Study to Evaluate Safety and Effectiveness of the Boston Orthokeratology (Oprifocon A) Shaping Lens in the Arise Orthokeratology Lens Design With Non-spherical Posterior Peripheral Curves
Phase: NA
Conditions: Myopia
Sponsor: Bausch & Lomb Incorporated

 
 
 
Study to Evaluate Safety and Effectiveness of the Boston Orthokeratology 
(oprifocon A) Shaping Lens in the Arise Orthokeratology Lens Design with 
Non-spherical Posterior Peripheral Curves 
 
CLINICAL STUDY PROTOCOL 
STUDY #918 
Sponsor: Bausch & Lomb Incorporated 
 
This clinical investigation is being conducted in accordance with 21 Code of Federal Regulations (CFR) 
Parts 11, 50, 54, 56, and 812; 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) (EU) 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 Investigator’s Brochure for 
the Boston Orthokeratology (oprifocon A) Shaping Lens, Arise Orthokeratology Lens Design. 
 
Revision Chronology: 
Amendment 5, Version 6.0 
- 
                            30 Nov 2023 
Amendment 4, Version 5.0 
- 
04 Aug 2023 
Amendment 3, Version 4.0 
- 
14 July 2023 
Amendment 2, Version 3.0 
- 
26 May 2023 
Amendment 1, Version 2.0 
- 
09 Feb 2023 
Original, Version 1.0  
- 
23 Jan 2023 
 
The information in the following document is confidential and provided to you, as an Investigator or 
consultant, for review by you, your study personnel, and the applicable Institutional Review Board/Ethics 
Committee (IRB/EC). By accepting this document, you agree that the information contained herein will not 
be disclosed to others without written authorization from Bausch & Lomb Incorporated, except to the 
extent necessary to obtain consent from those persons who participate in this study. 
 
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. 
 
Boston SIMPLUS® Multi-Action Solution, Boston® Rewetting Drops, and Biotrue® ONEday Contact 
Lenses are registered trademarks of Bausch & Lomb Incorporated. 

Study #918 
 
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INVESTIGATOR STATEMENT OF APPROVAL 
Study to Evaluate Safety and Effectiveness of the Boston Orthokeratology (oprifocon A) 
Shaping Lens in the Arise Orthokeratology Lens Design with Non-spherical Posterior 
Peripheral Curves 
STUDY #918 
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) (EU) 
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 IRBs, 
direct access to my medical records for study subjects. 
 
 
 
 
 
Principal Investigator, Signature 
Date 
 
Print Principal Investigator Name and Address below: 
 
_____________________________________________________ 
 
__________________________________________________________ 
 
__________________________________________________________ 

Study #918 
 
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TABLE OF CONTENTS 
 
 
 
 
 
 
 
PAGE 
TITLE PAGE………………………………………………………………………………………………..1 
SPONSOR APPROVAL PAGE…………………………………………………………………………....2 
INVESTIGATOR STATEMENT OF APPROVAL………...………………………………………...….3 
PERSONNEL AND FACILITIES……………………………………………………………………...….4 
TABLE OF CONTENTS…...……………………………………………………………………………....5 
GLOSSARY OF TERMS….……………………………………………………………………………….8 
LIST OF ABBREVIATIONS……………………………………………………………………………..11 
SYNOPSIS………………………………………………………………………………………………….12 
1. 
INTRODUCTION ..............................................................................................................................15 
2. 
BACKGROUND, RATIONALE AND OBJECTIVES ...................................................................15 
2.1 INTENDED PURPOSE OF DEVICE ........................................................................................................15 
2.2 TARGET POPULATION .......................................................................................................................15 
2.3 STATE OF THE ART............................................................................................................................15 
2.4 OBJECTIVE OF STUDY .......................................................................................................................15 
2.5 MINIMIZATION OF BIAS AND CONFOUNDING FACTORS.....................................................................16 
3. 
STUDY DESIGN .................................................................................................................................16 
3.1 DESCRIPTION OF STUDY DESIGN ......................................................................................................16 
3.2 INFORMED CONSENT PROCESS ..........................................................................................................17 
3.3 SELECTION OF STUDY POPULATION ..................................................................................................17 
3.3.1 
Eligibility ...............................................................................................................................17 
3.3.2 
Subject Completion ...............................................................................................................19 
3.3.3 
Subject Discontinuation .........................................................................................................20 
3.3.4 
Lost to Follow-Up .................................................................................................................21 
3.4 INVESTIGATORS ................................................................................................................................21 
3.5 FINANCES .........................................................................................................................................21 
3.6 STUDY DURATION ............................................................................................................................22 
4. 
STUDY MATERIALS ........................................................................................................................22 
4.1 DESCRIPTION OF TEST ARTICLE (TEST) ............................................................................................22 
4.2 DESCRIPTION OF COMPARATOR (COMPARATOR) ..............................................................................23 
4.3 INSTRUCTIONS FOR USE AND ADMINISTRATION ...............................................................................23 
4.3.1 
Storage Requirements ............................................................................................................23 
4.3.2 
Subject Instructions ...............................................................................................................23 
4.4 PACKAGING AND LABELING .............................................................................................................23 
4.4.1 
Lenses ....................................................................................................................................23 
4.4.2 
Study Supplies .......................................................................................................................24 
4.4.3 
Other Study Supplies .............................................................................................................24 
4.5 ACCOUNTABILITY .............................................................................................................................25 
4.6 MASKING/UNMASKING .....................................................................................................................25 
4.7 PRODUCT REPLACEMENT ..................................................................................................................25 
5. 
SAFETY AND EFFECTIVENESS VARIABLES ...........................................................................25 
5.1 SAFETY VARIABLES ..........................................................................................................................26 
5.2 EFFECTIVENESS VARIABLES .............................................................................................................26 
5.3 RISK ASSESSMENT AND MITIGATION ................................................................................................27 
6. 
STUDY METHODS............................................................................................................................27 
6.1 STUDY VISITS ...................................................................................................................................27 
6.1.1 
Screening (Visit 1) .................................................................................................................27 
6.1.2 
Dispensing (Visit 2) ...............................................................................................................29 

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6.1.3 
1-Day Follow-up (Visit 3) .....................................................................................................30 
6.1.4 
1-Week Follow-up (Visit 4) ...................................................................................................32 
6.1.5 
1-Month Follow-Up (Visit 5) ................................................................................................33 
6.1.6 
2-Month Follow-Up (Visit 6) ................................................................................................34 
6.1.7 
3-Month Follow-Up (Visit 7) ................................................................................................35 
6.1.8 
Exit Visit ................................................................................................................................36 
6.1.9 
Unscheduled Visits ................................................................................................................37 
6.1.10 
Missed Visits.....................................................................................................................39 
6.1.11 
Product Dispensing Only Visit .........................................................................................39 
6.1.12 
Post-study Follow-up ........................................................................................................40 
6.2 STUDY COMPLETION/EARLY STUDY TERMINATIONS/SUSPENSIONS .................................................40 
6.2.1 
Study Completion ..................................................................................................................40 
6.2.2 
Early Study Termination/Suspension ....................................................................................40 
6.3 SUBJECT CONCOMITANT MEDICATIONS/THERAPY ...........................................................................40 
6.4 TREATMENT COMPLIANCE ................................................................................................................41 
6.5 PROTOCOL DEVIATIONS ....................................................................................................................41 
7. 
ADVERSE EVENTS ..........................................................................................................................41 
7.1 INTRODUCTION TO ADVERSE EVENT DEFINITIONS ...........................................................................41 
7.1.1 
Serious Adverse Event (SAE) Definitions .............................................................................41 
7.1.2 
Significant Non-Serious Adverse Event Definitions .............................................................43 
7.1.3 
Non-Significant Non-Serious Adverse Events Definitions....................................................43 
7.1.4 
Adverse Device Effect (ADE) Definitions ............................................................................43 
7.1.5 
Relationship Definition: Study Device and/or Other Study Materials ...................................44 
7.1.6 
Severity Definitions ...............................................................................................................44 
7.2 PROCEDURES FOR EVALUATING ADVERSE EVENTS ..........................................................................45 
7.3 PROCEDURES FOR REPORTING ADVERSE EVENTS .............................................................................45 
7.3.1 
Procedures for Reporting Serious or Significant Adverse Events .........................................45 
7.3.2 
Procedures for Reporting Off-Site Unanticipated Serious Adverse Device Effects ..............46 
7.3.3 
Device Deficiencies: Definition and Reporting Procedures ..................................................47 
7.3.4 
Procedures for Reporting and Culturing of Corneal Ulcer or Suspected Ocular Infection ....47 
7.3.5 
Guidelines for Reporting Pregnancies ...................................................................................47 
8. 
STATISTICAL METHODS ..............................................................................................................48 
8.1 STUDY ENDPOINTS ...........................................................................................................................48 
8.1.1 
Primary Safety Outcomes ......................................................................................................48 
8.1.2 
Other Safety Outcomes ..........................................................................................................48 
8.1.3 
Primary Effectiveness Outcomes ...........................................................................................48 
8.1.4 
Other Effectiveness Outcomes...............................................................................................49 
8.2 HYPOTHESES.....................................................................................................................................49 
8.3 SAMPLE SIZE ....................................................................................................................................49 
8.4 RANDOMIZATION ..............................................................................................................................49 
8.5 STUDY POPULATIONS .......................................................................................................................49 
8.5.1 
Full Analysis Set (FAS) .........................................................................................................49 
8.5.2 
Per Protocol (PP) Set .............................................................................................................49 
8.5.3 
Safety Set ...............................................................................................................................50 
8.6 STATISTICAL ANALYSIS ....................................................................................................................50 
8.6.1 
Methods of Analysis ..............................................................................................................50 
8.6.2 
Adverse Events ......................................................................................................................50 
8.6.3 
Subject Demographics and Baseline Characteristics .............................................................51 
8.6.4 
Subject Discontinuation .........................................................................................................51 
8.6.5 
Protocol Deviations ...............................................................................................................51 
8.6.6 
Treatment Compliance...........................................................................................................51 
8.6.7 
Treatment Exposure ...............................................................................................................51 
8.6.8 
Missing Data ..........................................................................................................................51 
8.6.9 
Multiplicity Issues .................................................................................................................52 
8.6.10 
Interim Analyses ...............................................................................................................52 

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9. 
DATA QUALITY ASSURANCE ......................................................................................................52 
9.1 SUBJECT CONFIDENTIALITY ..............................................................................................................52 
9.2 STUDY MONITORING ........................................................................................................................52 
9.3 SOURCE DOCUMENTATION ...............................................................................................................53 
9.4 CASE REPORT FORMS AND DATA VERIFICATION ..............................................................................53 
9.5 RECORDING OF DATA AND RETENTION OF DOCUMENTS...................................................................54 
9.6 AUDITING PROCEDURES ...................................................................................................................54 
9.7 INSTITUTIONAL REVIEW BOARD/ETHICS COMMITTEE APPROVAL ....................................................55 
9.8 PUBLICATION OF RESULTS ................................................................................................................55 
10. REFERENCES ....................................................................................................................................55 
10.1 GLOBAL AND REGIONAL REGULATORY REFERENCES:......................................................................55 
10.2 LITERATURE REFERENCES ................................................................................................................56 
 
 
APPENDICES 
APPENDIX A: SCHEDULE OF VISITS AND PROCEDURES ............................................................57 
APPENDIX B: METHODS OF CLINICAL EVALUATION .................................................................59 
APPENDIX C: SUBJECT INSTRUCTIONS ...........................................................................................72 
APPENDIX D: FITTING GUIDE .............................................................................................................77 
APPENDIX E: TOPOGRAPHY EXAMPLES .........................................................................................90 
 
 
 

Study #918 
 
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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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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. 
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. 
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: 
̶ 
a life-threatening illness or injury, or 
̶ 
a permanent impairment of a body structure or a body 
function including chronic diseases, or 
̶ 
in-patient 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. 
• 
Fetal distress, fetal death, a congenital abnormality, or birth 
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, 

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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 any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with 
a device that relates to the rights, safety, or welfare of subjects. [FDA, 
21CFR 812.3] 
Unanticipated serious adverse 
device effect (USADE) 
Unanticipated serious adverse device effect is a serious adverse device 
effect which by its nature, incidence, severity, or outcome has not been 
identified in the current risk assessment. [EN ISO 14155:2020] 
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. 
Vulnerable subject 
Individuals who are unable to fully understand all aspects of the 
investigation that are relevant to the decision to participate, or who could 
be manipulated or unduly influenced as a result of a compromised 
position, expectation of benefits or fear of retaliatory response. 

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LIST OF ABBREVIATIONS 
Abbreviation 
/Acronym  
Term  
AE  adverse event 
ADE adverse device effect 
BSCVA best spectacle-corrected visual acuity 
CFR Code of Federal Regulations 
CI confidence interval 
eCRF electronic case report form 
D diopter 
EC ethics committee 
EDC electronic data capture 
FAS Full Analysis Set 
FDA United States Food and Drug Administration 
GCPs Good Clinical Practice 
HIPAA Health Insurance Portability and Accountability Act 
ICF informed consent form  
ICH International Council for Harmonisation 
ID identification 
IDE Investigational Device Exemption 
IRB Institutional Review Board 
ISO International Organization for Standardization 
logMAR logarithm of the minimum angle of resolution 
MCMC Markov Chain Monte Carlo 
MRSE Manifest Refractive Spherical Equivalent 
OD right eye 
OS left eye 
OU both eyes 
PAL product accountability log 
RGP rigid gas permeable 
SAE serious adverse event 
SOP standard operating procedure 
TEAE Treatment-emergent adverse event 
UADE unanticipated adverse device effect 
UDVA uncorrected distance visual acuity 
US United States 
USAN United States Adapted Name 
VA visual acuity 
NOTE: The first occurrence of some abbreviations is not spelled out in the document (e.g., units of 
measure). 
 

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SYNOPSIS 
Bausch & Lomb Incorporated Study #918  
Title: 
Study to Evaluate Safety and Effectiveness of the Boston Orthokeratology (oprifocon A) 
Shaping Lens in the Arise Orthokeratology Lens Design with Non-spherical Posterior 
Peripheral Curves 
Name of Test 
Article:  
Arise Orthokeratology Lens 
Number of Study 
Centers Planned: 
Approximately 6-10 Investigative sites in the United States 
Number of Subjects 
Planned: 
Approximately 90 subjects will be enrolled. 
Background: 
The Bausch + Lomb Vision Shaping Treatment VST is based on a reverse geometry 
orthokeratology design that includes a base curve/treatment curve, a reverse curve, 
alignment curves and peripheral curves. The base curve is used to only flatten the cornea 
and is not considered a fitting curve. The parameters of the Arise Orthokeratology Lens are 
controlled to be within the bounds determined by the spherical posterior curves of other 
lens designs prescribed for the Bausch + Lomb Vision Shaping Treatment. 
The term peripheral curves excludes the base curve and includes the zones defined as the 
reverse curve, alignment curves and peripheral curves. Peripheral curves are designed to 
help control centration of the lens. When there are elevation differences between the flat 
and steep meridians on the cornea (e.g., corneal toricity), spherical peripheral curves, 
including the reverse curve, alignment curves and peripheral curves, may not align 
completely to the cornea and can result in a lens with sub-optimal centration. Aspheric 
curves and toric (e.g., dual axis) peripheral curves on reverse geometry lenses for overnight 
orthokeratology have been available in the US market for more than 10 years for fitting 
lenses. The intent of the Arise Orthokeratology Lens is to provide a stable and centered 
lens that helps ensure the treatment zone of the lens is well positioned in relation to the 
pupil and is shaping the central portion of the cornea for optimal results.  
Objective(s): 
The objective of this orthokeratology study is to evaluate the safety and effectiveness of the 
Arise Orthokeratology Lens with non-spherical posterior peripheral curves.  
Study Design: 
Approximately 90 subjects will be enrolled in this multi-center, single-arm, open-label 
study. All subjects will be seen for a Screening Visit at which informed consent will be 
obtained and eligibility assessed. If subjects satisfy all eligibility criteria, they will be 
enrolled in the study. Subjects will be seen to assess the treatment effect of overnight 
orthokeratology over a 3-month period. 
Diagnosis and Main 
Criteria for 
Inclusion: 
To be eligible for entry into the study, the subject must: 
1. Be 12 years or older on the date the Informed Consent Form (ICF) is signed and, 
as subject or parent or legal guardian of a minor subject, have capacity to read, 
understand and provide written voluntary informed consent on the IRB-approved 
ICF and provide authorization as appropriate for local privacy regulations. 
2. Be orthokeratology lens naïve. 
3. Spherical refractive error between plano and -5.00D. 
4. Astigmatism no greater than 1.50D. 
5. Corneal topography sagittal height differential of ≥ 30 microns between the two 
main meridians (flat and steep) at an 8mm chord. 
6. Has keratometric readings from 39.00 to 48.00D. 
7. Has a clear and undistorted Mire Reflex. 
8. Be willing and able to comply with all treatment and follow-up study visits and 

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Bausch & Lomb Incorporated Study #918  
procedures. 
9. Must be willing to refrain from wearing habitual soft contact lenses during the 
study period. 
10. Subjects must be correctable through spherocylindrical refraction to 42 letters (0.1 
logMAR) or better (distance, high contrast) in each eye. 
Main Criteria for 
Exclusion: 
The subject is ineligible for entry into the study if the subject meets any of the following 
criteria: 
1. Subject is considered by the Investigator, to not be a suitable candidate for 
participation or it is not in the best interest of the subject to participate in the 
study.  
2. Subjects who have worn rigid gas permeable (RGP) contact lenses within the last 
30 days or who have worn polymethylmethacrylate (PMMA) lenses within the 
last three months. 
3. Prior eyelid, strabismus, intraocular, or refractive surgery. 
4. Keratoconus or an irregular cornea. 
5. Subjects with any systemic disease currently affecting ocular health or in the 
Investigator’s opinion may have an effect on ocular health during the course of the 
study. 
6. Subjects using any systemic or topical medications that will, in the Investigator’s 
opinion, affect ocular physiology or lens performance. 
7. A known allergy to fluorescein, benoxinate, or proparacaine. 
8. A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, 
corneal infiltrates, ocular viral or fungal infections or recurrent ocular infections. 
9. Subjects with an active ocular disease or who are using any ocular medication. 
10. Subjects with any Grade 2 or greater finding during the slit lamp examination. 
Subjects with corneal infiltrates, of ANY GRADE, are NOT eligible. Refer to 
Appendix B: Methods of Clinical Evaluation. 
11. Subjects with any “Present” finding during the slit lamp examination that, in the 
Investigator’s judgement, interferes with contact lens wear. Refer to Appendix B: 
Methods of Clinical evaluation. 
12. Subjects with any scar or neovascularization within the central 6mm of the cornea. 
Subjects with minor peripheral corneal scarring (that does not extend into the 
central area), that in the Investigator’s judgement, does not interfere with contact 
lens wear, are eligible for this study. 
13. Subjects participating in any drug or device clinical investigation within 2 weeks 
prior to entry into this study (Screening Visit) and/or planning to do so during the 
period of study participation. 
14. Subjects who are amblyopic. 
15. Immediate family or close relative is a member of the office staff, including the 
Investigator(s). 
16. Females of childbearing potential (those who are not surgically sterilized or 
postmenopausal) if they meet any one of the following: 
− 
They are currently pregnant 
− 
They plan to become pregnant during the study 
− 
They are breastfeeding 
Investigational 
Product, Dose and 
Mode of 
Administration: 
The Investigator will fit each qualifying subject according to Appendix D: Fitting Guide. 
The study lenses will be ordered specifically for each subject after fitting is assessed. 
Subjects will return approximately 15 days later to have the lenses dispensed. 

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INTRODUCTION 
The Bausch + Lomb Vision Shaping Treatment VST is based on a reverse geometry 
orthokeratology design that includes a base curve/treatment curve, a reverse curve, 
alignment curves and peripheral curves. The base curve is used to only flatten the cornea 
and is not considered a fitting curve. The parameters of the Arise Orthokeratology Lens 
are controlled to be within the bounds determined by the spherical posterior curves of 
other lens designs prescribed for the Bausch + Lomb Vision Shaping Treatment. 
The reverse curve, alignment curves and peripheral curves are designed to help control 
centration of the lens. When there are elevation differences between the flat and steep 
meridians of the cornea (e.g., corneal toricity), spherical peripheral curves, including the 
reverse curve, alignment curves and additional peripheral curves, may not align 
completely to the cornea and can result in a lens with poor centration. Throughout the 
protocol the term “peripheral curves” excludes the Base Curve and includes the zones 
defined in the Bausch + Lomb Vision Shaping Treatment as the Reverse Curve, 
Alignment Curves and Peripheral Curves.  
Aspheric curves and toric (e.g., dual axis) peripheral curves on reverse geometry lenses 
for overnight orthokeratology have been available in the U.S. market for more than 10 
years for fitting lenses. The intent of the Arise Orthokeratology Lens is to provide a 
stable and centered lens that helps ensure the treatment zone of the lens is well positioned 
in relation to the pupil and is shaping the central portion of the cornea for optimal results. 
1. 
BACKGROUND, RATIONALE AND OBJECTIVES 
2.1 Intended Purpose of Device 
The Arise Orthokeratology Lens is intended for use in the reduction of myopic refractive 
error in non-diseased eyes. 
2.2 Target Population 
The Arise Orthokeratology Lens is for use in the reduction of myopic refractive error, 
regardless of gender or ethnicity and who do not have contraindications for the device. 
2.3 State of the Art 
Further information regarding the relevance of this study in the context of state-of-the-art 
clinical practice such as background information, summary of relevant literature, 
mechanism of action, intended clinical performance, and a summary of existing relevant 
clinical data of the investigational device can be found in the Investigator Brochure for 
this study, Study 918, Boston Orthokeratology (oprifocon A) Shaping Lens Arise 
Orthokeratology Lens Design2, Section 5 Existing Data. 
2.4 Objective of Study 
The objective of this overnight orthokeratology study is to evaluate the safety and 
effectiveness of the Arise Orthokeratology Lens with non-spherical posterior peripheral 
curves. 

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2.5 Minimization of Bias and Confounding Factors 
The Sponsor will avoid improper influence on any parties participating in, or contributing 
to, the clinical investigation or the induction thereof. The selection and treatment of 
subjects and evaluation of clinical investigation data are potential sources of bias. 
Methods that are incorporated within the clinical investigation design to minimize 
potential bias include, but are not limited to, screening subjects to confirm eligibility with 
defined inclusion/exclusion criteria prior to enrollment; maintaining a log of all subjects 
screened and enrolled; collecting demographics and medical ocular history at baseline to 
later assess possible characteristics that may influence endpoints; standardizing data 
collection 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 to be conducted to verify adherence to the 
clinical investigation plan and source data. Compensation of the Investigators is not 
dependent on the study outcomes. 
2. 
STUDY DESIGN 
This is a multi-center, single-arm, open-label, bilateral clinical trial. 
3.1 Description of Study Design 
This is a single-treatment study evaluating the safety and effectiveness of the Arise 
Orthokeratology Lens with non-spherical posterior peripheral curves. 
Approximately 90 subjects (180 eyes) will be enrolled in this 3-month, multi-center, 
single-arm, open-label study at approximately 6-10 investigative sites in the United States 
(US). 
All subjects will be seen for a Screening Visit at which informed consent will be obtained 
and eligibility assessed. If subjects satisfy all eligibility criteria, they will be enrolled in 
the study. Subjects will be seen to assess the treatment effect of overnight 
orthokeratology over a 3-month period. All subjects will be assigned a subject 
identification (ID) number in sequential order by the Electronic Data Capture (EDC) 
system. At the Screening Visit, if a subject is eligible, study lenses will be ordered 
specifically for that subject. Eligible subjects will come back approximately 2 weeks after 
the Screening Visit for a Dispensing Visit. Each subject will also be dispensed Boston 
SIMPLUS Multi-Action Solution, including a study lens case, and Boston Rewetting 
Drops. These solutions will be replenished during the study as needed. Subjects must 
NOT use ANY other cleaning and disinfecting solution or rewetting drops during the 
study unless the Investigator transitions individual subjects to a different Boston Lens 
Care System. Subjects will be required to wear their study lenses for a minimum of eight 
(8) hours on an overnight wear basis for approximately 3 months, with scheduled in-
office 
follow-up 
visits 
at 
1-day, 
1-week,  
1-month, 2-months and 3-months. These follow-up visits must be conducted within 2 
hours of the subject removing the study lenses. 
Daily disposable soft contact lenses (Bausch + Lomb Biotrue ® ONEday (nesofilcon A) 
Contact Lenses known as “maintenance lenses”) will be dispensed to provide 
supplemental visual correction during the day as needed for the orthokeratology lens 
adaptation period. 

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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 informed consent form (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. A representative ICF for each 
investigative site is maintained in the Study Master File. 
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 informed consent, including Health Insurance 
Portability and Accountability Act (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 on the 
screening log 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 be 
completed for screen failure subjects and a copy of their signed ICF, and any information 
collected as part of screening (e.g., source documents, etc.) must be kept in their medical 
records. 
Once a subject is enrolled, a subject is considered active and must be accounted for at 
every visit until exited (completed or discontinued) from the study, even if they are not 
dispensed study materials. Refer to Section 3.3.4 for subjects determined to be lost to 
follow-up. 
3.3.1 Eligibility 
Any person who satisfies all eligibility criteria, and in the opinion of the Investigator, is 
suitable for rigid gas permeable (RGP) overnight orthokeratology contact lens wear may 

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be entered into the study. Subjects must agree to wear lenses on an overnight wear basis 
(every night). There are no restrictions as to the subject’s gender or occupation. Subjects 
of legal age must have the legal capacity to volunteer and must agree to sign an Informed 
Consent Form. Subjects not of legal age must agree to sign an Assent Form and their 
parent/guardian must sign the Informed Consent Form. 
3.3.1.1 
Inclusion Criteria 
The subject is eligible for entry into the study if the subject meets all of the following 
criteria: 
1. Be 12 years or older on the date the Informed Consent Form (ICF) is signed and, 
as subject or parent or legal guardian of a minor subject, have capacity to read, 
understand and provide written voluntary informed consent on the IRB-approved 
ICF and provide authorization as appropriate for local privacy regulations. 
2. Be orthokeratology lens naïve. 
3. Spherical refractive error between plano and -5.00D. 
4. Astigmatism no greater than 1.50D. 
5. Corneal topography sagittal height differential of ≥ 30 microns between the two 
main meridians (flat and steep) at an 8mm chord. 
6. Has keratometric readings from 39.00 to 48.00D. 
7. Has a clear and undistorted Mire Reflex. 
8. Be willing and able to comply with all treatment and follow-up study visits and 
procedures. 
9. Must be willing to refrain from wearing habitual soft contact lenses during the 
study period. 
10. Subjects must be correctable through spherocylindrical refraction to 42 letters (0.1 
logMAR) or better (distance, high contrast) in each eye. 
3.3.1.2 
Exclusion Criteria 
The subject is ineligible for entry into the study if the subject meets any of the following 
criteria: 
1. Subject is considered by the Investigator, to not be a suitable candidate for 
participation or it is not in the best interest of the subject to participate in the 
study.  
2. Subjects who have worn rigid gas permeable (RGP) contact lenses within the last 
30 days or who have worn polymethylmethacrylate (PMMA) lenses within the 
last three months. 
3. Prior eyelid, strabismus, intraocular, or refractive surgery. 
4. Keratoconus or an irregular cornea. 
5. Subjects with any systemic disease currently affecting ocular health or in the 
Investigator’s opinion may have an effect on ocular health during the course of 
the study. 

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6. Subjects using any systemic or topical medications that will, in the Investigator’s 
opinion, affect ocular physiology or lens performance. 
7. A known allergy to fluorescein, benoxinate, or proparacaine. 
8. A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, 
corneal infiltrates, ocular viral or fungal infections or recurrent ocular infections. 
9. Subjects with an active ocular disease or who are using any ocular medication. 
10. Subjects with any Grade 2 or greater finding during the slit lamp examination.  
Subjects with corneal infiltrates, of ANY GRADE, are NOT eligible. Refer to 
Appendix B: Methods of Clinical Evaluation. 
11. Subjects with any “Present” finding during the slit lamp examination that, in the 
Investigator’s judgement, interferes with contact lens wear. Refer to Appendix B: 
Methods of Clinical Evaluation. 
12. Subjects with any scar or neovascularization within the central 6mm of the 
cornea. Subjects with minor peripheral corneal scarring (that does not extend into 
the central area), that in the Investigator’s judgement, does not interfere with 
contact lens wear, are eligible for this study. 
13. Subjects participating in any drug or device clinical investigation within 2 weeks 
prior to entry into this study (Screening Visit) and/or planning to do so during the 
period of study participation. 
14. Subjects who are amblyopic. 
15. Immediate family or close relative is a member of the office staff, including the 
Investigator(s). 
16. Females of childbearing potential (those who are not surgically sterilized or 
postmenopausal) if they meet any one of the following: 
̶ They are currently pregnant 
̶ They plan to become pregnant during the study 
̶ They are breastfeeding 
If a subject meets all of the inclusion criteria, and does not exhibit any of the exclusion 
criteria, he or she is eligible for entry into the study.  Any subject enrolled in the study, 
who later is found to have had any of the exclusion criteria present at entry (Screening 
Visit or Dispensing Visit) will be discontinued at the Sponsor’s request. 
 
3.3.2 Subject Completion 
The subject has completed the study after completion of 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 Section 6.1.12. 

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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: 
1. 
An adverse event (AE) occurring during the course of the study, which 
precludes continued treatment or follow-up 
2. 
Persistent Grade 3 or 4 slit lamp findings (must be reported to the Sponsor 
within 24 hours) 
3. 
Persistent study-related symptoms/complaints 
A subject MUST be discontinued prior to the final study visit for any of the following 
reasons: 
1. 
Voluntary withdrawal  
2. 
Death 
3. 
Investigator decision that it is not in the best medical interest of the subject to 
continue participation in the investigation 
4. 
Ineligible at Screening Visit – a subject who was enrolled but was later found 
to have not met the eligibility criteria 
5. 
Inability to maintain recommended wearing schedule 
6. 
Continued failure to follow subject instructions 
7. 
Lack of motivation 
8. 
Lost to follow-up (refer to Section 3.3.4) 
9. 
Misses the Dispensing, 1-Day, or 1-Week Visit 
10. 
Misses more than one of the 1-Month, 2-Month or 3-Month Visits 
11. 
Instillation of non-medically indicated solution not specified in the protocol 
12. 
Unacceptable lens performance 
13. 
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 retrieve all 
study materials. Adverse events will be followed as described in Section 6.1.12. 
Subject discontinuations will be documented clearly on the source document and 
applicable electronic case report form (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 this information. 
Exit Visit assessments should be completed for early discontinued subjects, if possible. 
At the final study visit, all study subjects 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 

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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 for their appropriate method of vision correction. 
3.3.4 Lost to Follow-Up 
Subjects who do not return for scheduled follow-up visits, as defined by the visit window 
and could not be contacted via 2 telephone calls and 1 letter with delivery confirmation, 
are to be considered lost to follow-up. All follow-up attempts 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 date of last visit to the clinic as a study 
subject. Just prior to database lock, the database will be reviewed for all lost to follow-up 
entries to confirm, once again, that the contact with the subject was never made. A study 
subject may withdraw from the study at any time for any reason. 
3.4 Investigators 
The study will be conducted at approximately 6 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. 
Each Investigator will attempt to enroll approximately 11-12 subjects. In the event that 
selected sites do not meet full enrollment, the Sponsor may decide to increase enrollment 
as needed at other currently active sites and/or additional site(s) may be added to satisfy 
the enrollment requirements of the study. 
The Study 918 List of Investigative Sites identifies the names of the Principal 
Investigators, the address and contact information for each investigative site. For the 
purposes of this study, the Sponsor will not specify a Coordinating Investigator. The roles 
and responsibilities of the Principal Investigators are defined in the Clinical Trial 
Agreement, Device Investigator Agreement, and the Investigator Statement of Approval 
on Page 3 of this study protocol. 
3.5 Finances 
The study will be financed through Bausch + Lomb Corporate Research & Development. 
A Clinical Trial Agreement 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, and coverage 
for subject injury. Investigator and subject compensation are outlined in the Investigator’s 
Clinical Trial Agreement. Compensation will not be dependent on the study outcomes. 

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base curve and non-spherical posterior peripheral curves. The posterior curve is selected 
to properly fit an individual eye for orthokeratology and the anterior curve is selected to 
provide the necessary optical power for a temporary reduction of myopia. A peripheral 
curve system on the posterior surface allows tear exchange between the lens and the 
cornea. The Arise Orthokeratology Lens is manufactured by Bausch & Lomb 
Incorporated, Lancaster, NY and shipped in Boston SIMPLUS Multi-Action Solution. 
A Fitting Guide for Arise Orthokeratology Lens is provided in Appendix D: Fitting 
Guide. 
4.2 Description of Comparator (Comparator) 
Not Applicable; this is a single-treatment study evaluating safety and effectiveness of the 
Arise Orthokeratology Lens. 
4.3 Instructions for Use and Administration 
Each subject will be assigned a subject number. Eligible subjects will be dispensed lenses 
at the Dispensing Visit. Subjects will be required to wear their study lenses for a 
minimum of 8 hours overnight for 3 months. Subjects will be instructed to wear their 
lenses 
to 
the  
1-Day Follow-up Visit (Visit 3). Subjects will not wear their study lenses to subsequent 
Follow-up Visits (Visits 4, 5, 6 and 7). 
The Investigator or designee will instruct all subjects to adhere to the Subject Instructions 
provided at the Dispensing Visit. Refer to Appendix C: Subject instructions. 
4.3.1 Storage Requirements 
All study lenses and solutions provided by the Sponsor must be stored in a secure 
location and maintained at ambient room temperature. 
4.3.2 Subject Instructions 
All subjects must be given Subject Instructions for the study lenses (Appendix C: Subject 
instructions). Subjects must comply with the instructions provided to them. Subject 
Instructions will be supplied to the Investigator by Bausch + Lomb for distribution to the 
subject. 
The Investigator or other 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. 
Any subject who does not follow instructions to a degree that, in the Sponsor or 
Investigator's opinion, jeopardizes the subject's well-being or the validity of the study 
should be discontinued. 
4.4 Packaging and Labeling 
4.4.1 Lenses 
The study lenses will be packaged and labeled in a manner consistent with the study 
design. 

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Sample of label: 
 
The Arise Orthokeratology Lenses used in this study will be packaged in polycarbonate 
vials containing Boston SIMPLUS Multi-Action Solution with investigational labels. The 
labels will contain the following information: 
• Lens power 
• Base curve 
• Lens diameter 
• CT (Center thickness) 
• Eye (R or L) 
• Subject identifier (101 004: Investigative site 101 and Subject 004) 
• Lens color (right lenses are green, left lenses are blue) 
• Expiration date (denotes 30 days after lens was packaged for shipment) 
• Lot number 
• Manufacturer’s name and location 
• Investigational Device Caution Statement 
4.4.2 Study Supplies 
The Sponsor will provide the following study supplies for each subject: 
• Pair of study lenses 
• Bottle of Boston SIMPLUS Multi-Action Solution 
• Bottle of Boston Rewetting Drops 
• Study Lens Case  
• Subject Instructions 
4.4.3 Other Study Supplies 
A back-up pair of study lenses will be kept at the investigative site for each subject in the 
event a replacement is needed. 

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5.3 Risk Assessment and Mitigation 
Information concerning potential risks associated with the investigational device (as well 
as possible interactions with concomitant medical treatments and risk-to-benefit ratio) 
can be found within the Investigator’s Brochure for the study. Risks are also summarized 
within the Informed Consent Form. The assessments required for the study are routinely 
performed and are standard of care for contact lens wearers. The subjects will be 
informed of any potential study-specific risks in the ICF or if new risks become apparent 
during the study. Upon review of the clinical and preclinical data no additional risks were 
identified over the standard of 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 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 
lenses, use of contact lens care products is presented in the package insert. 
5. 
STUDY METHODS 
6.1 Study Visits 
Refer to Appendix A: Schedule of Visits and Procedures and the methods of clinical 
evaluation. 
Following identification of a potential subject, the Investigator (or designee) will explain 
the purpose of the study, procedures, risks/benefits, and subject responsibilities to the 
potential subject. The subject’s willingness and ability to meet the follow-up 
requirements of the study will be determined. If the subject chooses to participate in the 
investigation, written informed consent will be obtained. The subject and the person 
obtaining written consent, will sign and date the IRB -approved ICF. Both the 
Investigator and subject must keep the signed ICF document. The Investigator should 
retain the signed original document in the subject’s medical record and provide a copy to 
the subject. In addition, the applicable privacy regulation requirements (Health Insurance 
Portability Accountability Act; HIPAA) authorization must be met. 
6.1.1 Screening (Visit 1) 
A Screening Log will be provided by the Sponsor to track all consented subjects who the 
Investigator interviews regarding the study. Once all available lines on the Screening Log 
have been completed, or the Investigator has fulfilled his/her quota of subjects, the 
Investigator will sign and date the log to verify that all the subjects who interviewed for 
the study have provided informed consent and HIPAA authorization. 
After obtaining written informed consent, prospective subjects will be screened to 
determine whether they meet the entry criteria for the study. 
The screening visit will proceed as follows: 
a. Collect subject’s demographics such as age, gender, etc. 
b. Current type of vision correction: none, spectacles, contact lenses. 
c. Collect the following contact lens use history information: 

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− Average number of days per week worn 
− Average daily wearing time, hours per day 
− Average hours of comfortable wear per day 
− Hours lenses worn on the day of this visit 
− Current lens brand and lens wear modality 
− Current lens care products 
− Habitual rewetting drop use 
d. Collect ocular medical history (within 1 year of signing the ICF) and concomitant 
ocular medications. Concomitant ocular medications (as defined for this study) 
are any medications taken for ocular conditions within 30 days previous to 
signing the ICF (or) any medications taken for ocular AEs during the course of the 
study. 
e. For subjects with a habitual correction perform high-contrast distance visual 
acuity with their habitual correction. 
f. Perform high-contrast uncorrected distance visual acuity (UDVA) for each eye. 
g. Perform the following assessments (without lenses) using a phoropter: 
− Spherocylindrical refraction 
− Distance high-contrast BSCVA 
h. Perform corneal topography and record: 
− Sag differential (Screening visit only) 
− Mire reflex (central 3mm of Placido rings) 
− Keratometry readings 
− HVID (Screening Visit only) 
− Pupil size (Screening Visit only) 
i. Perform a slit lamp examination (without lenses) and record: 
− Any slit lamp findings including ungraded finding marked as “Present” 
− Any corneal scars 
− Any neovascularization within the central 6mm of the cornea 
− Any corneal staining 
− Any corneal infiltrate (record details of corneal infiltrates according to 
Section 2.0: Slit-Lamp Examination of Appendix B: Methods of Clinical 
Evaluation) 
− Record and sketch any scars and slit lamp findings greater than Grade 2 in 
the subject’s source document. 
j. Collect/assess all AEs/ADEs, including serious or significant non-serious AEs. 

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k. Confirm eligibility by indicating on the Screening Log whether the subject is a 
“Screen Pass” or “Screen Fail”. “Screen Fail” subjects are ineligible and cannot 
be dispensed in the study. The reason for screen failure must be documented in the 
eCRF and in the subject medical record and must be maintained with a copy of 
their ICF. Only “Screen Pass” subjects should be dispensed in the study. 
l. Provide subject with a copy of the signed ICF. 
m. Based on the measurements obtained, order two pairs of lenses by following 
instructions in the Lens Order Instructions Form. 
n. Complete the relevant Screening Visit eCRFs. 
6.1.2 Dispensing (Visit 2) 
Dispensing visit is scheduled based upon the delivery date of the lenses 
(Approximately 15 days) and should proceed as follows: 
a. Ensure the correct lenses for the subject have been received prior to dispensing 
the first lens. 
− Site designee will handle preparation of the lenses: After receipt of the 
study lenses and prior to the Study Lens Dispensing Visit, perform the 
following cleaning procedure: 
Soak the lenses for at least 4 hours in Boston SIMPLUS Multi-Action Solution. 
Rub both sides of the lenses carefully with 4 drops of Boston SIMPLUS Multi-
Action Solution in the palm of the hand for 20 seconds. Rinse for approximately 5 
seconds with a steady stream of Boston SIMPLUS Multi-Action Solution. The lens 
is ready for placement on the eye. 
b. Record changes in concomitant ocular medications. 
c. Perform uncorrected high-contrast distance visual acuity (UDVA) for each eye. 
d. Perform the following assessments(without lenses) using phoropter: 
− Spherocylindrical refraction 
− Distance high-contrast BSCVA 
e. Perform a slit lamp examination (without lenses) and record: 
− Any slit lamp findings including ungraded finding marked as “Present” 
− Any corneal scars 
− Any neovascularization within the central 6mm of the cornea 
− Any corneal staining 
− Any corneal infiltrate (record details of corneal infiltrates according to 
Section 2.0: Slit-Lamp Examination of Appendix B: Methods of Clinical 
Evaluation) 
− Record and sketch any scars and slit lamp findings greater than Grade 2 in 
the subject’s source document 
f. Insert a drop of anesthetics in each eye prior to lens insertion. 

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g. Evaluate the study lenses on the eye and record the following lens fit assessments: 
− Lens centration 
− Lens movement 
h. The study lenses will then be removed. The subject must disinfect and clean their 
lenses prior to insertion that evening. 
i. Collect/assess all AEs/ADEs, including serious or significant non-serious AEs. 
j. Following lens assessment, have the subject take the lenses with them. Instruct the 
subject that the lenses should be worn overnight for at least eight (8) hours each 
night. 
k. Dispense maintenance lenses, as needed. 
l. Give the subject a copy of the Subject Instructions and dispense Boston 
SIMPLUS Multi-Action Solution or other approved Boston Lens Care System 
and Boston Rewetting Drops. Review the lens and solution instructions with the 
subject. 
m. Remind subject that they must return the next day for their 1-Day Follow-up Visit 
with the lenses still on the eye from overnight wear period. 
n. Schedule the subject to return for their 1-Day Follow-up Visit within 2 hours of 
awakening. 
o. Complete the relevant Dispensing Visit eCRFs. 
6.1.3 1-Day Follow-up (Visit 3) 
The subject must return for the 1-Day Follow-up Visit one day (visit window of +1 
day) after the Dispensing Visit. 
a. Ensure that the subject arrives at the clinic while wearing the study lenses. 
b. Record any changes in concomitant ocular medications. 
c. Collect the following lens wear parameters: 
− Hours of lens wear the previous night 
− Frequency of rewetting drops use 
d. Evaluate the study lenses on the eye and record the following lens fit assessments: 
− Lens centration 
− Lens movement 
e. Remove the lens from the subject’s eye. 
f. Collect Symptoms/Complaints. 
g. Collect Lens Performance ratings using 0-100 scales. 
h. Perform monocular uncorrected high-contrast distance visual acuity (UDVA) for 
each eye. 
i. Perform the following assessments (without lenses) using a phoropter: 

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− Spherocylindrical refraction. Explain any induced refractive astigmatism 
greater than 1.00D compared to the Dispensing Visit (Visit 2). 
− Distance high-contrast BSCVA. Explain any loss of BSCVA of 2 or more 
lines compared to the Dispensing Visit (Visit 2). 
j. Perform corneal topography (within 30 minutes of lens removal) and record: 
− Topography reading 
− Mire reflex  
− Keratometry readings 
k. Perform a slit lamp examination (without lenses) and record: 
− Any slit lamp findings including ungraded finding marked as “Present” 
− Any new corneal scars 
− Any neovascularization within the central 6mm of the cornea 
− Any increase in grading of corneal staining 
− Any corneal infiltrate (record details of corneal infiltrates according to 
Section 2.0: Slit-Lamp Examination of Appendix B: Methods of Clinical 
Evaluation) 
− Record and sketch any scars and slit lamp findings greater than Grade 2 in 
the subject’s source document 
l. Collect/assess all AEs/ADEs, including serious or significant non-serious AEs. 
m. Following lens assessment, have the subject take the lenses with them. Instruct the 
subject that the lenses should be worn overnight for at least eight (8) hours each 
night. 
n. Schedule the subject to return for their 1-Week Follow-up Visit within 2 hours of 
the subject removing the lenses. 
o. Instruct the subject to soak and clean their lenses prior to insertion each evening. 
p. If the lens fit is unacceptable, order two lenses if refitting one eye (or two pairs of 
lenses if refitting both eyes) by following the instructions for lens refitting in the 
Lens Order Instructions Form. New lens(es) will be made and sent to the 
Investigator for dispensing. The subject should suspend wearing study lenses 
while the new lens(es) are being made. 
Upon receipt of the new lens(es), schedule an Unscheduled Visit for dispensing 
due to refinement of lens fit, and reset the sequence of follow-up visits on a 
subject basis starting with the 1-Day Follow-up Visit followed by a 1-Week 
Follow-up Visit, etc.  
Note: Each eye can only be refit one time, either at the 1-Day Follow-up Visit or 
the 1-Week Follow-up Visit. 
q. Complete the relevant Follow-up Visit eCRFs. 

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6.1.4 1-Week Follow-up (Visit 4)  
The subject must return for the 1-Week Follow-up Visit on day 7 (± 2 days). 
a. Record any changes in concomitant ocular medications. 
b. Collect the following lens wear parameters: 
− Hours since lens removal 
− Number of nights of lens wear 
− Average nightly wearing time, hours per night 
− Frequency of rewetting drops use 
Note: Do not perform any ophthalmic examinations with the maintenance lenses 
in place (if any). 
c. Collect Symptoms/Complaints. 
d. Collect Lens Performance ratings using 0-100 scales. 
e. Perform uncorrected high-contrast distance visual acuity (UDVA) for each eye. 
f. Perform the following assessments (without lenses) using a phoropter: 
− Spherocylindrical refraction. Explain any induced refractive astigmatism 
greater than 1.00D compared to the Dispensing Visit (Visit 2). 
− Distance high-contrast BSCVA. Explain any loss of BSCVA of 2 or more 
lines compared to the Dispensing Visit (Visit 2). 
g. Perform corneal topography and record: 
− Topography reading 
− Mire reflex  
− Keratometry readings 
h. Perform a slit lamp examination (without lenses) and record: 
− Any slit lamp findings including ungraded finding marked as “Present” 
− Any new corneal scars 
− Any neovascularization within the central 6mm of the cornea 
− Any increase in grading of corneal staining 
− Any corneal infiltrate (record details of corneal infiltrates according to 
Section 2.0: Slit-Lamp Examination of Appendix B: Methods of Clinical 
Evaluation) 
− Record and sketch any scars and slit lamp findings greater than Grade 2 in 
the subject’s source document 
i. Collect/assess all AEs/ADEs, including serious or significant non-serious AEs. 
j. Remind the subject that it is recommended that the lenses be worn overnight for at 
least eight (8) hours each night. 

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k. If the lens fit is unacceptable, order two lenses if refitting one eye (or two pairs of 
lenses if refitting both eyes) by following the instructions for lens refitting in the 
Lens Order Instructions Form. New lens(es) will be made and sent to the 
Investigator for dispensing. The subject should suspend wearing study lenses 
while the new lens(es) are being made. 
Upon receipt of the new lens(es) schedule an Unscheduled Visit due to refinement 
of lens fit and reset the sequence of follow-up visits on a subject basis starting 
with the 1-Day Follow-up Visit followed by a 1-Week Follow-up Visit, etc.  
Note: If the lens fit is not acceptable, refinement to the lens can be made at this 
visit only if a lens refit was not ordered at the 1-Day Follow-up Visit. 
l. Schedule the subject to return for 1-Month Follow-up Visit within 2 hours of the 
subject removing the lenses. 
m. Complete the relevant Follow-up Visit eCRFs. 
6.1.5 1-Month Follow-Up (Visit 5) 
The subject must return for the 1-Month Follow-up Visit on day 30 (± 3 days). 
a. Record any changes in concomitant ocular medications. 
b. Collect the following lens wear parameters: 
− Hours since lens removal 
− Average number of nights per week worn 
− Average nightly wearing time, hours per night 
− Frequency of rewetting drops use 
Note: At the 1-Month Follow-up Visit no additional refinement can be made to 
the lens design. If the lens performance is acceptable, continue with the scheduled 
visits. If the lens performance is unacceptable, subject should be discontinued. 
Note: Do not perform any ophthalmic examinations with the maintenance lenses 
in place (if any). 
c. Collect Symptoms/Complaints. 
d. Collect Lens Performance ratings using 0-100 scales. 
e. Perform uncorrected high-contrast distance visual acuity (UDVA) for each eye. 
f. Perform the following assessments (without lenses) using a phoropter: 
− Spherocylindrical refraction. Explain any induced refractive astigmatism 
greater than 1.00D compared to the Dispensing Visit (Visit 2). 
− Distance high-contrast BSCVA. Explain any loss of BSCVA of 2 or more 
lines compared to the Dispensing Visit (Visit 2). 
g. Perform corneal topography and record: 
− Topography reading 
− Mire reflex  

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− Keratometry readings 
h. Perform a slit lamp examination (without lenses) and record: 
− Any slit lamp findings including ungraded finding marked as “Present” 
− Any new corneal scars 
− Any neovascularization within the central 6mm of the cornea 
− Any increase in grading of corneal staining 
− Any corneal infiltrate (record details of corneal infiltrates according to 
Section 2.0: Slit-Lamp Examination of Appendix B: Methods of Clinical 
Evaluation) 
− Record and sketch any scars and slit lamp findings greater than Grade 2 in 
the subject’s source document 
i. Collect/assess all AEs/ADEs, including serious or significant non-serious AEs. 
j. Remind the subject that it is recommended that the lenses be worn overnight for at 
least eight (8) hours each night. 
k. Schedule the subject to return for their 2-Month Follow-up Visit within 2 hours of 
the subject removing the lenses. 
l. Complete the relevant Follow-up Visit eCRFs. 
6.1.6 2-Month Follow-Up (Visit 6) 
The subject must return for the 2-Month Follow-up Visit on day 60 (± 3 days). 
a. Record any changes in concomitant ocular medications. 
b. Collect the following lens wear parameters: 
− Hours since lens removal 
− Average number of nights per week worn 
− Average nightly wearing time, hours per night 
− Frequency of rewetting drops use 
Note: Do not perform any ophthalmic examinations with the maintenance lenses 
in place (if any). 
c. Collect Symptoms/Complaints. 
d. Collect Lens Performance ratings using 0-100 scales. 
e. Perform monocular uncorrected high-contrast distance visual acuity (UDVA) for 
each eye. 
f. Perform the following assessments (without lenses) using phoropter: 
− Spherocylindrical refraction. Explain any induced refractive astigmatism 
greater than 1.00D compared to the Dispensing Visit (Visit 2). 
− Distance high-contrast BSCVA. Explain any loss of BSCVA of 2 or more 
lines compared to the Dispensing Visit (Visit 2). 

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g. Perform corneal topography and record: 
− Topography reading 
− Mire reflex  
− Keratometry readings 
h. Perform a slit lamp examination (without lenses) and record: 
− Any slit lamp findings including ungraded finding marked as “Present” 
− Any new corneal scars 
− Any neovascularization within the central 6mm of the cornea 
− Any increase in grading of corneal staining 
− Any corneal infiltrate (record details of corneal infiltrates according to 
Section 2.0: Slit-Lamp Examination of Appendix B: Methods of Clinical 
Evaluation) 
− Record and sketch any scars and slit lamp findings greater than Grade 2 in 
the subject’s source document 
i. Collect/assess all AEs/ADEs, including serious or significant non-serious AEs. 
j. Remind the subject that it is recommended that the lenses be worn overnight for at 
least eight (8) hours each night. 
k. Schedule the subject to return for their 3-Month Follow-up Visit within 2 hours of 
the subject removing the lenses. 
l. Complete the relevant Follow-up Visit eCRFs. 
6.1.7 3-Month Follow-Up (Visit 7) 
Note: If a subject requires further follow-up due to an ongoing AE, the subject should not 
be exited until the event resolves or stabilizes. 
The subject must return for the 3-Month Follow-up Visit on day 90 (± 3 days). 
a. Record any changes concomitant ocular medications. 
b. Collect the following lens wear parameters: 
− Hours since lens removal 
− Average number of nights per week worn 
− Average nightly wearing time, hours per night 
− Frequency of rewetting drops use 
Note: Do not perform any ophthalmic examinations with the maintenance lenses 
in place (if any). 
c. Collect Symptoms/Complaints. 
d. Collect Lens Performance ratings using 0-100 scales. 
e. Perform monocular uncorrected high-contrast distance visual acuity (UDVA) for 
each eye. 

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f. Perform the following assessments (without lenses) using a phoropter: 
− Spherocylindrical refraction. Explain any induced refractive astigmatism 
greater than 1.00D compared to the Dispensing Visit (Visit 2). 
− Distance high-contrast BSCVA. Explain any loss of BSCVA of 2 or more 
lines compared to the Dispensing Visit (Visit 2). 
g. Perform corneal topography and record: 
− Topography reading 
− Mire reflex  
− Keratometry readings 
h. Perform a slit lamp examination (without lenses) and record: 
− Any slit lamp findings including ungraded finding marked as “Present” 
− Any new corneal scars 
− Any neovascularization within the central 6mm of the cornea 
− Any increase in grading of corneal staining 
− Any corneal infiltrate (record details of corneal infiltrates according to 
Section 2.0: Slit-Lamp Examination of Appendix B: Methods of Clinical 
Evaluation) 
− Record and sketch any scars and slit lamp findings greater than Grade 2 in 
the subject’s source document 
i. Collect/assess all AEs/ADEs, including serious or significant non-serious AEs. 
j. Collect all worn/unworn study lenses from the subject. 
k. Complete the relevant Follow-up eCRFs as appropriate. 
6.1.8 Exit Visit 
Note: If a subject requires further follow-up due to an ongoing AE, the subject should not 
be exited until the event resolves or stabilizes. 
a. Record any changes concomitant ocular medications. 
b. Perform monocular uncorrected high-contrast distance visual acuity (UDVA) for 
each eye. 
c. Perform the following assessments (without lenses) using a phoropter: 
− Spherocylindrical refraction. Explain any induced refractive astigmatism 
greater than 1.00D compared to the Dispensing Visit (Visit 2). 
− Distance high-contrast BSCVA. Explain any loss of BSCVA of 2 or more 
lines compared to the Dispensing Visit (Visit 2). 
d. Perform corneal topography and record: 
− Topography reading 
− Mire reflex  

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− Keratometry readings 
e. Perform a slit lamp examination (without lenses) and record: 
− Any slit lamp findings including ungraded finding marked as “Present” 
− Any new corneal scars 
− Any neovascularization within the central 6mm of the cornea 
− Any increase in grading of corneal staining 
− Any corneal infiltrate (record details of corneal infiltrates according to 
Section 2.0: Slit-Lamp Examination of Appendix B: Methods of Clinical 
Evaluation) 
− Record and sketch any scars and slit lamp findings greater than Grade 2 in 
the subject’s source document 
f. Collect/assess all AEs/ADEs, including serious or significant non-serious AEs. 
g. Collect all worn/unworn study lenses from the subject, if not already done. 
h. Complete the Exit Visit eCRF as appropriate. 
6.1.9 Unscheduled Visits 
Additional visits may be scheduled, as necessary, to ensure the safety and well-being of 
subjects. All additional exams should be fully documented in the source documents and 
on Unscheduled Visit eCRFs, as appropriate. Visits intended to fulfill scheduled visit 
requirements that fall outside the designated scheduled visit range, are not Unscheduled 
Visits. In these cases, the visit data will be collected and transcribed to the appropriate 
intended scheduled visit eCRF. 
If a subject is seen for multiple visits during a given visit timeframe, the data from the 
visit that is intended to meet the protocol requirements for the scheduled visit should be 
captured on the visit eCRF. Where such a determination cannot be made, the first visit 
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. 
If the exclusive purpose of the visit is to dispense replacement study lens/study supplies 
and the subject is not experiencing any problems, refer to Section 6.1.11. 
Procedures to be followed during an Unscheduled Visit will depend on the reason for the 
visit. Indicate the reason for the Unscheduled Visit: 
• 
Signs and Symptoms 
• 
Recheck 
• 
Dispensing due to refinement of lens fit (perform all assessments under 
Section 6.1.2 ) 
• 
1-Day due to refinement of lens fit (perform all assessments under Section 
6.1.3) 

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• 
1-Week due to refinement of lens fit (perform all assessments under 
Section 6.1.4) 
• 
Product Dispensing Only (same lens – e.g., back-up pair due to lost lens) 
• Visit Out of Range for visits within a scheduled visit interval not qualifying to 
represent the intended protocol requirement 
• Discontinued 
• 
Other (please explain) 
If the subject is experiencing problems, assessments will be performed according to the 
Investigator’s judgement. 
a. Collect any relevant medical treatment information, including any adverse events, 
including whether a culture may have been taken. 
b. Record any changes in concomitant ocular medications. 
c. Collect the following lens wear parameters: 
− Hours since lens removal 
− Average number of nights per week worn 
− Average nightly wearing time, hours per night 
− Frequency of rewetting drops use 
Note: Do not perform any ophthalmic examinations with the maintenance lenses 
in place (if any). 
d. Collect Symptoms/Complaints.  
e. Collect Lens Performance rating using 0-100 scales. 
f. Perform uncorrected high-contrast distance visual acuity (UDVA) for each eye. 
g.  Perform the following assessments (without lenses) using a phoropter: 
− Spherocylindrical refraction. Explain any induced refractive astigmatism 
greater than 1.00D compared to the Dispensing Visit (Visit 2). 
− Distance high-contrast BSCVA. Explain any loss of BSCVA of 2 or more 
lines compared to the Dispensing Visit (Visit 2). 
h. Perform a slit lamp examination (without lenses) and record: 
− Any slit lamp findings including ungraded finding marked as “Present” 
− Any new corneal scars 
− Any neovascularization within the central 6mm of the cornea 
− Any increase in grading of corneal staining 
− Any corneal infiltrate (record details of corneal infiltrates according to 
Section 2.0: Slit-Lamp Examination of Appendix B: Methods of Clinical 
Evaluation) 
− Record and sketch any scars and slit lamp findings greater than Grade 2 in 
the subject’s source document 
Note: Do not perform any ophthalmic examinations with the maintenance lenses 
in place (if any). 
i. Perform corneal topography and record: 
− Topography reading 

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− Mire reflex  
− Keratometry readings 
j. Collect/assess all AEs/ADEs including serious or significant non-serious AEs. 
k. If the subject needs to exit the study at this visit, complete the Exit Visit eCRF per 
Section 6.1.8 
l. Collect the study lenses dispensed to the subject (if subject is exiting). 
m. Complete the Unscheduled Visit eCRF. 
6.1.10 Missed Visits 
Missed visits will be handled as follows: 
If a subject misses any scheduled follow-up visit as defined by visit window, the visit is 
considered missed. Indicate a missed visit on the eCRF for that scheduled visit. Due to 
the study design, the subject must attend the Dispensing Visit, 1-Day Follow-up Visit and 
1-Week Follow-up Visits. If the subject misses any of these visits, they must be 
discontinued. In addition, if the subject misses more than one of the 1-Month, 2-Month or 
3-Month Follow-up Visits, the subject must be discontinued. If the subject must be 
discontinued, schedule the subject for an Exit Visit as soon as possible. If the subject 
cannot be reached or rescheduled, the subject should be recorded as Lost to Follow-Up. 
6.1.11 Product Dispensing Only Visit 
If a subject is seen for resupply or replacement of study materials and the subject is not 
experiencing any problems, a complete exam is not required. The Product Dispensing 
Only form can be found within the Unscheduled Visit eCRF. If any assessment is 
performed, then the corresponding additional forms within the Unscheduled Visit eCRF 
must be completed. 
If study lenses are dispensed, collect the following information in the source document 
for each being dispensed, and transcribe to the Product Dispensing Only eCRF form: 
• Visit date 
• Subject ID number 
• Subject initials 
• Primary reason for lens replacement 
Record the lens quantity dispensed, and for which eye the lenses are being dispensed in 
the Accountability Log. 
If back-up lenses are dispensed, order a new back-up pair of lenses by following 
instructions for lens re-order in the Lens Order Instructions Form. 
If study lenses were replaced for any reason other than lens loss, collect the worn lenses 
from the subject. All worn lenses will be returned to the Sponsor in lens case(s) at the end 
of the study. Place the lens case(s) in a labeled zippered bag. 
All study lenses must be returned to the Sponsor at the end of the study. 
Note: All unworn study lenses are to be returned as directed with the materials 
provided. All study lenses must be accompanied by a Product Accountability Log or as 
directed by the Sponsor. 

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6.1.12 Post-study Follow-up 
If a subject requires discontinuation or is completing the study, but has an ongoing AE, 
the subject should not be exited until the event resolves or stabilizes. This may imply that 
follow-up will continue via Unscheduled Visits and that additional evaluations may be 
requested by the Sponsor. 
Investigator must schedule Unscheduled Visits, as necessary. 
Note: All VA measurements MUST be made using a phoropter. 
a. Remove any contact lenses the subject may be wearing. Perform a slit lamp 
examination. Record and sketch the ocular results and findings in the subject’s 
source document. 
b. Complete an ocular examination without lenses on the eyes, including 
spherocylindrical refraction and high-contrast distance BSCVA. 
c. The Investigator is required to follow the subject until the condition no longer 
warrants further follow-up for study purposes. An Unscheduled Visit eCRF must 
be completed for each of these visits. 
Once the AE has resolved or stabilized, the Investigator may proceed with completing the 
Exit Visit. 
6.2 Study Completion/Early Study Terminations/Suspensions 
6.2.1 Study Completion 
The study is considered completed when all subjects have successfully completed the 
study or have been exited. Subjects who require further follow-up will be followed 
according to Section 6.1.12. There is no planned follow-up period after the clinical 
investigation is complete. 
The completion of the clinical investigation shall be deemed to coincide with the last visit 
of the last subject and when follow-up is complete. 
Bausch + Lomb will notify the Investigator when to contact the IRB to inform them that 
the study is complete. 
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 Subject Concomitant Medications/Therapy 
Ocular medications or systemic or topical medications that, in the Investigator’s opinion, 
could potentially affect ocular physiology or lens performance are prohibited, unless 
medically necessary during the course of the study. 

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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 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 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 and Medical Monitor immediately. Reporting of all other protocol deviations 
must adhere to the requirements of the governing IRB. 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., CRO) for sites or Investigators who deviate from 
this protocol in a way that adversely affects the rights, safety, or well-being of the 
subject(s) and/or the quality or integrity of data. The Site Corrective Action Plan will 
outline the deviation and the site’s corrective and/or remedial actions. Decisions 
regarding critical deviations that merit Investigator disqualification and site closure will 
be made by the Sponsor and documented in the Trial Master File. 
6. 
ADVERSE EVENTS 
7.1 Introduction to Adverse Event Definitions 
Adverse events, serious AEs (SAEs), significant non-serious AEs, non-significant non-
serious AEs, adverse device effects (ADEs), anticipated serious adverse device effects 
(ASADEs), and unanticipated adverse device effects (UADEs) 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): 
• 
Led to death. 

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• 
Led to serious deterioration in the health of the subject, that resulted in: 
o A life-threatening illness or injury; or 
o A permanent impairment of a body structure or a body function (e.g., 
blindness); or 
o Inpatient or prolonged hospitalization; or 
o Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
• 
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 
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 ≥2mm 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 6mm 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 6mm of the cornea 
• 
Permanent loss of ≥2 lines of BSCVA 
• 
All cases of iritis 

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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 7.3.1). These events include but are not limited to: 
 
• 
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 the central 6mm 
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 is not limited to the 
following and does not require expedited reporting: 
• Bacterial conjunctivitis 
• Viral conjunctivitis 
• Allergic conjunctivitis 
• Corneal edema 
• Contact lens related papillary conjunctivitis 
• Loss of contrast sensitivity 
7.1.4 Adverse Device Effect (ADE) Definitions 
An adverse device effect 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 

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• 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 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 
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, 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 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 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. 

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• 
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.   
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: 
• Whether the event is serious (refer to Section 7.1.1 and Section 7.1.2) 
• Whether the event is severe (refer to Section 7.1.6) 
• Whether the event is significant (refer to Section 7.1.2 and Section 7.1.3) 
• Whether the event is related to the study device (refer to Section 7.1.5) 
7.3 Procedures for Reporting Adverse Events 
7.3.1 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: 
• To ensure subject safety, all SAEs, regardless of relationship to the study device, 
must be immediately (i.e., within a maximum 24 HOURS after becoming aware 
of the event) reported to 
 and Sponsor. All information relevant to the 
SAE must be recorded on the Sponsor provided SAE report form signed by the 
Investigator. Within 24 hours of knowledge of a new SAE, the Investigator must 
enter the SAE information onto the hard copy SAE report form and send the form 
to the following email distribution: 
o 
 
• The Investigator must verify that the report was received by MedTrials and/or the 
Sponsor. If the Investigator is not able to verify it was successfully received by 

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 and/or Sponsor, the Investigator must call the CRO clinical study 
manager by phone to follow-up. The CRO will forward the documentation to the 
medical monitor and the sponsor for review. 
• Investigators should not wait to receive additional information to fully document 
the event before initially notifying 
 and Sponsor of an SAE or a 
Significant Non-Serious AE. Additional relevant information such as hospital 
records and autopsy reports should be provided to 
 and Sponsor 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 
 and the Sponsor within 24 hours. Whenever possible, it is suggested 
that the Investigator take photographs of all ocular AEs of possible clinical 
significance and forward them to 
 and the Sponsor. 
• 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. 
7.3.2 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. 

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7.3.3 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 lens during this trial to the Medical Monitor 
promptly using the Device Deficiency Report and provide all source documents and 
eCRFs 
that 
will 
assist 
with 
evaluation 
of 
risk 
to 
subject 
safety 
(e.g. 
symptoms/complaints, lens performance ratings, VA, topography, mire reflex, slit lamp, 
etc.). 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. 
7.3.4 Procedures for Reporting and 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. 
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. 
7.3.5 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 

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8.5.3 Safety Set 
The FAS will be used to evaluate safety outcomes. 
8.6 Statistical Analysis 
8.6.1 Methods of Analysis 
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. 
Data from the FAS will be used for analysis unless otherwise specified. 
For each assessment, the baseline value will be defined as the last observation before the 
first insertion of the study lenses. Change from baseline will be computed as follow-up 
value minus baseline value. 
As customary for contact lens 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. 
The proportion of subjects with non-missing monocular UDVA data for both eyes at the 
3-Month Visit who achieved monocular UDVA of 20/40 or better in both eyes at the  
3-Month Follow-up Visit will be presented. 
As a sensitivity analysis, the summary will be produced using the PP Set. 
8.6.2 Adverse Events 
All AEs occurring during the study will be recorded and classified on the basis of 
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 to 
treat the AE, and the outcome. All reported treatment—emergent AEs (TEAEs) will be 
summarized by the number of subjects (or eyes, as appropriate) reporting AEs, system 
organ class, severity, seriousness, and relationship to study device. TEAEs are those AEs 
with and onset on or after the date of the first study device use. 
Serious adverse events will be summarized at the subject and eye levels. 
Adverse events will be summarized by severity. Each subject (or eye, as appropriate) 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 relationship to study device. Each subject (or eye, 
as appropriate) 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 by the Investigator, preferred term, system organ class, start 

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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 study device. 
Serious adverse events (SAEs) will be tabulated. 
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 for the FAS 
and PP Set. 
8.6.4 Subject Discontinuation 
The reasons for study discontinuation will be summarized for the FAS. 
8.6.5 Protocol Deviations 
Important (major) protocol deviations will be summarized by category for the FAS in a 
table. 
Categories of important protocol deviations leading to exclusion from the PP Set will 
include the following: 
• Ineligibility at screening but treated 
• Not dispensed study treatment 
• Use of medications that could potentially affect the primary effectiveness 
endpoint 
• Errors in the assessment of the primary effectiveness endpoint 
• Compliance with study treatment of less than 80% 
Additional important protocol deviation categories may be added prior to database lock. 
8.6.6 Treatment Compliance 
Lens wear parameters (average number of nights worn per week and average nightly 
wearing time, in hours) will be summarized using continuous and categorical summary 
statistics by visit. The overall average number of nights per week, overall average nightly 
wearing time, and overall compliance (%), estimated for each subject based on visit dates 
and reported lens wear parameters, will also be summarized. Compliance will be based 
on an expected wearing time of eight hours per day. 
8.6.7 Treatment Exposure 
Treatment exposure (days), defined as the difference between the last date of lens wear 
and the first date of lens wear + 1, will be summarized using continuous summary 
statistics. 
8.6.8 Missing Data 
Missing data will not be imputed. 

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8.6.9 Multiplicity Issues 
Multiplicity issues do not pertain to this study because there is no hypothesis testing. 
8.6.10 Interim Analyses 
No interim analyses are planned. 
8. 
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 Personal Health Information will be escalated to 
Bausch + Lomb Data Privacy representative per 
 
 
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 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 
• Tthe 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 

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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 remains 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  
non-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, designated to ensure compliance with GCPs, study-
specific procedures, human rights and applicable regulations, are described in the 
Monitoring Plan.5 
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 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 
by drawing a single line through the original entry, entering the new information, and 
dating and initialing the change. 
Subjects should be provided the rating scales (separate document) to use while 
responding to the lens performance assessments being collected. Enter rating from 0-100 
(e.g., 90). 
9.4 Case Report Forms and Data Verification 
Subject data required by this protocol are to be transferred from 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 

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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 ID. Confidentiality of 
subject records must be maintained to ensure adherence to applicable local privacy 
regulations. 
The Investigator has 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: 
• 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) 
• All source documents 
• eCRFs 
• Subject’s signed ICF(including HIPAA) 
• Device Investigator Agreement 
• 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. 
9.6 Auditing Procedures 
Audits of clinical research activities in accordance with the Sponsor’s internal Standard 
Operating Procedures (SOPs) to evaluate compliance with the principles of GCP may 

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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/Ethics Committee Approval 
The Investigator should ensure that the following are approved by their institution’s IRB, 
or if not using their institution’s IRB/EC, approved by the reviewing central IRB 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/EC prior to implementation 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 the review by, and in consultation and agreement with the Sponsor, and such that 
confidential or proprietary information is not disclosed. 
Prior to publication or presentation, a copy of the final text should be forwarded by the 
Investigator(s) to the Sponsor or its designee, for comment. Such comments shall aim to 
ensure the scientific integrity of the proposed publications and/or presentations and 
ensure that the data and material referring to Bausch + Lomb products and activities 
receive fair, accurate, and reasonable presentation. 
9. 
REFERENCES 
10.1 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 

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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) 
REGULATION (EU) 2017/745 (also called European Medical Device Regulation MDR) 
– Regulation of the European Union on medical devices  
 
10.2 Literature References 
1Study 918 Investigator Contact List 
2 Study 918 - Boston Orthokeratology (oprifocon A) Shaping Lens, Arise 
Orthokeratology Lens Design Investigator Brochure 
3B&L SOP No 20-D022-3 Investigational Material Release for Bausch Health Companies 
R&D Activities 
4B&L SOP No. CLN 035 – Privacy of Clinical Data and Related Information 
5Study 918 Monitoring Plan

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APPENDIX A: SCHEDULE OF VISITS AND PROCEDURES 
All study tasks should be performed by qualified study site personnel as indicated on the delegation of authority log under the supervision of the 
Principal Investigator. (Refer to important footnote at the bottom of the table) 
PROCEDURES/ASSESSMENTS 
Screening 
Visit 1 
Dispensing 
Visit 2 
1-Day 
Visit 3 
1-Week 
Visit 4 
1-Month 
Visit 5 
2-Month 
Visit 6 
3-Month 
Visit 7 
Exit Visit 
Informed Consent/HIPAA Authorization 
X 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
Contact lens use history 
X 
 
 
 
 
 
 
 
Ocular medical history and concomitant ocular 
medications 
X 
 
 
 
 
 
 
 
Changes in Concomitant ocular medications  
 
X 
X 
X 
X 
X 
X 
X 
Eligibility 
X 
 
 
 
 
 
 
 
Dispense Study Materials 
 
X 
 
 
 
 
 
 
Collect Study Materials 
 
 
 
 
 
 
X 
X 
Monocular high-contrast distance VA with habitual 
correction 
X 
 
 
 
 
 
 
 
Anesthetic drops prior to lens insertion 
 
X 
 
 
 
 
 
 
To be performed 
with study lenses 
Lens fit assessment 
 
X 
Xa 
 
 
 
 
 
To be performed 
without lenses 
Monocular UDVA (each eye) 
X 
X 
X 
X 
X 
X 
X 
X 
Spherocylindrical refraction 
X 
X 
X 
X 
X 
X 
X 
X 
Distance high-contrast BSCVA 
X 
X 
X 
X 
X 
X 
X 
X 
Topography 
X 
 
X 
X 
X 
X 
X 
X 
Biomicroscopy 
X 
X 
X 
X 
X 
X 
X 
X 
Compare refractive astigmatism to 
Dispensing Visit  
 
 
X 
X 
X 
X 
X 
X 
Compare BSCVA to Dispensing Visit  
 
 
X 
X 
X 
X 
X 
X 
 

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APPENDIX A: SCHEDULE OF VISITS AND PROCEDURES (CONTINUED) 
Lens wear parameters 
 
 
X 
X 
X 
X 
X 
 
Adverse Events 
X 
X 
X 
X 
X 
X 
X 
X 
Symptoms/Complaints 
 
 
X 
X 
X 
X 
X 
 
Lens Performance Ratings 
 
 
X 
X 
X 
X 
X 
 
a The 1-Day Follow-up visit will be conducted within 2 hours of awakening and topography will be performed within 30 minutes of lens removal 

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APPENDIX C: SUBJECT INSTRUCTIONS 
INTRODUCTION 
You will participate in this study designed to evaluate the product performance of the 
investigational Arise Orthokeratology Lens. Study lenses will be dispensed at the 
Dispensing Visit. It is very important that you do not use any other contact lenses other 
than those dispensed to you during the study. 
During the initial week(s) of treatment, some patients may experience changes in vision 
that may require temporary alternate corrective eyewear. This should be discussed with 
your study doctor. 
You are cautioned to carefully follow the wearing schedule recommended by your study 
doctor regardless of how comfortable your lenses feel. The lenses are intended for 
overnight wear. Lenses should be removed each morning for disinfecting and cleaning. If 
the lenses continue to be well tolerated, they may be re-inserted each night. 
Please keep all appointments and follow these instructions thoroughly. If you have any 
questions or problems, call your study doctor at ________. 
Your study doctor or staff will schedule your 1-Day Follow-up appointment for within 2 
hours of your awakening the day after you sleep in your lenses for the first time. It is 
important that you wear your lenses to this appointment. Unless your study doctor 
finds it necessary to refine the fit of your lens, this will be the only appointment that you 
will need to wear your lenses to an appointment. The remaining appointments will be 
scheduled for within 2 hours of removing lenses from your eyes in the morning. 
 
PATIENT LENS CARE DIRECTIONS 
Your study doctor or staff will review instructions for the care of your contact lenses. 
To ensure proper disinfecting, all steps listed below must be followed: 
1. Wash your hands with mild soap. (Caution – pump soaps may contain oil-based 
suspension agents.) 
2. Place lenses in empty lens case and fill to top ridges with fresh Boston SIMPLUS 
Multi-Action Solution. Soak lenses for at least 4 hours before wearing. 
3. Wash hands with mild soap before cleaning (rubbing) lenses. After soaking, 
remove lenses from lens case and rub both sides of the lenses carefully with 4 
drops of Boston SIMPLUS Multi-Action Solution in the palm of your hand for 20 
seconds. 
4. Rinse for approximately 5 seconds with a steady stream of Boston SIMPLUS 
Multi-Action Solution to eliminate loosened surface deposits and insert lenses. 
5. Discard solution from lens case after each use. For lens rewetting and lubrication, 
use Boston® Rewetting Drops. 
If your study doctor recommends a different lens care regimen, appropriate 
instructions will be provided and reviewed with you. 
 

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INSERTION AND REMOVAL OF CONTACT LENSES 
Preparing the Lens for Wearing 
It is essential that you learn and use good hygienic methods in the care and handling of 
your contact lenses. Cleanliness is the first and most important aspect of proper contact 
lens care. Hands should be clean and free of any foreign substances when you handle 
your lenses. 
The procedures are: 
• Always wash, rinse and dry hands thoroughly before handling your contact 
lenses. 
• Avoid soaps containing cold cream, lotions or oily cosmetics prior to handling 
your lenses. These substances can adhere to the surface of the lens and be difficult 
to remove. 
• Handle lenses with the fingertips, avoiding use of fingernails that can scratch or 
chip lenses. 
• Always start with the same lens first to avoid mix-ups. 
• Remove the lens from its storage case and examine it. Be sure it is clean, moist 
and free of any nicks or cracks. 
Placing the Lens on the Eye 
• Prepare the lens for placement by following Step 3 (rubbing) and Step 4 (rinsing) 
in the Patient Lens Care Directions above. 
• Place lens on the top of index finger of dominant hand. 
• With other hand, hold down lower lid and lift upper lid up. Gently place lens on 
the center of your eye. It is not necessary to press the lens on the eye. 
• Gently release lids and blink. The lens should center automatically. 
• Use the same technique to insert the other lens. 
There are other methods of lens placement. If this method proves too difficult for you, 
discuss alternatives with your study doctor. 
Note: if vision is blurred after insertion, check for the following conditions: 
• Lens is not centered (refer to section below on “Centering a Lens”) 
• If lens is centered, remove and check for any of the following: 
a. Cosmetics or oil on the lens. Clean, rinse, disinfect and replace on eye. 
b. The lens may be on the wrong eye. 
If you find your vision is still blurred after checking the possibilities as listed above, 
remove both lenses and consult your study doctor. 
Centering the Lens 
Very rarely, a lens that is on the cornea will displace onto the white portion (sclera) of the 
eye during lens wear. This can also occur during insertion or removal of your lens if 
proper technique is not utilized. To center a lens, follow one of the procedures below or 
one recommended to you by your study doctor. 

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• Close your eyelids and gently massage the lens into place through the closed lids. 
OR 
• Gently push the off-centered lens onto the cornea while the eye is open using 
finger pressure on the upper or lower lid next to the edge of the lens. 
Removing the Lens 
Before attempting to remove your lens, it is very important that you verify the lens is 
moving. The lens is designed to be worn overnight and may be slightly stuck in place on 
the eye in the morning. Apply two to three drops of Boston Rewetting Drops to your eyes 
in the morning and wait until the lens begins to move freely with the blink before you 
attempt to remove it. 
It is recommended that you have the following items available when you are ready to 
remove your lenses: 
• A lens storage case 
• Solution for cleaning and storing your lenses 
• A clean towel 
Always remove the same lens first to avoid confusion. Wash, rinse and dry your hands 
thoroughly. 
There are two suggested methods of lens removal: 
TWO FINGER METHOD 
1. Place a towel on the counter to catch the lens. 
2. Place the tip of the forefinger of one hand on the middle of the upper lid margin 
and the forefinger of the other hand on the middle of the lower lid margin. 
3. Press the lid margin inward and then together. The lens should be wedged out of 
your eye and onto your hand or the towel. 
4. The lens may come out but remain on your eyelid or be de-centered onto the 
white part of your eye. If the latter occurs, re-center the lens onto your cornea 
before repeating the removal process. 
BLINK METHOD 
Seat yourself at a table covered with a clean towel and lean over until you are looking at 
the surface. 
1. Place your index finger at the outer junction of your upper and lower lids; stretch 
the skin outward and slightly upward. Do not allow your lid to slide over the lens. 
2. Blink briskly. The lens will be pinched by the pressure of your eyelids and pop 
out onto the clean surface of the towel, or you may catch the lens in the palm of 
your hand. 
Note: If these methods for removing your lens are difficult for you, your study doctor can 
provide you with alternatives. 
 

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IMPORTANT SAFETY INFORMATION 
• Always follow the product directions for use. Failure to follow product directions 
may lead to vision loss. 
• Always wash and dry hands before handling lenses. 
• Do not use tap water, bottled water or saliva with lenses or lens case. 
• Only use fresh solution to clean and disinfect contact lenses. 
• Always discard any remaining solution in your lens case after each disinfection 
cycle. 
• Saline solution or rewetting drops will not disinfect your lenses. 
• Always replace your solutions, lenses, and lens case(s) as directed. 
• To avoid contamination, do not touch tip of container to any surface. Replace cap 
after using. 
• Not for use with heat (thermal) disinfection. 
WARNINGS 
You should be aware of and fully discuss with your study doctor the following warnings 
pertaining to contact lens wear: 
− Problems with contact lenses could result in serious injury to your eye. It is 
essential that you follow your study doctor’s direction and all labeling instructions 
for proper use of lenses. Eye problems, including corneal ulcers, can develop 
rapidly and lead to loss of vision. 
− If you experience eye discomfort, excessive tearing, vision changes, or redness of 
the eye, you should immediately remove lenses and promptly contact your study 
doctor. 
− Strict compliance with your wearing restrictions, wearing schedule, and follow-up 
visit schedule should be followed. 
Arise Orthokeratology Lenses are to be worn overnight with removal during all or part of 
each following day. Wearing the lenses continuously (extended wear) presents increased 
risk, which increases with the number of consecutive days that the lenses are worn 
between removals. Although the process prescribes only overnight wear with the removal 
during waking hours, and although the safety risks of overnight wear with removal upon 
awakening may not be as great as with uninterrupted extended wear, there is still 
increased risk beginning with the first overnight period. 
The risk of ulcerative keratitis has been shown to be greater among wearers of extended 
wear lenses than among wearers of daily wear lenses. The risk among extended wear lens 
wearers increases with the number of consecutive days that lenses are worn between 
removals, beginning with the first overnight use. This risk can be reduced by carefully 
following directions for routine lens care, including cleaning the storage case. 
Additionally, smoking increases the risk of ulcerative keratitis for contact lens wearers. 
 
 

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ADVERSE EFFECTS 
You should be informed that the following problems might occur: 
• Eyes stinging, burning, itching (irritation), or other eye pains. 
• Comfort is less than when lens was first placed on eye. 
• Feeling of something in the eye, such as a foreign body or scratched area. 
• Excessive watering (tearing) of the eyes. 
• Unusual eye secretions. 
• Redness of the eyes. 
• Reduced sharpness of vision (poor visual acuity). 
• Blurred vision, rainbows, or halos around objects. 
• Sensitivity to light (photophobia). 
• Dry eyes. 
If you notice any of the above, IMMEDIATELY REMOVE YOUR LENSES. 
• If the discomfort or problem stops, then look closely at the lens. 
• If the lens is in any way damaged, DO NOT put the lens back on your eye. Place 
the lens in the storage case and contact your study doctor. 
• If the lens has dirt, an eyelash, or other foreign objects on it, or the problem stops, 
and the lens appears undamaged, you should thoroughly clean, rinse and disinfect 
the lens; then reinsert it. Do not use a tap water rinse, use the approved 
conditioning solution as a rinsing agent. 
• If the problem continues, you should IMMEDIATELY remove the contact lens 
and consult your study doctor. 
When any of the above problems occur, a serious condition such as infection, corneal 
ulcer, neovascularization, iritis, persistent stromal edema or GPC (giant papillary 
conjunctivitis) may be present. You should be instructed to keep the lens off the eye and 
seek immediate professional identification of the problem and prompt treatment to avoid 
serious eye damage. 
 
CARE FOR A STICKING (NON-MOVING) LENS 
Observe your lenses with a mirror to confirm that they move freely upon blinking before 
you attempt to remove them. If a lens sticks (stops moving/cannot be removed), you 
should apply two to three drops of Boston Rewetting Drops directly to the eye and wait 
until the lens begins to move freely on the eye before removing it. If non-movement 
continues after 5 minutes, re-instill rewetting drops and compress the lid margin above or 
below the lens to release the suction. If non-movement persists, do not attempt to remove 
the lens but immediately contact your study doctor. 
 

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APPENDIX D: FITTING GUIDE 
IMPORTANT 
This Fitting Guide has been developed to provide study doctors with information 
covering characteristics of the investigational orthokeratology contact lens and to 
illustrate fitting procedures. Please read carefully and keep this information for future 
use. 
PRODUCT DESCRIPTION 
Arise Orthokeratology (oprifocon A) Lenses are a lathe cut gas permeable contact lens. 
The posterior curve is selected to properly fit an individual eye for orthokeratology and 
the anterior curve is selected to provide the necessary optical power for a temporary 
reduction of myopia. A peripheral curve system on the posterior surface allows tear 
exchange between the lens and the cornea. 
Arise Orthokeratology Lenses are made of oprifocon A polymer with a water content of 
less than 1 percent that contains an ultraviolet absorber, Uvinul D-49. The blue tinted 
lenses for the right eye contain D&C Green #6 as a color additive. The green tinted lenses 
for the left eye contain D&C Green #6 and C.I. Solvent Yellow #18. 
DETAILED DESCRIPTION 
Arise Orthokeratology Lenses have a design known as reverse geometry. This means that 
the secondary curve on the posterior surface, next to the base curve, has a radius of 
curvature that is steeper (shorter radius) than the base curve (central curve). This curve is 
referred to as the “Fitting Curve” or the “Reverse Curve”. 
The Fitting Curve is surrounded by a flatter intermediate zone that is approximately equal 
in radius to the flat keratometer reading of the central cornea. This zone is referred to as 
the “Alignment Zone” or the “Alignment Curve.” In this way the geometry of the 
secondary curves are in the opposite relationship to the base curve, as occurs with 
standard GP contact lenses. Outside the Alignment Zone, at the edge of the lens, is a 
peripheral curve that allows for tear exchange under the lens to take place. The function 
of the steep Fitting Curve, on the Arise Orthokeratology Lenses, is to allow the base 
curve to be fit in a flat relationship to the central cornea and still maintain lens stability 
on the cornea. With a regular GP contact lens design that is fitted flat on the cornea there 
is only one support point for the contact lens, which occurs at the center of the lens. This 
lens will tend to rock and de-center on the cornea. With the Arise Orthokeratology Lens, 
there is support for the lens at both the central cornea and in the area of the Alignment 
Zone. This will reduce lens rocking and aid in centering. 
LENS PARAMETERS AVAILABLE 
Chord Diameter 
 
9.6mm to 11.6mm 
Center Thickness 
For Low Minus Lens 0.20mm to 0.32mm 
For Plus Lenses 
0.20mm to 0.32mm 
Base Curve 
 
 
7.30mm to 10.15mm 

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Reverse Curve 
 
5.0mm to 9.0mm Steeper than the base curve in proportion 
 
to the amount of correction 
Alignment Curve 1 
7.0mm to 9.0mm Steeper than the base but flatter than the 
reverse curve. Generally equal to the Flat K of the cornea 
being fit 
Alignment Curve 2 
7.25mm to 9.25mm Steeper than the base curve but flatter 
than AC1 and reverse curve 
Peripheral Curves 
9.00mm to 15.00mm 
Back Vertex Power 
+1.50 Diopters to -5.00 Diopters 
HOW THE LENS WORKS (ACTIONS) 
Arise Orthokeratology Lenses produces a temporary reduction of myopia by changing the 
shape (flattening) of the cornea, which is elastic in nature. Flattening the cornea reduces 
the focusing power of the eye, and if the amount of corneal flattening is properly 
controlled, it is possible to bring the eye into correct focus and completely compensate 
for myopia. 
The posterior surface of regular contact lenses generally aligns with the central cornea 
and rests directly on the corneal tear layer. Regular contact lenses are designed to cause 
little or no effect on the cornea but Arise Orthokeratology Lenses are designed to 
purposely flatten the shape of the cornea by applying slight pressure to the center of the 
cornea when the patient is asleep. 
After the lens is removed, the cornea retains its altered shape for all or most of one’s 
waking hours. The lenses are designed to be worn overnight with removal during the 
following day. The Arise Orthokeratology Lenses must be worn at night on a regular 
schedule to maintain the orthokeratology effect, or myopia will revert to the pretreatment 
level. 
INDICATIONS 
Arise Orthokeratology Lenses are indicated for use in the reduction of myopic refractive 
error in non-diseased eyes. The lenses are indicated for overnight wear for the temporary 
reduction of myopia up to 5.00 diopters in eyes having astigmatism up to 1.50 diopters. 
The lenses may only be disinfected using a chemical disinfection system. 
Note: To maintain the Orthokeratology effect of myopia reduction, overnight lens wear 
must be continued on a prescribed schedule. Failure to do so can affect daily activities 
(e.g., night driving),visual fluctuations and changes in intended correction. 
 
CONTRAINDICATIONS (REASONS NOT TO USE) 
DO NOT USE Arise Orthokeratology Lenses when any of the following conditions exist: 
• 
Acute and subacute inflammation or infection of the anterior chamber of the eye. 
• 
Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or 
eyelids. 

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• 
Severe insufficiency of tears (dry eyes). 
• 
Corneal hypoesthesia (reduced corneal sensitivity). 
• 
Any systemic disease which may affect the eye or be exacerbated by wearing contact 
lenses. 
• 
Allergic reactions of ocular surfaces or adnexa which may be induced or exaggerated 
by wearing contact lenses or use of contact lens solutions. 
• 
Allergy to any ingredient, such as mercury or thimerosal, in a solution which is to be 
used to care for your Arise Orthokeratology Lenses. 
• 
Any active corneal infection (bacterial, fungal, or viral). 
• 
If eyes become red or irritated. 
 
WARNINGS 
After a thorough eye examination, including appropriate medical background, subjects 
should be fully apprised by the study doctor of all the risks with contact lens wear. 
Subjects should be advised of the following warnings pertaining to contact lens wear: 
• 
Incorrect use of contact lenses and lens care products can result in serious injury to 
the eye. It is essential that subjects follow the study doctor’s directions and all 
labeling instructions for proper use of contact lenses and lens care products. 
• 
Eye problems, including corneal ulcers, can develop rapidly and lead to loss of vision. 
If the subject experiences eye discomfort, excessive tearing, vision changes, loss of 
vision or redness of the eye, immediately remove the lenses and do not wear them 
until instructed to do so by the study doctor. 
• 
All study subjects must see their study doctor according to the schedule given to 
them. 
• 
Arise Orthokeratology Lenses are to be worn overnight with removal during all or 
part of each following day. Wearing the lenses continuously (extended wear) presents 
increased risk, which increases with the number of consecutive days that the lenses 
are worn between removals. Although the Arise Orthokeratology process prescribes 
only overnight wear with removal during waking hours, and although the safety risks 
of overnight wear with removal upon awakening may not be as great as with 
uninterrupted extended wear, there is still increased risk beginning with the first 
overnight period. The risk of ulcerative keratitis has been shown to be greater among 
wearers of extended wear lenses than among wearers of daily wear lenses. The risk 
among extended wear lens wearers increases with the number of consecutive days 
that lenses are worn between removals, beginning with the first overnight use. The 
risk can be reduced by carefully following directions for routine lens care, including 
cleaning the storage case. Additionally, smoking increases the risk of ulcerative 
keratitis for contact lens wearers. 
 
 

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ADVERSE EFFECTS 
The subject should be informed that the following problems may occur: 
• 
Eyes stinging, burning, itching (irritation), or other eye pain. 
• 
Comfort is less than when lens was first placed on eye. 
• 
Feeling of something in the eye, such as foreign body or scratched area. 
• 
Excessive watering (tearing) of the eyes. 
• 
Unusual eye secretions. 
• 
Redness of the eyes. 
• 
Reduced sharpness of vision (poor visual acuity). 
• 
Blurred vision, rainbows, or halos around objects. 
• 
Sensitivity to light (photophobia). 
• 
Dry eyes. 
If the subject notices any of the above, he or she should be instructed to 
IMMEDIATELY REMOVE THE LENSES. 
• 
If the discomfort or problem stops, then look closely at the lens.  
• 
If the lens is in any way damaged, DO NOT put the lens back on the eye. Place the 
lens in the storage case and contact the study doctor. 
• 
If the lens has dirt, an eyelash, or other foreign body on it, or the problem stops and 
the lens appears undamaged, the subject should thoroughly clean, rinse and disinfect 
the lens; then reinsert it. Do not use tap water rinse, use the approved conditioning 
solution as a rinsing agent. 
• 
If the problem continues, the subject should IMMEDIATELY remove the contact 
lenses and consult the study doctor. 
When any of the above problems occur, a serious condition such as infection, corneal 
ulcer, neovascularization, iritis, persistent stromal edema or GPC (giant papillary 
conjunctivitis) may be present. The subject should be instructed to keep the lens off the 
eye and seek immediate professional identification of the problem and prompt treatment 
to avoid serious eye damage including corneal scarring, opacification, blindness or loss of 
eye. 
SELECTION OF SUBJECTS 
Patients are selected who have a demonstrated need and desire for a refractive reduction 
by orthokeratology with gas permeable contact lenses and who do not have any of the 
contraindications described above. Arise Orthokeratology Lenses are indicated for 
myopic patients who desire to have time periods during the day in which they do not need 
to wear their contact lenses, but still need to see clearly. Arise Orthokeratology Lenses 
are primarily intended for patients who are within the following parameters: 
Refractive error:  -1.00 diopters to -5.00 diopters with up to 1.50 diopters of astigmatism. 
Keratometry: 40.00 diopters to 46.00 diopters. 

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FITTING CONCEPT 
Arise Orthokeratology Lenses are designed to be fit so that they flatten the central cornea 
and thereby reduce myopia. This goal is accomplished by the lens design and the manner 
in which the lens is fitted. The goal in fitting is a well-centered lens having a base curve 
that is flatter than the flattest meridian of the cornea by at least the attempted treatment 
power in that meridian. A well-fit lens will have the proper sagittal depth to prevent 
vaulting off the central corneal apex and prevent excessive bearing in the alignment 
zone(s). There should be adequate edge lift to allow for proper tear exchange. 
FITTING PROCEDURE 
1. Screening Visit Examination 
A screening subject history and examination are necessary to: 
• 
determine whether a subject is a suitable candidate for orthokeratology contact 
lenses (consider subject hygiene and mental and physical state), 
• 
make ocular measurements for initial contact lens parameter selection, and 
• 
collect and record baseline clinical information to which post-fitting examination 
results can be compared. 
A screening examination should include spherocylindrical refraction and high-contrast 
distance BSCVA, corneal topography, and biomicroscopic examination. See Section 
6.1.1, Screening Visit. 
2. Initial Lens Selection 
The initial lens will be based on the subject’s spectacle refraction and corneal topography 
map file. The Investigator should complete the Arise Orthokeratology Lens Order 
Instruction Form and follow the instructions on the form to order the initial lenses for the 
subject. 
The following information will be required for the initial lens order: 
• 
Subject ID (6 digit): 
• 
Investigator Name: 
• 
Account ID: 0ARISE 
• 
Category: New Order 
• 
Pre-treatment topography map file for OD and OS 
○ File should be sent pre-populated with:  
▪ 
Subject ID (first name = type the word “SUBJECT”, last name = 6-digit 
subject ID) 
▪ 
Subject date of birth 
▪ 
Subject spectacle refraction. 
3. Initial Lens Evaluations (Dispensing Visit) 
• 
Insert a drop of anesthetics in each eye prior to lens insertion. 

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• 
Evaluate the study lenses on the eye and record the following lens fit assessments: 
− lens centration 
− lens movement 
• 
Fluorescein Pattern Interpretation: 
The fluorescein pattern should show a lens with definite central touch, 
approximately 4.0mm to 6.0mm in diameter with a surrounding area of pooling. 
The pattern should show alignment in the mid-periphery and there should be 
normal clearance at the edge. 
The area of pooling near the transition between the base curve and secondary 
curve serves as a reservoir for tears and as a potential space for corneal shifting 
during the flattening process of orthokeratology. The cornea adapts by flattening 
in the central area, which reduces the space near the transition reservoir. The size 
of the transition reservoir, as observed from the fluorescein pattern, is a good 
indicator not only of the initial fit of the lens but also of the progress of corneal 
flattening over time as the lens is worn. 
The fluorescein pattern provides a good method for monitoring the fit of the 
contact lens over time. As the cornea flattens, the area of pooling at the transition 
becomes less. 
The presence of the UV-absorber in the Arise Orthokeratology Lenses may 
require equipment enhancement to visualize fluorescein patterns adequately. A 
simple, inexpensive approach is the use of an auxiliary yellow Kodak Wratten 
#12 filter in conjunction with the cobalt blue filter of the biomicroscope. 
Slit Lamp Application: 
1. All customary light intensities and filter settings (Cobalt Blue) are left in place. 
2. The Kodak Wratten Filter #12* (yellow) is secured on the patient side of the slit 
lamp microscope with the Slit Lamp Filter Kit. 
ORTHO-K PROBLEM SOLVING 
Low Riding Lens: 
A slight low riding lens is the ideal position upon dispensing. The lens will then center 
with the eye closed. Do not make a change unless the lens is chronically low riding with 
eyelid closed (as demonstrated by topography) or if unacceptable ghosting persists. 
Cause: The cornea becomes flatter from the apex to the periphery. This degree of 
corneal flattening is different for everyone, with some corneas having a greater or 
lesser degree of flattening. If the flattening is too great, the alignment curves will 
be too steep. 
Loose Lens: 
Cause: Generally caused by a low amount of flattening of the peripheral cornea or 
from an asymmetrical corneal shape. 
High Riding Lens: 

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Cause: The high riding lens is usually caused either from the lens being too loose 
or from an asymmetrical corneal shape. 
Lateral Riding Lens: 
Cause: Generally caused by a very spherical cornea or a cornea with against the 
rule cylinder. 
Vaulting: 
Vaulting occurs when excessive bearing is present in the peripheral regions causing 
reduced central bearing. This will be seen as central pooling or increased fluorescein 
under the center of the lens. 
Cause: The major cause of central vaulting is an alignment curve that is too steep. 
The more peripheral one goes from the corneal apex, the more difficult it is to 
predict the rate of corneal flattening. When the alignment curve is too steep, the 
central portion of the lens will rise up, preventing it from applying compression to 
the center of the cornea. A fitting curve that is too steep can also cause central 
vaulting but is much less common. 
Under-Responders: 
An under-responder is a patient whose myopia does not reduce as anticipated. An 
example is a -3.00, which was reduced to -1.00 after one month of wear and has not 
changed for 3 weeks. You will be able to refract the patient, without the lenses in, to 
20/20 or better. 
Cause: Typically, the under-responder will have vaulting in the center. Some 
patients will, however, respond slower than others perhaps due to different cell 
structure of the cornea. You do not want to rush into making a change if the exam 
figures are correct. 
Central Islands: 
Central islands are areas of distortion in the visual axis that are observed with corneal 
topography. This condition differs from the under-responder in that you will not be able 
to refract the patient, without the lenses in, to 20/20. 
Cause: Generally caused by the fitting curve being too steep, causing the Base 
curve to lift off too much from the central cornea. Another cause is excessive 
astigmatism. With corneal astigmatism present, there are unequal bearing areas 
where the fitting curve comes into contact with the cornea. 
Central Staining: 
This is a complication due to either mechanical irritation or physiological problems. 
Cause: One major cause of central staining is a coated lens. Because of the steep 
Fitting Curve, it is difficult to clean the central posterior surface of the lens. This 
will create an irritating surface, which in turn causes the staining and a tendency 
for lens adherence. If the BC is too flat, the reduced mechanical pressure can also 

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cause irritation. Reduced oxygen availability can also cause central staining, but 
this is a rare occurrence. 
Solution: The first thing is to make sure the posterior surface of the lens is clean. 
Review the cleaning procedure being used by the subject. Make sure there are no 
dry spots. 
Air Bubbles: 
Air bubbles are a common occurrence and typically disappear after wear. Only when 
staining occurs under a persistent air bubble does the lens need to be changed. 
Cause: Air bubbles form when not enough solution is under the fitting curve. 
Usually the upper lids will compress the lens to the cornea and the bubbles will 
disappear in the morning. The fitting curve has a steep configuration, which is 
sometimes difficult to fill with tears. Occasionally, the resultant air bubble can 
encompass 270 degrees around the FC. Any staining present is due to the air 
bubble where the cornea is not getting the lubrication or oxygen that it needs. 
Solution: If the air bubble is less than 45 degrees in length upon insertion, just 
monitor the next day to see if any staining occurs. If the air bubble is greater than 
45 degrees, have the patient remove the lens and fill the concave surface with 
solution and have the patient reinsert while looking down. If a large air bubble 
persists, monitor the next day to see if still present and if staining is present. If 
staining is present, monitor for three days to see if the bubble and staining 
recedes. Air bubbles look bad but are usually a self-limiting condition. 
Reduced Holding Time: 
This is when the unaided visual acuity does not hold an acceptable amount of time. 
Cause: Generally caused by a lens that is not centered, with the steep area almost 
touching the visual axis. When the cornea normally regresses, the visual axis is 
impacted sooner because there is less distance between the visual axis and the 
edge of the peripheral steep ring. If some vaulting has occurred, there will be a 
smaller central visual zone with a corresponding wider concentric steep ring. The 
cornea can only undergo a limited amount of change. Usually, the more induced 
change, the faster the cornea will regress. Therefore, if you have reduced -5.00 
diopters of myopia, you should not expect the unaided visual acuity to hold all 
day. As a general rule, the lower the starting amount of myopia, the greater 
chance of holding all waking hours. The Arise Orthokeratology Lenses are not 
recommended for reducing myopia greater than -5.00 diopters. 
Ghosting at Night: 
Night ghosting is a normal observation. This usually recedes with time but may always 
be present to some extent. 
Cause: The main cause of ghosting is when the reduced illumination at night 
causes the pupil to become larger than the central correction area of the cornea. 
This might occur even with a well-centered lens. Patients with smaller pupils will 
not experience this to the extent of patients with very large pupils. Another cause 

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is a decentered lens. This can also cause ghosting during the day. Central islands 
can also give the same subjective complaints as ghosting. 
Solution: Time is the answer for normal ghosting. 
4. Follow-up Care 
From the day of dispensing, the following schedule is required for this study. 
• 
1-Day Follow-up Visit 
− The 1-Day Follow-up Visit will be conducted within 2 hours of awakening 
and topography will be performed within 30 minutes of lens removal. 
− Ensure that the subject arrives for their appointment wearing the study 
lenses. 
• 
1-Week Follow-up Visit 
• 
1-Month Follow-up Visit 
• 
2-Month Follow-up Visit 
• 
3-Month Follow-up Visit 
5. Maintenance Lenses 
Daily disposable soft contact lenses (Bausch + Lomb Biotrue ONEday (nesofilcon A) 
Contact Lenses, known as “maintenance lenses”) will be dispensed at the 1-Day Follow-
up Visit as needed to provide supplemental visual correction during the day as needed for 
the orthokeratology lens adaptation period. 
Although the majority of subjects may not require maintenance lenses, Bausch + Lomb 
will provide each investigative site a supply of Bausch + Lomb Biotrue ONEday 
(nesofilcon A) Contact Lenses in representative powers of -0.50, -1.00, -1.50, -2.00, -
2.50, and -3.00D for use as needed during the orthokeratology lens adaptation phase. 
6. To Refine Lens Fit 
Note: Each eye can only be refit one time, either at the 1-Day Follow-up Visit or the  
1-Week Follow-up Visit. 
If the lens fit is unacceptable, order two lenses if refitting one eye (or two pairs of lenses 
if re-fitting both eyes) by following the instructions for lens refitting in the Lens Order 
Instructions Form. 
The following information will be required for lens refitting: 
• 
Subject ID (6 digit): 
• 
Investigator Name: 
• 
Account ID: 0ARISE 
• 
Category: Refitting 
• 
Topography map file for OD and/or OS, taken after overnight wear of previously 
dispensed study lenses 

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○ File should be sent pre-populated with:  
▪ 
Subject ID (first name = type the word “SUBJECT”, last name = 6-digit 
subject ID) 
▪ 
Subject date of birth 
▪ 
Subject spectacle refraction. 
• 
Reason for refitting (indicate either OD or OS, if only applies to one): 
− Lens is Vaulting 
− Lens is riding High 
− Lens is riding Low 
− Lens has Lateral Displacement 
− Undercorrection or overcorrection of treatment with the following 
refraction data (without lens): 
• 
OD/OS sphere, cylinder, axis, visual acuity 
− Other reason(s) – please specify, e.g., lens discomfort 
7. Patient Education 
During the initial week(s) of treatment, some subjects may experience changes in vision 
that may require temporary alternate corrective eyewear. Daily disposable soft contact 
lenses (Bausch + Lomb Biotrue ONEday (nesofilcon A) Contact Lenses, known as 
“maintenance lenses”) will be dispensed to provide supplemental visual correction during 
the day as needed for the orthokeratology lens adaptation period. These lenses are to be 
worn on a daily disposable basis and replaced daily as needed during the initial week(s) 
of treatment. It is important to educate the subject of the occurrence of this potential 
change in vision and instruct them on the proper wear and care of maintenance lenses 
used during this period. 
WEARING SCHEDULE 
Subjects will be required to wear their study lenses for a minimum of eight (8) hours on 
an overnight wear basis (and worn every night). 
Note: To maintain the Orthokeratology effect of myopia reduction, overnight lens wear 
must be continued on a prescribed schedule. Failure to do so can affect daily activities 
(e.g., night driving), visual fluctuations and changes in intended correction. 
HANDLING OF LENSES 
When lenses are dispensed, the subject should be provided with appropriate and adequate 
instructions and warnings for lens handling. The Investigator should recommend 
appropriate and adequate procedures for each individual subject in accordance with the 
lens-wearing schedule. 
PATIENT LENS CARE DIRECTIONS 
The study doctor or staff will review the instructions for lens care with each subject. 
To ensure proper disinfecting, all steps listed below must be followed: 

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1. Wash your hands with mild soap. (Caution - pump soaps may contain oil-based 
suspension agents.) 
2. Place lenses in empty lens case and fill to top ridges with fresh Boston SIMPLUS 
Multi-Action Solution. Soak lenses for at least 4 hours before wearing. 
3. Wash hands with mild soap before cleaning (rubbing) lenses. After soaking, 
remove lenses from lens case and rub both sides of the lenses carefully with 4 
drops of Boston SIMPLUS Multi-Action Solution in the palm of your hand for 20 
seconds. 
4. Rinse for approximately 5 seconds with a steady stream of Boston SIMPLUS 
Multi-Action Solution to eliminate loosened surface deposits and insert lenses. 
5. Discard solution from lens case after each use. For lens rewetting and lubrication, 
use Boston® Rewetting Drops. 
If the study doctor recommends a different lens care regimen, appropriate 
instructions will be provided and reviewed with the subject. 
Preparing the Lens for Wearing 
It is essential that you learn and use good hygienic methods in the care and handling of 
your contact lenses. Cleanliness is the first and most important aspect of proper contact 
lens care. Hands should be clean and free of any foreign substances when you handle 
your lenses. 
The procedures are: 
• 
Always wash, rinse and dry hands thoroughly before handling your contact 
lenses. 
• 
Avoid soaps containing cold cream, lotions or oily cosmetics prior to handling 
your lenses. These substances can adhere to the surface of the lens and be difficult 
to remove. 
• 
Handle lenses with the fingertips, avoiding use of fingernails that can scratch or 
chip lenses. 
• 
Always start with the same lens first to avoid mix-ups. 
• 
Remove the lens from its storage case and examine it. Be sure it is clean, moist 
and free of any nicks or cracks. 
Placing the Lens on the Eye 
• 
Prepare the lens for placement by following Step 3 (rubbing) and Step 4 (rinsing) 
in the Patient Lens Care Directions above. 
• 
Place lens on the top of index finger of dominant hand. 
• 
With other hand, hold down lower lid and lift upper lid up. Gently place lens on 
the center of your eye. It is not necessary to press the lens on the eye. 
• 
Gently release lids and blink. The lens should center automatically. 
• 
Use the same technique to insert the other lens. 

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There are other methods of lens placement. If this method proves difficult for you, 
discuss alternatives with your study doctor. 
Note: if vision is blurred after insertion, check for the following conditions: 
• 
Lens is not centered (refer to section below on “Centering a Lens”) 
• 
If lens is centered, remove and check for any of the following: 
− Cosmetics or oil on the lens. Clean, rinse, disinfect and replace on eye. 
− The lens may be on the wrong eye. 
If you find your vision is still blurred after checking the possibilities as listed above, 
remove both lenses and consult your study doctor. 
Centering the Lens 
Very rarely, a lens that is on the cornea will displace onto the white portion (sclera) of the 
eye during lens wear. This can also occur during insertion or removal of your lens if 
proper technique is not utilized. To center a lens, follow one of the procedures below or 
one recommended by your study doctor. 
• 
Close your eyelids and gently massage the lens into place through the closed lids. 
OR 
• 
Gently push the off-centered lens onto the cornea while the eye is open using 
finger pressure on the upper or lower lid next to the edge of the lens. 
Removing the Lens 
Before attempting to remove your lens, it is very important that you verify the lens is 
moving. The lens is designed to be worn overnight and may be slightly stuck in place on 
the eye in the morning. Apply two to three drops of Boston Rewetting Drops to your eyes 
in the morning and wait until the lens begins to move freely with the blink before you 
attempt to remove it. 
It is recommended that you have the following items available when you are ready to 
remove your lenses: 
• 
A lens storage case 
• 
Solution for cleaning and storing your lenses 
• 
A clean towel 
Always remove the same lens first to avoid confusion. Wash, rinse and dry your hands 
thoroughly. 
There are two suggested methods of lens removal: 
TWO FINGER METHOD 
1. Place a towel on the counter to catch the lens. 
2. Place the tip of the forefinger of one hand on the middle of the upper lid margin 
and the forefinger of the other hand on the middle of the lower lid margin. 

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3. Press the lid margin inward and then together. The lens should be wedged out of 
your eye onto your hand or the towel. 
4. The lens may come out but remain on your eyelid or be de-centered onto the 
white part of your eye. If the latter occurs, re-center the lens onto your cornea 
before repeating the removal process. 
BLINK METHOD 
Seat yourself at a table covered with a clean towel and lean over until you are looking 
down at the surface. 
1. Place your index finger at the outer junction of your upper and lower lids; stretch 
the skin outward and slightly upward. Do not allow your lid to slide over the lens. 
2. Blink briskly. The lens will be pinched by the pressure of your eyelids and pop 
out onto the clean surface of the towel, or you may catch the lens in the palm of 
your hand. 
Note: If these methods for removing your lenses are difficult for you, your study doctor 
can provide you with alternatives. 
CARE FOR A STICKING (NON-MOVING) LENS 
If a lens sticks (stops moving/cannot be removed), the subject should be instructed to 
apply one to three drops of Boston Rewetting Drops directly to the eye and wait until the 
lens begins to move freely on the eye before removing it. If non-movement continues 
after 5 minutes, re-instill re-wetting drops and compress the lid margin above or below 
the lens to release the suction. If non­movement persists do not attempt to remove the 
lens but immediately contact the study doctor. 
HOW SUPPLIED 
Primary and backup lenses will be provided individually in a polycarbonate vial 
containing Boston SIMPLUS Multi-Action Solution.  
The label will include the following information: 
• 
Lens power 
• 
Base curve 
• 
Lens diameter 
• 
CT (Center Thickness) 
• 
Eye (R or L) 
• 
Subject identifier (101 004: investigative site 101 and subject 4) 
• 
Lens color (Right lenses are Green, Left lenses are Blue) 
• 
Expiration date (denotes 30 days after lens was packaged for shipment) 
• 
Lot number  
• 
Manufacturer’s name and location 
• 
Investigational Device Caution statement