Comparison of Clinical Performance of Two Monthly Replacement Toric Soft Contact Lenses
Phase: NA
Conditions: Ametropia, Astigmatism
Sponsor: Alcon Research

 
 
 
 
 
Comparison of Clinical Performance of Two Monthly 
Replacement Toric Soft Contact Lenses 
 
STUDY ID 
CLV201-P003 
 
PROTOCOL 
 
 
NCT06165627 

Document ID: 
V-CLN-0183501 
Status: Approved, Version: 3.0 
Approved Date: 15 Dec 2023 
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Alcon – Business Use Only 
 
 
 
 
Device Protocol for CLV201-P003 
Title: Comparison of Clinical Performance of Two Monthly Replacement 
Toric Soft Contact Lenses 
Protocol Number: 
CLV201-P003 
 
Clinical Investigation 
Type:  
Postmarket Interventional 
Test Product: 
TOTAL30™ for Astigmatism (lehfilcon A) 
Sponsor Name and 
Address: 
Alcon Research, LLC, and its affiliates (“Alcon”) 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
 
 
 
 
 
 
Property of Alcon 
Confidential 
May not be used, divulged, published, or otherwise disclosed without the consent of Alcon 

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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: 
 
 
 
 

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Table of Contents 
Device Protocol for CLV201-P003 ............................................................................................ 1 
Table of Contents ....................................................................................................................... 3 
List of Tables.............................................................................................................................. 5 
List of Figures ............................................................................................................................ 6 
1 
GLOSSARY OF TERMS .................................................................................................... 7 
2 
LIST OF ACRONYMS AND ABBREVIATIONS ........................................................... 13 
3 
PROTOCOL SUMMARY ................................................................................................. 15 
 
 
5 
INTRODUCTION ............................................................................................................. 26 
5.1 
Rationale and Background ................................................................................ 26 
5.2 
Purpose of the Study .......................................................................................... 27 
5.3 
Risks and Benefits ............................................................................................. 27 
6 
STUDY OBJECTIVES ..................................................................................................... 28 
6.1 
Primary Objective(s) ......................................................................................... 28 
6.2 
Secondary Objective(s) ..................................................................................... 28 
6.3 
Safety Objective(s) ............................................................................................ 28 
7 
INVESTIGATIONAL PLAN ............................................................................................ 28 
7.1 
Study Design ..................................................................................................... 28 
7.2 
Rationale for Study Design ............................................................................... 29 
7.3 
Rationale for Duration of Treatment/Follow-up................................................ 29 
7.4 
Rationale for Choice of Comparator Product .................................................... 30 
8 
STUDY POPULATION .................................................................................................... 30 
8.1 
Inclusion Criteria ............................................................................................... 30 
8.2 
Exclusion Criteria .............................................................................................. 31 
8.3 
Rescreening of Subjects .................................................................................... 33 
9 
TREATMENTS ADMINISTERED .................................................................................. 33 
9.1 
Investigational Product(s) .................................................................................. 33 
9.2 
Other Medical Device or Medication Specified for Use During the Study ...... 36 
9.3 
Treatment Assignment/Randomization ............................................................. 36 
9.4 
Treatment Masking ............................................................................................ 37 

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9.5 
Accountability Procedures ................................................................................. 39 
9.6 
Changes to Concomitant Medications, Treatments/Procedures ........................ 39 
10 STUDY PROCEDURES AND ASSESSMENTS ............................................................. 40 
10.1 Informed Consent and Screening ...................................................................... 40 
10.2 Description of Study Procedures and Assessments ........................................... 40 
10.2.1 
Demographics .................................................................................... 41 
10.2.2 
Medical History and Concomitant Medication ................................. 41 
10.2.3 
Investigational Product Compliance ................................................. 41 
10.2.4 
Adverse Event Collection: Safety Assessment .................................. 41 
10.2.5 
Slit Lamp Biomicroscopy: Safety Assessment .................................. 41 
10.2.6 
Device Deficiencies: Safety Assessment ........................................... 41 
 
 
10.3 Unscheduled Visits ............................................................................................ 42 
 
 
10.5 Discontinued Subjects ....................................................................................... 42 
10.5.1 
Screen Failures .................................................................................. 42 
10.5.2 
Discontinuations ................................................................................ 43 
10.5.3 
Schedule of Procedures and Assessments for Subjects 
Discontinued from Investigational Product ....................................... 43 
10.6 Clinical Study Termination ................................................................................ 43 
10.6.1 
Follow-up of Subjects after Study Participation has Ended .............. 44 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ................................................... 44 
11.1 General Information .......................................................................................... 44 
11.2 Monitoring for Adverse Events ......................................................................... 47 
11.3 Procedures for Recording and Reporting .......................................................... 47 
11.4 Return Product Analysis .................................................................................... 49 
11.5 Unmasking of the Study Treatment ................................................................... 50 
11.6 Follow-up of Subjects with Adverse Events ..................................................... 50 
11.7 Pregnancy in the Clinical Study ........................................................................ 50 
12 ANALYSIS PLAN ............................................................................................................ 51 
12.1 Subject Evaluability........................................................................................... 51 
12.2 Analysis Sets ..................................................................................................... 51 
12.2.1 
Safety Analysis Set ............................................................................ 51 
12.3 Demographic and Baseline Characteristics ....................................................... 51 

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12.4 Effectiveness Analyses ...................................................................................... 51 
12.4.1 
Analysis of Primary Effectiveness Endpoint(s) ................................ 52 
12.4.1.1 
Statistical Hypotheses ........................................................ 52 
12.4.1.2 
Analysis Methods .............................................................. 52 
12.5 Handling of Missing Data ................................................................................. 54 
12.6 Safety Analyses ................................................................................................. 54 
12.7 Interim Analyses and Reporting ........................................................................ 55 
 
 
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ............................... 55 
13.1 Subject Confidentiality ...................................................................................... 55 
13.2 Completion of Source Documents and Case Report Forms .............................. 55 
13.3 Data Review and Clarifications ......................................................................... 56 
13.4 Sponsor and Monitoring Responsibilities ......................................................... 56 
13.5 Regulatory Documentation and Records Retention .......................................... 57 
13.6 Quality Assurance and Quality Control ............................................................. 57 
14 ETHICS ............................................................................................................................. 58 
15 REFERENCES .................................................................................................................. 59 
15.1 Regulations and Standards ................................................................................ 59 
15.2 Scientific and Other References ........................................................................ 60 
 
 
List of Tables 
Table 2–1 
List of Acronyms and Abbreviations Used in This Protocol ........................... 13 
Table 3–1 
Schedule of Study Procedures and Assessments ............................................. 21 
Table 6–1 
Primary Objective(s) ........................................................................................ 28 
Table 6–2 
Safety Objective(s) .......................................................................................... 28 
Table 9–1 
Test Product ..................................................................................................... 33 
Table 9–2 
Comparator Product ......................................................................................... 35 

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List of Figures 
Figure 11-1 
Categorization of All Adverse Events .............................................................. 45 
Figure 11-2 
Categorization of All Serious Adverse Events ................................................. 45 
 
 
 
 

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1 GLOSSARY OF TERMS 
 
Names of Test Product(s) 
Throughout this document, test product(s) will be referred to 
as TOTAL30 for Astigmatism (lehfilcon A) soft contact 
lenses 
Name of Comparator 
Product(s) 
CooperVision® Biofinity® Toric (comfilcon A) soft contact 
lenses (No Biofinity Toric XR) 
Adverse Device Effect 
(ADE) 
 
Adverse event related to the use of an investigational 
medical device or comparator. 
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.  
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 or comparator 
and whether anticipated or unanticipated.  
Note: For subjects, 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 the use of the investigational 
medical device or comparator. 
Requirements for reporting adverse events in the study can 
be found in Section 11. 
Anticipated Serious 
Adverse Device Effect 
(ASADE) 
 
An effect which by its nature, incidence, severity, or 
outcome has been identified in the risk assessment. 
Clinical Investigation Plan 
The document(s) stating the rationale, objectives, design, 

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(CIP) 
 
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 related to the investigational medical 
device or the comparator. 
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 
in addition to those available as normal clinical practice and 
burden the subject. 

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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). 
Noninterventional Study 
 
Clinical investigation that draws inferences about the 
possible effect of an intervention on subjects, but the 
investigator has not assigned subjects into intervention 
groups based on a protocol and has not made any attempts to 
collect data on variables beyond those available throughout 
the course of normal clinical practice and burden to the 
subject. 
NOTE: The term “noninterventional” is synonymous with 
“observational.” 
Nonserious Adverse Event 
Adverse event that does not meet the criteria for a serious 
adverse event. 
Postmarketing / 
Postauthorization study 
 
Any study conducted within the conditions laid down in 
product labelling and other conditions laid down for the 
marketing of the product or under normal conditions of use. 
A postmarketing study falls either within the definitions of 
an interventional or a noninterventional study and may also 
fall within the definition of a postapproval study. 
Product Complaint 
 
Any oral, electronic, or written communication that alleges 
deficiencies related to the identity (labeling), quality, 
durability, reliability, safety, effectiveness, or performance 
of a marketed product, including failure of the product, 

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labeling, or packaging to meet specifications, whether or not 
the product is related to or caused the alleged deficiency. A 
complaint may allege that an adverse event or medical 
device malfunction has occurred. 
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. 
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 

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birth defect including physical or mental impairment. 
Note: Planned hospitalization for a preexisting 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.  
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 

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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) soft contact lenses (No 
Biofinity Toric XR)  
BVL 
Blue-violet light 
CFR 
Code of Federal Regulations 
CI 
Confidence interval 
CIP 
Clinical investigation plan 
CIR 
Clinical investigation report 
CL 
Confidence limit 
 
 
COL 
Clinical Operations Lead 
CRF 
Case report form 
CSM 
Clinical Site Manager 
CTT 
Clinical Trail Team 
D 
Diopter 
DEP 
Data evaluability plan 
DFU 
Directions for use 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
EN 
European Standard 
FDA 
US Food and Drug Administration 
GCP 
Good Clinical Practice 
IB 
Investigator’s brochure 
ICF 
Informed consent form 
IEC 
Independent ethics committee 
IP 
Investigational product 
IRB 
Institutional review board 
IRT 
Interactive Response Technology  
ISO 
International Organization for Standardization 
LogMAR 
Logarithm of the minimum angle of resolution 
mm 
millimeter 
MOP 
Manual of procedures 
N/A 
Not applicable 
OD 
Right eye 
OS 
Left eye 
 
 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 
SD 
Standard deviation 
SLE 
Slit lamp examination 
SOP 
Standard operating procedure 

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Abbreviation 
Definition 
T30fA 
TOTAL30 for Astigmatism (lehfilcon A) soft contact lenses 
USA 
United States of America 
USADE 
Unanticipated serious adverse device effect 
UV 
Ultraviolet 
VA 
Visual acuity 
 
 

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3 PROTOCOL SUMMARY 
Investigational 
product type 
Device 
Study type 
Interventional 
Investigational 
products 
Test Product: TOTAL30 for Astigmatism soft contact lenses 
(T30fA; lehfilcon A)   
Comparator Product: CooperVision Biofinity Toric soft contact 
lenses (Biofinity Toric; comfilcon A) (No Biofinity Toric XR) 
Purpose and Scientific 
Rationale for the 
Study 
Purpose of the study: 
The purpose of this study is to assess the clinical performance of 
TOTAL30 for Astigmatism (T30fA) soft contact lenses with 
Biofinity Toric soft contact lenses 
 
 
 
 
Brief Summary of the 
Protocol 
The objective of this study is to evaluate the clinical 
performance of 2 toric lenses: T30fA and Biofinity Toric soft 
contact lenses in a 30-day trial 
 
. This will be a randomized (participants 
are placed into groups by chance) 
 
 bilateral 
crossover (participants will wear both study lenses that are 
intended for astigmatism), double-masked (both participants and 
investigators do not know which study lens they are receiving), 
multicenter study.  
This study will include volunteer participants 18-45 years old 
who currently wear toric contact lenses (participants who 
already wear Biofinity Toric or Alcon brand toric soft contact 
lenses, or those who wear daily disposable contact lenses will be 
excluded from this study). The participants need to have worn 
their toric contact lenses for at least 5 days per week and at least 
12 hours a day during the past 3 months to qualify for this study. 
 
 
 
 
 

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Objective(s) 
The primary objective is to evaluate the clinical performance of 
TOTAL30 for Astigmatism (T30fA) soft contact lenses as 
compared to Biofinity Toric soft contact lenses.  
The safety objective is to describe the safety profile of the study 
products.  
Endpoint(s)  
 
Primary Effectiveness  
• 
Distance VA (logMAR; OD, OS) with study lenses at Day 
30 

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Safety 
• 
AEs 
• 
Biomicroscopy findings 
• 
Device deficiencies 
Assessment(s)  
Effectiveness 
• 
Distance VA (logMAR; OD, OS) with study lenses  

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• 
Distance VA (logMAR) with habitual lenses 
• 
Manifest refraction 
• 
BCVA (logMAR distance with manifest refraction) 
• 
Medical history/concomitant medication 
Safety 
• 
AEs 
• 
Biomicroscopy 
• 
Device deficiencies 
Study Design 
This will be a prospective, randomized 
, bilateral, 
crossover, double-masked, multicenter study. 
Subjects will be expected to attend 5 office visits including 
screening. The total duration of the subject’s participation in the 
study will be approximately 74 days. Subject is expected to 
wear each of the assigned study lenses (test and comparator 
lenses) for 30 days of bilateral wear (total of 60 days of lens 
wear). 
Subject population 
• Volunteer subjects aged 18-45 years of age.  
• Current habitual toric soft contact lens wearers, with at least 
3 months of contact lens wearing experience (excluding any 
Biofinity Toric soft habitual contact lens wearers, Alcon 
Toric contact lens wearers, and habitual daily disposable 
lens wearers). 
• Wear habitual lenses at least 5 days per week and at least 12 
hours per day during the past 3 months. 
• To qualify, subjects must be able to wear contact lenses 
within a range of sphere & cylinder power and axes (Sphere: 

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-0.50 D to -6.00 D in 0.25 D steps; Cylinder: -0.75 D and  
-1.25 D; Axis: 10º, 80º, 90º, 100º, 170º, 180º). 
 
 
 
Planned number of subjects enrolled/consented: ~ 66 
Planned number of completed subjects: 60 
Sites and Locations 
Planned number of clinical sites: ~ 5 
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 
complete list of 
inclusion criteria) 
• Successful wearer of toric soft contact lenses in both 
eyes for a minimum of 5 days per week and at least 12 
hours per day during the past 3 months. 
• Best corrected distance visual acuity (as determined by 
manifest refraction at screening) better than or equal to 
0.10 logMAR in each eye. 
• Able to wear contact lenses within a range of sphere & 
cylinder power and axes (Sphere: -0.50 D to -6.00 D in 
0.25 D steps; Cylinder: -0.75 D and -1.25 D; Axis: 10º, 
80º, 90º, 100º, 170º, 180º). 
Key exclusion criteria 
(See Section 8.2 for a 
complete list of 
exclusion criteria) 
• 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. 
• Monovision and multifocal contact lens wearers. 
• Habitual Biofinity Toric soft contact lens wearers, daily 
disposable contact lens wearers, and Alcon Toric contact 
lens wearers in the past 3 months prior to consent. 
• Wearing habitual contact lenses in extended wear 
modality (routinely sleeping in lenses for at least 1 night 
per week) over the last 3 months prior to enrollment 

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Data analysis and 
sample size 
justification 
Planned Data Analysis  
All effectiveness endpoints will be summarized descriptively 
according to their respective measurement scales. 
 
 
Associated materials 
• CLEAR CARE® Cleaning and Disinfecting solution 
• LacriPure saline will be permitted for rinsing the lens(es) if 
needed. 
• Lubrication/rewetting drops will not be permitted during 
study. 
 
 

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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. 
  
5 INTRODUCTION 
5.1 Rationale and Background 
T30fA are a new monthly replacement soft contact lenses, which utilize water gradient 
technology, and contain 55% water content at the core that gradually increases to nearly 
100% at the outer surface. The lenses also use biomimetic Celligent Technology, which has 
properties that allow the lens to mimic the corneal surface. The innovative surface chemistry 
provides an extremely soft and lubricious lens surface and helps to resist bacterial and lipid 
deposit adhesion. T30fA contact lenses also offer UV and blue-violet light (BVL) filtering. 
T30fA lenses are indicated for the optical correction of refractive ametropia (myopia and 
hyperopia, with astigmatism) in persons with nondiseased eyes. 
 

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5.2 Purpose of the Study 
The purpose of this study is to assess the clinical performance of T30fA contact lenses 
compared to the commercially available Biofinity Toric soft contact lenses 
 
 
 
The endpoints have been 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 package insert. Biofinity Toric soft contact lenses were chosen as the 
comparator product because these lenses have the same wear modality and replacement 
schedule. 
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, as 
recommended by the eye care professional. Lenses should be discarded and replaced after 
one month. 
There are no immediate plans to submit the results of this study for publication; however, the 
results may be offered for publication if they are of scientific interest, or if the results relate to 
a product that is subsequently approved or cleared for marketing.  
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.  
T30fA (lehfilcon A) soft contact lenses and Biofinity Toric contact lenses are commercially 
available for daily wear use under a frequent replacement wear modality; further details on 
any known potential risks and benefits can be found in the DFU.  
A summary of the known potential risks and benefits associated with the T30fAand Biofinity 
Toric soft contact lenses can be found in the package insert. Any risk to subjects in this 
clinical study will be minimized by compliance with the eligibility criteria and study 
procedures, as well as through close clinical supervision by a licensed clinician during 

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exposure to the study lenses. The site personnel will educate subjects on proper hygiene and 
lens handling, as well as compliance with the use of contact lenses according to the protocol. 
Refer to the package insert for additional information on risks and benefits.   
6 STUDY OBJECTIVES 
6.1 Primary Objective(s) 
Table 6–1 
Primary Objective(s) 
Objective(s) 
Endpoint(s) 
The objective of this study is to evaluate the 
clinical performance of TOTAL30 for 
Astigmatism (T30fA) soft contact lenses as 
compared to Biofinity Toric soft contact lenses 
• 
Distance VA (logMAR; OD, OS) with 
study lenses at Day 30 
 
 
 
 
6.2 Secondary Objective(s) 
Not applicable. 
6.3 Safety Objective(s)  
Table 6–2 
Safety Objective(s) 
Objective(s) 
Endpoint(s) 
Describe the safety profile of the study products 
• 
Adverse events 
• 
Biomicroscopy findings 
• 
Device deficiencies 
7 INVESTIGATIONAL PLAN 
7.1 Study Design 
This is a prospective, randomized, bilateral crossover, controlled, double-masked, clinical 
study to be conducted at approximately 5 sites. Eligible habitual toric soft contact lens 
wearers will be randomized to 1 of the 2 crossover sequences. Investigator and subject will 
be masked. A designated unmasked study staff member will prepare the contact lenses for 
dispensing. 

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Subjects will be expected to attend 5 office visits and will be dispensed study lenses (per 
randomization sequence) for 30-day duration of bilateral wear with each study lens (~60 days 
of lens wear). 
 
 
 the 
subject will wear the lenses each day for at least 12 hours per day.  
At Visit 1 screening/baseline, lens fitting and randomization will be performed. Subject will 
return to the office for Visit 2 and Visit 4 after washout period (2-4 days) and will be 
dispensed their assigned study lens by an unmasked study staff member.  
At Visit 3 and Visit 5 (Day 30 -1/+3 days) in-office lens fitting assessments for study lenses 
will be performed; once Visit 5 is complete subjects will exit from the study.  
7.2 Rationale for Study Design  
The crossover design will ensure that the same subject is exposed to both the test and 
comparator lens materials; therefore, 
objective assessments 
 
will be obtained for both lenses from the same subject. The study will include only those 
subjects who are current wearers of toric soft contact lenses in both eyes with at least 3 
months wearing experience, with a minimum wearing time of 5 days per week, and at least 
12 hours per day. This will avoid confounding 
 safety responses in nonadapted 
subjects. Furthermore, the subjects will not be permitted to use lubrication/rewetting drops 
during the duration of the study 
 
7.3 Rationale for Duration of Treatment/Follow-up 
The duration of product use is in accordance with product labeling. 
 

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7.4 Rationale for Choice of Comparator Product 
The Biofinity Toric soft contact lens was chosen as the comparator product as these lenses 
have the same wear modality and replacement schedule as T30fA.  
8 STUDY POPULATION 
The study population consists of male and female subjects ages 18-45 who are habitual toric 
soft contact lens wearers who have at least 3 months of contact lens wearing experience 
(excluding any Biofinity Toric habitual lens wearers, Alcon Toric contact lens wearers and 
habitual daily disposable lens wearers) and who wear their habitual lenses at least 5 days per 
week and at least 12 hours per day 
 
 
. To qualify, subjects must be able to wear contact lenses within a range of sphere 
and cylinder power and axes (Sphere: -0.50 D to -6.00 D in 0.25 D steps; Cylinder: -0.75 D 
and -1.25 D; Axis: 10º, 80º, 90º, 100º, 170º, 180º). 
 
 
It is aimed to enroll (consent) approximately 66 subjects in approximately 5 sites in the USA 
with a target of 60 total subjects completed 
 
. Site-specific targets 
may vary based upon individual site capabilities. Estimated time needed to recruit subjects 
for the study is approximately 6 weeks; however, unanticipated circumstances may shorten or 
lengthen this time and would not require amendment of this protocol. Because a 10% 
screening failure rate is expected, approximately 66 subjects are expected to be enrolled.   
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. 

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Subjects eligible for inclusion in this study must fulfill all of the following criteria: 
1. 
Subject must be 18-45 years old and must be able to understand and sign an 
IRB/IEC approved informed consent form.  
2. 
Willing and able to attend all scheduled study visits as required per protocol. 
3. 
Successful wearer of toric soft contact lenses in both eyes for a minimum of 5 days 
per week and at least 12 hours per day during the past 3 months. 
4. 
Best corrected distance visual acuity (as determined by manifest refraction at 
screening) better than or equal to 0.10 logMAR in each eye. 
5. 
Able to wear contact lenses within a range of sphere and cylinder power and axes 
(Sphere: -0.50 D to -6.00 D in 0.25 D steps; Cylinder: -0.75 D and -1.25 D; Axis: 
10º, 80º, 90º, 100º, 170º, 180º). 
6. 
Subject must be willing to stop wearing their habitual contact lenses for the duration 
of study participation. 
8. 
Subject must possess spectacles and willing to wear habitual spectacles for vision 
correction when study lenses are not worn, as needed. 
9. 
Subject must be willing to NOT use rewetting/lubricating drops and topical ocular 
medication at any time during study. 
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 
investigator, 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. 
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. 
11. 
Participation of the subject in a clinical trial within the previous 30 days or currently 
enrolled in any clinical trial. 
12. 
Monovision and multifocal contact lens wearers. 
13. 
Habitual Biofinity Toric/Biofinity Toric XR, daily disposable contact lens wearers, 
and Alcon Toric contact lens wearers in the past 3 months prior to consent. 
14. 
Wearing habitual contact lenses in extended wear modality (routinely sleeping in 
lenses for at least 1 night per week) over the last 3 months prior to enrollment 
15. 
Currently pregnant, as stated by subject. 

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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): 
TOTAL30 for Astigmatism (lehfilcon A)  
 
Comparator Product(s) (If 
applicable): 
CooperVision Biofinity Toric (comfilcon A)  
Table 9–1 
Test Product 
Test Product 
TOTAL30 for Astigmatism (lehfilcon A) soft contact lenses  
Manufacturer 
Alcon Laboratories, Inc. 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
USA 
Indication for use 
and intended 
purpose in the 
current study  
TOTAL30 for Astigmatism (lehfilcon A) soft contact lenses are 
indicated for the optical correction of ametropia (myopia or 
hyperopia, with astigmatism) in persons with nondiseased eyes. 
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, as recommended by the eye 
care professional. Lenses should be discarded and replaced after one 
month. 
Product description 
and parameters 
available for this 
study 
• Material: lehfilcon A 
• Water content: 55% by weight in normal saline 
• Power range: 
o Sphere: -0.50 to -6.00 D in 0.25 D steps 
o Cylinder: -0.75 and -1.25 D  
o Axis: 10º, 80º, 90º, 100º, 170º, 180º 
• Base curve (mm): 8.6 
• Diameter (mm): 14.5 

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Formulation 
Refer to the package insert/DFU for the lens material and package 
saline formulation. 
Usage 
• Wear: 
o Daily Wear  
o Bilateral 
• Replacement period:  30-day replacement 
• Exposure: Subject duration of exposure to test lenses will be 
approximately 30 days and at least 12 hours per day. 
 
 
 
 
 
 
• Lens Care: CLEAR CARE Cleaning & Disinfecting Solution 
will be used during the duration of the study. 
Number/Amount of 
product to be 
provided to the 
subject 
Each site will procure their own test lenses. 
Packaging 
description 
Provided in commercial packaging 
Labeling description Commercial foil 
 
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. 
Additional 
information 
N/A 

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Supply 
Site will procure the lenses which are commercially available. Refer 
to the MOP for a detailed description. 
 
Table 9–2 
Comparator Product 
Comparator 
Product(s) 
Biofinity® Toric (comfilcon A) soft contact lenses 
(No Biofinity Toric XR) 
Manufacturer 
CooperVision 
Indication for Use 
The intended use of this product is for vision correction. 
Product description 
and parameters 
available for this 
study 
• Material: comfilcon A 
• Water content: 48% 
• Power range:  
o Sphere: -0.50 to -6.00 D in 0.25 D steps 
o Cylinder: -0.75 and -1.25 D  
o Axis: 10º, 80º, 90º, 100º, 170º, 180º 
• Base curve (mm): 8.7 
• Diameter (mm):14.5 
Formulation 
Refer to the package insert/DFU for the lens material and package 
saline formulation. 
Usage 
• Wear: 
o Daily Wear 
o Bilateral 
• Replacement period: 30-day replacement 
• Exposure: Subject duration of exposure to comparator lenses 
will be approximately 30 days and at least 12 hours per day. 
 
 
 
 
• Lens Care: CLEAR CARE Cleaning & Disinfecting Solution 
will be used during the duration of the study. 
 

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Number/Amount of 
Product to be 
Provided to the 
subject 
Each site will procure their own comparator lenses. 
Packaging 
description 
Provided in commercial packaging 
Labeling description Commercial foil 
 
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. 
Additional 
identifying 
information 
N/A 
Supply 
Site will procure the lenses which are available commercially. Refer 
to the MOP for a detailed description. 
 
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 
Qualified subjects will be 
 randomized in a 1:1 ratio to 
receive treatment (lens) in crossover sequence: test product then comparator product or 
comparator product then test product, respectively. 
Sequence 1: T30fA/Biofinity Toric 
Sequence 2: Biofinity Toric/T30fA 

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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 
system to one of the treatments (lens sequences). The unmasked delegate will access the 
respective system after 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 (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 crossover manner for 30 days 
bilateral wear of T30fA soft contact lens and Biofinity Toric soft contact lens (total of 60 days 
of lens wear).
 
 

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This level of masking will be maintained throughout the conduct of the study. Unmasking 
will occur only after all planned study data have been validated, and the database locked.  
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. 
Unmasking must be done according to the instructions provided for the study IRT system. 

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9.5 Accountability Procedures 
Upon receipt of the IPs, the unmasked delegate must conduct an inventory, as applicable. 
During the study, designated unmasked study staff will provide the study lens to the subjects 
in accordance with their randomization assignment. Throughout the study, the unmasked 
delegate must maintain records of IP dispensation and collection for each subject. This record 
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 unmasked delegate should make every effort to collect used lenses 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, solutions 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 or site staff 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)  

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The investigator must document this information in the subject’s case history source 
documents. 
10 STUDY PROCEDURES AND ASSESSMENTS 
Subjects will be expected to attend 5 office visits, as shown below. 
Visit # 
Visit Type 
Visit Window 
Visit 1 
Screen/Baseline/Lens Fitting 
N/A 
Visit 2 
Dispense Lens 1 
2 days (at least 48 hours) - 4 days 
washout period with habitual spectacles 
only after Visit 1 
Visit 3 
Day 30 Follow-up Lens 1 
Day 30 (-1/+3 days)  
Visit 4 
Dispense Lens 2  
2 days (at least 48 hours) - 4 days 
washout period with habitual spectacles 
only after Visit 3 
Visit 5 
Day 30 Follow-up Lens 2/Exit 
Day 30 (-1/+3 days) 
 
Unscheduled visits and early exit visits are allowed, if necessary. 
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.  
10.2 Description of Study Procedures and Assessments 
Study-specific procedures and assessments described here may include standard of care; 
other standard of care procedures performed in the clinical management of the subject are not 
excluded. 
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. 

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10.2.1 Demographics 
Obtain demographic information including age, race, ethnicity, and sex. 
10.2.2 Medical History and Concomitant Medication 
Collect medical history information (within 1 year prior to screening visit), 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. 
Targeted 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. 
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. See Section 11 
for further details regarding AE collection and reporting. 
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. 
Note: AEs and device deficiencies must be recorded for all enrolled subjects from the time of 
signature of informed consent, regardless of subject enrollment status (screen failure or 
randomized). 

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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, as applicable 
• 
Collect device deficiency information, as applicable 
• 
Record changes in medical condition or concomitant medication 
• 
Biomicroscopy  
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 as possible. 
10.4 Unplanned Lens Replacement 
No spare lenses will be dispensed to the subject. If a lens is lost, damaged, or needs to be 
replaced due to a device deficiency/ADE, the subject will be instructed to return for an 
unplanned lens replacement. Refer to MOP for details.  
10.5 Discontinued Subjects 
10.5.1 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. 

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10.5.2 Discontinuations 
Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the 
study by the investigator after signing the informed consent.   
Subject numbers of discontinued subjects must not be reused (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 10.5.3, 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. 
10.5.3 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 and the MOP for details.  
10.6 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: 

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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 poststudy 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. 
10.6.1 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, 
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. 

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Figure 11-1 
Categorization of All Adverse Events 
 
 
Figure 11-2 
Categorization of All Serious Adverse Events 
 
Serious Adverse Events  
In addition to reporting all adverse events (serious and nonserious) meeting the definitions, 
the investigator must report any occurrence of the following as an SAE:  
• 
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  

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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 BCVA from Baseline 
Visit that fails to resolve  
• 
Uveitis (anterior, intermediate, or posterior)  
• 
Corneal abrasion affecting ≥ 50% of corneal surface area  
NOTE: For cultured events, document available results in the narrative section(s) of the 
corresponding ADE-SAE eCRF.  
Other Ocular Adverse Events  
The investigator must also report any ocular AE that is nonserious, device-related, nonsight 
threatening, and warrants discontinuation of any Contact Lens wear for greater than or equal 
to 2 weeks. The following are examples of such AEs:  
• 
Peripheral nonprogressive noninfectious ulcers  
• 
All symptomatic corneal infiltrative events  
• 
Corneal staining score moderate (dense coalescent staining up to 2 mm) or greater  
• 
Temporary vision loss as defined by loss of 2 or more lines of BCVA from baseline 
visit that persists for 2 or more weeks  
• 
Neovascularization with vessel penetration of 1 mm or greater  
 

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The above events are based on the categories provided in the International Organization for 
Standardization (ISO) 11980 and the US FDA Premarket Notification (510(k)) Guidance 
Document for Daily Wear Contact Lenses and Contact Lens Care. 
Device Deficiencies 
A device deficiency may or may not be associated with subject 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 for the identified or suspect device deficiency and report 
any subject harm separately. Examples of device deficiencies include the following:  
• 
Failure to meet product specifications (e.g., incorrect lens power/diameter/base 
curve/color) 
• 
Lens cloudy 
• 
Lens surface/edge defect 
• 
Torn lens during handling/in pack 
• 
Packaging deficit (e.g., mislabeled product) 
• 
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 since your last study visit?” 
In addition, changes in any protocol-specific parameters 
 evaluated 
during the study are to be reviewed by the investigator. Any untoward (unfavorable and 
unintended) change in a protocol-specific parameter 
 that is 
clinically relevant, in 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 preexisting medical conditions or 
signs/symptoms present in a subject prior to the start of the study (i.e., before informed 

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consent is signed) are not considered AEs in the study and should be recorded in the medical 
history section of the eCRF. 
In addition, temporary lens awareness or visual changes during the fitting process are not 
considered AEs if the investigator assesses that the symptom(s) can reasonably resolve within 
the anticipated adaptation period.  
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: 
• 
All SAEs must be reported immediately (within 24 hours) of the investigator’s or site’s 
awareness.  
• 
ADEs that do not meet seriousness criteria and device deficiencies must be reported 
within 10 calendar days 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 adverse device effect (for related 
AEs) and Serious Adverse Event 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. 
 
 
 
 
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. 

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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. 
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 AE that is 
upgraded from nonserious to serious or from unrelated to related. 
11.4 Return Product Analysis  
Study sponsor representatives and their contact information are provided in the MOP that 
accompanies this protocol.  

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11.5 Unmasking of the Study Treatment 
Masked information on the identity of the assigned medical device should not be disclosed 
during the study. 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 subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (i.e., database lock).  
All complaints received after this time period will be considered and processed as 
spontaneous (following the post market 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 (i.e., Biofinity Toric) 
directly to the manufacturer as per the manufacturer’s instructions or local regulatory 
requirements. 
11.7 Pregnancy in the Clinical Study 
Women who are pregnant (as stated by subject) at the time of study entry are excluded from 
participation. However, pregnancy should be included in the Pregnancy eCRF if a woman 
becomes pregnant (as stated by the subject) 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. 

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12 ANALYSIS PLAN 
Continuous variables will be summarized using the number of observations, mean, SD, 
median, minimum, and maximum, as well as CIs or CLs where applicable. 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 
Final subject evaluability must be determined prior to breaking the code for masked treatment 
(lens sequence) assignment and locking the database, based upon the data evaluability plan 
(DEP). 
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. 
 
 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. 
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 (race 
subgroups), 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 primary effectiveness endpoint 
 
. All effectiveness evaluations will use the safety analysis set. 

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12.4.1 Analysis of Primary Effectiveness Endpoint(s) 
The primary objective is to evaluate the clinical performance of T30fA soft contact lenses as 
compared to Biofinity Toric soft contact lenses. 
The primary endpoint is distance VA with study lenses at Day 30, 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 will be provided as number of observations, mean, SD, median, 
minimum, and maximum. 
  

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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 effectiveness 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 AEs as well as the other listed 
parameters. 
All AEs occurring from the time a subject signs the 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 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 will be 
presented. A supportive listing will be generated which will include all biomicroscopy data 
from all visits for those eyes experiencing the increase. 
Two listings for device deficiencies, prior to exposure to study 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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12.7 Interim Analyses and Reporting 
There are no plans to conduct an interim analysis and no criteria by which the study would be 
terminated early based upon statistical determination. 
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, 
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 

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• 
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. 
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 wellbeing of the subjects are protected, the 
reported data are accurate, complete, and verifiable from the source documents, and the study 

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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. 
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. 
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. 

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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. The investigator is not allowed to deviate from the protocol 
except to protect the rights, safety, and wellbeing of human subjects under emergency 
circumstances. Emergency deviations may proceed without prior approval of the sponsor and 
the IRB/IEC, but shall be documented and reported to the sponsor and the IRB/IEC as soon 
as possible. 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. Failure to implement identified corrective and preventative actions may result in site 
closure by the sponsor. 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. Any additional 
requirements imposed by the EC or regulatory authority shall be followed. At the end of the 
study, the investigator must notify the IRB/IEC about the study’s completion. The 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. 

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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 designs of this protocol will be registered on public 
databases where required by current regulations, and, as applicable, results will be posted.   
15 REFERENCES 
15.1 Regulations and Standards 
The following references may be applicable in whole or in part for this clinical trial. 
• 
ISO 11980:2012 Ophthalmic optics - Contact lenses and contact lens care products - 
Guidance for clinical investigations 
• 
EN ISO 14155:2020 - Clinical Investigation of Medical Devices for Human Subjects - 
Good Clinical Practice 
• 
21 CFR Part 11 - Electronic Records; Electronic Signatures 
• 
21 CFR Part 50 - Protection of Human Subjects 
• 
21 CFR Part 56 - Institutional Review Boards 

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• 
21 CFR Part 812 - Investigational Device Exemptions 
• 
21 CFR Part 54 - Financial Disclosure by Clinical Investigators 
15.2 Scientific and Other References 
Truong TN, Graham AD, Lin MC. Factors in Contact Lens Symptoms. Optometry and Vision 
Science. 2014; 91 (2): 133-141. doi: 10.1097/OPX.0000000000000138 

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