Clinical Assessment of a Daily Wear Monthly Replacement Silicone Hydrogel Toric Contact Lens
Phase: NA
Conditions: Refractive Errors, Astigmatism
Sponsor: Alcon Research



Document ID: 
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Status: Approved, Version: 2.0 
Approved Date: 28 Jan 2022 
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Investigator Agreement: 
• 
I have read the clinical study described herein, recognize its confidentiality, and 
agree to conduct the described trial in compliance with Good Clinical Practices; 
applicable international and national regulations, laws, guidelines, and standards; the 
conditions of approval imposed by the reviewing IRB or regulatory authority; and in 
accordance with the ethical medical research principles outlined in the Declaration 
of Helsinki.  
• 
I will supervise all testing of the device involving human subjects and ensure that 
the requirements relating to obtaining informed consent and IRB review and 
approval are met in accordance with applicable local and governmental regulations. 
• 
I have read and understand the appropriate use of the investigational product(s) as 
described in the protocol, current investigator’s brochure, product information, or 
other sources provided by the sponsor. 
• 
I understand the potential risks and side effects of the investigational product(s). 
• 
I agree to maintain adequate and accurate records in accordance with government 
regulations and to make those records available for inspection. 
• 
I agree to comply with all other requirements regarding the obligations of clinical 
investigators and all other pertinent requirements of the sponsor and government 
agencies. 
• 
I agree to ensure that all associates, colleagues, and employees assisting in the 
conduct of the study are informed of their obligations in meeting the above 
commitments. 
Have you ever been disqualified as an investigator by any Regulatory Authority? 
 No        Yes 
Have you ever been involved in a study or other research that was terminated? 
 No        Yes 
If yes, please explain here: 
Principal investigator: 
 
Signature 
 
 
 
 
 
Date 
Name and professional 
position: 
 
Address: 
Phone Number:  
Off-hours Emergency 
Phone Number: 
 
 

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Table of Contents 
Device Protocol for CLV201-C002 ........................................................................................... 1 
Table of Contents ....................................................................................................................... 3 
List of Tables .............................................................................................................................. 5 
List of Figures ............................................................................................................................ 6 
1 
GLOSSARY OF TERMS .................................................................................................... 7 
2 
LIST OF ACRONYMS AND ABBREVIATIONS ........................................................... 12 
3 
PROTOCOL SUMMARY ................................................................................................. 14 
4 
PROTOCOL AMENDMENTS ......................................................................................... 23 
5 
INTRODUCTION ............................................................................................................. 23 
5.1 
Rationale and Background ................................................................................. 23 
5.2 
Purpose of the Study .......................................................................................... 24 
5.3 
Risks and Benefits ............................................................................................. 24 
6 
STUDY OBJECTIVES...................................................................................................... 24 
6.1 
Primary Objective(s) .......................................................................................... 24 
6.2 
Secondary Objective(s) ...................................................................................... 25 
 
 
6.4 
Safety Objective(s) ............................................................................................ 25 
7 
INVESTIGATIONAL PLAN ............................................................................................ 26 
7.1 
Study Design...................................................................................................... 26 
7.2 
Rationale for Study Design................................................................................ 26 
7.3 
Rationale for Duration of Treatment/Follow-Up ............................................... 27 
7.4 
Rationale for Choice of Comparator Product .................................................... 27 
7.5 
Data Monitoring Committee .............................................................................. 27 
8 
STUDY POPULATION .................................................................................................... 27 
8.1 
Inclusion Criteria ............................................................................................... 28 
8.2 
Exclusion Criteria .............................................................................................. 28 
8.3 
Rescreening of Subjects ..................................................................................... 30 
9 
TREATMENTS ADMINISTERED................................................................................... 30 
9.1 
Investigational Product(s) .................................................................................. 30 
9.2 
Other Medical Device or Medication Specified for Use During the Study ....... 34 

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9.3 
Treatment Assignment / Randomization ........................................................... 34 
9.4 
Treatment masking ............................................................................................ 35 
9.5 
Accountability Procedures ................................................................................. 36 
9.6 
Changes to concomitant medications, treatments/ procedures .......................... 37 
10 STUDY PROCEDURES AND ASSESSMENTS ............................................................. 38 
10.1 Informed Consent and Screening ...................................................................... 38 
10.2 Description of Study Procedures and Assessments ........................................... 38 
10.2.1 
Demographics .................................................................................... 38 
10.2.2 
Medical History ................................................................................. 38 
10.2.3 
Investigational Product compliance .................................................. 38 
10.2.4 
Adverse Event Collection: Safety Assessment .................................. 39 
10.2.5 
Slit Lamp Biomicroscopy: Safety Assessment .................................. 39 
10.2.6 
Device Deficiencies: Safety Assessment ........................................... 39 
10.3 Unscheduled Visits ............................................................................................ 39 
10.4 Discontinued Subjects ....................................................................................... 40 
10.4.1 
Screen Failures .................................................................................. 40 
10.4.2 
Discontinuations ................................................................................ 40 
10.4.3 
Schedule of Procedures and Assessments for Subjects 
Discontinued from Investigational Product ....................................... 41 
10.5 Clinical Study Termination ................................................................................ 41 
10.5.1 
Follow-up of subjects after study participation has ended ................ 41 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ................................................... 41 
11.1 General Information .......................................................................................... 41 
11.2 Monitoring for Adverse Events ......................................................................... 44 
11.3 Procedures for Recording and Reporting .......................................................... 45 
11.4 Return product analysis (as applicable) ............................................................. 47 
11.5 Unmasking of the Study Treatment ................................................................... 47 
11.6 Follow-Up of Subjects with Adverse Events ..................................................... 47 
11.7 Pregnancy in the Clinical Study ........................................................................ 48 
12 ANALYSIS PLAN ............................................................................................................ 48 
12.1 Subject Evaluability ........................................................................................... 48 
12.2 Analysis Sets...................................................................................................... 48 
12.2.1 
Safety Analysis Set ............................................................................ 48 
12.2.2 
Full Analysis Set ................................................................................ 49 

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12.3 Demographic and Baseline Characteristics ....................................................... 49 
12.4 Effectiveness Analyses ...................................................................................... 49 
12.4.1 
Analysis of Primary Effectiveness Endpoint(s)................................. 49 
12.4.1.1 
Statistical Hypotheses ........................................................ 49 
12.4.1.2 
Analysis Methods............................................................... 49 
12.5 Handling of Missing Data .................................................................................. 52 
12.6 Safety Analyses.................................................................................................. 52 
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ............................... 53 
13.1 Subject Confidentiality ...................................................................................... 53 
13.2 Completion of Source Documents and Case Report Forms .............................. 53 
13.3 Data Review and Clarifications ......................................................................... 54 
13.4 Sponsor and Monitoring Responsibilities.......................................................... 55 
13.5 Regulatory Documentation and Records Retention .......................................... 55 
13.6 Quality Assurance and Quality Control ............................................................. 56 
14 ETHICS ............................................................................................................................. 56 
15 REFERENCES .................................................................................................................. 57 
15.1 Regulations and Standards................................................................................. 57 
15.2 Scientific and Other References ........................................................................ 58 
 
 
List of Tables 
Table 2–1 
List of Acronyms and Abbreviations Used in This Protocol ........................... 12 
Table 3–1 
Schedule of Study Procedures and Assessments ............................................. 18 
Table 6–1 
Primary Objective(s) ........................................................................................ 24 
 
 

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Table 6–3 
Safety Objective(s)........................................................................................... 25 
Table 9–1 
Test Product ..................................................................................................... 30 
Table 9–2 
Comparator Product ......................................................................................... 32 
 
 
 
List of Figures 
 
 
Figure 11–1 
Categorization of All Adverse Events .............................................................. 42 
Figure 11–2 
Categorization of All Serious Adverse Events ................................................. 42 
 
 
 

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1 GLOSSARY OF TERMS 
Names of test product(s) 
Throughout this document, test product(s) will be referred to 
as 
 Toric soft contact lenses or
 Toric contact 
lenses (LID205255). 
Name of Comparator 
Product(s) 
CooperVision® Biofinity® Toric (comfilcon A) contact 
lenses will be referred to as Biofinity Toric. 
Adverse Device Effect 
(ADE) 
 
Adverse event related to the use of an investigational 
medical device (investigational product) or comparator 
product. 
Note: This definition includes adverse events resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation; any malfunction; 
and use error or intentional misuse of the investigational 
medical device (investigational product) or comparator 
product.  
Adverse Event (AE) 
 
Untoward medical occurrence, unintended disease or injury, 
or untoward clinical signs (including abnormal laboratory 
findings) in subjects, users or other persons, whether or not 
related to the investigational medical device (investigational 
product).  
Note: This definition includes events related to the 
investigational medical device, comparator, or the 
procedures involved. For users or other persons, this 
definition is restricted to events related to the use of 
investigational medical devices (investigational product) or 
comparator product. 
Requirements for reporting Adverse Events in the study can 
be found in Section 11. 
Anticipated Serious 
Adverse Device Effect 
An effect which by its nature, incidence, severity, or 
outcome has been identified in the risk assessment. 

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(ASADE) 
 
Clinical Investigation Plan 
(CIP) 
 
The document(s) stating the rationale, objectives, design, 
and prespecified analysis, methodology, organization, 
monitoring, conduct, and record-keeping of the clinical 
investigation.  
Note: The protocol and other documents referenced in the 
protocol (for example, the Statistical Analysis Plan, the 
Manual of Procedures, the Deviations and Evaluability 
Plan, and the Protocol Monitoring Plan) comprise the CIP. 
Clinical Investigation 
Report (CIR) / Clinical 
Study Report 
The document describing the design, execution, statistical 
analysis, and results of a clinical investigation. The Clinical 
Investigation Report is synonymous with the Clinical Study 
Report. 
Device Deficiency 
 
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, usability, safety, or 
performance.  
Note: This definition includes malfunctions, use errors, and 
inadequacy in the information supplied by the manufacturer 
including labelling. 
Requirements for reporting Device Deficiencies in the study 
can be found in Section 11. 
Enrolled Subject 
Any subject who signs an informed consent form for 
participation in the study. 
Point of Enrollment 
The time at which, following recruitment and before any 
clinical investigation-related procedures are undertaken, a 
subject signs and dates the informed consent form. 
Interventional Clinical Trial  A pre- or postmarket clinical investigation where the 
assignment of a subject to a particular medical device is 
decided in advance by a clinical investigation plan, or 
diagnostic or monitoring procedures requested in the CIP are 

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in addition to those available as normal clinical practice and 
burden the subject. 
Investigational Product 
A preventative (vaccine), a therapeutic (drug or biologic), 
device, diagnostic, or palliative used as a test or comparator 
product in a clinical trial, including a product with a 
marketing authorization when used or assembled 
(formulated or packaged) in a way different from the 
authorized form, or when used for an unauthorized 
indication, or when used to gain further information about 
the authorized form. 
Malfunction 
 
Failure of an investigational medical device to perform in 
accordance with its intended purpose when used in 
accordance with the instructions for use or clinical 
investigation plan (CIP), or investigator’s brochure (IB). 
Nonserious Adverse Event 
Adverse event that does not meet the criteria for a serious 
adverse event. 
Randomized Subject 
Any subject who is assigned a randomized treatment. 
Serious Adverse Device 
Effect (SADE) 
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
Serious Adverse Event 
(SAE) 
 
Adverse event that led to any of the following:  
• Death. 
• A serious deterioration in the health of the subject, users 
or other persons as defined by one or more of the 
following:  
a) a life-threatening illness or injury   
Note: Life-threatening means that the individual was 
at immediate risk of death from the event as it 
occurred, i.e., it does not include an event which 
hypothetically might have caused death had it 
occurred in a more severe form. 

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b) any potentially sight-threatening event or permanent 
impairment to a body structure or a body function 
including chronic diseases. 
c) inpatient hospitalization or prolonged 
hospitalization. 
d) a medical or surgical intervention to prevent a) or b).  
e) any indirect harm as a consequence of incorrect 
diagnostic test results when used within 
manufacturer’s instructions for use. 
• Fetal distress, fetal death, congenital abnormality or 
birth defect including physical or mental impairment. 
Note: Planned hospitalization for a pre-existing condition, 
or a procedure required by the CIP, without serious 
deterioration in health, is not considered a serious adverse 
event.  
Refer to Section 11 for additional SAEs. 
Serious Health Threat 
 
Signal from any adverse event or device deficiency that 
indicates an imminent risk of death or a serious deterioration 
in the health in subjects, users, or other persons, and that 
requires prompt remedial action for other subjects, users, or 
other persons. 
Note: This would include events that are of significant and 
unexpected nature such that they become alarming as a 
potential serious health hazard or possibility of multiple 
deaths occurring at short intervals.  
Significant Nonserious 
Adverse Event 
 
A symptomatic, device-related, non-sight-threatening 
adverse event that warrants discontinuation of any contact 
lens wear for greater than or equal to 2 weeks. 
Refer to Section 11 for additional Significant Nonserious 
AEs. 

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Study Start 
The start of the study is considered to coincide with the 
enrollment of the first patient.  
Study Completion 
The completion of the study is considered to coincide with 
the study-level last subject last visit or the decision to 
terminate the trial, whichever is later. 
Unanticipated Serious 
Adverse Device Effect 
(USADE) 
Serious adverse device effect which by its nature, incidence, 
severity, or outcome has not been identified in the risk 
assessment.  
Use Error 
 
User action or lack of user action while using the medical 
device that leads to a different result than that intended by 
the manufacturer or expected by the user.  
Note: 
a) Use error includes the inability of the user to 
complete a task. 
b) Use errors can result from a mismatch between the 
characteristics of the user, user interface, task, or 
use environment. 
c) Users might be aware or unaware that a use error 
has occurred. 
d) An unexpected physiological response of the patient 
is not by itself considered a use error. 
e) A malfunction of a medical device that causes an 
unexpected result is not considered a use error.” 
Vulnerable Subject 
 
An individual who is unable to fully understand all aspects 
of the investigation that are relevant to the decision to 
participate, or who could be manipulated or unduly 
influenced as a result of a compromised position, 
expectation of benefits or fear of retaliatory response. 
 
 
 

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2 LIST OF ACRONYMS AND ABBREVIATIONS 
Table 2–1 
List of Acronyms and Abbreviations Used in This Protocol 
Abbreviation 
Definition 
ADE  
Adverse device effect 
AE 
Adverse event 
ASADE 
Anticipated serious adverse device effect 
BCVA 
Best corrected visual acuity 
Biofinity Toric 
CooperVision® Biofinity® Toric (comfilcon A) contact lenses 
CFR 
Code of Federal Regulations 
CI 
Confidence interval 
CIP 
Clinical investigation plan 
CIR 
Clinical investigation report 
COL 
Clinical operations lead 
CRF 
Case report form 
CSM 
Clinical study manager 
CTT 
Clinical trial team 
 
D/C 
Discontinue 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
FAS 
Full analysis set 
FDA 
US Food and Drug Administration 
GCP 
Good Clinical Practice 
GPCMS 
Global Product Complaint Management System 
 
IB 
Investigator’s brochure 
ICF 
Informed consent form 
IEC 
Independent ethics committee 
IP 
Investigational product 
IRB 
Institutional review board 
ISO 
International Organization for Standardization 
LID 
Lens Identification Number 
LogMAR 
Logarithm of the minimum angle of resolution 
 
MOP 
Manual of procedures 
N 
Number of subjects 
N/A 
Not applicable 
OD 
Right eye 
OS 
Left eye 
Toric 
 Toric contact lenses (LID205255) 
PP 
Per protocol 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 

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Abbreviation 
Definition 
SD 
Standard deviation 
SLE 
Slit lamp examination 
SOP 
Standard operating procedure 
US or USA 
United States 
USADE 
Unanticipated serious adverse device effect 
VA 
Visual acuity 
 
 
 
 

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3 PROTOCOL SUMMARY 
Investigational 
product type 
Device 
Study type 
Pivotal 
Investigational 
products 
Test Product:
Toric (LID205255) 
Comparator Product: Biofinity Toric 
Purpose and 
Scientific Rationale 
for the Study 
The overall objective of this clinical study is to describe the 
clinical performance of the investigational
Toric contact 
lenses over 30 days of daily wear. 
Objective(s) 
The primary objective is to evaluate visual acuity of the
Toric soft contact lenses. 
 
 
Endpoint(s)  
 
Primary Effectiveness 
• 
Distance VA (logMAR) with study lenses 

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Safety 
• 
Adverse events 
• 
Biomicroscopy findings 
• 
Device deficiencies 
Assessment(s)  
Effectiveness 
• 
Distance VA (logMAR) 
• 
Distance VA (logMAR) with habitual lenses  
• 
Manifest refraction 

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• 
BCVA (Snellen distance with manifest refraction) 
• 
Keratometry 
Safety 
• 
Adverse Events 
• 
Biomicroscopy 
• 
Device deficiencies 
Study Design 
This is a prospective, randomized, bilateral, crossover, double-
masked study comparing the 
 Toric and Biofinity Toric 
contact lenses. Subjects will be randomized 1:1 to receive one of 
two sequences: 
Sequence 1 = LID205255/Biofinity Toric 
Sequence 2 = Biofinity Toric/LID205255 
 
Subjects will be exposed to both lenses for a total of 
approximately 60 days (approximately 30 days for each lens).  
Subject population 
Planned number of subjects enrolled/consented: ~72 
Planned number of completed subjects: 58 
The study population consists of volunteer subjects aged 18 or 
over who are habitual toric weekly/monthly soft contact lens 
wearers, have at least 3 months of contact lens wearing experience, 
and who wear their habitual lenses at least 5 days per week and at 
least 10 hours per day. 
Sites and Locations 
Planned number of clinical sites: ~ 6 
Planned locations (initial list of locations, which may change 
during start up or conduct according to study needs): United States 
Key inclusion 
criteria 
(See Section 8.1 for a 
• Successful wearer of weekly/monthly toric soft contact lenses 
in both eyes for a minimum of 5 days per week and 10 hours 
per day during the past 3 months. 

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4 PROTOCOL AMENDMENTS 
Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments must be created by the study sponsor and must be 
approved by the IRB/IEC and global and regional Health Authorities, as applicable, prior to 
implementation except when required to mitigate immediate safety risks or when the changes 
involve only logistical or administrative revisions.  
Amendments may necessitate that the informed consent and other study-related material be 
revised. If the consent form is revised, all subjects currently enrolled in the study must sign 
the approved, revised informed consent (re-consent), as required by the IRB/IEC. 
Refer to Appendix A for detailed description of amendments.  
5 INTRODUCTION 
5.1 Rationale and Background 
 Toric soft contact lenses are a new monthly replacement water gradient contact lens 
with a gradual transition from a 55% water, highly breathable core, to a surface that is nearly 
100% water. The toric lens utilizes the Precision Balance 8|4™ ballasted toric design.  
Lehfilcon A toric soft contact lenses are indicated for the optical correction of refractive 
ametropia (myopia and hyperopia) in phakic (having the natural eye lens) or aphakic (not 
having the natural eye lens) persons with nondiseased eyes with up to 6.00 diopters (D) of 
astigmatism. 
The lenses are intended for daily wear (less than 24 hours while awake) with removal for 
cleaning and disinfection (chemical, not heat) prior to reinsertion, or disposal. Lenses should 
be discarded after one month. 
 These 
new silicone hydrogel lenses have been designed to provide favorable performance for daily 
wear with 1-month replacement. 
In this clinical study, the clinical performance of the investigational 
 Toric contact 
lens will be assessed and the 
 Toric contact lens will be compared to the 
commercially available Biofinity Toric contact lens in a crossover dispense trial, both to be 
worn in a daily wear modality and replaced on a monthly basis. 

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5.2 Purpose of the Study 
The purpose of this study is to assess the clinical performance of the investigational
 
Toric contact lens over 30 days of daily wear. The primary endpoint was selected to address 
the primary objective of the study. Procedures for measurement of these endpoints were 
selected based on common practice for these assessments. The design of this study is justified 
based upon preclinical and clinical testing, as described within the Investigator’s Brochure. 
Biofinity Toric contact lenses were chosen as the comparator product because these lenses 
have the same wear modality and replacement schedule. 
At the end of the study, a clinical study report will be prepared in accordance with applicable 
regulatory requirements and standards.  
5.3 Risks and Benefits 
The clinical investigation process risks are managed through appropriate training and 
monitoring according to the protocol-specific monitoring plan. Investigational device risks, 
including risks associated with use of device and methods and procedures for application of 
device, are defined in the investigator’s brochure and/or product labeling and are managed 
through review of safety assessments outlined in this protocol.  
There may also be unknown risks to use of 
 Toric. Any risk to subjects in this clinical 
study will be minimized by compliance with the eligibility criteria and study procedures, 
clinical oversight and monitoring. 
Refer to the product label for additional information.  
6 STUDY OBJECTIVES 
6.1 Primary Objective(s) 
Table 6–1 
Primary Objective(s) 
Objective(s) 
Endpoint(s) 
Evaluate visual acuity of the
 Toric 
soft contact lenses. 
Distance VA (logMAR) with study lenses 

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The bilateral, crossover study design will ensure that the same subject is exposed to both the 
test and comparator lens materials during the study visits and wearing period; therefore, 
assessments can be obtained for both lenses from the same subject. 
The study will include only those subjects who are successful wearers of soft toric contact 
lenses in both eyes during the past 3 months for a minimum of 5 days per week and 10 hours 
per day. This will avoid confounding safety responses in nonadapted subjects. Moreover, the 
subjects will not be permitted to use artificial tears/rewetting drops during study participation 
as this may confound the primary effectiveness
 The study will 
exclude any habitual Biofinity Toric/Biofinity Toric XR contact lens wearers in the past 3 
months prior to consent in order to reduce potential bias of wearers to their habitual contact 
lenses. The study will also exclude subjects who are monovision or multifocal contact lens 
wearers and daily disposable contact lens wearers. 
7.3 Rationale for Duration of Treatment/Follow-Up 
The primary 
endpoint will be assessed on Day 1 and Day 30. Hence, subjects 
will wear each study product bilaterally for approximately 30 days.  
7.4 Rationale for Choice of Comparator Product 
Biofinity Toric contact lenses were chosen as the comparator product as these lenses have the 
same wear modality and replacement schedule as
Toric contact lenses.  
7.5 Data Monitoring Committee 
Not applicable 
8 STUDY POPULATION 
The study population consists of volunteer subjects aged 18 or over who are habitual toric 
weekly/monthly soft contact lens wearers, have at least 3 months of contact lens wearing 
experience, and who wear their habitual lenses at least 5 days per week and at least 10 hours 
per day. It is aimed to enroll (consent) approximately 72 subjects at approximately 6 sites in 
the United States, with a target of 58 total subjects completed. Site-specific targets may vary 
based upon individual site capabilities. Estimated time needed to recruit subjects for the study 
is approximately 8 weeks; however, unanticipated circumstances may shorten or lengthen this 
time and would not require amendment of this protocol.  

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8.1 Inclusion Criteria 
Written informed consent must be obtained before any study specific assessment is 
performed. Upon signing informed consent, the subject is considered enrolled in the study. 
Subjects eligible for inclusion in this study must fulfill all of the following criteria: 
1.  
Subjects must be at least 18 years of age 
2.  
Subject must be able to understand and sign an IRB/IEC approved Informed 
Consent form. 
3.  
Subject must be willing and able to attend all study visits as required per protocol. 
4.  
Successful wearer of weekly/monthly toric soft contact lenses in both eyes for a 
minimum of 5 days per week and 10 hours per day during the past 3 months. 
5.  
Best corrected distance visual acuity (as determined by manifest refraction at 
screening) better than or equal to 20/25 in each eye. 
6.  
Able to wear contact lenses within a range of sphere & cylinder power and axes 
 
 
 
7.  
Subject must be willing to stop wearing their habitual contact lenses for the duration 
of the study participation. 
8.  
Subject must possess spectacles and willing to wear habitual spectacles for vision 
correction when study lenses are not worn, as needed,
 
 
8.2 Exclusion Criteria 
Subjects fulfilling any of the following criteria are not eligible for participation in this study. 
1.  Any anterior segment infection, inflammation, or abnormality or disease (including 
systemic) that contraindicates contact lens wear, as determined by the investigator 

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2.  Any use of systemic or ocular medications for which contact lens wear could be 
contraindicated, as determined by the investigator. 
3.  History of refractive surgery or plan to have refractive surgery during the study or 
irregular cornea in either eye. 
4.  Ocular or intraocular surgery (excluding placement of punctal plugs) within the 
previous 12 months or planned during the study. 
5.  Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or 
corneal vascularization that is mild (Grade 2) or higher; presence of corneal 
infiltrates 
6.  Current or history of pathologically dry eye in either eye that, in the opinion of the -
nvestigator, would preclude contact lens wear. 
7.  Current or history of herpetic keratitis in either eye. 
8.  Eye injury in either eye within 12 weeks immediately prior to enrollment for this 
trial. 
9.  Current or history of intolerance, hypersensitivity or allergy to any component of the 
study products. 
10.  Any use of topical ocular medications and artificial tear or rewetting drops that 
would require instillation during contact lens wear. 
11.  The investigator, his/her staff, family members of the investigator, family members 
of the investigator’s staff, or individuals living in the households of the 
aforementioned persons may not participate in the study. 
12.  Participation of the subject in a clinical trial within the previous 30 days or currently 
enrolled in any clinical trial. 
13.  Monovision and multifocal contact lens wearers. 
14.  Daily Disposable contact lens wearers 
15.  Habitual Biofinity Toric/Biofinity Toric XR contact lens wearers in the past 3 
months prior to consent. 

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16.  Wearing habitual contact lenses in an extended wear modality (routinely sleeping in 
lenses for at least 1 night per week) over the last 3 months prior to enrollment. 
 
8.3 Rescreening of Subjects 
Rescreening of subjects is not allowed in this study. 
9 TREATMENTS ADMINISTERED 
9.1 Investigational Product(s) 
Test Product(s): 
 Toric 
Comparator Product(s) (If 
applicable): 
Biofinity Toric 
 
Table 9–1 
Test Product 
Test Product 
Toric 
Lens Identification 
Number (LID) 
LID205255 
Manufacturer 
Alcon Laboratories, Inc. 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
USA 
Indication for use 
and intended 
purpose in the 
current study  
The intended use of this product is for vision correction. 
Product description 
 
 
• Material: Lehfilcon A 
• Water content: 55% 
• Base curve (mm): 8.6 (Target) 
• Diameter (mm): 14.5 (Target) 
 

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- 
lot number 
- 
expiration date 
- 
content statement 
- 
investigational device statement 
- 
sponsor information 
- 
Country of origin 
 
• Provided in ~24 lenses per power per package, identified with 
the following at a minimum: 
- 
a color coded label stating the protocol number 
- 
 LID number 
- 
power 
- 
an investigational use only statement 
- 
Handling unit number 
Training and/or 
experience 
requirements for 
device 
No additional training or experience is required to administer the 
test product.  
Storage conditions 
Lenses are to be stored at room temperature 
Supply 
• Lenses supplied by the Sponsor 
• CLEAR CARE contact lens solution supplied by Sponsor to 
be provided to the subject 
• LacriPure saline will be permitted for rinsing the lens(es) if 
needed. 
 
Table 9–2 
Comparator Product 
Comparator 
Product(s) 
CooperVision® Biofinity® Toric (comfilcon A) contact lenses 
No Biofinity Toric XR 
Manufacturer 
CooperVision 
Indication for Use 
The intended use of this product is for vision correction. 
Product description 
 
• Material: comfilcon A 
• Water content: 48% 
• Base curve (mm): 8.7 

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requirements for 
device 
Storage conditions 
Lenses are to be stored at room temperature 
Supply 
• Each site will procure their own comparator lenses. 
• CLEAR CARE contact lens solution supplied by Sponsor to 
be provided to the subject 
• LacriPure saline will be permitted for rinsing the lens(es) if 
needed. 
 
More information on the test product can be found in the
investigator’s brochure; 
information on the comparator product can be found in the Biofinity Package Insert.  
9.2 Other Medical Device or Medication Specified for Use During the 
Study 
No other medical devices or medications are required to be used in conjunction with the 
treatments during the clinical study. 
9.3 Treatment Assignment / Randomization 
Subjects will be randomized in a 1:1 ratio to receive treatment (lens) in crossover sequence of 
Test product then Comparator product or Comparator product then Test product, respectively.  
Sequence 
EDC/randomization integration system 
Lens Name 
Sequence 1 
LID205255/Biofinity Toric 
Toric/Biofinity Toric 
Sequence 2 
Biofinity Toric/ LID205255 
Biofinity Toric/
 Toric 
 
Only after signing the ICF, a subject will be assigned a subject number by the electronic data 
capture system.  
A randomization list will be generated using a validated system that automates the random 
assignment of treatment arms to randomization numbers in the specified ratio. Subjects will 
be assigned treatment according to the randomization list uploaded in the randomization 
system. The randomization list will be generated and maintained by the study sponsor.  
At Visit 1, all eligible subjects will be randomized via the EDC/randomization integration to 
one of the treatment arms. The investigator’s delegate will access the respective system after 

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confirming that the subject meets all the eligibility criteria. A randomization number will be 
automatically assigned to the subject according to the subject randomization list but will not 
be communicated to the site user. The EDC/randomization integration system will inform the 
site user of the treatment sequence (lens sequence) assignment to be dispensed to the subject. 
9.4 Treatment masking 
This study is double-masked, with subjects randomized in a 1:1 ratio to receive
 Toric 
and Biofinity Toric contact lenses in a crossover sequence for the duration of the two 30-day 
treatment period.
 

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 Unmasking 
will occur only after all planned study data have been validated, and the database locked.  
Masked study personnel must avoid seeking information that may compromise masking. 
  
In the event of a medical emergency where the knowledge of subject treatment is required, an 
individual investigator will have the ability to unmask the treatment assignment for a specific 
subject after contacting an appropriate study sponsor representative if time allows.  
9.5 Accountability Procedures 
Upon receipt of the IPs, the investigator or delegate must conduct an inventory.
 Throughout the study, the investigator or 
delegate must maintain records of IP dispensation and collection for each subject. This record 

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must be made available to the study monitor for the purposes of verifying the accounting of 
IP supplies. Any discrepancies and/or deficiencies between the observed disposition and the 
written account must be recorded along with an explanation. All IPs sent to the investigator 
must be accounted for by study sponsor personnel, and in no case be used in an unauthorized 
situation. 
The investigator should make every effort to collect unused lenses, foils, and supplies from 
subjects. 
It is the investigator’s responsibility to ensure that: 
• 
All study products are accounted for and not used in any unauthorized manner 
• 
All unused products are available for return to the study sponsor, as directed 
• 
Any study lenses associated with a device deficiency or with any product-related 
adverse event (i.e., ADE or SADE) are returned to the study sponsor for investigation, 
unless otherwise directed by the sponsor. Refer to Section 11 of this protocol for 
additional information on the reporting of device deficiencies and AEs and the return 
of study products associated with these events. 
The investigator is responsible for proper disposition of all unused IPs at the conclusion of 
the study, according to the instructions provided in the MOP. 
9.6 Changes to concomitant medications, treatments/ procedures 
After the subject is enrolled into the study, the investigator must instruct the subject to notify 
the study site about: 
• 
Any new medications  
• 
Alterations in dose or dose schedules for current medications,  
• 
Any medical procedure or hospitalization that occurred or is planned 
• 
Any nondrug therapies (including physical therapy and blood transfusions).  
The investigator must document this information in the subject’s case history source 
documents. 

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10 STUDY PROCEDURES AND ASSESSMENTS 
10.1 Informed Consent and Screening 
The investigator or delegate must explain the purpose and nature of the study, and have the 
subject read, sign, and date the IRB/IEC-approved informed consent document. The subject 
must sign the ICF BEFORE any study-specific procedures or assessments can be performed, 
including study-specific screening procedures. Additionally, have the individual obtaining 
consent from the subject and a witness, if applicable, sign and date the informed consent 
document.  
The investigator or delegate must provide a copy of the signed document to the subject and 
place the original signed document in the subject’s chart, or provide documentation as 
required by local regulations. 
10.2 Description of Study Procedures and Assessments 
Detailed descriptions of assessments and procedures are provided in the MOP. The 
investigator is responsible for ensuring responsibilities for all procedures and assessments are 
delegated to appropriately qualified site personnel. 
10.2.1 Demographics 
Obtain demographic information including age, race, ethnicity, and sex. 
10.2.2 Medical History 
Collect medical history information, including information on all medications used within the 
past 30 days. Include herbal therapies, vitamins, and all over-the-counter as well as 
prescription medications. Throughout the subject’s participation, obtain information on any 
changes in medical health and/or the use of concomitant medications. 
Medical History and Concomitant Medications will be collected in the eCRF as outlined in 
the MOP. 
10.2.3 Investigational Product compliance 
Review subject compliance with the IP usage and adjunct product usage and collect all used 
and unused study IPs and other products that were dispensed. 

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10.2.4 Adverse Event Collection: Safety Assessment 
Assess and record any adverse events that are observed or reported since the previous visit, 
including those associated with changes in concomitant medication dosing. 
10.2.5 Slit Lamp Biomicroscopy: Safety Assessment 
SLE of the cornea, iris/anterior chamber and lens must be performed in both eyes before 
instillation of any diagnostic eye drops. 
10.2.6 Device Deficiencies: Safety Assessment 
Assess and record any Device Deficiencies that are reported or observed since the previous 
visit. Requirements for reporting device deficiencies in the study can be found in Section 11. 
10.3 Unscheduled Visits 
If a subject visit occurs between any regularly scheduled visit and the visit is conducted by 
study personnel, this visit must be documented as an Unscheduled Visit. If the subject seeks 
medical attention outside the clinic (for example, at an Emergency Room) or at the clinic but 
is seen by nonstudy personnel, the investigator is to capture adverse event-related 
information on the Adverse Event form upon becoming aware. 
During all unscheduled visits, the investigator must conduct the following procedures:  
• 
Collect Adverse Event information 
• 
Collect device deficiency information 
• 
Record changes in medical condition or concomitant medication 
• 
Perform a biomicroscopy  
• 
VA w/study lenses (OD, OS, logMAR distance) 
The investigator may perform additional procedures for proper diagnosis and treatment of the 
subject. The investigator must document this information in the subject’s case history source 
documents. 
If during an Unscheduled Visit the subject is discontinuing the IP or discontinuing from the 
study, the investigator must conduct Exit procedures according to Table 3–1 Schedule of 
Study Procedures and Assessments and Section 10.4.3, as possible. 

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10.4 Discontinued Subjects 
10.4.1 Screen Failures 
Subjects who were excluded from the study after signing the informed consent and prior to, 
randomization to product/dispense of study product. 
The investigator must document the reason for screen failure in the subject’s case history 
source documents. 
Subject numbers must not be reused. 
10.4.2 Discontinuations 
Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the 
study by the investigator after signing informed consent. 
Subject numbers of discontinued subjects must not be re-used (i.e., subject replacement is not 
allowed). 
Subjects may discontinue from study or study treatment at any time for any reason. Subjects 
may also be discontinued from study treatment at any time if, in the opinion of the 
investigator, continued treatment poses a risk to their health. 
If a subject discontinues from study treatment, every effort must be made to keep the subject 
in the study and to continue with the study assessments as specified in the schedule of study 
procedures and assessments until the final visit. 
For subjects discontinuing from the study, the investigator must complete all Exit procedures 
according to Table 3–1 Schedule of Study Procedures and Assessments and Section 10.4.3, if 
the subject is willing and able, and if in the opinion of the investigator it is safe for the 
subject to do so. 
The investigator must document the reason for study or treatment discontinuation in the 
subject’s case history source documents. 
To ensure the safety of all subjects who discontinue early, investigators must assess each 
subject and, if necessary, advise them of any therapies and/or medical procedures that may be 
needed to maintain their health. 

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10.4.3 Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product  
Other than screen failures, if a subject discontinues from the study, the subject should 
undergo an Early Exit Visit. Refer to Table 3–1. 
10.5 Clinical Study Termination 
The study sponsor reserves the right to suspend or close the investigational site or suspend or 
terminate the study in its entirety at any time. 
If the clinical study is prematurely terminated or suspended by the study sponsor:  
• 
The study sponsor must: 
o Immediately notify the investigator(s) and subsequently provide 
instructions for study termination. 
o Inform the investigator and the regulatory authorities of the 
termination/suspension and the reason(s) for the termination/suspension.  
• 
The investigator must: 
o Promptly notify the IRB/IEC of the termination or suspension and of the 
reasons.  
o Provide subjects with recommendations for post-study treatment options 
as needed. 
The investigator may terminate the site’s participation in the study for reasonable cause. 
Breaking of the masked treatment codes will be done after locking the database. 
10.5.1 Follow-up of subjects after study participation has ended  
Following this study, the subject will return to their eye care professional for their routine eye 
care. 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
11.1 General Information 
An AE is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, 

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whether or not related to the investigational medical device (test product). Refer to the 
Glossary of Terms and figures below for categories of AEs and SAEs. 
Figure 11–1 
Categorization of All Adverse Events 
ADE
Device /
procedure-
related?
Symptomatic, 
device-related, non 
sight-threatening, 
D/C lens wear?
Meets 
seriousness 
criteria?
SAE
All AEs
AE
Significant     
non-serious AE
Yes
Yes
 
Figure 11–2 
Categorization of All Serious Adverse Events 
All SAEs
Device /
procedure 
related?
SAE
SADE
Anticipated?
Unanticipated 
SADE
No
Yes
No
Anticipated 
SADE
Yes
 
 
Specific Events Relevant to this Protocol  
Serious Adverse Events 
In addition to reporting all AEs (serious and nonserious) meeting the definitions, the 
investigator must report any occurrence of the following as an SAE: 

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• 
An ocular infection including a presumed infectious ulcer with any of the following 
characteristics:  
o Central or paracentral location 
o Penetration of Bowman’s membrane 
o Infiltrates >2 mm diameter 
o Iritis 
o Increase in intraocular pressure 
o Culture positive for microorganisms 
o Increasing size or severity at subsequent visits 
• 
Any central or paracentral corneal event (such as neovascularization) that results in 
permanent opacification 
• 
Hypopyon 
• 
Hyphema 
• 
Neovascularization within the central 6 mm of the cornea 
• 
Permanent vision loss as defined by loss of 2 or more lines of Distance BCVA from 
enrollment visit that fails to resolve 
• 
Uveitis (anterior, intermediate, or posterior) 
• 
Corneal abrasion affecting ≥50% of corneal surface area 
 
Significant Nonserious Adverse Events 
A significant nonserious AE is a device-related, non-sight-threatening adverse event that 
warrants discontinuation of any contact lens wear for greater than or equal to 2 weeks. In 
addition, the investigator must report any occurrence of the following as a Significant 
Nonserious Adverse Event: 
• 
Peripheral nonprogressive noninfectious ulcers 
• 
All symptomatic corneal infiltrative events 
• 
Corneal staining score greater than or equal to grade 3 (Refer to MOP for grading 
scales) 

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• 
Temporary vision loss as defined by loss of 2 or more lines of Distance BCVA from 
enrollment visit that persists for 2 or more weeks 
• 
Neovascularization score greater than or equal to grade 2 (Refer to MOP for grading 
scales) 
The above events are based on the categories provided in the ISO 11980 and the US FDA 
Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses. 
Device Deficiencies 
A device deficiency is inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. A device deficiency may or may not be 
associated with patient harm (i.e., ADE or SADE); however, not all ADEs or SADEs are due 
to a device deficiency. The investigator should determine the applicable category listed in the 
Device Deficiency eCRF for the identified or suspect device deficiency and report any 
patient harm separately. Examples of device deficiencies include the following:  
• 
Failure to meet product specifications (e.g., incorrect lens power/diameter/base 
curve/color) 
• 
Lens/solution cloudy 
• 
Lens surface/edge defect  
• 
Torn lens during handling/in pack  
• 
Packaging deficit (e.g., mislabeled product, tampered seal, leaking bottle/container) 
• 
Suspect product contamination 
11.2 Monitoring for Adverse Events 
At each visit, after the subject has had the opportunity to spontaneously mention any problems, 
the investigator should inquire about AEs by asking the standard questions shown below and 
report as applicable: 
• 
“Have you had any health problems since your last study visit?” 
• 
“Have there been any changes in the medicines you take because of a new health issue 
since your last study visit?” 
In addition, changes in biomicroscopy findings 
evaluated during the 
study are to be reviewed by the investigator. Any untoward (unfavorable and unintended) 
change in a biomicroscopy parameter 
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the opinion of the investigator, is to be reported as an AE. These clinically relevant changes 
will be reported regardless of causality.  
11.3 Procedures for Recording and Reporting 
AEs are collected from the time of informed consent Any pre-existing medical conditions or 
signs/symptoms present in a subject prior to the start of the study (i.e., before informed 
consent is signed) are not considered AEs in the study and should be recorded in the Medical 
History section of the eCRF. 
For each recorded event, the ADEs and SAEs documentation must include: date of 
occurrence, severity, treatment (if applicable), outcome, and assessments of the seriousness 
and causality. In addition, the investigator must document all device deficiencies reported or 
observed with test and comparator products on the Device Deficiency eCRF. The site must 
submit all available information on ADEs, SAEs, and device deficiencies to the Study 
Sponsor immediately as follows: 
• 
ADEs or SAEs are documented on the Serious Adverse Event and Adverse Device 
Effect eCRF within 24 hours of the investigator’s or site’s awareness.  
• 
Device deficiencies are documented on the Device Deficiency eCRF within 24 hours 
of the investigator’s or site’s awareness.  
• 
Additional relevant information after initial reporting must be entered into the eCRF as 
soon as the data become available.   
• 
Document any changes to concomitant medications on the appropriate eCRFs. 
• 
Document all relevant information from Discharge Summary, Autopsy Report, 
• 
Certificate of Death etc., if applicable, in narrative section of the Serious Adverse 
Event and Adverse Device Effect eCRF. 
Note: Should the EDC system become nonoperational, the site must complete the appropriate 
paper Serious Adverse Event and Adverse Device Effect and/or Device Deficiency Form. The 
completed form is emailed to the Study Sponsor at msus.safety@Alcon.com according to the 
timelines outlined above; however, the reported information must be entered into the EDC 
system once it becomes operational. 

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Any AEs and device deficiencies for nonstudy marketed devices/products (i.e. CLEAR 
CARE contact lens solution) will be considered and processed as spontaneous (following the 
postmarket vigilance procedures) and should be communicated to the device’s/product’s 
manufacturer as per local requirements. 
Study Sponsor representatives may be contacted for any protocol related question and 
their contact information is provided in the Manual of Procedures that accompanies 
this protocol. 
Further, depending upon the nature of the AE or device deficiency being reported, the Study 
Sponsor may request copies of applicable portions of the subject’s medical records. The 
investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC. 
Intensity and Causality Assessments 
Where appropriate, the investigator must assess the intensity (severity) of the AE based on 
medical judgment with consideration of any subjective symptom(s), as defined below: 
Intensity (Severity) 
Mild  
An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom. 
Moderate  
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities. 
Severe  
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities. 
For every AE in the study, the investigator must assess the causality (Related or Not Related 
to the medical device or study procedure). An assessment of causality will also be performed 
by Study Sponsor utilizing the same definitions, as shown below: 
Causality 
Related 
An AE classified as related may be either definitely related or possibly related 
where a direct cause and effect relationship with the medical device or study 
procedure has not been demonstrated, but there is a reasonable possibility that 
the AE was caused by the medical device or study procedure. 

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Not Related  An AE classified as not related may either be definitely unrelated or simply 
unlikely to be related (i.e., there are other more likely causes for the AE). 
The Study Sponsor will assess the AEs and may upgrade the investigator’s assessment of 
seriousness and/or causality. The Study Sponsor will notify the investigator of any AEs that is 
upgraded from nonserious to serious or from unrelated to related. 
11.4 Return product analysis (as applicable) 
Study Sponsor representatives and their contact information are provided in the MOP that 
accompanies this protocol.  
Alcon study products associated with device deficiencies and/or product related AEs should 
be returned and must include the Complaint # which will be provided by Study Sponsor after 
the case is entered in the Study Sponsor’s Global Product Complaint Management System 
(GPCMS) after the database lock. 
11.5 Unmasking of the Study Treatment  
Masked information on the identity of the assigned medical device should not be disclosed 
during the study (See Section 9.4 for details on the masking procedure). If the treatment code 
needs to be broken in the interest of subject safety, the investigator is encouraged to contact 
an appropriate Study Sponsor representative prior to unmasking the information if there is 
sufficient time. Dependent upon the individual circumstances (i.e., medical emergency), the 
code may be broken prior to contact with the Study Sponsor. The Study Sponsor must be 
informed of all cases in which the code was broken and of the circumstances involved. 
Additionally, the Study Sponsor may be required to unmask the information in order to fulfill 
expedited regulatory reporting requirements. 
11.6 Follow-Up of Subjects with Adverse Events 
The investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study.  
The investigator should provide the Study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ ongoing at time of discontinuation, any 
additional information received at follow-up should be documented in the eCRFs up to study 
completion (i.e., database lock).  Any additional data received up to 1 month after subject 
completed the study should be documented and available upon the Study Sponsor’s request.    

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All complaints received after this time period will be considered and processed as 
spontaneous (following the postmarket vigilance procedures) and should be communicated to 
the medical device’s manufacturer as per local requirements. The investigator should also 
report complaints on non-Alcon products directly to the manufacturer as per the 
manufacturer’s instructions or local regulatory requirements. 
11.7 Pregnancy in the Clinical Study 
Women of childbearing potential or women who are pregnant at the time of study entry are 
not excluded from participation. Pregnancy should be included in the corresponding section 
of the eCRF (i.e., Pregnancy CRF) when a pregnant woman enters the study or if a woman 
becomes pregnant during the study. Pregnancy is not reportable as an AE; however, 
complications may be reportable and will be decided on a case-by-case basis.  
12 ANALYSIS PLAN 
Continuous variables will be summarized using the number of observations, mean, standard 
deviation, median, minimum, and maximum. Categorical variables will be summarized with 
frequencies and percentages from each category.  
Any deviations to this analysis plan will be updated during the course of the study as part of a 
protocol amendment or will be detailed in the clinical study report. 
12.1 Subject Evaluability 
The final subject evaluability will be determined prior to breaking of the code for masked 
treatment (lens sequence) assignment and locking the database, based on the Deviations and 
Evaluability Plan. 
12.2 Analysis Sets 
12.2.1 Safety Analysis Set 
Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. 
As such, the safety analysis set will include all subjects/eyes exposed to any study lenses 
evaluated in this study. 
 
 
Therefore, any AE or device deficiency occurring after Informed Consent and prior to the 
initial exposure to the study lenses (test or comparator) under evaluation in this clinical 
protocol will be listed as pretreatment. For treatment-emergent safety analyses, subjects/eyes 
will be categorized under the actual study lenses exposed in the corresponding lens sequence.  

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12.2.2 Full Analysis Set 
The full analysis set (FAS) is the set of all randomized subjects who are exposed to any study 
lenses evaluated in this study,
 
 
12.3 Demographic and Baseline Characteristics 
Demographic information will be summarized by lens sequence and overall. Frequencies and 
percentages will be presented for categorical variables such as sex, age group, race, and 
ethnicity. Number of observations, mean, SD, median, minimum, and maximum will be 
presented for continuous variables such as age. 
12.4 Effectiveness Analyses 
This study defines 1 primar
effectiveness 
endpoint
 will use the FAS as the primary analysis set. 
 
12.4.1 Analysis of Primary Effectiveness Endpoint(s) 
The primary objective of this study is to evaluate visual acuity of the 
 Toric soft 
contact lenses. 
The primary endpoint is distance VA with study lenses, collected for each eye in logMAR. 
12.4.1.1 Statistical Hypotheses 
No inferences are to be made on the primary effectiveness endpoint; therefore, no hypotheses 
are formulated. 
12.4.1.2 Analysis Methods 
Descriptive statistics used for continuous variables will be presented. 

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12.5 Handling of Missing Data 
All data obtained in evaluable subjects/eyes will be included in the analysis. No imputation 
for missing values will be carried out for the primary 
ffectiveness 
analyses. 
12.6 Safety Analyses 
The safety endpoints are: 
• 
AEs 
• 
Biomicroscopy findings 
• 
Device Deficiencies 
There are no safety hypotheses planned in this study. The focus of the safety analysis will be 
a comprehensive descriptive assessment of occurrence of adverse events as well as the other 
listed parameters. 
All AEs occurring from the time a subject signs informed consent to study exit will be 
accounted for in the reporting. Safety analyses will be conducted using the safety analysis set 
on a treatment-emergent basis. Descriptive summaries (frequencies and percentages) for 
ocular and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities 
Preferred Terms. AEs leading to study discontinuation, significant nonserious AEs, and SAEs 
will be identified. Individual subject listings will be provided, as necessary. 
Individual subject listings will be provided for AEs that occur after signing informed consent 
but prior to exposure to IP. 
Each biomicroscopy parameter will be tabulated by its grade. For each biomicroscopy 
parameter, counts and percentages of eyes that experience an increase of ≥ 2 grades from 
baseline (last assessment prior to study lens exposure) to any subsequent visit within the 
same period will be presented. A supportive listing will be generated which will include all 
biomicroscopy data from all visits within the same period for those eyes experiencing the 
increase. 
Two listings for device deficiencies, prior to exposure to study contact lenses and treatment-
emergent, will be provided. Additionally, each device deficiency category will be tabulated. 
No inferential testing will be conducted for the safety analyses. 

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13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS 
13.1 Subject Confidentiality 
The investigator must ensure that the subject’s identity is kept confidential throughout the 
course of the study. In particular, the investigator must keep an enrollment log with 
confidential identifying information that corresponds to the subject numbers and initials of 
each study participant. The study sponsor may collect a copy of the enrollment log without 
any directly identifying subject information.  
The study sponsor may share patient-level data collected in this trial with qualified 
researchers to help facilitate product development or enhancements in research that is not 
directly related to the study objectives. The Informed Consent explains this to the study 
subject.  
13.2 Completion of Source Documents and Case Report Forms 
The nature and location of all source documents will be identified to ensure that original data 
required to complete the CRFs exist and are accessible for verification by the site monitor, 

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and all discrepancies shall be appropriately documented via the query resolution process. Site 
monitors are appointed by the study sponsor and are independent of study site staff. 
If electronic records are maintained, the method of verification must be determined in 
advance of starting the study.  
At a minimum, source documents include the following information for each subject: 
• 
Subject identification (name, sex, race/ethnicity) 
• 
Documentation of subject eligibility 
• 
Date of informed consent 
• 
Dates of visits 
• 
Documentation that protocol specific procedures were performed 
• 
Results of study parameters, as required by the protocol 
• 
IP accountability records 
• 
Documentation of AEs and other safety parameters (if applicable) 
• 
Records regarding medical histories and the use of concomitant therapies prior to and 
during the study 
• 
Date of study completion and reason for early discontinuation, if applicable 
It is required that the author of an entry in the source documents be identifiable. Direct access 
to source documentation (medical records) must be allowed for the purpose of verifying that 
the data recorded on the CRF are consistent with the original source data. 
Only designated individuals at the site will complete the CRFs. The CRFs must be completed 
at regular intervals following the clinical study visit schedule. It is expected that all data 
reported have corresponding entries in the source documents. The principal investigator is 
responsible for reviewing and certifying that the CRFs are accurate and complete. The only 
subject identifiers recorded on the CRFs will be subject number, and subject demographic 
information.  
13.3 Data Review and Clarifications 
A review of CRF data to the subject’s source data will be completed by the site monitor to 
ensure completeness and accuracy. After the CRFs have been completed, additional data 
clarifications and/or additions may be needed as a result of the data cleaning process. Data 
clarifications are documented and are part of each subject’s CRF. 

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13.4 Sponsor and Monitoring Responsibilities 
The study sponsor will select principal investigators that are qualified by education, training, 
and experience to assume responsibility for the proper conduct of this clinical trial.  
The study sponsor is financially funding this clinical trial and will compensate the 
investigator and/or the Institution(s) at which the study is conducted in accordance with a 
signed clinical trial agreement. 
The study sponsor will designate a monitor to conduct the appropriate site visits at the 
appropriate intervals according to the study monitoring plan. The clinical investigation will 
be monitored to ensure that the rights and well-being of the subjects are protected, the 
reported data are accurate, complete, and verifiable from the source documents, and the study 
is conducted in compliance with the current approved protocol (and amendments[s], if 
applicable), with current GCP, and with applicable regulatory requirements. 
The site may not screen subjects or perform the informed consent process on any subject 
until it receives a notification from an appropriate study sponsor representative that the site 
may commence conducting study activities. Monitoring will be conducted periodically while 
the clinical study is ongoing. Monitoring methods may include site visits, telephone, written 
and fax correspondence. Close-out visits will take place after the last visit of the last subject 
at the site. 
A coordinating investigator may be identified by the study sponsor to review and endorse the 
final study report. In cases where a coordinating investigator is engaged, the study sponsor 
will select the coordinating investigator based upon their experience, qualifications, active 
study participation, and their willingness and availability to take on this role. 
13.5 Regulatory Documentation and Records Retention 
The investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the study sponsor and the investigator’s files will be reviewed as part of the 
ongoing study monitoring. Financial information is to be kept separately.  
Additionally, the investigator must keep study records and source documents consistent with 
the terms of the clinical study agreement with the study sponsor. If the investigator retires, 
relocates, or for any other reason withdraws from responsibility of keeping the study records, 
then the study sponsor must be notified and suitable arrangements made for retention of study 
records and source documents needed to comply with national and international regulations. 

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13.6 Quality Assurance and Quality Control 
The study sponsor will secure agreement from all involved parties to ensure direct access to 
all study related sites, source data and documents, and reports for the purpose of monitoring 
and auditing by the study sponsor, and inspection by domestic and foreign regulatory 
authorities. Quality control will be applied to each stage of data handling to ensure that all 
data are reliable and have been processed correctly. Agreements made by the study sponsor 
with the investigator/institution and any other parties involved in the clinical study will be 
provided in writing as part of the protocol or as a separate agreement. 
14 ETHICS 
Investigations are conducted in compliance with Good Clinical Practices; international and 
national regulations, laws and guidelines; the conditions of approval imposed by reviewing 
IRBs/IECs or regulatory authorities; and in accordance with the ethical medical research 
principles outlined in the Declaration of Helsinki.  
• 
The SOPs of the study sponsor and contract research organizations participating in the 
conduct of the clinical study and all other applicable regulations shall apply.  
• 
Notifications and timelines for reporting protocol deviations should be based upon 
applicable Ethics Committee requirements. 
The investigator must ensure that all personnel involved in the conduct of the study are 
qualified to perform their assigned responsibilities through relevant education, training, and 
experience. The investigator and all clinical study staff must conduct the clinical study in 
compliance with the protocol. Deviations from this protocol, regulatory requirements, and/or 
GCP must be recorded and reported to the Sponsor prior to database lock. If needed, 
corrective and preventive action should be identified, implemented, and documented within 
the study records. Use of waivers to deviate from the clinical protocol is prohibited. 
Before clinical study initiation, this protocol, the informed consent form any other written 
information given to subjects, and any advertisements planned for subject recruitment must 
be approved by an IRB/IEC. The investigator must provide documentation of the IRB/IEC 
approval to the study sponsor. The approval must be dated and must identify the applicable 
protocol, amendments (if any), informed consent form, assent form (if any), all applicable 
recruiting materials, written information for subject, and subject compensation programs. The 
IRB/IEC must be provided with a copy of the Package Insert, any periodic safety updates, 
and all other information as required by local regulation and/or the IRB/IEC. At the end of 
the study, the investigator must notify the IRB/IEC about the study’s completion. The 

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IRB/IEC also must be notified if the study is terminated prematurely. Finally, the investigator 
must report to the IRB/IEC on the progress of the study at intervals stipulated by the 
IRB/IEC. 
Voluntary informed consent must be obtained in writing from every subject. The obtaining of 
consent shall be documented before any procedure specific to the clinical investigation is 
applied to the subject.  
The investigator must have a defined process for obtaining the required consent. Specifically, 
the investigator, or their delegate, must explain the clinical study to each potential subject and 
the subject must indicate voluntary consent by signing and dating the approved informed 
consent form. The subject must be provided an opportunity to ask questions of the 
investigator, and if required by local regulation, other qualified personnel. The investigator 
must provide the subject with a copy of the consent form written in a language the subject 
understands. The consent document must meet all applicable local laws and provide subjects 
with information regarding the purpose, procedures, requirements, and restrictions of the 
study, along with any known risks and potential benefits associated with the IP and the study, 
the available compensation, and the established provisions for maintaining confidentiality of 
personal, protected health information. Subjects will be told about the voluntary nature of 
participation in the study and must be provided with contact information for the appropriate 
individuals should questions or concerns arise during the study. The subject also must be told 
that their records may be accessed by appropriate authorities and sponsor-designated 
personnel. The investigator must keep the original, signed copy of the consent (file in 
subject’s medical records) and must provide a duplicate copy to each subject according to 
local regulations.  
The study sponsor assures that the key design elements of this protocol will be registered on 
www.clinicaltrials.gov if required by current regulations and, if applicable, other public 
databases as required by local country regulations. In addition, results of this study will be 
made publicly available on www.clinicaltrials.gov regardless of outcome if required by 
current regulations and, if applicable, in other public databases as required by local country 
regulations. 
15 REFERENCES 
15.1 Regulations and Standards 
The following references may be applicable in whole or in part for this clinical trial. 
• 
21 CFR Part 11 - Electronic Records; Electronic Signatures 

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• 
21 CFR Part 50 - Protection of Human Subjects 
• 
21 CFR Part 56 - Institutional Review Boards 
• 
21 CFR Part 812 - Investigational Device Exemptions 
• 
21 CFR Part 54 - Financial Disclosure by Clinical Investigators 
• 
The California Bill of Rights, if applicable 
15.2 Scientific and Other References 
Not applicable. There are no references.