 Hours. 
• All device deficiencies must be evaluated by the Investigator, and then evaluated by 
GPRM and Design Quality. 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 27 of 48 
 
• The Principal Investigator (PI) will record, evaluate, and report via applicable forms 
any complaints/deficiencies or malfunctions experienced with the study devices 
using the Device Deficiency form and when applicable, AE form (if AE has 
occurred). The PI will evaluate the Device Deficiency and record whether an AE 
occurred related to the device deficiency and also determine the potential of the 
device deficiency to cause a serious adverse device effect (SADE). The device 
deficiency form is then sent to GPRM to evaluate as the Sponsor, their independent 
determination if the device deficiency led to or could have led to a SADE.  See ISO 
14155:2020 for resolving any discrepancies between the interpretation by the PI and 
Sponsor on whether the device deficiency could have led to SADE.     
o If there was an Adverse Event that occurred as well as the device deficiency, 
then it should be reported as both an Adverse Event and a Device Deficiency 
(both forms should be completed). 
o If the Device Deficiency is unrelated to an Adverse Event, then just the 
Device Deficiency should be reported on the Device Deficiency form. 
• Additionally, the Device Deficiency form will be sent to Bausch + Lomb Design 
Quality to evaluate whether any updates to Design Records need to be made. 
 
6.6 Emergency Contact Details for Reporting SAE and ADE 
 
 
  
 
 
 
 
 
7.0 STATISTICAL METHODS 
 
7.1 Study Endpoints 
The primary endpoint is Primary gaze orientation 
 
 
7.2 Hypotheses 
No statistical hypotheses were performed for this feasibility study. 
 
7.3 Sample Size 
Sample size calculations were not performed for this feasibility study. The sample size of 
30 subjects has proven in previous feasibility studies conducted by B+L to be sufficiently 
large to identify meaningful trends in outcomes between one test lens and one comparator 
lens. The determined sample size also ensures that the study can be completed within the 
desired time frame. 
 
7.4 Randomization 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 28 of 48 
 
To minimize or avoid bias, subjects will be assigned randomization numbers as they are 
enrolled according to unique randomization schedules created for the study. The 
randomization schedule will be produced prior to study enrollment. Subjects will be 
receiving each of the study lens types once, in a randomized order.  
 
The randomization schedule is verified up to 5 times during the course of the study:  
The CRT visually verifies the study material against the randomization schedule during 
CTM preparation (if applicable) and before dispensing any study materials. The 
randomization schedule is also verified in EDC after dispensing the CTM.  Once the study 
is complete, randomization is verified again during CTM reconciliation. Upon completion 
of the study, the EDC programmer also verifies randomization.  
 
7.5 Study Populations 
Subjects will be included in all summaries under the treatment that they actually 
received. Analyses of safety data will include all dispensed subjects. All other summaries 
will include all eligible, completed subjects. 
7.6 Statistical Analysis 
Continuous data will be summarized using descriptive statistics: n, mean, standard 
deviation, median, minimum and maximum. Categorical data will be presented by the total 
counts for each category and corresponding percentages. The data for each of the ordinal 
dependent measures (i.e., those assigned a clinical grade) will be analyzed using appropriate 
nonparametric techniques. Unless otherwise noted, paired t-tests will be used to test for 
differences in means for each of the parametric dependent variables. Differences at the p ≤ 
0.05 level will be considered statistically significant. 
 
7.6.1 Pass/Fail Criteria 
There are no pass/fail criteria for the results of the clinical investigation. 
 
7.6.2 Interim Analyses 
No interim analyses are planned. 
 
7.6.3 Exploratory/Sensitivity Analysis 
There are no planned exploratory or sensitivity analyses for this study. 
 
7.6.4 Deviations 
Any deviations from the original statistical analysis plan will be summarized in the Clinical 
Study Report.  
8.0 DATA QUALITY ASSURANCE 
Steps will be taken to ensure the accuracy and reliability of data, including the selection of 
qualified investigators and review of protocol procedures. Prior to the start of the study, 
member(s) of the Research Clinic and Investigators will review the protocol, e-CRFs, 
regulatory obligations, and other material or equipment relevant to the conduct of the study. 
The Principal Investigator, in turn, must ensure that all Sub-Investigators and clinical 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 29 of 48 
 
personnel are familiar with the protocol and all study-specific procedures and have 
appropriate knowledge of the study article. The CRT’s are trained on completing case report 
forms. 
 
The data for this study will be captured on electronic case report forms using an EDC 
System (Inform). Inform is a fully validated EDC system and is compliant with 21 CFR Part 
11.  Once the EDC system is installed, test scripts are completed to test the functionality of 
Inform and ensure the system is complaint. Documentation of compliance with 21 CFR Part 
11 is on file with B+L Quality. The clinical data will be recorded on dedicated eCRF’s 
specifically designed to match the study procedures for each visit.  
 
Once completed, the eCRF’s will be reviewed for accuracy and completeness and signed by 
the Investigator. The database will them be locked. Each user has his/her own username and 
password.  Only registered users assigned to the study can login to the clinical study. 
 
Edit checks, electronic queries, and audit trails are built into the EDC system to ensure 
accurate and complete data collection. Data will be stored in a secure database, ensuring 
information accuracy, security, and confidentiality.  
 
During the study, if it is determined that an Investigator is not compliant with the protocol 
and/or applicable regulatory requirements, action will be taken to secure compliance. In 
addition, the Investigator’s participation in the study may be terminated if appropriate, or if 
the Investigator remains non-compliant. 
 
A data monitoring plan or committee is not needed due to the short duration and/or frequent 
follow up visits and low risk exposure (daily wear contact lenses). 
 
8.1 Study Monitoring 
The monitoring plan for this study includes Informed Consent and Data Verification.  
 
8.1.1 Monitoring Subject Risk  
The risks involved with contact lens wear in this study will be minimized because the 
subjects will be examined frequently and at specified intervals.  The risks are further 
minimized by the study eligibility criteria.  The subject population will be restricted to 
persons who are 18 years of age or older and have full legal capacity to volunteer; no 
restrictions are made as to gender. 
  
8.1.2 Monitoring Informed Consent Process  
Informed consent forms are verified for all subjects enrolled in each study.  Subject and 
witness signature and date are visually verified by the CRT and then confirmed in the EDC 
System at the time of enrollment. Informed Consent Form signatures are also verified 
during study reconciliation by CRT. The signed informed consent forms are kept in the 
study folder. 
  

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 30 of 48 
 
8.1.3 Data Verification 
Subject data required by this protocol are entered into EDC by the CRT or Delegate using 
either Direct Entry with Verification or Double Data Entry (outlined in Section 8.1.3.1 and 
Section 8.1.3.2). The Investigator and the study personnel will be responsible for 
completing the eCRFs. The Investigator is required to verify that all of the requested 
information is accurately recorded on the eCRFs by providing an electronic signature. All 
information requested on the eCRFs needs to be supplied, including subject identification 
and initials, date(s), assessment values, etc, and any omission or discrepancy will require 
explanation. 
 
The Investigator and study site personnel will be responsible for answering all queries. 
 
Edit checks are built into the EDC System to minimize the chance of error.  For example, 
the EDC System does not allow the same lens to be dispensed more than once. The 
expected ranges of values are specified in the EDC System. If data falls outside of the 
expected range, the CRT will be prompted to answer a query. If a value is omitted, the CRT 
will be prompted to answer a query. The queries are answered in real time. 
 
Data is verified for two randomly selected subjects by the EDC Analyst or designee.  After 
the data is extracted from the EDC System, it is checked for accuracy by comparing the 
reformat to the data recorded in the EDC System. The data extract is verified by confirming 
the entered values, study materials, and study eye(s) match. Calculations performed by the 
EDC System are checked for accuracy. If there is a discrepancy between the values, the 
EDC Analyst or designee corrects the code to resolve the difference. 
 
8.1.3.1 Direct Entry with Verification  
Direct Entry with Verification is the preferred method for entering study data. Data is 
collected by the CRT or Delegate and entered directly into the EDC System.  A second 
person, typically the Primary Investigator (or Delegate), will visually verify the data as it is 
entered, except masked information when applicable. 
• In the event that the EDC System is unavailable, a paper CRF will be used to collect 
study data for later entry into the EDC System. After each page of the CRF is 
entered into the EDC System, the CRT or Delegate will initial the CRF to indicate 
the data has been entered into the EDC System and visually verified. 
• Randomization Verification is required at the conclusion of each study prior to data 
distribution. The CRT or Delegate will verify each dispensed article against the 
study randomization and Clinical Trial Material (CTM) label, if applicable. After 
Randomization Verification of dispensed article, the CRT or Delegate will mark the 
Verification checkbox in the EDC System to acknowledge completion of dispensed 
article verification. 
• If discrepancies arise during the verification of a paper source, the CRT or Delegate 
assesses the discrepancy and obtains additional information to determine if the 
correct entry was made or corrects paper source as appropriate. The CRT or 
Delegate may consult the Primary Investigator if necessary. 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 31 of 48 
 
• The data is extracted from the EDC System and checked for accuracy by comparing 
the extracted data to the data originally recorded in the EDC System. The data 
extract is checked to confirm the lens reformat codes match the lens key. 
Calculations performed by the EDC System are checked for accuracy. 
• Database Randomization Verification is performed, if applicable, prior to data 
distribution. 
  
8.1.3.2 Double Entry of Data  
If data is not entered directly in the EDC system, the data will be double entered (entered 
twice) and the two sets of data will be compared to each other and then checked for 
discrepancies.  
  
When a paper source (i.e. subject questionnaire) is used to collect study data, this method 
may be used.  For example, a subject questionnaire will be entered into two different 
spreadsheets.  The two spreadsheets are then compared to each other. 
• If discrepancies arise during the verification of a paper source, the CRT or Delegate 
assesses the discrepancy and obtains additional information to determine if the 
correct entry was made or corrects the paper source as appropriate. The CRT or 
Delegate may consult the Primary Investigator if necessary. 
• After the study data from the paper source is entered, each CRT or Delegate entering 
the data will initial the paper source to indicate that the data has been entered into 
the EDC System visually verified, and dispensed articles verified against study 
randomization, prior to data distribution. 
• The data is extracted from the EDC System and checked for data accuracy and 
necessary calculations are performed. 
  
8.1.3.3 The Data Management Summary (DMS)  
A Data Management Summary is created after all data has been verified. 
  
8.1.4 Annual Research Clinic Monitoring Plan 
 
 
 
 
   
 
 
 
 
. 
 
8.1.4.1 Monitoring Procedure 
1. 
 
 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 32 of 48 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2. RC Regulatory Binder and IRB/IEC approval documentation will be reviewed. 
3. Relevant documentation will be completed.  
 
8.1.4.2 Site Performance Evaluation & Monitoring Report  
The Monitor should complete the appropriate Site Performance Evaluation & Monitoring 
Report within ten business days of the site visit and forward an electronic copy of the 
completed draft report to the Research Clinic Director (RCD) or Delegate for review. 
 
8.2 Auditing Procedures 
Audits of clinical research activities in accordance with Bausch + Lomb’s internal Standard 
Operating Procedures to evaluate compliance with the principles of GCP may take place. A 
regulatory authority may also wish to conduct an inspection (during the study or after its 
completion).  
 
8.3 Source Documentation 
Source documentation consists of original subject documents, as well as data and records 
with information relevant to the subject and his/her participation in the study.  The data 
collected in the CRF/e-CRFs at all the visits will be available to the Investigator after the 
conclusion of the trial.   
Examples of source documents include hospital records, clinical and office charts, 
laboratory notes, memoranda, signed ICF, evaluation checklists, recorded data from 
automated instruments, copies or transcriptions certified after verification as being accurate 
copies, and information initially recorded in an electronic format.  
 
Subject completed forms are also considered to be source data, if applicable to the study. 
The Investigator or designee should review subject completed forms for completeness and 
accuracy. 
 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 33 of 48 
 
8.4 Maintaining Subject Privacy 
 
Subject data recorded on eCRFs during the study will be documented in a coded fashion. The 
subject will only be identified by the subject number and by their initials if also required. 
Confidentiality of subject records must be maintained to ensure adherence to applicable local 
privacy regulations. 
 
Subjects’ participation in this study and their study records (including photographs and 
video/audiotapes) will be held in a way that will protect their privacy, except when ordered 
by law.  It may be necessary for other people to review their records for study reasons.  These 
people may include:   
  
• 
The Investigator  
• The United States Food and Drug Administration (FDA)  
• Other state or federal regulatory agencies  
• The Institutional Review Board (IRB)  
• Contracted monitors or auditors  
• Bausch + Lomb personnel associated with the study analysis and reporting  
  
If this occurs, their identity will be protected as legally required.  If results of the study are 
published, subjects will not be identified by name.   
  
The Institutional Review Board (IRB) and accrediting agencies may inspect and copy 
subjects’ records, which may have the subjects’ name on them.  Therefore, total 
confidentiality cannot be guaranteed.  If the study results are presented at meetings or 
printed in publications, subject names will not be used.  
 
Data pertaining to subjects is only available to Bausch + Lomb personnel. Physical data 
remains locked and electronic data is password protected. When subjects receive an 
electronic recruitment invitation, all other potential subjects are blind carbon copied on the 
invitation to ensure patient privacy.  
 
Clinical trial data is input into a secure, electronic data capture system in which only 
relevant study personnel have access. Subject data recorded on CRF/e-CRFs during the 
study will be documented in a coded fashion. The subject will only be identified by the 
subject number. Confidentiality of subject records must be maintained to ensure subject 
privacy.  
 
8.5 Locking the Database 
After the study is complete, the data is approved by the Principal Investigator via electronic 
signature. The database is then locked. Any change to the data after database lock will 
require approval from the EDC Programmer and is documented via electronic audit trail. 
 
8.6 Retention of Documents 
Bausch + Lomb must retain essential documents indefinitely after the completion of the 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 34 of 48 
 
study. The Research Clinic keeps physical study related documents physically on-site for a 
minimum of 3 years. After 3 years, the documents may be securely stored in an off- site 
location. Additionally, data is securely stored electronically.  
 
Essential documents include but are not limited to the following: 
• 
IRB approvals for the study protocol, all amendments, ICF(s), and advertisements 
• 
IRB correspondence and reports (e.g., AE reports, protocol deviations, and safety 
updates) 
• 
regulatory documents  
• 
subject’s signed ICF 
• 
accountability records for the test article(s) 
• 
any other documents relevant to the conduct of the study  
 
8.7 Clinical Quality Assurance 
Prior to being evaluated clinically, investigational devices such as contact lenses or 
solutions are analyzed and approved for release by the project manager and design quality at 
Bausch and Lomb, Rochester, NY.   Documentation of pre-clinical testing can be found on 
the study’s clinical scorecard for the relevant products.  
 
For the commercially available competitor products, information can be found in the 
respective package inserts, patient instruction booklets, professional fitting guides and in the 
IB1-2. 
 
8.8 Institutional Review Board 
The Investigator should ensure their participation in the study, in addition to the protocol, 
subject recruitment materials and the ICF to be used in this study are approved by the 
reviewing IRB prior to entering any subjects in the study. In addition, the Investigator must 
ensure that the reviewing IRB has provided approval for any protocol amendments prior to 
implementation. If the amendment necessitates a revision to the ICF, the Investigator should 
ensure the revised form is also submitted to and approved by the IRB and implemented as 
directed. 
 
8.9 Statements of Compliance 
This study is being conducted in accordance with 21CFR Parts 11, 50, 54, 56 and 812; 42 
USC 282(j); ISO 14155:2020 Clinical investigation of medical devices for human subjects – 
Good Clinical Practice; International Council for Harmonization (ICH) Good Clinical 
Practice (GCP) - Declaration of Helsinki and applicable local regulations. 
 
The devices for this study conform to applicable general safety and performance 
requirements apart from aspects covered by the clinical investigation and that, with regard 
to those aspects, every precaution has been taken to protect the health and safety of the 
subjects. 
 
This clinical investigation will demonstrate compliance with this document. 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 35 of 48 
 
The clinical investigation shall not begin until the required approval from the IRB has been 
obtained. Any additional requirements imposed by the IRB shall be followed. 
No insurance will be provided to the subjects.  
Bausch + Lomb is financing this clinical investigation. The investigators are paid 
employees of Bausch + Lomb.  
 
8.10 Informed Consent Process 
All subjects will be given a copy of the Informed Consent Form (ICF) to read prior to 
enrollment.  Subjects will have an opportunity to ask questions prior to enrollment and 
throughout the study. The ICF also contains information on payment for participating in the 
study.  All subjects will need to sign the ICF prior to participation in the study. The person 
obtaining informed consent will also sign and date the form.  The subject’s signed informed 
consent must be obtained before conducting any study related procedures. The original will 
be retained by the investigative site. A copy of the signed ICF will be given to the subject. If 
modifications are made to the ICF, the new version must be approved by the IRB. The new 
version of revised ICF(s) must be reviewed and signed by all active (if required by the IRB) 
and new subjects at the first opportunity after approval by the IRB. 
 
For this study, subjects will have the capacity to provide written voluntary informed 
consent. Emergency treatment is not applicable. No minors or those who cannot speak 
English or read or write will be recruited for this study. 
8.10.1 Vulnerable Population 
 
   
 
 
 
  
 
All subjects will be given a copy of the Informed Consent Form (ICF) to read and will also 
have an opportunity to ask questions to the Investigator or designee prior to enrollment. All 
subjects will need to sign the Informed Consent Form prior to participation in the study.  
 
 
  
 
After the study is complete, there is no planned/routine medical follow-up care. 
 
8.11 Publication of Results 
All study data generated as a result of this study will be regarded as confidential, until 
appropriate analysis and review by Bausch + Lomb or its designee and the Investigator(s) 
are completed. The results of the study may be published or presented by Bausch + Lomb.  

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 36 of 48 
 
 
9.0 REFERENCES 
1. Acuvue Oasys 1-Day for Astigmatism Package Insert and Fitting Guide. 
https://www.acuvue.com/sites/acuvue_us/files/ao-03-16-13_web_final_pi.pdf 
2. Acuvue Oasys 1-Day for Astigmatism Patient Instruction Guide 
https://www.acuvue.com/sites/acuvue_us/files/ao-03-16-12_final_pig.pdf 
 
 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared to 
Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 37 of 48 
 
APPENDIX A: METHODS OF CLINICAL EVALUATION 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared to 
Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 38 of 48 
 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
  
 
 
 
 
 
 
 
  
 
 
 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared to 
Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 39 of 48 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.0 PERFORMANCE RATING 
Performance rating scales are used for collecting subjective data for clinical studies.  
 
 
  
 
 
 
 
 
 
 
 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared to 
Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 41 of 48 
 
APPENDIX B: SUBJECT INSTRUCTIONS FOR USE 
 
CAUTION: Investigational device. Limited by Federal (U.S.A.) Law to investigational use only. 
 
INTRODUCTION 
 
As a participant in this study, you will wear 
 
 You will wear the study lens types in a randomized order.  
 
Do not discuss or describe the study or the study materials with anyone except the person who 
gave you the study materials at the Screening/Dispensing Visit. You should not show the study 
blister packs and foils to the Investigator unless instructed to do so. 
 
STUDY PRODUCT INFORMATION 
 
 
 
  
 
 
 
  
 
 
 
 
Do not use any other contact lenses, eye drops or lens care products than those listed above while 
you are wearing the study lenses. 
 
All study materials, used and unused, must be returned.  
 
If you have questions or problems, call: 
 
  
  
 
 
 
If you require a medical referral for any eye problems experienced during the study, please refer 
to your informed consent form. 
 
 
GENERAL INFORMATION 
 
Please keep all appointments and follow the instructions thoroughly. Remember to wear your 
glasses to your appointments.  

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared to 
Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 42 of 48 
 
 
These subject instructions apply to all study lens types. For all study lenses, it is essential to your 
safety that you read and understand the information and instructions in these subject instructions, 
and have your questions answered before and after you receive contact lenses. 
 
Wearing contact lenses is different from wearing eyeglasses. Because they are worn directly on 
your eyes, contact lenses affect the way in which your eyes function. These effects tend to 
increase with the length of time that the lenses remain on your eyes between removals. Although 
the great majority of people successfully wear contact lenses without problems, before you 
decide whether to begin or to continue wearing contact lenses, you should discuss with the study 
investigator the effects of contact lenses on your eyes and the risks associated with wearing 
contact lenses. You also should read the sections in these subject instructions entitled 
"Warnings”, “Adverse Reactions", "Precautions”, and “Wearing Restrictions and Indications". 
Ask the investigator to explain anything that you do not understand, including any additional 
restrictions which may be given to you.  
 
You also need to remember that soft contact lenses, including those covered by these subject 
instructions, are made of a type of plastic that absorbs liquids, vapors, and small particles, and, 
for some people, may collect deposits from your natural eye fluids. Therefore, you should strictly 
follow the instructions contained in these subject instructions entitled “Personal Cleanliness and 
Lens Handling”, and any other instructions given to you by your eye care professional. Any 
failure to follow these instructions and the wearing restrictions will increase the chances of 
contamination, damage to the lenses, or a build-up of deposits on the lenses, which can lead to 
serious, sight-threatening eye infections and injuries. 
 
If problems or symptoms should occur, immediately remove your contact lenses and follow the 
steps described in the sections in these subject instructions entitled "Warnings” and “Adverse 
Reactions". Prompt attention to problems is essential and may require immediate professional 
care.  
 
Remember, when wearing soft contact lenses your eyes should look and feel good, and your 
vision should be clear. 
WEARING RESTRICTIONS AND INDICATIONS 
The study lenses are indicated for the correction of refractive ametropia (myopia, hyperopia and 
astigmatism) in persons with non-diseased eyes.  
 
WARNINGS 
You should be aware of and fully discuss with the study investigator the following warnings 
pertaining to contact lens wear: 
• 
Problems with contact lenses could result in serious injury to your eye. It is essential that 
you follow your eye care professional's direction and all labeling instructions for proper use 
of lenses. Eye problems, including corneal ulcers, can develop rapidly and lead to loss of 
vision. 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared to 
Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 43 of 48 
 
• 
Strict compliance with your wearing restrictions, wearing schedule, and follow-up visit 
schedule must be followed. 
• 
Clinical studies have shown that the risk of serious adverse reactions is increased when 
daily wear lenses are worn overnight. Study lenses should not be worn overnight. 
• 
Studies have shown that contact lens wearers who are smokers have a higher incidence of 
adverse reactions than nonsmokers. 
• 
If you experience eye discomfort, excessive tearing, vision changes, or redness of the eye, 
you should immediately remove lenses and promptly contact your eye care professional. 
 
PRECAUTIONS 
You should be aware of and fully discuss with your eye care professional the following safety 
precautions: 
 
Lens Handling Precautions 
• 
Always wash and rinse hands before handling lenses. Do not get cosmetics, lotions, soaps, 
creams, deodorants, or sprays in the eyes or on the lenses. It is best to put on lenses before 
putting on makeup. Water-base cosmetics are less likely to damage lenses than oil-base 
products. 
• 
Do not touch contact lenses with your fingers or hands if your hands are not free of  foreign 
materials, as microscopic scratches of the lenses may occur, causing distorted vision and/or 
injury to your eye. 
• 
Do not use saliva or anything other than the recommended solutions for lubricating or 
wetting your lenses. 
• 
Be certain that the fingers or hands are free of foreign materials before touching your 
lenses, as microscopic scratches of the lenses may occur, causing distorted vision and/or 
injury to the eye. 
• 
Always handle your lenses carefully and gently and avoid dropping them.  
• 
Always hand the same lens (right or left) to avoid mix-ups.  
• 
Do not touch the lens with your fingernails. 
• 
Carefully follow the handling, insertion, removal, storing and wearing instructions in these 
subject instructions and those prescribed by the study investigator. 
• 
Never use tweezers or other tools to remove your lenses from the lens container unless 
specifically indicated for that use. Pour the lens into the hand. 
 
Lens Wearing Precautions 
• 
Never wear your lenses beyond the period recommended by your eye care professional. 
• 
If the lens sticks (stops moving) on the eye, follow the recommended directions on Care for 
a Sticking (Nonmoving) Lens. The lens should move freely on the eye for the continued 
health of the eye. If nonmovement of the lens continues, you should immediately consult 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared to 
Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 44 of 48 
 
your eye care professional. 
• 
Avoid, if possible, all harmful or irritating vapors and fumes when wearing lenses. 
• 
If aerosol products are used while wearing lenses, exercise caution and keep eyes closed 
until the spray has settled. 
 
Topics to Discuss with the Eye Care Professional: 
• 
You should not wear contact lenses during water related activities. Exposure to water while 
wearing contact lenses in activities such as swimming, water skiing and hot tubs may 
increase the risk of ocular infection including but not limited to Acanthamoeba keratitis. 
• 
Always contact your eye care professional before using any medicine in the eyes. 
 
Who should know that you are wearing contact lenses? 
• 
You may decide to inform your health care professional about being a contact lens wearer. 
• 
Always inform your employer of being a contact lens wearer. Some jobs may require the 
use of eye protection equipment or may require that you not wear lenses. 
• 
Ask the study investigator whether there are any other wearing restrictions that apply to 
you. Write those restrictions in the spaces provided below and follow them carefully: 
 
 
 
 
 
 
 
 
 
ADVERSE REACTIONS (PROBLEMS AND WHAT TO DO) 
You should be aware that the following problems may occur: 
• 
Eyes stinging, burning, itching (irritation), or other eye pain 
• 
Comfort is less than when lens was first placed on eye 
• 
Abnormal feeling of something in the eye (foreign body, scratched area) 
• 
Excessive watering (tearing) of the eyes 
• 
Unusual eye secretions 
• 
Redness of the eyes 
• 
Reduced sharpness of vision (poor visual acuity) 
• 
Blurred vision, rainbows, or halos around objects 
• 
Sensitivity to light (photophobia) 
• 
Dry eyes 
 
If you notice any of the above, you should: 
Immediately remove your lenses. 
• 
If the discomfort or problem stops, then look closely at the lens. If the lens is in any way 
damaged, do not put the lens back on your eye. You should remove the lens and place it in 
the provided contact lens case dry. Then insert a new lens on the eye. If the problem 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared to 
Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 45 of 48 
 
continues, you should immediately remove the lenses and consult your eye care 
professional. 
 
When any of the above problems occur, a serious condition such as infection, corneal ulcer, 
neovascularization, or iritis may be present. You should keep the lens off your eye and seek 
immediate professional identification of the problem and prompt treatment to avoid serious eye 
damage. 
 
PERSONAL CLEANLINESS, LENS CARE AND LENS HANDLING: 
 
1. Preparing the Lens for Wearing: 
It is essential that you learn and use good hygienic methods in the care and handling of 
your new lenses. Cleanliness is the first and most important aspect of proper contact lens 
care. Your hands should be clean and free of any foreign substances when you handle 
your lenses. The procedures are: 
• 
Always wash your hands thoroughly with a mild soap, rinse completely, and dry 
with a lint-free towel before touching your lenses. 
• 
Avoid the use of soaps containing cold cream, lotion, or oily cosmetics before 
handling your lenses, since these substances may come into contact with the lenses 
and interfere with successful wearing. 
• 
Handle your lenses with your fingertips and be careful to avoid contact with 
fingernails. It is helpful to keep your fingernails short and smooth. 
• 
Start off correctly by getting into the habit of always using proper hygienic 
procedures so that they become automatic. 
 
2. Handling the Lenses: 
• 
Develop the habit of always working with the same lens first to avoid mix-ups. 
• 
Position the lens on your index finger and examine it to be sure that it is moist, 
clean, clear, and free of any nicks or tears. 
• 
Should you accidentally place an inside-out lens on your eye, one of the following 
signs should signal you to remove and replace it correctly. 
a) Less than usual comfort, 
b) The lens may fold on the eye, 
c) Excessive lens movement on blink, 
d) Blurred vision. 
 
• 
If the lens folds and sticks together: Place the lens in the palm of your hand and wet 
thoroughly with the recommended rinsing or storing solution. Then GENTLY rub 
the lens between your index finger and palm in a gentle back and forth motion. 
• 
If the lens flattens or drapes across your finger, the lens or your finger may be too 
wet. To correct this, dry your finger by transferring the lens several times from one 
index finger to the other, drying the opposite finger each time. 
 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared to 
Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 46 of 48 
 
3. 
Placing the Lens on the Eye 
There are other methods of lens placement. If the following methods are difficult for you, 
your Study Doctor will provide you with an alternate method.  
 
NOTE: If after placement of the lens, your vision is blurred, check for the following:  
The lens is not centered on the eye (see “Centering the Lens,” next in these instructions).  
If the lens is centered, remove the lens (see “Removing the Lens” section) and check for 
the following:  
• cosmetics or oils on the lens (replace the lens)  
• the lens is on the wrong eye  
• the lens is inside-out (it would also not be as comfortable as normal)  
 
If you find that your vision is still blurred after checking the above possibilities, remove 
both lenses and consult your eye care professional.  
 
A. The One-Hand Placement Technique  
• Place the lens on your index finger. Head up, looking straight ahead, pull down your 
lower eyelid with the middle finger of your placement hand. Look up steadily at a point 
above you. Then place the lens on the lower white part of your eye. Remove your index 
finger and slowly release the lower lid. Look down to position the lens properly. Close 
your eyes for a moment; the lens will center itself on your eye.  
 
 
 
B. The Two-Hand Placement Technique  
• With the lens on your index finger, use the middle finger of the other hand to pull the 
upper lid against the brow. Use the middle finger of your placement hand to pull down 
the lower lid and then place the lens centrally on your eye. While holding this position, 
look downward to position the lens properly. Slowly release your eyelids.  
• If the lens feels uncomfortable, then look in the mirror and gently place a finger on the 
edge of the contact lens and slowly slide the lens away from your nose while looking in 
the opposite direction. Then by blinking, the lens will re-center itself. If the lens still feels 
uncomfortable, follow the steps described in the section of these instructions entitled 
“Adverse Reactions.”  

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared to 
Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 47 of 48 
 
 
 
 
4. Centering the Lens 
Very rarely, a lens that is on the cornea will be displaced onto the white part of the eye 
during lens wear. This can also occur during placement and removal of the lenses if the 
correct techniques are not performed properly. To center a lens, follow one of the 
procedures below.  
• Hold the upper and lower eyelids open with your fingers. Then while looking in a 
mirror, gently place a finger on the contact lens and gently slide the lens towards the 
center of the eye.  
OR 
• Hold the upper and lower eyelids open with your fingers. Then, while looking in a 
mirror, move your eye towards the lens to place it on the center of the eye.  
 
5. Removing the Lens 
• Always remove the same lens first.  
• Wash, rinse, and dry your hands thoroughly.  
• Always be sure that the lens is in the correct position on your eye before you try to 
remove it (a simple check of your vision, closing one eye at a time, will tell you if the 
lens is in the correct position). Look up and slowly pull down your lower eyelid with 
the middle finger of your removal hand and place your index finger on the lower edge 
of lens. Squeeze the lens lightly between the thumb and the index finger and remove 
it. Avoid sticking the edges of the lens together. 
• Remove the other lens by following the same procedure. 
• Follow the required lens care procedures described by your eye care professional. 
• NOTE: If this method of removing your lens is difficult for you, your eye care 
professional will provide you with an alternate method. 
 
6. Care for a Sticking (Nonmoving) Lens 
• It is important to the health of your eyes that your contact lenses move freely. If a lens 
sticks (stops moving), put a few drops of the Bausch + Lomb Sensitive Eyes® Drops 
provided by your study doctor into your eye. In this case, do not use plain water or 
anything other than the recommended solutions. Do not attempt to remove a lens that 
is sticking, which could damage your eye. If the lens does not begin to move when 

ROC2-23-006: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared to 
Acuvue Oasys 1-Day for Astigmatism Contact Lenses 
 
 
Version 1.0                                                              CONFIDENTIAL                   
July 25, 2023 
 
 
 
 
Page 48 of 48 
 
you blink after several applications of the solution or, contact your study doctor 
immediately. Do not attempt to remove the lens except on the advice of your study 
doctor. 
 
7. Return of Your Study Lenses 
Do not discard worn lenses. At each visit, you must return all used and unused study 
materials that were dispensed to you during the designated wear periods.  
 
8. Emergency: 
If chemicals of any kind (household products, gardening solutions, laboratory chemicals, 
etc.) are splashed into your eyes, you should: FLUSH EYES IMMEDIATELY WITH 
TAP WATER AND THEN REMOVE LENSES PROMPTLY. CONTACT YOUR 
EYE CARE PROFESSIONAL OR VISIT A HOSPITAL EMERGENCY ROOM 
WITHOUT DELAY.