A Safety and Effectiveness Study of a Contact Lens Cleaning and Disinfecting Solution
Phase: NA
Conditions: Refractive Ametropia
Sponsor: Bausch & Lomb Incorporated

Study #914 - Protocol 
19 Jan 2023 
Confidential 
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A Safety and Effectiveness Study of a Contact Lens Cleaning and Disinfecting Solution 
CLINICAL STUDY PROTOCOL 
STUDY # 914 
Sponsor: 
Bausch & Lomb Incorporated 
This clinical investigation is being conducted in accordance with 21 CFR Parts 11, 50, 54, 56 and 
812; 42 CFR Part 11 – Clinical Trials Registration and Results Information Submission; EN ISO 
14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice; 
Medical Device Regulation (MDR) 2017/745; International Council for Harmonization (ICH) 
Good Clinical Practice; the Declaration of Helsinki and applicable local regulations. Additional 
information on the investigational test article(s) is presented in the BL-3100-NBR03 Multi-Purpose 
Solution Investigator’s Brochure1.   
Revision Chronology:  
(Original) 
   19 JAN 2023 
The information in the following document is confidential and is provided to you, as an Investigator or 
consultant, for review by you, your study personnel, and the applicable Institutional Review Board / Ethics 
Committee. 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. 
Key design elements of this protocol will be registered on www.clinicaltrials.gov as required by current 
regulations and, if applicable, other public databases as required by local country regulations. In addition, 
results of this study will be made publicly available on www.clinicaltrials.gov regardless of outcome as 
required by current regulations and, if applicable, in other public databases as required by local country 
regulations. The identity of the subjects who participated in the study will be maintained confidential. 
Ultra®, PureVision2®, Sensitive Eyes®, and renu® are registered trademarks of Bausch & Lomb 
Incorporated. All other brand names/product names are trademarks of their respective owners.  
NCT# 05565937

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19 Jan 2023 
Confidential 
 
 
 
 
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INVESTIGATOR STATEMENT OF APPROVAL 
 
A Safety and Effectiveness Study of a Contact Lens Cleaning and Disinfecting Solution 
 
STUDY # 914 
I have read this clinical study protocol and 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 CFR Parts 11, 50, 54, 56 and 812; 42 CFR Part 11 – 
Clinical Trials Registration and Results Information Submission; EN ISO 14155:2020 Clinical investigation 
of medical devices for human subjects – Good clinical practice; Medical Device Regulation (MDR) 
2017/745; International Council for Harmonization (ICH) Good Clinical Practice; the Declaration of Helsinki 
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 agree to obtain written informed consent from each study subject prior to performing any 
study specific procedures. 
I understand my obligation as the Principal Investigator to supervise all testing of the investigational products 
used in this study involving human subjects and to ensure that the investigational product is dispensed as per 
protocol. 
I understand my obligation as the Principal Investigator to ensure that all study personnel assisting in the 
conduct of the study are qualified and are properly trained to conduct their assigned tasks and obligations 
during the entire course of the trial.  I agree to maintain adequate and accurate records in accordance with 
government regulations and to make those records available for inspection. 
I testify that I have never been disqualified as an Investigator by any Regulatory Authority, and have never 
been involved in a study or other research that was terminated due to misconduct or fraudulent activity.  
I understand that my signature on this document indicates my agreement to this Clinical Investigational 
Plan/Protocol and to review and, if appropriate, sign the clinical study report. I understand that my signature 
on electronic case report forms 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 
 
 
Address of Principal Investigator 
 
_______________________________________________________ 
 
_______________________________________________________ 
 

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SYNOPSIS 
 
Name of Sponsor/ Company:  
Bausch & Lomb Incorporated 
Study #914 
Name of Investigational Product:  
• Test: BL-3100-NBR03 multi-purpose solution  
• Control: renu® Advanced Formula multi-purpose solution 
Title of Study:  
A Safety and Effectiveness Study of a Contact Lens Cleaning and Disinfecting Solution 
Number of Clinical Centers:  
Approximately 22 investigative sites, United States 
Objective:  
The objective of this study is to evaluate the safety and effectiveness of BL-3100-NBR03 multi-purpose 
solution (Test) compared to renu® Advanced Formula multi-purpose solution (Control) when used by 
habitual contact lens wearers to clean and disinfect their contact lenses for approximately three months.  
Intended Purpose:  
BL-3100-NBR03 Multi-Purpose Solution is intended for use in cleaning, disinfecting, removing 
proteins, conditioning and storing all soft contact lenses, including silicone hydrogels. 
Target Population: 
BL-3100-NBR03 Multi-Purpose Solution is intended for users who wear soft (hydrophilic) contact 
lenses which require daily conditioning, cleaning, chemical (not heat) disinfection and storage of soft 
contact lenses, regardless of gender, age, or ethnicity, and who do not have contraindications for the 
device. 
Methodology: 
• Approximately 340 subjects (680 eyes) will be enrolled in this three-month, two-arm, 1:1 
randomized, parallel-group, bilateral, double-masked study at approximately 22 investigative sites in 
the United States.  
• Subjects will be required to wear dispensed study lenses on a daily wear basis for three months with 
scheduled in-office replacement of study lenses at the 1-Month and 2-Month Follow-Up Visits. 
Number of Subjects Planned: 
Approximately 340 subjects (680 eyes), with at least 300 subjects expected to complete the study 
Diagnosis and Main Criteria for Inclusion: 
• Is of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and has the 
capacity to provide voluntary informed consent 
• Is a habitual wearer (at least 3 months) of one of the following lens types: 
Lens 
Group 
Lens Material 
Trade Name 
Manufacturer 
4 
Etafilcon A 
Acuvue2 
Vistakon 
5-A 
Balafilcon A 
PureVision2 
Bausch + Lomb 
5-C 
Samfilcon A 
Ultra 
Bausch + Lomb 
5-Cm 
Lotrafilcon B 
Air Optix Aqua 
Alcon 
5-Cr 
Senofilcon A 
Vita 
Vistakon 
• Has typically cleaned and disinfected their pre-study contact lenses daily 
• Is a habitual user of lens care products for cleaning, disinfecting, and storage of lenses. 
• Requires lens correction in both eyes 
• Must have spectacle correctable distance visual acuity through spherocylindrical refraction to 40 
letters [0.14 logarithm of the minimal angle of resolution (logMAR)] or better in each eye at 2 
meters distance using a high contrast chart 
• Wears the same brand of contact lenses in both eyes 
• Agrees to wear study lenses on a daily wear basis for approximately three months 

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• Is willing and able to comply with all treatment and follow-up study procedures  
Exclusion Criteria: 
• Is currently using a hydrogen-peroxide cleaning and disinfecting solution 
• Participated in any drug or device clinical investigation within 30 days prior to entry into this study 
• Is a female of childbearing potential (those who are not surgically sterilized or postmenopausal) if 
they meet any one of the following conditions: 
‒ they are currently pregnant 
‒ they plan to become pregnant during the study 
‒ they are breastfeeding 
• Has worn gas permeable (GP) lenses within the last 30 days 
• Has worn polymethylmethacrylate (PMMA) lenses within the last three months  
• Has typically worn their pre-study contact lenses on an extended wear basis, sleeping in their lenses 
one night or more per week, during the last year 
• Has any systemic disease currently affecting ocular health or which in the Investigator’s opinion 
may have an effect on ocular health during the course of the study 
• Subjects with an active ocular disease or who are using any ocular medication 
• Is using any medications that will, in the Investigator’s opinion, affect ocular physiology or lens 
performance 
• Currently wears monovision, multifocal, or toric contact lenses 
• Has ocular astigmatism of 1.00 D or greater in either eye 
• Has anisometropia (spherical equivalent) of greater than 2.00 D 
• Has any grade 2 or greater finding during the slit-lamp examination (refer to Appendix B for 
Methods of Clinical Evaluation)  
• Has corneal infiltrates of ANY GRADE 
• Has any “Present” ungraded finding during the slit-lamp examination (refer to Appendix B for 
Methods of Clinical Evaluation) that, in the Investigator’s judgment, interferes with contact lens 
wear 
• Has any scar or neovascularization within the central 6 mm of the cornea, irregular cornea or a 
history of herpetic keratitis  
 
◊ 
Note that subjects with minor peripheral corneal scarring (that does not extend into the 6 
mm central area), that, in the Investigator’s judgment, does not interfere with contact lens 
wear, are eligible for this study. 
• Is aphakic 
• Is amblyopic 
• Has had any corneal surgery (e.g., refractive surgery) 
• Is allergic to any component in the study care products 
• Is an employee of any of the study investigative sites or a family member of an employee of the 
investigative site, including family members living outside of the employee’s household  
• Is an Ophthalmologist, an Optometrist, an Optician, or an Ophthalmic Assistant/Technician, or 
currently resides with a person with any of these specialties 
Is an employee of a manufacturer of contact lenses or contact lens care products (e.g., Alcon, Bausch 
+ Lomb, Ciba Vision, CooperVision, Vistakon, Johnson & Johnson, etc.) or currently resides with a 
person employed by any of these manufacturers. 
Investigational Product, Dosage and Mode of Administration: 
• The Investigator or designee will instruct all subjects that they must comply with the instructions 
provided to them. Subject Instructions (Instructions for Use) will be included with each carton of 
study solution.  
• In order to ensure that the Investigator and site staff remain masked to the study lens, an unmasked 
designee at each site will be responsible for all study materials accountability, including 
dispensation and collection of study supplies to subjects. 
• Subjects are to be instructed not to discuss or show the dispensed study lenses to the Investigator or 
masked site staff during the study. 
• Subjects will be instructed that other contact lenses (other than the assigned study lenses) and 
contact lens care products (other than any eye drops provided) are not allowed to be used during the 
study.  

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Study Duration of Treatment: 
Approximately 3 months 
Criteria for Evaluation: 
The primary endpoints are as follows: 
• Effectiveness: 
o Overall comfort averaged over all scheduled follow-up visits 
o Vision averaged over all scheduled follow-up visits 
o The proportion of eyes with a maximum degree of front surface deposits grade of < 2 over all 
scheduled follow-up visits  
• Safety: 
o The proportion of eyes with any slit-lamp findings greater than Grade 2 over all follow-up visits 
Statistical Methods: 
• Continuous variables will be summarized using the sample size, mean, standard deviations, median, 
minimum, and maximum. Categorical variables will be summarized using frequencies and 
percentages.  
• Each primary endpoint will be evaluated statistically using a one-sided non-inferiority test with a 
one-sided alpha risk of 0.025. For overall comfort and dryness, each non-inferiority hypothesis will 
be tested using an analysis of variance model including the fixed factors of treatment, site, and lens 
group with a non-inferiority margin of -5 points. For front surface deposits, the non-inferiority 
hypothesis will be tested using a one-sided Newcombe-Wilson 97.5% lower confidence limit with a 
non-inferiority margin of -10%. For slit-lamp findings, the non-inferiority hypothesis will be tested 
using a one-sided Newcombe-Wilson 97.5% upper confidence limit with a non-inferiority margin of 
5%. 
Sample Size Calculations: 
Approximately 30 Test group subjects will be completed for each lens group in the table of lens types 
above. For each lens type, the probability of observing at least one subject-level event will be 0.95 when 
the probability of an event is 0.1. When the sample size is 150 subjects in each treatment group, the 
overall power of the trial will be 95%. To allow for losses of up to 10%, approximately 340 subjects 
(680 eyes) will be enrolled. 
 
 

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TABLE OF CONTENTS 
PAGE 
INVESTIGATOR STATEMENT OF APPROVAL ................................................................................. 4 
PERSONNEL RESPONSIBLE FOR CONDUCTING THE STUDY ..................................................... 5 
SYNOPSIS .................................................................................................................................................... 6 
TABLE OF CONTENTS ............................................................................................................................. 9 
GLOSSARY OF TERMS ............................................................................................................................12 
LIST OF ACRONYMS AND ABBREVIATIONS ...................................................................................15 
1.0 INTRODUCTION ..............................................................................................................................16 
2.0 BACKGROUND, RATIONALE AND OBJECTIVES ...................................................................16 
2.1 INTENDED PURPOSE OF DEVICE ........................................................................................................16 
2.2  TARGET POPULATION .......................................................................................................................16 
2.3 STATE OF THE ART............................................................................................................................16 
2.4 OBJECTIVE OF STUDY .......................................................................................................................17 
2.5 STUDY RATIONALE ...........................................................................................................................17 
2.6 MINIMIZATION OF BIAS AND CONFOUNDING FACTORS.....................................................................17 
3.0 STUDY DESIGN .................................................................................................................................18 
3.1 DESCRIPTION OF STUDY DESIGN ......................................................................................................18 
3.2 INFORMED CONSENT PROCESS ..........................................................................................................19 
3.3 SELECTION OF STUDY POPULATION ..................................................................................................19 
3.3.1 ELIGIBILITY ......................................................................................................................................20 
3.3.1.1 
INCLUSION CRITERIA ..............................................................................................................20 
3.3.1.2 
EXCLUSION CRITERIA .............................................................................................................20 
3.3.2 SUBJECT COMPLETION ......................................................................................................................22 
3.3.3 SUBJECT DISCONTINUATION .............................................................................................................22 
3.3.4 LOST TO FOLLOW-UP ........................................................................................................................23 
3.4 INVESTIGATORS ................................................................................................................................23 
3.5 FINANCES .........................................................................................................................................23 
3.6 STUDY DURATION ............................................................................................................................24 
3.7 TREATMENTS ....................................................................................................................................24 
4.0 STUDY MATERIALS ........................................................................................................................24 
4.1 DESCRIPTION OF INVESTIGATIONAL TEST ARTICLE (TEST) ..............................................................24 
4.2 DESCRIPTION OF CONTROL PRODUCT (COMPARATOR) .....................................................................25 
4.3 INSTRUCTIONS FOR USE AND ADMINISTRATION ...............................................................................25 
4.3.1 STORAGE REQUIREMENTS ................................................................................................................25 
4.3.2 SUBJECT INSTRUCTIONS....................................................................................................................25 
4.4 PACKAGING AND LABELING .............................................................................................................25 
4.4.1 LENSES .............................................................................................................................................25 
4.4.2 STUDY KITS ......................................................................................................................................26 
4.4.3 OTHER STUDY SUPPLIES ...................................................................................................................26 
4.5 ACCOUNTABILITY AND TRACEABILITY .............................................................................................26 
4.6 MASKING/UNMASKING .....................................................................................................................27 
4.7 PRODUCT REPLACEMENT ..................................................................................................................28 
5.0 SAFETY AND EFFECTIVENESS VARIABLES ...........................................................................28 
5.1 KEY SAFETY VARIABLES ..................................................................................................................28 
5.2 PRIMARY EFFECTIVENESS VARIABLES .............................................................................................28 
5.3 RISK ASSESSMENT AND MITIGATION ................................................................................................28 
6.0 STUDY METHODS............................................................................................................................29 

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6.1 STUDY VISITS ...................................................................................................................................29 
6.1.1 SCREENING/DISPENSING VISIT .........................................................................................................29 
6.1.2 2-WEEK FOLLOW-UP VISIT ...............................................................................................................31 
6.1.3 1-MONTH AND 2-MONTH FOLLOW-UP VISITS...................................................................................32 
6.1.4 3-MONTH FOLLOW-UP ......................................................................................................................34 
6.1.5 EXIT VISIT ........................................................................................................................................35 
6.1.6 UNSCHEDULED VISITS ......................................................................................................................36 
6.1.7 MISSED VISITS ..................................................................................................................................38 
6.1.8 PRODUCT DISPENSING ONLY VISIT ...................................................................................................38 
6.2 STUDY COMPLETION / EARLY STUDY TERMINATIONS / SUSPENSIONS ..............................................38 
6.2.1 STUDY COMPLETION .........................................................................................................................38 
6.2.2 EARLY STUDY TERMINATION/SUSPENSION ......................................................................................38 
6.3 CONCOMITANT MEDICATIONS/THERAPY ..........................................................................................38 
6.4 TREATMENT COMPLIANCE ................................................................................................................39 
6.5 PROTOCOL DEVIATIONS ....................................................................................................................39 
7.0 ADVERSE EVENTS ..........................................................................................................................39 
7.1 INTRODUCTION TO ADVERSE EVENT DEFINITIONS ...........................................................................39 
7.1.1 SERIOUS ADVERSE EVENT (SAE) DEFINITIONS ................................................................................39 
7.1.2 SIGNIFICANT NON-SERIOUS ADVERSE EVENT DEFINITIONS .............................................................40 
7.1.3 NON-SIGNIFICANT NON-SERIOUS ADVERSE EVENTS DEFINITIONS ..................................................41 
7.1.4 ADVERSE DEVICE EFFECT (ADE) DEFINITIONS ................................................................................41 
7.1.4.1 
ANTICIPATED SERIOUS ADVERSE DEVICE EFFECT (ASADE) DEFINITION .............................41 
7.1.4.2 
UNANTICIPATED SERIOUS ADVERSE DEVICE EFFECT (USADE) DEFINITIONS .......................41 
7.1.5 RELATIONSHIP DEFINITION: STUDY DEVICE AND/OR OTHER STUDY MATERIALS ............................42 
7.1.6 SEVERITY DEFINITIONS ....................................................................................................................42 
7.2 PROCEDURES FOR EVALUATING ADVERSE EVENTS ..........................................................................42 
7.2.1 PROCEDURES FOR REPORTING SERIOUS OR SIGNIFICANT ADVERSE EVENTS ....................................43 
7.2.2 PROCEDURES FOR REPORTING OFF-SITE UNANTICIPATED SERIOUS ADVERSE DEVICE EFFECTS ......44 
7.2.3 DEVICE DEFICIENCIES: DEFINITION AND REPORTING PROCEDURES .................................................44 
7.2.4 PROCEDURES FOR CULTURING OF CORNEAL ULCER OR SUSPECTED OCULAR INFECTION ................45 
7.2.5 GUIDELINES FOR REPORTING PREGNANCIES .....................................................................................45 
8.0 STATISTICAL METHODS ..............................................................................................................46 
8.1 STUDY ENDPOINTS ...........................................................................................................................46 
8.1.1 PRIMARY EFFECTIVENESS ENDPOINTS ..............................................................................................46 
8.1.2 SECONDARY EFFECTIVENESS ENDPOINTS .........................................................................................46 
8.1.4 PRIMARY SAFETY ENDPOINT ............................................................................................................46 
8.2 HYPOTHESES.....................................................................................................................................46 
8.2.1 OVERALL COMFORT AVERAGED OVER ALL FOLLOW-UP VISITS ......................................................46 
8.2.2 VISION AVERAGED OVER ALL FOLLOW-UP VISITS ...........................................................................46 
8.2.3 FRONT SURFACE DEPOSITS AT ALL FOLLOW-UP VISITS ...................................................................47 
8.2.4 SLIT-LAMP FINDINGS GREATER THAN GRADE 2 ...............................................................................47 
8.2.5 SUBJECT ASSESSMENTS ....................................................................................................................47 
8.2.5.1 
PROPORTION OF TEST GROUP RESPONDENTS AGREEING .......................................................47 
8.2.5.2 
COMPARISON BETWEEN GROUPS OF THE PROPORTION OF RESPONDENTS AGREEING ............47 
8.3 SAMPLE SIZE ....................................................................................................................................48 
8.3.1 OVERALL COMFORT .........................................................................................................................48 
8.3.2 VISION ..............................................................................................................................................48 
8.3.3 FRONT SURFACE DEPOSITS ...............................................................................................................48 
8.3.4 SLIT-LAMP FINDINGS GREATER THAN GRADE 2 ...............................................................................48 
8.3.5 LENS GROUPS ...................................................................................................................................48 
8.3.6 OVERALL POWER ..............................................................................................................................48 
8.3.7 ENROLLMENT TARGETS ....................................................................................................................49 
8.4 RANDOMIZATION ..............................................................................................................................49 
8.5 STUDY POPULATIONS .......................................................................................................................49 
8.5.1 INTENT-TO-TREAT (ITT) POPULATION .............................................................................................49 
8.5.2 PER PROTOCOL (PP) POPULATION ....................................................................................................49 
8.5.3 SAFETY POPULATION ........................................................................................................................49 

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8.6 STATISTICAL ANALYSIS ....................................................................................................................50 
8.6.1 METHODS OF ANALYSIS ...................................................................................................................50 
8.6.1.1 
GENERAL METHODS ...............................................................................................................50 
8.6.1.2 
OVERALL COMFORT ...............................................................................................................50 
8.6.1.3 
VISION ....................................................................................................................................50 
8.6.1.4 
FRONT SURFACE DEPOSITS ....................................................................................................50 
8.6.1.5 
GRADED SLIT-LAMP FINDINGS > GRADE 2 ............................................................................51 
8.6.1.6 
SUBJECT ASSESSMENT ...........................................................................................................51 
8.6.2 ADVERSE EVENTS .............................................................................................................................51 
8.6.3 SUBJECT DEMOGRAPHICS AND BASELINE CHARACTERISTICS...........................................................52 
8.6.4 SUBJECT DISCONTINUATION .............................................................................................................52 
8.6.5 PROTOCOL DEVIATIONS ....................................................................................................................52 
8.6.6 TREATMENT COMPLIANCE ................................................................................................................52 
8.6.7 TREATMENT EXPOSURE ....................................................................................................................52 
8.6.8 MISSING DATA .................................................................................................................................53 
8.6.9 MULTIPLICITY ISSUES .......................................................................................................................53 
8.6.10 
INTERIM ANALYSES ................................................................................................................53 
9.0 DATA QUALITY ASSURANCE ......................................................................................................53 
9.1 SUBJECT CONFIDENTIALITY ..............................................................................................................53 
9.2 STUDY MONITORING ........................................................................................................................54 
9.3 SOURCE DOCUMENTATION ...............................................................................................................54 
9.4 ELECTRONIC CASE REPORT FORMS AND DATA VERIFICATION .........................................................55 
9.5 RECORDING OF DATA AND RETENTION OF DOCUMENTS...................................................................55 
9.6 AUDITING PROCEDURES ...................................................................................................................56 
9.7 INSTITUTIONAL REVIEW BOARD .......................................................................................................56 
9.8 PUBLICATION OF RESULTS ................................................................................................................56 
10.0 REFERENCES ....................................................................................................................................57 
APPENDICES 
APPENDIX A: 
SCHEDULE OF VISITS AND PARAMETERS .................................................. A-1 
APPENDIX B: 
METHODS OF CLINICAL EVALUATION ........................................................B-1 
APPENDIX C: 
SUBJECT INSTRUCTIONS...…………………………………………………….C-1 

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GLOSSARY OF TERMS 
Adverse Device Effect (ADE) Adverse event related to the use of an investigational medical device. 
Note 1: This definition includes adverse events resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation, or any malfunction of the 
investigational medical device. 
Note 2: This definition includes any event resulting from use error or 
from intentional misuse of the investigational medical device.   
Adverse Event (AE) 
Untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the 
investigational medical device and whether anticipated or 
unanticipated. 
Note 1: This definition includes events related to the investigational 
medical device. 
Note 2: This definition includes events related to the procedures 
involved. 
Note 3: For users or other persons, this definition is restricted to 
events related to the use of investigational medical devices. 
Anticipated Serious Adverse 
Device Effect (ASADE) 
Anticipated serious adverse device effect is an effect which by its 
nature, incidence, severity or outcome has been identified in the risk 
assessment. 
Device Deficiency 
Inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, usability, safety or performance. 
Note 1: Device deficiencies include malfunctions, use errors, and 
inadequacy in the information supplied by the manufacturer including 
labelling. 
Note 2: This definition includes device deficiencies related to the 
investigational medical device. 
Investigational Medical 
Device 
A medical device being assessed for clinical performance, 
effectiveness, or safety in a clinical investigation 
Note 1: This includes medical devices already on the market that are 
being evaluated for new intended uses, new populations, new 
materials or design changes. 
Note 2: This includes medical devices already on the market that are 
being evaluated within their intended use in a post-market clinical 
investigation (interventional or non-interventional). 
Note 3: The terms “investigational medical device” and 
“investigational device” are used interchangeably. 
Life-threatening Adverse 
Event 
An adverse event is considered “life-threatening” if, in the view of 
either the Investigator or Sponsor, its occurrence places the patient or 
subject at immediate risk of death. It does not include an adverse 
event or suspected adverse reaction that, had it occurred in a more 
severe form, might have caused death. 

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Medical Device 
An instrument, apparatus, implement, machine, appliance, implant, 
reagent for in vitro use, software, material or other similar or related 
article, intended by the manufacturer to be used, alone or in 
combination, for human beings, for one or more of the specific 
purpose(s) of: 
• diagnosis, prevention, monitoring, treatment or alleviation of 
disease; 
• diagnosis, monitoring, treatment, alleviation of or compensation 
for an injury; 
• investigation, replacement, modification, or support of the 
anatomy or of a physiological process; 
• supporting or sustaining life; 
• control of conception; 
• disinfection of medical devices; 
• providing information by means of in vitro examination of 
specimens derived from the human body; and does not achieve its 
primary intended action by pharmacological, immunological or 
metabolic means, in or on the human body, but which may be 
assisted in its intended function by such means. 
Malfunction 
Failure of a medical device to perform in accordance with its intended 
purpose when used in accordance with the instructions for use or 
clinical investigation plan. 
Product Complaints 
Any oral, electronic, or written communication that alleges 
deficiencies related to the identity (labeling), quality, durability, 
reliability, safety, effectiveness, or performance of a marketed 
product, including failure of the product, labeling or packaging to 
meet specifications, whether or not the product is related to or caused 
the alleged deficiency. A complaint may allege that an adverse event 
or medical device malfunction has occurred. 
Serious Adverse Device 
Effect (SADE) 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
Serious Adverse Event (SAE) 
An adverse event that led to any of the following outcomes: 
• death 
• serious deterioration in the health of the subject, users, or other 
persons as defined by one or more of the following: 
o a life-threatening illness or injury, or 
o a permanent impairment of a body structure or a body 
function including chronic diseases, or 
o in-patient or prolonged hospitalization, or 
o medical or surgical intervention to prevent life-threatening 
illness or injury, or permanent impairment to a body 
structure or a body function, 
• fetal distress, fetal death, a congenital abnormality, or birth 

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defect including physical or mental impairment. 
Serious Health Threat 
Signal from any adverse event or device deficiency that indicates an 
imminent risk of death or a serious deterioration in the health in 
subjects, users or other persons, and that requires prompt remedial 
action for other subjects, users or other persons. 
Note 1: This would include events that are of significant and 
unexpected nature such that they become alarming as a potential 
serious health hazard or possibility of multiple deaths occurring at 
short intervals. 
Treatment-Emergent Adverse 
Event (TEAE) 
A treatment-emergent adverse event is defined as any event not 
present prior to the initiation of the treatments or any event already 
present that worsens in either intensity or frequency following 
exposure to the treatments. 
Unanticipated Adverse 
Device Effect (UADE) 
Unanticipated adverse device effect is an adverse event caused by or 
related to use a medical device not previously identified in nature, 
severity, or degree of incidence in the current risk assessment, or any 
other unanticipated problem associated with a device that relates to 
the rights, safety, or welfare of subjects. 
Unanticipated Serious 
Adverse Device Effect 
(USADE) 
Unanticipated adverse device effect is a serious adverse event caused 
by or related to use of a medical device not previously identified in 
nature, severity, or degree of incidence in the current risk assessment, 
or any unanticipated serious problem associated with a device that 
relates to the rights, safety, or welfare of subjects. 
Use Error 
User action or lack of user action while using the medical device that 
leads to a different result than that intended by the manufacturer or 
expected by the user. 
Note 1: Use errors includes slips, lapses and mistakes. Use error 
includes the inability of the user to complete a task. 
Note 2: Use errors can result from a mismatch between the 
characteristics of the user, user interface, task or use environment. 
Note 3: Users might be aware or unaware that a use error has 
occurred. 
Note 4: An unexpected physiological response of the patient is not by 
itself considered a use error. 
Note 5: A malfunction of a medical device that causes an unexpected 
result is not considered a use error.   
 
 

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LIST OF ACRONYMS AND ABBREVIATIONS  
Abbreviation 
/Acronym  
Term  
ADE Adverse Device Effect 
AE  Adverse Event 
ASADE Anticipated Serious Adverse Device Effect 
BSCVA Best Spectacle Corrected Visual Acuity 
CFR Code of Federal Regulations 
CIP Clinical Investigation Plan 
CRO Contract Research Organization 
D Diopter 
eCRF Electronic Case Report Form 
EDC Electronic Data Capture 
FDA United States Food and Drug Administration 
GCP Good Clinical Practice 
GP Gas Permeable 
H0 Null Hypothesis 
H1 Alternative Hypothesis 
HIPAA Health Insurance Portability and Accountability Act 
ICF Informed Consent Form  
ICH The International Council for Harmonisation 
IRB Institutional Review Board 
ISO International Standards Organization 
ITT Intent-to-Treat 
 logMAR Logarithm of the Minimum Angle of Resolution 
MDR Medical Device Regulation 
MedDRA Medical Dictionary for Regulatory Activities 
mm Millimeter 
OD Right Eye 
RTSM Randomization and Trial Supply Management  
OS Left Eye 
PP Per Protocol 
PMMA Polymethylmethacrylate 
SAE Serious Adverse Event 
SD Standard Deviation 
TEAE Treatment-Emergent Adverse Event 
USADE Unanticipated Serious Adverse Device Effect 
US United States 
VA Visual Acuity 

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requirements and clinical investigation procedures; requiring a Financial Disclosure by 
Investigators; using standardized training materials for all trial personnel; and by 
scheduling regular monitoring visits will be conducted to verify adherence to the CIP and 
source data. 
This clinical investigation is double-masked. The Investigator and site staff, with the 
exception of an unmasked designee, will be masked (blinded) to the subject’s treatment 
group. An unmasked designee will be assigned at each site and will be responsible for all 
study materials accountability, including dispensation to and collection of study supplies 
from subjects. Subjects are to be instructed not to discuss or show the dispensed study 
materials to the Investigator or masked site staff during the study. The Investigator and all 
other study personnel will remain masked until database lock. The subjects will be 
randomized (1:1) to receive either the Test or Control solution using a Randomization and 
Trial Supply Management (RTSM) system. 
3.0 
STUDY DESIGN 
This is a multicenter, randomized, double-masked, parallel-group, bilateral clinical trial.  
3.1 
Description of Study Design  
The study is designed to examine whether BL-3100-NBR03 multi-purpose solution 
cleaning and disinfecting solution is non-inferior to renu® Advanced Formula multi-
purpose solution in several primary endpoints. 
Approximately 340 subjects (680 eyes) will be enrolled in this three-month multicenter, 
randomized, double-masked, parallel-group, bilateral study at approximately 22 
investigative sites in the United States (US). Approximately one-half (50%) of the eligible 
subjects will be randomized to receive Bausch + Lomb investigational BL-3100-NBR03 
multi-purpose solution (Test), and approximately one-half (50%) of the eligible subjects 
will be randomized to receive renu® Advanced Formula multi-purpose solution (Control). 
In addition, all subjects will be dispensed three new pairs (including two back-up pairs) of 
their habitual lenses at the beginning of the study for daily wear, and scheduled replacement 
lenses at the 1-Month and 2-Month Follow-up Visits. 
All subjects will be seen for a Screening/Dispensing Visit, at which the informed consent 
form (ICF), including the Health Insurance Portability Accountability Act (HIPAA), will 
be obtained and eligibility will be assessed. If eligible, subjects will be dispensed three new 
pairs of their habitual lenses and a Study Kit containing a cleaning and disinfecting solution 
according to the subject’s randomly assigned treatment.  Subjects may also be dispensed a 
supply of Bausch + Lomb renu® Contact Lens Moisture Drops to be used on an as needed 
basis. Subjects must NOT use ANY other cleaning and disinfecting solution or rewetting 
drops during the study.   
Subjects are to wear their study lenses on a daily wear basis and are to use the Test or 
Control multi-purpose solution and care regimen after removing the lenses each day. 
Subjects will return their worn lenses to the unmasked designee at each monthly follow-up 
visit and will return their used and unused study solutions to the unmasked designee at the 
three-month follow-up visit (or early study termination/suspension visit) for return to the 
Sponsor.   
Eligible subjects will be enrolled into one of five lens groups based on their habitual contact 
lenses. Subjects will be randomized to receive either the Test or Control multi-purpose 

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solution.  The five lens groups will be comprised of habitual wearers of soft lenses based 
on lens material as indicated in the table below. 
Table 2: Lens Groups 
Lens Group 
Lens Material 
Trade Name 
Manufacturer 
4 
Etafilcon A 
Acuvue2 
Vistakon 
5-A 
Balafilcon A 
PureVision2 
Bausch + Lomb 
5-C 
Samfilcon A 
Ultra 
Bausch + Lomb 
5-Cm 
Lotrafilcon B 
Air Optix Aqua 
Alcon 
5-Cr 
Senofilcon C 
Vita 
Vistakon 
 
3.2 
Informed Consent Process 
Voluntary written informed consent must be obtained from every subject prior to the 
initiation of any study related activities. The Investigator must have a defined process for 
obtaining consent. Subjects must be given ample time to read, understand, and ask 
questions, in order to consider voluntary participation. The subject must indicate voluntary 
consent by providing a written signed and dated ICF. A copy of the signed and dated ICF 
must be provided to the subject, and the original document must be filed in the subject’s 
study records. 
The ICF must meet all applicable local laws and be written in language that the subject 
understands. Subjects must be informed that their participation in the study is voluntary 
and that their decision to withdraw from participation at any time during the study will not 
impact any aspect of their standard care. Subjects will be provided with contact information 
for the appropriate individuals should questions or concerns arise after signing the ICF 
during the clinical study.  
Subjects must also be informed that their records may be accessed by appropriate 
authorities and Sponsor-designated personnel. The Investigator must ensure all procedures 
and practices are in place to protect the privacy and the best interest of the subject. 
3.3 
Selection of Study Population  
Recruitment for the study may start at any point after the Investigator agrees, in writing, to 
participate in the study. Written ICF, including HIPAA, enrollment in the study, or 
dispensing of study products cannot begin until the Investigator has received Institutional 
Review Board (IRB) and Sponsor approval to conduct the study. The Sponsor and IRB 
must approve any advertising used to recruit subjects prior to use of that advertising. 
All consented subjects must be accounted for, whether or not they participate in the study. 
The Sponsor will record information for each potential study subject who signs an ICF. 
Once a potential subject is consented, their information will be recorded in the 
Randomization and Trial Supply Management (RTSM) system and the Investigator should 
proceed with screening procedures. 
Potential subjects will be classified as eligible or “Screen Failures.” A subject deemed a 
Screen Failure cannot participate in the study since he/she has not met the study inclusion 
criteria or has met the exclusion criteria. Electronic case report forms (eCRFs) must not be 
completed for subjects who are Screen Failures; however, the copy of their signed ICF and 

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any information collected as part of screening (e.g., source documents, etc.) must be kept 
in their medical records. 
Once a subject is randomized to a treatment group, the individual 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 3.3.4 for subjects 
determined to be lost to follow-up. 
3.3.1 
Eligibility 
3.3.1.1 
Inclusion Criteria  
To be considered for entry into the study, the candidate must meet all of the 
following criteria: 
1. Is of legal age (at least 18) on the date the Informed Consent Form (ICF) is 
signed and has the capacity to provide voluntary informed consent 
2. Is able to read, understand, and provide written informed consent on the 
Institutional Review Board (IRB) approved ICF and provide authorization 
as appropriate for local privacy regulations 
3. Is a habitual wearer (at least 3 months) of one of the lens types presented in 
Table 2 
4. Has typically cleaned and disinfected their pre-study contact lenses daily 
5. Must have spectacle correctable distance visual acuity through 
spherocylindrical refraction to 40 letters [0.14 logarithm of the minimal 
angle of resolution (logMAR)] or better in each eye at 2 meters distance 
using a high contrast chart 
6. Has clear central corneas and is free of any anterior segment disorders 
7. Is a habitual user of a lens care product for cleaning, disinfecting, and 
storage of lenses 
8. Requires lens correction in both eyes 
9. Wears the same brand of contact lens in both eyes 
10. Agrees to wear study lenses on a daily wear basis for approximately three 
months 
11. Is willing and able to comply with all treatment and follow-up study 
procedures. 
3.3.1.2 
Exclusion Criteria 
The candidate is ineligible for entry into the study if they meet any of the 
following criteria: 
1. Is currently using a hydrogen-peroxide cleaning and disinfecting solution 
2. Participated in any drug or device clinical investigation within 30 days prior 
to entry into this study 

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3. Is a female of childbearing potential (those who are not surgically sterilized 
or postmenopausal) if they meet any one of the following conditions: 
− they are currently pregnant 
− they plan to become pregnant during the study 
− they are breastfeeding 
4. Has worn gas permeable (GP) lenses within the last 30 days 
5. Has worn polymethylmethacrylate (PMMA) lenses within the last  
three months  
6. Has typically worn their pre-study contact lenses on an extended wear basis, 
sleeping in their lenses one night or more per week, during the last year 
7. Has any systemic disease currently affecting ocular health or which in the 
Investigator’s opinion may have an effect on ocular health during the course 
of the study 
8. Subjects with an active ocular disease or who are using any ocular 
medication 
9. Is using any medications that will, in the Investigator’s opinion, affect ocular 
physiology or lens performance 
10. Currently wears monovision, multifocal, or toric contact lenses 
11. Has ocular astigmatism of 1.00 D or greater in either eye 
12. Has anisometropia (spherical equivalent) of greater than 2.00 D 
13. Has any grade 2 or greater finding during the slit-lamp examination (refer 
to Appendix B for Methods of Clinical Evaluation)  
14. Has corneal infiltrates of ANY GRADE 
15. Has any “Present” ungraded finding during the slit-lamp examination (refer 
to Appendix B for Methods of Clinical Evaluation) that, in the Investigator’s 
judgment, interferes with contact lens wear 
16. Has any scar or neovascularization within the central 6 mm of the cornea, 
irregular cornea or a history of herpetic keratitis  
◊ 
Note that subjects with minor peripheral corneal scarring (that does not 
extend into the 6 mm central area), that, in the Investigator’s judgment, 
does not interfere with contact lens wear, are eligible for this study. 
17. Is aphakic 
18. Is amblyopic 
19. Has had any corneal surgery (e.g., refractive surgery) 
20. Is allergic to any component in the study care products 
21. Is an employee of any of the study investigative sites or a family member of 
an employee of the investigative site, including family members living 
outside of the employee’s household  

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22. Is an Ophthalmologist, an Optometrist, an Optician, or an Ophthalmic 
Assistant/Technician, or currently resides with a person with any of these 
specialties 
23. Is an employee of a manufacturer of contact lenses or contact lens care 
products (e.g., Alcon, Bausch + Lomb, Ciba Vision, CooperVision, 
Vistakon, Johnson & Johnson, etc.) or currently resides with a person 
employed by any of these manufacturers. 
If a subject meets all the inclusion criteria and does not meet any of the exclusion criteria, 
the subject is eligible for entry into the study. Ineligible subjects MUST NOT be enrolled 
in this study. Any subject enrolled in the study who later is found to have not met the 
eligibility criteria at entry will be discontinued. 
3.3.2 
Subject Completion 
A subject has completed the study when the individual has completed the Exit Visit 
procedures at the 3-Month Follow-up Visit.  Subjects who require further follow-up for an 
adverse event (AE) will be followed according to Sections 3.3.3. and 7.0.  
3.3.3 
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 AE occurring during the course of the study, which precludes continued treatment 
or follow-up 
• 
Persistent grade 3 or 4 slit-lamp findings 
• 
Persistent study related symptoms/complaints 
• 
Unacceptable distance lens visual acuity (VA) 
• 
Unacceptable lens centration 
• 
Unacceptable lens movement 
• 
Failure to follow study procedures 
A subject MUST be discontinued prior to the final study visit for any of the following 
reasons: 
• 
Voluntary withdrawal  
• 
Death  
• 
Investigator decision that it is not in the best medical interest of the subject to 
continue participation in the investigation 
• 
Lost to follow-up (refer to Section 3.3.4) 
• 
Either eye is discontinued 
• 
Becomes pregnant during the study 
Prior to discontinuing a subject, every effort should be made to contact the subject, 
schedule a final study visit, obtain as much follow-up data as possible, and to retrieve all 
study materials. Adverse events will be followed as described in Section 7.0.  
Subject discontinuations must 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 voluntarily withdraw from the study 
are not required to provide a reason for their decision but should be encouraged to share 

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this information. Subjects that are discontinued from the study following randomization 
will not be replaced. 
Exit Visit assessments should be completed for early discontinued subjects, if possible. 
At the final study visit, all study subjects who are discontinuing should be examined to 
ensure that their ocular health is consistent with pre-study, baseline conditions. Any 
adverse effects determined to have been reasonably caused by participation in the study 
will be followed per the standard of care. Participation in the study will not impact post-
study choices of study subjects for correcting their vision using marketed products (e.g., 
contact lenses and contact lens care solutions). 
Whether a subject completes or is discontinued from the study, they will be directed by the 
Investigator to resume their habitual lens care regimen.   
3.3.4 
Lost to Follow-up 
Subjects who did not return for scheduled follow-up visits, as defined by the visit window, 
and could not be contacted via two telephone calls and one letter with delivery 
confirmation, 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. If the Investigator determines that a subject has been 
lost to follow-up, the “study exit date” should be recorded as the last successful contact or 
the date a certified letter was sent. Just prior to database lock, the database will be reviewed 
for all lost to follow-up entries to confirm, once again, that contact with the subject was 
never made. A study participant may withdraw from the study at any time for any reason. 
3.4 
Investigators 
The study will be conducted at approximately 22 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. This will include appropriate current state licensing 
and study-specific training. Principal Investigators will sign the Device Investigator 
Agreement form prior to the start of the study. Investigators will be compensated for their 
services with appropriate standard professional rates. Compensation will not be dependent 
on the study outcomes.  
Each Investigator should enroll approximately 15 subjects, 30 eyes. 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.  
3.5 
Finances 
The study will be financed through Bausch & Lomb Corporate Research & Development.  
A Clinical Trial Agreement3 will be executed between Bausch + Lomb and each 
Investigator prior to their participation in the clinical trial.  The agreement will include the 
responsibilities of each party, payment and reimbursement procedures and requirements, 
intellectual property and publication terms, insurance and indemnification, coverage for 
subject injury.  Investigator and subject compensation are outlined in the Investigator’s 
Clinical Trial Agreement.   Each Investigator will be required to maintain General Liability 
and Professional/Medical Malpractice Insurance during the duration of the study.  Bausch 
+ Lomb agrees to indemnify investigative sites per conditions outlined in the Clinical Trial 

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. The Investigational Test Article 
will be provided to subjects with masked labeling (Section 4.4.2). 
4.2 
Description of Control Product (Comparator)  
renu® Advanced Formula multi-purpose solution is a marketed product indicated for the 
care of soft contact lenses. It is a sterile, isotonic, aqueous solution that contains 
poloxamine, poloxamer 181, diglycine, sodium citrate, boric acid, sodium borate, edetate 
disodium and sodium chloride and preserved with polyaminopropyl biguanide 0.00005%, 
polyquaternium 0.00015%, and alexidine 0.0002%. The Control solution will be provided 
to subjects with masked labeling  
4.3 
Instructions for Use and Administration  
Each subject will be issued a Study Kit labeled with a unique Study Kit number. Subject 
Instructions for use of the assigned study solution (Test Article or Control) will be provided 
by the unmasked designee. Subjects will be dispensed three pairs (two for back-up) of their 
habitual lenses at the Screening/Dispensing Visit with additional pairs of lenses being 
dispensed at each of the monthly follow-up visits except for Month 3.  Subjects will wear 
their assigned lenses on a daily wear basis for the duration of the study.  
The Investigator or designee will instruct all subjects to adhere to the Subject Instructions 
provided for the daily care of their contact lenses. 
In order to ensure that the Investigator and site staff remain masked to the lens care system, 
an unmasked designee at the site will be responsible for all dispensation and collection of 
study supplies to/from the subjects.  
4.3.1 
Storage Requirements 
All Test and Control study solutions provided by the Sponsor must be stored in a secure 
location accessible only by the unmasked designee and maintained at room temperature. 
4.3.2 
Subject Instructions 
a. Subjects must comply with the instructions provided to them (refer to Appendix C). 
b. The unmasked designee must review with the subject, the Subject Instructions and the 
precautions and warnings for lens wear, lens care, handling, cleaning, and disinfecting, 
and return of study materials.  
4.4 
Packaging and Labeling   
4.4.1 
Lenses 
The site is responsible for ordering all habitual contact lenses needed for the study and 
submitting an invoice for reimbursement for non-Bausch + Lomb lenses. Six pairs of the 
subject’s habitual contact lenses will be provided for each subject; three pairs will be 
dispensed to the subject at the Screening/Dispensing Visit (two for back-up) and a new pair 
will be dispensed at each of the 1-Month and 2-Month Follow-up Visits. The sixth pair will 
be retained in-office in the event a non-scheduled replacement is required.  Additional 
lenses can be ordered and dispensed, if needed. 

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4.4.2 
Study Kits 
The Sponsor will provide Study Kits for each subject. All Study Kits will be assigned by 
the randomization system and distributed to the subject by the unmasked designee. Each 
Study Kit will include the following materials: 
• 
1 bottle of study solution (Test or Control).  Each labeled bottle will be enclosed in 
a labeled white carton.  Each carton and bottle will be labeled with an investigational 
label including a unique 5-digit Study Kit number. The subject number may be written 
on the outside carton ONLY.  The bottles should not be written on or labelled.   
• 
Study Lens Cases.  A new lens case will be included with each carton of study solution 
for the subject to use for the month.  Subjects are required to use the supplied lens case.  
• 
Subject Instructions. Instructions will be provided by unmasked designee at study 
visit. 
4.4.3 
Other Study Supplies 
The following will be stored at the sites to be provided to subjects as needed:  
• 
Carton/Bottle Return Materials.  Comprised of opaque bags and pre-printed labels 
for return of Test and Control solutions (full, partially full, and empty bottles along 
with their cartons) to the Sponsor.   
• 
Contact Lenses: New contact lenses will be dispensed at the Screening/Dispensing, 1-
Month and 2-Month Follow-up Visits. 
• 
Rewetting Drops: Bausch + Lomb renu® Contact Lens Moisture Drops. 
The following will be stored at the sites to return study materials to the Sponsor: 
• Solution for Returning Lenses: Bausch + Lomb Sensitive Eyes® Saline Solution 
• 
Lens Return Materials.  Comprised of zippered plastic bags and pre-printed labels for 
return of worn lenses in a lens case filled with Bausch + Lomb Sensitive Eyes® Saline 
Solution to the Sponsor. The unmasked designee will prepare the lenses for return. 
4.5 
Accountability and Traceability 
The unmasked designee will be responsible to keep current and accurate records of study 
materials during the study. The records will include receipt and acknowledgement of all 
study lenses, Study Kits, and other supplies as identified in Sections 4.4.2 and 4.4.3. The 
disposition of study solutions and habitual contact lenses dispensed and returned by the 
subjects will be recorded on study product accountability logs. The study solutions are to 
be dispensed only to subjects enrolled in the study, in accordance with the conditions 
specified in this protocol. 
Upon completion of the study, a Clinical Monitor will review and verify the Investigator’s 
accountability logs.   
Following verification, and as directed by the Sponsor, all used and unused study supplies 
(study solutions, unused contact lenses, and worn lens in cases filled with Bausch + Lomb 
Sensitive Eyes® Saline Solution must be returned to the Sponsor at the address below: 
 
 

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Bausch & Lomb Incorporated 
Clinical Trial Materials Supply Chain 
 
1400 North Goodman Street 
Rochester, NY 14609 
The study will use a randomization trial supply management (RTSM) system. All clinical 
supply kit orders, shipments, receipts, and subject dispensation will be tracked in the 
RTSM system. The clinical supply label includes a unique kit number and a labeling and 
packaging batch number for material lot number traceability. 
4.6 
Masking/Unmasking  
Study solutions will be provided in sealed opaque white boxes with Study Kit numbers 
preprinted on them.  
 
This is a double-masked study. The Investigator and Sponsor or their representatives 
involved in the conduct of the study will be masked to the study cleaning and disinfecting 
solutions. These procedures are intended to reduce or eliminate bias that might impact 
study outcomes and their interpretation. 
The randomization schedule will be created by an unmasked statistician not otherwise 
involved in the study and uploaded into the RTSM system. Personnel involved with any 
repackaging/ relabeling of clinical trial material will also be unmasked.  A Clinical Monitor 
will become unmasked during product reconciliation, at the conclusion of each site’s 
participation in the study and prior to locking the database.  Unmasked designees at the site 
will manage dispensing and return of study solutions, study contact lenses and related 
supplies.  
Study solutions will be provided in sealed opaque white boxes with Study Kit numbers 
preprinted on them. Subjects are not to show or discuss the study the study solution 
appearance with the Investigator or site staff unless instructed to do so.  Subjects may 
discuss any questions they have with the unmasked designee at the site. 
 
In the event that unmasking of a subject’s randomly assigned treatment is required, the 
Investigator (or other designee) is required to contact the Medical Monitor to request 
permission to unmask.  The Medical Monitor will contact the Sponsor designee and obtain 
approval to grant permission to unmask.  Upon receipt of authorization from the Sponsor 
designee, the Medical Monitor will advise the Investigator (or other qualified designee) to 
log into the RTSM system and unmask the subject.  If the Medical Monitor cannot be 
contacted, the Investigator (or other qualified designee) should then contact the Sponsor 
designee who can authorize the unmasking of a subject.  In the event that the Medical 
Monitor or Sponsor designee cannot be contacted, and the Investigator (or other qualified 
designee) deems the unmasking emergent, the Investigator may log into the RTSM system 
without authorization and unmask the subject. Whether unmasking occurs inadvertently or 
intentionally, the Investigator must notify the Medical Monitor or Sponsor designee as soon 
as possible after unmasking. In addition, the Investigator must record the date, time, and 
reason for unmasking the study treatment in the source documentation. 

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4.7 
Product Replacement 
Any additional/replacement (in the case of loss or damage) Test or Control study solutions 
must be ordered through the RTSM system. 
5.0 
SAFETY AND EFFECTIVENESS VARIABLES 
Key safety variables and the primary effectiveness variables are presented below. A full 
list and description of all safety and efficacy variables and study procedures are provided 
in Appendix A (Schedule of Visits and Parameters) and Appendix B (Methods of Clinical 
Evaluation). A summary of the planned statistical analyses is presented in Section 8.0. 
Product risks are also described in the Investigator’s Brochure. 
5.1 
Key Safety Variables 
The safety of the Test and Control solutions will be determined by the following 
parameters: 
• 
The primary safety endpoint will be the proportion of eyes with any slit-lamp findings 
greater than grade 2 over all follow-up visits. 
• 
Adverse Events will also be evaluated. Information regarding any subject- or 
Investigator- reported AEs will be obtained at each follow-up visit. The rate of adverse 
events is not a primary endpoint and is not associated with a predefined success 
criterion. 
5.2 
Primary Effectiveness Variables 
The effectiveness of the Test and Control solutions will be determined by the following 
parameters: 
• 
Overall comfort averaged over all scheduled follow-up visits 
• 
Vision averaged over all scheduled follow-up visits 
• 
The proportion of eyes with a maximum degree of front surface deposits grade of < 2 
over all scheduled follow-up visits. 
5.3 
Risk Assessment and Mitigation 
Laboratory, pre-clinical studies and a preliminary clinical study have evaluated BL3100-
NBR03 multi-purpose disinfection solution and/or its components. The results support the 
safety of the formulation for the further evaluation for the proposed use.  
The clinical procedures required in Protocol 914 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. Upon review of 
the clinical and preclinical data no additional risks were identified over the standard contact 
lens and care solution use. Risk mitigation includes periodic assessments of ocular health 
by vision care specialists throughout the study, oversight by the study Sponsor, its 
representatives and the Medical Monitor, and well-defined procedures for the management 
of adverse events, should they occur.     
Anticipated serious adverse device effects are presented in Section 7.1.4.1. Additional 
descriptions of the risks and benefits to subject safety associated with wearing contact 

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− Average hours per day of comfortable wear 
− Current lens brand, sphere power and base curve 
− Current lens care products 
c. For females of child-bearing potential, inform the potential subject they must use an 
effective method for birth control during the study and for 2 weeks following the last 
visit, in a manner that risk of contraceptive failure is minimized. Abstinence is 
allowed as a birth control method. 
d. Perform the following baseline assessments (without lenses; remove the lenses if the 
subject wore lenses to the visit):  
NOTE: All VA measurements MUST be made using a phoropter. 
− Spherocylindrical refraction 
− High contrast 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 sketch any scars and slit-lamp findings greater than Grade 2 in the 
subject’s source document.  
f. If the subject continues to be eligible, have the subject complete and initial the 
following form: 
− The Initial Lens Performance Assessment Form (Worn Lens Performance Rating 
Scales), including use of rewetting drops. 
g. Complete 
the 
Initial 
Symptoms/Complaints 
Form 
(Worn 
Lenses 
Symptoms/Complaints Form). 
h. Dispense three pairs (two for back up only) of the subject’s habitual contact lenses. 
Explain to the subject that the used lenses will be removed at the follow-up visits and 
returned to the Sponsor. 
i. Instruct subject to insert study lenses  
NOTE: wait 2-3 minutes for the new contact lenses to settle on the eye before 
proceeding  
j. Instruct subject to complete Lens Performance Assessment Form (Abbreviated 
version: Study Lenses Lens Performance Rating Scale). 
k. Complete the Symptoms/Complaints Form (Study Lenses Symptoms/Complaints). 
l. Record the following:  
NOTE: All VA measurements MUST be made using a phoropter. 
− Dispensed lens type (brand), sphere power, base curve 
− High contrast distance lens VA 
− Over-refraction and distance VA 
− Lens wettability  
− Lens centration 
− Lens movement 

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− For each eye, compare the distance lens VA to the Distance Best Spectacle-
Corrected VA obtained at this visit. If the VA has decreased by 5 letters (0.1 
logMAR) or more, provide an explanation. 
− If the subject meets all Eligible requirements, log into RTSM system to randomize 
the subject.   
− If the subject is a “Screen Fail”, the reason for screen failure must be entered in 
the RTSM system and maintain a copy of their ICF. 
m. Following randomization, designated study site staff should dispense one Study Kit 
to the subject via the RTSM system and record in the subject’s individual Product 
Accountability Log.   
n. The unmasked designee will explain to the subject that: 
− Carton and bottle are NOT to be opened in front of any other site personnel.    
− The subject should retain all study materials and bring these items back to the study 
site at each visit. Place the cartons containing the multi-purpose solution bottles and 
contact lens cases into the opaque bag provided and return it to the unmasked 
designee.  
o. The unmasked Designee can dispense the Other Supplies, as needed by the subject 
(refer to Section 4.4.3).    
p. Complete the following visit eCRFs:   
− Screening/Dispensing Visit  
− Exit Visit (to be completed if the subject is discontinued after randomization) 
− Collect Adverse Events 
6.1.2 
2-Week Follow-up Visit 
The 2-Week Follow-up Visit will proceed as follows: 
a. Collect the following lens wear parameters from the subject: 
− Average daily wearing time (since last visit) 
− Average hours of comfortable wear (since last visit) 
− Hours lenses worn on the day of this visit  
− Did subject replace their lenses?  (If so, when)  
b. Complete the Symptoms/Complaints Form (Study Symptoms/Complaints Rating 
Scales). 
c. Have the subject complete and initial the Lens Performance Assessment Form (Study 
Lenses Performance Rating Scales, including use of rewetting drops.) 
d. Collect any relevant medical treatment information, including any adverse events, 
including whether a culture may have been taken. 
e. If the subject did not come to the visit wearing one or more study lenses, go to Step f 
(below, slit-lamp assessment). Otherwise, evaluate the lenses (while on eye) and record 
the following assessments:  
NOTE: All VA measurements MUST be made using a phoropter. 
− High contrast distance lens VA 

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− For each eye, compare the distance lens VA to the distance lens VA obtained at the 
Screening / Dispensing visit. If the VA has decreased by 10 letters (0.2 logMAR) 
or more, provide an explanation. 
− Over-refraction and distance VA 
− Lens wettability 
− Lens deposits (type, percent and degree) 
− Lens centration 
− Lens movement 
 
f. Perform a slit-lamp examination (remove and store the lenses if the subject wore lenses 
to the visit).  A lens case must be filled with Bausch + Lomb Sensitive Eyes® Saline 
Solution (NOT dispensed study solution) for storage of subject’s lenses during the 
exam.  If a corneal infiltrate is noted record details according to Corneal Infiltrates, 
Section 2.0: Slit-Lamp Examination of Appendix B: Methods of Clinical Evaluation.   
g. Record and sketch any scars and slit-lamp findings greater than Grade 2 in the subject’s 
source document. 
h. Return the lenses to the subject to wear until the next study visit. 
i. If an unscheduled lens replacement is required, dispense a new pair of the subject’s 
habitual contact lenses and go to Unscheduled Visits Section 6.1.6. 
j. Complete the following visit eCRFs:   
− 2-Week Follow-up Visit  
− Exit Visit (to be completed if the subject is discontinued or exited at this visit) 
− Collect Adverse Events 
6.1.3 
1-Month and 2-Month Follow-up Visits 
The 1-Month and 2-Month Follow-up Visits will proceed as follows: 
a. If a subject misses either the 1-Month or 2-Month scheduled follow-up visit and cannot 
be seen prior to the start of the visit window for the next scheduled follow-up visit, then 
the visit is considered missed.   
b. Collect the following lens wear parameters from the subject: 
− Average daily wearing time (since last visit) 
− Average hours of comfortable wear (since last visit) 
− Hours lenses worn on the day of this visit 
− Did subject replace their lenses?  (If so, when)  
c. Complete the Symptoms/Complaints Form (Study Lenses Symptoms/Complaints 
Rating Scales) 
d. Have the subject complete and initial the Lens Performance Assessment Form. (Study 
Lenses Performance Rating Scales, including use of rewetting drops.) 
e. Collect any relevant medical treatment information including any adverse events, 
including whether a culture may have been taken. 

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f. If the subject did not come to the visit wearing one or more study lenses, go to Step g. 
Otherwise, evaluate the lenses (while on eye):  
NOTE: All VA measurements MUST be made using a phoropter. 
− distance lens VA 
− For each eye, compare the distance lens VA obtained at the Screening / Dispensing 
visit with the distance lens VA obtained at this visit. If the VA has decreased by 10 
letters (0.2 logMAR) or more, provide an explanation. 
− Over-refraction and distance VA 
− Lens wettability 
− Lens deposits (type, percent, and degree) 
− Lens centration  
− Lens movement 
g. Perform a slit-lamp examination (remove the lenses if the subject wore lenses to the 
visit). Record and sketch any scars and slit-lamp findings greater than Grade 2 in the 
subject’s source document.  If a corneal infiltrate is noted record details according to 
Corneal Infiltrates, Section 2.0: Slit-Lamp Examination of Appendix B: Methods of 
Clinical Evaluation. 
h. Unmasked designee to collect the worn lenses from the subject. All worn lenses will 
be returned to the Sponsor in lens cases filled with Bausch + Lomb Sensitive Eyes® 
Saline Solution at the end of the study. Place the lens case in a labeled zippered bag. 
i.  Unmasked designee to collect used Study Kit (bottle and carton) dispensed at the 
subject’s previous visit. 
j. Unmasked designee to place the lens case in the labeled zippered bag and the used 
Study Kit (bottle and carton) in subject’s bag. DO NOT seal subject bags until there is 
a full accountability by a Clinical Monitor at the end of the study.   
k. Dispense a new pair of subject’s habitual lenses, instruct the subject to insert the lenses, 
and record the following information: 
NOTE: All VA measurements MUST be made using a phoropter. 
− Dispensed lens type (brand), sphere power, base curve 
− distance lens VA 
− For each eye, compare the distance lens VA obtained at the Screening / Dispensing 
visit with the distance lens VA obtained at this visit. If the VA has decreased by 10 
letters (0.2 logMAR) or more, provide an explanation 
− Over-refraction and distance VA 
− Lens wettability  
− Lens centration  
− Lens movement  
l. Unmasked designee to dispense a new Study Kit through the RTSM system, and record 
in the subject’s individual Product Accountability Log.  If needed, dispense any other 
supplies. 
m. Complete the following visit eCRFs: 
− 1-Month or 2-Month Follow-Up Visit  

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− Exit Visit (to be completed if subject is discontinued at this visit) 
− Collect Adverse Events 
6.1.4 
3-Month Follow-up  
The 3-Month Follow-up will proceed as follows: 
NOTE: All VA measurements MUST be made using a phoropter. 
a. Collect the following lens wear parameters from the subject: 
− Average daily wearing time (since last visit) 
− Average hours of comfortable wear (since last visit) 
− Hours lenses worn on the day of this visit 
− Did subject replace their lenses?  (If so, when)  
− Last date that lenses were worn after cleaning and storing them in study solution 
− Number of days on study that the subject did not wear the study lenses 
− Percentage of days on study that the subject used study solution and wore their 
lenses on average (less than 80% = fewer than four out of five days, or 80% or more 
= at least four out of five days) 
b. Complete the Symptoms/Complaints Form (Study Lenses Symptoms/Complaints 
Rating Scales). 
c. Have the subject complete Lens Performance Assessment Form (Study Lenses 
Performance Rating Scales), including use of rewetting drops. 
d. Collect any relevant medical treatment information, including any adverse events, 
including whether a culture may have been taken. 
e. If the subject did not come to the visit wearing one or more study lenses, go to Step g. 
Otherwise, evaluate the lenses (while on eye): 
NOTE: All VA measurements MUST be made using a phoropter. 
− High contrast distance lens VA 
− For each eye, compare the distance lens VA obtained at the Screening / Dispensing 
visit with the distance lens VA obtained at this visit. If the VA has decreased by 10 
letters (0.2 logMAR) or more, provide an explanation. 
− Over-refraction and distance VA 
− Lens wettability 
− Lens deposits (type, percent, and degree) 
− Lens centration  
− Lens movement  
f. Perform a slit-lamp examination (remove the lenses if the subject wore lenses to the 
visit). Record and sketch any scars and slit-lamp findings greater than Grade 2 in the 
subject’s source document.  If a corneal infiltrate is noted record details according to 
Corneal Infiltrates, Section 2.0: Slit-Lamp Examination of Appendix B: Methods of 
Clinical Evaluation. 
g. Unmasked designee to collect all worn dispensed lenses from the subject. All worn 
lenses will be returned to the Sponsor in lens cases filled with Bausch + Lomb Sensitive 

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Eyes® Saline Solution at the end of the study. Place the lens case in a labeled zippered 
bag. 
h. Unmasked designee to collect used Study Kit (carton and bottle) dispensed at the 
subject’s previous visit. 
i. Unmasked Designee to place the lens case in the labeled zippered bag and the used 
Study Kit (bottle and carton) in the subject’s bag. DO NOT seal the subject’s bags until 
a full accountability is performed by a Clinical Monitor at the end of the study. 
j. All study materials (refer to Sections 4.4.2 and 4.4.3) must be returned to the Sponsor 
at the end of the study.  
k. Complete the following visit eCRFs:   
− 3-Month Follow-up Visit 
− Exit Visit (if there is an ongoing AE at the time of the 3-month visit, do not 
complete the Exit Visit and follow up via Unscheduled visit (s) instead  
− Collect Adverse Events 
6.1.5 
Exit Visit  
Do not continue with the Exit Visit until/unless the subject is ready to exit the 
study. Subjects who require further follow-up at the conclusion of the 3-Month 
Follow-up Visit will be followed according to the AE and/or Unscheduled Visit Section 
until the AE is resolved or stabilized. 
The Exit Visit will proceed as follows: 
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. For all subjects, complete an exit ocular examination without lenses on the eyes. Collect 
the following assessments: 
NOTE: All VA measurements MUST be made using a phoropter. 
 
− Spherocylindrical refraction 
− BSCVA Contrast Distance Lens VA 
○ Compare the Exit Visit distance BSCVA to the distance BSCVA obtained at 
the Screening/Dispensing Visit. If the VA has decreased by 10 letters (0.2 
logMAR) or more, explain. 
− Keratometry 
○ For each eye, compare the Exit visit Horizontal and Vertical keratometry 
readings to the Screening/Dispensing Visit Horizontal and Vertical keratometry 
readings. If there is a change of 1.00 D or more, explain. 
c. Indicate if there were any changes to pre-existing corneal scars. 
d. Unmasked designee to collect all worn lenses from the subject. All worn lenses will be 
returned to the Sponsor in lens cases filled with Bausch + Lomb Sensitive Eyes® Saline 
Solution at the end of the study. Place the lens case in a labeled zippered bag. 
e. Unmasked designee to collect used Study Kit (bottle and carton) dispensed at the 
subject’s previous visit. 

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f. Unmasked designee to place the lens case in the labeled zippered bag and the used 
Study Kit (bottle and carton) in the subject’s bag. DO NOT seal subject bags until a 
full study accountability is performed by a Clinical Monitor at the end of the study.  
g. All study materials (refer to Section 4.4.2) must be returned to the Sponsor at the end 
of the study.      
h. Have the subject complete the Subject Assessment Questionnaire. 
6.1.6 
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. Refer to Section 7.2 for the procedures required 
should an AE be present at an Unscheduled visit. 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 eCRFs.  
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 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. 
Procedures to be followed during an Unscheduled Visit will depend on the reason for the 
visit: 
a. Indicate the reason for the Unscheduled Visit.  
b. If the subject is experiencing problems, assessments will be performed according to the 
Investigator’s judgement.  
c. If the exclusive purpose of the visit is to dispense study lens/ Study Kit and the subject 
is not experiencing any problems (refer to Section 6.1.8.).  
d. Collect the following lens wear parameters from the subject: 
− Average daily wearing time (since last visit) 
− Average hours of comfortable wear (since last visit) 
− Hours lenses worn on the day of this visit 
− Did subject replace their lenses?  (If so, when)  
e. Complete the Symptoms/Complaints Form (Study Lenses Symptoms/Complaints), 
including use of rewetting drops  
f. Have the subject complete and initial the Lens Performance Assessment record (Study 
Lenses Performance Rating Scales). 
g. Collect any relevant medical treatment information, including any adverse events, 
including whether a culture may have been taken.  
h. If the subject did not come to the visit wearing one or more study lenses, go to Step i. 
Otherwise, evaluate the lenses (while on eye):  
NOTE: All VA measurements MUST be made using a phoropter. 

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− High contrast distance lens VA 
− Over-refraction and distance VA 
− Lens wettability 
− Lens deposits (type, percent and degree) 
− Lens centration  
− Lens movement 
− For each eye, compare the high contrast distance lens VA to the high contrast 
distance lens VA obtained at the Screening/Dispensing Visit. If the VA has 
decreased by 10 letters (0.2 logMAR) or more, explain. 
i. Perform a slit-lamp examination (remove the lenses if the subject wore lenses to the 
visit). Record and sketch any scars and slit-lamp findings greater than Grade 2 in the 
subject’s source document and transcribe this information to the visit eCRF.  If a 
corneal infiltrate is noted record details according to Corneal Infiltrates, Section 2.0: 
Slit-Lamp Examination of Appendix B: Methods of Clinical Evaluation. 
j. If a new Study Kit is required, designated site staff will log into RTSM system to 
dispense a new Study Kit (refer to Section 4.4.2) to the subject according to RTSM 
notification email and record in the Product Accountability Log.  
k. If an unscheduled lens replacement is required at this visit, dispense a new pair of 
subject’s habitual lenses and collect the following information:  
− Primary (one) reason for replacement 
− Dispensed lens type (brand), sphere power, base curve 
− Distance lens VA 
− Over-refraction and distance VA 
− Lens wettability 
− Lens centration  
− Lens movement  
− For each eye, compare the distance lens VA to the distance lens VA obtained at the 
Screening/Dispensing Visit. If the VA has decreased by 10 letters (0.2 logMAR) or 
more, provide an explanation. 
l. If Study Lenses were replaced, unmasked designee to collect the worn lenses from the 
subject. All worn lenses will be returned to the Sponsor in lens cases filled with Bausch 
+ Lomb Sensitive Eyes® Saline Solution at the end of the study. Place the lens in a 
labeled zippered bag. 
m. Unmasked designee to place the lens case in the labeled zippered bag and the used 
Study Kit (bottle and carton) in the subject’s bag. DO NOT seal subject bags until a 
full accountability is performed by a Clinical Monitor at the end of the study. 
n. All study materials (refer to Sections 4.4.2 and 4.4.3) must be returned to the Sponsor 
at the end of the study.      
o. If the subject needs to exit the study at this visit,  
− Complete the Exit Visit as per Section 6.1.5.  
− Unmasked designee to collect the Study Kit (bottle and carton) dispensed to the 
subject. 

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− Complete the form(s) listed below and transcribe the information to the eCRF as 
appropriate:   
○ Unscheduled Visit Form 
○ Exit Visit Form (to be used if the subject is discontinued or exited at this visit) 
6.1.7 
Missed Visits  
Missed Visits will be handled as follows: 
a. 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.  
6.1.8 
Product Dispensing Only Visit  
Product Dispensing Only Visits will proceed as follows: 
a. If a subject is seen exclusively for resupply or replacement of study materials, a 
complete exam is not required, as long as the subject is not experiencing any problems. 
If any assessment is performed, then an Unscheduled Visit Form must be completed 
(see section 6.1.6). 
− If additional study solution is required at this visit, go to Unscheduled Visit Section 
6.1.6, j.  
− If a lens replacement is required, go to Unscheduled Visit Section 6.1.6, k.  
6.2 
Study Completion / Early Study Terminations / Suspensions 
6.2.1 
Study Completion 
For purposes of the Investigator notifying the IRB, the study is complete when all 
subjects at the sites have been exited. Sponsor approval is required prior to IRB 
notification. 
6.2.2 
Early 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), 
IRBs, and FDA, as applicable. Bausch + Lomb will instruct the Investigators to stop/restart 
dispensing study materials and will arrange for study closeout, if applicable, at each site. 
6.3 
Concomitant Medications/Therapy  
Study subjects are not allowed to use other lens care products, ocular solutions, ocular 
medications, or eye drops (over-the-counter or prescription) during the study unless 
specifically approved by the Investigator following consultation with the Sponsor. Use of 
other contact lenses is not allowed. 
Ocular medications, 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 recorded in the appropriate eCRF. 

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6.4 
Treatment Compliance 
Treatment compliance will be assessed using lens wear parameter data. 
6.5 
Protocol Deviations 
A deviation from the protocol is an unintended and/or unanticipated departure from the 
procedures and/or processes approved by the Sponsor and the IRB and agreed to by the 
Investigator.  It is a Sponsor expectation that Investigators will follow the protocol and 
procedures as written.  The Sponsor will not grant protocol waivers for this study.  The 
Investigator may implement a deviation from the protocol to eliminate an immediate 
hazard to study subjects without prior IRB/EC approval.  As soon as possible after such an 
occurrence, the implemented deviation, as well as the reasons for it should be submitted to 
the IRB/EC for review and approval.  It should also be submitted to the Sponsor for 
agreement, and to the regulatory authorities, if required. 
 
 
In the event a protocol deviation occurs, the date of and reason for deviations must be 
documented in all cases.  Significant or major protocol deviations impacting the rights or 
safety of the subject or the integrity of the study must be reported by the Investigator to the 
IRB/EC and Medical Monitor immediately.  Reporting of all other protocol deviations must 
adhere to the requirements of the governing IRB/EC. Unless the protocol deviations put 
the subject at risk or the subject’s condition requires that they be discontinued from the 
study, subjects may continue to participate until the end of the study. 
 
Site Corrective Action Plans will be developed and completed as deemed necessary by the 
Sponsor, Sponsor Designee (e.g., Contract Research Organization, CRO) for sites or 
Investigators who deviate from this protocol in a way that adversely affects the rights, 
safety or well-being of the subject(s) and/or the quality or integrity of data. The Site 
Corrective Action Plan will outline the deviation and the site’s corrective and/or remedial 
actions. Decisions regarding critical deviations that merit Investigator disqualification and 
site closure will be made by the Sponsor and documented in the Trial Master File. 
7.0 
ADVERSE EVENTS 
7.1 
Introduction to Adverse Event Definitions 
AEs, Serious AEs (SAEs), Significant Non-Serious AEs, Non-Significant Non-Serious 
Adverse Events, Adverse Device Effects and Anticipated Serious Adverse Device Effects 
are defined in this section and in the Protocol’s Glossary.  
An AE is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, 
whether or not related to the investigational medical device, comparator, or the procedures 
involved. For users or other persons, this definition is restricted to events not related to 
investigational medical devices. 
7.1.1 
Serious Adverse Event (SAE) Definitions 
An AE that (related or not related to the investigational test articles, comparator products 
or study procedures): 
o Led to death 

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o Led to serious deterioration in the health of the subject, that resulted in: 
‒ A life-threatening illness or injury; or 
‒ A permanent impairment of a body structure or a body function (e.g., 
blindness); or 
‒ Inpatient or prolonged hospitalization; or 
‒ Medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function 
o Led to fetal distress, fetal death, or a congenital abnormality or birth defect. 
Note: A planned hospitalization for a pre-existing condition, or a procedure 
required by the protocol, without serious deterioration in health, is not considered 
an SAE. 
Serious adverse events may include but are not limited to any hazardous, sight-threatening 
conditions occurring after exposure to the investigational test article or control product 
including, but not limited to, the following: 
• A presumed infectious ulcer (defined as a progressive erosion of the corneal 
tissue). For the purposes of reporting, this includes: 
o Central or para-central location 
o Penetration of Bowman’s membrane 
o Infiltrate ≥2 mm diameter 
o Associated with iritis  
o Associated with any increase in intraocular pressure 
o Culture positive for microorganisms 
o Increasing size or severity at subsequent visits 
NOTE: Signs of a presumed infectious corneal ulcer may include irregular focal 
infiltrates, active lesions with raised edges, significant diffuse infiltration, anterior 
corneal to mid-stromal involvement, erosion with overlying staining, conjunctival 
and lid edema, anterior chamber reaction (iritis), and severe bulbar and limbal 
redness. Symptoms associated with a presumed infectious ulcer (microbial 
keratitis) may include pain of rapid onset, severe redness, purulent or 
mucopurulent discharge, tearing, and photophobia. 
• Any central or paracentral (within the central 6 mm of cornea) corneal event that 
results in permanent opacification (such as corneal scar or vascularization) 
• Any serious adverse ophthalmic events including hypopyon and/or hyphema 
• Any neovascularization within the central 6 mm of the cornea 
• Permanent loss of ≥2 lines of BSCVA 
• All cases of iritis. 
7.1.2 
Significant Non-Serious Adverse Event Definitions 
A significant non-serious adverse event is an AE that does not meet the serious criteria, is 
considered significant by the Sponsor, and requires expedited reporting to the Sponsor (see 
Section 7.2.1.). These events include but are not limited to:  

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• Peripheral non-progressive non-infectious corneal ulcers 
• All symptomatic corneal infiltrative events 
• All cases of corneal staining greater than or equal to Grade 3 
• A temporary loss of two or more lines of BSCVA (for greater than or equal to 2 
weeks) 
• Neovascularization cases Grade 2 or greater (if not within 6 mm of the cornea) 
• Any ocular event that necessitates temporary lens discontinuation of greater than 
or equal to 2 weeks. 
7.1.3 
Non-Significant Non-Serious Adverse Events Definitions 
A non-significant non-serious adverse event may include but are not limited to the 
following and does not require expedited reporting: 
• Bacterial Conjunctivitis; 
• Viral Conjunctivitis; 
• Allergic Conjunctivitis; 
• Corneal Edema; 
• Contact Lens Related Papillary Conjunctivitis; and 
• Loss of Contrast Sensitivity. 
7.1.4 
Adverse Device Effect (ADE) Definitions 
An adverse device effect (ADE) is an AE that is assessed to be related to the use of an 
investigational medical device. This definition includes AEs resulting from insufficient or 
inadequate instructions for use; deployment, implantation, installation, or operation; or any 
malfunction of the investigational medical device. This definition also includes any event 
resulting from use error or from intentional misuse of the investigational medical device. 
7.1.4.1 
Anticipated Serious Adverse Device Effect (ASADE) Definition 
An anticipated serious adverse device effect (ASADE) is an ADE that first meets the 
serious criteria (see Section 7.1.1) and which, by its nature, incidence, severity or outcome, 
has been previously identified in the investigational plan or application (including a 
supplementary plan or application) and/or in the risk analysis report. ASADEs include 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 
7.1.4.2 
Unanticipated Serious Adverse Device Effect (USADE) Definitions 
An unanticipated serious ocular or non-ocular adverse device effect (USADE) is an adverse 
event related to the use of an investigational medical device that has resulted in any of the 
consequences characteristic of a serious adverse event as described in section 7.1.1 and 

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which by its nature, incidence, severity or outcome has not been identified in the current 
version of the risk analysis report.  
This definition includes but is not limited to AEs resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device.  
This definition also includes any event resulting from use error or from intentional misuse 
of the investigational medical device. USADEs include but are not limited to: 
• Any central or paracentral (within 6 mm of cornea) corneal event that results in 
permanent opacification (such as corneal scar or vascularization) 
• Any serious adverse ophthalmic events including hypopyon and/or hyphema 
• Any neovascularization within the central 6 mm of the cornea 
• Permanent loss of ≥2 lines of BSCVA 
• All cases of iritis. 
7.1.5 
Relationship Definition: Study Device and/or Other Study Materials 
• Related: There is at least a reasonable possibility that the AE is related to the 
study device (study solution) 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.   
• Not related: There is little or no reasonable possibility that the AE is related 
to the study device (study solution) and/or rewetting drops. This assessment 
implies that the AE has no evidence to suggest either a causal relationship or 
association to the study device and/or rewetting drops and a more likely or 
certain alternative etiology exists. 
7.1.6 
Severity Definitions 
• 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 
7.2 
Procedures for Evaluating Adverse Events 
Throughout the course of this study all efforts will be made to remain alert to reportable 
AEs. If an AE occurs the first concern will be the safety of the subject and appropriate 
medical intervention will be made. All SAEs, ocular and systemic, must be recorded and 
reported as required. 
All reportable AEs occurring after signing of informed consent and through the subject’s 
end of participation in the study must be reported. All reportable AEs must be followed 
until the event resolves or stabilizes. 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. 

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Ocular AEs of possible clinical significance should be photo-documented and shared with 
the Medical Monitor in electronic form. 
When evaluating for reportable AEs, the Investigator should refer to the definitions for 
AEs to determine: 
a) whether the event is serious (refer to Section 7.1.1 and 7.1.2.)  
b) whether the event is severe (refer to Section 7.1.6.) 
c) whether the event is significant (refer to Sections 7.1.2 and 7.1.3.) 
d) whether the event is related to the study device (refer to Section 7.1.5.) 
7.2.1 
Procedures for Reporting Serious or Significant Adverse Events 
An AE classified as a SAE or a Significant Non-Serious Ocular AE requires expeditious 
handling and reporting to the Sponsor to comply with regulatory requirements, as follows: 
• The event must be reported to the Medical Monitor 
(
 within 24 hours of the Investigator’s 
awareness of the event via facsimile/email transmission on a paper SAE or 
Significant Non-Serious AE Report Form signed by the Investigator. 
• The Medical Monitor will email a copy of the form (within 24 hours) to all 
parties listed below: 
o 
  
 
 
 
 
 
    
 
 
Investigators should not wait to receive additional information to fully document 
the event before initially notifying the Medical Monitor of an SAE or a Significant 
Non-Serious AE. Additional relevant information such as hospital records and 
autopsy reports should be provided to the Medical Monitor as soon as they are 
available. 
• The Investigator should take all appropriate measures to ensure the safety of the 
subjects: notably, he/she should follow a subject with an SAE or Significant 
Non-Serious AE until the event has resolved or the condition has stabilized. 
This may imply that follow-up will continue after the subject has left the study, 
and that additional evaluations may be requested by the Sponsor. 
• Ensure that the subject’s identity is protected and the subject’s identifiers in the 
clinical trial are properly mentioned on the form. 
• BEGIN TREATMENT OF THE AE IMMEDIATELY BY A SUITABLY 
LICENSED EYE CARE PROFESSIONAL. 
• Continue to update the paper SAE or Significant Non-Serious AE Report Form, 
if applicable, each time the subject is seen during the management of the event 
and at resolution of the event.  All updated report forms should be submitted by 
the site to the Medical Monitor within 24 hours. The Medical Monitor should 
distribute the updated reports to appropriate Sponsor personnel. Whenever 

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possible, it is suggested that the Investigator take photographs of all ocular AEs 
of possible clinical significance and forward them to the Medical Monitor. 
• Events 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. 
• Report all USADEs to the reviewing IRB within 10 working days following 
awareness of the USADE or according to the established reporting procedures 
of the IRB, whichever is shorter. 
• Submit all bills, prescription receipts, and culture reports/fees related to the AE 
to the Bausch + Lomb Clinical Operations.  Expense incurred for study related 
medical treatment will be paid by Bausch +Lomb Clinical Operations. 
7.2.2 
Procedures for Reporting Off-Site Unanticipated Serious Adverse Device 
Effects 
When participating in multicenter clinical investigations, Investigators may receive off-site 
USADE reports. These are Sponsor reports of USADEs which occurred at other clinical 
sites for the same trial, or in different trials using the same investigational test article or 
comparator, 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. 
7.2.3 
Device Deficiencies: Definition and Reporting Procedures 
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 any complaints/ deficiencies or 
malfunctions experienced with the study solution during this trial to the Medical Monitor 
promptly. The Sponsor and Medical Monitor shall review all device deficiencies and, upon 
the Sponsor’s request, Investigators must supply any additional information related to the 
safety reporting of a particular event. 
Report device deficiencies within 24 hours of knowledge to: 
o 
 
 
 
 
 
The Medical Monitor will distribute, within 24 hours of knowledge, all device deficiencies 
to the Sponsor.  
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. 

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7.2.4 
Procedures for Culturing of Corneal Ulcer or Suspected Ocular Infection 
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 required culturing techniques are outlined in Appendix B, Section 8.0). 
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 local clinical laboratory designated by the site. 
Microbial data generated from returned subject supplies (e.g., lenses, lens cases, and/or 
lens case solutions) are for information only. Because microbes may be introduced into 
subject supplies during use, recovery of microbes from returned subject supplies cannot be 
presumed to indicate etiology or direction of organism transmission. 
The ocular cultures, along with the associated contact lenses and contact lens cases, will 
be sent to the local clinical laboratory designated by the site for analysis. The clinical 
laboratory will report the culture results to the Investigator who will record the results in 
the eCRF. 
7.2.5 
Guidelines for Reporting Pregnancies  
During the study, all female subjects of childbearing potential should be instructed to 
contact the Investigator immediately if they suspect they might be pregnant (e.g., missed 
or late menstrual period). Female subjects who become pregnant during the study will be 
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 on a Pregnancy Report and submitted to the 
Medical Monitor via facsimile or email transmission within 24 hours of the Investigator’s 
awareness of the pregnancy.  The Medical Monitor will distribute the completed report to 
the Sponsor as per the distribution listed below. 
All pregnancies will be followed until outcome even after study closure.  The outcome of 
all pregnancies will be reported on a paper Pregnancy Outcome Report and submitted to 
the Medical Monitor via facsimile or email transmission once the outcome is learned. The 
Medical Monitor will distribute the completed report to the Sponsor as per the distribution 
listed below. 
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 Medical Monitor within 24 hours 
on the SAE or Significant Non-Serious AE Report Form along with the Pregnancy Report 
Form. 
The contact for reporting pregnancies and pregnancy outcomes are: 
 
 
 
 
 
 

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8.0 
STATISTICAL METHODS 
Changes to these statistical plans that are made prior to unmasking of study treatments will 
be documented in protocol amendments and/or the statistical analysis plan. Changes made 
after unmasking will be described in the clinical study report. 
8.1 
Study Endpoints 
8.1.1 
Primary Effectiveness Endpoints 
The primary effectiveness endpoints are as follows. 
a. Overall comfort averaged over all scheduled follow-up visits (Appendix B, Section 6.0, 
Rating Scale #3) 
b. Vision averaged over all scheduled follow-up visits (Appendix B, Section 6.0, Rating 
Scale #12) 
c. The proportion of eyes with a maximum degree of front surface deposits grade of < 2 
over all scheduled follow-up visits. 
8.1.2 
Secondary Effectiveness Endpoints 
There are no predefined secondary effectiveness endpoints.   
8.1.3 
Supportive Effectiveness 
The supportive effectiveness outcomes are the percentages of subjects agreeing with the 
consumer survey statements. 
8.1.4 
Primary Safety Endpoint 
The primary safety endpoint is the proportion of eyes with any slit-lamp findings greater 
than Grade 2 over all follow-up visits.   
8.2 
Hypotheses 
The noninferiority margins that follow are commonly used values in the industry for the 
corresponding endpoints. The study will be statistically successful if the Test lens is 
statistically successful in all primary endpoints. 
8.2.1 
Overall Comfort Averaged Over All Follow-up Visits 
The null hypothesis (𝐻𝐻0) is that the difference in mean overall comfort (test group mean 
[𝜇𝜇𝑇𝑇] minus standard group mean [𝜇𝜇𝑆𝑆]) is less than or equal to negative five points. The 
alternative hypothesis (𝐻𝐻1) is that the difference is greater than negative five points. 
𝐻𝐻0: 𝜇𝜇𝑇𝑇−𝜇𝜇𝑆𝑆≤−5 
𝐻𝐻1: 𝜇𝜇𝑇𝑇−𝜇𝜇𝑆𝑆> −5 
8.2.2 
Vision Averaged Over All Follow-up Visits 
The null hypothesis (𝐻𝐻0) is that the difference in mean vision score (test group mean [𝜇𝜇𝑇𝑇] 

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minus standard group mean [𝜇𝜇𝑆𝑆]) is less than or equal to negative five points. The 
alternative hypothesis (𝐻𝐻1) is that the difference is greater than negative five points. 
𝐻𝐻0: 𝜇𝜇𝑇𝑇−𝜇𝜇𝑆𝑆≤−5 
𝐻𝐻1: 𝜇𝜇𝑇𝑇−𝜇𝜇𝑆𝑆> −5 
8.2.3 
Front Surface Deposits at All Follow-up Visits 
The null hypothesis (𝐻𝐻0) is that the difference in the proportion of eyes with maximum 
front surface deposits grade of < 2 at all Follow-up Visits (test group proportion [𝜋𝜋𝑇𝑇] minus 
standard group proportion [𝜋𝜋𝑆𝑆]) is less than or equal to -0.1 (-10%). The alternative 
hypothesis (𝐻𝐻1) is that the difference is greater than -0.1 (-10%). 
𝐻𝐻0: 𝜋𝜋𝑇𝑇−𝜋𝜋𝑆𝑆≤−0.1 
𝐻𝐻1: 𝜋𝜋𝑇𝑇−𝜋𝜋𝑆𝑆> −0.1 
8.2.4 
Slit-Lamp Findings Greater than Grade 2 
The null hypothesis (𝐻𝐻0) is that the difference in the proportion of eyes with slit-lamp 
findings greater than grade 2 (test group proportion [𝜋𝜋𝑇𝑇] minus standard group proportion 
[𝜋𝜋𝑆𝑆]) is greater than or equal to 0.05 (5%). The alternative hypothesis (𝐻𝐻1) is that the 
difference is less than 0.05 (5%). 
𝐻𝐻0: 𝜋𝜋𝑇𝑇−𝜋𝜋𝑆𝑆≥0.05 
𝐻𝐻1: 𝜋𝜋𝑇𝑇−𝜋𝜋𝑆𝑆< 0.05 
8.2.5 
Subject Assessments 
Each of the following hypotheses will be evaluated for each of twelve statements in the 
Subject Assessment Questionnaire. 
8.2.5.1 
Proportion of Test Group Respondents Agreeing 
The null hypothesis (H0) is that the proportion of respondents in the Test group agreeing 
with the statement (πT) is less than or equal to 0.5. The alternative hypothesis (H1) is that 
the proportion agreeing is less than 0.5. 
𝐻𝐻0: 𝜋𝜋𝑇𝑇≤0.5 
𝐻𝐻1: 𝜋𝜋𝑇𝑇> 0.5 
8.2.5.2 
Comparison Between Groups of the Proportion of Respondents Agreeing  
The null hypothesis (H0) is that the proportion of respondents in the Test group agreeing 
with the statement (πT) is less than or equal to the proportion of respondents in the Control 
group (πT). The alternative hypothesis (H1) is that the proportion agreeing in the Test group 
is greater than the proportion agreeing in the Control group. 
𝐻𝐻0: 𝜋𝜋𝑇𝑇≤𝜋𝜋𝐶𝐶 
𝐻𝐻1: 𝜋𝜋𝑇𝑇> 𝜋𝜋𝐶𝐶 

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8.3 
Sample Size 
Estimates of standard deviations and proportions were obtained from Bausch + Lomb 
Study #872.5 
The sample size calculations assume that the unit of analysis will be the eye and that the 
outcomes from each subject’s eyes will be independent. 
Sample size calculations were completed using nQuery software, Version 9.  
8.3.1 
Overall Comfort 
When the sample size in each group is 300 eyes (150 subjects), a two-group one-sided 
0.025 significance level t-test will have 99% power to reject the null hypothesis that the 
test is not non-inferior to the standard (the difference in means, μT-μS, is -5 or farther from 
zero in the same direction) in favor of the alternative hypothesis that the Test is non-
inferior, assuming that the expected difference in means is 0 and the common standard 
deviation is 13.264. 
8.3.2 
Vision 
When the sample size in each group is 300 eyes (150 subjects), a two-group one-sided 
0.025 significance level t-test will have 99% power to reject the null hypothesis that the 
test is not non-inferior to the standard (the difference in means, μT-μS, is -5 or farther from 
zero in the same direction) in favor of the alternative hypothesis that the  non-inferior, 
assuming that the expected difference in means is 0 and the common standard deviation is 
11.7. 
8.3.3 
Front Surface Deposits 
With 300 eyes (150 subjects) in each group, the observed one-sided 97.5% confidence 
interval will be expected to exceed -0.1 with 99% power when the Standard proportion, π₀, 
is 0.942 and the  Test expected proportion, π₁, is 0.942; results are based on 100,000 
simulations using the Newcombe-Wilson score6 method to construct the confidence 
interval.6  
8.3.4 
Slit-Lamp Findings Greater than Grade 2 
With 300 eyes (150 subjects) in each group, the observed one-sided 97.5% confidence 
interval will be expected to be less than 0.05 with 99% power when the Standard 
proportion, π₀, is 0.008 and the Test expected proportion, π₁, is 0.008; results are based on 
100,000 simulations using the Newcombe-Wilson score method to construct the 
confidence interval.  
8.3.5 
Lens Groups  
For each lens group in Table , at least approximately 30 test group subjects will complete 
the study. For a sample size of 30, the probability of observing at least one complication 
will be at least 95% when the true complication rate is 10% or greater.   
8.3.6 
Overall Power 
If the four primary endpoints are independent, then the overall power of the study is 99% 
x 99% x 99% x 99% = 96%. 

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8.3.7 
Enrollment Targets 
Approximately 300 subjects (150 in each treatment group) will complete the trial. Allowing 
for up to 10% losses and for equal enrollment across sites, the enrollment target will be 
approximately 340 subjects (680 eyes). 
To allow for approximately 30 completed test group subjects per lens group, each lens 
group will enroll approximately 34 test group subjects. 
8.4 
Randomization 
An unmasked statistician who is not otherwise involved in the trial will create the 
randomization schedule. 
Each subject will be randomized to one of the treatment arms in a 1:1 ratio (Test to 
Control). Randomization will be managed using a RTSM system. The randomization will 
be stratified by lens group and investigational site.   
Efforts will be made to enroll subjects in at least three of the lens strata within each site to 
minimize confounding between site and lens group.  While the target enrollment for each 
lens group is approximately 68 subjects, some lens strata may be difficult to enroll.   
8.5 
Study Populations 
8.5.1 
Intent-to-Treat (ITT) Population 
The ITT Population will consist of all randomized subjects for subject level summaries 
and, for eye level summaries, both of their eyes. Subjects will be included in ITT 
Population summaries according to the treatment group to which they were randomly 
assigned. 
8.5.2 
Per Protocol (PP) Population 
The PP Population will consist of all ITT Population subjects without important (major) 
protocol deviations for subject level summaries and, for eye level summaries, both of their 
eyes. Important protocol deviation categories are defined in Section 8.6.5 below. Subjects 
will be included in PP Population summaries according to the treatment group to which 
they were randomly assigned. The membership of the PP population will be determined 
prior to unmasking. 
8.5.3 
Safety Population 
The Safety Population will consist of all dispensed subjects and, for eye level summaries, 
both of their eyes. Subjects will be included in Safety summaries according to the treatment 
that they received. If a subject receives more than one treatment and one of those treatments 
is the Test solution, then the subject will be included in Safety Population summaries under 
the Test treatment group.  

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8.6 
Statistical Analysis 
8.6.1 
Methods of Analysis 
8.6.1.1 
General Methods 
Continuous data will be summarized using sample size (n), mean, standard deviation (SD), 
median, minimum, and maximum. Categorical data will be presented using the total counts 
for each category and corresponding percentages. The denominator for each percentage 
will be the number of subjects or eyes with non-missing data unless otherwise indicated. 
As is customary for contact lens solution trials, eyes will be treated as independent 
sampling units in eye level analyses unless otherwise noted. 
Listings of data will be produced in addition to tables of summary statistics. 
8.6.1.2 
Overall Comfort 
At each follow-up visit, overall comfort will be assessed for each eye on a scale from 0 to 
100, with 100 denoting the most favorable response. For each eye, mean overall comfort 
over all follow-up visits will be computed as the average of the non-missing values over 
all scheduled follow-up visits. Missing data will not be imputed for the primary analysis. 
Mean overall comfort over all follow-up visits will be summarized at the eye level by 
treatment using continuous summary statistics for the ITT Set in a table. A one-sided lower 
97.5% confidence limit around the difference in means between the Test and Control 
treatment groups, computed using an analysis of variance model including the fixed factors 
of treatment, site, and lens group will be displayed. If the lower confidence limit is greater 
than -5.0, then the null hypothesis that the test solution is not noninferior will be rejected, 
and the test solution will be statistically successful in this outcome.  
As a sensitivity analysis, the PP Population will be analyzed for this endpoint.  
8.6.1.3 
Vision 
At each follow-up visit, vision will be assessed for each eye on a scale from 0 to 100, with 
100 denoting the most favorable response. Vision will be analyzed using the methods 
described above for overall comfort.  
8.6.1.4 
Front Surface Deposits 
At each follow-up visit, the degree of front surface deposits will be graded for each eye as 
0, 1, 2, 3, or 4. Using only the non-missing observations from scheduled follow-up visits 
without imputation, each eye will be classified with respect to the maximum grade of front 
surface deposits (< 2, > 2) observed over all follow-up visits. Maximum Front Surface 
Deposits Over All Follow-up Visits (< 2, > 2) will be summarized at the eye level by 
treatment using categorical summary statistics for the ITT Set in a table. A one-sided lower 
97.5% confidence limit around the difference in “< 2” proportions between the Test and 
Control treatment groups will be constructed using the Newcombe-Wilson score method. 
If the lower confidence limit is greater than -10.0% or if no deposits with grade greater 
than 2 are observed in either treatment group, then the null hypothesis that the Test solution 
is not noninferior will be rejected, and the Test solution will be statistically successful in 
this outcome. 
As a sensitivity analysis, the PP Population will be analyzed for this endpoint.  

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8.6.1.5 
Graded Slit-Lamp Findings > Grade 2 
At each follow-up visit, graded slit-lamp findings will be assessed for each eye using 
Grades 0 through 4. Using only the non-missing observations from all visits, each eye will 
be classified with respect to findings greater than grade 2 at any visit (Absent, Present). 
Greater than grade 2 findings (Absent, Present) will be summarized at the eye level by 
treatment using categorical summary statistics for the Safety Set in a table. A one-sided 
upper 97.5% confidence limit around the difference in “Present” proportions between the 
Test and Control treatment groups will be constructed using the Newcombe-Wilson score 
method. If the upper confidence limit is less than 5.0% or if no findings greater than grade 
2 are observed in either treatment group, then the null hypothesis that the Test solution is 
not noninferior will be rejected, and the Test solution will be statistically successful in this 
outcome. 
8.6.1.6 
Subject Assessment 
At the Exit visit, subjects will report their level of agreement with each of a series of twelve 
statements in the Subject Assessment Questionnaire. Responses will be on a scale of one 
(strongly disagree) through six (strongly agree). These values will be dichotomized for 
analysis, with responses of one through three being mapped to the category of “Disagree” 
and responses of four through six being mapped to “Agree.”  
Statistical testing will proceed in two hierarchical families of twelve statistical tests each 
(one test per statement), with the null hypotheses of the first family eligible for rejection if 
all the primary endpoints are met.  
The first family will employ a one-sided exact binomial test to compare the proportion of 
respondents in the Test group agreeing with each statement to 0.5.  
The second family will employ a one-sided chi-square test to compare the proportion of 
respondents agreeing with each statement between the treatment groups.  
Within each family of hypothesis tests, the P-values will be adjusted for multiplicity using 
the Holm method. Adjusted one-sided P-values less than 0.025 will show statistical 
significance. 
The responses to each statement will be summarized categorically (1, 2, 3, 4, 5, 6, Agree, 
Disagree) by treatment group in a table for the ITT Set. The adjusted P-values from the 
statistical tests will also be displayed along with an indicator of statistical significance. If 
the statistical tests in a family are not eligible for rejection due to hierarchy, then the 
adjusted P-values for that family will not be displayed. 
8.6.2 
Adverse Events 
All AEs occurring during the study will be recorded and classified on the basis of Medical 
Dictionary for Regulatory Activities (MedDRA) terminology. Descriptions of AEs will 
include the date of onset, the date the AE ended, the severity of the AE, the relationship to 
the study device, the action taken regarding study medication usage, the action taken to 
treat the AE, and the outcome. All reported treatment-emergent AEs (TEAEs) will be 
summarized by the number of subjects reporting AEs, system organ class, severity, 
seriousness, and relationship to study device. TEAEs are those AEs with an onset on or 
after the date of the first study device use. 

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Adverse events will be summarized by treatment group and severity. Each subject will be 
counted only once within a system organ class or a preferred term by using the AEs with 
the highest severity within each category. 
Adverse events will be summarized by treatment group and relationship to study 
medication. Each subject will be counted only once within a system organ class or a 
preferred term by using the AEs with the greatest relationship within each category. 
All information pertaining to AEs noted during the study will be listed by subject, detailing 
verbatim given the Investigator, preferred term, system organ class, start date, stop date, 
severity, action taken, and device relatedness. The AE onset will also be shown relative (in 
number of days) to the day of initial use of the randomized study device. 
Serious adverse events (SAEs) will be tabulated by subject within treatment groups. 
In addition, a list of subjects who discontinued from the study and a list of subjects who 
experienced SAEs will also be provided.  
8.6.3 
Subject Demographics and Baseline Characteristics 
Demographics and baseline characteristics will be summarized descriptively by treatment 
and overall, for the ITT, PP, and Safety Populations. 
8.6.4 
Subject Discontinuation 
The reasons for study discontinuation will be summarized by treatment and overall, for the 
ITT Population. 
8.6.5 
Protocol Deviations 
Important (major) protocol deviations will be summarized by category and treatment group 
for the ITT Population in a table.  
Categories of important protocol deviations will include the following. 
• Ineligibility at screening/dispensing but randomized 
• Not dispensed study treatment 
• Misrandomization 
• Dispensing of the incorrect solution 
• Dispensing and use of lenses from the incorrect lens group 
• Use of medications that could potentially affect any of the primary effectiveness 
endpoints 
• Failure to comply with the procedures used to assess the primary effectiveness 
endpoints, such as missing the scheduled visit or failing to complete the procedure 
in accordance with instructions 
Additional important protocol deviation categories may be added prior to unmasking. 
8.6.6 
Treatment Compliance 
As is customary for contact lens solution trials, treatment compliance will not be 
summarized. 
8.6.7 
Treatment Exposure 
As is customary for contact lens solution trials, treatment exposure will not be summarized. 

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8.6.8 
Missing Data 
Imputation of missing data is not conservative in a non-inferiority analysis setting. 
Therefore, primary effectiveness analyses will be completed without imputation of missing 
data.  
The effects of missing data on the primary effectiveness endpoint analyses will be explored 
by considering best- and worst-case imputation scenarios and tipping point analysis with 
the ITT Set.7 
8.6.9 
Multiplicity Issues 
The overall Type I error will be controlled by requiring the four co-primary endpoints to 
be statistically significant for overall success to be achieved. Failure of any one of the 
primary endpoints will invalidate the statistical significance of the secondary effectiveness 
endpoints. If the primary endpoints are met, then statistical testing of the supportive 
effectiveness endpoints will proceed in two hierarchical families with Holm multiplicity 
adjustments applied within each family. 
8.6.10 
Interim Analyses 
No interim analyses are planned. 
9.0 
DATA QUALITY ASSURANCE  
9.1 
Subject Confidentiality  
All personal subject data collected and processed for the purposes of this trial will be 
maintained by the Investigator and his/her staff with adequate precautions as to ensure that 
the confidentiality of the data is in accordance with local, state, and federal laws and 
regulations. 
 
Monitors, auditors, and other authorized representatives of CRO, the Sponsor, the IRB 
approving this trial, the FDA, the Department of Health and Human Services, other 
domestic government agencies, and other foreign regulatory agencies will be granted direct 
access to the trial subject’s original medical and trial records for verification of the data 
and/or clinical trial procedures. Access to this information will be permitted to the 
aforementioned individuals to the extent permitted by law. 
 
A report of the results of this trial may be published or sent to the appropriate health 
authorities in any country in which the product may ultimately be marketed, but the 
subject’s identity will not be disclosed in these documents. 
 
Suspected data breaches involving Personnel Health Information will be escalated to 
Bausch + Lomb Data Privacy representative per B+L SOP CLN-035 - Privacy of Clinical 
Data and Related Protection.8  

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9.2 
Study Monitoring 
Bausch + Lomb 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  
Bausch + Lomb Clinical Operations.  
Prior to the start of the study, member(s) of the Bausch + Lomb Clinical Operations, 
Clinical Affairs, and Global Regulatory Affairs will review the protocol, eCRF, regulatory 
obligations, and other material or equipment relevant to the conduct of the study with the 
Investigator/Sub-Investigator and relevant study site personnel.  
Monitoring visits and telephone consultations will occur as necessary, or per the 
monitoring plan, during the course of the investigation to verify the following: 
• 
the rights and well-being of subjects are protected 
• 
the conduct of the investigation is in compliance with the currently approved 
protocol/amendment, 21 CFR Parts 11, 50, 54, 56 and 812; 42 CFR Part 11 – Clinical Trials 
Registration and Results Information Submission; EN ISO 14155:2020 Clinical investigation 
of medical devices for human subjects – Good clinical practice; Medical Device Regulation 
(MDR) 2017/745; International Council for Harmonization (ICH) Good Clinical Practice; the 
Declaration of Helsinki and applicable local regulations  
• 
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 
• 
investigational 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.  
Plans for monitoring study sites, designed to ensure compliance with Good Clinical 
Practice (GCP), study-specific procedures, human rights and applicable regulations, are 
described in the Monitoring Plan.9   
9.3 
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 ICFs, 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.  In no instance, should an 
Investigator or study site personnel record any data or make changes to subject completed 
forms. The Investigator or designee should review subject completed forms during study 
visits for completeness and accuracy. If an entry is found to be illegible or a mistake is 
found (e.g., incorrect year was recorded), the subject should be instructed to edit the entry 

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by drawing a single line through the original entry, entering the new information, and 
dating and initialing the change.  
9.4 
Electronic 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 
accurately recorded on the eCRFs. All information required on the eCRFs needs to be 
supplied, including subject identification, date(s), assessment values, etc., and any 
omission or discrepancy will require explanation. All information on eCRFs must be 
traceable to source documents. 
A Clinical Monitor will be responsible for reviewing and verifying 100% of the data 
recorded on the eCRFs, utilizing the original source documentation, and will query 
discrepant findings. The Investigator and study site personnel will be responsible for 
answering all queries.  
The eCRF data will be reviewed for completeness, accuracy, consistency, and medical 
sense. Programmed edit checks will be used to reduce data entry errors and identify unusual 
data for verification prior to statistical analysis. 
A copy of the eCRF data will be retained at the conclusion of the study by the Investigator, 
who must ensure that it is stored in a secure place.  
9.5 
Recording of Data and Retention of Documents 
Subject data recorded on eCRFs during the study will be documented to maintain subject 
confidentiality. The subject will only be identified by the subject number. Confidentiality 
of subject’s records must be maintained to ensure adherence to applicable local privacy 
regulations. 
The Investigators have to retain records for 2 years after the investigational product is 
approved by the FDA. 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: 
• 
Device Investigator Agreement 
• 
IRB/EC approvals for the study protocol, all amendments, ICF(s), and advertisements 
• 
IRB/EC annual study review 
• 
IRB/EC correspondence and reports (e.g., AE reports, protocol deviations, and safety 
updates) 
• 
regulatory documents (e.g., financial disclosure and delegation of authority forms or 
records) 
• 
all source documents  
• 
eCRFs 
• 
subject’s signed ICF (including HIPAA) 
• 
accountability records for the test article(s) 
• 
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 Clinical Operations. 

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9.6 
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/EC, the 
Investigator must inform the Sponsor immediately that this request has been made. 
9.7 
Institutional Review Board 
The Investigator should ensure that the following are approved by their institution’s 
IRB/EC, or if not using their institution’s IRB/EC, approved by the reviewing central 
IRB/EC prior to entering any subjects in the study: 
• 
The protocol 
• 
The Investigator’s participation in the study 
• 
Subject recruitment materials (written information or materials including web pages, 
radio advertisements, television spots or written text developed to encourage subject 
enrollment) 
• 
The ICF to be used in this study.  
Documentation of IRB/EC 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/EC 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.  
9.8 
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 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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10.0 REFERENCES  
 
Global and Regional Regulatory References: 
• 
EN ISO 14155:2020 Clinical investigation of medical devices for human subjects 
– Good Clinical Practice 
• 
EN ISO 11980:2012 Ophthalmic Optics – Contact Lenses and contact lens care 
products – Guidance for clinical investigations 
• 
21 CFR Part 11 – Electronic Records; Electronic Signatures 
• 
21 CFR Part 50 – Protection of Human Subjects 
• 
21 CFR Part 54 – Financial Disclosure by Clinical Investigators 
• 
21 CFR Part 56 – Institutional Review Boards 
• 
21 CFR Part 812 – Investigational Device Exemptions 
• 
42 USC 282(j) 
• 
MDR 2017/745 – Regulation of the European Union on the clinical investigation 
and sale of medical devices for human use 
 
Literature References: 
1  Study 914 -Multi-Purpose Solution BL-3100-NBR03 -Investigator’s Brochure  
2 Protocol 914 Investigator Contact List 
3 Protocol 914 Investigator Clinical Trial Agreements 
4 B&L SOP No. 20-D022-3 Investigational Material Release for Bausch Health 
Companies R&D Activities 
5 Bausch + Lomb Study 872 ‘A Safety and Effectiveness Study of a New Contact Lens 
Cleaning and Disinfecting Solution’ Final Clinical Study Report, (Version 1, 
14MAR2016) 
6 Newcombe RG (1988) Interval estimation for the difference between independent 
proportions: comparison of eleven methods.  Statistics in Medicine 17:873-890 
7 Yan X, Lee S, and Li N (2009) Missing Data Handling Methods in Medical Device 
Clinical Trials.  Journal of Biopharmaceutical Statistics, 19: 1085-1098 
8 B&L SOP No. CLN 035 – Privacy of Clinical Data and Related Information 
9 Protocol 914 Monitoring Plan

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APPENDIX B: 
METHODS OF CLINICAL EVALUATION  
Any changes to the procedures described in this appendix will be provided under separate 
cover. Equipment and Instrumentation used to perform clinical evaluations should be 
maintained and calibrated per the investigative site’s procedures.   
1.0 
Visual Acuity/Refraction 
It is essential that a standard procedure be used to obtain VA measurements. The VA and 
refraction measurements should be obtained by a physician, optometrist, or trained 
technician. All VA/Refraction must be measured using a phoropter in 0.25 D steps. One 
standard logMAR, chart high 90% contrast, with Sloan letters will be used to obtain the 
VA measurements in this study. The following VA equipment from Precision Vision, Inc. 
will be used in this study: 90% high contrast 6.5 feet (2.0 meters) testing distance 
Translucent Chart (CAT. NO. 2103-2), and the Precision Vision Small Illuminator Cabinet 
(CAT. NO. 914). 
1.1 
Illumination of the logMAR Chart and Room Illumination 
The internal illumination of the logMAR chart should be turned on. This will provide the 
nominal contrast for each of the charts. Room illumination should be turned off, to 
ensure that the illumination is consistent for each measurement. Ambient sources of light 
in the room, such as computer monitors, should be turned off or covered. A small source 
of illumination may be used to allow recording of data and to ensure that it is not difficult 
or dangerous for staff or subjects to move around the testing area, but these light sources 
should not be placed so that they are directed toward the subject during testing. The room 
lighting and any ambient sources should be consistent in their use and placement at each 
subject visit throughout the course of this study. 
1.2 
Determination of Visual Acuity 
The subject should be seated so that the distance from the subject’s eyes to the logMAR 
chart is 6.5 feet (2.0 meters). The chart should be at eye level for the subject. The logMAR 
charts have two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-
0.3 logMAR). It is recommended that one letter sequence is used for the right eye, and the 
second letter sequence is used for the left eye, to minimize learning effects at each visit. 
Care should be taken to completely occlude the eye not being measured.  
Since the test distance of the chart is not at optical infinity, refractive power compensation 
is required to simulate optical infinity. The VA should be measured through the phoropter 
using the distance refractive correction with the addition of +0.50 D to compensate for the 
reduced test distance of 6.5 feet (2.0 meters). 
If all letters are correctly identified on any given line, then the subject is encouraged to read 
the next smaller line. When the subject says they cannot read a letter, they should be 
required to guess. A maximum effort should be made to identify each letter. A scoring 
sheet for each eye is provided to keep track of the letters correctly identified. The subject 
continues reading down the chart to the last letter of a given line, until the subject has 
missed 3 letters on a line with 5 letters. The incorrect letters can occur at the beginning, 
middle, or end of this line and do not have to be consecutive. 
 
 

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1.3 
Recording and Scoring logMAR Values 
Using the Sponsor supplied recording/scoring sheet, an example of which is shown below, 
the tester will record the actual VA measure. 
The number of letters CORRECT will be recorded on the recording/scoring sheet in the far 
right box on the corresponding line. The lines will then be added up and the “TOTAL” 
number of letters correctly identified will be recorded on the recording/scoring sheet. The 
“TOTAL” is the number that will be entered onto the eCRF.  
Example of Distance VA: 
In the example below, all letters in lines 1 through 6 were read correctly. Line 7 had 4 
correct responses, and line 8 had only 1 correct response. After line 8, the VA test would 
be considered complete. In this example, the total letters correctly identified is 32. This 
number is recorded in the space marked “TOTAL” and also recorded on the eCRF.  
 

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2.0  
Slit-Lamp Examination  
The following parameters will be assessed during the Slit-Lamp Examination (without 
lenses): 
Epithelial Edema 
0 -  
None: No epithelial or sub-epithelial haziness. Normal transparency. 
1 -  
Trace: Barely discernible localized epithelial or sub-epithelial haziness. 
2 - 
Mild: Faint but definite localized or generalized epithelial haziness. 
3 - 
Moderate: Significant localized or general epithelial haziness. 
4 - 
Severe: Definite widespread, epithelial cloudiness giving dull glass appearance to 
cornea, or numerous coalescent bullae. 
 
Epithelial Microcysts 
 
0 - 
None: no microcysts; normal transparency. 
1 - 
Trace: 1 to 20 microcysts; barely discernible local epithelial haziness. 
2 - 
Mild: 21 to 50 microcysts; faint but definite localized generalized haziness. 
3 - 
Moderate: 51 to 100 microcysts; significant localized or generalized haziness.  
4 - 
Severe: > 100 microcysts; definite widespread epithelial cloudiness giving a dull 
glass appearance to the cornea or numerous coalescing bullae.  
 
 
Stromal Edema 
0 - 
None: no oedema. 
1 - 
Trace: just detectable clouding. 
2 - 
Mild: faint corneal striae (2 or fewer).  
3 - 
Moderate: pronounced corneal striae (3). 
4 - 
Severe: folds in Descemet's membrane pronounced striae. 
 
Endothelial regularity 
 
 
0 - 
None: regular endothelial mosaic. 
 
1 - 
Minimal: isolated difference in cell size. 
 
2 - 
Mild: just noticeable variation in cell size or bumpiness of cell layer. 
 
3 - 
Moderate: easily detected difference in cell size or bumpiness of cell layer.  
 
4 - 
Severe: noticeable cell layer bumpiness and loss of definition of cell borders.  
 
 
 
 

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Corneal Staining 
Corneal staining must be assessed after the instillation of fluorescein. A Wratten Gel Filter 
will be provided by the Sponsor for the evaluation of corneal staining. The Wratten Gel 
Filter must be used as a barrier filter in the observation pathway, in combination with the 
cobalt blue filter. 
0 - 
None: No fluorescein staining. 
1 - 
Trace: Minimal superficial staining or stippling, and non-coalescing. Includes 
superficial foreign body staining. 
2 - 
Mild: Lightly coalescent or diffuse punctate staining, with no stain diffusion into 
stroma. 
3 - 
Moderate: Significant or densely coalescent punctate staining, including slight 
diffusion of stain into stroma. 
4 - 
Severe: Severe abrasion or erosion with loss of epithelial substance. Marked and 
rapid diffusion of stain into stroma. 
Limbal Injection 
0 - 
None: No hyperemia present. Normal appearance of limbal vessels including 
prominent limbal vascular arcades. 
1 - 
Trace: Very slight hyperemia of limbal vessels in one quadrant. 
2 - 
Mild: Mild hyperemia of limbal vessels in more than one quadrant. 
3 - 
Moderate: Marked hyperemia of limbal vessels in any quadrant. 
4 - 
Severe: Marked hyperemia of limbal vessels in all quadrants

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Bulbar Injection 
0 - 
None: No hyperemia present. Normal appearance of conjunctival vessels. 
1 - 
Trace: Slight hyperemia of conjunctival vessels in one quadrant. 
2 - 
Mild: Mild hyperemia of conjunctival vessels in more than one quadrant. 
3 - 
Moderate: Marked hyperemia of conjunctival vessels in any quadrant. 
4 - 
Severe: Marked hyperemia of conjunctival vessels in all quadrants. 
 
Upper Lid Tarsal Conjunctival Abnormalities 
0 - 
None: Normal, velvet tarsal conjunctival appearance. No hyperemia or enlarged 
papillae. 
1 - 
Trace: Slight tarsal conjunctival hyperemia with slight loss of smoothness. 
2 - 
Mild: Slight tarsal conjunctival hyperemia with slight loss of smoothness. 
Noticeable enlargement of papillae, but less than 1.0 mm in diameter. 
3 -  
Moderate: Definite loss of smoothness with enlarged papillae, but less than 1.0 mm 
in diameter with marked tarsal conjunctival hyperemia. 
4 - 
Severe: Localized or generalized giant papillae, larger than 1.0 mm in diameter 
and/or severe tarsal conjunctival hyperemia.  
 
Corneal Neovascularization 
0 - 
None: Normal appearing limbus, including prominent limbal vascular arcades. 
1 - 
Trace: Vascularization less than 1.0 mm of advancement into cornea in one 
quadrant. 
2 - 
Mild: Vascularization greater than 1.0 mm to less than 1.5 mm of advancement into 
cornea in more than one quadrant. 
3 - 
Moderate: Vascularization greater than 1.5 mm to less than 2.0 mm of advancement 
into cornea in any quadrant. 
4 - 
Severe: Vascularization more than 2.0 mm of advancement into cornea in any 
quadrant. 
 
Corneal Infiltrates 
0 - 
None - No infiltrates. 
1 - 
Trace - single or multiple epithelial infiltrates < 1 mm in diameter. 
2 - 
Mild - single or multiple epithelial infiltrates ≥ 1mm and < 2mm in diameter. 
3 - 
Moderate - multiple infiltrates ≥ 2 mm and < 3 mm in diameter. 
4 - 
Severe - multiple dense infiltrates ≥ 3 mm in diameter. 
 

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Infiltrate Size (Largest): OD: _____(X.X mm) OS: _____(X.X mm) 
Infiltrate Depth (Deepest): 
OD: _____ OS: _____ 
1. E - Epithelial
2. AS - Anterior Stroma
3. P - mid/posterior stromal
Infiltrate Density: 
Grade  Description 
0 
None 
1 
Faint 
2 
Moderate (iris/lens details clear) 
3 
Marked (iris/lens details hazy) 
4 
Intense (iris/lens details obscured) 
OD: _____ OS: _____ 
Infiltrate Type: 
OD: _____ OS: _____ 
Grades 
0 None 
1 Micropunctate 
2 Macropunctate 
3 Coalesced Macropunctate 
4 Patch 
5 Watery 
Degree of Pain: 
OD: _____ OS: _____ 
Size of Any Overlying Defect: 
OD: _____(X.X mm) OS: _____(X.X mm) 

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Location: 
Check all that apply 
OD: 
Central (central 6 mm, 3 mm from corneal center)  
Nasal 
 Inferior 
 Temporal 
 Superior 
Draw: 
OS: 
Central (central 6 mm, 3 mm from corneal center)  
Nasal 
 Inferior 
 Temporal 
 Superior 
Draw: 

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Bulbar Conjunctival Lens Compression/Indentation 
OD: 
Absent 
Present 
OS: 
Absent 
Present 
Other Slit-Lamp Findings: 
OD: 
OS: 
Absent 
 Present 
_____________ (specify). 
 Absent 
 Present 
_____________ (specify). 
New Corneal Scar: 
OD: 
Absent 
Present 
OS: 
Absent 
 Present 
If present is selected, please indicate size and draw.  
Size of any New Corneal scar: 
OD: _____(X.X mm) OS: _____(X.X mm) 

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Location: 
Check all that apply 
OD: 
Central (central 6 mm, 3 mm from corneal center)  
Nasal 
 Inferior 
 Temporal 
 Superior 
Draw: 
OS: 
Central (central 6 mm, 3 mm from corneal center)  
Nasal 
 Inferior 
 Temporal 
 Superior 
Draw: 

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3.0  
Method for the Examination, Description and Classification of Lens Deposits at 
Follow-up Visits 
Introduction: 
The following procedure has been developed to assist in the examination, description, and 
classification of deposits found on contact lenses at all follow-up visits in the Investigator's office. 
Materials needed: 
Slit-Lamp 
Procedure: 
Each lens should be examined on the eye using the slit-lamp employing a 7X to 15X 
magnification. 
Classify the deposit and record findings at each visit as follows: 
I.
Type of Deposit
Indicate the type of the most prominent lens surface deposit found using the following 
classifications: 
•
None
•
Crystalline deposits
•
Crust-like deposits
•
Film
•
Spots
II.
Estimated Percentage of Lens Surface Covered By Deposits
Estimate the percentage of the lens surface that is covered by deposits using the following 
classifications: 
•
None
•
1  -  25%
•
26  -  50%
•
51  -  75%
•
76  - 100%
III.
Degree of Deposit (Front and Back Surface)
Indicate the degree of the deposit on the lens surface using the following classifications:
Front Surface Deposits
0 - 
Absent, clean surface. 
1 - 
Very slight, only visible after tear film drying. 
2 - 
Slight, visible deposits easily removable. 
 
3 - 
Moderate, deposits adherent and not removable. 
4 - 
Severe, non-removable deposits and comfort affected. 
Back Surface Deposits 
0 - 
absent, clean surface. 
1 - 
very slight, 3 spots or less of moving particles. 

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2 - 
slight, up to 10 spots of moving particles. 
 
3 - 
moderate, 3 or less non-moving deposits adherent to lens.  
4 - 
severe, 4 or more deposits adherent to the lens and/or corneal indentation.  
IV. Wettability 
0 - 
a smooth uniformly reflecting surface. 
 
1 - 
a coarse hazy surface which seems resolved momentarily with each blink and becomes 
exacerbated with staring. 
 
2 - 
one stable dry (non-wetting) area of some magnitude. 
 
3 - 
more than one stable dry (non-wetting) area of some magnitude. 
 
4 - 
non-wettable lens surface. 
 
 
4.0  
Method for the Examination, Description and Classification of Lens Fit at all Visits 
The following procedure has been developed to assist in the examination, description, and 
classification of contact lenses fit at all visits in the Investigator’s office. 
Materials needed:  Slit-Lamp 
Procedure:  Each lens should be examined on the eye using the slit-lamp employing a 7X to 15X 
magnification. 
Lens fit will be assessed utilizing the scales below: 
I. 
Lens Centration  
Enter Rating 0 – 3: 
Qualitative Lens Centration 
• Compare lens edge overlap of limbus in all visible sectors. 
• The centration diagram is pictured as lateral decentration toward 9:00 on the clock dial. 
Centration assessment applies to all clock hours. 
o If the limbus is an ill-defined band, assess from the center of the band. 
o If the contact lens edge translates with blinking, assess to the average lens edge 
position. 
o Centration assessment applies to primary gaze. 
o  If the inferior edge of the contact lens is not visible, gently pull the lower eyelid 
away. 
• Rate and record lens centration on a scale of 0 to 3 based on the following lens diagrams 
and descriptors: 
 
0) Equal Overlap 360 degrees 
1) Maximum overlap ≤ 2/3 in any sector 
2) Maximum overlap > 2/3 in any sector 
3) Any Corneal Exposure 
. 
II. 
Lens Movement  
• As the subject blinks normally, observe lens movement, with particular attention to the 

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inferior portion of the lens. 
o All movement depicted in the diagram below is from the absolute centered 
position. 
o All movement descriptions apply from the various decentered positions. 
o Corneal exposure in any sector is an unacceptable fit. 
o If the inferior edge of the contact lens is not visible, gently pull the lower eyelid 
away. 
 
• Rate and record lens movement on a scale of -2 to +2 based on the following lens 
diagrams and descriptors: 
 
-2 -  No observable movement (perform Josephson push-up test, see below) 
-1 -  Minimal; Just observable movement, lens returns to origin. 
 0 -  Optimal/Free movement, lens returns to origin.  
+1 - Substantial movement; but lens does not immediately return to origin. 
+2 - Excessive movement; lens does not return to origin, may result in corneal 
exposure. 
 

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5.0 
 Symptoms/Complaints Rating Scales 
For 
completion 
of 
the 
Symptoms/Complaints 
Rating 
Scale 
Form 
(conducted 
at 
Screening/Dispensing for the subject’s habitual lenses and all follow-up visits with the study 
lenses), the Investigator or designee will obtain Subject responses according to the following 
procedure for the specific symptoms listed in the Symptoms/ Complaints Rating Table (below): 
Step 1:  
Ask the Subject: “Are you experiencing any Symptoms or problems with the lenses?” 
Step 2: 
If the Subject answers “No”, enter “0” on the subject source documentation for all 
symptoms. 
Step 3: 
If the Subject answers “Yes”, then ask: “What specifically are you noticing”.  Note that 
the subject will not be shown the list of options / descriptions.   
Step 4: 
From the Subject’s response, select the most appropriate symptom (from the 
Symptoms/Complaints Rating Scale Table below) and ask the Subject to rate the 
symptom on the following scale: 
 
0 -  
None 
1 - 
Slight symptoms.  The symptom is felt or noticed occasionally. 
2 - 
Mild symptoms.  The symptom is noticeable but not irritating or limiting use. 
3 - 
Moderate symptoms.  The symptom is moderately irritating or annoying; the use of 
device is limited by <25% (short wear time, etc.). 
4 - 
Severe symptoms.  The symptom is very irritating or annoying, and the lens cannot be 
tolerated. 
Symptoms/Complaint Rating Table 
 
Symptom 
OS (left eye) 
OD (right eye) 
Discomfort 
0-4 
0-4 
Excessive tearing 
0-4 
0-4 
Photophobia 
0-4 
0-4 
Halos 
0-4 
0-4 
Itching/Burning 
0-4 
0-4 
Spectacle Blur 
0-4 
0-4 
Variable Vision 
0-4 
0-4 
Blurred Vision 
0-4 
0-4 
Lens needs cleaning 
0-4 
0-4 
Handling 
0-4 
0-4 
 
 
 

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6.0 
Subject Assessment Questionnaire 
For completion of the Subject Assessment Questionnaire (conducted at Exit Visit), the Investigator 
or designee will instruct the subject to complete the form according to the care system care system 
that they have been using during the study.   For each statement, the subject will check the box 
next to the appropriate number from 1 to 6, with 1 = strongly disagree and 6 = strongly agree. 
Boxes one through three will also be visibly grouped into a category named “disagree,” while boxes 
four through six will be labeled as “agree.” The statements are as follows: 
• My lenses feel clean upon insertion 
• Makes my lenses feel clean throughout the day  
• Makes my lenses feel comfortable upon insertion  
• Makes my lenses feel comfortable throughout the day  
• Helps prevent dryness and discomfort  
• My vision remains clear throughout the day  
• Feels as gentle as natural tears 
• Makes my lenses feel moist throughout the day  
• Makes my lenses feel like a fresh pair  
• Keeps my eyes feeling healthy  
• Gives me a feeling of freedom to wear my lenses worry-free  
• Provides long lasting comfort 
 
7.0 
Lens Performance Rating Scales 
For completion by Subjects. Refer to Rating Scales (separate document) that should be provided 
to subjects to reference while completing form.  Enter rating from 0-100 (e.g., 90). 
 
Lens Performance Rating Scale 
Scale Number 
Burning and Stinging Upon Lens Insertion 
1 
Comfort Upon Insertion 
2 
Overall Comfort 
3 
Comfort at the End of Day 
4 
Ease of Handling/Insertion 
5 
Ease of Handling/Removal 
6 
Dryness 
8 
Vision Upon Insertion 
11 
Vision 
12 
Vision in Low Light 
13 
Vision at End of Day 
26 
Lens Cleanliness Upon Removal 
15 
Overall Impression 
19 
 
 

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Abbreviated Lens Performance 
Rating Scale 
Scale Number 
Burning and Stinging Upon Lens Insertion 
1 
Comfort Upon Insertion 
2 
Ease of Handling/Insertion 
5 
 
 
8.0   
Culture Procedures 
 
NOTE: The site must use their standard of care culture kit and ship specimens to their local 
laboratory for testing per the local labs required procedures.  Hard copy results must be filed 
in the subject record and entered into the eCRF. 
 
PROCEDURES FOR THE INVESTIGATOR 
A. 
In the case of corneal ulcer or suspected ocular infection, the cul-de-sac, lower lid margin, 
and the corneal lesion (if applicable) of the affected eye must be cultured. 
1. Cul-de-sac Culture 
a. The swab from the culture collection kit (provided by the central laboratory) is moistened 
in sterile, physiological saline solution, with no preservatives. 
b. The ocular specimen is obtained by holding the lids open and asking the subject to gaze 
upward. The moistened swab should be drawn across the cul-de-sac while rotating the 
swab 360 degrees around the axis of the stick. Care should be taken to avoid contact of 
the swab with the lashes and the lid margins. 
c. Place the swab in the transport tube media according to manufacturer's directions. 
d.  Repeat Steps a through c using a separate swab and a separate tube of transport media 
for the other eye if both eyes require culturing. 
2. Eyelid Culture 
a. The swab from the culture collection kit (provided by the central laboratory) is moistened 
in sterile, physiological saline solution, with no preservatives. 
b. The specimen is obtained from the margin of the lower lid by drawing the swab along 
the margin of the lid. 
c. Place the swab in the transport tube media according to manufacturer's directions. 
d. Repeat Steps a through c using a separate swab and a separate tube of transport media 
for the other eye if both eyes require culturing. 
3. Corneal Culture 
a. The swab from the culture collection kit (provided by the central laboratory) is moistened 
in sterile, physiological saline solution, with no preservatives. 
b. The specimen is obtained from the corneal lesion by rotating the swab on the lesion for 
10 seconds. 

Study #914 - Protocol 
19 JAN 2023 
 
Page B-17 
Confidential 
c. Place the swab in the transport tube media according to manufacturer's directions. 
d. Repeat Steps a through c using a separate swab and a separate tube of transport media 
for the other eye if both eyes require culturing.