Orientation Characteristics of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Commercially Available Daily Disposable Toric Contact Lenses
Phase: NA
Conditions: Astigmatism
Sponsor: Bausch & Lomb Incorporated

ROC2-23-007: Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses Compared 
to Commercially Available Daily Disposable Toric Contact Lenses 
 
 
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Orientation Characteristics of kalifilcon A Daily Disposable Toric Contact Lenses 
Compared to Commercially Available Daily Disposable Toric Contact Lenses 
 
 
CLINICAL INVESTIGATIONAL PLAN 
STUDY: ROC2-23-007 
IRB / B+L Reference Code #: AD23-01-00 
PROJECT NAME:  
 
 
Sponsor:  Bausch & Lomb, Incorporated 
 
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. 
 
Revision Chronology: 
Version 1.0 
August 9, 2023 
 
The information in the following document is confidential. The information contained 
herein will not be disclosed to others without written authorization from Bausch & Lomb, 
Incorporated. 
 
  
 
 
 
 
 

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TABLE OF CONTENTS 
LIST OF ABBREVIATIONS/ACRONYMS ......................................................................... 5 
INVESTIGATIONAL SITE AND STUDY PERSONNEL ................................................... 6 
SYNOPSIS .............................................................................................................................. 7 
1.0 INTRODUCTION .......................................................................................................... 11 
2.0 OBJECTIVE ................................................................................................................... 11 
3.0 STUDY DESIGN............................................................................................................ 11 
3.1 Description of Study Design ....................................................................................... 11 
3.2 Selection of Study Population ..................................................................................... 11 
3.2.1 Eligibility ............................................................................................................. 12 
3.2.1.1 Inclusion Criteria .............................................................................................. 12 
3.2.1.2 Exclusion Criteria .......................................................................................... 13 
3.2.2 Point of Enrollment and Randomization .............................................................. 13 
3.2.3 Subject Completion .............................................................................................. 13 
3.2.4 Lost to Follow-up ................................................................................................. 14 
3.3 Investigators ................................................................................................................ 14 
3.4 Study Duration ............................................................................................................ 14 
3.5 Protocol Changes and Amendments ........................................................................... 14 
4.0 STUDY MATERIALS ................................................................................................... 14 
4.1 Description of the Test Lens: ...................................................................................... 14 
4.2 Description of Comparator Lenses ............................................................................. 14 
4.3 Instructions for Use and Administration ..................................................................... 15 
4.3.1 Storage Requirements .......................................................................................... 15 
4.3.2 Subject Instructions .............................................................................................. 15 
4.4 Other Study Materials ................................................................................................. 15 
4.5 Packaging and Labeling .............................................................................................. 16 
4.6 Accountability ............................................................................................................. 16 
4.7 Masking....................................................................................................................... 16 
4.8 Product Replacement .................................................................................................. 17 
4.9 Risk Assessment ......................................................................................................... 17 
4.9.1 Risk Related to Subject ........................................................................................ 17 
4.9.2 Risk Related to Data Management ...................................................................... 17 
4.10 Relevance of Clinical Investigation .......................................................................... 18 

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5.0 STUDY METHODS ....................................................................................................... 18 
5.1 Measurements and Procedures .................................................................................... 18 
5.1.1 Study Visits .......................................................................................................... 18 
5.1.2 Unscheduled Visits .............................................................................................. 19 
5.1.3 Missed Visits ........................................................................................................ 19 
5.1.4 Post-Study Follow-up Visit ................................................................................. 19 
5.2 Study Completion ....................................................................................................... 19 
5.2.1 Study Termination/Suspension ............................................................................ 20 
5.2.2 Study Termination Procedure .............................................................................. 20 
5.3 Concomitant Medications/Therapy ............................................................................. 20 
5.4 Protocol Deviations ..................................................................................................... 20 
6.0 ADVERSE EVENTS (AE) ............................................................................................. 21 
6.1 Adverse Event Definitions .......................................................................................... 21 
6.1.1 Adverse Event (AE) ............................................................................................. 21 
6.1.2 Serious Adverse Event (SAE) .............................................................................. 21 
6.1.3 Serious Adverse Ocular Event ............................................................................. 22 
6.1.4 Significant, Non-Serious Adverse Event ............................................................. 22 
6.1.5 Non-significant, Non-serious Adverse Event ...................................................... 23 
6.1.6 Adverse Device Effect (ADE) ............................................................................. 23 
6.1.6.1 Anticipated Serious Adverse Device Effect (ASADE) ................................. 23 
6.1.6.2 Unanticipated Serious Adverse Device Effect (USADE) .............................. 23 
6.1.7 Device Deficiency ................................................................................................ 24 
6.2 Adverse Event Treatment and Culturing .................................................................... 24 
6.3 Adverse Event Identification and Evaluation ............................................................. 24 
6.4 Adverse Event Collection and Reporting ................................................................... 25 
6.5 Reporting Device Deficiencies ................................................................................... 26 
6.6 Emergency Contact Details for Reporting SAE and ADE ......................................... 27 
7.0 STATISTICAL METHODS ........................................................................................... 27 
7.1 Study Endpoints .......................................................................................................... 27 
7.2 Hypotheses .................................................................................................................. 27 
7.3 Sample Size ................................................................................................................. 27 
7.4 Randomization ............................................................................................................ 28 
7.5 Study Populations ....................................................................................................... 28 

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7.6 Statistical Analysis ...................................................................................................... 28 
7.6.1 Pass/Fail Criteria .................................................................................................. 28 
7.6.2 Interim Analyses .................................................................................................. 28 
7.6.3 Exploratory/Sensitivity Analysis ......................................................................... 28 
7.6.4 Deviations ............................................................................................................ 28 
8.0 DATA QUALITY ASSURANCE .................................................................................. 28 
8.1 Study Monitoring ........................................................................................................ 29 
8.1.1 Monitoring Subject Risk ...................................................................................... 29 
8.1.2 Monitoring Informed Consent Process ................................................................ 29 
8.1.3 Data Verification .................................................................................................. 30 
8.1.3.1 Direct Entry with Verification ....................................................................... 30 
8.1.3.2 Double Entry of Data ..................................................................................... 31 
8.1.3.3 The Data Management Summary (DMS) ...................................................... 31 
8.1.4 Annual Research Clinic Monitoring Plan ............................................................ 31 
8.1.4.1 Monitoring Procedure .................................................................................... 32 
8.1.4.2 Site Performance Evaluation & Monitoring Report ...................................... 32 
8.2 Auditing Procedures.................................................................................................... 32 
8.3 Source Documentation ................................................................................................ 32 
8.4 Maintaining Subject Privacy ....................................................................................... 33 
8.5 Locking the Database .................................................................................................. 33 
8.6 Retention of Documents ............................................................................................. 34 
8.7 Clinical Quality Assurance ......................................................................................... 34 
8.8 Institutional Review Board ......................................................................................... 34 
8.9 Statements of Compliance .......................................................................................... 34 
8.10 Informed Consent Process ........................................................................................ 35 
8.10.1 Vulnerable Population ....................................................................................... 35 
8.11 Publication of Results ............................................................................................... 36 
9.0 REFERENCES ............................................................................................................... 36 
APPENDIX A: METHODS OF CLINICAL EVALUATION ............................................. 37 
APPENDIX B: SUBJECT INSTRUCTIONS FOR USE ..................................................... 41 
 
 
 

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LIST OF ABBREVIATIONS/ACRONYMS 
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 
EDC 
Electronic Data Capture 
EC 
Ethics Committee 
GCPs 
Good Clinical Practices 
GPRM 
Global Pharmacovigilance and Risk Management 
IB 
Investigator's Brochure 
IDE 
Investigational Device Exemption 
ICF 
Informed Consent Form 
IRB 
Institutional Review Board 
TMF 
Trial Master File 
NOTE:  The first occurrence of some abbreviations is not spelled out in the document (e.g., units of measure). 
 
 

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To reduce the foreseeable factors that could compromise the outcome of the clinical 
investigation, subjects are targeted who are experienced 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. There are no known or foreseeable factors that may compromise the outcome 
of this clinical investigation that are not already controlled for by the Inclusion and 
Exclusion criteria. 
 
Healthy male and female volunteers will be recruited and screened as per criteria outlined 
below. The subjects will all be experienced soft contact lens wearers in both eyes.  
 
Enrollment will take place throughout the duration of the study.  
 
Intended Purpose/Use 
The kalifilcon A Daily Disposable 
 lenses are intended for the daily wear 
correction of refractive ametropia (myopia, hyperopia and astigmatism). Daily disposable 
lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended 
to be cleaned or disinfected and should be discarded after a single use. 
 
Additional information can be found in IB and in the comparator lens package insert, 
patient instruction booklet, and professional fitting guide1-8. 
 
Investigational and Target Population  
The relationship between the investigative population and the target population is they are 
both contact lens wearers. Daily disposable toric lenses are for use by patients prescribed 
the correction of refractive ametropia (myopia, hyperopia and astigmatism), regardless of 
gender or ethnicity and who do not have contraindications for the device. This study will be 
conducted on adults of at least 18 years of age.  
Recruitment for this study will target experienced soft contact lens wearers that have 
refractive error requiring contact lens correction. Subjects will be targeted that have a toric 
contact lens correction. 
 
Additional information can be found in IB.  
 
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.  

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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.  
 
3.2.2 Point of Enrollment and Randomization 
The study is randomized.  The study investigator and subject will be masked. An unmasked 
designee will be responsible for dispensing study products to the subjects according to the 
randomization schedule. The randomization schedule will be produced prior to study 
enrollment by Bausch + Lomb’s unmasked statistician not otherwise involved in the study. 
 
Randomization will be completed by the unmasked designee. The subjects will be assigned 
randomization numbers sequentially as they are enrolled. The unmasked designee is 
responsible for preparing the clinical trial materials according to the randomization 
schedule. The unmasked designee is also responsible for maintaining study lens inventory, 
randomization schedule and the Product Accountability Log in a masked fashion. 
 
3.2.3 Subject Completion 
The subject will have completed the study when he/she has worn all of the study lens types. 
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  
• 
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.  
 

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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 CRF/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 Optometrists 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 1 month 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 visits.  Use of other prescribed contact lenses and solution is 
not permitted during the study visits. 
 
4.1 Description of the Test Lens:  
Test Lens: kalifilcon A Daily Disposable Toric 
 (T01: kali A toric) 
 
4.2 Description of Comparator Lenses 
Comparator Lenses: Commercially available contact lenses 
C01: Total1 for Astigmatism (C01: Total1fA) 
C02: Precision1 for Astigmatism (C02: Precision1fA) 
C03: MyDay Toric (C03: MyDay Toric) 
 

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More information on the commercially available study lenses can be found in the package 
inserts patient instruction booklets and professional fitting guide 1-2. 
 
4.3 Instructions for Use and Administration 
Study lenses will be dispensed to subjects meeting all eligibility requirements including any 
dispensing requirements in this clinical protocol. Subjects will be dispensed an adequate 
supply of study lenses to complete the study. Lost or damaged study lenses may be replaced 
at the discretion of the Investigator. An unmasked designee will be responsible for all study 
lens accountability, including dispensation and collection of study supplies to subjects. 
 
The investigator or designee will instruct all subjects to adhere to the Subject Instructions 
provided with their study contact lenses.  
 
Subjects will be instructed not to use any other contact lenses or lens care products while 
wearing the study lenses. 
 
The subjects will be masked to the study lenses. An unmasked designee at each site will be 
responsible for all study lens accountability, including dispensation and collection of study 
supplies to subjects. 
 
Subjects will be receiving each of the study lens types once, in a randomized order. The 
subject will wear a pair of study contact lenses for approximately 10 minutes. See Appendix 
B for additional Instructions for Use. 
 
4.3.1 Storage Requirements 
All study materials provided by the Sponsor must be stored in a secure location 
accessible only to unmasked study personnel. 
 
4.3.2 Subject Instructions 
Subject Instructions for the use of study lenses are included in Appendix B, which include 
precautions and warnings related to contact lens wear. Subjects must comply with the 
instructions provided to them.  
 
The Investigator or other designee must review, with the subject, the Subject 
Instructions and the precautions and warnings, as appropriate for the study. 
 
Any subject who does not follow instructions to a degree that, in the Sponsor or 
Investigator's opinion, jeopardizes the subject's well-being or the validity of the study, 
should be discontinued. 
 
4.4 Other Study Materials 
Worn and unworn study lenses will be returned after the study is complete. No other study 
materials will be used in this study. 
 

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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, Vision Care Clinical 
Research and/or the Principal Investigator (PI). A final slit lamp examination should be 
performed, and adverse events handled accordingly. In the event that this study is 
suspended or terminated early, the Investigator (or designee) will reference the subject 
specific randomization schedule (or login to the EDC System) and unmask the subject. 
 
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 topical medications that, in the Investigator’s opinion, 
could potentially affect ocular physiology or lens/solution 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. 
 
All investigators participating in this study agree to conduct the study in accordance with 
the relevant, current protocol and agree to only make changes in a protocol after being 
notified by the Sponsor, except when necessary to protect the safety, rights, or welfare of 
subjects. Under emergency circumstances investigators may proceed without prior approval 
of the IRB. These deviations will be documented and reported to the IRB as soon as 
possible. The sponsor will not grant protocol waivers for this study.  
 
Corrective Action plans will be developed and completed as deemed necessary for 
Investigators who deviate from this protocol in a way that adversely affects the rights, 
safety or well-being of the subject(s) and/or the quality or integrity of data. The Corrective 
Action Plan will outline the deviation and the site’s corrective and/or remedial actions. 

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Decisions regarding critical deviations that merit investigator disqualification and will be 
documented in the Trial Master File. 
 
6.0 ADVERSE EVENTS (AE) 
Subjects who experience an adverse event 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- 
Serious AEs are defined as follows: 
 
6.1.1 Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in 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; or 
o Chronic disease 
• Led to fetal distress, fetal death, or a congenital abnormality or birth defect. 

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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 study lens, 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. 
 
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 Best Spectacle Corrected Visual 
Acuity (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) 

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• 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. 
 
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. 

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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 applicable form. 
 
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) 

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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 
accuracy. 
 
8.4 Maintaining Subject Privacy 
 
Subject data recorded on eCRFs during the study will be documented in a coded fashion. The 
subject will only be identified by the subject number and by their initials if also required. 
Confidentiality of subject records must be maintained to ensure adherence to applicable local 
privacy regulations. 
 
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 

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require approval from the EDC Programmer and is documented via electronic audit trail. 
 
8.6 Retention of Documents 
Bausch + Lomb must 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) 
• 
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.  
 
For the commercially available competitor products, information can be found in the 
respective package inserts, patient instruction booklets, professional fitting guides and in the 
IB1-8. 
 
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. 
 
The devices for this study conform to applicable general safety and performance 
requirements apart from aspects covered by the clinical investigation and that, with regard 

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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 REFERENCES 
1. Dailies Total1 for Astigmatism Package Insert. 
http://embed.widencdn.net/pdf/plus/alcon/xe3t4jzpll/W900038292_I_DELFCN_US.
pdf?u=4rqn%209d  
2. Dailies Total1 for Astigmatism Patient Instruction Booklet. 
http://embed.widencdn.net/pdf/plus/alcon/kaaikddkvz/W900060572_PB_DELFA_U
S.pdf?u=4rqn9d  
3. Dailies Total1 for Astigmatism Professional Fitting Guide. 
https://p.widencdn.net/7utjdt/W900236422_PFIG_DELFCON_A_US 
4. Precision1 for Astigmatism Package Insert. https://alcon.widen.net/s/hqk29vrghm 
5. Precision1for Astigmatism Patient Instruction Booklet. 
https://alcon.widen.net/s/rfkcrrnb8p 
6. Precision1 for Astigmatism Professional Fitting Guide. 
https://alcon.widen.net/s/fphscnjggw 
7. CooperVision Stenfilcon A Soft (Hydrophilic) Contact Lenses Single Use Daily 
Disposable Wear Practitioner Fitting Guide. 
https://coopervision.com/sites/coopervision.com/files/pfg01013-_myday-stenfilcon-
a-asphere-toric-multifocal-and-multifocal-toric-lensespfg-rev-d.pdf  
8. CooperVision MyDay Soft (Hydrophilic) Daily Disposable Contact Lenses package 
insert. https://coopervision.com/sites/coopervision.com/files/pi01100-myday-
stenfilcon-a-asphere-toric-multifocal-and-multifocal-toric-lenses-pi-rev-d.pdf  
 
 

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These subject instructions apply to all study lens types. 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 lenses are indicated for the correction of refractive ametropia (myopia, 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. 

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• 
Strict compliance with your wearing restrictions, wearing schedule, and follow-up visit 
schedule must be followed. 
• 
Clinical studies have shown that the risk of serious adverse reactions is increased when 
daily wear lenses are worn overnight. Study lenses should not be 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 

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your eye care professional. 
• 
Avoid, if possible, all harmful or irritating vapors and fumes when wearing lenses. 
• 
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 

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continues, you should immediately remove the lenses and consult your eye care 
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: 
 
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. 
 

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3. 
Placing the Lens on the Eye 
There are other methods of lens placement. If the following methods are difficult for you, 
your Study Doctor will provide you with an alternate method.  
 
NOTE: If after placement of the lens, your vision is blurred, check for the following:  
The lens is not centered on the eye (see “Centering the Lens,” next in these instructions).  
If the lens is centered, remove the lens (see “Removing the Lens” section) and check for 
the following:  
• cosmetics or oils on the lens (replace the lens)  
• the lens is on the wrong eye  
• 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.  
 
A. 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.  
 
 
 
B. 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. 
• NOTE: If this method of removing your lens is difficult for you, your eye care 
professional will provide you with an alternate method. 
 
6. Care for a Sticking (Nonmoving) Lens 
• It is important to the health of your eyes that your contact lenses move freely. If a lens 
sticks (stops moving), put a few drops of the Bausch + Lomb Sensitive Eyes® Drops 
provided by your study doctor into your eye. In this case, do not use plain water or 
anything other than the recommended solutions. Do not attempt to remove a lens that 
is sticking, which could damage your eye. If the lens does not begin to move when 

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you blink after several applications of the solution or, contact your study doctor 
immediately. Do not attempt to remove the lens except on the advice of your study 
doctor. 
 
7. Return of Your Study Lenses 
Do not discard worn lenses. At each visit, you must return all used and unused study 
materials that were dispensed to you during the designated wear periods.  
 
8. 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.