Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses
Phase: NA
Conditions: Presbyopia, Astigmatism
Sponsor: Alcon Research

 
 
 
 
Clinical Performance Evaluation of Two Frequent 
Replacement Silicone Hydrogel Multifocal Toric Contact 
Lenses 
 
STUDY ID: 
CLR624-C001 
 
 
PROTOCOL v.2 
August 01, 2024 
 
 
NCT06461455 

Document ID:
V-CLN-0196199
Status: Approved, Version: 2.0
Approved Date: 01 Aug 2024
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Device Protocol for CLR624-C001
Title: Clinical Performance Evaluation of Two Frequent Replacement 
Silicone Hydrogel Multifocal Toric Contact Lenses
Protocol Number:
CLR624-C001
Clinical Investigation 
Type: 
Pivotal 
Test Product:
TOTAL30 Multifocal for Astigmatism 
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:
x
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. 
x
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.
x
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.
x
I understand the potential risks and side effects of the investigational product(s).
x
I agree to maintain adequate and accurate records in accordance with 
government regulations and to make those records available for inspection.
x
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.
x
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 CLR624-C001.................................................................................1 
Table of Contents.............................................................................................................3 
List of Tables....................................................................................................................6 
List of Figures..................................................................................................................6 
1 
GLOSSARY OF TERMS..........................................................................................7 
2 
LIST OF ACRONYMS AND ABBREVIATIONS .................................................13 
3 
PROTOCOL SUMMARY.......................................................................................15 
4 
PROTOCOL AMENDMENTS ...............................................................................33 
5 
INTRODUCTION...................................................................................................33 
5.1 
Rationale and Background ......................................................................33 
5.2 
Purpose of the Study................................................................................34 
5.3 
Risks and Benefits...................................................................................34 
6 
STUDY OBJECTIVES ...........................................................................................35 
6.1 
Primary Objective....................................................................................35 
6.2 
Secondary Objective................................................................................35 
 
 
6.4 
Safety Objective ......................................................................................39 
7 
INVESTIGATIONAL PLAN ..................................................................................40 
7.1 
Study Design ...........................................................................................40 
7.2 
Rationale for Study Design .....................................................................40 
7.3 
Rationale for Duration of Treatment/Follow-up......................................41 
7.4 
Rationale for Choice of Comparator Product..........................................41 
7.5 
Data Monitoring Committee....................................................................41 
8 
STUDY POPULATION ..........................................................................................42 
8.1 
Inclusion Criteria.....................................................................................42 
8.2 
Exclusion Criteria....................................................................................43 
8.3 
Rescreening of Subjects ..........................................................................44 
9 
TREATMENTS ADMINISTERED ........................................................................45 
9.1 
Investigational Product(s)........................................................................45 
9.2 
Other Medical Device or Medication Specified for Use During the Study
50 
9.3 
Treatment Assignment/Randomization ...................................................50 

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9.4 
Treatment Masking..................................................................................51 
9.5 
Accountability Procedures.......................................................................53 
9.6 
Changes to Concomitant Medications, Treatments/Procedures ..............53 
10 STUDY PROCEDURES AND ASSESSMENTS...................................................54 
10.1 Informed Consent and Screening ............................................................54 
10.2 Description of Study Procedures and Assessments.................................54 
10.2.1 
Demographics.............................................................................. 54 
10.2.2 
Medical History and Concomitant Medications.......................... 54 
 
 
10.2.4 
Habitual Lens Information .......................................................... 55 
10.2.5 
Keratometry................................................................................. 55 
10.2.6 
Autorefractometry ....................................................................... 55 
10.2.7 
VA with Habitual Correction....................................................... 55 
 
 
 
 
 
10.2.10 HC/HI VA with Study Lenses: Effectiveness Assessment .......... 55 
 
 
 
 
 
 
 
 
10.2.18 Worn Lens Collection.................................................................. 56 
10.2.19 Investigational Product Compliance ........................................... 57 
10.2.20 Adverse Event Collection: Safety Assessment............................ 57 
10.2.21 Slit Lamp Biomicroscopy: Safety Assessment............................ 57 
10.2.22 Device Deficiencies: Safety Assessment..................................... 57 
 
 
 
10.3 Unscheduled Visits ..................................................................................57 
10.4 Unplanned Lens Replacement.................................................................58 
10.5 Discontinued Subjects .............................................................................58 
10.5.1 
Screen Failures ............................................................................ 58 
10.5.2 
Discontinuations.......................................................................... 59 
10.5.3 
Schedule of Procedures and Assessments for Subjects 
Discontinued from Investigational Product................................. 59 

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10.6 Clinical Study Termination......................................................................59 
10.6.1 
Follow-up of Subjects after Study Participation has Ended........ 60 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES .........................................60 
11.1 General Information ................................................................................60 
11.2 Monitoring for Adverse Events ...............................................................63 
11.3 Procedures for Recording and Reporting ................................................64 
11.4 Return Product Analysis..........................................................................66 
11.5 Unmasking of the Study Treatment.........................................................66 
11.6 Follow-up of Subjects with Adverse Events ...........................................66 
11.7 Pregnancy in the Clinical Study ..............................................................67 
12 ANALYSIS PLAN ..................................................................................................67 
12.1 Subject Evaluability.................................................................................67 
12.2 Analysis Sets ...........................................................................................68 
12.2.1 
Safety Analysis Set...................................................................... 68 
12.2.2 
Full Analysis Set.......................................................................... 68 
12.2.3 
Per Protocol Analysis set............................................................. 68 
12.3 Demographic and Baseline Characteristics.............................................68 
12.4 Effectiveness Analyses ............................................................................68 
12.4.1 
Analysis of Primary Effectiveness Endpoint(s) .......................... 69 
12.4.1.1 
Statistical Hypotheses.................................................. 69 
12.4.1.2 
Analysis Methods ........................................................ 70 
 
 
 
 
 
 
12.5 Handling of Missing Data .......................................................................77 
12.6 Safety Analyses .......................................................................................77 
 
 
12.8 Interim Analyses and Reporting..............................................................79 
12.9 Sample Size Justification.........................................................................79 
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS.....................79 
13.1 Subject Confidentiality............................................................................79 
13.2 Completion of Source Documents and Case Report Forms....................80 
13.3 Data Review and Clarifications...............................................................81 
13.4 Sponsor and Monitoring Responsibilities ...............................................81 
13.5 Regulatory Documentation and Records Retention ................................82 
13.6 Quality Assurance and Quality Control...................................................82 

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14 ETHICS ...................................................................................................................82 
15 REFERENCES........................................................................................................84 
15.1 Regulations and Standards ......................................................................84 
15.2 Scientific and Other References ..............................................................84 
 
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 ....................................... 26 
Table 6–1 
Primary Objective...................................................................................... 35 
 
 
Table 6–3 
Safety Objective......................................................................................... 39 
Table 9–1 
Test Product ............................................................................................... 45 
Table 9–2 
Comparator Product................................................................................... 47 
 
 
List of Figures
 
 
Figure 11-1 
Categorization of All Adverse Events........................................................ 61 
Figure 11-2 
Categorization of All Serious Adverse Events........................................... 61 

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1 GLOSSARY OF TERMS
Names of Test Product(s)
Throughout this document, test product TOTAL30 
Multifocal for Astigmatism will be referred to as T30 MFfA.
Name of Comparator 
Product(s)
Throughout this document, comparator product ULTRA®
Multifocal for Astigmatism will be referred to as ULTRA 
MFfA.
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.

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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 SAP, the MOP, the DEP, 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.
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, 
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.

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Serious Adverse Event 
(SAE)
Adverse event that led to any of the following: 
x
Death.
x
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.
x
Fetal distress, fetal death, congenital abnormality or 
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.

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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 significant nonserious adverse event is 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.
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. 

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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
ADD
Addition
ADE 
Adverse device effect
AE(s)
Adverse event(s)
ASADE
Anticipated serious adverse device effect
CFR
Code of Federal Regulations
CIs
Confidence intervals
CIP
Clinical investigation plan
CIR
Clinical investigation report
CLs
Confidence limits
cm
centimeter(s)
COL
Clinical operations lead
CRF
Case report form
CSM
Clinical study manager
D
Diopter
DEP
Data evaluability plan
ECP
Eye care professional
eCRF
Electronic case report form
EDC
Electronic data capture
EN
European Standard
FAS
Full analysis set
FDA
US Food and Drug Administration
GCP
Good Clinical Practice
HC/HI
High contrast/high illumination 
HI
High
Hrs
Hours
IB
Investigator’s brochure
ICF
Informed consent form
IEC
Independent ethics committee
IP
Investigational product
IRB
Institutional review board
ISO
International Organization for Standardization
LCL
Lower confidence limit
LO
Low
logMAR
Logarithm of the minimum angle of resolution
M
Meter
MED
Medium
min
minute(s)
mm
millimeter
MOP
Manual of procedures
N
Number of subjects
N/A
Not applicable

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Abbreviation
Definition
NI
Noninferiority 
OD
Right eye
OS
Left eye
OU
Both eyes
PI
Principal investigator
PP
Per protocol
pt
point
SADE
Serious adverse device effect
SAE
Serious adverse event
SAP
Statistical analysis plan
SD
Standard deviation
SLE
Slit lamp examination
SOP
Standard operating procedure
T30 MFfA
TOTAL30 Multifocal for Astigmatism; LID230451
UCL
Upper confidence limit
ULTRA MFfA
ULTRA Multifocal for Astigmatism
US
United States
USADE
Unanticipated serious adverse device effect
VA
Visual acuity

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3 PROTOCOL SUMMARY
Investigational product type
Device
Study type
Interventional
Investigational products
Test Product: TOTAL30 Multifocal for Astigmatism 
(T30 MFfA)
Comparator Product: ULTRA Multifocal for 
Astigmatism (ULTRA MFfA)
Purpose and Scientific 
Rationale for the Study
This confirmatory, dispensing clinical trial will evaluate 
on-eye clinical performance of investigational contact 
lenses, T30 MFfA (lehfilcon A), following 30 days of 
wear, in the intended population.
 
 
Brief Summary of the 
Protocol
The clinical trial will be prospective, meaning the trial 
will identify voluntary participants and collect data 
about their experience with the contact lenses over time. 
The trial will also be randomized (participants are 
placed into groups by chance) 
 
 This trial 
will be double masked, meaning the investigators and 
participants will not know which contact lens they are 
currently wearing. This trial will be bilateral, crossover, 
and dispensing, which means that all subjects will have 
the opportunity to wear both the test and the comparator 
lenses in both eyes, and be able to take the lenses home 
with them. This clinical study will be conducted at 
multiple external sites. The target population will consist 
of male and female subjects ages 40 years or older with 
normal eyes (other than correction for refractive error). 
Objective(s)
The primary objective of this study is to demonstrate 
noninferiority (NI) in visual acuity (VA) at distance 
when wearing T30 MFfA lenses compared to ULTRA 
MFfA lenses, after 30 days of wear (Day 30).

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The safety objective of this study is to describe the 
safety profile of the study products. 
Endpoint(s) 
Primary effectiveness
x
Binocular high contrast/high illumination (HC/HI) 
VA (logMAR) at distance (4 m) at Day 30 with study 
lenses
 
 
  
 
 
 
 
 
 
 
 
 
 

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Safety
x
Adverse events
x
Biomicroscopy findings
x
Device deficiencies
Assessment(s) 
Effectiveness
x
HC/HI logMAR VA at distance (4 m; 
OD/OS/OU)
 
 
 
 
 
 
 
 

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Safety
x
Adverse events
x
Biomicroscopy 
x
Device deficiencies
Study Design
This is a prospective, randomized
bilateral,
crossover, double masked (study lenses), dispensing 
study. Subjects will be expected to attend 5 office visits 
and will be dispensed study lenses (T30 MFfA and 
ULTRA MFfA lenses) for a 30-day duration of bilateral 
wear each (total of 60 days of lens wear), with a 
washout period (wearing habitual spectacles) of 2-3
days (at least 48 hours) prior to each dispense visit.
Subject population
x
Age and habitual wear consideration: The subject 
population consists of volunteer subjects aged 
≥40 years, who are habitual biweekly/monthly 
replacement soft multifocal or multifocal toric 
contact lens wearers for at least past 3 months 
and wear their habitual lenses at least 5 days per 
week and at least 8 hours per day.
 
 
 
 
 
 
 
 
 
 
 
 

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Planned number of subjects enrolled/consented:
approximately 82
Planned number of completed subjects: 74
Sites and Locations
Planned number of clinical sites: approximately 8
Planned locations (initial list of locations, which may 
change during start up or conduct according to study 
needs): US
Key inclusion criteria
(See Section 8.1 for a complete 
list of inclusion criteria)
x
Habitual biweekly/monthly replacement soft 
multifocal or multifocal toric contact lens 
wearers aged ≥ 40 years
x
Habitual wearer in both eyes for a minimum of 5 
days per week and 8 hours per day during the
past 3 months
x
Manifest cylinder ≥0.75 D in each eye at 
Screening
x
Willing to wear the study contact lenses for at 
least 8 hours per day during the treatment period 
and for at least 12 hours on the day before each 
Day 30 Follow-Up Visit
x
Subject must be willing to not use readers while 
wearing study contact lenses for duration of the 
study
Key exclusion criteria
(See Section 8.2 for a complete 
list of exclusion criteria)
x
Any use of topical ocular medications and 
artificial tear or rewetting drops that would 
require instillation during contact lens wear
x
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
x
Monovision contact lens wearers and wearers of 
contact lens in one eye only

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Data analysis and sample size 
justification
Planned Data Analysis 
To address the primary effectiveness 
 
 planned inferential 
analyses are summarized below:
Endpoint
Comparison
Statistical Model
Primary
Binocular 
HC/HI VA at 
Distance
T30 MFfA vs 
ULTRA MFfA
NI*
Mixed effects 
repeated measures
NI margin = 0.05 
(logMAR)

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Sample Size
Sample size calculation is based on a prior feasibility 
clinical study 
Associated materials
x
Subjects will be provided with CLEAR CARE® 
Cleaning & Disinfecting solution. 
x
Lubrication/rewetting drops will not be permitted 
during study lens wear. However, habitual 
lubrication/rewetting drop usage is allowed up to 
10 minutes prior to lens insertion and any time 
after lens removal during the study. 
x
Lubrication/rewetting drops during clinic visits 
will only be administered per investigator 
discretion. 
x
LacriPure saline will be permitted for rinsing the 
lens(es) after removal and prior to insertion, if 
required.

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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
Presbyopia is a refractive error condition that develops as part of normal aging in which the 
natural crystalline lens of the eye progressively loses the focusing ability, resulting in 
difficulty at focusing for close objects and for activities like reading. The signs of presbyopia 
become noticeable around the age of 40 years. Presbyopia may be corrected with single-
vision, bifocal or progressive spectacles, progressive addition lenses, monovision contact 
lenses or multifocal contact lenses. 
Astigmatism is a refractive error condition that describes when the curvature of the cornea 
and/or lens inside the eye is imperfect, i.e., not perfectly curved. Common symptoms of 
astigmatism include blurry vision and specifically, blurry vision occurring more in one 
direction than another, a symptom that is commonly observed when looking at headlights at 
night. One can be born with astigmatism, or it may be developed after birth. Common 
corrections for astigmatism include spectacles, toric contact lenses, and refractive surgery. 
To address the growing needs of a presbyopic population with astigmatism, T30 MFfA soft 
contact lenses, which is intended to be a monthly replacement water gradient contact lens, 
has been developed. These multifocal toric lenses use the Alcon Precision Profile® center-
near aspheric multifocal design and the Alcon Precision Balance 8|4® ballast toric design, 
which have been successfully adopted for TOTAL30® for Presbyopia and TOTAL30® for 
Astigmatism, respectively. 
TOTAL30 Multifocal for Astigmatism (T30 MFfA) is intended for daily wear (with removal 
for daily cleaning and disinfection) for the optical correction of refractive ametropia (myopia 

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and hyperopia) in persons with nondiseased eyes who require a reading addition of +3.00 D
or less and who have astigmatism.
The lenses are intended for daily wear (less than 24 hours while awake) with removal for 
disposal, or cleaning and disinfection (chemical, not heat) prior to reinsertion, as 
recommended by an eye care professional. Lenses should be discarded and replaced with a 
new pair after one month or more often, if recommended by an eye care professional.
The T30 MFfA contact lens possesses unique material properties and inherently wettable core 
material with a water gradient surface to provide sustained long-lasting performance. These 
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 T30 MFfA contact lens 
will be assessed and compared to the commercially available ULTRA MFfA contact lens in a 
crossover dispense trial, both to be worn in a daily wear modality and replaced on a monthly 
basis.
5.2
Purpose of the Study
The study will compare the clinical performance of T30 MFfA contact lenses with ULTRA 
MFfA. 
 
 
 
At the end of the study, a clinical study report will be prepared in accordance with applicable 
regulatory requirements and standards.
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
Risk management principles have been applied to both the planning and the intended conduct 
of the clinical investigation, in order to ensure the reliability of the clinical data generated and 
the safety of the subjects. 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 

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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 test product. 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 IB for additional information.
6 STUDY OBJECTIVES
6.1
Primary Objective
Table 6–1
Primary Objective
Objective
Endpoint
The primary objective of this study is to 
demonstrate NI in VA at distance when 
wearing T30 MFfA lenses compared to 
ULTRA MFfA lenses, after 30 days of wear 
(Day 30).
Binocular HC/HI VA (logMAR) at distance 
(4 m) at Day 30 with study lenses
6.2
Secondary Objective
Not applicable. 

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6.4
Safety Objective 
Table 6–3
Safety Objective
Objective(s)
Endpoint(s)

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The safety objective of this study is to 
describe the safety profile of the study 
products.
x
Adverse events
x
Biomicroscopy findings
x
Device deficiencies
7 INVESTIGATIONAL PLAN
7.1
Study Design
This is a prospective, randomized 
 dispense, double masked, bilateral, crossover 
study comparing 2 reusable multifocal toric soft contact lenses. The expected duration of 
subject participation in the study is approximately 66 days (~30 days for each lens type with 
2 to 3 days (at least 48 hours) of washout prior to each lens period), with 5 scheduled visits. 
Subjects will be asked to wear their habitual spectacles only (no contact lens wear) during the 
washout periods after Visit 1 and after Visit 3. Subjects will be asked to wear their study 
lenses for at least 8 hours a day during the lens wear period and for at least 12 hours on the 
day prior to each follow-up visit (Visits 3 and 5).
7.2
Rationale for Study Design 
This study design is justified based upon an evaluation of the results of relevant preclinical 
and clinical testing, as described within the IB. 

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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 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 multifocal 
contact lenses in both eyes during the past 3 months for a minimum of 5 days per week and 
8 hours per day. This will avoid confounding safety responses in non-adapted subjects. 
Habitual ULTRA MFfA and ULTRA for Presbyopia contact lens wearers are allowed to 
participate in this trial and may constitute up to approximately 50% of the total subject 
population. The study will exclude subjects who are monovision contact lens and wearers of 
contact lens in one eye only. 
Lubrication/rewetting drops will not be permitted during study lens wear, as this may 
confound the primary effectiveness and key exploratory variables. However, habitual 
lubrication/rewetting drop usage is allowed up to 10 minutes prior to lens insertion and any 
time after lens removal during the study. 
Currently pregnant or lactating women and participants with any history of amblyopia, 
strabismus or binocular vision abnormalities will be excluded from the trial, to prevent 
confounding the safety/effectiveness endpoints. Subjects who become pregnant during the 
study will not be discontinued; however, data will be excluded from the effectiveness 
analyses because pregnancy can alter refraction and VA results.
7.3
Rationale for Duration of Treatment/Follow-up
The primary 
 will be assessed on Day 30. Additionally, the 
product is intended for daily wear with monthly replacement. Therefore, subjects will wear 
each study product bilaterally for approximately 30 days.
7.4
Rationale for Choice of Comparator Product
ULTRA MFfA contact lenses are chosen for the comparator product because these lenses 
have the same wear modality and monthly replacement schedule as T30 MFfA lenses. 
Additionally, ULTRA MFfA’s intended use and intended population are similar to T30 
MFfA’s.
7.5
Data Monitoring Committee
Not applicable.

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8 STUDY POPULATION
The study population consists of male and female subjects 40 years old and above with a 
diagnosis of both presbyopia and astigmatism. It is aimed to enroll (consent) approximately 
82 subjects in approximately 8 sites in the US, with a target of 74 total subjects completed, 
with approximately 10 (intended minimum) to 12 (intended maximum) subjects per site. Site-
specific targets may vary based upon individual site capabilities. Estimated time needed to 
recruit subjects for the study is approximately 5 weeks; however, unanticipated circumstances 
may shorten or lengthen this time and would not require amendment of this protocol. 
Because an approximately 5% screening failure rate and 5% discontinue rate is expected, 
approximately 82 subjects are expected to be enrolled.
This protocol allows enrollment of the following vulnerable population(s), with associated 
justification for each population: 
Elderly (age 65 years or above) – Presbyopia and associated gradual loss of accommodation 
is part of the aging process and worsens with increasing age. Multifocal contact lenses are a 
commonly used correction option for this condition. The contact lens under study is intended 
to alleviate this condition. Therefore, it is appropriate and necessary to include elderly 
subjects in this clinical trial to gain data regarding the safety and effectiveness of the T30 
MFfA contact lenses in this population. Elderly subjects will be protected through the 
informed consent process, which will include any risks specific to the elderly subjects, as 
well as any specific responsibilities associated with their participation. In addition, an 
IRB/IEC will review and approve the inclusion of elderly subjects in this clinical trial prior to 
enrollment of elderly subjects. Any specific requirements imposed by the IRB/IEC regarding 
participation of elderly subjects will be implemented and documented, as appropriate. Upon 
conclusion of the clinical trial, all subjects, including elderly subjects, will return to standard 
medical care for ongoing conditions. 
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.
Subject must be able to understand and sign an IRB/IEC approved informed consent 
form.
2.
Subject must be willing and able to attend all scheduled study visits as required per 
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3.
Subject must be at least 40 years of age at Screening.
4.
Subject must be willing to stop wearing their habitual contact lenses for the duration 
of study participation.
5.
Subject must be a current wearer of biweekly/monthly replacement multifocal or 
multifocal toric soft contact lenses in both eyes for a minimum of 5 days per week 
and 8 hours per day during the past 3 months.
6.
Manifest cylinder ≥0.75 D in each eye at Screening.
7.
BCVA distance (as determined by manifest refraction at Screening) 20/25 or better 
in each eye with a spherical refractive error in the range of the provided parameters 
of the study and requiring a near ADD of +0.75 to +2.50 D in each eye.
8.
Subject must be willing to wear the study contact lenses for at least 8 hours per day 
during the treatment period and for at least 12 hours on the day before each Day 30 
Follow-Up Visit.
9.
Subject must possess spectacles and be willing to wear habitual spectacles for 
vision correction when study lenses are not worn, as needed.
10.
Subject must be willing to not use readers while wearing study contact lenses for 
duration of the 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.
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 planning 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.

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5.
Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or 
corneal vascularization that is mild (Grade 2) or higher, and/or the presence of 
corneal infiltrate.
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.
Currently pregnant or lactating, as stated by subject at Screening.
11.
Any history of amblyopia, strabismus, or binocular vision abnormalities.
12.
Any use of topical ocular medications and artificial tear or rewetting drops that 
would require instillation during contact lens wear.
13.
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.
14.
Participation of the subject in a clinical trial within the previous 30 days or currently 
enrolled in any clinical trial.
15.
Monovision contact lens wearers and wearers of contact lens in one eye only.
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.

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9 TREATMENTS ADMINISTERED
9.1
Investigational Product(s)
Test Product(s):
TOTAL30 Multifocal for Astigmatism (T30 MFfA); 
LID230451
Comparator Product(s)
ULTRA Multifocal for Astigmatism (ULTRA MFfA)
Table 9–1
Test Product
Test Product
TOTAL30 Multifocal for Astigmatism (T30 MFfA); LID230451
Manufacturer
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134-2099
USA
Regulatory/Market
Status
Regulatory/Market Status of Product at Time of Protocol 
Approval
US: Product has received FDA 510(k) clearance; not yet
marketed.
Indication for use and 
intended purpose in 
the current study 
TOTAL30 Multifocal for Astigmatism (lehfilcon A) soft contact 
lenses are indicated for the optical correction of presbyopia with 
or without refractive ametropia (myopia and hyperopia) in phakic 
or aphakic persons with non-diseased eyes who may require a 
reading addition of +3.00 D or less and who may have up to 6.00 
D of astigmatism.
The lenses are to be prescribed for daily wear with removal for 
cleaning and disinfection prior to reinsertion, or disposal, as 
recommended by the eye care professional. Lenses should be 
discarded and replaced with a new pair each month, or more often 
if recommended by an eye care professional.
Product description 
and parameters 
available for this 
study
x
Material: lehfilcon A
x
Water content: 55 ± 2 %
x
Power range: Limited lens parameters of the investigational 
product will be provided: 
Sphere: -1.25 to -3.00 D in 0.25 D steps
Cylinder: -0.75 D, -1.25 D

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Axis: 080°, 090°, 100°, 180°
ADD: LO, MED, HI
Note: The following power combinations will not be 
included in the study:
x
Sphere -1.50 D, Cylinder -1.25 D, Axis 180°, ADD HI  
x
Sphere -2.00 D, Cylinder -0.75 D, Axis 090°, ADD LO
Sphere: -1.00 D
Cylinder: -0.75 D
Axis: 080°, 090°, 100°, 180°
ADD: LO, MED, HI
Sphere: +1.00 to +4.00 D in 1 D steps
Cylinder: -0.75 D
Axis: 080°, 090°, 100°, 180°
ADD: LO, MED, HI
x
Base curve (mm): 8.6
x
Diameter (mm): 14.5
Formulation
N/A
Usage
x
Wear:
o
Daily wear
o
Bilateral
x
Replacement period: monthly replacement, daily wear
x
Exposure: Study lenses are to be worn during typical contact 
lens wearing hours, for at least 8 hours per day, every day
during the 30-day period. Subjects will be asked to wear their 
study lenses for at least 12 hours on the day before their Day 
30 Follow-up Visit. 
x
Lens Care: Subjects will be provided with CLEAR CARE® 
Cleaning & Disinfecting Solution for cleaning and disinfecting 
the study lenses after each use.
Number/Amount of 
product to be 
provided to the 
subject
Lenses (to be used for fitting and study lens wear) will be 
provided in bulk by the sponsor. Subjects will be dispensed one 
pair of study lenses at the Dispense Visit. No spare lenses will be 
provided to the subjects. 
If a replacement lens(es) is required, the subject must return to the 
clinic for an unplanned lens replacement. Until the replacement 

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lens(es) is obtained, the subject must store both study lenses as 
instructed. Refer to MOP for detailed instructions. 
Packaging description
Blister foil pack
Labeling description
Lens foil label includes:
x
material name and identifier
x
base curve
x
diameter
x
packing solution
x
power
x
lot number
x
expiration date
x
content statement
x
investigational device statement
x
sponsor information
Lens inventory will be provided in packages and identified with 
the following:
x
a color-coded label stating the study protocol number/LID 
number
x
power
x
an investigational use only statement
x
handling unit/tracking 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
Test lenses will be provided by the sponsor. Refer to the MOP for 
a detailed description.
Table 9–2
Comparator Product
Comparator
Product(s)
ULTRA Multifocal for Astigmatism (ULTRA MFfA)

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Manufacturer
Bausch and Lomb
Regulatory/Market
Status 
Regulatory/Market Status of Product at Time of Protocol Approval
US: Product approved; product marketed 
Indication for Use
Refer to package insert
Product description 
and parameters 
available for this 
study
x
Material: samfilcon A
x
Water content: 46%
x
Power range: Limited ULTRA MFfA parameters will be used in 
this study:
Sphere: -1.00 to -3.25 D in 0.25 D steps
Cylinder: -0.75 D, -1.25 D
Axis: 080°, 090°, 100°, 180°
ADD: Low, High
Sphere: -0.75 to -1.25 D in 0.25 D steps
Cylinder: -0.75 D
Axis: 080°, 090°, 100°, 180°
ADD: Low, High
Sphere: +0.75 D, +1.00 D, +1.25 D, +1.75 D, +2.00 D, +2.25 D,
+2.75 D, +3.00 D, +3.25 D, +3.75 D, +4.00 D
Cylinder: -0.75 D
Axis: 080°, 090°, 100°, 180°
ADD: Low, High
x
Base curve (mm): 8.6
x
Diameter (mm): 14.5
Formulation
N/A
Usage
x
Wear:
o
Daily wear
o
Bilateral
x
Replacement period: monthly replacement, daily wear 
x
Exposure: Study lenses are to be worn during typical contact 
lens wearing hours, for at least 8 hours per day, every day
during the 30-day period. Subjects will be asked to wear their 

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study lenses for at least 12 hours on the day before their Day 30 
Follow-up Visit.
x
Lens care: Subjects will be provided with CLEAR CARE® 
Cleaning & Disinfecting Solution for cleaning and disinfecting 
the study lenses after each use.
Number/Amount of 
Product to be 
Provided to the 
subject
Sites will be using commercially available ULTRA MFfA Fitting 
Set lenses (to be used for fitting and study lens wear). Subjects will 
be dispensed one pair of study lenses at the Dispense Visit. No 
spare lenses will be provided to the subjects. 
If a replacement lens(es) is required, the subject must return to the 
clinic for an unplanned lens replacement. Until the replacement 
lens(es) is obtained, the subject must store both study lenses as 
instructed. Refer to MOP for detailed instructions. 
Packaging 
description
Commercial packaging
Labeling description
Commercial labeling
Training and/or 
experience 
requirements for 
device
No additional training or experience is required to administer the 
comparator.
Storage conditions
Refer to Package Insert
Additional 
identifying
information
N/A
Supply
Sites will procure ULTRA MFfA Fitting Sets, as needed. Refer to 
the MOP for details.
More information on the test product can be found in the investigator’s brochure; information 
on the comparator product can be found in the Package Insert for ULTRA MFfA.

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9.2
Other Medical Device or Medication Specified for Use During the 
Study
During the clinical study, additional medical devices and/or medications that are required in 
conjunction with the treatment include the following:
x
CLEAR CARE Cleaning & Disinfecting Solution: Subjects will be provided CLEAR 
CARE Cleaning & Disinfecting Solution in commercial packaging with provided 
instructions. 
9.3
Treatment Assignment/Randomization
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/sequences to randomization numbers in the specified ratio. 
Subjects will be assigned treatment (lens sequence) 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 investigator or delegate will access the 

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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) to be dispensed 
to the subject.
9.4
Treatment Masking
This study is double masked (study lenses), with subjects randomized to use T30 MFfA or 
ULTRA MFfA for the duration of 30-days per treatment period. 
 
 
 
 
 

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Masked study personnel must avoid seeking information that may compromise masking. 
Unmasked study personnel must not disseminate information that is potentially unmasking to 
any masked personnel. The masked and unmasked site personnel must coordinate all study 
activities as necessary to protect masking and minimize bias during the study.
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. 

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9.5
Accountability Procedures
Upon receipt of the IPs, the investigator or delegate must conduct an inventory. During the 
study, unmasked designated study staff must provide the IPs to the subjects in accordance 
with their randomization assignment. Throughout the study, the investigator or 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 investigator should make every effort to collect unused lenses, foils, and supplies from 
subjects.
It is the investigator’s responsibility to ensure that:
x
All study products are accounted for and not used in any unauthorized manner
x
All unused products are available for return to the study sponsor, as directed
x
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:
x
Any new medications 
x
Alterations in dose or dose schedules for current medications, 
x
Any medical procedure or hospitalization that occurred or is planned
x
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
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
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.
10.2.1 Demographics
Obtain demographic information including age, race, ethnicity, and sex. Refer to the MOP for 
details.
10.2.2 Medical History and Concomitant Medications
Fully document concomitant medications (taken within the past 30 days prior to the 
screening visit) and medical history (within 1 year prior to the screening visit) in the subject 
source documents. 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.

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10.2.4 Habitual Lens Information
At Visit 1, the subject’s habitual contact lens information will be collected. Refer to the MOP 
for details. 
10.2.5 Keratometry
Keratometry is required at Visit 1. Refer to the MOP for details. 
10.2.6 Autorefractometry
Autorefractometry (OD, OS) will be performed either uncorrected or with the study contact 
lenses. Refer to the MOP for details. 
10.2.7 VA with Habitual Correction
VA (Snellen distance; OD, OS) with the subject’s habitual spectacles correction will be 
collected at Visit 1 and at the Exit Visit (Visit 5 or Early Exit) and is optional for 
Unscheduled Visit. Refer to the MOP for details. 
10.2.8 Fitting of Study Products with Fitting Lenses: Effectiveness 
Assessment
Fitting of study products will be performed for both the test and comparator study lenses at 
Visit 1 per the randomization assignment. 
 
 
10.2.10 HC/HI VA with Study Lenses: Effectiveness Assessment
HC/HI logMAR 
 VA with study lenses will be 
performed at Visits 2, 3, 4, 5, and Early Exit and is optional at Unscheduled Visit. Refer to 
the MOP for details.

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10.2.18 Worn Lens Collection
Worn lenses will be collected and returned. Refer to the MOP for details.

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10.2.19 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.
10.2.20 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 in the subject 
source documents. See Section 11 for further details regarding AE collection and reporting.
10.2.21 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.
10.2.22 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 

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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: 
x
Collect adverse event information
x
Collect device deficiency information
x
Record changes in medical condition or concomitant medication
x
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 and 
Section 10.5.3 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 the 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 are considered screen failures. 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 informed consent and after randomization.
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 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: 
x
The study sponsor must:

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R
Immediately notify the investigator(s) and subsequently provide 
instructions for study termination.
R
Inform the investigator and the regulatory authorities of the 
termination/suspension and the reason(s) for the termination/suspension. 
x
The investigator must:
R
Promptly notify the IRB/IEC of the termination or suspension and of the 
reasons. 
R
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. Refer to the Glossary of Terms 
and the figures below for categories of AEs and SAEs.

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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:
x
An ocular infection, including a presumed infectious ulcer with any of the following 
characteristics: 
R
Central or paracentral location

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R
Penetration of Bowman’s membrane
R
Infiltrates > 2 mm diameter
R
Iritis
R
Increase in intraocular pressure
R
Culture positive for microorganisms
R
Increasing size or severity at subsequent visits
x
Any central or paracentral corneal event (such as neovascularization) that results in 
permanent opacification
x
Hypopyon
x
Hyphema
x
Neovascularization within the central 6 mm of the cornea
x
Permanent vision loss as defined by loss of 2 or more lines of BCVA from baseline 
visit that fails to resolve
x
Uveitis (anterior, intermediate, or posterior)
x
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.
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 occurrences of the following as a significant 
nonserious adverse event:
x
Peripheral nonprogressive noninfectious ulcers
x
All symptomatic corneal infiltrative events
Corneal staining score greater than or equal to grade 3 (Refer to MOP for grading 
scales)
x
Temporary vision loss as defined by loss of 2 or more lines of BCVA from baseline 
visit that persists for 2 or more weeks

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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 and 
Contact Lens Care Products.
Device Deficiencies
A device deficiency is an 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: 
x
Failure to meet product specifications (e.g., incorrect lens power/diameter/base 
curve/color)
x
Lens/solution cloudy
x
Lens surface/edge defect 
x
Torn lens during handling/in pack 
x
Packaging deficit (e.g., mislabeled product, tampered seal, leaking bottle/container)
x
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:
x
"Have you had any health problems since your last study visit?"
x
"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 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. 

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11.3 Procedures for Recording and Reporting
AEs are collected from the time of signing 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 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 ADE/SAE documentation must include: the 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:
x
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. 
x
Device deficiencies are documented on the Device Deficiency eCRF within 24 hours 
of the investigator's or site's awareness. 
A printed copy of the completed serious adverse event and adverse device effect 
and/or device deficiency eCRF must be included with product returns, if applicable.
x
Additional relevant information after initial reporting must be entered into the eCRF 
as soon as the data become available. 
x
Document any changes to concomitant medications on the appropriate eCRFs.
x
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.
In addition to recording all AEs into the EDC system, any AEs and device deficiencies for 
nonstudy marketed devices/products (i.e., CLEAR CARE® Cleaning & Disinfecting 
Solution used concomitantly during the study will be considered and processed as 

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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.
Note, 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.
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).

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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 
are 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. 
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). 
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 assignment needs to be unmasked 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 treatment may be unmasked prior to contact with the study sponsor. 
The study sponsor must be informed of all cases in which the masking 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 3 months after subject has 
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 who are pregnant (as stated by the subject) at the time of study entry are excluded 
from participation. However, pregnancy should be included in the corresponding 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. Subjects who become pregnant during the study will not be discontinued; 
however, data will be excluded from the effectiveness analysis because pregnancy can alter 
refraction and VA results.
12 ANALYSIS PLAN
Continuous variables will be summarized using the number of observations, mean, standard 
deviation (SD), median, minimum, and maximum, as well as confidence intervals (CIs) or 
confidence limits (CLs) where applicable. Categorical variables will be summarized with 
frequencies and percentages from each category. 
Any deviations to the 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 assignment and locking the database, based upon the data evaluability plan (DEP).

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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 study lens sequence.
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, 
.
12.2.3 Per Protocol Analysis set
The per protocol (PP) analysis set is a subset of FAS and excludes all data/subjects that have 
met any of the critical deviation or evaluability criteria identified in the DEP.
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 primary effectiveness endpoint, 
 
 
 evaluations will use the FAS as the primary analysis set. 
 
 
 
 

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All effectiveness analyses will be carried based on the randomization assignment.
12.4.1 Analysis of Primary Effectiveness Endpoint(s)
The primary objective of this study is to demonstrate NI in VA at distance when wearing T30 
MFfA lenses compared to ULTRA MFfA lenses, after 30 days of wear (Day 30).
The primary endpoint is binocular HC/HI VA at distance (4 m) at Day 30 with study lenses, 
collected on the logMAR scale.
12.4.1.1 Statistical Hypotheses
The null and alternative hypotheses are formulated in terms of the predefined margin of 0.05 
for NI:
H0: μ(T) – μ(C) ≥ 0.05
Ha: μ(T) – μ(C) < 0.05
where μ(T) and μ(C) denote the mean distance binocular HC/HI VA at Day 30 for T30 MFfA 
and ULTRA MFfA, respectively, in logMAR scale.

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12.4.1.2 Analysis Methods
A mixed effects repeated measures model will be utilized to test these hypotheses. The model 
will include terms for lens, visit, lens-by-visit interaction, period, and study lens sequence. 
Within-subject correlation due to crossover will also be accounted for in the model.
Lens difference (T30 MFfA minus ULTRA MFfA) and the corresponding one-sided 95% 
upper confidence limit (UCL) at Day 30 will be computed. Noninferiority will be declared if 
the UCL is less than 0.05.

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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:
x
AEs
x
Biomicroscopy findings
x
Device deficiencies

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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, frequencies 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 ≥ 2 
grades 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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12.8 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.
12.9 Sample Size Justification
Sample size calculation is based on a prior feasibility clinical study (
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. 

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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:
x
Subject identification (name, sex, race/ethnicity)
x
Documentation of subject eligibility
x
Date of informed consent
x
Dates of visits
x
Documentation that protocol specific procedures were performed
x
Results of study parameters, as required by the protocol
x
IP accountability records
x
Documentation of AEs and other safety parameters (if applicable)
x
Records regarding medical histories and the use of concomitant therapies prior to and 
during the study
x
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. 

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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. For this 
study, the principal investigator and subinvestigators must be eye care professionals 
appropriately trained and licensed to diagnose and treat subjects with the condition under 
study.
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.

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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.
14 ETHICS
Investigations are conducted in compliance with GCPs; international and national 
regulations, laws, and guidelines; EN ISO 14155; 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. 
x
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. 
x
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 well-being of human subjects under emergency 

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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 IB, 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.
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 

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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 investigator must have a defined process in case a subject would like to withdraw their 
consent(s). The investigator is the designated contact point for any such withdrawals.
The investigator must have a defined process in case a subject would like to exercise any of 
their rights under applicable data protection laws. The investigator is the designated contact 
point for any such requests.
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.
x
ISO 11980 Ophthalmic optics - Contact lenses and contact lens care products - 
Guidance for clinical investigations
x
EN ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects - Good 
Clinical Practice
x
21 CFR Part 11 - Electronic Records; Electronic Signatures
x
21 CFR Part 50 - Protection of Human Subjects
x
21 CFR Part 56 - Institutional Review Boards
x
21 CFR Part 812 - Investigational Device Exemptions
x
21 CFR Part 54 - Financial Disclosure by Clinical Investigators
x
The California Bill of Rights, if applicable
15.2 Scientific and Other References
Not applicable. There are no references.

Document ID:
V-CLN-0196199
Status: Approved, Version: 2.0
Approved Date: 01 Aug 2024
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