Insertion Clinical Study to Evaluate the Aberration Characteristics of Kalifilcon A Toric Lenses
Phase: NA
Conditions: Contact Lens Wearer
Sponsor: Bausch & Lomb Incorporated



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SYNOPSIS 
 
Name of Sponsor/Company: Bausch + Lomb Incorporated 
Name of Investigational Product: 
Test Lenses:  kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 
0D, -3D, -6D, and -9D 
Control:  N/A.  
Title of Study: Insertion Clinical Study to Evaluate the Aberration Characteristics of 
kalifilcon A Toric Lenses 
Number of Clinical Centers: One Investigational Site; Bausch + Lomb Incorporated 
Primary Objective: This objective of this clinical study aims to confirm whether 
multiple kalifilcon A daily disposable toric contact lenses are providing the intended 
level of spherical aberration correction when worn. 
Methodology: Approximately 30 subjects per study lens power (more than 30 
subjects total will be enrolled because all subjects won’t wear all of the study lens 
powers) will be enrolled in this single eye, non-randomized, unmasked insertion 
study. All subjects will be seen for a Screening/Dispensing Visit at which informed 
consent will be obtained and eligibility will be assessed. If subjects satisfy all 
eligibility criteria, study lenses will be inserted. 
Number of Subjects Planned: The target is to have 30 subjects complete each study 
lens. The subject’s refractive error will determine which study lenses are to be worn. 
We are anticipating needing to enroll approximately 75 subjects in order to fulfill the 
30 subjects per lens target. The clinical investigation will take approximately 2 
months to complete. 
Diagnosis and Main Criteria for Inclusion: 
To be eligible for entry into the study, the subject must:  
1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and 
have capacity to read, understand and provide written voluntary informed 
consent.   
2. Have physiologically normal anterior segments not exhibiting clinically 
significant biomicroscopy findings.  
3. Have no active ocular disease or allergic conjunctivitis.  
4. Not be using any topical ocular medications.  
5. Be willing and able to follow instructions.  
6. Have signed a statement of informed consent. 
Key Exclusion Criteria: 
The subject is not eligible to participate in the study if the subject is:  
1. Participating in a conflicting study in the opinion of the Investigator.  
2. Considered by the Investigator to not be a suitable candidate for participation.  
3. A women of childbearing potential (those who are not surgically sterilized or 
postmenopausal) are excluded from participation in the investigation if they 
meet any one of the following conditions: she is currently pregnant, she plans to 
become pregnant during the study, she is breastfeeding. 
Investigational Product, Dosage and Mode of Administration:  
The Investigator and subjects will be unmasked and the study lenses will not be 
randomized. Subjects will wear eligible lenses.   

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Study Duration of Treatment: There are a total of 6 study lenses. The number of 
lenses the subject will complete will depend on the subject’s refractive error.  The 
number of lenses subjects are eligible for will determine the number of study visits the 
subject will complete. Each study lens will be worn for approximately 10 minutes. 
Subjects will complete a minimum of 1 study visit and a maximum of 2 study visits.  
Visit 1: Approximately 60 minutes.  
Visit 2: Approximately 60 minutes. 
 
Schedule of Visits: 
  Study Visit 1: 
 Ocular dilation safety precautions (which may include case history, anterior angle 
assessment, slit lamp examination and IOP measurement) will be taken before the 
instillation of dilating drops (Tropicamide 0.5 % or 1% and/or Phenylephrine 
2.5%) in the study eye.  
 When the pupil has dilated to at least 6 mm, three (3) baseline Zywave wavefront 
aberration measurements will be performed on the study eye.  
 A study lens will be inserted onto the study eye (powers should be within +/- 5D 
of subject’s refractive error). 
 Comfort will be evaluated after 3 minutes. 
 The study lens will be evaluated for centration. 
 The study lens toric etch will be evaluated. 
 Three (3) Zywave wavefront aberration measurements will be performed on the 
study eye while wearing the study lens. 
 The study lens will then be removed.   
 This procedure may be repeated on the same eye with additional study lens 
powers depending on the subject’s prescription (powers should be within +/- 5D 
of subject’s refractive error).  
 Additional visits may be required for scheduling purposes.   
Study Endpoints/Criteria for Evaluation:  
Primary Endpoint: 
1. Spherical aberration measurement (Zywave) 
 Secondary Endpoint: 
1. Visibility of Toric Etch Mark by the Investigator 
Statistical Methods: Continuous data will be summarized using descriptive statistics: 
n, mean, standard deviation, median, minimum and maximum. Categorical data will be 
presented by the total counts for each category and corresponding percentages. The data 
for each of the ordinal dependent measures (i.e., those assigned a clinical grade) will be 
analyzed using appropriate nonparametric techniques. 
Sample Size Calculations: Sample size calculations were not performed for this study.  
 
 
 

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TABLE OF CONTENTS 
INVESTIGATIONAL SITE AND STUDY PERSONNEL ..................................................... 2 
SYNOPSIS ................................................................................................................................ 3 
TABLE OF CONTENTS .......................................................................................................... 5 
LIST OF ABBREVIATIONS ................................................................................................... 8 
1.0 INTRODUCTION ............................................................................................................... 9 
2.0 OBJECTIVE ........................................................................................................................ 9 
3.0 STUDY DESIGN ................................................................................................................ 9 
3.1 Description of Study Design ........................................................................................... 9 
3.2 Selection of Study Population ......................................................................................... 9 
3.2.1 Eligibility ................................................................................................................ 10 
3.2.1.1 Inclusion Criteria .............................................................................................. 10 
3.2.1.2 Exclusion Criteria ............................................................................................. 10 
3.2.2 Point of Enrollment and Randomization ................................................................ 10 
3.2.3 Subject Completion ................................................................................................ 10 
3.2.4 Lost to Follow-up ................................................................................................... 11 
3.3 Investigators................................................................................................................... 11 
3.4 Study Duration ............................................................................................................... 11 
3.5 Protocol Changes and Amendments .............................................................................. 11 
4.0 STUDY MATERIALS ...................................................................................................... 11 
4.1 Description of the Test Article(s) (Study Lenses) ......................................................... 12 
4.2 Description of Comparator Product(s) (Control Lenses) .............................................. 12 
4.3 Instructions for Use and Administration ....................................................................... 12 
4.3.1 Storage Requirements ............................................................................................. 12 
4.3.2 Subject Instructions ................................................................................................ 12 
4.4 Other Study Materials .................................................................................................... 12 
4.5 Packaging and Labeling ................................................................................................. 13 
4.6 Accountability ............................................................................................................... 13 
4.7 Masking ......................................................................................................................... 13 
4.8 Product Replacement ..................................................................................................... 13 
4.9 Risk Assessment ............................................................................................................ 13 
4.9.1 Risk Related to Subject........................................................................................... 13 
4.9.2 Risk Related to Data Management ......................................................................... 14 
4.10 Relevance of Clinical Investigation ............................................................................. 14 
5.0 STUDY METHODS ......................................................................................................... 14 

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5.1 Study Visits ................................................................................................................... 14 
5.1.1 Study Visit 1 ........................................................................................................... 14 
5.1.2 Unscheduled Visits ................................................................................................. 15 
5.1.3 Missed Visits .......................................................................................................... 15 
5.1.4 Post-Study Follow-up Visit .................................................................................... 15 
5.2 Study Completion .......................................................................................................... 15 
5.2.1 Study Termination/Suspension ............................................................................... 16 
5.2.2 Study Termination Procedure ................................................................................. 16 
5.3 Concomitant Medications/Therapy ............................................................................... 16 
5.4 Protocol Deviations ....................................................................................................... 16 
6.0 ADVERSE EVENTS ........................................................................................................ 16 
6.1 Adverse Event Definitions............................................................................................. 16 
6.1.1 Adverse Event......................................................................................................... 17 
6.1.2 Serious Adverse Event (SAE) ................................................................................ 17 
6.1.3 Serious Adverse Ocular Event ................................................................................ 17 
6.1.4 Significant, Non-Serious Adverse Event ................................................................ 18 
6.1.5 Non-significant, Non-serious Adverse Event ......................................................... 18 
6.1.6 Adverse Device Effect (ADE) ................................................................................ 18 
6.1.6.1 Anticipated Serious Adverse Device Effect (ASADE) .................................... 19 
6.1.6.2 Unanticipated Serious Adverse Device Effect (USADE) ................................ 19 
6.1.7 Device Deficiency .................................................................................................. 19 
6.2 Adverse Event Treatment and Culturing ....................................................................... 19 
6.3 Adverse Event Identification and Evaluation ................................................................ 20 
6.4 Adverse Event Collection and Reporting ...................................................................... 21 
6.5 Reporting Device Deficiencies ...................................................................................... 22 
6.6 Emergency Contact Details for Reporting Serious Adverse Events and Adverse Device 
Effects .................................................................................................................................. 22 
7.0 STATISTICAL METHODS ............................................................................................. 23 
7.1 Study Endpoints ............................................................................................................. 23 
7.2 Hypotheses..................................................................................................................... 23 
7.3 Sample Size ................................................................................................................... 23 
7.4 Randomization ............................................................................................................... 23 
7.5 Study Populations .......................................................................................................... 23 
7.6 Statistical Analysis ........................................................................................................ 23 
7.6.1 Pass/Fail Criteria..................................................................................................... 23 

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7.6.2 Interim Analyses ..................................................................................................... 23 
7.6.3 Exploratory/Sensitivity Analysis ............................................................................ 23 
7.6.4 Deviations ............................................................................................................... 23 
8.0 DATA QUALITY ASSURANCE .................................................................................... 24 
8.1 Study Monitoring ........................................................................................................... 24 
8.1.1 Monitoring Subject Risk ......................................................................................... 24 
8.1.2 Monitoring Informed Consent Process ................................................................... 24 
8.1.3 Data Verification .................................................................................................... 24 
8.1.3.1 Direct Entry with Verification .......................................................................... 24 
8.1.3.2 Double Entry of Data ........................................................................................ 25 
8.1.3.3 The Data Management Summary (DMS) ......................................................... 25 
8.1.4 Annual Research Clinic Monitoring Plan ............................................................... 25 
8.1.4.1 Monitoring Procedure ....................................................................................... 26 
8.1.4.2 Site Performance Evaluation & Monitoring Report ......................................... 26 
8.2 Auditing Procedures ...................................................................................................... 26 
8.3 Source Documentation .................................................................................................. 26 
8.4 Maintaining Subject Privacy ......................................................................................... 27 
8.5 Locking the Database .................................................................................................... 27 
8.6 Retention of Documents ................................................................................................ 27 
8.7 Clinical Quality Assurance ............................................................................................ 28 
8.8 Institutional Review Board ............................................................................................ 28 
8.9 Statements of Compliance ............................................................................................. 28 
8.10 Informed Consent Process ........................................................................................... 28 
8.10.1 Vulnerable Population .......................................................................................... 29 
8.11 Publication of Results .................................................................................................. 29 
9.0 BIBLIOGRAPHY ............................................................................................................. 29 
APPENDIX A: METHODS OF CLINICAL EVALUATION ............................................... 30 
APPENDIX B: SUBJECT INSTRUCTIONS FOR USE........................................................ 35 
 
 
 

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LIST OF ABBREVIATIONS 
 
Abbreviation/Acronym Term 
AE 
Adverse Event 
B+L 
Bausch + Lomb 
BSCVA 
Best Spectacle-Corrected Visual Acuity 
CFR 
Code of Federal Regulations 
CRT 
Clinical Research Technician  
CRF/e-CRF 
Case Report Form / Electronic Case Report Form 
D 
Diopter 
DOB 
Date of Birth 
EDC 
Electronic Data Capture 
EC 
Ethics Committee 
FDA 
United States Food and Drug Administration 
GCPs 
Good Clinical Practices 
GPRM 
Global Pharmacovigilance and Risk Management 
GPS 
Global Product Surveillance 
GSSP 
Global Safety Surveillance and Pharmacovigilance 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
IOP 
Intraocular Pressure 
ID 
Identification 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
SA 
Spherical Aberration  
US 
United States 
USC 
United States Code 
NOTE:  The first occurrence of some abbreviations is not spelled out in the document (e.g., units of 
measure). 
 
 
 

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1.0 INTRODUCTION 
 
Bausch + Lomb is finalizing the kalifilcon A Daily Disposable Toric LD213001 contact lens 
design. For the development of kalifilcon A daily disposable toric contact lens designs, the 
lenses have anterior and posterior optic zone surfaces that are aspheric, designed to provide 
a controlled level of negative spherical aberration on-eye across the entire power range to 
reduce the natural positive spherical aberration (SA) present in the average eye. The 
specific target for the spherical aberration control of the kalifilcon A toric lenses is to behave 
as a lens containing negative SA, and close to -0.18 µm on-eye. This target aims to reduce the 
population average spherical aberration value of the eye itself of +0.18 µm (+/- 0.05 µm) 
over a 6mm pupil.  
 
2.0 OBJECTIVE 
 
This objective of this clinical study aims to confirm whether kalifilcon A Daily Disposable 
Toric LD213001 contact lenses are providing the intended level of spherical aberration 
correction when worn. 
 
3.0 STUDY DESIGN 
 
3.1 Description of Study Design 
Approximately 30 subjects per study lens power (more than 30 subjects total will be enrolled 
due to the fact that subjects won’t wear all of the study lens powers) will be enrolled in this 
single eye, non-randomized, unmasked insertion study.  All subjects will be seen for a 
Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be 
assessed. If subjects satisfy all eligibility criteria, study lenses will be inserted.  
 
There are a total of 6 study lenses. The number of lenses the subject will complete will 
depend on the subject’s refractive error.  The number of lenses subjects are eligible for will 
determine the number of study visits the subject will complete. Each study lens will be worn 
for approximately 10 minutes. Subjects will complete a minimum of 1 study visit and a 
maximum of 2 study visits.  
 
Visit 1: Approximately 60 minutes.  
Visit 2: Approximately 60 minutes. 
 
The target is to have 30 subjects complete each study lens. The subject’s refractive error will 
determine which study lenses will be worn. We are anticipating the need to enroll 
approximately 75 subjects in order to fulfill the 30 subjects per lens target. The clinical 
investigation will take approximately 2 months to complete. 
 
3.2 Selection of Study Population 
Written informed consent, enrollment in the study, or dispensing of study products 
cannot begin until the Investigator has received Institutional Review Board (IRB)/Ethics 
Committee (EC) approval to conduct the study. 
Recruitment for this study will target soft contact lens adapted subjects per study lens 

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power with no more than 2.50 diopters of refractive astigmatism in either eye. Subjects 
shall have a spectacle spherical correction within +/- 5D in at least one eye that falls 
in the ranges: (+6.00D, +3.00D, 0.00D, -3.00D, -6.00D, -9.00D).  
To reduce the foreseeable factors that could compromise the outcome of the clinical 
investigation, subjects are targeted who are habitual contact lens wearers. To be 
eligible to participate, subjects must have physiologically normal anterior segments 
not exhibiting clinically significant biomicroscopy findings, no active ocular disease 
or allergic conjunctivitis, not using any topical ocular medications and be willing and 
able to follow instructions. 
 
3.2.1 Eligibility 
3.2.1.1 Inclusion Criteria 
To be eligible for entry into the study, the subject must:  
1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have 
capacity to read, understand and provide written voluntary informed consent.   
2. Have physiologically normal anterior segments not exhibiting clinically 
significant biomicroscopy findings.  
3. Have no active ocular disease or allergic conjunctivitis.  
4. Not be using any topical ocular medications.  
5. Be willing and able to follow instructions.  
6. Have signed a statement of informed consent.  
 
3.2.1.2 Exclusion Criteria 
The subject is not eligible to participate in the study if the subject is:  
1. Participating in a conflicting study in the opinion of the Investigator.  
2. Considered by the Investigator to not be a suitable candidate for participation.  
3. A women of childbearing potential (those who are not surgically sterilized or 
postmenopausal) are excluded from participation in the investigation if they meet any 
one of the following conditions: she is currently pregnant, she plans to become 
pregnant during the study, she is breastfeeding. 
 
3.2.2 Point of Enrollment and Randomization 
Both the study subject and investigator will be unmasked. This study will not be randomized.  
 
The subjects will be assigned subject numbers sequentially as they are enrolled. The Clinical 
Research Technician (CRT) is responsible for maintaining study lens inventory and the 
Product Accountability Log. 
 
3.2.3 Subject Completion 
The subject will have completed the study when he/she has worn all eligible study lenses. 
Subjects who require further follow-up due to an ongoing Adverse Event will be followed 
according to the Adverse Event Section 6.0. 
 
The Investigator may discontinue a subject during the study for any reason if, in his or her 
opinion, it is in the best interest of the subject. Reasons for discontinuation include but are not 
limited to:  
• 
adverse effects  

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• 
other ocular complications  
• 
subject non-compliance  
• 
subject request  
• 
subject found to be ineligible during study participation*  
 
Any subject enrolled in the study, who later is found to have not met any of the eligibility 
criteria at entry, will be discontinued at the Sponsor’s request.  
  
Subject discontinuations will be documented clearly on the applicable case report form.   
Subjects that are discontinued from the study following randomization will not be replaced.  
 
Exit visits should be completed for early terminated subjects. 
 
The completion of the clinical investigation shall be deemed to coincide with the last visit of 
the last subject and when follow-up is complete. 
 
3.2.4 Lost to Follow-up 
Subjects who do not return for scheduled follow-up visits, as defined by the visit window and 
cannot be contacted, are to be considered lost to follow-up. All attempts to contact the subject 
should be documented and kept with the subject’s source documentation, and the 
applicable eCRFs will be completed.  
 
3.3 Investigators 
The study will be conducted at one investigative site, the Bausch + Lomb Research Clinic in 
Rochester, NY by Investigators who are employed by Bausch + Lomb. The Investigators are 
qualified by training and experience to conduct this study. All the study procedures will be 
performed by an Optometrist who are licensed to fit contact lenses.  
 
The assessments required for the study are routinely performed by Optometrists and are 
standard of care for contact lens wearers. (See Appendix A: Methods of Clinical Evaluation 
for detailed information about study procedures). 
 
3.4 Study Duration 
The clinical investigation will take approximately 2 months to complete. 
 
3.5 Protocol Changes and Amendments 
Changes to the protocol will be approved by the Sponsor. An amendment to the protocol 
may also require submission and approval from the IRB before implementation. The 
Investigator is responsible for the ensuring that staff involved have completed 
training on the changes before implementing with subjects. 
 
4.0 STUDY MATERIALS 
Bausch + Lomb will provide all study materials. Subjects must use only study supplied 
contact lenses during the study visit 
 
 
 

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4.5 Packaging and Labeling 
The Bausch + Lomb kalifilcon A Daily Disposable Toric LD213001 lens is supplied in a 
polypropylene blister that contains a phosphate buffered saline solution containing potassium 
chloride, poloxamine, poloxamer 181, glycerol (glycerin), erythritol, and polyquaternium. 
The contact lens packaging solution contains known elements in the ophthalmic 
industry and is safe for use. The blisters are sealed with a plastic-coated aluminum foil lid 
stock, with each blister labeled with the manufacturing lot number of the lens, diameter, 
sphere power, cylinder power, cylinder axis, base curve, and expiration date. 
 
4.6 Accountability 
The site is responsible for keeping current and accurate records of the quantity of study lenses 
received and dispensed, and their disposition. The study lenses must be stored under the 
appropriate conditions in a secure area and are to be dispensed only to subjects enrolled in the 
study, in accordance with the conditions specified in this protocol.  
 
All test materials will be accounted for on the Clinical Trial Materials Form and 
Lens/Solution Tracking Form. Subjects must return all study materials to the Investigator or 
designee after study procedures are complete.  
 
4.7 Masking 
The Investigator and subjects will be unmasked to the study lenses. Unmasked study 
personnel will be responsible for dispensing and collecting the study Test lenses and 
accountability.  There is not a randomization schedule for this study.  
 
4.8 Product Replacement 
Not applicable, as subjects will not leave the office with study lenses for this insertion only 
study. 
 
4.9 Risk Assessment 
Information concerning potential risks associated with the investigational device (as well as 
possible interactions with concomitant medical treatments and risk-to-benefit ratio) can be 
found within the Investigator’s Brochure. Risks are also summarized within the Informed 
Consent document. The assessments required for the study are routinely performed and are 
standard of care for contact lens wearers. The subjects will be informed of any potential study 
specific risks in the ICF or if new risks become apparent during the study. 
 
4.9.1 Risk Related to Subject  
With contact lens wear there may be increased risk of corneal edema (swelling of the cornea) 
which may temporarily affect vision or comfort, neovascularization (small blood vessels 
growing into the cornea), giant papillary conjunctivitis (small bumps on the inside of the 
eyelids), iritis (internal inflammation in the eye), corneal infiltrates (corneal inflammation) 
and corneal erosion/abrasion or corneal infection, which if untreated may cause ocular 
problems. 
 
The risks involved in this study will be minimized because the subjects will be examined 
frequently and at specified intervals.  The risks are further minimized by the study eligibility 
criteria.    

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The subject may not personally benefit from being in this study other than getting the 
opportunity to wear different types of contact lenses.  However, study results may allow a 
new or improved product to be marketed in the future giving benefit to other contact lens 
users. 
  
4.9.2 Risk Related to Data Management 
The risks involved in this study related to data management will be minimized because the 
CRT will enter the data directly into the Electronic Data Capture (EDC) system. The Primary 
Investigator or Delegate will visually verify the data as it is entered, except masked 
information when applicable.  If data is not entered directly into the EDC System, the data 
will be double entered.  Then, the two sets of data will be compared to each other and then 
checked for discrepancies.  
  
Risk of data management is further minimized by edit checks built into the EDC system to 
minimize the chance of error.  For example, the EDC system does not allow the same lens to 
be dispensed more than once. Also, the expected ranges of values are specified in the EDC 
system. If data falls outside of the expected range, the CRT will be prompted to answer a 
query. 
 
4.10 Relevance of Clinical Investigation 
Bausch + Lomb is finalizing the kalifilcon A toric lens design. This this clinical study aims to 
confirm whether the kalifilcon A daily disposable toric contact lenses are providing the 
intended level of spherical aberration correction when worn. 
 
5.0 STUDY METHODS 
The clinical procedures in this study are part of normal eye examination. There are not any 
deviations from normal clinical practice. The procedures conducted in the study are outlined 
below and described in Appendix A Methods of Clinical Evaluation. 
 
Following identification of a potential subject, the Investigator (or designee) will explain the 
purpose of the study, procedures, risks/benefits, and subject responsibilities to the potential 
subject. The subject’s willingness and ability to meet the follow-up requirements of the study 
will be determined. If the subject chooses to participate in the investigation, written informed 
consent will be obtained. The subject and the person obtaining written consent will sign and 
date the IRB-approved ICF. The Investigator must keep the signed ICF document. The signed 
original document should be retained in the subject’s records, and a copy should be provided 
to the subject. In addition, the applicable privacy regulation requirements must be met. 
Additional Informed Consent information is provided in Section 8.10. 
 
5.1 Study Visits 
5.1.1 Study Visit 1 
 Ocular dilation safety precautions (which may include case history, anterior angle 
assessment, slit lamp examination and IOP measurement) will be taken before the 
instillation of dilating drops (Tropicamide 0.5 % or 1% and/or Phenylephrine 2.5%) 
in the study eye.  

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 When the pupil has dilated to at least 6 mm, three (3) baseline Zywave wavefront 
aberration measurements will be performed on the study eye.  
 A study lens will be inserted onto the study eye (powers should be within +/- 5D of 
subject’s refractive error). 
 Comfort will be evaluated after 3 minutes. 
 The study lens will be evaluated for centration. 
 The study lens toric etch will be evaluated for visibility by the investigator using the 
slit lamp. 
 Three (3) Zywave wavefront aberration measurements will be performed on the study 
eye while wearing the study lens. 
 The study lens will then be removed.   
 This procedure may be repeated on the same eye with additional study lens powers 
depending on the subject’s refractive error (powers should be within +/- 5D of 
subject’s refractive error).  
 Additional visits may be required for scheduling purposes.   
 Grading scales for the biomicroscopic evaluations and subject assessments are 
according to applicable Research Clinic procedures. See Appendix A.  
 
5.1.2 Unscheduled Visits 
Additional visits may be scheduled, as necessary, to ensure the safety and well-being of 
subjects. All additional exams should be fully documented on Unscheduled Visit eCRFs, as 
appropriate.  
 
5.1.3 Missed Visits 
If a subject misses a Study Visit, the visit is considered missed and the subject must be exited 
from the study. The Investigator or designee must check the missed visit box on the first page 
of the applicable e-CRF for that visit. 
 
See Section 3.2.4 Lost to Follow-Up for applicable instructions for subjects who do not 
return for the final visit. 
 
5.1.4 Post-Study Follow-up Visit 
There is no planned follow-up period after the clinical investigation is complete. If a subject 
requires further follow-up upon discontinuation or completion of the study, the 
Investigator must schedule post-study follow-up visits, as necessary. The Investigator is 
required to follow the subject until the condition no longer warrants further follow-up for 
study purposes. A Post-Study Follow-up Visit e-CRF/CRF must be completed for each of 
these visits. 
 
There will not be any routine eye care provided after the clinical investigation is complete. 
Subjects should follow-up with their eye care provider every 1-2 years for comprehensive eye 
care or sooner as recommended by their eye care provider.   
 
5.2 Study Completion 
The subject will have completed the study when the last eligible study lens is concluded. 
Subjects who require further follow-up will be followed according to the Adverse Event or 
Post- Study Follow-Up Section. There is no planned follow-up period after the clinical 

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investigation is complete. 
 
The completion of the clinical investigation shall be deemed to coincide with the last visit 
of the last subject and when follow-up is complete. 
 
5.2.1 Study Termination/Suspension  
If during the study it becomes evident that the study should be stopped prematurely or placed 
on hold, appropriate notification will be given to the requestor and IRB/ECs, as applicable. 
Should the Investigator and/or study requester wish to terminate the study, the following 
Research Clinic procedure will be followed. Any subjects with ongoing Adverse Events at 
the time of premature study termination or hold will be followed by the Investigator. 
 
5.2.2 Study Termination Procedure 
The decision to terminate a study will be made by the Director of Clinical Affairs and the 
Principal Investigator (PI). A final slit lamp examination should be performed, and adverse 
events handled accordingly. All investigational materials (lenses, solutions, and / or devices) 
will be retrieved, all subjects will be exited, and the Trial Master File will be reconciled.  A 
clinical report will be written and include the reason for study termination.   
 
5.3 Concomitant Medications/Therapy 
Ocular, systemic or topic medications that, in the Investigator’s opinion, could potentially 
affect ocular physiology or lens performance are prohibited. 
 
5.4 Protocol Deviations 
The date of and reason for deviations will be documented in all cases. Significant or 
major protocol deviations impacting the safety of the subject or the integrity of the study 
must be reported by the Investigator to the IRB immediately. Reporting of all other protocol 
deviations must adhere to the requirements of the governing IRB/EC.  
 
Any subject enrolled in the study who later is found to have not met the eligibility criteria 
at entry will be discontinued. Otherwise, unless the protocol deviations put the subject at 
risk or the subject’s condition requires that they be discontinued from the study, subjects 
may continue to participate until the end of the study. 
 
6.0 ADVERSE EVENTS 
Subjects who experience an Adverse Event (AE) during study participation will 
be discontinued from study participation but will be followed by the Investigator until 
resolution of the adverse event or until the Investigator determines that further improvement 
is not expected. 
 
6.1 Adverse Event Definitions 
For the purposes of this study, reportable AEs include ocular AEs and non-ocular serious 
adverse events (SAEs). All AEs will be classified first for seriousness and significance and 
then as to whether or not they are device related or non-device related and if device related, 
then, if it is an adverse device effect (ADE), an anticipated serious adverse device effect 
(ASADEs) or an unanticipated serious adverse device effect (USADEs). AEs, ADEs, 
ASADEs, USADEs, SAEs, Significant Non-Serious AEs and Non-Significant Non- 

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Serious AEs are defined as follows: 
 
6.1.1 Adverse Event  
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects or users, whether or not related to the 
investigational medical device. Adverse events should be categorized as device related or 
non-device related.  
Throughout the course of this study all efforts will be made to remain alert to reportable 
AEs. If an AE occurs, the first concern will be the safety of the subject and appropriate 
medical intervention will be made. 
 
All reportable AEs occurring after signing of informed consent and through the subject’s 
end of participation in the study must be reported. All reportable AEs must be followed 
until the event resolves or stabilizes. 
 
6.1.2 Serious Adverse Event (SAE) 
An adverse event which:  
• Led to death; 
• Led to serious deterioration in the health of the subject, that resulted in: 
o A life-threatening illness or injury; or 
o A permanent impairment of a body structure or a body function (e.g., 
blindness); or  
o Inpatient or prolonged hospitalization; or 
o Medical or surgical intervention to prevent life-threatening illness or  
o Injury or permanent impairment to a body structure or a body function; 
• Led to fetal distress, fetal death, or a congenital abnormality or birth defect 
 
6.1.3 Serious Adverse Ocular Event  
Serious Adverse Ocular Event is a serious adverse event that results in, or has potential to 
cause, either permanent impairment of an ocular function or damage to an ocular structure 
and may necessitate medical or surgical intervention. Serious Adverse Events require 
expedited reporting. Serious adverse events include any hazardous, sight-threatening 
conditions occurring after exposure to a 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, a corneal ulcer which has any of the following 
characteristics should be considered in this category: 
o Central or paracentral location; 
o Penetration of Bowman’s membrane; 
o Infiltrate ≥2 mm diameter; 
o Associated with iritis;  
o Associated with any increase in intraocular pressure; 
o Culture positive for microorganisms; 
o Increasing size or severity at subsequent visits. 
 

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Note: Signs of a presumed infectious ulcer may include irregular focal infiltrates; 
active lesions with raised edges; significant diffuse infiltration; anterior corneal to 
mid-stromal involvement; erosion with overlying staining; conjunctival and lid 
edema; anterior chamber reaction (iritis); severe bulbar and limbal redness. 
Symptoms associated with a presumed infectious ulcer (microbial keratitis) may 
include pain of rapid onset; severe redness; purulent or mucopurulent discharge; 
tearing; photophobia. 
 
• Any central or paracentral (within 6 mm of cornea) corneal event that results in 
permanent opacification (such as corneal scar or vascularization) 
• Any serious adverse ophthalmic events including hypopyon and hyphema. 
• Any neovascularization within the central 6 mm of the cornea. 
• Permanent loss of 2 or more lines (10 letters) of BSCVA. 
• All cases of iritis. 
 
6.1.4 Significant, Non-Serious Adverse Event  
A Significant, Non-Serious Adverse Event is an Adverse Event that does not meet the serious 
criteria, is considered significant, and requires expedited reporting. These events include (but 
are not limited to): 
• Peripheral non-progressive non-infectious corneal ulcer 
• All symptomatic corneal infiltrative events 
• All cases of corneal staining severity greater than or equal to Grade 3 
• A temporary loss of 2 or more lines (10 or more letters) of BSCVA (for greater than 
or equal to 2 weeks) 
• Increase in neovascularization of 1.5mm or greater. 
• Any ocular event that necessitates temporary lens discontinuation of greater than or 
equal to 2 weeks. 
 
6.1.5 Non-significant, Non-serious Adverse Event 
A Non-Significant Non-Serious Adverse Event may include (but are not limited to) and does 
not require expedited reporting: 
• Asymptomatic, peripheral, corneal infiltrative events. 
• Bacterial Conjunctivitis 
• Viral Conjunctivitis 
• Allergic Conjunctivitis 
• Corneal Edema 
• Contact Lens Related Papillary Conjunctivitis 
 
6.1.6 Adverse Device Effect (ADE) 
An ADE is an Adverse Event that is assessed to be related to the use of an investigational 
medical device. This definition includes Adverse Events resulting from insufficient or 
inadequate instructions for use; deployment, implantation, installation, or operation; or any 
malfunction of the investigational medical device. This definition also includes any event 
resulting from use error or from intentional misuse of the investigational medical device. 
 

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6.1.6.1 Anticipated Serious Adverse Device Effect (ASADE)  
An ASADE is an ADE that first meets the serious criteria (see definition above for Serious 
Adverse Event) or significant, non-serious criteria (see above definition for significant, non-
serious AE) and which, by its nature, incidence, severity or outcome, has been previously 
identified in the investigational plan or application (including a supplementary plan or 
application) and/or in the risk analysis report. ASADEs include: 
• Corneal Ulcer (infectious or non-infectious) 
• Keratitis 
• Sensitivity to light (photophobia) 
• Excessive eye secretions including mucopurulent discharge 
• Blurred vision, rainbows or halos around objects 
• Poor visual acuity (reduced sharpness of vision) 
• Moderate to severe eye pain not relieved by removing the lens 
 
6.1.6.2 Unanticipated Serious Adverse Device Effect (USADE) 
An USADE is an ADE that first meets the serious criteria (see definition above for Serious 
Adverse Event) or significant, non-serious criteria (see above definition for significant, non-
serious AE) and has an effect on health or safety or any life-threatening problem or death 
caused by, or associated with, a device if that effect, problem or death was not previously 
identified in nature, severity or degree of incidence in the investigational plan or application 
(including a supplementary plan or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects. 
 
6.1.7 Device Deficiency 
Inadequacy of an investigational medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. This includes malfunctions, use errors, 
inadequate labelling, insufficient or inadequate instructions for use. A Device Deficiency can 
occur with or without the occurrence of an Adverse Event. 
 
6.2 Adverse Event Treatment and Culturing 
With any Adverse Event, treat the subject as appropriate to prevent further complications and 
to potentially resolve the event consistent with the standard of care. 
 
A culture should be obtained in cases of corneal ulcer or suspected  ocular infection, unless 
medically contraindicated. Cultures should be taken from the cul-de-sac, lower eyelid 
margin, and the corneal lesion (if applicable). When a culture is obtained, the contact lenses 
and contact lens cases which were being utilized by the subject at the time of the AE should 
be collected from the subject (if available at the time of the culture) for culturing and 
processing by the clinical laboratory designated by the Research Clinic. Microbial data 
generated from returned subject supplies (e.g., lenses, lens cases and/or lens case solutions) 
are for  information only. Because microbes may be introduced into subject supplies during 
use, recovery of microbes from returned subject supplies cannot be presumed to indicate 
etiology or direction of organism transmission. The ocular cultures, along with the associated 
contact lenses and contact lens cases, will be sent to the clinical laboratory designated by the 
Research Clinic for analysis. The clinical laboratory will report the culture results to both the 
Investigator and to the Research Clinic, the Investigator will record the results in the CRF. 

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6.3 Adverse Event Identification and Evaluation  
Throughout the course of a study all efforts will be made to remain alert to Adverse Events 
(AEs). If an AE occurs, the first concern will be the safety of the subject and appropriate 
medical intervention will be made. The associated product should be retained for further 
analysis, if needed. 
 
All AEs occurring after signing the informed consent and through the end of the subject’s 
participation in the study must be recorded and reported, if applicable. All AEs must be 
followed until the event resolves or stabilizes.  
 
Identify potential adverse events during a clinical study by using the following sources: 
• 
Direct observation by the Investigator 
• 
Asking the study participant using a non-specific question (i.e. Have you had any 
problems since the last visit?) 
• 
Unsolicited volunteering of information by the study participant (i.e. Doctor, I have 
had numerous headaches since I started using this lens) 
• 
Laboratory or test results that meet protocol requirements for classification as an 
adverse event (i.e. IOP over 30mmHg) 
When evaluating AEs, the Investigator should classify the AE based on the following three 
criteria: Seriousness and/or significance (based on the criteria provided in Section 6.1)  
 
1. Severity: 
• Mild: Subject awareness of a sign or symptom that is easily tolerated, requires no 
treatment, and does not interfere with subject’s daily activities. 
 
• Moderate: Subject awareness of a sign or symptom which may be a low level of 
concern to the subject and may interfere with daily activities but can be relieved by 
simple therapeutic care. 
 
• Severe: A sign or symptom that interrupts the subject’s daily activity and requires 
systemic therapy or other treatment. 
 
2. The relationship of the event to the study device using the following guidelines   
• Related: There is at least a reasonable possibility that the AE is related to the study 
device (contact lens) and/or solution or rewetting drops. Reasonable possibility means 
that there is evidence to suggest a causal relationship or association between the study 
device and/or solution or rewetting drops and the AE. Also referred to as an ADE.  
• Not Related: There is little or no reasonable possibility that the AE is related to the 
study device (contact lens) and/or solution or rewetting drops. This assessment 
implies that the AE has no evidence to suggest either a causal relationship or 
association to the study device and/or solution or rewetting drops and a more likely or 
certain alternative etiology exists.  
 
3. Expectedness of the event  

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• Unexpected Adverse Event (UAE):  Unexpected Adverse Events must be reported 
to the IRB within 10 calendar days of discovery. 
• Expected Adverse Event: An adverse event of which, the nature or severity of which 
is consistent with the current product labeling, investigator brochure, data sheet, etc. 
 
6.4 Adverse Event Collection and Reporting 
• The Research Clinic will delegate each function’s roles and responsibilities related to 
adverse event reporting. The Director of Clinical Affairs is responsible for ensuring 
that all Research Clinic Staff understand their responsibilities for collecting and 
assessing adverse event information and forwarding applicable adverse event 
information to the appropriate business function. 
• Research Clinic Staff are responsible for understanding the procedures for adverse 
event collection, evaluation, documentation, and reporting. 
• Collect and record information about any identified adverse event (including the date 
of the adverse event, treatment, resolution, assessment of both the seriousness and the 
relationship to the investigational device and the related procedure) on the Adverse 
Event form. The Adverse Event Form will be completed each time the subject is seen 
during the management of the incident and at resolution of the incident.  
• If an adverse event is determined to be serious or significant and non-serious, notify 
the Principal Investigator immediately. 
• Report all serious or significant and non-serious adverse events within twenty-four 
(24) hours to Regulatory Affairs, Global Product Surveillance and/or Global Safety 
Surveillance and Pharmacovigilance as appropriate for the product being evaluated. 
Continue to send follow-up information or provide support to the appropriate 
reporting business function for any serious adverse event as soon as it becomes 
available. 
• Ensure that the subject’s identity is protected and the subject’s identifiers in the study 
are properly documented on the form.  
 
• Report all unexpected adverse device effects to the reviewing Institutional Review 
Board within 10 business days of discovery.  Continue to send follow-up information 
as soon as it becomes available. 
• Report any adverse event resulting from Intentional Misuse of an investigational 
medical device per the same procedures as above.  
• Report any adverse event resulting from a Device Deficiency per the same procedures 
as above. All Device Deficiencies should be recorded and evaluated for the potential 
to cause a serious adverse event.  
 
• All appropriate measures will be taken to ensure the safety of the subject. Follow the 
subject until the adverse event resolves or until an appropriate endpoint is reached. 
This may imply that follow-up will continue after the subject has left the study.  
• A treatment of an AE will depend on the severity of the adverse event. The Principal 
Investigator will refer the subject to a suitably licensed eye  care professional for 
immediate treatment if necessary. 
• Expenses incurred for study-related medical treatment will be paid by Bausch + 
Lomb. Research Clinic Staff will contact Environmental Health and Safety to initiate 
the medical payment claims process. 
• If it is determined, based on evaluation of any serious adverse event or serious 

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adverse event trending, that the study presents an unreasonable risk, the Research 
Clinic may choose to terminate the study. Refer to the applicable SOP: Study 
Termination (RCD-103) for study termination procedures for additional information 
and relevant periods for terminating a study.  
• All adverse events will be documented in the final study report. Adverse Event 
documentation must be saved in the Trial Master File and in the respective study 
folder in the electronic repository. 
 
6.5 Reporting Device Deficiencies  
• Report to Global Pharmacovigilance and Risk Management (GPRM) and Design 
Quality within 24 Hours. 
• All device deficiencies must be evaluated by the Investigator, and then evaluated by 
GPRM and Design Quality. 
• The Principal Investigator (PI) will record, evaluate, and report via applicable forms 
any complaints/deficiencies or malfunctions experienced with the study devices using 
the Device Deficiency form and when applicable, AE form (if AE has occurred). The 
PI will evaluate the Device Deficiency and record whether an AE occurred related to 
the device deficiency and also determine the potential of the device deficiency to 
cause a serious adverse device effect (SADE). The device deficiency form is then sent 
to GPRM to evaluate as the Sponsor, their independent determination if the device 
deficiency led to or could have led to a SADE.  See ISO 14155:2020 for resolving any 
discrepancies between the interpretation by the PI and Sponsor on whether the device 
deficiency could have led to SADE.  
• If there was an Adverse Event that occurred as well as the device deficiency, then it 
should be reported as both an Adverse Event and a Device Deficiency (both forms 
should be completed). 
• If the Device Deficiency is unrelated to an Adverse Event, then just the Device 
Deficiency should be reported on the Device Deficiency form. 
• Additionally, the Device Deficiency form will be sent to Bausch + Lomb Design 
Quality to evaluate whether any updates to Design Records need to be made. 
 
6.6 Emergency Contact Details for Reporting Serious Adverse Events and Adverse 
Device Effects 
Jeffery Schafer, OD, MS 
Clinical Research Fellow 
Bausch + Lomb Incorporated  
1400 North Goodman Street Rochester, NY 14609 
Tel: 585 338 5664 
Cell:  585 754 4680 (24 Hours) 
Email: Jeffery.Schafer@bausch.com 
 
 
 
 
 
 
 

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7.0 STATISTICAL METHODS 
 
7.1 Study Endpoints 
Primary Endpoint: 
1. Spherical aberration measurement (Zywave) 
Secondary Endpoint:  
1. Visibility of toric etch mark by the investigator.  
 
7.2 Hypotheses 
No statistical hypotheses were performed for this study. 
 
7.3 Sample Size 
Sample size calculations were not performed for this study. 
 
7.4 Randomization 
This will be an unmasked study.  
 
7.5 Study Populations 
Subjects will be included in all summaries under the treatment that they actually 
received. Analyses of safety data will include all dispensed subjects. All other summaries 
will include all eligible, completed subjects. 
7.6 Statistical Analysis 
Continuous data will be summarized using descriptive statistics: n, mean, standard deviation, 
median, minimum and maximum. Categorical data will be presented by the total counts for 
each category and corresponding percentages. The data for each of the ordinal dependent 
measures (i.e., those assigned a clinical grade) will be analyzed using appropriate nonparametric 
techniques.  
 
7.6.1 Pass/Fail Criteria 
There are no pass/fail criteria for the results of the clinical investigation. 
 
7.6.2 Interim Analyses 
No interim analyses are planned. 
 
7.6.3 Exploratory/Sensitivity Analysis 
There are no planned exploratory or sensitivity analyses for this study. 
 
7.6.4 Deviations 
Any deviations from the original statistical analysis plan will be summarized in the Clinical 
Study Report.  
 
 
 
 
 
 

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8.0 DATA QUALITY ASSURANCE 
Prior to the start of the study, member(s) of the Research Clinic and Investigators will review 
the protocol, e-CRFs, regulatory obligations, and other material or equipment relevant to the 
conduct of the study. 
During the study, if it is determined that an Investigator is not compliant with the protocol 
and/or applicable regulatory requirements, action will be taken to secure compliance. In 
addition, the Investigator’s participation in the study may be terminated if appropriate, or if 
the Investigator remains non-compliant. 
 
8.1 Study Monitoring 
The monitoring plan for this study includes Informed Consent and Data Verification.  
 
8.1.1 Monitoring Subject Risk  
The risks involved with contact lens wear in this study will be minimized because the 
subjects will be examined frequently and at specified intervals.  The risks are further 
minimized by the study eligibility criteria.  The subject population will be restricted to 
persons who are 18 years of age or older and have full legal capacity to volunteer; no 
restrictions are made as to gender. 
 
8.1.2 Monitoring Informed Consent Process  
Informed consent forms are verified for all subjects enrolled in each study.  Subject and 
witness signature and date are visually verified by the CRT and then confirmed in the EDC 
System at the time of enrollment. Informed Consent Form signatures are also verified during 
study reconciliation by CRT. The signed informed consent forms are kept in the study folder. 
 
8.1.3 Data Verification 
Edit checks are built into the EDC System to minimize the chance of error.  For example, the 
EDC System does not allow the same lens to be dispensed more than once. The expected 
ranges of values are specified in the EDC System. If data falls outside of the expected range, 
the CRT will be prompted to answer a query. 
  
Data is collected by the CRT or Delegate using either Direct Entry with Verification or 
Double Data Entry.   
 
8.1.3.1 Direct Entry with Verification  
Direct Entry with Verification is the preferred method for entering study data. Data is 
collected by the CRT or Delegate and entered directly into the EDC System.  A second 
person, typically the Primary Investigator (or Delegate), will visually verify the data as it is 
entered, except masked information when applicable. 
• In the event that the EDC System is unavailable, a paper CRF will be used to collect 
study data for later entry into the EDC System. After each page of the CRF is entered 
into the EDC System, the CRT or Delegate will initial the CRF to indicate the data 
has been entered into the EDC System and visually verified. 
• Randomization Verification is required at the conclusion of each study prior to data 
distribution. The CRT or Delegate will verify each dispensed article against the study 
randomization and Clinical Trial Material (CTM) label, if applicable. After 

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Randomization Verification of dispensed article, the CRT or Delegate will mark the 
Verification checkbox in the EDC System to acknowledge completion of dispensed 
article verification. 
• If discrepancies arise during the verification of a paper source, the CRT or Delegate 
assesses the discrepancy and obtains additional information to determine if the correct 
entry was made or corrects paper source as appropriate. The CRT or Delegate may 
consult the Primary Investigator if necessary. 
• The data is extracted from the EDC System and checked for accuracy by comparing 
the extracted data to the data originally recorded in the EDC System. The data extract 
is checked to confirm the lens reformat codes match the lens key. Calculations 
performed by the EDC System are checked for accuracy. 
• Database Randomization Verification is performed, if applicable, prior to data 
distribution. 
 
8.1.3.2 Double Entry of Data  
If data is not entered directly in the EDC system, the data will be double entered (entered 
twice) and the two sets of data will be compared to each other and then checked for 
discrepancies.  
  
When a paper source (i.e. subject questionnaire) is used to collect study data, this method 
may be used.  For example, a subject questionnaire will be entered into two different 
spreadsheets.  The two spreadsheets are then compared to each other. 
• If discrepancies arise during the verification of a paper source, the CRT or Delegate 
assesses the discrepancy and obtains additional information to determine if the correct 
entry was made or corrects the paper source as appropriate. The CRT or Delegate may 
consult the Primary Investigator if necessary. 
• After the study data from the paper source is entered, each CRT or Delegate entering 
the data will initial the paper source  to indicate that the data has been entered into the 
EDC System visually verified, and dispensed articles verified against study 
randomization, prior to data distribution. 
• The data is extracted from the EDC System and checked for data accuracy and 
necessary calculations are performed. 
 
8.1.3.3 The Data Management Summary (DMS)  
A Data Management Summary is created after all data has been verified. 
 
8.1.4 Annual Research Clinic Monitoring Plan 
On a yearly basis, unless otherwise specified, a qualified internal or external Clinical Monitor 
will audit a random sample of approximately 10% or a minimum of 5 of the IRB/IEC 
approved and conducted trials from the previous year. The selected trials should be 
representative of the Primary Investigators and Clinical Research Technicians that have 
worked on trials that year.  
  
The Monitor will ensure that subject protection/privacy was adhered to, all eligibility criteria 
were met and that all study procedures and the reporting of adverse events were performed 
according to the IRB/IEC approved protocols and that Clinical Trial Material was 
appropriately managed and reconciled. 

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8.1.4.1 Monitoring Procedure 
1. Review 10% of the subjects for the trials selected. When reviewing the 10% of 
selected subjects, if greater than 25% discrepancies are found on study and safety 
endpoints then data from all subjects for the selected trials will be reviewed. Informed 
Consent Forms are checked for all subjects enrolled in each study. If applicable, 
Adverse Events (AEs) and/or medical treatment events are reviewed for all subjects 
enrolled in each study. 
a. Verify 100% of the CRF fields for all subjects to the available source 
documentation for primary variables, visual acuity and slit lamp exam. 
b. Review source documents (if applicable) for AEs and/or medical treatment 
events. If any safety events have occurred, review safety event documentation 
to ensure that all events have been reported to Sponsor and/or IRB/IEC and 
that supporting documentation is consistent (i.e., source, Adverse Event (AE) 
form, medical treatments, etc.). If an unreported safety event is discovered, 
notify the Principal Investigator. 
c. Review all test product/IP randomization assignment, dispensing and the 
Clinical Trial Material Tracking Document entries to ensure proper 
randomization, dispensing and return of IP and accuracy of the data, if 
applicable. 
2. RC Regulatory Binder and IRB/IEC approval documentation will be reviewed. 
3. Relevant documentation will be completed.  
 
8.1.4.2 Site Performance Evaluation & Monitoring Report  
The Monitor should complete the appropriate Site Performance Evaluation & Monitoring 
Report within ten business days of the site visit and forward an electronic copy of the 
completed draft report to the Research Clinic Director (RCD) or Delegate for review. 
 
8.2 Auditing Procedures 
Audits of clinical research activities in accordance with Bausch + Lomb’s internal Standard 
Operating Procedures to evaluate compliance with the principles of GCP may take place. A 
regulatory authority may also wish to conduct an inspection (during the study or after its 
completion).  
8.3 Source Documentation 
Source documentation consists of original subject documents, as well as data and records 
with information relevant to the subject and his/her participation in the study.  The data 
collected in the e-CRFs at all the visits will be available to the Investigator after the 
conclusion of the trial.   
Examples of source documents include: hospital records, clinical and  office charts, 
laboratory notes, memoranda, signed ICF, evaluation checklists, recorded data from 
automated instruments, copies or transcriptions certified after verification as being accurate 
copies, and information initially recorded in an electronic format.  
 
Subject completed forms are also considered to be source data, if applicable to the study. The 
Investigator or designee should review subject completed forms for completeness and 

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accuracy. 
 
8.4 Maintaining Subject Privacy 
Subjects’ participation in this study and their study records (including photographs and 
video/audiotapes) will be held in a way that will protect their privacy, except when ordered 
by law.  It may be necessary for other people to review their records for study reasons.  These 
people may include:   
  
• 
The Investigator  
• The United States Food and Drug Administration (FDA)  
• Other state or federal regulatory agencies  
• The Institutional Review Board (IRB)  
• Contracted monitors or auditors  
• Bausch + Lomb personnel associated with the study analysis and reporting  
 
If this occurs, their identity will be protected as legally required.  If results of the study are 
published, subjects will not be identified by name.   
  
The Institutional Review Board (IRB) and accrediting agencies may inspect and copy 
subjects’ records, which may have the subjects’ name on them.  Therefore, total 
confidentiality cannot be guaranteed.  If the study results are presented at meetings or printed 
in publications, subject names will not be used.  
 
Data pertaining to subjects is only available to Bausch + Lomb personnel.  Physical data 
remains locked and electronic data is password protected. When subjects receive an 
electronic recruitment invitation, all other potential subjects are blind carbon copied on the 
invitation to ensure patient privacy.  
 
Clinical trial data is input into a secure, electronic data capture system in which only relevant 
study personnel have access. Subject data recorded on CRF/e-CRFs during the study will be 
documented in a coded fashion. The subject will only be identified by the subject number. 
Confidentiality of subject records must be maintained to ensure subject privacy.  
 
8.5 Locking the Database 
After the study is complete, the data is approved by the Principal Investigator via electronic 
signature. The database is then locked. Any change to the data after database lock will require 
approval from the EDC Programmer and is documented via electronic audit trail. 
 
8.6 Retention of Documents 
Bausch + Lomb will retain essential documents indefinitely after the completion of the 
study. The Research Clinic keeps physical study related documents physically on-site for a 
minimum of 3 years. After 3 years, the documents may be securely stored in an off- site 
location. Additionally, data is securely stored electronically.  
 
Essential documents include but are not limited to the following: 
• 
IRB approvals for the study protocol, all amendments, ICF(s), and advertisements 
• 
IRB correspondence and reports (e.g., AE reports, protocol deviations, and safety 
updates) 

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• 
regulatory documents  
• 
subject’s signed ICF 
• 
accountability records for the test article(s) 
• 
any other documents relevant to the conduct of the study  
 
8.7 Clinical Quality Assurance 
Prior to being evaluated clinically, investigational devices such as contact lenses or solutions 
are analyzed and approved for release by the project manager and design quality at Bausch 
and Lomb, Rochester, NY.   Documentation of pre-clinical testing can be found on the 
study’s clinical scorecard for the relevant products.  
 
8.8 Institutional Review Board 
The Investigator should ensure their participation in the study, in addition to the protocol, 
subject recruitment materials and the ICF to be used in this study are approved by the 
reviewing IRB prior to entering any subjects in the study. In addition, the Investigator must 
ensure that the reviewing IRB has provided approval for any protocol amendments prior to 
implementation. If the amendment necessitates a revision to the ICF, the Investigator should 
ensure the revised form is also submitted to and approved by the IRB and implemented as 
directed. 
 
8.9 Statements of Compliance 
This study is being conducted in accordance with 21CFR Parts 11, 50, 54, 56 and 812; 42 
USC 282(j); ISO 14155:2020 Clinical investigation of medical devices for human subjects - 
Good Clinical Practice; International Council for Harmonization (ICH) Good Clinical 
Practice (GCP) - Declaration of Helsinki and applicable local regulations.  
 
This clinical investigation will demonstrate compliance with this document. 
The clinical investigation shall not begin until the required approval from the IRB has been 
obtained. Any additional requirements imposed by the IRB shall be followed. 
No insurance will be provided to the subjects.  
Bausch + Lomb is financing this clinical investigation. The investigators are paid employees 
of Bausch + Lomb.  
 
8.10 Informed Consent Process 
All subjects will be given a copy of the Informed Consent Form (ICF) to read prior to 
enrollment.  Subjects will have an opportunity to ask questions prior to enrollment and 
throughout the study. The ICF also contains information on payment for participating in the 
study.  All subjects will need to sign the ICF prior to participation in the study. The person 
obtaining informed consent will also sign and date the form.  The subject’s signed informed 
consent must be obtained before conducting any study related procedures. The original will 
be retained by the investigative site. A copy of the signed ICF will be given to the subject. If 
modifications are made to the ICF, the new version must be approved by the IRB. The new 
version of revised ICF(s) must be reviewed and signed by all active (if required by the IRB) 
and new subjects at the first opportunity after approval by the IRB. 
 

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For this study, subjects will have the capacity to provide written voluntary informed consent 
Emergency treatment is not applicable. No minors or those who cannot speak English or read 
or write will be recruited for this study. 
8.10.1 Vulnerable Population 
The subject population recruited for this clinical investigation could be considered vulnerable 
due to subjects being employees of Bausch + Lomb.   
 
Employees volunteer to participate in the Research Clinic.  Based on the individual study 
inclusion and exclusion criteria, employees are notified of potential eligibility and asked to 
respond if they are interested in participation. Participation is completely voluntary.  
All subjects will be given a copy of the Informed Consent Form (ICF) to read and will also 
have an opportunity to ask questions to the Investigator or designee prior to enrollment. All 
subjects will need to sign the Informed Consent Form prior to participation in the study.  
The Informed Consent form addresses voluntary participation and the decision to participate 
or not will not affect your performance evaluation, possible promotion, or pay.  
After the study is complete, there is no planned/routine medical follow-up care. 
 
8.11 Publication of Results 
All study data generated as a result of this study will be regarded as confidential, until 
appropriate analysis and review by Bausch + Lomb or its designee and the Investigator(s) are 
completed. The results of the study may be published or presented by Bausch + Lomb.  
 
9.0 BIBLIOGRAPHY  
 
There are no references for this study.  

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APPENDIX A: METHODS OF CLINICAL EVALUATION 
Maintenance and calibration of the equipment relevant to study assessments must be 
appropriately performed and documented by the investigative site, where applicable. Any 
changes to the procedures described in this appendix will be provided under separate cover. 
 
1.0 SLIT LAMP EXAMINATION 
 
1.1 Anterior Chamber Angle Assessment 
The Intraocular Pressure (IOP) and the Anterior Chamber angle will be evaluated prior to 
instilling dilating drops. These tests serve to rule out the risk of angle closure due to the 
mydriatic effect of the cycloplegic agents. If the anterior chamber angle is estimated to be 
¼:1 or less using Van Herick angle estimation, dilation will not be performed.   
 
1.2 Estimating the Depth of the Anterior Chamber Angle (Van Herick Technique) 
1. Align patient at the slit lamp/primary gaze 
2. Slit Lamp Set-up 
a. Position illumination arm temporally 
b. Set magnification to medium 
c. Beam- Optic Section 
3. Focus the optic section sharply on the temporal limbus (temporal edge of cornea) 
4. Compare the width of the corneal section to the width of the shadow adjacent to it. 
5. Record observation in EDC using scale below: 
1:1 – Open angle, VH Grade 4 
1:1/2 – Open angle, VH Grade 3 
1:1/4 – Angle closure possible, VH Grade 2 
1: <1/4 – Angle closure likely, VH Grade 1 
 
1.3 Grading Contact Lens Centration 
1.3.1 Qualitative Lens Centration 
• Compare lens edge overlap of limbus in all visible sectors. 
• If the limbus is an ill-defined band, assess from the center of the band. 
• If the contact lens edge translates with blinking, assess to the average lens edge 
position. 
• Centration assessment applies to primary gaze. 
• If the inferior edge of the contact lens is not visible, gently pull the lower eyelid away. 
 
• Rate and record lens centration on a scale of 0 to 3 based on the following lens 
diagrams and descriptors: 
1) Equal Overlap 360 degrees 
2) Maximum overlap ≤ 2/3 in any sector 
3) Maximum overlap > 2/3 in any sector 
4) Any Corneal Exposure 
 
1.3.2 Quantitative Lens Centration 
• Lens to limbus overlap is the distance from the limbus to the lens edge. 
• Measure the distance in millimeters (mm) in primary gaze using a slit lamp eyepiece 

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reticule. 
• Measure the lens-limbus overlap in the temporal, nasal and inferior directions. 
• If the limbus is an ill-defined band, assess from the center of the band. 
• If the contact lens edge translates with blinking, assess to the average lens edge 
position. 
• Centration assessment applies to primary gaze. 
• If the inferior edge of the contact lens is not visible, gently pull the lower eyelid away. 
• Rate and record lens centration measurements in millimeters (mm). 
o A positive value indicates corneal coverage. 
o A negative value indicates corneal exposure. 
 
1.4 Grading Movement 
1.4.1 Quantitative Lens Movement 
• Vertical lens movement is measured in millimeters (mm) in straight-ahead gaze using 
a slit lamp eyepiece reticule. 
• Lens movement is measured from the most inferior point where the lens habitually 
rests following a blink, to the most superior point of the excursion 
• Movement is measured immediately following a blink. 
• If the inferior edge of the contact lens is not visible, gently pull the lower eyelid away. 
• Rate and record measurements in millimeters (mm). 
 
2.0 INTRAOCULAR PRESSURE (IOP) MEASUREMENT 
IOP will be measured with an IOP measuring device prior to instilling dilating drops.   
 
2.1 IOP Measurement with iCare 
1. With patient looking straight ahead and chin level, bring tonometer near eye.  
2. Keep device/probe in horizontal position. Probe should be perpendicular to the 
cornea. 
3. Make adjustment to the forehead rest as necessary. 
4. Take measurement 
5. Record the final IOP in EDC. 
2.2 IOP Measurement with Non-contact Tonometer (Hand-Held) 
1. Position patient looking straight ahead, chin level, back of head supported 
2. Look though the eyepiece and slowly move closer to patient.  
3. When aligned, instrument will automatically measure. 
4. Record measurement in EDC. 
 
 
 
 
 
 

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4.0 SUBJECTIVE ASSESSMENT RATING SCALES 
Subjective Assessment Rating Scales used for collecting subjective data for clinical studies.  
4.1 Subjective Assessment Rating Scales 
Subjects will be asked to rate subjective judgements associated with the use of contact lenses, 
solutions or drops utilizing Subjective Assessment Rating Scales.  
Subjects will be provided with a specific Rating Scale and the optometrist or the technician 
will ask them to provide their rating for the attribute the Rating Scale is referencing.  
Each Rating Scale ranges from 0 (very unfavorable) to 100 (very favorable) with descriptors 
at increments of 20 for the subject to reference. 
 
 
 

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5.0 Spherical Aberration Measurement using Zywave  
 
1. Zywave Set-up 
a. Enter subject information  
b. Position subject at instrument properly and dim lights 
c. Have subject fixate on target 
2. Zywave Measurements: Refractive Error and Wavefront 
a. Center and focus images 
b. Instruct subject to blink and keep eyes open 
c. Acquire image 
d. Instruct subject to blink and keep eyes open 
e. Acquire image 
f. Save files 
g. Export to excel spreadsheet 
 
 

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APPENDIX B: SUBJECT INSTRUCTIONS FOR USE 
 
Bausch + Lomb Daily Disposable Contact Lenses 
 
CAUTION: Investigational device. Limited by Federal (U.S.A.) Law to investigational use only. 
 
INTRODUCTION 
 
As a participant in this study, you will be assigned to wear the Test lenses based on your 
spectacle prescription (refractive error) for approximately 10 minutes per lens. 
 
Do not discuss or describe the study or the study materials with anyone except the person who 
gave you the study materials at the Screening/Dispensing Visit.  
 
STUDY PRODUCT INFORMATION 
 
 
Study Contact Lenses- You will be provided with test lenses to wear in one eye based on your 
spectacle prescription (refractive error). 
 
Study Solution-There is no solution for this study. 
 
Study Lens Case- There will not be a contact lens storage case provided for this study.  
 
Other study supplies- There will not be any other study supplies or rewetting drop for this 
study. 
 
Do not use any other contact lenses, eye drops or lens care products than those listed above 
during the study visits. 
 
All lenses, used and unused, must be returned.  
 
If you have questions or problems, call: 
Jeffery Schafer, OD, MS 
Bausch + Lomb Incorporated  
1400 North Goodman Street  
Rochester, NY 14609 
Cell: 585 754 4680 (24 Hours) 
 
If you require a medical referral for any eye problems experienced during the study, please refer 
to your informed consent form. 
 
GENERAL INFORMATION 
 
Please keep all appointments and follow the instructions thoroughly. Remember to wear your 
glasses to your appointment(s).   
 

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

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

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

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

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

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4. Centering the Lens 
Very rarely, a lens that is on the cornea will be displaced onto the white part of the eye 
during lens wear. This can also occur during placement and removal of the lenses if the 
correct techniques are not performed properly. To center a lens, follow one of the 
procedures below.  
• Hold the upper and lower eyelids open with your fingers. Then while looking in a 
mirror, gently place a finger on the contact lens and gently slide the lens towards the 
center of the eye.  
OR 
• Hold the upper and lower eyelids open with your fingers. Then, while looking in a 
mirror, move your eye towards the lens to place it on the center of the eye.  
 
5. Removing the Lens 
• Always remove the same lens first.  
• Wash, rinse, and dry your hands thoroughly.  
• Always be sure that the lens is in the correct position on your eye before you try to 
remove it (a simple check of your vision, closing one eye at a time, will tell you if the 
lens is in the correct position). Look up and slowly pull down your lower eyelid with 
the middle finger of your removal hand and place your index finger on the lower edge 
of lens. Squeeze the lens lightly between the thumb and the index finger and remove 
it. Avoid sticking the edges of the lens together. 
• Remove the other lens by following the same procedure. 
• Follow the required lens care procedures described by your eye care professional. 

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• NOTE: If this method of removing your lens is difficult for you, your eye care 
professional will provide you with an alternate method. 
 
6. Return of Your Study Lenses 
At each visit, you must return all used and unused study materials that were dispensed to 
you during the designated wear periods.  
 
7. Emergency: 
If chemicals of any kind (household products, gardening solutions, laboratory chemicals, 
etc.) are splashed into your eyes, you should: FLUSH EYES IMMEDIATELY WITH 
TAP WATER AND THEN REMOVE LENSES PROMPTLY. CONTACT YOUR EYE 
CARE PROFESSIONAL OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT 
DELAY.