A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens
Phase: NA
Conditions: Contact Lens Wear
Sponsor: Bausch & Lomb Incorporated

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1.0 
TITLE PAGE 
A Study to Evaluate the Safety and Effectiveness of a 
Silicone Hydrogel Custom Contact Lens 
PROTOCOL 
STUDY #886 
Sponsor: 
Bausch & Lomb Incorporated 
This clinical investigation is being conducted in accordance with 21 Code of Federal 
Regulations (CFR) Parts 11, 50, 54, 56, and 812. The protocol was developed with 
consideration of the provisions in: International Organization for Standardization (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; International Conference on Harmonisation (ICH) Good Clinical Practice 
(GCP) and applicable local regulations. The Sponsor intends to register this clinical trial 
with the public database https://ClinicalTrials.gov. 
Revision Chronology: 
Original 
1.0 
November 2, 2018 
Revision 
2.0 
December 12, 2018 
Revision 
3.0 
January 25, 2019 
The confidential information in the following document is provided to you, as an Investigator or 
consultant, for review by you, your study personnel, and the applicable IRB/EC. By accepting 
this document, you agree that the information contained herein will not be disclosed to others 
without written authorization from Bausch & Lomb Incorporated, except to the extent necessary 
to obtain consent from those persons who participate in this study.  
Alden Optical® HP Sphere, Biotrue®, and ReNu MultiPlus® Lubricating and Rewetting Drops are 
registered trademarks of Bausch & Lomb Incorporated.  
NCT03897712

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3.0 
INVESTIGATOR STATEMENT OF APPROVAL 
 
A Study to Evaluate the Safety and Effectiveness of a 
Silicone Hydrogel Custom Contact Lens 
 
PROTOCOL 
STUDY #886 
 
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 21 Code of Federal Regulations (CFR) 
Parts 11, 50, 54, 56, and 812. The protocol was developed with consideration of the 
provisions in: International Organization for Standardization (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, International 
Conference on Harmonisation (ICH) Good Clinical Practice (GCP) and applicable local 
regulations.. I will not initiate the study until I have obtained written approval by the 
appropriate IRB/EC 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 a 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 IRB/ECs, 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 Incorporated and 
retain a copy for your files.  

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4.0 
PERSONNEL AND FACILITIES RESPONSIBLE FOR CONDUCTING 
STUDY 
NOTE: The information on this page is subject to change. All changes will be provided under separate 
cover. 
Sponsor  
Bausch & Lomb Incorporated 
1400 North Goodman Street 
Rochester, NY 14609 
 
CRO 
Promedica International 
3100 Bristol Street, Suite 250 
Costa Mesa, CA  92626  
 
 

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5.0 
TABLE OF CONTENTS 
PAGE 
1.0 TITLE PAGE ....................................................................................................................................... 1 
2.0 SPONSOR APPROVAL PAGE ......................................................................................................... 2 
3.0 INVESTIGATOR STATEMENT OF APPROVAL ......................................................................... 3 
4.0 PERSONNEL AND FACILITIES RESPONSIBLE FOR CONDUCTING STUDY .................... 4 
5.0 TABLE OF CONTENTS .................................................................................................................... 5 
6.0 LIST OF ABBREVIATIONS ............................................................................................................. 8 
7.0 INTRODUCTION ............................................................................................................................... 9 
8.0 OBJECTIVE ........................................................................................................................................ 9 
9.0 STUDY DESIGN .................................................................................................................................. 9 
9.1 DESCRIPTION OF STUDY DESIGN ....................................................................................................... 9 
9.2 SELECTION OF STUDY POPULATION ................................................................................................... 9 
9.2.1 
Eligibility ...............................................................................................................................10 
9.2.2 
Subject Completion ...............................................................................................................12 
9.2.3 
Subject Discontinuation .........................................................................................................12 
9.2.4 
Lost to Follow-Up .................................................................................................................13 
9.3 INVESTIGATORS ................................................................................................................................13 
9.4 STUDY DURATION ............................................................................................................................13 
9.5 TREATMENTS ....................................................................................................................................14 
10.0 STUDY MATERIALS ........................................................................................................................14 
10.1 DESCRIPTION OF TEST ARTICLE ........................................................................................................14 
10.2 DESCRIPTION OF COMPARATOR PRODUCT ........................................................................................14 
10.3 INSTRUCTIONS FOR USE AND ADMINISTRATION ...............................................................................14 
10.3.1 
Storage Requirements .......................................................................................................14 
10.3.2 
Subject Instructions ...........................................................................................................15 
10.3.3 
Fitting Guide .....................................................................................................................15 
10.4 OTHER MATERIALS ...........................................................................................................................15 
10.4.1 
Care System ......................................................................................................................15 
10.5 PACKAGING AND LABELING .............................................................................................................15 
10.6 ACCOUNTABILITY .............................................................................................................................16 
10.7 MASKING/UNMASKING .....................................................................................................................16 
10.8 REPLACEMENT LENSES .....................................................................................................................17 
10.9 RISK ASSESSMENT ............................................................................................................................17 
10.10 
METHODS OF ASSIGNING SUBJECTS TO TREATMENT GROUPS.....................................................17 
10.10.1 
Treatment Allocation ........................................................................................................17 
10.10.2 
Randomization Method .....................................................................................................17 
11.0 EFFECTIVENESS AND SAFETY VARIABLES ...........................................................................17 
11.1 PRIMARY EFFECTIVENESS VARIABLE ...............................................................................................17 
11.2 SECONDARY EFFECTIVENESS VARIABLES .........................................................................................18 
11.3 SAFETY VARIABLES ..........................................................................................................................18 
12.0 STUDY METHODS............................................................................................................................18 
12.1 STUDY VISITS ...................................................................................................................................18 
12.1.1 
Screening Visit (Visit 1) ...................................................................................................18 
12.1.2 
Dispensing Visit (Visit 2) .................................................................................................20 
12.1.3 
1-Week, 1-Month, 2-Month, and 3-Month Visits (Visits 3, 4, 5, and 6) ...........................21 
12.1.4 
Exit Visit ...........................................................................................................................22 
12.1.5 
Unscheduled Visits ...........................................................................................................22 

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12.1.6 
Missed Visits.....................................................................................................................24 
12.2 STUDY COMPLETION .........................................................................................................................24 
12.2.1 
Study Termination/Suspension .........................................................................................24 
12.3 CONCOMITANT MEDICATIONS/THERAPY ..........................................................................................24 
12.4 TREATMENT COMPLIANCE ................................................................................................................24 
12.5 PROTOCOL DEVIATIONS ....................................................................................................................25 
13.0 ADVERSE EVENTS ..........................................................................................................................25 
13.1 ADVERSE EVENT DEFINITIONS .........................................................................................................25 
13.1.1 
Adverse Events .................................................................................................................25 
13.1.2 
Adverse Device Effect ......................................................................................................25 
13.1.3 
Anticipated Serious Adverse Device Effect ......................................................................26 
13.1.4 
Unanticipated Adverse Device Effect ...............................................................................26 
13.1.5 
Serious Adverse Events (SAE) .........................................................................................26 
13.1.6 
Significant Non-Serious Adverse Events ..........................................................................27 
13.1.7 
Non-Significant Non-Serious Adverse Events ..................................................................27 
13.2 ADVERSE EVENT TREATMENT AND CULTURING ...............................................................................28 
13.2.1 
Medical Treatment Including Non-Adverse Events ..........................................................28 
13.3 EVALUATIONS ..................................................................................................................................28 
13.3.1 
Severity .............................................................................................................................28 
13.3.2 
Relationship to Study Device and/or Rewetting Drops ....................................................29 
13.4 PROCEDURES FOR REPORTING SERIOUS ADVERSE EVENTS, UNANTICIPATED ADVERSE DEVICE 
EVENTS, AND SIGNIFICANT NON-SERIOUS ADVERSE EVENTS ..........................................................29 
13.4.1 
On-Site Serious Adverse Event and Unanticipated Adverse Device Effect Reporting.....31 
13.4.2 
Off-Site Unanticipated Adverse Device Effect Reporting ................................................31 
13.4.3 
Reporting Device Deficiencies .........................................................................................32 
13.4.4 
Guidelines for Reporting Pregnancies ..............................................................................32 
14.0 STATISTICAL METHODS ..............................................................................................................33 
14.1 STUDY ENDPOINTS ...........................................................................................................................33 
14.1.1 
Primary Effectiveness Endpoint........................................................................................33 
14.1.2 
Primary Safety Endpoint ...................................................................................................33 
14.2 HYPOTHESES.....................................................................................................................................33 
14.2.1 
Primary Effectiveness Endpoint........................................................................................33 
14.3 PRIMARY SAFETY ENDPOINT ............................................................................................................33 
14.4 SAMPLE SIZE ....................................................................................................................................33 
14.4.1 
Primary Effectiveness Endpoint........................................................................................33 
14.4.2 
Primary Safety Endpoint ...................................................................................................34 
14.4.3 
Overall Power and Sample Size ........................................................................................34 
14.5 RANDOMIZATION ..............................................................................................................................34 
14.6 STUDY POPULATIONS .......................................................................................................................34 
14.6.1 
Intent-to-Treat Population .................................................................................................34 
14.6.2 
Per-Protocol Population ....................................................................................................34 
14.6.3 
Safety Population ..............................................................................................................35 
14.7 STATISTICAL ANALYSIS ....................................................................................................................35 
14.7.1 
Methods of Analysis .........................................................................................................35 
14.7.2 
Multiple Comparisons .......................................................................................................36 
14.7.3 
Interim Analyses ...............................................................................................................36 
14.7.4 
Missing Data .....................................................................................................................36 
15.0 DATA QUALITY ASSURANCE ......................................................................................................36 
15.1 STUDY MONITORING ........................................................................................................................36 
15.2 SOURCE DOCUMENTATION ...............................................................................................................37 
15.3 CASE REPORT FORMS AND DATA VERIFICATION ..............................................................................37 
15.4 RECORDING OF DATA AND RETENTION OF DOCUMENTS...................................................................38 
15.5 AUDITING PROCEDURES ...................................................................................................................39 
15.6 INSTITUTIONAL REVIEW BOARD APPROVAL .....................................................................................39 
15.7 PUBLICATION OF RESULTS ................................................................................................................39 

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16.0 REFERENCES ....................................................................................................................................40 
 
TABLES 
Table 1. Schedule of Visits ............................................................................................................................13 
Table 2. Non-serious Adverse Events ...........................................................................................................30 
Table 3. Serious Adverse Events, Unanticipated Device Adverse Events and Significant Non-Serious 
Adverse Events ..............................................................................................................................................31 
 
APPENDICES 
APPENDIX A: 
SCHEDULE OF VISITS AND PARAMETERS...................................................... A-1 
APPENDIX B: 
METHODS OF CLINICAL EVALUATION ............................................................B-1 
APPENDIX C: 
CORNEAL INFILTRATES EVALUATION FORM ................................................C-1 
APPENDIX D: 
SUBJECT INSTRUCTIONS FOR DAILY WEAR ................................................. D-1 
APPENDIX E: 
FITTING GUIDE FOR DAILY WEAR .................................................................... E-1 
APPENDIX F: 
CULTURE PROCEDURE ......................................................................................... F-1 
 

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6.0 
LIST OF ABBREVIATIONS 
Abbreviation Term  
ADE adverse device effect 
AE adverse event 
ANOVA analysis of variance 
BSCVA best spectacle-corrected visual acuity 
CFR Code of Federal Regulations 
eCRF electronic Case Report Form 
D diopter 
FDA US Food and Drug Administration 
GCP Good Clinical Practice 
HIPAA Health Insurance Portability 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 
MCMC Markov chain Monte Carlo 
MedDRA Medical Dictionary for Regulatory Activities 
MPS multi-purpose solution 
OD Doctor of Optometry 
PP per-protocol 
SAE serious adverse event 
SAP Statistical Analysis Plan 
SD standard deviation 
UADE unanticipated adverse device effect 
US United States 
USAN United States Adapted Name 
VA visual acuity 
NOTE: The first occurrence of some abbreviations is not spelled out in the document (eg, units of 
measure). 
 

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7.0 
INTRODUCTION  
Bausch + Lomb is evaluating the safety, efficacy, and product performance of an 
investigational silicone hydrogel contact lens. Silicone hydrogel contact lenses offer the 
advantage of high oxygen transmissibility compared to non-silicone hydrogel soft contact 
lenses, promoting the level of health of the eye. 
8.0 
OBJECTIVE 
The objective of this study is to evaluate the safety and efficacy of a custom silicone 
hydrogel contact lens when worn on a daily basis by currently adapted soft contact lens 
wearers. 
9.0 
STUDY DESIGN 
9.1 
Description of Study Design  
This is a multicenter, randomized 2:1, parallel, bilateral, double-masked study at 7 to 
10 investigative sites in the United States (US) comparing the Bausch + Lomb custom 
samfilcon B (test) lens with the hioxifilcon D, 54% water, Alden Optical® HP Sphere 
(control) lens. 
Approximately 84 subjects will be enrolled in this 3-month study.  
At the Screening Visit, approximately two-thirds of the eligible subjects will be 
randomized to receive the test lens (custom samfilcon B lenses) and the other one-third 
eligible subjects will be randomized to receive the control lens (Alden Optical HP 
Sphere). Both groups will wear their assigned lenses on a daily wear basis throughout the 
study with visits planned for Screening (Visit 1), Dispensing (Visit 2), 1 Week (Visit 3), 1 
Month (Visit 4), 2 Months (Visit 5), 3 Months (Visit 6) and/or a final Exit Visit.   
Subjects will be randomized sequentially by the randomization system as they are 
enrolled. Subjects will be dispensed product according to their assigned treatment and 
will remain masked during the entire study period.  
Subjects will be provided with test or control lenses as part of the dispensing package 
along with instructions for the use and care of the lenses.  
Subjects will be provided with ReNu MultiPlus® Lubricating and Rewetting Drops for 
use as needed during the study.   
Subjects will store their worn study lenses in a lens case filled with Bausch + Lomb 
Biotrue® multi-purpose solution (MPS).   
9.2 
Selection of Study Population  
Written informed consent, enrollment in the study, or dispensing of study products cannot 
begin until the Investigator has received Institutional Review Board (IRB) 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 

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subject who signs an Informed Consent Form (ICF). All screened subjects must be 
entered onto the Screening Log, in the order in which they were consented, where they 
will be assigned a sequential subject identification (ID) number. Once a potential subject 
is consented and their initials are entered onto the Screening Log, the Investigator should 
proceed with Screening procedures. 
Potential subjects are deemed either “Screen Pass” or “Screen Fail.” “Screen Fail” 
subjects are subjects who have not met the study inclusion criteria or have met the 
exclusion criteria and cannot be randomized into the study.  
“Screen Pass” subjects have met all of the study inclusion criteria and have not met any 
of the exclusion criteria. Only “Screen Pass” subjects can be randomized to receive the 
study lenses and can be assigned a subject identification (ID) number from the 
randomization system. 
Once a subject is randomized, a subject is considered active and must be accounted for at 
every visit until exited (completed or discontinued) from the study, even if they are not 
dispensed study materials. Refer to Section 9.2.4 for subjects determined to be lost to 
follow-up. 
9.2.1 
Eligibility 
 
Inclusion Criteria  
1. Subjects must be 18 to 40 years old on the date the ICF is signed and have the 
capacity to provide voluntary informed consent.  
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 have clear central corneas and be free of any anterior segment 
disorders in each eye. 
4. Subjects must be myopic, require contact lens correction from -1.00 diopter (D) to -
6.00 D, and wear contact lenses in each eye. 
5. Subjects must be correctable through spherocylindrical refraction to 47 letters 
(0.0 logarithm of the minimum angle of resolution [logMAR]) or better (distance, 
high-contrast) in each eye.  
6. Subjects must be able and willing to comply with all treatment and follow-up/study 
procedures. 
7. Subjects must be adapted soft contact lens wearers and agree to wear their study 
lenses on a daily wear basis for approximately 3 months. 
 
Exclusion Criteria 
1. Subjects participating in any drug or device clinical investigation within 2 weeks 
prior to entry into this study 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: 

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− She is currently pregnant. 
− She plans to become pregnant during the study. 
− She is breastfeeding. 
3. Subjects who have worn gas permeable lenses in either eye within the last 30 days or 
who have worn polymethylmethacrylate lenses in either eye within the last 3 months.  
4. Subjects with any systemic disease currently affecting ocular health or which in the 
Investigator’s opinion may have an effect on ocular health in either eye during the 
course of the study. 
5. Subjects using any systemic or topical medications that will, in the Investigator’s 
opinion, affect ocular physiology or lens performance. 
6. Subjects with an active ocular disease in either eye or who are using any ocular 
medication. 
7. Subjects who currently wear monovision, multifocal, or toric contact lenses in either 
eye.  
8. Subjects with an ocular astigmatism >1.00 D in either eye. 
9. Subjects with anisometropia (spherical equivalent) >2.00 D. 
10. Subjects with any Grade ≥2 finding in either eye during the slit lamp examination 
(refer to APPENDIX B for methods of clinical evaluation). Subjects with corneal 
infiltrates in either eye, of ANY GRADE, are not eligible to participate in this study. 
11. Subjects with any “Present” finding during the slit lamp examination in either eye 
(refer to APPENDIX B for methods of clinical evaluation) 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 in 
either eye. 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 to participate in this study.  
13. Subjects who are aphakic in either eye. 
14. Subjects who are amblyopic in either eye. 
15. Subjects who have had any corneal surgery (eg, refractive surgery) in either eye. 
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 (eg, Alcon, 
Bausch + Lomb, Ciba Vision, CooperVision, Johnson & Johnson, etc.) 
− The subject, or a member of the subject’s household, is an employee of a market 
research firm. 

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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 and are considered a “Screen Fail”. Any subject enrolled in the 
study who later is found to have not met the eligibility criteria at entry will be 
discontinued. 
9.2.2 
Subject Completion 
The subject has completed the study when the 3-Month Visit is concluded. Subjects who 
require further follow-up will be followed according to the Adverse Event or 
Unscheduled Visit Section. 
9.2.3 
Subject Discontinuation 
A subject MAY be discontinued (at the discretion of the Investigator, the Sponsor, and/or 
the IRB) prior to the final study visit for a variety of reasons, including, but not limited 
to:  
• An adverse event (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 
A subject MUST be discontinued prior to the final study visit (3-Month Visit [Visit 6]) 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 
• Ineligible after randomization – a subject who was enrolled but was later found to 
have not met the eligibility criteria in the protocol 
• Inability to maintain recommended wearing schedule 
• Continued failure to follow subject instructions 
• Misses more than one consecutive follow-up visit 
• Lack of motivation 
• Lost to follow-up (refer to Section 9.2.4) 
• Instillation of non-medically indicated solution not specified in the protocol 
• Other eye is discontinued 
• Becomes pregnant during the study 
Prior to discontinuing a subject, every effort should be made to contact the subject, 
schedule an Exit Visit, obtain as much follow-up data as possible, and retrieve all study 
materials. Adverse events will be followed as described in Section 13.0. Subject 

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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 who are discontinued from the study following 
randomization will not be replaced. 
Exit Visit assessments should be completed for discontinued subjects. 
9.2.4 
Lost to Follow-Up 
Subjects who do not return for scheduled follow-up visits, as defined by the visit window 
and cannot be contacted, are to be considered lost to follow-up. All attempts to contact 
the subject should be documented and kept with the subject’s source documentation, and 
the applicable eCRFs will be completed. The exit date will be the date of the subject’s 
last visit to the clinic as a study subject. 
9.3 
Investigators 
The study will be conducted at approximately 7-10 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. Principal Investigators and Sub-
Investigators will be identified on the Device Investigator Agreement Form. 
Each Investigator will attempt to enroll approximately 8-12 subjects. In the event that 
selected sites do not meet full enrollment, the Sponsor may decide to increase enrollment 
as needed at other currently active sites and/or additional site(s) may be added to satisfy 
the enrollment requirements of the study.  
9.4 
Study Duration 
Subjects will be followed for 3 months after dispensing (unless discontinued or lost to 
follow-up) and must adhere to the following schedule: 
Table 1. Schedule of Visits 
Visit Number 
Visit Name 
Target 
Acceptable Visit Range  
1 
Screening Visit 
None 
Day -30 to Day-7 
2 
Dispensing Visit 
Day 1 
Not applicable 
3 
1-Week Visit 
Day 8 
Day 5 – 9 
4 
1-Month Visit 
Day 31  
Day 27 – 35 
5 
2-Month Visit 
Day 61 
Day 54 – 68 
6 
3-Month Visit 
Day 92  
Day 91* – 101 
 *CRITICAL NOTE: The 3-Month Visit must occur no earlier than Day 91. 
The visit range is based on the date test lenses are initially dispensed (Dispensing Visit). 
A visit scheduling table will be provided in the initial study shipment to aid the 
Investigator in scheduling follow-up visits. 

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9.5 
Treatments 
Approximately 56 subjects (112 eyes) will be randomized to receive Bausch + Lomb 
investigational custom samfilcon B lenses and approximately 28 subjects (56 eyes) will be 
randomized to receive Alden Optical HP Sphere contact lenses. Subjects will be assigned 
randomization numbers, according to the randomization system. 
Subjects will wear their lenses on a daily wear basis for 3 months. 
NOTE: Use of other contact lenses is not allowed during the study. 
10.0 STUDY MATERIALS 
Bausch + Lomb will provide all study materials at no charge to the Investigator. All study 
materials will be provided to the site for each subject prior to the start of the study. Refer 
to Section 10.8 for ordering replacement test or control product in the case of loss or 
damage.  
10.1 Description of Test Article  
The Bausch + Lomb investigational custom samfilcon B contact lens (test) is an 
investigational silicone hydrogel contact lens which will be provided in the following 
parameters: 
• Sphere Power: -1.00 to -6.00 D in steps of 0.25 D 
• Diameter: 14.2 mm 
• Base Curve: 8.6 mm 
• Material: samfilcon B, 41% water 
10.2 Description of Comparator Product  
The Alden Optical HP Sphere contact lens (control) is a hydrogel contact lens which will 
be provided in the following parameters: 
• Sphere Power: -1.00 to -6.00 D in steps of 0.25 D 
• Diameter: 14.2 mm Visibility tint  
• Base Curve: 8.3 mm 
• 
Material: hioxifilcon D, 54% water  
10.3 Instructions for Use and Administration  
New study lenses will be dispensed at the Dispensing Visit. Lenses will be worn on a 
daily basis for 3 months. Subjects must wear their study lenses to all follow-up visits.  
10.3.1 
Storage Requirements 
All test and control lenses provided by the Sponsor must be stored in a secure location 
accessible only to study personnel and maintained at room temperature. 

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10.3.2 
Subject Instructions 
a. All subjects must be given Subject Instructions (see APPENDIX D) for use of the 
study lenses. Subjects must comply with the instructions provided to them. 
Subject Instructions will be supplied to the Investigator by Bausch + Lomb for 
distribution to the subject.  
b. All subjects must refer to the Bausch + Lomb Biotrue Multi-Purpose solution 
package insert for care instructions, precautions, and warnings related to contact 
lens wear.  
c. The Investigator or other designee must review instructions and warnings for lens 
wear, lens care, handling, cleaning, and disinfecting with the subject. 
d. Any subject who does not follow instructions to a degree that, in the Sponsor’s or 
Investigator's opinion, jeopardizes the subject's well-being or the validity of the 
study, must be discontinued. 
10.3.3 
Fitting Guide 
The Investigator should refer to the Fitting Guide (see APPENDIX E) for fitting the test 
and control lenses. 
10.4 Other Materials  
10.4.1 
Care System  
All subjects will be dispensed the following care products for use during the study: 
• Biotrue Multi-Purpose solution for daily rinsing, cleaning, disinfecting, and 
storing their lenses in lens cases. All commercially available Biotrue bottles 
include a green lens case. 
• ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the 
study 
Investigators will be provided Biotrue Multi-Purpose solution and lens cases for return of 
study lenses to the Sponsor at the end of the study. 
NOTE:  Use of other contact lens care products is not allowed during the study.   
10.5 Packaging and Labeling 
The test lenses (custom samifilcon B) used in this study will be packaged in glass vials 
with investigational labels. The labels will contain the following information: 
• Lens power 
• Base curve 
• Lens diameter 
• Lot number 
• Expiration date 
• Manufacturer’s name and location 
• Caution statement 

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The control lenses (Alden Optical HP Sphere) used in this study will be provided in the 
glass vials. The labels will contain the following information: 
• Lens power 
• Base curve 
• Lens diameter 
• Lot number 
• Expiration date 
• Manufacturer’s name and location 
10.6 Accountability 
The unmasked designee will be responsible for keeping current and accurate records of 
the amount of study test lenses received and dispensed, and its disposition. The study 
lenses must be stored under the appropriate conditions in a secure area and are to be 
dispensed only to subjects enrolled in the study, in accordance with the conditions 
specified in this protocol. During the course of the study, the unmasked designee must 
maintain an inventory of all lenses dispensed to or returned by the subject, including 
subject identifiers. A Product Accountability Log will be provided to the sites to maintain 
records of the study lenses assigned to each enrolled subject. 
At time points throughout the study and/or upon completion of the study, the 
Sponsor/Sponsor's representative will review and verify the Investigator's Product 
Accountability Logs. Following verification, and as directed by the Sponsor, all worn and 
unworn lenses must be returned to the Clinical Trial Materials Supply Management at the 
address listed on the Personnel and Facilities page. 
10.7 Masking/Unmasking  
This study is double-masked; therefore, the Investigator/site staff, subjects, and Bausch + 
Lomb personnel or designee(s) involved in the collection of study data will be masked to 
the study lenses. Each site must have an unmasked designee that will be responsible for 
dispensing and accountability. This designee shall not participate in study assessments 
that may cause bias to the study data. Study Monitors will become unmasked during site 
visits when they perform product accountability.  
Lens markings on both products are not product-specific. Markings and lens tints are 
similar between products and are indistinguishable.  
Randomization will be produced prior to study enrollment by an unmasked statistician 
not otherwise involved in the trial. An unmasked designee will be responsible for 
dispensing the test and control lenses according to the randomization system. 
Investigators will not have access to the randomization system information and lenses 
will be dispensed directly to the subject, thereby maintaining Investigator masking. In an 
effort to ensure that both the Investigator and subject remain masked, the unmasked 
designee MUST dispense the study lenses and MUST remove lenses from their glass 
vials out of the Investigator’s and subject’s sight immediately prior to dispensing. 
Subjects will not be given additional replacement lenses to take home, thereby 

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maintaining subject masking. A reserve pair will remain at the site if a replacement is 
needed. 
The Investigator should contact the Medical Monitor prior to unmasking of study lenses. 
In an emergency situation, however, where knowledge of the study lenses is critical to 
subject safety, the code may be broken by requesting the allocated treatment for that 
subject from the unmasked designee.  
The Investigator must notify the Sponsor 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. 
10.8 Replacement Lenses 
Replacements are permitted for damage, satisfaction, and vision at the discretion of the 
Principal Investigator. All lens replacements need to be tracked for reason and date and 
must also be rechecked for fit. 
A reserve pair of study lenses for each dispensed subject should be retained in-office at 
all times in case a non-scheduled lens replacement is required. If the reserve is used, an 
immediate replacement order is required. Any additional/replacement of test or control 
products (in the case of loss or damage) must be ordered through Clinical Trial Materials 
using the Replacement Lens Order Form for Study #886. Do not order through 
Bausch + Lomb Customer Service. The form can be scanned to 
10.9 Risk Assessment 
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. 
10.10 Methods of Assigning Subjects to Treatment Groups 
10.10.1 Treatment Allocation 
Randomized treatment assignments will be allocated to eligible subjects sequentially 
using the next available assignment in the randomization schedule. 
10.10.2 Randomization Method  
Randomization will be provided to the sites via the randomization system. When it is 
time to randomize an eligible subject, the unmasked designee will use the randomization 
system to obtain the subject’s treatment assignment. 
11.0 EFFECTIVENESS AND SAFETY VARIABLES 
11.1 Primary Effectiveness Variable 
The primary effectiveness endpoint will be statistical non-inferiority with respect to mean 
distance high-contrast logMAR lens VA for each eye between the test and control lenses.  

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11.2 Secondary Effectiveness Variables 
Not applicable. 
11.3 Safety Variables  
The primary safety endpoint will be statistical non-inferiority with respect to the 
proportion of eyes with any slit lamp findings Grade >2 at any follow-up visit between 
the test and control lenses. 
12.0 STUDY METHODS 
12.1 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. Both the Investigator 
and subject must keep the signed ICF document. It is strongly preferred that the signed 
original document be retained in the subject’s records, while a copy be provided to the 
subject. In addition, the applicable privacy regulation requirements must be met.  
12.1.1 
Screening Visit (Visit 1) 
NOTE: All VA measurements MUST be made using a phoropter. 
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 and any other applicable state requirements. 
The Investigator will send a copy of the Screening Log to the Sponsor. The Investigator 
will retain the original document for his/her records. 
After obtaining written informed consent, prospective subjects will be screened to 
determine whether they meet the entry criteria for the study.  
Screening will proceed as follows: 
a. Enter the subject information on the next available line of the Screening Log. 
b. Collect subject’s medical history 
c. Collect the following lens history information from the subject: 
‒ Average number of days per week worn 
‒ Average daily wearing time, hours per day  
‒ Average hours of comfortable wear per day 

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‒ Hours lenses worn on the day of this visit 
‒ Current lens brand and lens wear modality 
‒ Current lens care products  
d. Collect demographic and baseline information and perform the following baseline 
assessments (without lenses) and record in the subject’s source document: 
‒ Spherocylindrical refraction 
‒ Distance best spectacle-corrected visual acuity (BSCVA) 
‒ Keratometry 
e. Perform a slit lamp examination (remove the lenses if the subject wore lenses to 
the visit). Record and diagram the results and findings in the subject’s source 
document and appropriate eCRF: 
− 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 [APPENDIX C]) 
− any other graded slit lamp findings Grade 2 or greater   
f. Indicate on the Screening Log whether the subject is a “Screen Pass” or “Screen 
Fail.”  
‒ “Screen Fail” subjects are ineligible and cannot be randomized in the 
study. The reason for screen failure must be documented on the Screening 
Log and in the subject record and must be maintained with a copy of their 
ICF. 
‒ Only “Screen Pass” subjects should be randomized in the study. 
g. If the subject is eligible, collect Symptoms/Complaints and Subjective 
Assessment information from the subject regarding their habitual lenses. 
h. Assign subject numbers based on the randomization system. The unmasked 
designee will determine the subject’s randomized lens by using the randomization 
system and record on the Screening Log.  
i. Assess BSCVA to determine subject prescription. The prescription determined 
from this fitting assessment will be used to dispense/order test or control lenses 
according to the lens to which the subject is randomized.  
j. Record the lens parameters to be dispensed/ordered based on the diagnostic 
fitting. 
k. For each subject, use the lens order form to order the appropriate study contact 
lenses (test or control). Schedule the subject for their Dispensing Visit within 30 
days. 

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l. Collect/assess all AEs, including serious or significant non-serious AEs, since 
consent was signed. 
m. For female subjects, re-emphasize the exclusion criterion stating that if the subject 
is of childbearing potential and is pregnant and or breast feeding, she is ineligible 
to be a part of the study. 
12.1.2 
Dispensing Visit (Visit 2) 
a. Collect/assess all AEs, including serious or significant non-serious AEs. 
b. Perform a slit lamp examination (remove the lenses if the subject wore lenses to 
the visit). Record all slit lamp findings and, at a minimum, sketch the following in 
the subject’s source document: 
‒ any ungraded finding marked as “PRESENT” 
‒ any new 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 [APPENDIX C])  
‒ any other graded slit lamp findings Grade 2 or greater 
c. Dispense study lens, record sphere power, record in Product Accountability Log. 
In an effort to ensure that both the Investigator and subject remain masked, the 
unmasked designee MUST dispense the study lenses and MUST remove lenses 
from their glass vials out of the Investigator’s and subject’s sight immediately 
prior to dispensing.   
d. Subject inserts pair of the study lenses in his/her eyes. 
NOTE:  Study lenses should be allowed to equilibrate a minimum of 3 minutes on the eye.  
e. After a minimum of 3 minutes, perform the following assessments: 
‒ Collect Symptoms/Complaints and Subjective Assessment information  
‒ Distance high-contrast logMAR lens VA 
‒ Over-refraction and distance VA 
‒ Lens wettability, centration, movement  
‒ Lens deposits 
For each eye, compare the distance high-contrast logMAR lens VA to the distance 
BSCVA obtained at the Screening visit. If the VA has decreased by ≥5 letters 
(0.1 logMAR), explain. 
f. Dispense lens case. Instruct the subject to store their study lenses in the lens case 
filled with Bausch + Lomb Biotrue MPS according to the Subject Instructions 
(APPENDIX D). 
g. If the subject is discontinued or exited at this visit, complete the Exit Visit eCRF. 

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h. For female subjects, re-emphasize the exclusion criterion stating that if the subject 
is of childbearing potential and is pregnant and or breast feeding, she is ineligible 
to be a part of the study. 
12.1.3 
1-Week, 1-Month, 2-Month, and 3-Month Visits (Visits 3, 4, 5, and 6) 
NOTE:  All VA measurements MUST be made using a phoropter. 
 
NOTE:  If all scheduled visits are performed on time and the subject completed the 3-Month Visit, the 
Exit Visit will be done at the same time. 
NOTE:  Study lenses should not be dispensed at this visit unless replacement lenses are required. Lenses 
worn to this visit should be returned to the subject for use until the next scheduled visit. 
NOTE:  If the subject does not come to a visit wearing lenses due to requiring a replacement and is not 
experiencing any problems, it is preferred to do an Unscheduled Visit for Product Dispensing 
Only and reschedule the current visit within the visit window. Refer to Unscheduled Visit, 
Section 12.1.4.  
a. Collect/assess all AEs, including serious or significant non-serious AEs. 
b. Collect the following lens information from the subject: 
‒ Average number of days per week worn 
‒ Average daily wearing time, hours per day  
‒ Average hours of comfortable wear per day 
‒ Hours lenses worn on the day of this visit  
c. Collect Symptoms/Complaints and Subjective Assessment information from the 
subject regarding their study lenses. 
d. Evaluate the lenses (while on eye), and record the following assessments: 
‒ Distance high-contrast logMAR lens VA 
‒ Over-refraction and distance VA 
‒ Lens wettability, centration, movement 
‒ Lens deposits 
For each eye, compare: 
‒ The distance high-contrast logMAR lens VA at this visit to the distance 
high-contrast logMAR lens VA obtained at the Dispensing Visit.  
‒ The distance high-contrast logMAR lens VA at this visit to the distance 
BSCVA obtained at the Screening Visit 
‒ If the VA has decreased by ≥10 letters (0.2 logMAR), explain. 
e. Perform a slit lamp examination (remove the lenses if the subject wore lenses to 
the visit) and note the following: 
‒ Any ungraded finding marked as “Present” 
‒ Any new corneal scars 
‒ Any neovascularization within the central 6 mm of the cornea 
‒ Any corneal staining 

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‒ Any corneal infiltrate (record details on the Corneal Infiltrates Evaluation 
Form – APPENDIX C) 
‒ Any other graded slit lamp findings Grade >2  
f. For female subjects, re-emphasize the exclusion criterion stating that if the subject 
is of childbearing potential and is pregnant and or breast feeding, she is ineligible 
to be a part of the study. 
12.1.4 
Exit Visit 
NOTE:  All VA measurements MUST be made using a phoropter. 
 
NOTE:  If a subject requires further follow-up on an AE/SAE upon discontinuation or completion of 3-
Month Visit, the Investigator must schedule Unscheduled Visits to follow up as necessary. At 
these unscheduled follow-up visits, the subject should remove contact lenses s/he may be 
wearing. At a minimum, a slit lamp examination, keratometry, spherocylindrical refraction, and 
distance BSCVA should be completed. The Investigator is required to follow the subject until 
the condition no longer warrants further follow-up for study purposes. An Unscheduled Visit 
eCRF must be completed for each of these follow-up visits.  
a. 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. 
b. Collect/assess all AEs, including serious or significant non-serious AEs. 
c. Collect study lens from subject and record in Product Accountability Log. 
d. For all subjects, complete an exit ocular examination without lenses on the eyes. 
Collect the following assessments at the 3-Month Visit or at the Exit Visit: 
‒ Spherocylindrical refraction 
‒ Distance BSCVA 
‒ Keratometry 
e. For each eye, compare the final visit distance BSCVA to the distance BSCVA 
obtained at the Screening Visit. If the VA has decreased by ≥10 letters 
(0.2 logMAR), explain. 
f. For each eye, compare the final visit keratometry readings to the Screening Visit 
keratometry readings. If there is a change of ≥1.00 D, explain. 
g. The Subject Exit eCRF should be completed.   
12.1.5 
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. 
If a subject is seen for multiple visits during a given visit timeframe, the data from the 
visit that is intended to meet the protocol requirements for the scheduled visit should be 
captured on the visit eCRF. Where such a determination cannot be made, the first visit 

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within the scheduled visit interval will be used for completion of the protocol-required 
scheduled visit eCRF. Data from any additional visits within a scheduled visit interval 
will be captured on an Unscheduled Visit eCRF.  
 
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 an effort to ensure the 
Investigator remains masked, an unmasked designee MUST dispense the lens(es) to the 
subject. Record lenses dispensed in the Product Accountability Log.  
12.1.5.1.1. If study lenses are dispensed, collect the following information in the source 
document and transcribe to the Product Dispensing Only eCRF Form: 
• Visit date 
• Subject ID number 
• Subject initials 
• Primary reason for lens replacement 
• Dispensed lens power 
 
If any assessment is performed, then an Unscheduled Visit Form must be 
completed instead of a Product Dispensing Only Form. 
NOTE:  All worn study lenses are to be returned to the Sponsor at the end of the study as directed with 
the materials provided. Worn lenses will be dry stacked in lens cases and returned to Bausch 
and Lomb. All contact lenses must be accompanied by a CTM Product Accountability Log. 
If a subject is experiencing problems, complete the following: 
a. Indicate the reason for the Unscheduled Visit. 
b. Collect/assess all AEs, including serious or significant non-serious AEs. 
c. Collect Symptoms/Complaints and Subjective Assessment information.  
d. Evaluate the lenses (while on eye) and record the following assessments in the source 
documentation and eCRF: 
‒ Distance high-contrast logMAR lens VA 
‒ Over-refraction and distance VA 
‒ Lens wettability, centration and movement 
‒ Lens deposits 
For each eye, compare the distance high-contrast logMAR lens VA to the distance 
BSCVA obtained at the Screening Visit. If the VA has decreased by ≥10 letters (0.2 
logMAR), record in the subject’s source document and explain. 
e. Perform the following assessments without lenses and record in the subject’s source 
document: spherocylindrical refraction, distance BSCVA, and keratometry. 

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f. Perform a slit lamp examination (without lenses). Record all slit lamp findings and, at 
a minimum, sketch the following in the subject’s source document: 
‒ Any ungraded finding marked as “PRESENT” 
‒ Any new 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 [APPENDIX C]) 
‒ Any other graded slit lamp findings Grade ≥2 
g. For female subjects, re-emphasize the exclusion criterion stating that if the subject is 
of childbearing potential and is pregnant and or breast feeding, she is ineligible to be 
a part of the study. 
h. If the subject is discontinued or exited at this visit, the Exit Visit Form should also be 
completed. 
12.1.6 
Missed Visits  
If a subject misses any scheduled follow-up visit and cannot be seen prior to the start of 
the visit range for the next scheduled follow-up visit, the visit is considered missed. 
Indicate a missed visit on the eCRF for that scheduled visit. 
12.2 Study Completion  
Bausch + Lomb Global Clinical Operations will notify the Investigator when to contact 
the IRB to inform them that the study is complete. 
12.2.1 
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 US Food and Drug Administration (FDA) or Local Health 
Authority, as applicable. Bausch + Lomb Global Clinical Operations will instruct the 
Investigators to stop/restart dispensing study materials and will arrange for study 
closeout, if applicable, at each site. 
12.3 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 also prohibited, unless 
medically necessary during the course of the study. If used during the course of the study, 
these medications must be reported in the source and the appropriate eCRF. 
12.4 Treatment Compliance  
The Investigator or other designee will review instructions and warnings for lens wear, 
lens care, handling, cleaning, and disinfecting with the subject. Any subject who does not 

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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 must be discontinued. 
12.5 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.  
Subjects may continue to participate until the end of the study, unless the protocol 
deviations put the subject at risk or the subject’s condition requires that they be 
discontinued from the study. 
13.0 ADVERSE EVENTS 
13.1 Adverse Event Definitions 
For the purposes of this study, AEs include ocular AEs in the study eye(s), all ocular and 
non-ocular serious adverse events (SAEs), adverse device effects (ADEs), and 
unanticipated adverse device effects (UADEs). AEs, SAEs, ADEs, and UADEs are 
defined as follows: 
13.1.1 
Adverse Events 
An adverse event (AE) is 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 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 possible 
AEs. The term “AEs” includes both SAEs and significant non-serious AE. Each are 
defined below. 
If an AE occurs, the first concern will be the safety of the subject and appropriate medical 
intervention will be made. All AEs (SAEs and significant non-serious AEs) that occur 
will be reported in this study. 
AEs should be differentiated into device related and non-device related. Any corneal 
infiltrate, ulcer, neovascularization, etc. shall be presumed to be device related, in the 
absence of an alternative explanation. 
All AEs occurring after signing of informed consent and through the subject’s end of 
participation in the study must be reported. All AEs must be followed until the event 
resolves or stabilizes. 
All AEs should be photo documented and communicated to the CRO and Sponsor in 
electronic form. 
13.1.2 
Adverse Device Effect 
An adverse device effect (ADE) is an AE related to the use of an investigational medical 
device. This definition includes AEs resulting from insufficient or inadequate instructions 

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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. 
13.1.3 
Anticipated Serious Adverse Device Effect 
An anticipated serious adverse device effect (ASADE) is a serious adverse device effect 
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 may include but are not limited to:   
• 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 
13.1.4 
Unanticipated Adverse Device Effect  
An unanticipated adverse device effect (UADE) is any serious adverse 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. 
13.1.5 
Serious Adverse Events (SAE) 
• Serious adverse event is 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 
(eg, 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:  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 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. 

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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: 
o Central or para-central location;  
o Penetration of Bowman’s membrane; 
o Infiltrate ≥2 mm diameter; 
o Associated with iritis Grade ≥2;  
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 vascularization); 
• Any serious adverse ophthalmic events including hypopyon and hyphema; 
• Any neovascularization within the central 6 mm of the cornea; 
• Permanent loss of ≥2 lines of BSCVA; 
• All cases of iritis. 
13.1.6 
Significant Non-Serious Adverse Events 
Significant non-serious AEs should include: 
• Peripheral non-progressive non-infectious corneal ulcers; 
• All symptomatic corneal infiltrative events; 
• All cases of corneal staining Grade ≥3; 
• A temporary loss of ≥2 lines of BSCVA (for ≥2 weeks); 
• Neovascularization cases Grade ≥2. 
Any ocular event that necessitates temporary lens discontinuation of ≥2 weeks 
13.1.7 
Non-Significant Non-Serious Adverse Events 
Non-significant non-serious AEs may include but are not limited to:          
• Bacterial conjunctivitis; 
• Viral conjunctivitis; 

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• Allergic conjunctivitis; 
• Corneal edema; 
• Contact lens‒related papillary conjunctivitis; and, 
• Loss of contrast sensitivity. 
13.2 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). The culturing techniques are outlined in APPENDIX F. 
When a culture is obtained, the contact lenses and contact lens cases which were being 
utilized by the subject at the time of the AE should be collected from the subject for 
culturing and processing by the clinical lab designated by the site. 
Microbial data generated from returned subject supplies (eg, lenses, lens cases, and/or 
lens case solutions) are for information only. Because microbes may be introduced into 
subject supplies during use, recovery of microbes from returned subject supplies cannot 
be presumed to indicate etiology or direction of organism transmission. 
The ocular cultures, along with the associated contact lenses and contact lens cases, will 
be sent to the clinical laboratory designated by the site for analysis. The clinical 
laboratory will report the culture results to both the Investigator and to the Sponsor. 
13.2.1 
Medical Treatment Including Non-Adverse Events 
In the event that a subject requires medical treatment (prescription medication) for an 
ocular condition, treat the subject as appropriate to prevent further complications and to 
potentially resolve the event. 
 
13.3 Evaluations 
When evaluating AEs, the Investigator must determine if the event is serious (refer to 
Section 13.1.5 for criteria) and assess the severity of symptoms and the relationship of the 
event to the study device using the following guidelines: 
13.3.1 
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. 

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13.3.2 
Relationship to Study Device and/or Rewetting Drops 
• Related: There is at least a reasonable possibility that the AE/SAE is related to 
the study device and/or Rewetting Drops. Reasonable possibility means that there 
is evidence to suggest a causal relationship or association between the study 
device and/or Rewetting Drops and the AE. Also referred to as an ADE. 
• Unrelated: There is little or no reasonable possibility that the AE/SAE is related 
to the study device and/or Rewetting Drops. This assessment implies that the 
AE/SAE has no evidence to suggest either a causal relationship or association to 
the study device and/or Rewetting Drops and a more likely or certain alternative 
etiology exists. 
13.4 Procedures for Reporting Serious Adverse Events, Unanticipated Adverse 
Device Events, and Significant Non-Serious Adverse Events 
Events classified as SAE/UADE or significant non-serious AEs require expeditious 
handling and reporting to the Sponsor or designee to comply with regulatory 
requirements, as follows: 
• Must be immediately reported to the Medical Monitor within 24 hours of 
knowledge of the event using the Sponsor-provided form (SAE/UDE reporting 
form) by emailing the completed form to 
. The 
Medical Monitor will email a copy of the form to: 
; 
 upon receipt. The Medical Monitor will email/fax 
a copy of the form immediately (within 24 hours) for SAEs only to 
upon receipt. 
• Investigators should not wait to receive additional information to fully document 
the event before notifying the medical monitor and Sponsor/designee of an 
SAE/UADE/significant non-serious AE. If only limited information is initially 
available, follow-up reports are required. Additional relevant information such as 
hospital records and autopsy reports should be provided to the Sponsor/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/UADE/significant 
non-serious AEs 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. 
In the case of an AE (serious and significant non-serious) or medical treatment (non-AE), 
the Investigator must: 
• Report the AE or medical treatment to the Medical Monitor and Sponsor/designee 
within 24 hours of knowledge of the event using the Sponsor-provided form 
(SAE/UADE Report Form) by emailing the completed form to the Medical 
Monitor and Sponsor/designee. 
• Indicate on the Initial SAE/UADE Report Form whether the SAE/UADE is 
presumed to be not study related, lens related, solution related, or both 
lens/solution related. 

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• 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. 
• Enter the SAE/UADE/significant non-serious AE into the eCRF within 3 business 
days of submitting the Initial SAE/UADE Report Form. 
• Continue to update the eCRF, if applicable, each time the subject is seen during 
the management of the incident and at resolution of the incident. Whenever 
possible, it is suggested that the Investigator take photographs of all AEs and 
forward them to the Sponsor. 
• Cases requiring medical treatment will be evaluated by the Sponsor. Upon review 
of the medical treatment, Bausch + Lomb Clinical Operations representatives may 
contact the Investigator to request further information concerning the treatment. 
• Submit all bills, prescription receipts, and culture reports/fees related to the AE to 
Bausch + Lomb Clinical Operations. Expenses incurred for study-related medical 
treatment will be paid by Bausch + Lomb Clinical Operations. 
Actions required by Investigators for reporting non-serious ocular AEs in the study eye(s) 
are summarized below. 
Table 2. Non-serious Adverse Events 
Actions required by Investigators for reporting all SAEs in the study eye(s) and/or non-
study eye are summarized below. 
 
 
Non-serious ocular 
AEs in the study eye(s) 
 
Non-device-related 
 
Device-related 
Required action 
Recorded on AE CRF only; 
No expedited report to Sponsor;  
No report to IRB 

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Table 3. Serious Adverse Events, Unanticipated Device Adverse Events and 
Significant Non-Serious Adverse Events 
SAEs (ocular and non-
ocular), UADE, significant 
non-serious AE 
Non-device-
related 
Device-related 
Anticipated 
Unanticipated 
Required action 
Recorded on SAE/UADE Report 
Form and AE CRF 
 
Investigator submits expedited 
report to Sponsor and its 
representative within 24 hours;   
Report to IRB, if required per 
IRB policy 
 
Recorded on SAE/UADE Report 
Form and AE CRF 
 
Investigator submits expedited report 
to Sponsor and its representative 
within 24 hours; Investigator reports 
to IRB within 10 working days or 
per IRB policy, whichever is shorter 
Sponsor conducts evaluation 
 
Sponsor or its representative reports 
to FDA, all IRBs, and all 
Investigators within 10 working days 
13.4.1 
On-Site Serious Adverse Event and Unanticipated Adverse Device Effect 
Reporting 
The site must report any SAE or UADE on a SAE/UADE report form and any available 
documents 24 hours of becoming aware of an event.  
The contacts for reporting SAEs/UADEs are: 
 
 
 
and 
 
  
 
  
  
The site must also report UADEs to the reviewing IRB within 10 working days following 
awareness of the UADE or according to the established reporting procedures of the IRB, 
whichever is shorter. The site should also complete applicable CRFs within 3 working 
days of event identification. The Sponsor or its representative will report the UADE to 
the FDA, all other IRBs, and all Investigators within 10 working days after first being 
informed by the Investigator. 
13.4.2 
Off-Site Unanticipated Adverse Device Effect Reporting 
When participating in multicenter clinical investigations, Principal 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 article, that 
met the criteria for reporting to a regulatory agency. These should be reported to the 
reviewing IRB within 10 working days or per their established reporting procedures, 
whichever is shorter. 

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13.4.3 
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 with a test or control lens during this trial to the 
Sponsor and its representative promptly. The Sponsor 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. 
The contact for reporting device deficiencies is: 
 
 
 
The Sponsor shall review all device deficiencies and determine and document in writing 
whether they could have led to an SAE. In the event of a disagreement between the 
Sponsor and the Investigator(s), the Sponsor shall communicate both opinions to the 
reviewing IRB per their established reporting procedures and the health authority. 
13.4.4 
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 (eg, missed 
or late menstrual period). Female subjects who become pregnant during the study will be 
followed until completion of pregnancy. Every effort will be made to obtain the health 
status of the mother and infant or fetus (in cases of miscarriage or therapeutic abortion) at 
term. Pregnancy itself is not considered an AE. 
All confirmed pregnancies must be reported to the medical monitor and CRO via 
confirmed facsimile or email transmission and must be submitted on a Pregnancy Report 
Form to the Sponsor or designee within 24 hours of the Investigator’s awareness of the 
pregnancy.   
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. Any serious complication or 
event resulting from the pregnancy should be reported to the Sponsor within 24 hours on 
a SAE/UADE Report Form along with the Pregnancy Report Form. 
The contacts for reporting pregnancies are: 
 
 
 
and 
 
 

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14.0 STATISTICAL METHODS 
14.1 Study Endpoints 
14.1.1 
Primary Effectiveness Endpoint 
The primary effectiveness endpoint will be statistical non-inferiority with respect to mean 
distance high-contrast logMAR lens VA for each eye between the test and control lenses. 
For each eye, distance high-contrast logMAR lens VA will be averaged over all scheduled 
visits as the primary endpoint. A non-inferiority upper bound of 0.06 (3 letters) will be 
used to assess the difference (test – control) in mean logMAR lens VA. 
14.1.2 
Primary Safety Endpoint 
The primary safety endpoint will be statistical non-inferiority with respect to the 
proportion of eyes with any slit lamp findings Grade >2 at any follow-up visit between 
the test and control lenses. A non-inferiority upper bound of 0.10 will be used to assess 
the difference (test – control) in proportions of slit lamp outcomes. 
14.2 Hypotheses 
14.2.1 
Primary Effectiveness Endpoint 
The null hypothesis (H0) for the primary effectiveness endpoint is that the difference 
between the test mean (μT) and the control mean (μC) in distance high-contrast logMAR 
lens VA averaged over all scheduled visits is ≥0.06. The alternative hypothesis (H1) is 
that the difference is <0.06. 
𝐻0: 𝜇𝑇−𝜇𝐶≥0.06 
𝐻1: 𝜇𝑇−𝜇𝐶< 0.06 
14.3 Primary Safety Endpoint 
The null hypothesis (H0) for the primary effectiveness endpoint is that the difference 
between the test (πT) and the control (πC) in the proportion of eyes with any slit lamp 
findings Grade >2 at any follow-up visit is ≥0.10. The alternative hypothesis (H1) is that 
the difference is <0.10. 
𝐻0: 𝜋𝑇−𝜋𝐶≥0.10 
𝐻1: 𝜋𝑇−𝜋𝐶< 0.10 
14.4 Sample Size 
Sample size calculation inputs (eg, standard deviations [SDs] and expected percentages) 
were estimated based on the results of a previous clinical trial evaluating the test lens.1 
14.4.1 
Primary Effectiveness Endpoint 
When the sample sizes in the groups are 100 eyes and 50 eyes, a 2-group 0.05 one-sided 
t-test will have 99% power to reject the null hypothesis that the test lens is inferior to the 

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control lens (the difference in means, T - C, is ≥0.060) in favor of the alternative 
hypothesis that the test lens is non-inferior to the control lens, assuming that the expected 
difference in means is 0.000 and the common SD is 0.076.  
14.4.2 
Primary Safety Endpoint 
With 50 eyes in the control group and 100 eyes in the test group, the upper limit of the 
observed 1-sided 95% confidence interval will be expected to be <0.100 with 99% power 
when the control proportion, C, is 0.012 and the test expected proportion, T, is 0.012; 
results are based on 10000 simulations using the Newcombe-Wilson score method to 
construct the confidence interval.2 
14.4.3 
Overall Power and Sample Size 
Assuming independence of the primary endpoints, the overall power of the study to show 
non-inferiority for both endpoints is 98%. Accounting for up to 10% losses, 
approximately 168 eyes (84 subjects) should be enrolled. 
14.5 Randomization 
Subjects will be randomized to 1 of 2 treatment arms in a 2:1 ratio (test:control), wearing 
either test or control lenses in both eyes for the duration of the study. Randomization will 
be stratified by investigational site.   
Subjects will be randomized, after they are deemed eligible to participate, according to 
subject-specific randomization information provided by the randomization system.  
14.6 Study Populations 
14.6.1 
Intent-to-Treat Population 
The intent-to-treat (ITT) population will consist of all randomized eyes. Eyes will be 
included in treatment groups according to the treatments to which they were randomized 
for ITT population summaries. 
14.6.2 
Per-Protocol Population 
The per-protocol (PP) population will consist of all randomized eyes without the 
following important protocol deviations: 
• Ineligible when randomized 
• Not dispensed study lenses 
• Use of an incorrect lens type (eg, due to improper randomization, erroneous 
dispensing, return to habitual lens brand, etc.) 
• Use of a lens care system other than the lens care system dispensed  
• Failure to wear the assigned lenses at least 80% of the expected days 
• Failure to provide non-missing distance high-contrast logMAR lens VA data at all 
of the scheduled visits (Dispensing Visit and 1-Week, 1-Month, 2-Month, and 3-
Month Visits) 

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Additional important protocol deviations may be identified prior to unmasking of the 
treatment assignments 
14.6.3 
Safety Population 
The safety population will consist of all dispensed eyes. Eyes will be included in 
treatment groups according to the treatments that were actually dispensed to them for 
safety population summaries. If an eye uses both lens types, then the eye will be included 
in the test lens group for safety population summaries. 
14.7 Statistical Analysis 
A full declaration of planned statistical analyses will be documented in a formal statistical 
analysis plan (SAP). Any deviations from the SAP will be documented in the final study 
report. 
14.7.1 
Methods of Analysis 
 
General 
In general, data will be summarized by treatment group and visit as appropriate.  
Eyes will be treated as independent. In other words, the correlation between eyes within 
subjects will be ignored. 
Summaries for continuous variables will include the sample size, mean, SD, median, 
minimum, and maximum. Means and medians will be presented with 1 more decimal 
place than the recorded raw data. Standard deviations will be presented with 2 more 
decimal places than the recorded raw data. Minima and maxima will be presented with 
the same number of decimal places as the recorded raw data. Values with magnitude <1 
will be presented with a leading zero to the left of the decimal (eg, 0.123 or 0.123). 
Categorical data will be summarized using frequencies and percentages. Percentages will 
be presented with 1 decimal place. Percentages may not be presented when the count is 0. 
Unless otherwise specified, the denominator for percentages will be the number of non-
missing values within the group being presented. 
 
Primary Effectiveness Analysis 
Monocular distance high-contrast logMAR lens VA will be assessed at each scheduled 
visit (Dispensing Visit and 1-Week, 1-Month, 2-Month, and 3-Month Visits). VA will be 
converted to logMAR units. For each eye, logMAR VA will be averaged over all 
scheduled visits resulting in 1 value of “All Study” logMAR lens VA per eye. 
“All Study” logMAR lens VA will be presented using continuous summary statistics for 
the PP population by treatment group in a table at the eye level. A 2-sided 90% 
confidence interval for the difference (test – control) in “All Study” logMAR lens VA will 
be constructed using an analysis of variance (ANOVA) model with fixed factors of 
treatment and site. If the upper limit of the confidence interval is ≤0.06 then the null 
hypothesis will be rejected and the test lens will be statistically successful in this 
outcome. 
The previous analysis will also be completed using the ITT Population as a sensitivity 
analysis. For this sensitivity analysis, missing logMAR VA values will be imputed 25 

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times using the Markov chain Monte Carlo (MCMC) method. The seed used to generate 
the imputations will be 1187871241. The results of analyses (as described above for the 
PP population) by imputation will be combined to produce a 2-sided 90% confidence 
interval for the difference between treatments. 
 
Primary Safety Analysis 
Graded slit lamp findings will be assessed at each scheduled follow-up visit (1-Week, 1-
Month, 2-Month, and 3-Month Visits) and, optionally, at unscheduled visits. Each eye 
will be classified with respect to having 1 or more observations with Grade >2 (Yes, No) 
at any follow-up visit, including unscheduled visits. 
The number and percentage of eyes with findings Grade >2 at any follow-up visit will be 
presented for the safety population by treatment group in a table. A 2-sided 90% 
confidence interval for the difference (test – control) between treatment groups will be 
constructed using the Newcombe-Wilson score method. If the upper confidence limit 
≤10% (0.10) then the null hypothesis will be rejected and the test lens will be statistically 
successful in this outcome. If both treatment groups have 0 eyes with a slit lamp finding 
Grade >2, then the confidence interval will not be calculable, the null hypothesis will be 
rejected, and the test lens will be statistically successful in this outcome.   
14.7.2 
Multiple Comparisons 
Adjustment for multiple comparisons will not be necessary because statistical success 
will require success in both primary endpoints. 
14.7.3 
Interim Analyses 
No interim analyses are planned. 
14.7.4 
Missing Data  
Missing data will be imputed for the ITT population sensitivity analysis of the primary 
effectiveness endpoint as described above. Unless otherwise specified, missing data will 
not be imputed. 
15.0 DATA QUALITY ASSURANCE  
15.1 Study Monitoring 
Bausch + Lomb Global Clinical Operations 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 the 
Bausch + Lomb Global Clinical Operations Department.  
Prior to the start of the study, member(s) of the Bausch + Lomb Global Clinical 
Operations Department (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. 

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• This clinical investigation is being conducted in accordance with 21 CFR Parts 
11, 50, 54, 56, and 812. The protocol was developed 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 GCP and 
applicable local regulations. The Sponsor intends to register this clinical trial with 
the public database https://ClinicalTrials.gov. 
• The integrity of the data, including adequate study documentation. 
• The facilities remain acceptable. 
• The Investigator and site personnel remain qualified and able to conduct the 
study. 
• Test article accountability 
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. 
15.2 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.  
Subject-completed forms are also considered to be source data. Only subjects are to 
record information on subject-completed forms. 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 (eg, 
incorrect year was recorded), the subject should be instructed to edit the entry by drawing 
a single line through the original entry, entering the new information, and dating and 
initialing the change.    
15.3 Case Report Forms and Data Verification 
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 

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accurately recorded on the eCRFs by providing an electronic signature. All information 
requested on the eCRFs needs to be supplied, including subject identification and initials, 
date(s), assessment values, etc., and any omission or discrepancy will require 
explanation. All information on eCRFs must be traceable to source documents.  
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.  
The eCRFs will be submitted to Bausch + Lomb Global Clinical Operations for quality 
assurance review and statistical analysis.  
A copy of the eCRFs will be provided to the Investigator at the conclusion of the study, 
who must ensure that it is stored in a secure place.  
15.4 Recording of Data and Retention of Documents 
Subject data recorded on eCRFs during the study will be documented in a coded fashion. 
The subject will only be identified by the subject number and by their initials if also 
required. Confidentiality of subject records must be maintained to ensure adherence to 
applicable local privacy regulations. 
The Investigator must retain essential documents indefinitely after the completion of the 
study, unless otherwise notified by the Sponsor. The Investigator agrees to adhere to the 
document retention procedures when signing the protocol Investigator Statement of 
Approval.  
Essential documents include but are not limited to the following: 
• IRB approvals for the study protocol, all amendments, ICF(s), and advertisements 
• IRB annual study review 
• IRB correspondence and reports (eg, AE reports, protocol deviations, and safety 
updates) 
• Regulatory documents (eg, financial disclosure and delegation of authority forms) 
• All source documents  
• Archive of eCRFs 
• Subject’s signed ICF 
• Device Investigator Agreement 
• Accountability records for the test article 
• Correspondence from and to the Sponsor 
• Any other documents relevant to the conduct of the study 
In the event that study records are transferred to another location, the Investigator will 
provide notice of such transfer in writing to Bausch + Lomb Global Clinical Operations. 

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15.5 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. 
15.6 Institutional Review Board Approval 
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 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.  
15.7 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. 

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16.0 REFERENCES  
1. Study 661: A Study to Evaluate the Safety and Efficacy of a New Silicone 
Hydrogel Contact Lens Design. 
2. Newcombe RG. Interval estimation for the difference between independent 
proportions: comparison of eleven methods. Statistics in Medicine 1988; 17:873-
890. 

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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 
Visit 1 
Day -30 to -7 
Dispensing 
Visit 2 
Day 1 
1-Week 
Visit 3 
Day 5-9 
1-Month 
Visit 4 
Day 27-35 
2-Month 
Visit 5 
Day 54-68 
3-Month 
Visit 6 
Day 91-101a 
Exit 
Visit 
Informed consent/HIPAA authorization  
X 
 
 
 
 
 
 
Demographics/baseline eye/lens characteristics 
X 
 
 
 
 
 
 
Contact lens use history and useb 
X 
 
X 
X 
X 
X 
 
Medical history 
X 
 
 
 
 
 
 
Eligibility 
X 
 
 
 
 
 
 
Randomization 
X 
 
 
 
 
 
 
Dispense and/or return study materials 
 
X 
 
 
 
 
X 
Symptoms/complaints and subjective assessments (including rewetting drops [Yes/No]) 
X 
X 
X 
X 
X 
X 
 
Adverse events 
X 
X 
X 
X 
X 
X 
X 
Without lenses 
 
 
 
 
 
 
 
  Spherocylindrical refraction 
X 
 
 
 
 
 
X 
  Distance BSCVA 
X 
 
 
 
 
 
X 
  Keratometry 
X 
 
 
 
 
 
X 
  Slit lamp exam  
X 
X 
X 
X 
X 
X 
 
  Keratometry comparison (Exit Visit to Screening Visit) 
 
 
 
 
 
 
X 
With study lenses 
 
 
 
 
 
 
 
  Distance high-contrast logMAR lens VA  
 
X 
X 
X 
X 
X 
 
  Over-refraction and distance VA 
 
X 
X 
X 
X 
X 
 
  Lens wettability/centration/movement 
 
X 
X 
X 
X 
X 
 
  Lens deposits 
 
X 
X 
X 
X 
X 
 
VA line change comparison 
Distance high-contrast logMAR lens VA at Visit 2 to distance BSCVA at Visit 1 
 
X 
 
 
 
 
 
Distance BSCVA at Exit Visit to Distance BSCVA at Visit 1 
 
 
 
 
 
 
X 
Distance high-contrast logMAR lens VA at Visit 3-6 to distance high-contrast logMAR 
lens VA at Visit 2 
 
 
X 
X 
X 
X 
 
Distance high-contrast logMAR lens VA at Visit 3-6 to distance BSCVA at Visit 1 
 
 
X 
X 
X 
X 
 
a. The 3-Month Visit MUST occur no earlier than Day 91. 
b. Contact lens use history is taken at the Screening Visit and contact lens use is taken at each of the follow-up visits. 

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