A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
Phase: NA
Conditions: Myopia
Sponsor: Bausch & Lomb Incorporated

Study #893
28 June 2019
NCT04901897

Study #893 - Protocol 
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INVESTIGATOR STATEMENT OF APPROVAL 
 
A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact 
Lens  
 
PROTOCOL 
STUDY #893 
 
I have read the attached document, concur that it contains all information necessary to 
conduct the study, and agree to abide by all provisions set forth therein. 
I agree to conduct this study in accordance with 21CFR Parts 11, 50, 54, 56, 812, and 
42 USC 282(j); and with consideration of the provision in: ISO 14155-1:2009 Clinical 
investigation of medical devices for human subjects – Part 1: General requirements; 14155-
2:2009 Part 2: Clinical investigation of medical devices for human subjects – Part 2: 
Clinical investigational plan; ISO 11980:2009 Ophthalmic Optics – Contact Lenses and 
contact lens care products – Guidance for clinical investigations; ICH, GCPs, and 
applicable local regulations. I will not initiate the study until I have obtained written 
approval by the appropriate IRB and have complied with all financial and administrative 
requirements of the governing body of the clinical institution and the Sponsor.  I will obtain 
written informed consent from each study subject prior to performing any study specific 
procedures.  
I understand that my signature on this document indicates my agreement to this clinical 
Investigational Plan/Protocol and to review and, if appropriate, sign the clinical study 
report. 
I understand that my e-signature on an electronic case report form indicates that the data 
therein has been reviewed and accepted by me. 
I understand that this document and related information is subject to confidentiality terms 
found in my signed Confidentiality or Clinical Services Agreement.  I agree to protect the 
confidentiality of my patients when allowing the Sponsor of this clinical investigation, 
and/or relevant regulatory authorities and IRBs, direct access to my medical records for 
study subjects. 
 
 
 
 
 
Principal Investigator, Printed Name 
 
 
 
 
 
 
 
Principal Investigator, Signature 
 
Date 
 
Upon signing, provide a copy of this page to Bausch + Lomb and retain a copy for your files.   

Study #893 - Protocol 
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PERSONNEL AND FACILITIES 
NOTE: The information on this page is subject to change.  All changes will be provided separately. 
 
 
Sponsor 
Bausch + Lomb, Inc. 
1400 North Goodman Street 
Rochester, NY 14609 
US 
Clinical Operations 
 
 
  
 
 
 
 
Study Manager (Primary Study Contact) 
  
 
 
 
 
 
Scientific & Clinical Affairs 
 
 
 
 
 
 
 
 
Global Regulatory Affairs 
 
 
 
 
 
 
 
 
 
Biostatistics 
 
 
  
 
 
 
 
Data Management 
 
  
 
  
 
Clinical Trial Materials 
 
 
  
 
 
  
 
 
 
  
Medical Monitor (for Safety Reporting) 
 
 
 
 
   
 
Pharmacovigilance (not for Safety Reporting) 
  
 
 
 
 
  
 
 
 

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SYNOPSIS 
Name of Sponsor/Company: Bausch + Lomb Incorporated 
Name of Investigational Product:  
Test: Bausch + Lomb kalifilcon A daily disposable contact lens 
Controls: Johnson & Johnson Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon 
A) daily disposable contact lens and Alcon DAILIES TOTAL1® (delefilcon A) daily 
disposable contact lenses 
Title of Study: A Study to Evaluate the Product Performance of a New Silicone 
Hydrogel Contact Lens  
Number of Clinical Centers: Approximately 35 investigative sites, United States 
only 
Primary Objective:  
The objective of this study is to evaluate the product performance of a new silicone 
hydrogel daily disposable contact lens, kalifilcon A, compared to the Johnson & 
Johnson Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable 
contact lens and Alcon DAILIES TOTAL1® (delefilcon A) daily disposable contact 
lenses when worn by current soft contact lens wearers on a daily disposable wear 
basis. 
Methodology:  The study is evaluating the product performance of a new silicone 
hydrogel daily disposable contact lens packaged in a unique phosphate buffered 
solution.  The silicone hydrogel contact lens infused with a unique phosphate buffered 
solution offers the advantage of a high oxygen material infused with ingredients for 
moisture retention and osmoprotection designed to promote a consistent level of 
health of the eye. 
Approximately 800 subjects (1600 eyes) will be enrolled in this two-week, three arms, 
randomized, parallel, bilateral, single-masked study at approximately 35 investigative 
sites in the United States.  The study is designed to include habitual wearers of silicone 
hydrogel lenses.  Subjects must habitually wear Alcon’s Air Optix Aqua, Air Optix 
with HydraGlyde, Air Optix Night & Day, Bausch + Lomb’s PureVision 2, Bausch + 
Lomb ULTRA, CooperVision’s Biofinity, Johnson & Johnson Acuvue Oasys® with 
HydraClear™ or Acuvue Vita soft contact lenses.  Approximately one-quarter of the 
subjects enrolled in this study must currently wear the Alcon silicone hydrogel lenses, 
one-quarter of the subjects must currently wear Bausch + Lomb silicone hydrogel 
lenses, one-quarter of the subjects must currently wear CooperVision silicone 
hydrogel lenses and one-quarter of the subjects must currently wear Johnson & 
Johnson silicone hydrogel lenses. 
At the Screening/Dispensing Visit, approximately 400 subjects will be randomized to 
receive Bausch + Lomb investigational kalifilcon A daily disposable contact lenses 
(Test), approximately 200 subjects will be randomized to receive Johnson & Johnson 
Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact 

Study #893 - Protocol 
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lenses (Control), and approximately 200 subjects will be randomized to receive Alcon 
DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses (Control). 
Subjects will be assigned randomization numbers sequentially as they are enrolled 
and deemed eligible to participate.  Randomization will be stratified by investigational 
site.  Lenses will be dispensed according to randomization schedules provided to the 
unmasked designee at each site. 
Number of Subjects Planned: Approximately 800 subjects (1600 eyes) 
Diagnosis and Main Criteria for Inclusion: 
• Subjects must be 18 to 40 years old on the date the ICF is signed and have capacity 
to provide voluntary informed consent.  
• Subjects must be myopic and require lens correction from -0.50 to -6.00 Diopter 
(D) with 0.25 D steps, in each eye. 
• Subjects must be correctable through spherocylindrical refraction and with soft 
spherical contact lenses to 32 letters (0.3 logarithm of the minimum angle of 
resolution [logMAR]) or better (2 meters distance, high-contrast chart) in each 
eye.  
• Subjects must be free of any anterior segment disorders. 
• Subjects must be adapted soft contact lens wearers and willing to wear their study 
lenses for at least 8 hours per day on a daily disposable wear basis for 
approximately 2 weeks. 
• Subjects must have access to internet connection and personal email to 
send/receive emails. 
• Subjects must habitually wear either Alcon’s Air Optix Aqua, Air Optix with 
HydraGlyde, Air Optix Night & Day, Bausch + Lomb’s PureVision 2, Bausch + 
Lomb ULTRA, CooperVision’s Biofinity, Johnson & Johnson Acuvue Oasys® 
with HydraClear™, or Acuvue Vita soft contact lenses. 
Key Exclusion Criteria:  
• Subjects participating in any drug or device clinical investigation within 2 weeks 
prior to entry into this study (Screening/Dispensing Visit) and/or during the period 
of study participation. 
• Subjects who have worn gas permeable (GP) contact lenses within the last 30 days 
or who have worn polymethylmethacrylate (PMMA) lenses within the last three 
months.  
• Subjects who have any systemic or ocular disease currently affecting ocular health 
in the Investigator’s opinion may have an effect on ocular health during the course 
of the study.   
• Subjects using any systemic, topical or topical ocular medications that will in the 
Investigator’s opinion, affect ocular physiology or lens performance.   

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• Subjects who currently wear daily disposable, monovision, multifocal, or toric 
contact lenses.  
• Subjects with an refractive astigmatism of greater than 0.75 D in either eye. 
• Subjects with anisometropia (spherical equivalent) of greater than 2.00 D. 
• Subjects who are amblyopic. 
• Subjects who have had any corneal surgery (e.g., refractive surgery). 
Investigational Product, Dosage and Mode of Administration: 
The investigator or designee will instruct all subjects to adhere to the Subject 
Instructions provided with their study contact lenses. 
In order to ensure that the investigator and site staff remain masked to the study lens, 
an unmasked designee at each site will be responsible for all study lens accountability, 
including dispensation and collection of study supplies to subjects.  
Subjects are to be instructed not to discuss or show the dispensed study lenses to the 
Investigator or masked site staff during the study. 
Subjects will be instructed that other contact lenses (other than the study lenses) and 
contact lens care products (other than the drops provided) are not allowed to be used 
during the study period.   
Study Duration of Treatment:  approximately 2 weeks 
Criteria for Evaluation: 
The primary endpoints are as follows: 
Effectiveness: 
The primary effectiveness endpoints to be evaluated at the 2-Week Follow-Up Visit 
are as follows: 
• Mean logMAR contact lens visual acuity at the 2-Week Follow-Up Visit 
• Proportion of subjects in the Test lens group agreeing with the statement “Are 
comfortable throughout the day”  
• Proportion of subjects in the Test lens group agreeing with the statement 
“Provide clear vision throughout the day”  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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• 
 
 
 
Safety: 
The primary safety endpoint will be the proportion of subjects with slit lamp findings 
greater than Grade 2 at any follow-up visit. 
 
 
 
 
 
 
 
 
 
 
 
 
Statistical Methods: 
Continuous data will be summarized using descriptive statistics: sample size (n), 
mean, standard deviation (SD), median, minimum and maximum.  Categorical data 
will be presented using the total counts for each category and corresponding 
percentages.  The denominator for each percentage will be the number of subjects or 
eyes with non-missing data at the given visit for each respective study treatment, 
unless otherwise indicated. 
Monocular contact lens logMAR visual acuity will be compared between the test lens 
and each comparator using a one-sided two-sample t-test and a non-inferiority margin 
of 0.06. 
The proportions of subjects agreeing with each of two statements on the subject 
questionnaires will be compared to 0.5 (50%) using one-sided χ2 tests. 
The proportion of eyes with slit lamp findings greater than Grade 2 at the follow-up 
visit will be compared between the test lens and each comparator using confidence 
limits constructed using the Newcombe-Wilson score method and a non-inferiority 
margin of 0.05 (5%).       
If the test lens is statistically successful in all primary endpoints, then the test lens will 
be statistically successful overall. 
Sample Size Calculations: 
Assuming that the test is identical in performance to each comparator for all primary 
endpoints, that the primary endpoints are independent, and that the assumptions used 
in each power calculation are correct, the overall power of the trial is greater than 
90%. 
 
 

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TABLE OF CONTENTS 
PAGE 
INVESTIGATOR STATEMENT OF APPROVAL ................................................................................. 2 
PERSONNEL AND FACILITIES .............................................................................................................. 3 
SYNOPSIS .................................................................................................................................................... 4 
TABLE OF CONTENTS ............................................................................................................................. 8 
LIST OF ABBREVIATIONS .....................................................................................................................12 
1.0 
INTRODUCTION ..........................................................................................................................13 
2.0 
OBJECTIVE ...................................................................................................................................13 
3.0 
STUDY DESIGN ............................................................................................................................13 
3.1 
DESCRIPTION OF STUDY DESIGN ..................................................................................................13 
3.2 
SELECTION OF STUDY POPULATION ..............................................................................................14 
3.2.1 
Eligibility.............................................................................................................................14 
3.2.1.1 
Inclusion Criteria ............................................................................................................14 
3.2.1.2 
Exclusion Criteria ...........................................................................................................15 
3.2.2 
Subject Completion .............................................................................................................16 
3.2.3 
Lost to Follow-up ................................................................................................................17 
3.3 
INVESTIGATORS ............................................................................................................................17 
3.4 
STUDY DURATION ........................................................................................................................17 
3.5 
PROTOCOL CHANGES AND AMENDMENTS ....................................................................................18 
4.0 
STUDY MATERIALS ...................................................................................................................18 
4.1 
DESCRIPTION OF TEST ARTICLE(S) (STUDY LENSES) ....................................................................18 
4.2 
DESCRIPTION OF COMPARATOR PRODUCT(S) ...............................................................................19 
4.3 
INSTRUCTIONS FOR USE AND ADMINISTRATION ...........................................................................19 
4.3.1 
Storage Requirements .........................................................................................................19 
4.3.2 
Subject Instructions .............................................................................................................19 
4.3.3 
Fitting Guide .......................................................................................................................20 
4.4 
OTHER STUDY MATERIALS ...........................................................................................................20 
4.5 
PACKAGING AND LABELING .........................................................................................................20 
4.6 
ACCOUNTABILITY .........................................................................................................................20 
4.7 
MASKING/UNMASKING .................................................................................................................21 
4.8 
PRODUCT REPLACEMENT ..............................................................................................................21 
4.9 
RISK ASSESSMENT ........................................................................................................................21 
5.0 
STUDY METHODS .......................................................................................................................22 
5.1 
STUDY VISITS ...............................................................................................................................22 
5.1.1 
Screening/Dispensing Visit (Day 1) ....................................................................................22 
5.1.2 
2-Week Follow-up Visit (Day 11-17) .................................................................................24 
5.1.3 
Exit Visit .............................................................................................................................25 
5.1.4 
Market Research Surveys ....................................................................................................26 
5.1.4.1 
Online Consumer Survey ................................................................................................26 
5.1.4.2 
Investigator Questionnaire ..............................................................................................27 
5.1.5 
Unscheduled Visits ..............................................................................................................27 
5.1.6 
Missed Visits .......................................................................................................................29 
5.2 
STUDY COMPLETION.....................................................................................................................29 
5.2.1 
Study Termination/Suspension ............................................................................................29 
5.3 
CONCOMITANT MEDICATIONS/THERAPY ......................................................................................29 
5.4 
PROTOCOL DEVIATIONS................................................................................................................29 
6.0 
ADVERSE EVENTS ......................................................................................................................30 
6.1.1 
ADVERSE EVENT (AE) ..................................................................................................................30 
6.1.2 
Adverse Device Effect (ADE) .............................................................................................30 

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6.1.2.1 
Anticipated Serious Adverse Device Effect (ASADE) ...................................................31 
6.1.2.2 
Unanticipated Adverse Device Effect (UADE) ..............................................................31 
6.1.3 
Serious Adverse Event (SAE) .............................................................................................31 
6.1.4 
Significant Non-Serious Adverse Events ............................................................................32 
6.1.5 
Non-Significant Non-Serious Adverse Events ....................................................................32 
6.2 
ADVERSE EVENT TREATMENT AND CULTURING ...........................................................................33 
6.3 
EVALUATIONS ..............................................................................................................................33 
6.3.1 
Severity ...............................................................................................................................33 
6.3.2 
Relationship to Study Device ..............................................................................................33 
6.4 
PROCEDURES FOR REPORTING SAES AND SIGNIFICANT NON-SERIOUS ADVERSE EVENTS...........34 
6.4.1 
Off-site Unanticipated Adverse Device Effect Reporting ...................................................35 
6.4.2 
Reporting Device Deficiencies ............................................................................................35 
6.4.3 
Guidelines for Reporting Pregnancies .................................................................................36 
7.0 
STATISTICAL METHODS ..........................................................................................................36 
7.1 
STUDY ENDPOINTS .......................................................................................................................36 
7.1.1 
Primary Effectiveness Endpoints ........................................................................................36 
7.1.2 
Secondary Effectiveness Endpoints ....................................................................................36 
7.1.3 
Other/Supportive Effectiveness Variables ..........................................................................37 
7.1.4 
Primary Safety Endpoint .....................................................................................................37 
7.1.5 
Other Safety Variables ........................................................................................................37 
7.2 
HYPOTHESES ................................................................................................................................37 
7.2.1 
Contact Lens Visual Acuity (VA) .......................................................................................37 
7.2.2 
Proportions of Subjects Agreeing ........................................................................................37 
7.2.3 
Slit Lamp Findings ..............................................................................................................37 
7.3 
SAMPLE SIZE ................................................................................................................................38 
7.3.1 
Contact Lens Visual Acuity ................................................................................................38 
7.3.2 
Proportions of Subjects Agreeing ........................................................................................38 
7.3.2.1 
Test Lens Group ..............................................................................................................38 
7.3.2.2 
Comparator Lens Groups ................................................................................................38 
7.3.3 
Slit Lamp Findings ..............................................................................................................38 
7.3.4 
Overall Power and Enrollment Targets ...............................................................................38 
7.3.4.1 
Overall Power .................................................................................................................38 
7.3.4.2 
Enrollment Target ...........................................................................................................39 
7.4 
RANDOMIZATION ..........................................................................................................................39 
7.5 
STUDY POPULATIONS ...................................................................................................................39 
7.5.1 
Intent-to-Treat (ITT) Population .........................................................................................39 
7.5.2 
Per Protocol (PP) Population ...............................................................................................39 
7.5.3 
Safety Population ................................................................................................................39 
7.6 
STATISTICAL ANALYSIS ................................................................................................................39 
7.6.1 
Methods of Analysis ............................................................................................................39 
7.6.1.1 
General Methods .............................................................................................................39 
7.6.1.2 
Primary Endpoint Analysis .............................................................................................39 
7.6.1.3 
Definition of Statistical Success .....................................................................................40 
7.6.2 
Subject Demographics and Baseline Characteristics ...........................................................40 
7.6.3 
Subject Disposition .............................................................................................................41 
7.6.4 
Protocol Deviations .............................................................................................................41 
7.6.5 
Treatment Compliance ........................................................................................................41 
7.6.6 
Treatment Exposure ............................................................................................................41 
7.6.7 
Missing Data .......................................................................................................................41 
7.6.8 
Multiple Comparisons .........................................................................................................41 
7.6.9 
Interim Analyses .................................................................................................................41 
8.0 
DATA QUALITY ASSURANCE ..................................................................................................41 
8.1 
STUDY MONITORING ....................................................................................................................41 
8.2 
SOURCE DOCUMENTATION ...........................................................................................................42 
8.3 
CASE REPORT FORMS AND DATA VERIFICATION ..........................................................................43 
8.4 
RECORDING OF DATA AND RETENTION OF DOCUMENTS ..............................................................43 
8.5 
AUDITING PROCEDURES ...............................................................................................................44 

Study #893 - Protocol 
 
 
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8.6 
INSTITUTIONAL REVIEW BOARD ...................................................................................................44 
8.7 
PUBLICATION OF RESULTS ............................................................................................................44 
8.8 
STATEMENTS OF COMPLIANCE .....................................................................................................44 
8.8.1 
Ethics Review ......................................................................................................................44 
8.8.2 
Ethical Conduct of the Investigation ...................................................................................45 
8.8.3 
Informed Consent Process ...................................................................................................45 
9.0 
REFERENCES ...............................................................................................................................46 
9.0 
CORNEAL INFILTRATES EVALUATION FORM.............................................................................B-15 
 
 
 

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APPENDICES 
APPENDIX A: 
SCHEDULE OF VISITS AND PARAMETERS..................................................... A-1 
APPENDIX B: 
METHODS OF CLINICAL EVALUATION ...........................................................B-1 
APPENDIX C: 
SUBJECT INSTRUCTIONS .................................................................................... C-1 
APPENDIX D: 
FITTING GUIDE ...................................................................................................... D-8 
 

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LIST OF ABBREVIATIONS 
Abbreviation 
/Acronym  Term  
ADE Adverse Device Effect 
AE  Adverse Event 
ASADE Anticipated Serious Adverse Device Effect 
BSCVA Best Spectacle-Corrected Visual Acuity 
CFR Code of Federal Regulations 
CRA Clinical Research Associate 
CRO Clinical Research Organization 
D Diopter 
eCRF Electronic Case Report Form 
FDA United States Food and Drug Administration 
GCPs Good Clinical Practices 
GP Gas Permeable 
HIPAA Health Insurance Portability and Accountability Act 
ICF Informed Consent Form  
ICH International Conference on Harmonisation 
ID Identification 
IRB Institutional Review Board 
ISO International Organization for Standardization 
ITT Intent-to-Treat 
 logMAR Logarithm of the Minimum Angle of Resolution 
mm Millimeter 
OD Right Eye 
OS Left Eye 
PP Per Protocol 
PMMA Polymethylmethacrylate 
ROPI Report of Prior Investigations 
SAE Serious Adverse Event 
SD Standard Deviation 
Tel Telephone 
UADE Unanticipated Adverse Device Effect 
US United States 
VA Visual Acuity 
NOTE: The first occurrence of some abbreviations is not spelled out in the document (e.g., units of 
measure). 

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1.0 
INTRODUCTION  
Bausch + Lomb is evaluating the product performance of a newsilicone hydrogel contact 
lens packaged in a unique phosphate buffered solution.  The silicone hydrogel contact lens 
infused with a unique phosphate buffered solution offers the advantage of a high oxygen 
material infused with ingredients for moisture retention and osmoprotection designed to 
promote a consistent level of health of the eye.  
2.0 
OBJECTIVE 
The objective of this study is to evaluate the product performance of a new silicone 
hydrogel daily disposable contact lens, kalifilcon A, compared to the Johnson & Johnson 
Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lenses 
and Alcon DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses when worn 
by current soft contact lens wearers on a daily disposable wear basis. 
3.0 
STUDY DESIGN 
3.1 
Description of Study Design  
Approximately 800 subjects (1600 eyes) will be enrolled in this two-week, three arm, 
randomized, parallel, bilateral, single-masked study at approximately 35 investigative sites 
in the United States (US).  Subjects will be assigned randomization numbers sequentially 
as they are enrolled and deemed eligible to participate.  Lenses will be dispensed according 
to randomization schedules provided to the unmasked designee at each site.   
At the Screening/Dispensing Visit, approximately 400 subjects will be randomized to 
receive Bausch + Lomb kalifilcon A daily disposable contact lenses (Test), approximately 
200 subjects will be randomized to receive Johnson & Johnson Acuvue Oasys® 1-Day with 
HydraLuxe™ (senofilcon A) daily disposable contact lenses (Control), and approximately 
200 subjects will be randomized to receive Alcon DAILIES TOTAL1® (delefilcon A) daily 
disposable contact lenses (Control).  Subjects in all three study arms will wear the assigned 
lenses on a daily disposable wear basis for approximately two weeks.  The lenses must be 
replaced with a new lens each day.  Note: A new lens must be inserted/replaced whenever 
a lens is removed, however, this is intended to occur once each day and in general, should 
not occur multiple times throughout the day.   
The study is designed to include habitual wearers of silicone hydrogel lenses.  Subjects 
must habitually wear Alcon’s Air Optix Aqua, Air Optix with HydraGlyde, Air Optix Night 
& Day, Bausch + Lomb’s PureVision 2, Bausch + Lomb ULTRA, CooperVision’s 
Biofinity, Johnson & Johnson Acuvue Oasys® with HydraClear™, or Acuvue Vita soft 
contact lenses.  Approximately one-quarter of the subjects enrolled in this study must 
currently wear the Alcon ® silicone hydrogel lenses, one-quarter of the subjects must 
currently wear Bausch + Lomb silicone hydrogel lenses, one-quarter of the subjects must 
currently wear CooperVision silicone hydrogel lenses and one-quarter of the subjects must 
currently wear Johnson & Johnson silicone hydrogel lenses.  Randomization will be 
stratified by investigational site. 
Each subject will be required to complete an online survey after at least seven days of 
wearing the study lenses (and prior to their 2-week follow-up visit).  Investigators will be 
required to complete an online investigator questionnaire at the completion of each 
subject’s participation in the study.   

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3.2 
Selection of Study Population  
Recruitment for the study may start at any point after the Investigator agrees, in writing, to 
participate in the study.  Written informed consent, enrollment in the study, or dispensing 
of study products cannot begin until the Investigator has received both Institutional Review 
Board (IRB) and Sponsor approval to conduct the study.  The Sponsor and IRB must 
approve any advertising used to recruit subjects prior to use of that advertising. 
All consented subjects must be accounted for, whether they participate in the study or not.  
Bausch + Lomb will provide a Screening Log on which to enter information for each 
subject who signs an Informed Consent Form (ICF).  Once a potential subject is consented, 
the Investigator should proceed with screening procedures. 
Potential subjects are deemed either “Screen Pass” or “Screen Fail”.  “Screen Fail” subjects 
are those subjects who have not met the study inclusion criteria or have met the exclusion 
criteria.  “Screen Fail” subjects cannot participate in the study.  Electronic case report forms 
(eCRFs) will not be completed for “Screen Fail” subjects; however, the copy of their signed 
ICF and any information collected as part of screening (e.g., source documents, etc.) must 
be kept in their permanent records. 
“Screen Pass” subjects are those subjects who have met all of the study inclusion criteria 
and have not met any of the exclusion criteria.  Only “Screen Pass” subjects are eligible to 
participate in the study and can be assigned to a treatment using the schedule provided to 
the Unmasked Designee at each site. 
Once a subject is randomized (i.e., a treatment is assigned), a subject is considered active 
and must be accounted for at every visit until exited (completed or discontinued) from the 
study.  Refer to Section 3.2.3 for subjects determined to be lost to follow-up. 
3.2.1 
Eligibility 
3.2.1.1 
Inclusion Criteria  
1. Subjects must be 18 to 40 years old on the date the ICF is signed.  
2. Subjects must be able to read, understand and provide written informed consent on the 
IRB approved ICF and provide authorization as appropriate for local privacy 
regulations. 
3. Subjects must be myopic and require lens correction from -0.50 to -6.00 Diopter (D) 
with 0.25 D steps, in each eye. 
4. Subjects must be correctable through spherocylindrical refraction and with soft 
spherical contact lenses to 32 letters (0.3 logarithm of the minimum angle of resolution 
[logMAR]) or better (2 meters distance, high-contrast chart) in each eye.  
5. Subjects must be free of any anterior segment disorders. 
6. Subjects must be adapted soft contact lens wearers and willing to wear their study 
lenses for at least 8 hours per day on a daily disposable wear basis for approximately 2 
weeks. 
7. Subjects must be willing and able to comply with all treatment and follow-up/study 
procedures, as well as willing and able to refrain from using any other contact lenses 
or solutions other than those provided for the duration of the study. 

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8. Subjects must have access to an internet connection, and have personal email to receive 
and send emails. 
9. Subjects must habitually wear either Alcon’s Air Optix Aqua, Air Optix with 
HydraGlyde, Air Optix Night & Day, Bausch + Lomb’s PureVision 2, Bausch + Lomb 
ULTRA, CooperVision’s Biofinity, Johnson & Johnson Acuvue Oasys® with 
HydraClear™, or Acuvue Vita soft contact lenses.  
10. Subjects must habitually use a lens care product for cleaning, disinfection, and storage. 
 
3.2.1.2 
Exclusion Criteria 
1. Subjects participating in any drug or device clinical investigation within 2 weeks prior 
to entry into this study (Screening/Dispensing Visit) and/or during the period of study 
participation. 
2. Subjects who are women of childbearing potential (those who are not surgically 
sterilized or postmenopausal) are excluded from participation in the investigation if 
they meet any one of the following conditions: 
− she is currently pregnant 
− she plans to become pregnant during the study 
− she is breastfeeding 
3. Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or 
who have worn polymethylmethacrylate (PMMA) lenses within the last three months.  
4. Subjects who have any systemic or ocular disease currently affecting ocular health in 
the Investigator’s opinion may have an effect on ocular health during the course of the 
study. 
5. Subjects using any systemic, topical or topical ocular medications that will, in the 
Investigator’s opinion, affect ocular physiology or lens performance. 
6. Subjects who currently wear daily disposable contact lenses. 
7. Subjects who currently wear monovision, multifocal, or toric contact lenses.  
8. Subjects with a refractive astigmatism of 0.75 D or greater in either eye. 
9. Subjects with anisometropia (spherical equivalent) of greater than 2.00 D. 
10. Subjects with any Grade 2 or greater finding during the slit lamp examination 
 
.  Subjects with corneal infiltrates, of 
ANY GRADE, are not eligible. 
11. Subjects with any “Present” finding during the slit lamp examination 
 
 that, in the Investigator’s judgment, 
interferes with contact lens wear. 
12. Subjects with any scar or neovascularization within the central 6 mm of the cornea.  
Subjects with minor peripheral corneal scarring (that does not extend into the central 
area), that in the Investigator’s judgment, does not interfere with contact lens wear, are 
eligible for this study.  

Study #893 - Protocol 
 
 
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13. Subjects who are aphakic. 
14. Subjects who are amblyopic. 
15. Subjects who have had any corneal surgery (e.g., refractive surgery). 
16. Subjects who are allergic to any component in the study care products. 
17. Subjects who meet any of the following criteria: 
− the subject is an employee of the investigative site  
− the subject, or a member of the subject’s household, is an Ophthalmologist, an 
Optometrist, an Optician, or an Ophthalmic Assistant/Technician 
− the subject, or a member of the subject’s household, is an employee of a 
manufacturer of contact lenses or contact lens care products (e.g., Alcon, Bausch 
+ Lomb, CooperVision, Johnson & Johnson, etc.) 
− the subject, or a member of the subject’s household, is an employee of a market 
research firm 
If a subject meets all the inclusion criteria and does not exhibit any of the exclusion criteria, 
the subject is eligible for entry into the study.  Ineligible subjects MUST NOT be enrolled 
in this study.  Any subject enrolled in the study who later is found to have not met the 
eligibility criteria at entry will be discontinued. 
3.2.2 
Subject Completion 
If a subject has no ongoing Adverse Event (AE) at the conclusion of the 2-Week Follow-
up Visit, the subject should be exited from the study (per Section 5.1.3) and will be 
considered “Complete.” Subjects who require further follow-up at the conclusion of the 2-
Week Follow-up Visit will be followed by the Investigator, until the AE is resolved or 
stabilized.  Once the AE has resolved or stabilized, the subject should be exited from the 
study (per Section 5.1.3) and will be considered “Complete.”  
A subject MAY be discontinued (at the discretion of the Investigator, the Sponsor, and/or 
the IRB/EC) prior to the final study visit for a variety of reasons, including, but not limited 
to:  
• 
an AE occurring during the course of the study, which precludes continued treatment 
or follow-up 
• 
persistent Grade 3 or 4 slit lamp findings (must be reported to the Sponsor within  
24 hours) 
• 
persistent study related symptoms/complaints 
• 
unacceptable distance lens visual acuity (VA) 
• 
unacceptable lens centration 
• 
unacceptable lens movement 
• 
other reason related to failure to follow study procedures 
A subject MUST be discontinued prior to the final study visit for any of the following 
reasons: 
• 
voluntary withdrawal  
• 
death  
• 
Investigator decision that it is not in the best medical interest of the subject to continue 
participation in the investigation 

Study #893 - Protocol 
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• 
ineligible at Screening/Dispensing Visit- subject does not meet the eligibility criteria 
in the protocol 
• 
inability to maintain recommended wearing schedule 
• 
continued failure to follow subject instructions 
• 
lack of motivation 
• 
lost to follow-up (refer to Section 3.2.3) 
• 
instillation of non-medically indicated solution not specified in the protocol 
• 
if either eye is discontinued 
• 
becomes pregnant during the study 
Prior to discontinuing a subject, every effort should be made to contact the subject, 
schedule a final study visit, obtain as much follow-up data as possible, and to retrieve all 
study materials.  AEs will be followed as described in Section 6.0.  
Subject discontinuations will be documented clearly on the source document and 
applicable eCRF.  The Investigator should indicate the PRIMARY (one) reason that the 
subject was discontinued for each eye.  Subjects that are discontinued from the study 
following randomization will not be replaced. 
The Exit Visit assessments judged as appropriate by the Investigator, should be completed 
for discontinued subjects. 
3.2.3 
Lost to Follow-up 
Subjects who do not return for scheduled follow-up visits, as defined by the visit window, 
and cannot be contacted (following two attempts by site personnel via phone call or email), 
are to be considered lost to follow-up.  The attempts to contact the subject should be 
documented and kept with the subject’s source documentation. 
3.3 
Investigators 
The study will be conducted at approximately 35 investigative sites located in the US by 
Investigators who are determined by Bausch + Lomb to be suitably qualified by training 
and experience to conduct this study.  The Principal Investigator will sign the Device 
Investigator Agreement form prior to the start of the study.  This form contains a statement 
specifying that the investigator is not allowed to deviate from the study protocol, except 
under emergency circumstances where the deviation protects the rights, safety and well-
being of human subjects. 
  
 
 
 
  
3.4 
Study Duration 
 
 
  
Subjects will be followed for approximately 2 weeks (unless discontinued or lost to follow-
up) from the initial Screening/Dispensing Visit and must adhere to the following schedule: 
 

Study #893 - Protocol 
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Schedule of Visits   
Visit 
Target 
 
Screening/Dispensing Visit  Day 1 
 
2-Week Follow-up Visit 
Day 15 
  
Exit Visit 
N/A 
 
 
 
 
 
 
 
 
 
 
 
 
 
The visit range is based on the date the study lenses are initially dispensed 
(Screening/Dispensing Visit).  
3.5 
Protocol Changes and Amendments 
Changes to the protocol will be approved by the Sponsor.  An amendment to the protocol 
will also require submission and approval from the IRB before implementation.  The 
Sponsor (or designee) will distribute protocol amendments to the investigative sites.  The 
Investigator is responsible for ensuring that staff involved at his/her site complete training 
on the changes before implementing with subjects.  
4.0 
STUDY MATERIALS 
Bausch + Lomb will provide all study materials (with the exception of any kits for ocular 
cultures) at no charge to the Investigator.  
 
  Sites 
will be provided with dispensing sets for the kalifilcon A (Test) and each competitor lenses 
(Control).  All other materials will be provided to the site prior to the start of the study.  
 
  
 
  All used and unused lenses will be returned to the 
Sponsor at end of the study.   
Subjects must use only study supplied lenses/solutions.  Use of other contact lenses or care 
products is not allowed and will be considered a Protocol Deviation. 
4.1 
Description of Test Article(s) (Study Lenses) 
The Test lens to be used in this study is the Bausch + Lomb kalifilcon A daily disposable 
contact lens, manufactured by Bausch + Lomb Incorporated, Rochester, NY.  The 
description of the Test lens is as follows: 
• 
Sphere Power: -0.50 to -6.00 D in steps of 0.25 D 
• 
Diameter: 14.2 mm 
• 
Base Curve: 8.6 mm 
• 
Material: kalifilcon A 

Study #893 - Protocol 
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• 
Packaging Solution:  Phosphate buffered solution 
 
4.2 
Description of Comparator Product(s) 
One of the Control lenses to be used in this study is the currently marketed Johnson & 
Johnson Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact 
lenses.  The description of this Control lens is as follows: 
• 
Sphere Power: -0.50 to -6.00 D in steps of 0.25 D 
• 
Diameter: 14.3 mm 
• 
Base Curve: 8.5 mm 
• 
Material: senofilcon A 
• 
Packaging Solution: Buffered saline solution with methyl ether cellulose. 
The other Control lens to be used in this study is the currently marketed Alcon DAILIES 
TOTAL1® (delefilcon A) daily disposable contact lens.  The description of this Control 
lens is as follows: 
• 
Sphere Power: -0.50 to -6.00 D in steps of 0.25 D 
• 
Diameter: 14.1 mm 
• 
Base Curve: 8.5 mm 
• 
Material: delefilcon A 
• 
Packaging Solution: Phosphate buffered saline solution with approximately 0.3% of 
polymeric wetting agents consisting of copolymers of polyamidoamine and 
poly(acrylamide-acrylic) acid. 
4.3 
Instructions for Use and Administration  
Test or Control lenses will be worn on a daily disposable wear basis.  New study lenses 
will be dispensed at the Screening/Dispensing Visit in sufficient quantities to maintain a 
daily disposable wear modality for the duration of the study.  Subjects must wear their 
study lenses to the 2-Week Follow-up Visit.  After contact lens assessments are complete 
at the 2-Week Follow-up Visit, the unmasked designee from the study site will collect and 
store worn lenses for subsequent return to the Sponsor. 
4.3.1 
Storage Requirements 
All Test and Control lenses provided by the Sponsor must be stored in a secure location 
accessible only to unmasked study personnel and maintained at room temperature above 
34°C (1°F). 
4.3.2 
Subject Instructions 
a) All subjects must be given Subject Instructions for the use of study lenses (refer to 
Appendix C for Subject Instructions).  Subjects must comply with the instructions 
provided to them.  Subject Instructions will be supplied to the Investigator by Bausch 
+ Lomb (or Clinical Research Organization [CRO]) for distribution to the subject. 
b) The Investigator or other designee must review, with the subject, the Subject 
Instructions and the precautions and warnings, as appropriate for the study. 
c) 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. 

Study #893 - Protocol 
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4.3.3 
Fitting Guide 
The Investigator should refer to the Fitting Guide (see Appendix D) for fitting the Test and 
Control lenses. 
4.4 
Other Study Materials  
All subjects will be dispensed Bausch + Lomb Sensitive Eyes® Drops for use as needed 
and lens cases for return of worn study lenses to the Investigator during the study.  Subjects 
are not to use their own contact lens drops/solutions, but rather the drops/solutions provided 
to them.  OTHER CONTACT LENS CARE PRODUCTS ARE NOT ALLOWED TO BE 
USED. 
Investigators will return worn and unworn study lenses to the Sponsor at the end of the 
study. 
4.5 
Packaging and Labeling 
The Test lenses will be packaged in a blister pack with an investigational label.  The label 
will contain the following information at minimum: 
• 
lens power 
• 
base curve 
• 
lot number 
• 
expiration date 
• 
manufacturer’s name 
• 
manufacturer’s place of business 
• 
caution statement 
Control lenses will be packaged in standard commercial blister pack packaging. 
4.6 
Accountability 
The unmasked designee at each site will be responsible for keeping current and accurate 
records of the amount of study lenses received and dispensed, and their 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.  A Product Accountability Log will be provided to the sites for the 
unmasked designee to maintain records of the study lenses assigned to each enrolled 
subject. 
At the completion of the study, the Sponsor/Sponsor's representative will review and verify 
the Investigator's accountability records.  Following verification, and as directed by the 
Sponsor, all study lenses (Test and Control, both worn and unworn) must be returned to 
the Sponsor 
 
                                                                                                              
 
 
 
 

Study #893 - Protocol 
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4.7 
Masking/Unmasking  
The Investigator/site staff and Bausch + Lomb personnel or designee(s) involved in the 
conduct of the study will be masked to the study lenses.  Each site must have an unmasked 
designee that will be responsible for dispensing and collecting the study Test and Control 
lenses and for performing accountability.  This designee shall not participate in clinical 
assessments after the subject has been randomized.  
The randomization schedule will be created by an unmasked statistician 
 
  Personnel involved with repackaging and supply 
of clinical trial material will also be unmasked.  Field Clinical Research Associates (CRAs) 
will become unmasked during product reconciliation, at the conclusion of each site’s 
participation in the study, and prior to locking the database.  Unmasked designees at the 
site will manage the dispensation and return of study lenses and related supplies.  All other 
study personnel will remain masked until database lock.  
In the event that unmasking of a subject’s randomly assigned treatment is required, the 
Investigator (or other designee) is required to contact the Medical Monitor (or designee) to 
request permission to unmask.  The Medical Monitor (or designee) will contact the Sponsor 
study manager and obtain approval to grant permission to unmask.  Upon receipt of 
authorization from the Sponsor study manager, the Medical Monitor (or designee) will 
advise the Investigator (or other qualified designee) to obtain the treatment assignment 
from the unmasked designee.  If the Medical Monitor cannot be contacted, the Investigator 
(or other qualified designee) should then contact the Sponsor designee who can authorize 
the unmasking of a subject.  In the event that the Medical Monitor or Sponsor designee 
cannot be contacted and the Investigator (or other qualified designee) deems the unmasking 
necessary the Investigator may confer with the unmasked designee, without authorization 
and unmask the subject.  Whether unmasking occurs inadvertently or intentionally, the 
Investigator must notify the Medical Monitor or Sponsor designee as soon as possible after 
unmasking.  In addition, the Investigator must record the date, time, and reason for 
unmasking the study treatment in the source documentation. 
Subjects will be instructed to insert the study lenses out of the sight of the Investigator or 
site staff other than the unmasked designee.  Subjects are not to show the study blister 
packs and foils to the Investigator or site staff other than the unmasked designee, unless 
instructed to do so. 
4.8 
Product Replacement 
Subjects will be given an adequate supply of study lenses to wear on a daily disposable 
basis for the duration of the study.  
Should the site’s inventory be low or depleted, additional inventory of lenses (either Test 
or Control) can and must be ordered 
 
 
 
 
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 

Study #893 - Protocol 
Page 22 of 79 
 
 
 
be found within the Report of Prior Investigations (ROPI) for the study.  Risks are also 
summarized within the Informed Consent 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. 
5.0 
STUDY METHODS 
5.1 
Study Visits  
Refer to Appendix A for a schedule of visits and parameters and Appendix B for 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. 
5.1.1 
Screening/Dispensing Visit (Day 1) 
A Screening Log will be provided by the Sponsor to track all consented subjects that the 
Investigator interviews regarding the study.  Once all available lines on the Screening Log 
have been completed, or the Investigator has fulfilled his/her quota of subjects, the 
Investigator will sign and date the form to verify that all the subjects who interviewed for 
the study have provided informed consent and Health Insurance Portability Accountability 
Act (HIPAA) authorization. 
After obtaining written informed consent, prospective subjects will be screened to 
determine whether they meet the entry criteria for the study.  
Screening/Dispensing will proceed as follows: 
a. Enter the subject information on the next available line of the Screening Log. 
b. Collect the subject’s demographics. 
c. Collect the following lens use history information from the subject: 
− 
 
 
 
 
 
 
 
 
 
 
 
 
  
d. Collect ocular medical history (within 1 year of signing the ICF) and concomitant 
medications.  Concomitant medications (as defined for this study) include any 

Study #893 - Protocol 
Page 23 of 79 
 
 
 
medications for ocular conditions taken within 30 days of signing the ICF and any 
concomitant medications taken during the study.  
e. Perform high-contrast distance VA with the subject’s habitual lenses. 
f. 
 
   . 
g. Perform the following assessments (without lenses): 
− spherocylindrical refraction using a phoropter 
− distance high-contrast best spectacle-corrected visual acuity (BSCVA) using a 
phoropter 
− keratometry 
h. Perform a slit lamp examination (without lenses) and record: 
− Any ungraded finding marked as “Present” 
− Any corneal scars 
− Any neovascularization within the central 6 mm of the cornea 
− Any corneal staining 
− Any corneal infiltrate (record details on the Corneal Infiltrates Evaluation Form in 
Section 8.0 of Appendix B) 
− Record and sketch any scars and slit lamp findings greater than Grade 2 in the 
subject’s source document 
− After fluorescein is used, flush the eyes with sterile saline solution.  Wait at least 
5 minutes before inserting new lenses. 
i. Indicate on the Screening Log whether the subject is a “Screen Pass” or “Screen Fail”.  
Only “Screen Pass” subjects should be randomized in the study.  If the subject is a “Screen 
Pass”, perform the following: 
j. Randomize the subject using the Randomization Schedule provided to the unmasked 
designee at each site.  Dispensation will be stratified by investigative site. 
The unmasked designee will then dispense lenses (in the subject’s randomized study 
lens assignment and appropriate sphere power) to maintain a daily disposable modality 
until the 2-Week Follow-up Visit and record the dispensation in the Product 
Accountability Log.  
In an effort to ensure the Investigator remains masked, the unmasked designee MUST 
dispense the lens blister packs. 
k. Have the subject insert one pair of the study lenses in their eyes.  In an effort to ensure 
the Investigator remains masked, the subject MUST insert the lenses out of the sight of 
the Investigator and other masked site personnel. 
l. Review Subject Instructions with the subject and provide the subject with a copy of the 
instructions.  Dispense two lens cases.  Instruct the subject to place all worn lenses in 
a lens case 
  Remind the subject 
to bring all lenses 
 to the 2-
Week Follow-up Visit. 

Study #893 - Protocol 
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NOTE: Study lenses should be allowed to equilibrate a minimum of three minutes on the eye.  
m. Record the dispensed lens sphere power and after a minimum of three minutes of the 
subject wearing the lenses, perform the following assessments: 
− distance high-contrast lens VA 
− over-refraction and distance high-contrast VA (using a phoropter) 
− lens wettability  
− lens centration  
− lens movement  
For each eye, compare the distance high-contrast lens VA to the distance high-contrast 
BSCVA obtained at this visit.  If the VA has decreased by 5 letters (0.1 logMAR) or 
more, explain. 
n. Collect abbreviated Lens Performance Rating Scales regarding the study lenses 
 
: 
• 
  
 
  
 
 
o. The site will enter subject ID and contact information 
 
 immediately after the Screening/Dispensing Visit.  
This information will not be available to anyone via data export.  The subject will 
be able to login via phone app or computer to complete the survey.  This should be 
done only for randomized subjects. 
p. Internet Survey Instructions will be given to the subject.  Remind the subject to 
complete the online survey after at least 7 days (but prior to 2-week Follow-Up Visit) 
of wearing study lenses.  
 
 
Note: If the subject is discontinued or exited at this visit (after randomization), complete 
the “Exit Visit” and collect any AEs (per Section 5.1.3). 
5.1.2 
2-Week Follow-up Visit (Day 11-17) 
NOTE:  The online survey should be completed by the subject after a minimum of 7 days of wear 
but before the subject comes into the office for the 2-Week Follow-up Visit. 
NOTE:  If the subject does not come to a visit wearing lenses and is not experiencing any 
problems, it is preferred if the current visit is rescheduled within the visit window. 
a. Obtain information on any changes in ocular medical history and/or the use of 
concomitant medications. 
b. Collect the following lens information from the subject: 
− 
  
 
  
 
  
 
 
 
 

Study #893 - Protocol 
Page 25 of 79 
 
 
 
c. Perform the Lens Performance Rating Scales 
 from 
the subject regarding their study lenses  
d. Collect Symptom/Complaints information 
. 
e. Evaluate the study lenses (while on eye) and record the following assessments: 
− distance high-contrast lens VA 
− over-refraction and distance high-contrast VA (using a phoropter) 
− lens wettability 
− lens deposits 
− lens centration 
− lens movement 
For each eye, compare  
- 
The distance high-contrast lens VA to the distance high-contrast lens VA obtained 
at the Screening/Dispensing Visit.  
- 
The distance high-contrast lens VA to the distance high-contrast BSCVA obtained 
at the Screening/Dispensing Visit.  
- 
If the VA has decreased by ≥ 10 letters (0.2 logMAR) or more, explain. 
e. Perform a slit lamp examination (without lenses) and record the following: 
− Any ungraded finding marked as “Present” 
− Any new corneal scars 
− Any neovascularization within the central 6 mm of the cornea 
− Any increase in grading of corneal staining 
− Any corneal infiltrate 
 
  
− Record and sketch any scars and slit lamp findings greater than Grade 2 in the 
subject’s source document. 
− After fluorescein is used, flush the eyes with sterile saline solution.  Ensure that at 
least 5 minutes pass if the subject inserts a new pair of lenses at this visit. 
f. Investigator fill out the Investigator Questionnaire  
g. The unmasked designee will collect all worn and unworn lenses from the Subject for 
return to the Sponsor.  Record the collection in the subject’s Product Accountability 
Log. 
h. Collect/assess all AEs/ADEs, including serious or significant non-serious AEs. 
i. The following eCRF should be completed: 
− 2-Week Follow-up Visit 
5.1.3 
Exit Visit  
(To occur on the same day immediately following the 2-Week Follow-Up Visit or 
Unscheduled Visit for any subject(s) being discontinued from the study or subjects 
being followed beyond 2 weeks for ongoing AE) 

Study #893 - Protocol 
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Do not continue with the Exit Visit until/unless the subject is ready to exit the 
study.  Subjects who require further follow-up due to an AE at the conclusion of 
the 2-Week Follow-Up Visit will be followed according to the AE and/or 
Unscheduled Visit Section until the AE is resolved or stabilized. 
a. Obtain information on any changes in ocular medical history and/or the use of 
concomitant medications. 
b. Indicate status of the subject on the Subject Exit Form.  If the status is “Discontinued” 
or “Non-dispensed,” indicate the PRIMARY exit reason for each eye on the Subject 
Exit Form. 
c. For all subjects, complete an exit ocular examination without lenses on the eyes.  
Collect the following assessments: 
− spherocylindrical refraction using a phoropter 
− distance high-contrast BSCVA using a phoropter 
− keratometry 
d. For each eye, compare the Exit Visit distance high-contrast BSCVA to the distance 
high-contrast BSCVA obtained at the Screening/Dispensing Visit.  
 
 
e. For each eye, compare the Exit Visit (horizontal and vertical) keratometry readings to 
the Screening/Dispensing Visit (horizontal and vertical) keratometry readings.  If
 
 
f. The unmasked designee will collect all worn and unworn lenses from the Subject for 
return to the Sponsor.  Record the collection in the subject’s Product Accountability 
Log. 
g. The following eCRF should be completed: 
− Subject Exit 
5.1.4 
Market Research Surveys 
5.1.4.1 
Online Consumer Survey 
Each subject will be required to complete a Subjective Assessment through an internet 
survey.  Each enrolled subject will be provided with an internet address to access after at 
least 7 days of lens wear (but prior to the 2-week follow-up visit).  Each subject will be 
provided with a confidential unique ID and password (login) in order to access the online 
survey.  If the user forgets their password, there will be a “forgot password” option within 
the system.  The system will send reminders to the subject via email or mobile alerts.  The 
study coordinator will call the subject prior to the visit date to remind the subject to 
complete the survey. 
There will be a specified timeframe in which the survey must be completed.  The 
Investigator will provide the market research firm with the subject’s email address.  If the 
subject has not completed the survey during the specified duration, the market research 
firm will contact that subject by email with a reminder to complete the survey.  If the 
subject has not completed the survey by the time of the 2-week Follow-up visit the subject 
may complete it at that time.  

Study #893 - Protocol 
Page 27 of 79 
 
 
 
5.1.4.2 
Investigator Questionnaire 
The Investigator (or designee) will complete a survey to answer questions about each 
subject’s study lens wear at the subject’s exit visit.  This information will be collected 
within the eCRF system. 
5.1.5 
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 in the source documents and 
on Unscheduled Visit eCRFs, as appropriate.  Visits intended to fulfill scheduled visit 
requirements that fall outside the designated scheduled visit range are not Unscheduled 
Visits.  In these cases, the visit data will be collected and transcribed to the appropriate 
scheduled visit eCRF. 
 
 
 
 
 
  
Subjects who require further follow-up on an AE/SAE upon discontinuation or at the 
conclusion of the 2-Week Follow-Up Visit will be followed according to the AE and/or 
Unscheduled Visit Section as necessary.  At these follow-up visits, the subject should 
remove contact lenses s/he may be wearing.  Assessments will be performed according to 
the investigator’s judgement.   The Investigator is required to follow the subject until the 
condition no longer warrants further follow-up for study purposes. 
Product Dispensing Only (Part of the Unscheduled Visit - used only if lens replacement is 
needed) 
If a subject is only seen for an unscheduled lens replacement, a complete exam is not 
required as long as the subject is not experiencing any problems.  In these cases, the 
following information will be collected in the source documents and transcribed to the 
Product Dispensing Only eCRF: 
• 
Visit date 
• 
Subject Identification (ID) number 
• 
Subject initials 
• 
Primary reason for replacement 
NOTE: For study lens replacement, an unmasked designee MUST dispense the study lens 
blister packs to the subject to ensure the Investigator remains masked.  The unmasked 
designee will also record the lenses dispensed on the Product Accountability Log.  If the 
subject inserts lenses at the visit, the subject MUST insert the lenses out of the sight of the 
Investigator and other masked site staff. 
If a subject is experiencing problems, complete the following, as appropriate, and complete 
an Unscheduled Visit eCRF instead of a Product Dispensing Only eCRF: 
a. Indicate the reason for the Unscheduled Visit. 

Study #893 - Protocol 
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b. Obtain information on any changes in ocular medical history and/or the use of 
concomitant medications. 
c. Collect the following lens information from the subject regarding the study lenses: 
− 
  
 
  
 
  
 
 
 
 
d. If the subject did not come to the visit wearing one or more study lenses, go to step g. 
Otherwise, evaluate the lenses (while on eye), and record the following assessments: 
− distance high-contrast lens VA 
− over-refraction and distance high-contrast VA (using a phoropter) 
− lens wettability 
− lens deposits 
− lens centration 
− lens movement  
For each eye, compare the distance high-contrast lens VA to the distance high-contrast 
lens VA obtained at the Screening/Dispensing Visit.  
 
 
For each eye, compare the distance high-contrast lens VA to the distance high-contrast 
BSCVA obtained at the Screening/Dispensing Visit.  
  
 
e. Perform the Lens Performance Rating Scales 
 from 
the subject regarding their study lenses  
f. Collect Symptoms/Complaints information 
 
g. Perform a slit lamp examination (without lenses) and record the results and findings.  
Record and sketch any scars and slit lamp findings greater than Grade 2 in the subject’s 
source document. 
g. If an unscheduled lens replenishment is required, the unmasked designee will dispense 
additional lenses ensuring that the subject has sufficient lenses to maintain a daily 
disposable wear modality until the Follow-Up Visit according to the Randomization 
assignment for each subject and record in the Product Accountability Log.  
h. Record the following in the source documentation and transcribe to the appropriate 
eCRF form for the Unscheduled Visit: 
− dispensed lens sphere power 
i. If a lens parameter change is required, the subject MUST insert one pair of the 
dispensed lenses in their eyes.  After the lenses have equilibrated for at least 3 minutes, 
confirm the lenses are acceptable for study continuation.  If the lenses are unacceptable 
for study continuation, complete the “Exit Visit” (per Section 5.1.3) and discontinue 
the subject from the study. 
j. The unmasked designee will collect the worn lenses from the Subject (if brought by the 
subject to the Unscheduled Visit) and record the collection in the Product 

Study #893 - Protocol 
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Accountability Log.  If additional lenses are dispensed, record the dispensation in the 
Product Accountability Log.  Dispense additional lens cases, if needed.  Instruct the 
subject to place all worn lenses in a lens case (10 pairs of lenses per case) with no 
solution (dry).  The subject should return the lens cases to the site at the 2-Week 
Follow-Up Visit. 
k. Collect/assess all AEs/ADEs, including serious or significant non-serious AEs. 
l. The following eCRFs should be completed:  
− Unscheduled visit  
Note: If the subject is discontinued or exited at this visit, complete the “Exit Visit” (per 
5.1.3). 
5.1.6 
Missed Visits  
If a subject misses the scheduled follow-up visit, the visit is considered missed.  Indicate a 
missed visit on the eCRF for that scheduled visit.  Schedule the subject for an Exit Visit as 
soon as possible.  If subject can’t be reached or can’t be rescheduled, the subject should be 
recorded as Lost to Follow up. 
5.2 
Study Completion  
Bausch + Lomb will notify the Investigator when to contact the IRB to inform them that 
the study is complete. 
5.2.1 
Study Termination/Suspension 
If, during the study, it becomes evident to the Sponsor that the study should be stopped 
prematurely or placed on hold, appropriate notification will be given to the Investigator(s) 
and IRBs, and the United States Food and Drug Administration (FDA) or Local Health 
Authority, as applicable.  Bausch + Lomb will instruct the Investigators to stop/restart 
dispensing study materials and will arrange for study closeout, if applicable, at each site. 
5.3 
Concomitant Medications/Therapy 
Other contact lenses/solutions are not allowed to be used by subjects during the study.  
Ocular medications or systemic or topical medications that, in the Investigator’s opinion, 
could potentially affect ocular physiology or lens performance are prohibited during the 
course of the study.  Use of prohibited medications will be documented in the Exit CRF 
form. 
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.  
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. 

Study #893 - Protocol 
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According to the Device Investigator Agreement, 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.    
Site Corrective Action plans will be developed and completed as deemed necessary by the 
CRO for sites or 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 
Site 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 site closure will be made by the Sponsor and documented in the Trial 
Master File.    
6.0 
ADVERSE EVENTS 
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 the AE is device related or non-device related.  If the AE is 
assessed as device related, then the AE will be classified as an adverse device effect (ADE).  
ADEs will then be further classified as an anticipated serious adverse device effect 
(ASADE) or an unanticipated adverse device effect (UADE).  AEs, ADEs, ASADEs, 
UADEs, 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 a subject, user, or other persons, whether or 
not related to the investigational medical device.  This definition includes events not related 
to the investigational medical device, comparator, or the procedures involved.  For users 
or other persons, this definition is restricted to events related to investigational medical 
devices. 
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. 
Applicable AEs (from slit lamp examination) should be photo documented and 
communicated to the Medical Monitor. 
6.1.2 
Adverse Device Effect (ADE) 
An ADE is an AE that is assessed to be related to the use of an investigational medical 
device.  This definition includes AEs 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. 

Study #893 - Protocol 
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6.1.2.1 
Anticipated Serious Adverse Device Effect (ASADE) 
An ASADE is an ADE that first meets the Serious Adverse Event criteria 
 
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 
6.1.2.2 
Unanticipated Adverse Device Effect (UADE) 
A UADE is an ADE that first meets the Serious Adverse Event criteria (see Section 6.1.3) 
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. 
6.1.3 
Serious Adverse Event (SAE) 
An AE that: 
o Led to death; 
o Led to serious deterioration in the health of the subject, that resulted in: 
‒ A life-threatening illness or injury; or 
‒ A permanent impairment of a body structure or a body function (e.g., 
blindness); or 
‒ Inpatient or prolonged hospitalization; or 
‒ Medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function; 
o Led to fetal distress, fetal death, or a congenital abnormality or birth defect. 
Note: A planned hospitalization for a pre-existing condition, or a procedure 
required by the protocol, without serious deterioration in health, is not considered 
an SAE. 
Serious adverse events are also those events that result in, or have 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 may include any hazardous, sight-threatening conditions occurring 
after exposure to the test article, including the following: 
• A presumed infectious ulcer (defined as a progressive erosion of the corneal 
tissue).  For the purposes of reporting, this includes: 

Study #893 - Protocol 
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o Central or para-central 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 corneal 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), and 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, and 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/or hyphema; 
• Any neovascularization within the central 6 mm of the cornea;  
• Permanent loss of ≥ 2 lines/10 letters of BSCVA; 
• All cases of iritis. 
6.1.4 
Significant Non-Serious Adverse Events 
A significant non-serious adverse event is an AE that does not meet the serious criteria, is 
considered significant by the Sponsor, and requires expedited reporting.  These events 
include: 
 
• Peripheral non-progressive non-infectious corneal ulcers;  
• All symptomatic corneal infiltrative events;  
• All cases of corneal staining greater than or equal to Grade 3; 
• A temporary loss of two or more lines/10 or more letters of BSCVA (for greater 
than or equal to 2 weeks); 
• Neovascularization cases Grade 2 or greater; 
• Any ocular event that necessitates temporary lens discontinuation of greater than 
or equal to 2 weeks. 
6.1.5 
Non-Significant Non-Serious Adverse Events 
A non-significant non-serious adverse event may include but are not limited to the 
following and does not require expedited reporting: 
• Bacterial Conjunctivitis; 
• Viral Conjunctivitis; 

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• Allergic Conjunctivitis; 
• Corneal Edema; 
• Contact Lens Related Papillary Conjunctivitis; and, 
• Loss of Contrast Sensitivity 
6.2 
Adverse Event Treatment and Culturing 
With any AE, treat the subject as appropriate to prevent further complications and to 
potentially resolve the event consistent with the standard of care. 
For purposes of this study, the Sponsor requests that cultures 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).  
 
 
 
 
 
 
 
 
 
  
 
 
 
6.3 
Evaluations 
When evaluating for reportable AEs, the Investigator must first determine if the event is 
serious (refer to Section 6.1.3 for criteria) and/or significant (refer to Sections 6.1.4 and 
6.1.5) and then assess the severity of symptoms and the relationship of the event to the 
study device using the following guidelines: 
6.3.1 
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 
6.3.2 
Relationship to Study Device  
• Related: There is at least a reasonable possibility that the AE is related to 
the study device (contact lens).  Reasonable possibility means that there is 
evidence to suggest a causal relationship or association between the study 
device and the AE.  Also referred to as an ADE. 

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• Not Related: There is little or no reasonable possibility that the AE is 
related to the study device (contact lens).  This assessment implies that the 
AE has no evidence to suggest either a causal relationship or association to 
the study device and a more likely or certain alternative etiology exists. 
6.4 
Procedures for Reporting SAEs and Significant Non-Serious Adverse Events 
An AE classified as an SAE or a Significant Non-Serious AE requires expeditious handling 
and reporting to the Sponsor to comply with regulatory requirements, as follows: 
• The event must be reported to the Medical Monitor (or designee) within 24 
hours of the Investigator’s awareness of the event via facsimile/email 
transmission on a paper SAE or Significant Non-Serious AE Report Form 
signed by the Investigator. 
 
 
 
 
 
• 
 
 
 
  
• Investigators should not wait to receive additional information to fully 
document the event before initially notifying the Medical Monitor (or 
designee) of an SAE or a Significant Non-Serious AE.  Additional relevant 
information such as hospital records and autopsy reports should be provided 
to the Medical Monitor (or designee) as soon as they are available. 
• The Investigator should take all appropriate measures to ensure the safety of 
the subjects: notably, he/she should follow a subject with an SAE or 
Significant Non-Serious AE until the event has resolved or the condition has 
stabilized.  This may imply that follow-up will continue after the subject has 
left the study, and that additional evaluations may be requested by the 
Sponsor. 
• Ensure that the subject's identity is protected and the subject's identifiers in the 
clinical trial are properly mentioned on the form. 
• BEGIN TREATMENT OF THE AE IMMEDIATELY BY A SUITABLY 
LICENSED EYE CARE PROFESSIONAL. 
• Continue to update the paper SAE or Significant Non-Serious AE Report 
Form, if applicable, each time the subject is seen during the management of 
the event and at resolution of the event.  All updated report forms should be 
submitted to the Medical Monitor (or designee) who will distribute the reports 
as stated above.  Whenever possible, it is suggested that the Investigator take 
photographs of all applicable AEs and forward them to the Medical Monitor 
(or designee). 

Study #893 - Protocol 
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• Events requiring medical treatment will be evaluated by the Sponsor.  Upon 
review of the medical treatment, Bausch + Lomb representatives may contact 
the Investigator to request further information concerning the treatment. 
• 
 
 
 
• 
 
 
 
• 
 
 
6.4.1 
Off-site Unanticipated Adverse Device Effect Reporting 
When participating in multicenter clinical investigations, Investigators may receive off-site 
UADE reports.  These are Sponsor reports of UADEs which occurred at other clinical sites 
for the same trial, or in different trials using the same test or control lenses, that met the 
criteria for reporting to a regulatory agency.  
 
 
 
6.4.2 
Reporting Device Deficiencies 
A device deficiency is defined as an inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, safety, or performance.  Device deficiencies include 
malfunctions, use errors, and inadequate labeling. 
Investigators must evaluate, record, and report via applicable forms any complaints/ 
deficiencies or malfunctions experienced during this trial to the Medical Monitor (or 
designee) promptly.  The Sponsor and Medical Monitor shall review all device deficiencies 
and, upon the Sponsor’s request, Investigators must supply any additional information 
related to the safety reporting of a particular event. 
 
 
 
 
 
 
 
 
 
 
 
 

Study #893 - Protocol 
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6.4.3 
Guidelines for Reporting Pregnancies  
All female subjects of childbearing potential must use an effective method of birth control 
during the study, to include 2 weeks after last visit, in a manner such that risk of 
contraceptive failure is minimized.  Abstinence is allowed as a birth control method.   
During the study, all female subjects of childbearing potential should be instructed to 
contact the Investigator immediately if they suspect they might be pregnant (e.g., missed 
or late menstrual period).  Female subjects who become pregnant during the study will be 
discontinued from the study and followed until completion of pregnancy.  Every effort will 
be made to obtain the health status of the mother and infant at term or fetus (in cases of 
miscarriage or therapeutic abortion).  Pregnancy itself is not considered an AE. 
 
 
  
 
 
 
All pregnancies will be followed until outcome even after study closure.  
 
 
 
 
  
Although pregnancy occurring in a clinical study is not considered to be an AE or SAE, 
any pregnancy complication, spontaneous abortion, or elective termination of a pregnancy 
for medical reasons, will be recorded as an SAE.  
 
 
 
 
 
 
 
 
 
7.0 
STATISTICAL METHODS 
7.1 
Study Endpoints 
7.1.1 
Primary Effectiveness Endpoints 
• Mean logMAR contact lens visual acuity at the 2-Week Visit 
• Proportion of subjects in the Test lens group agreeing with the statement “Are 
comfortable throughout the day”  
• Proportion of subjects in the Test lens group agreeing with the statement “Provide 
clear vision throughout the day”  
 
 
 

Study #893 - Protocol 
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7.1.4 
Primary Safety Endpoint 
The primary safety endpoint will be the proportion of subjects with slit lamp findings 
greater than Grade 2 at any visit. 
 
 
 
 
 
 
 
 
 
 
 
 
7.2 
Hypotheses 
7.2.1 
Contact Lens Visual Acuity (VA) 
The null hypothesis (𝐻0) is that the difference in mean logMAR VA between the test lens 
and the comparator lens (𝜇𝑇−𝜇𝐶) is equal to or greater than 0.06. The alternative 
hypothesis (𝐻1) is that the difference is less than 0.06. 
𝐻0: 𝜇𝑇−𝜇𝐶≥0.06 
𝐻1: 𝜇𝑇−𝜇𝐶< 0.06 
7.2.2 
Proportions of Subjects Agreeing 
For each of these endpoints, the null hypothesis (𝐻0) is that the proportion of subjects in 
each lens group agreeing with the statement (𝜋) is less than or equal to 0.5 (50%).  The 
alternative hypothesis (𝐻1) is that the proportion is greater than 0.5. 
𝐻0: 𝜋≤0.5 
𝐻1: 𝜋> 0.5 
7.2.3 
Slit Lamp Findings 
The null hypothesis (𝐻0) is that the difference in the proportion of eyes with any slit lamp 
finding greater than Grade 2 between the test group and the comparator group (𝜋𝑇−𝜋𝐶) 
is 0.05 or more.  The alternative hypothesis (𝐻1) is that the difference is less than 0.05. 
𝐻0: 𝜋𝑇−𝜋𝐶≥0.05 

Study #893 - Protocol 
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𝐻0: 𝜋𝑇−𝜋𝐶< 0.05 
7.3 
Sample Size 
For the purpose of estimating power, it is assumed that 5% of the subjects will exit the 
study prior to the primary analysis visit.  
As is customary for contact lens studies, the two eyes of each subject will be treated as 
independent sampling units.  Consequently, the power calculations for lens visual acuity 
and slit lamp findings are completed using the number of eyes rather than the number of 
subjects. 
7.3.1 
Contact Lens Visual Acuity 
When the sample sizes in the groups are 760 and 380 eyes, a two group one-sided 0.05 
significance level t-test will have greater than 99% power to reject the null hypothesis that 
the test is inferior to the standard in favor of the alternative hypothesis that the treatment is 
non-inferior, assuming that the expected difference in means is 0, a non-inferiority margin 
of 0.06 and the common standard deviation is 0.07. 
7.3.2 
Proportions of Subjects Agreeing 
7.3.2.1 
Test Lens Group 
A one group χ² test with a 5% one-sided significance level will have greater than 99% 
power to detect the difference between the Null hypothesis proportion, π₀, of 0.5 and the 
Alternative proportion, π₁, of 0.86 when the sample size is 380 subjects. 
7.3.2.2 
Comparator Lens Groups 
A one group χ² test with a 5% one-sided significance level will have greater than 99% 
power to detect the difference between the Null hypothesis proportion, π₀, of 0.5 and the 
Alternative proportion, π₁, of 0.86 when the sample size is 190 subjects. 
7.3.3 
Slit Lamp Findings 
With 380 eyes in the control group and 760 eyes in the test group, the upper limit of the 
observed one-sided 95% confidence interval will be expected to be less than 0.05 with 
greater than 99% power when the Standard proportion, π₀, is 0.01 and the Test expected 
proportion, π₁, is 0.01; results are based on 100 simulations using the Newcombe-Wilson 
score method to construct the confidence interval. (Newcombe RG (1988) Interval 
estimation for the difference between independent proportions: comparison of eleven 
methods.  Statistics in Medicine 17:873-890.) 
7.3.4 
Overall Power and Enrollment Targets 
7.3.4.1 
Overall Power 
Assuming that the test is identical in performance to each comparator for all primary 
endpoints, that the primary endpoints are independent, and that the assumptions used in 
each power calculation are correct, the overall power of the trial is greater than 90%. 

Study #893 - Protocol 
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7.3.4.2 
Enrollment Target 
To allow for up to 5% losses prior to the primary analysis time point, the enrollment targets 
will be  
• 400 subjects (800 eyes) in the test (Bausch + Lomb kalifilcon A) group 
• 200 subjects (400 eyes) in each of the comparator groups  
The total enrollment target will be approximately 800 subjects (1600 eyes). 
7.4 
Randomization 
Subjects will be randomly assigned to the three treatment groups in a 2:1:1 ratio (Bausch 
+ Lomb kalifilcon A: Johnson & Johnson Acuvue Oasys® 1-Day with HydraLuxe™: Alcon 
DAILIES TOTAL1®(delefilcon A).  Randomization will be stratified by site. 
7.5 
Study Populations 
7.5.1 
Intent-to-Treat (ITT) Population 
The ITT Population will include all randomized subjects.  Summaries of the ITT Set will 
include subjects in their randomized treatment group. 
7.5.2 
Per Protocol (PP) Population 
The PP Population will include all ITT Population subjects without major protocol 
deviations. 
7.5.3 
Safety Population 
The Safety Population will include all subjects who were dispensed study lenses.  
Summaries of the Safety Set will include subjects in the treatment group corresponding to 
the treatment they actually received. 
7.6 
Statistical Analysis 
7.6.1 
Methods of Analysis 
7.6.1.1 
General Methods 
Continuous data will be summarized using descriptive statistics: sample size (n), mean, 
standard deviation (SD), median, minimum and maximum.  Categorical data will be 
presented using the total counts for each category and corresponding percentages.  The 
denominator for each percentage will be the number of subjects or eyes with non-missing 
data at the given visit for each respective study treatment, unless otherwise indicated. 
 
 
7.6.1.2 
Primary Endpoint Analysis 
Each primary effectiveness endpoint hypothesis will be evaluated using the ITT Population 
and will be evaluated again using the PP Population as a sensitivity analysis.  

Study #893 - Protocol 
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7.6.1.2.1 
Contact Lens Visual Acuity 
Visual acuity will be reported as letters read correctly.  The letters read will be converted 
to logMAR acuity, which will be summarized using continuous summary statistics by 
treatment group.  The test lens will be compared to each of the two comparators.  The 
primary analyses will be conducted using eye level data.  A two-sample t-test will be used 
to estimate the difference between treatment groups and a one-sided upper 95% confidence 
limit for the difference.  If the confidence limit is less than or equal to 0.06 for the 
comparison to each comparator, then the test lens will be statistically successful in this 
endpoint. 
7.6.1.2.2 
Proportions of Subjects Agreeing 
Subjects will respond to each statement with one of the following responses. 
• Strongly agree 
• Agree 
• Slightly agree 
• Slightly disagree 
• Disagree 
• Strongly disagree 
For each endpoint, responses will be classified as either “Top 3 Boxes” (strongly agree, 
agree, slightly agree) or “Bottom 3 Boxes” (slightly disagree, disagree, strongly disagree).  
The proportion of subjects in each lens group in the Top 3 Boxes category will be 
summarized and compared to 0.5 using a one-sided χ2 test.  If the P-value is less than 0.05 
for the Test lens group, then the Test lens will be statistically successful in this outcome. 
7.6.1.2.3 
Slit Lamp Findings 
At each follow-up visit, graded slit lamp findings will be assessed for each eye using 
Grades 0 through 4.  Using only the non-missing observations from all visits without 
imputation, each eye will be classified with respect to findings greater than Grade 2 at any 
visit (Absent, Present).  Missing data will not be imputed.  Greater than Grade 2 findings 
(Absent, Present) will be summarized at the eye level by treatment using categorical 
summary statistics for the Safety Set in a table.  A one-sided upper 95% confidence limit 
around the difference in “Present” proportions between the test and control treatment 
groups will be constructed using the Newcombe-Wilson score method.  If the upper 
confidence limit is less than 5%, then the null hypothesis that the Test lens is not non-
inferior will be rejected, and the Test lens will be statistically successful in this outcome. 
7.6.1.3 
Definition of Statistical Success 
If the test lens is statistically successful in all primary endpoints, then the test lens will be 
statistically successful overall. 
7.6.2 
Subject Demographics and Baseline Characteristics 
Subject demographics and baseline characteristics will be summarized by treatment group 
and overall. 

Study #893 - Protocol 
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7.6.3 
Subject Disposition 
Subject disposition (completed, discontinued) will be summarized categorically, as will the 
reasons for discontinuation. 
7.6.4 
Protocol Deviations 
Important (major) protocol deviations will be summarized by category and treatment group 
for the ITT Population in a table.  
Categories of important protocol deviations will include the following, which will be 
derived via data entered on the case report forms. 
• 
Ineligibility 
• 
Not dispensed study treatment 
• 
Misrandomization 
• 
Dispensing of the incorrect lens (type or prescription) 
• 
Use of medications that could potentially affect the primary effectiveness 
endpoint 
• 
Failure to comply with the procedures used to assess the primary effectiveness 
endpoint, such as missing a scheduled visit or failing to complete the procedure 
in accordance with instructions 
Additional important protocol deviation categories may be added prior to unmasking. 
Important (major) protocol deviations will also be displayed in a listing. 
 
 
 
 
 
 
7.6.7 
Missing Data 
Missing data will not be imputed. 
7.6.8 
Multiple Comparisons 
Success in all primary endpoint comparisons is required for statistical success, so no 
adjustment for multiple comparisons is required. 
7.6.9 
Interim Analyses 
No interim analyses are planned. 
 
8.0 
DATA QUALITY ASSURANCE  
8.1 
Study Monitoring 
Bausch + Lomb representatives must be allowed to visit all study site locations to assess 
the data, quality, and study integrity in a manner consistent with applicable health authority 
regulations and the procedures adopted by Bausch + Lomb.  

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Prior to the start of the study, member(s) of Bausch + Lomb (or designees) will review the 
protocol, eCRF, regulatory obligations, and other material or equipment relevant to the 
conduct of the study with the Investigator/Sub-Investigator and relevant study site 
personnel.  
Monitoring visits and telephone consultations will occur as necessary, or per the 
monitoring plan, during the course of the investigation to verify the following: 
• 
the rights and well-being of subjects are protected 
• 
the conduct of the investigation is in compliance with the currently approved 
protocol/amendment, 21CFR Parts 11, 50, 54, 56, 812, and 42 USC 282(j); and with 
consideration of the provisions in: ISO 14155-1:2011 Clinical investigation of medical 
devices for human subjects – Part 1:  General requirements; 14155-2:2011 Part 2:  
Clinical investigation of medical devices for human subjects – Part 2:  Clinical 
investigational plan; ISO 11980:2012 Ophthalmic Optics – Contact lenses and contact 
lens care products – Guidance for clinical investigations; ICH, GCPs, and applicable 
local regulations 
• 
the integrity of the data, including adequate study documentation 
• 
the facilities remain acceptable 
• 
the Investigator and site personnel remains qualified and able to conduct the study 
• 
study lenses accountability (at the conclusion of each site’s participation) 
During the course of the study, if the Sponsor determines that an Investigator is not 
compliant with the protocol and/or applicable regulatory requirements, the Sponsor will 
take action to secure compliance.  In addition, the Sponsor may terminate the Investigator’s 
participation 
in 
the 
study 
if 
appropriate, 
or 
if 
the 
Investigator 
remains  
non-compliant despite the Sponsor’s actions. 
Full details for site monitoring procedures will be outlined in the Monitoring Plan.  
8.2 
Source Documentation 
All medical information obtained at each study visit must be recorded in the subject’s 
record (source documentation) in real time as it is collected.  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.  
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.  Source documentation 
worksheets may be provided by the Sponsor to record pertinent information.  Data captured 
by the market research group is not considered source documentation.  
Subject completed forms are also considered to be source data.  In no instance should an 
Investigator or study site personnel record any data or make changes to subject completed 
forms.  The Investigator or designee should review subject completed forms during study 
visits for completeness and accuracy.  If an entry is found to be illegible or a mistake is 
found (e.g., incorrect year was recorded), the subject should be instructed to edit the entry 

Study #893 - Protocol 
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by drawing a single line through the original entry, entering the new information, and 
dating and initialing the change.  
 
 
 
 
Subject data required by this protocol are to be transferred from the source to the eCRFs.  
The Investigator and his/her study site 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 but not limited to, subject 
identification, date(s), assessment values, etc., and any omission or discrepancy will 
require explanation.  All information on eCRFs must be traceable to source documents.  
Market research data will be collected via ePRO and processed according to the policies 
and procedures of the market research group.  The data will not be included on eCRFs or 
verified by Bausch + Lomb. 
The study monitor will be responsible for reviewing and verifying the data recorded on the 
eCRFs per the study Monitoring Plan, utilizing the original source documentation and will 
query discrepant findings.  The Investigator and study site personnel will be responsible 
for answering all queries.  
Details regarding procedures used for data review, database cleaning and issuing and 
resolving queries will be outlined in the Monitoring Plan and Data Management Plan.   
A copy of the complete subjects’ eCRFs for the site will be provided to the Investigator at 
the conclusion of the study, who must ensure that it is stored in a secure place. 
8.4 
Recording of Data and Retention of Documents 
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. 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 

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8.5 
Auditing Procedures 
Audits of clinical research activities in accordance with the Sponsor’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).  If an inspection is requested by a regulatory authority and/or IRB, the 
Investigator must inform the Sponsor immediately that this request has been made. 
8.6 
Institutional Review Board 
The Investigator should ensure their participation in the study, in addition to the protocol, 
subject recruitment materials (written information or materials including web pages, radio 
advertisements, television spots or written text developed to encourage subject enrollment) 
and the ICF to be used in this study are approved by their institution’s IRB, or if not using 
their institution's IRB, approved by the reviewing central IRB prior to entering any subjects 
in the study. Documentation of IRB approval of the study protocol and informed consent 
must be provided to the Sponsor prior to initiation of 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 
Sponsor and the IRB and implemented as directed.  
8.7 
Publication of Results 
All study data generated as a result of this study will be regarded as confidential, until 
appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are 
completed.  The results of the study may be published or presented by the Investigator(s) 
after the review by, and in consultation and agreement with the Sponsor, and such that 
confidential or proprietary information is not disclosed. 
Prior to publication or presentation, a copy of the final text should be forwarded by the 
Investigator(s) to the Sponsor or its designee, for comment.  Such comments shall aim to 
ensure the scientific integrity of the proposed publications and/or presentations and ensure 
that the data and material referring to Bausch + Lomb products and activities receive fair, 
accurate, and reasonable presentation. 
The Sponsor may also choose to submit the results of this study for publication. 
8.8 
Statements of Compliance 
8.8.1 
Ethics Review 
The final protocol, including the final version of the Subject Instructions and Informed 
Consent Form, must be approved by an IRB before enrollment of any subject into the study.  
The Principal Investigator (or Sponsor/CRO on behalf of the Principal Investigator) is 
responsible for informing the IRB of any amendment to the protocol as per local 
requirements.  Any additional requirements imposed by the IRB shall be followed.  

Study #893 - Protocol 
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8.8.2 
Ethical Conduct of the Investigation 
The study will be performed in accordance with the ethical principles that have their origin 
in the most recent version of the Declaration of Helsinki, and with applicable regulatory 
requirements.  Subjects who are close colleagues, associates or family members of, or in 
any way dependent on the Sponsor or the investigator, will not be included in this study.   
8.8.3 
Informed Consent Process 
The Principal Investigator will ensure that each subject is given full and adequate oral and 
written information about the nature, purpose, possible risks and benefits of the study.  
Subjects must also be notified that they are free to discontinue participation in the study at 
any time.  The subject should be given the opportunity to ask questions and time for 
consideration.  
The subject’s signed informed consent must be obtained before conducting any study 
related procedures.  The original must be filed by the investigative site.  A copy of the 
signed Informed Consent Form should be given to the subject.  If modifications are made 
to the Informed Consent Form, the new version must be approved by the IRB.  The new 
version of revised Informed Consent Form(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.  

Study #893 - Protocol 
 
 
 
 
 
 
 
  
 
 
 
 
 

Study #893 - Protocol 
                                                                                                           
       
 
 
                      
           Page A-1  
 
 
APPENDIX A: SCHEDULE OF VISITS AND PARAMETERS  
All study tasks should be performed by qualified study site personnel as indicated on the delegation of authority log under the supervision of the Principal Investigator.  
PROCEDURE/ASSESSMENTS 
Screening/Dispensing Visit 
Day 1 
2-Week Follow-up 
Visit 
(Day 11-17) 
Exit 
Informed Consent/HIPAA Authorization 
X 
 
 
Demographics  
X 
 
 
Contact Lens Use History and Contact Lens Usec  
(e.g., average daily wear time, # of days worn, lens brand, lens care 
system brand, wear modality, product use history) 
X 
X 
 
Ocular Medical History and Concomitant Medications 
X 
X 
X 
High-contrast distance VA (with habitual lenses) 
X 
 
 
Eligibility 
X 
 
 
Randomization 
X 
 
 
Dispense Study Materials   
X 
 
 
Return Worn /Unworn Lenses, blister foils and Study Materials 
 
X 
Xe 
Study Lens Performance Scales (VAS;100-point scales)a  
Xd 
X 
 
Symptoms/Complaints rating scales 
 
X 
 
Remind subject to complete online survey form after minimum 7 days 
of wear but prior to the 2-Week Follow-up Visit.   
X 
 
 
Adverse Events 
X 
X 
 
To be performed 
without study 
lenses 
Spherocylindrical refraction 
X 
 
X 
Distance BSCVA 
X 
 
X 
Keratometry 
X 
 
X 
Slit Lamp Exam 
X 
X 
 
Lens Performance dispensed 
X 
 
 
To be performed 
with study lenses 
Distance lens VA 
X 
Xb 
 
Over-refraction and distance VA 
X 
Xb 
 
Lens Wettability 
X 
Xb 
 
Lens Deposits 
 
Xb 
 
Lens Centration 
X 
Xb 
 
Lens Movement 
X 
Xb 
 
Investigator Questionnaire 
 
X 
 
       
a Use the Lens Performance Rating Scales included in initial study shipment.; b To be assessed only for lenses worn to the visit.;c Contact lens use history is taken at the Screening Visit and contact lens use is taken at the  
Follow-Up Visit;d Lens Performance Rating Scales at Screening Visit are to be recorded with habitual lenses and again (abbreviated) with study lenses; at least 3-minutes following insertion of study lenses;eIf the exit  
visit is prior to 2-Week Follow-up 

Study #893 - Protocol 
Page B-1  
 
 
APPENDIX B: 
METHODS OF CLINICAL EVALUATION  
Maintenance and calibration of the equipment relevant to study assessments must be 
appropriately performed and documented by the investigative site, where applicable.  Any 
changes to the procedures described in this appendix will be provided under separate cover. 
1.0 
Visual Acuity/Refraction 
It is essential that a standard procedure be used to obtain VA measurements.  The VA and 
refraction measurements should be obtained by a physician, optometrist, or trained 
technician.  One standard logMAR chart, high 90% contrast, with Sloan letters will be used 
to obtain the VA measurements in this study.  The following VA equipment from Precision 
Vision, Inc. will be used in this study: 90% High Contrast 6.5 feet (2.0 meters) testing 
distance Translucent Chart (CAT.  NO. 2103-2), and the Precision Vision Small 
Illuminator Cabinet (CAT.  NO. 914). 
1.1 
Illumination of the logMAR Chart and Room Illumination 
The internal illumination of the logMAR chart should be turned on.  This will provide the 
nominal contrast for each of the charts.  Room illumination should be turned off, to 
ensure that the illumination is consistent for each measurement.  Ambient sources of light 
in the room, such as computer monitors, should be turned off or covered.  A small source 
of illumination may be used to allow recording of data and to ensure that it is not difficult 
or dangerous for staff or subjects to move around the testing area, but these light sources 
should not be placed so that they are directed toward the subject during testing.  The room 
lighting and any ambient sources should be consistent in their use and placement at each 
subject visit throughout the course of this study. 
1.2 
Determination of High Contrast Visual Acuity 
The subject should be seated so that the distance from the subject’s eyes to the logMAR 
chart is 6.5 feet (2.0 meters).  The chart should be at eye level for the subject.  The logMAR 
charts have two alternative letter sequences from 28 letters (0.3 logMAR) to  
62 letters (-0.3 logMAR).  It is recommended that one letter sequence is used for the right 
eye, and the second letter sequence is used for the left eye, to minimize learning effects at 
each visit.  Care should be taken to completely occlude the eye not being measured.  
Since the test distance of the chart is not at optical infinity, refractive power compensation 
is required to simulate optical infinity.  The VA should be measured through the 
phoropter using the distance refractive correction with the addition of  
+0.50 D to compensate for the reduced test distance of 6.5 feet (2.0 meters). 
If all letters are correctly identified on any given line, then the subject is encouraged to read 
the next smaller line.  When the subject says they cannot read a letter, they should be 
required to guess.  A maximum effort should be made to identify each letter.  A scoring 
sheet for each eye is provided to keep track of the letters correctly identified by writing an 
“X” over the incorrectly identified letter.  The subject continues reading down the chart to 
the last letter of a given line, until the subject has missed 3 letters on a line with 5 letters.  
The incorrect letters can occur at the beginning, middle, or end of this line and do not have 
to be consecutive. 

Study #893 - Protocol 
       
Page B-2  
1.3 
Recording and Scoring logMAR Values 
Using the Sponsor supplied recording/scoring sheet, an example of which is shown below, 
the tester will record the actual VA measurement. 
The number of letters CORRECT will be recorded on the recording/scoring sheet in the far 
right box on the corresponding line.  The lines will then be added up and the “TOTAL” 
number of letters correctly identified will be recorded on the recording/scoring sheet.  The 
“TOTAL” is the number that will be entered onto the eCRF.  
Example of Distance VA: 
In the example below, all letters in lines 1 through 8 were read correctly.  Line 9 had  
4 correct responses, and line 10 had only 1 correct response.  After line 10, the VA test 
would be considered complete.  In this example, the total letters correctly identified is 42.  
This number is recorded in the space marked “TOTAL” and also recorded on the eCRF. 
 

Study #893 - Protocol 
      
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2.0  
Slit Lamp Examination  
The following parameters will be assessed during the Slit Lamp Examination (without 
lenses): 
Epithelial Edema 
0 -  
None: No epithelial or sub-epithelial haziness.  Normal transparency. 
1 -  
Trace: Barely discernible localized epithelial or sub-epithelial haziness. 
2 - 
Mild: Faint but definite localized or generalized epithelial haziness. 
3 - 
Moderate: Significant localized or general epithelial haziness. 
4 - 
Severe: Definite widespread, epithelial cloudiness giving dull glass appearance to 
cornea, or numerous coalescent buliae. 
Epithelial Microcysts 
0 - 
None: No microcysts seen using retroillumination. 
1 - 
Trace: Fewer than 50 microcysts over central or para-central cornea.  No overlying 
staining or surface anomaly. 
2 - 
Mild: More than 50 microcysts over central or paracentral cornea.  No overlying 
staining or surface anomaly. 
3 - 
Moderate: More than 50 microcysts, tending to be coalescent and accompanied by 
overlying faint staining or dry spots. 
4 - 
Severe: Numerous, dense, coalescent microcysts accompanied by overlying 
significant staining or erosion. 
Corneal Staining 
Corneal staining must be assessed after the instillation of fluorescein.  If needed, a Wratten 
Gel Filter will be provided by the Sponsor for the evaluation of corneal staining.  The 
Wratten Gel Filter must be used as a barrier filter in the observation pathway, in 
combination with the cobalt blue filter. 
0 - 
None: No fluorescein staining. 
1 - 
Trace: Minimal superficial staining or stippling, and non-coalescing.  Includes 
superficial foreign body staining. 
2 - 
Mild: Lightly coalescent or diffuse punctate staining, with no stain diffusion into 
stroma. 
3 - 
Moderate: Significant or densely coalescent punctate staining, including slight 
diffusion of stain into stroma. 
4 - 
Severe: Severe abrasion or erosion with loss of epithelial substance.  Marked and 
rapid diffusion of stain into stroma. 
Limbal Injection 
0 - 
None: No hyperemia present.  Normal appearance of limbal vessels including 
prominent limbal vascular arcades. 
1 - 
Trace: Very slight hyperemia of limbal vessels in one quadrant. 
2 - 
Mild: Mild hyperemia of limbal vessels in more than one quadrant. 
3 - 
Moderate: Marked hyperemia of limbal vessels in any quadrant. 
4 - 
Severe: Marked hyperemia of limbal vessels in all quadrants. 
  

Study #893 - Protocol 
           
Page B-4  
 
 
Bulbar Injection 
0 - 
None: No hyperemia present.  Normal appearance of conjunctival vessels. 
1 - 
Trace: Slight hyperemia of conjunctival vessels in one quadrant. 
2 - 
Mild: Mild hyperemia of conjunctival vessels in more than one quadrant. 
3 - 
Moderate: Marked hyperemia of conjunctival vessels in any quadrant. 
4 - 
Severe: Marked hyperemia of conjunctival vessels in all quadrants. 
 
Upper Lid Tarsal Conjunctival Abnormalities 
0 - 
None: Normal, velvet tarsal conjunctival appearance.  No hyperemia or enlarged 
papillae. 
1 - 
Trace: Slight tarsal conjunctival hyperemia with slight loss of smoothness. 
2 - 
Mild: Slight tarsal conjunctival hyperemia with slight loss of smoothness.  
Noticeable enlargement of papillae, but less than 1.0 mm in diameter. 
3 -  
Moderate: Definite loss of smoothness with enlarged papillae, but less than 1.0 mm 
in diameter with marked tarsal conjunctival hyperemia. 
4 - 
Severe: Localized or generalized giant papillae, larger than 1.0 mm in diameter 
and/or severe tarsal conjunctival hyperemia.  
 
Corneal Neovascularization 
0 - 
None: Normal appearing limbus, including prominent limbal vascular arcades. 
1 - 
Trace: Vascularization less than 1.5 mm of advancement into cornea in one 
quadrant. 
2 - 
Mild: Vascularization less than 1.5 mm of advancement into cornea in more than 
one quadrant. 
3 - 
Moderate: Vascularization 1.5 mm to less than 2.5 mm of advancement into cornea 
in any quadrant. 
4 - 
Severe: Vascularization more than 2.5 mm of advancement into cornea in any 
quadrant. 
 
Corneal Infiltrates 
0 - 
No infiltrates. 
1 - 
Single infiltrate; (focal and peripheral), asymptomatic. 
2 - 
Single or multiple infiltrate(s); with injection and/or associated symptoms. 
3 - 
Single or multiple infiltrate(s); injection with overlying corneal defect(s). 
4 - 
Single or multiple infiltrate(s); injection with diffusion of stain into stroma. 
 
New corneal scar or pre-existing corneal scar 
Absent or Present 
Location: 
Check all that apply 
 Central (central 6 mm, 3 mm from corneal center) 

Study #893 - Protocol 
          
Page B-5  
 
 
 Nasal 
 Inferior 
 Temporal 
 Superior 
Size: X.X (mm) 
Draw: 
 
 
 
Absent or Present 
New Corneal Scar 
Corneal Striae 
Conjunctivitis 
Other Anterior Segment Abnormalities  
External Adnexa Abnormalities 
  
3.0  
Method for the Examination, Description and Classification of Lens Deposits 
and Wettability  
Introduction: 
 
The following procedure has been developed to assist in the examination, 
description, and classification of wettability and deposits found on contact lenses 
in the Investigator's office. 
Materials needed: 
 
Slit Lamp 
Procedure: 
 
Each lens should be examined on the eye using the slit lamp employing a 7X to 
15X magnification. 
Classify the deposit and record findings at applicable visits as follows: 
I. 
Type of Deposit 

Study #893 - Protocol 
   
Page B-6  
 
 
Indicate the most prominent lens surface deposit found 
 
 
 
 
 
 
 
 
 
 
 
 
 
II. 
Estimated Percentage of Lens Surface Covered By Deposits 
Estimate the percentage of the lens surface that is covered by deposits 
 
: 
 
 
 
 
 
 
 
 
 
III. 
Degree of Deposit 
Indicate the degree of the deposit on the lens surface 
 
: 
 
 
 
 
 
 
 
 
IV. Wettability 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study #893 - Protocol 
                                             
                       
Page B-7  
 
 
 
4.0 
Method for the Examination, Description and Classification of Lens Fit at all 
Visits 
The following procedure has been developed to assist in the examination, description, and 
classification of contact lenses fit at all visits in the Investigator’s office. 
Materials needed:  Slit Lamp 
Procedure:  Each lens should be examined on the eye using the slit lamp employing a 7X 
to 15X magnification. 
Lens fit will be assessed utilizing the scales below: 
I. 
Lens Centration  
 
Qualitative Lens Centration 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
II. 
Lens Movement  
• As the subject blinks normally, observe lens movement, 
 
 
 
 
 
 
 
 
 

Study #893 - Protocol 
      
Page B-8  
 
 
o 
 
 
 
• 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study #893 - Protocol 
         
Page B-9  
 
 

Study #893 - Protocol 
Page B-10  
 
 
5.0 
Symptoms/Complaints Rating Scales 
For completion of the Symptoms/Complaints Rating Scale Form (conducted at applicable 
visits with the Test or Control lenses), the Investigator or designee will obtain Subject 
responses 
 
 
 
 
 
 
 
   
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study #893 - Protocol 
               
Page B-11  
 
 
6.0 
Len Performance Rating Scales 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.0 
Investigator Questionnaire 
   
 
 
 
 
 
 
 
 
 
 
 
 
 

Study #893 - Protocol 
            
Page B-12  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study #893 - Protocol 
          
Page B-13  
 
 
8.0   
Culture Procedures 
 
NOTE: The site must use their standard of care culture kit and ship specimens to 
their local laboratory for testing per the local lab’s required procedures.  Hard copy 
results must be filed in the subject record and entered into the eCRF. 
 
PROCEDURES FOR THE INVESTIGATOR 
A. 
In the case of corneal ulcer or suspected ocular infection, the cul-de-sac, lower lid 
margin, and the corneal lesion (if applicable) of the affected eye must be cultured. 
1. Cul-de-sac Culture 
a. The swab from a culture collection kit is moistened in sterile, physiological 
saline solution, with no preservatives. 
b. The ocular specimen is obtained by holding the lids open and asking the subject 
to gaze upward.  The moistened swab should be drawn across the cul-de-sac 
while rotating the swab 360 degrees around the axis of the stick.  Care should be 
taken to avoid contact of the swab with the lashes and the lid margins. 
c. Place the swab in the transport tube media according to manufacturer's 
directions. 
d.  Repeat steps a through c using a separate swab and a separate tube of transport 
media for the other eye if both eyes require culturing. 
2. Eyelid Culture 
a. The swab from a culture collection kit is moistened in sterile, physiological 
saline solution, with no preservatives. 
b. The specimen is obtained from the margin of the lower lid by drawing the swab 
along the margin of the lid. 
c. Place the swab in the transport tube media according to manufacturer's 
directions. 
d. Repeat steps a through c using a separate swab and a separate tube of transport 
media for the other eye if both eyes require culturing. 
3. Corneal Culture 
a. The swab from a culture collection kit is moistened in sterile, physiological 
saline solution, with no preservatives. 
b. The specimen is obtained from the corneal lesion by rotating the swab on the 
lesion for 10 seconds. 
c. Place the swab in the transport tube media according to manufacturer's 
directions. 
d. Repeat steps a through c using a separate swab and a separate tube of transport 
media for the other eye if both eyes require culturing. 
 
B.  
Labeling and Transportation of Cultures to the Clinical Laboratory: 

Study #893 - Protocol 
Page B-14  
 
1. Complete the requisition supplied by your laboratory included with the culture 
collection kit.  Affix labels supplied in the culture collection kit to the ocular 
specimens as well as to the container used to transport the contact lens case (which 
contains the contact lens[es] and contact lens case solution) if available. 
2. The specimens, contact lens(es), lens case(s), lens case solution(s) and report form 
are then sent to the local laboratory under refrigerated conditions using the supplies 
provided by your laboratory. 
 

Study #893 - Protocol 
Page B-15  
 
 
9.0 
Corneal Infiltrates Evaluation Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study #893 - Protocol 
               
Page B-16  
 

Study #893 - Protocol 
    
Page C-1  
APPENDIX C: SUBJECT INSTRUCTIONS 
FOR SINGLE-USE DISPOSABLE WEAR 
CAUTION:  Investigational Device. Limited by Federal law (U.S.A.) to 
investigational use. 
 
INTRODUCTION  
You will participate in this study designed to evaluate the product performance of an 
investigational daily disposable contact lens (Test) when compared to the currently 
marketed the Johnson & Johnson Acuvue Oasys® 1-Day with HydraLuxe™ (Control) and 
Alcon DAILIES TOTAL1® (delefilcon A) (Control).  As a participant in this study, you 
will be randomly assigned to wear either the Test or Control lenses on a daily disposable 
basis.  Study lenses will be dispensed at the Screening/Dispensing Visit.  It is very 
important that you do not use any other contact lenses or solutions other than those 
dispensed to you during the study. 
You will wear the lenses on a daily disposable basis and replace the lenses daily but do not 
discard your worn lenses as they will be collected at your 2-Week follow-up visit.  
Throughout the study, place all worn lenses in a study lens case that was provided to you 
(up to 10 pairs of lenses per case) with no solution (dry).  You will return the lens cases to 
the office at your 2-Week Follow-Up visit/Exit visit.  Bring all lenses (worn in lens cases 
and unworn blister packs) and blister foils to the 2-Week follow-up visit/Exit visit or any 
unscheduled visit. 
Do not discuss or describe your contact lenses with anyone except the person who 
gave you the study lenses at the Screening/Dispensing Visit.  You should not show the 
study blister packs and foils to the Investigator or site staff unless instructed to do so. 
Please keep all appointments and follow these instructions thoroughly.  If you have any 
questions or problems, call your study doctor at _________________.  
Note: Please schedule your 2-Week Follow-up Visit at the Screening/Dispensing Visit. 
Follow-Up Visit Schedule 
Visit 
Day/Month/Year 
Time 
2-Week Follow-Up 
          /            / 
_____________ 
Note: Wear your study lenses to your follow-up visit. 
For this study, you will be using the following products: 
• Bausch + Lomb Sensitive Eyes® Drops (to be used if needed). 
• Lens cases for storage of worn study lenses (up to 10 pairs of lenses, stacked dry). 
 
 
 

Study #893 - Protocol 
       
Page C-2  
GENERAL INFORMATION 
Do NOT use any products other than those dispensed to you by your study doctor for use 
in this study. 
If problems or symptoms should occur, immediately remove your lenses and follow the 
steps described in the sections of these instructions entitled Warnings and Adverse Effects.  
Prompt attention to problems is essential and may require immediate professional care. 
Remember, when wearing contact lenses, your eyes should look and feel good and your 
vision should be clear. 
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 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 continue wearing contact 
lenses for daily disposable wear, you should discuss with your study doctor the effects of 
contact lenses on your eyes and the risks associated with wearing contact lenses.  You also 
should read the sections of these instructions entitled “Warnings”, “Adverse Reactions”, 
“Precautions”, and “Wearing Restrictions and Indications”.  Ask your study doctor to 
explain anything that you do not understand, including any additional restrictions which 
may be given to you by your study doctor.  These contact lenses have been prescribed for 
single-use disposable wear and should be replaced each time lenses are removed from your 
eyes. 
You also need to remember that soft contact lenses, including those covered by these 
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 these instructions and any other instructions given to you by your 
study doctor.  Any failure to follow these instructions and the wearing restrictions will 
increase the chances of contamination, damage to the lenses, or a buildup of deposits on 
the lenses, which can lead to serious, sight-threatening eye infections and injuries. 
Adherence to your prescribed wearing schedule and regular check-up visits to your study 
doctor are also necessary for the proper and safe use of contact lenses.  Soft contact lenses 
generally are comfortable from the beginning.  Therefore, be sure to follow the wearing 
schedule prescribed for you, and do not over wear your lenses simply because they remain 
comfortable and you are not experiencing a problem.  Only your study doctor, through a 
professional examination, can determine how your eyes are reacting to the contact lenses 
and whether there are any early signs of possible problems. 
Finally, if problems or symptoms should occur, immediately remove your lenses and 
follow the steps described in the section of these instructions entitled “Warnings and 
Adverse Reactions.” Prompt attention to problems is essential and may require 
immediately professional care. 
Remember, when wearing soft contact lenses your eyes should look and feel good, and 
your vision should be clear. 
 
 
 

Study #893 - Protocol 
          
Page C-3  
1. WEARING RESTRICTIONS and INDICATIONS 
The lenses have been prescribed for single-use disposal wear and will be replaced after 
each removal. 
− Keep a spare pair of lenses and a lens case available in case you have to remove 
your lenses immediately upon the appearance of a problem or symptom. 
− Do not use aerosol products such as hair spray while wearing your lenses.  The 
lenses may absorb the spray, resulting in injury to the eye and damage to the lens. 
− Avoid wearing the lenses around fumes, irritating vapors, smoky or dusty 
conditions.  The lenses may absorb the chemicals or particles, resulting in injury to 
the eye. 
− Avoid rubbing your eyes with the lenses in, which can irritate the eye or dislodge 
the lens. 
− If you get something in your eye, remove the lens immediately.  Do not replace 
with new lens until your eye feels normal. 
− Tell your regular physician and every other doctor that you visit, that you wear 
contact lenses and the type of lenses that you wear.  If you are admitted to a hospital, 
also tell your nurses that you wear contact lenses. 
− A bottle of Bausch + Lomb Sensitive Eyes® Drops will be dispensed to you at the 
Screening/Dispensing Visit.  You may use these drops as needed throughout the 
study.  Your Study Doctor can provide you with additional drops should you need 
a new bottle. 
− Do not use any eye drops, ointments, or medicines in your eye unless they are 
specifically approved by your study doctor or physician.  Some drops, ointments, 
or medicines will cause injury to the eye if used by a contact lens wearer. 
− Ask your study doctor whether there are any other wearing restrictions that apply 
to you, write those restrictions in the spaces provided below and follow them 
carefully. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study #893 - Protocol 
                 
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2. WARNINGS 
You should be aware of and fully discuss with your study doctor 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 study doctor’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.  
− Daily disposable lenses are not indicated for overnight wear, and you should not 
wear lenses while sleeping.  Clinical studies have shown that the risk of serious 
adverse reactions is increased when daily disposable lenses are worn overnight. 
− Strict compliance with your wearing restrictions, wearing schedule, and follow-up 
visit schedule should be followed. 
− 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 study 
doctor. 
3. PRECAUTIONS 
You should be aware of and fully discuss with your study doctor the following safety 
precautions: 
− Do not use saliva or anything other than the recommended solutions for lubricating 
or wetting your lenses. 
− If the lens sticks (stops moving), you should use the Bausch + Lomb Sensitive 
Eyes® Drops rewetting drops provided to you for this study.  The lens should move 
freely on your eye for the continued health of your eye.  If non-movement of the 
lens continues, you should immediately consult your study doctor.  Do not attempt 
to remove the lens, except on the instructions of your study doctor. 
− Always wash and rinse your hands before handling lenses.  Do not get cosmetics, 
lotions, soaps, creams, deodorants, or sprays in your 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. 
− Carefully follow these handling, insertion, and wearing instructions for the daily 
disposable contact lenses and those instructions prescribed by your study doctor. 
− Never wear lenses beyond the period recommended by your study doctor. 
− Always handle lenses gently and avoid dropping them. 
− Ask your study doctor about wearing lenses during water activities and other sports. 

Study #893 - Protocol 
          
Page C-5  
− Inform your doctor (health care professional) about being a contact lens wearer. 
− Never use tweezers or other tools to remove lenses from the lens container unless 
specifically indicated for that use.  Pour the lens into your hand. 
− Do not touch the lens with your fingernails. 
− Always contact your study doctor before using any medicine in your eyes. 
− Always inform your employer of being a contact lens wearer.  Some jobs may 
require use of eye protection equipment or may require that you not wear contact 
lenses. 
− As with any contact lens, follow-up visits are necessary to assure the continuing 
health of your eyes.  Your study doctor should provide you with a recommended 
follow-up schedule. 
 
4. 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 has dirt, 
an eyelash, or other foreign body on it, or the problem stops and the lens appears 
undamaged, insert a new lens.  After insertion of a new lens, if the problem 
continues, you should immediately remove the lenses and consult your study doctor. 
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 immediately professional identification of the problem and prompt treatment to avoid 
serious eye damage. 
 
 

Study #893 - Protocol 
           
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5. PERSONAL CLEANLINESS and LENS HANDLING 
− Preparing the Lens for Wearing: 
It is essential that you learn and use good hygienic methods in the care and handling of the 
lenses.  Cleanliness is the first and most important aspect of proper contact lens care.  In 
particular, 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 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. 
○ 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: 
▪ 
Less than usual comfort, 
▪ 
The lens may fold on the eye, 
▪ 
Excessive lens movement on blink, 
▪ 
Blurred vision. 
If the lens folds and sticks together: Place the lens in the palm of your hand and GENTLY 
rub the lens between your index finger and palm in a gentle back and forth motion.  Replace 
the lens if it does not unfold. 
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. 
 
- 
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, 

Study #893 - Protocol 
          
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▪ 
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 professional. 
 
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. 
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.” 
 
− 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. 
− Removing the Lens: 
Always remove the same lens first. 
1) 
Always wash your hands thoroughly with mild soap, rinse completely, and dry with 
a lint-free towel before touching your lenses.  

Study #893 - Protocol 
 
Page C-8  
. 
2) 
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. 
3) 
Remove the other lens by following the same procedure. 
Note: If this method of removing your lens is difficult for you, your study doctor will 
provide you with an alternate method. 
 
− 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 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. 
 
6. EMERGENCIES 
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 
STUDY DOCTOR OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT 
DELAY. 
 
 
 

Study #893 - Protocol 
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APPENDIX D: FITTING GUIDE 
FOR SINGLE-USE DISPOSABLE WEAR 
CAUTION:  Investigational device.  Limited by Federal law (U.S.A.) to investigational 
use. 
IMPORTANT 
This Fitting Guide has been developed to provide professionals with information covering 
characteristics of the investigational daily disposable contact lens and to illustrate fitting 
procedures.  Please read carefully and keep this information for future use.  This Fitting 
Guide is intended for the eye care professional, but should be made available to subjects 
upon request.  The eye care professional should provide the subject with the Subject 
Instructions that pertain to the subject’s prescribed lens, and the recommended wearing 
schedule. 
LENS PARAMETERS AVAILABLE (For the Test and Control lenses used in this 
study) 
Test and Control Articles:  
The Test lens to be used in this study is the Bausch + Lomb kalifilcon A daily disposable 
contact lens.  The description of the Test lens is as follows: 
• 
Sphere Power: -0.50 to -6.00 D in steps of 0.25 D 
• 
Diameter: 14.2 mm 
• 
Base Curve: 8.6 mm 
• 
Material: kalifilcon A 
A Control lens to be used in this study is the currently marketed Johnson & Johnson Acuvue 
Oasys® 1-Day with HydraLuxe™.  The description of this Control lens is as follows: 
• 
Sphere Power: -0.50 to -6.00 D in steps of 0.25 D 
• 
Diameter: 14.3 mm 
• 
Base Curve: 8.5 mm 
• 
Material: senofilcon A  
A Control lens to be used in this study is the currently marketed Alcon DAILIES TOTAL1® 
(delefilcon A) daily disposable contact lens.  The description of this Control lens is as 
follows: 
• 
Sphere Power: -0.50 to -6.00 D in steps of 0.25 D 
• 
Diameter: 14.1 mm 
• 
Base Curve: 8.5 mm 
• 
Material: delefilcon A  
 
HOW THE LENS WORKS (ACTIONS) 
In their hydrated state, when the contact lens is placed on the cornea, they act as a refracting 
medium to focus light rays on the retina.  
 
INDICATIONS 

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The Bausch + Lomb daily disposable contact lens is intended for the daily disposable wear 
correction of refractive ametropia (myopia and hyperopia) in aphakic and  
not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 D or less, that 
does not interfere with visual acuity.  The lenses may be prescribed in spherical powers 
ranging from -0.50 D to -6.00 D.  The lenses have been prescribed for single-use disposal 
wear and will be replaced after each removal. 
CONTRAINDICATIONS (REASONS NOT TO USE) 
DO NOT USE the Bausch + Lomb daily disposable contact lens when any of the following 
conditions exist: 
• 
Acute and subacute inflammation or infection of the anterior chamber of the eye, 
• 
Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids, 
• 
Severe insufficiency of lacrimal secretion (dry eyes), 
• 
Corneal hypoesthesia (reduced corneal sensitivity), 
• 
Any systemic disease that may affect the eye or be exaggerated by wearing contact 
lenses, 
• 
Allergic reactions of ocular surfaces or adnexa (surrounding tissue) that may be 
induced or exaggerated by wearing contact lenses or use of contact lens solutions, 
• 
Any active corneal infection (bacterial, fungal, or viral), 
• 
If eyes become red or irritated. 
WARNINGS 
After a thorough eye examination, including appropriate medical background, subjects 
should be fully apprised by the prescribing professional of all the risks with contact lens 
wear.  Subjects should be advised of the following warnings pertaining to contact lens wear: 
• 
Problems with contact lenses could result in serious injury to the eye.  It is essential 
that subjects follow their 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. 
• 
Daily disposable lenses are not indicated for overnight wear, and subjects should be 
instructed not to wear lenses while sleeping.  Clinical studies have shown that the 
risk of serious adverse reactions is increased when daily disposable lenses are worn 
overnight. 
• 
Studies have shown that contact lens wearers who are smokers have a higher incidence 
of adverse reactions than nonsmokers. 
• 
If a subject experiences eye discomfort, excessive tearing, vision changes, or redness 
of the eye, the subject should be instructed to immediately remove lenses and 
promptly contact his or her eye care professional. 
PRECAUTIONS 
Precautions for Eye Care Professionals: 

Study #893 - Protocol 
      
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• 
Due to the small number of subjects enrolled in clinical investigation of lenses, all 
refractive powers, design configurations, or lens parameters available in the lens 
material are not evaluated in significant numbers.  Consequently, when selecting an 
appropriate lens design and parameters, the eye care professional should consider all 
characteristics of the lens that can affect lens performance and ocular health, including 
oxygen permeability, wettability, central and peripheral thickness, and optic zone 
diameter. 
• 
The potential impact of these factors on the subject’s ocular health should be carefully 
weighed against the subject's need for refractive correction; therefore, the continuing 
ocular health of the subject and lens performance on eye should be carefully monitored 
by the prescribing eye care professional. 
• 
Fluorescein should not be used while the subject is wearing the lenses, because the 
lenses will become discolored.  Whenever fluorescein is used, flush the eyes with sterile 
saline solution.  Wait at least 5 minutes before inserting new lenses.  If it is not possible 
to flush the eyes, wait a minimum of 1 hour before inserting new lenses.  If inserted too 
soon, the lenses may absorb residual fluorescein. 
• 
Before leaving the eye care professional’s office, the subject should be able to promptly 
remove lenses. 
• 
The lenses are prescribed for disposable wear and are to be stored for return to the eye 
care professional once they are removed from the subject’s eye.  It is important that 
subjects be instructed to always have available a pair of replacement lenses.  In the 
event that a lens must be removed from the eye because of dust, a foreign body or other 
contaminant gets on the lens or the lens becomes dehydrated, the lens should be 
removed and replaced with a replacement lens. 
Eye care professionals should carefully instruct subjects about the following safety 
precautions: 
• 
If the lens sticks (stops moving) on the eye, follow the recommended directions on Care 
for a Sticking Lens.  The lens should move freely on the eye for the continued health 
of the eye.  If non-movement of the lens continues, the subject should be instructed to 
immediately consult his or her eye care professional.  Do not attempt to remove the 
lens, except on the instructions of the eye care professional. 
• 
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 the fingers or hands if the hands are not free of foreign 
materials, as microscopic scratches of the lenses may occur, causing distorted vision 
and/or injury to the eye. 
• 
Carefully follow the handling, insertion, removal, and wearing instructions in the 
Subject Instructions and those prescribed by the eye care professional. 
• 
Never wear lenses beyond the period recommended by the eye care professional. 
• 
If aerosol products such as hair spray are used while wearing lenses, exercise caution 
and keep eyes closed until the spray has settled. 

Study #893 - Protocol 
   
Page D-11  
 
 
• 
Always handle lenses gently and avoid dropping them. 
• 
Avoid all harmful or irritating vapors and fumes while wearing lenses. 
• 
Ask the eye care professional about wearing lenses during water activities and other 
sports. 
• 
Inform the doctor (health care professional) about being a contact lens wearer. 
• 
Never use tweezers or other tools to remove lenses from the lens container unless 
specifically indicated for that use.  Pour the lens into the hand. 
• 
Do not touch the lens with fingernails. 
• 
Always contact the eye care professional before using any medicine in the eyes. 
• 
Always inform the employer of being a contact lens wearer.  Some jobs may require 
use of eye protection equipment or may require that the subject not wear contact lenses. 
• 
As with any contact lens, follow-up visits are necessary to assure the continuing health 
of the subject’s eyes.  The subject should be instructed as to a recommended follow-up 
schedule. 
ADVERSE REACTIONS 
The subject should be informed 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 the subject notices any of the above, he or she should be instructed to: 
• 
Immediately remove 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 the eye.  Place the lens in the storage case 
and contact the eye care professional.  If the lens has dirt, an eyelash, or other foreign 
body on it, or the problem stops and the lens appears undamaged, the subject should 
insert a new lens.  After insertion of a new lens, if the problem continues, the subject 
should immediately remove the lenses and consult the eye care professional. 
If the above symptoms continue after removal of the lens, or upon insertion of a new lens, 
the subject should immediately remove the lenses and contact his or her eye care 

Study #893 - Protocol 
   
Page D-12  
 
 
professional or physician, who must determine the need for examination, treatment or 
referral without delay. 
(See Important Treatment Information for Adverse Reactions.) A serious condition such as 
infection, corneal ulcer, corneal vascularization, or iritis may be present, and may progress 
rapidly.  Less serious reactions such as abrasions, epithelial stinging or bacterial 
conjunctivitis must be managed and treated carefully to avoid more serious complications. 
IMPORTANT TREATMENT INFORMATION FOR ADVERSE REACTIONS 
Sight-threatening ocular complications associated with contact lens wear can develop 
rapidly, and therefore early recognition and treatment of problems are critical.  Infectious 
corneal ulceration is one of the most serious potential complications, and may be 
ambiguous in its early stage. 
Signs and symptoms of infectious corneal ulceration include discomfort, pain, 
inflammation, purulent discharge, sensitivity to light, cells and flare and corneal infiltrates.  
Initial symptoms of a minor abrasion and an early-infected ulcer are sometimes similar. 
Accordingly, such epithelial defect, if not treated properly, may develop into an infected 
ulcer.  In order to prevent serious progression of these conditions, a subject presenting 
symptoms of abrasions or early ulcers should be evaluated as a potential medical 
emergency, treated accordingly, and be referred to a corneal specialist when appropriate.  
Standard therapy for corneal abrasions such as eye patching or the use of steroids or 
steroid/antibiotic combinations may exacerbate the condition.  If the subject is wearing a 
contact lens on the affected eye when examined, the lens should be removed immediately 
and the lens and lens care products retained for analysis and culturing. 
SELECTION OF SUBJECTS 
Persons who require vision correction and who would not or could not adhere to the 
replacement regimen for the Bausch + Lomb daily disposable contact lenses or are unable 
to place and remove the lenses should not be provided with them.  Failure to follow 
handling instructions could lead to serious eye infections, which might result in corneal 
ulcers. 
Subject communication is vital because it relates not only to subject selection but also to 
ensure compliance.  It is also necessary to discuss the information contained in the Subject 
Instructions with the subject at the time of the initial examination.  Subjects selected to 
wear the Bausch + Lomb daily disposable contact lens should be chosen for their 
motivation to wear contact lenses, general health, and cooperation.  The eye care 
professional must take care in selecting, examining, and instructing contact lens subjects.  
Subject hygiene and willingness to follow eye care professional instructions are essential 
to their success. 
A detailed history is crucial to determining subject needs and expectations.  Your subject 
should be questioned regarding vocation, desired lens-wearing time (full or part time), and 
desired lens usage (reading, recreation or hobbies).  Initial evaluation of the lens should be 
preceded by a complete eye examination, including visual acuity, keratometry, and slit 
lamp examination. 
It is normal for the subject to experience mild symptoms such as lens awareness, variable 
vision, occasional tearing (watery eyes), and slight redness during the adaptation period.  

Study #893 - Protocol 
     
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Although the adaptation period varies for each individual, generally within one week these 
symptoms will disappear.  If these symptoms persist, the subject should be instructed to 
contact his or her eye care professional. 
FITTING PROCEDURE 
1. Pre-fitting Examination 
A pre-fitting subject history and examination are necessary to: 
− 
determine whether a subject is a suitable candidate for daily disposable contact 
lenses (consider subject hygiene and mental and physical state), 
− 
make ocular measurements for initial contact lens parameter selection, and 
− 
collect and record baseline clinical information to which post-fitting examination 
results can be compared. 
A pre-fitting examination should include spherocylindrical refraction and VA, keratometry, 
and biomicroscopic examination. 
2. Initial Lens Power Selection 
− 
Lens power is determined from the subject's spherical equivalent prescription 
corrected to the corneal plane. 
− 
Select the appropriate power lens and place the lens on the eye.  Allow the lens to 
remain on the eye long enough (3 minutes) to achieve a state of equilibrium.  Small 
variations in the tonicity, pH of the lens solutions, and individual tear composition 
may cause slight changes in fitting characteristics. 
− 
Allow any increase in tear flow to subside before evaluating the lens.  The time 
required will vary with the individual. 
3. Initial Lens Evaluation 
− 
To determine proper lens parameters observe the lens relationship to the eye using 
a slit lamp. 
○ Movement: The lens should provide discernible movement with: 
▪ 
Primary gaze blink 
▪ 
Up gaze blink 
▪ 
Up gaze lag 
○ Centration: The lens should provide full corneal coverage. 
− 
Lens evaluation allows the contact lens fitter to evaluate the lens/cornea 
relationship in the same manner as would be done with any soft lens. 
4. Criteria of a Well-Fitted Lens 
If the initial lens selection fully covers the cornea, provides discernible movement after a 
blink, is comfortable and provides satisfactory visual performance, it is a well-fitted lens 
and can be dispensed. 
5. Characteristics of a Tight (Steep) Lens 

Study #893 - Protocol 
        
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A lens which is much too steep may subjectively and objectively cause distortion which 
will vary after a blink.  However, if a lens is only marginally steep, the initial subjective 
and objective vision and comfort findings may be quite good.  A marginally steep lens may 
be differentiated from a properly fitted lens by having the subject gaze upward.  A properly 
fitted lens will tend to slide downward approximately 0.5mm while a steep lens will remain 
relatively stable in relationship to the cornea, particularly with the blink. 
6. Characteristics of a Loose (Flat) Lens 
If the lens is too flat, it will: 
− 
Decenter, especially on post-blink. 
− 
Have a tendency to edge lift inferiorly and sit on the lower lid, rather than 
positioning between the sclera and palpebral conjunctiva. 
− 
Have a tendency to be uncomfortable and irritating with fluctuating vision. 
− 
Have a tendency to drop or lag greater than 2.0 mm on up-gaze post-blink. 
7. Follow-up Care 
− 
From the day of dispensing, the following schedule is required for this study. 
○ 2-Week Follow-Up Visit 
− 
Prior to a follow-up examination, the contact lenses should be worn for 
approximately 1 continuous hour and the subject should be asked to identify any 
problems which might be occurring related to contact lens wear. 
− 
With lenses in place on the eyes, evaluate fitting performance to assure that 
CRITERIA OF A WELL FITTED LENS continue to be satisfied.  Examine the 
lenses closely for surface deposition and/or damage. 
− 
After the lens removal, instill sodium fluorescein (unless contraindicated) into the 
eyes and conduct a thorough biomicroscopy examination. 
○ The presence of vertical corneal striae in the posterior central cornea and/or 
corneal neovascularization may be indicative of excessive corneal edema. 
○ The presence of corneal staining and/or limbal-conjunctival hyperemia can be 
indicative of an unclean lens, a reaction to solution preservatives, excessive lens 
wear, and/or a poorly fitting lens. 
○ Papillary conjunctival changes may be indicative of an unclean and/or damaged 
lens.  If any of the above observations are judged abnormal, various 
professional judgments are necessary to alleviate the problem and restore the 
eye to optimal conditions.  
WEARING SCHEDULE 
The wearing and daily disposable schedules should be determined by the eye care 
professional.  Regular checkups, as determined by the eye care professional, are extremely 
important. 
Daily Disposable: 
There may be a tendency for the daily disposable subject to over-wear the lenses initially.  
Therefore, the importance of adhering to a proper, initial daily disposable schedule should 

Study #893 - Protocol 
          
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be stressed to these subjects.  The wearing schedule should be determined by the eye care 
professional.  The wearing schedule chosen by the eye care professional should be provided 
to the subject.  The lens is to be prescribed for single-use disposable wear and is to be 
replaced after each removal. 
All subjects should be supplied with a copy of the Subject Instructions. 
HANDLING OF LENSES 
When lenses are dispensed, the subject should be provided with appropriate and adequate 
instructions and warnings for lens handling.  The eye care professional should recommend 
appropriate and adequate procedures for each individual subject in accordance with the 
particular lens-wearing schedule. 
CARE FOR A STICKING (NONMOVING) LENS 
If the lens sticks (stops moving), the subject should be instructed to use their study Bausch 
+ Lomb Sensitive Eyes® Drops.  The subject should be instructed to not use plain water, 
or anything other than the recommended solutions.  The subject should be instructed to 
contact the eye care professional if the lens does not begin to move upon blinking after 
several applications of the solution, and to not attempt to remove the lens except on the 
advice of the eye care professional. 
REPORTING OF ADVERSE REACTIONS 
All serious adverse experiences and adverse reactions observed in subjects wearing the 
Bausch + Lomb daily disposable contact lens should be reported according to the Protocol. 
HOW SUPPLIED 
The lenses are provided individually in a plastic blister containing sterile packaging 
solution.  Each container is marked with the manufacturing lot number of the lens, power, 
base curve, and expiration date.