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

 
 
 
 
 
Clinical Performance of Two Frequent Replacement 
Silicone Hydrogel Multifocal Contact Lenses 
 
STUDY ID 
CLM234-C001 
 
 
PROTOCOL v.3 
31 Jul 2024 
 
 
NCT06469242 

Document ID: 
V-CLN-0196000 
Status: Approved, Version: 3.0 
Approved Date: 31 Jul 2024 
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Device Protocol for CLM234-C001 
Title: Clinical Performance of Two Frequent Replacement Silicone 
Hydrogel Multifocal Contact Lenses      
Protocol Number: 
CLM234-C001 
Clinical Investigation 
Type:  
Pivotal 
Test Product: 
Alcon serafilcon A Multifocal contact lenses (LID233309) 
Sponsor Name and 
Address: 
Alcon Research, LLC, and its affiliates (“Alcon”) 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
 
 
 
 
Property of Alcon 
Confidential 
May not be used, divulged, published, or otherwise disclosed without the consent of Alcon 

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

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Table of Contents 
Device Protocol for CLM234-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 ......................................................................................... 27 
5 
INTRODUCTION ............................................................................................................. 27 
5.1 
Rationale and Background ................................................................................. 27 
5.2 
Purpose of the Study .......................................................................................... 28 
5.3 
Risks and Benefits ............................................................................................. 28 
6 
STUDY OBJECTIVES...................................................................................................... 30 
6.1 
Primary Objective(s) .......................................................................................... 30 
6.2 
Secondary Objective(s) ...................................................................................... 30 
 
 
6.4 
Safety Objective(s) ............................................................................................ 32 
7 
INVESTIGATIONAL PLAN ............................................................................................ 32 
7.1 
Study Design...................................................................................................... 32 
7.2 
Rationale for Study Design................................................................................ 33 
7.3 
Rationale for Duration of Treatment/Follow-Up ............................................... 33 
7.4 
Rationale for Choice of Comparator Product .................................................... 34 
7.5 
Data Monitoring Committee .............................................................................. 34 
8 
STUDY POPULATION .................................................................................................... 34 
8.1 
Inclusion Criteria ............................................................................................... 35 
8.2 
Exclusion Criteria .............................................................................................. 36 
8.3 
Rescreening of Subjects ..................................................................................... 37 
9 
TREATMENTS ADMINISTERED................................................................................... 38 
9.1 
Investigational Product(s) .................................................................................. 38 
9.2 
Other Medical Device or Medication Specified for Use During the Study ....... 42 

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9.3 
Treatment Assignment / Randomization ........................................................... 42 
9.4 
Treatment Masking ............................................................................................ 43 
9.5 
Accountability Procedures ................................................................................. 45 
9.6 
Changes to Concomitant Medications, Treatments/Procedures ........................ 46 
10 STUDY PROCEDURES AND ASSESSMENTS ............................................................. 46 
10.1 Informed Consent and Screening ...................................................................... 46 
10.2 Description of Study Procedures and Assessments ........................................... 47 
10.2.1 
Demographics .................................................................................... 47 
10.2.2 
Medical History ................................................................................. 47 
10.2.3 
Lens Fitting ........................................................................................ 47 
 
 
 
 
 
 
10.2.7 
Habitual Lens Information ................................................................ 48 
10.2.8 
Keratometry ....................................................................................... 48 
10.2.9 
VA with Habitual Correction ............................................................. 48 
 
 
 
10.2.13 Worn Lens Collection ........................................................................ 49 
10.2.14 Investigational Product Compliance .................................................. 49 
10.2.15 Adverse Event Collection: Safety Assessment .................................. 49 
10.2.16 Slit Lamp Biomicroscopy: Safety Assessment .................................. 49 
10.2.17 Device Deficiencies: Safety Assessment ........................................... 49 
 
 
10.3 Unscheduled Visits ............................................................................................ 49 
 
 
10.5 Discontinued Subjects ....................................................................................... 50 
10.5.1 
Screen Failures .................................................................................. 50 
10.5.2 
Discontinuations ................................................................................ 50 
10.5.3 
Schedule of Procedures and Assessments for Subjects 
Discontinued from Investigational Product ....................................... 51 
10.6 Clinical Study Termination ................................................................................ 51 
10.6.1 
Follow-up of Subjects after Study Participation has Ended .............. 52 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ................................................... 52 

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11.1 General Information .......................................................................................... 52 
11.2 Monitoring for Adverse Events ......................................................................... 55 
11.3 Procedures for Recording and Reporting .......................................................... 55 
11.4 Return Product Analysis .................................................................................... 57 
11.5 Unmasking of the Study Treatment ................................................................... 58 
11.6 Follow-Up of Subjects with Adverse Events ..................................................... 58 
11.7 Pregnancy in the Clinical Study ........................................................................ 58 
12 ANALYSIS PLAN ............................................................................................................ 59 
12.1 Subject Evaluability ........................................................................................... 59 
12.2 Analysis Sets...................................................................................................... 59 
12.2.1 
Safety Analysis Set ............................................................................ 59 
12.2.2 
Full Analysis Set ................................................................................ 60 
12.2.3 
Per Protocol Analysis Set .................................................................. 60 
12.3 Demographic and Baseline Characteristics ....................................................... 60 
12.4 Effectiveness Analyses ...................................................................................... 60 
12.4.1 
Analysis of Primary Effectiveness Endpoint(s)................................. 60 
12.4.1.1 
Statistical Hypotheses ........................................................ 61 
12.4.1.2 
Analysis Methods............................................................... 61 
 
 
 
 
 
 
12.5 Handling of Missing Data .................................................................................. 63 
12.6 Safety Analyses.................................................................................................. 63 
12.7 Interim Analyses and Reporting ........................................................................ 64 
12.8 Sample Size Justification ................................................................................... 64 
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ............................... 64 
13.1 Subject Confidentiality ...................................................................................... 64 
13.2 Completion of Source Documents and Case Report Forms .............................. 64 
13.3 Data Review and Clarifications ......................................................................... 65 
13.4 Sponsor and Monitoring Responsibilities.......................................................... 66 
13.5 Regulatory Documentation and Records Retention .......................................... 66 
13.6 Quality Assurance and Quality Control ............................................................. 67 
14 ETHICS ............................................................................................................................. 67 

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15 REFERENCES .................................................................................................................. 69 
15.1 Regulations and Standards................................................................................. 69 
15.2 Scientific and Other References ........................................................................ 69 
 
 
List of Tables 
Table 2–1 
List of Acronyms and Abbreviations Used in This Protocol ........................... 13 
Table 3–1 
Schedule of Study Procedures and Assessments ............................................. 21 
Table 6–1 
Primary Objective(s) ........................................................................................ 30 
 
 
Table 6–3 
Safety Objective(s)........................................................................................... 32 
Table 9–1 
Test Product ..................................................................................................... 38 
Table 9–2 
Comparator Product ......................................................................................... 40 
 
 
 
List of Figures 
Figure 7-1 
Study Design .................................................................................................... 33 
Figure 11-1 
Categorization of All Adverse Events .............................................................. 52 
Figure 11-2 
Categorization of All Serious Adverse Events ................................................. 53 
 
 
 
 
 

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1 GLOSSARY OF TERMS 
Names of Test Product(s) 
Throughout this document, test product will be referred to as 
LID233309. 
Name of Comparator 
Product(s) 
ACUVUE® OASYS MULTIFOCAL with PUPIL 
OPTIMIZED DESIGN (Oasys MF) contact lenses 
(senofilcon A).  
 
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 statistical analysis plan, the 
manual of procedures, the deviations and evaluability plan, 
and the protocol monitoring plan) comprise the CIP. 
Clinical Investigation 
Report (CIR) / Clinical 
Study Report 
The document describing the design, execution, statistical 
analysis, and results of a clinical investigation. The clinical 
investigation report is synonymous with the clinical study 
report. 
Device Deficiency 
 
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, usability, safety, or 
performance.  
Note: This definition includes malfunctions, use errors, and 
inadequacy in the information supplied by the manufacturer 
including labeling 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 

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in addition to those available as normal clinical practice and 
burden the subject. 
Investigational Product 
A preventative (vaccine), a therapeutic (drug or biologic), 
device, diagnostic, or palliative used as a test or comparator 
product in a clinical trial, including a product with a 
marketing authorization when used or assembled 
(formulated or packaged) in a way different from the 
authorized form, or when used for an unauthorized 
indication, or when used to gain further information about 
the authorized form. 
Malfunction 
 
Failure of an investigational medical device to perform in 
accordance with its intended purpose when used in 
accordance with the instructions for use or clinical 
investigation plan (CIP), or investigator’s brochure (IB). 
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 

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complaint may allege that an adverse event or medical 
device malfunction has occurred. 
Randomized Subject 
Any subject who is assigned a randomized treatment. 
 
Serious Adverse Device 
Effect (SADE) 
 
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
Serious Adverse Event 
(SAE) 
 
Adverse event that led to any of the following:  
• Death. 
• A serious deterioration in the health of the subject, users 
or other persons as defined by one or more of the 
following:  
a) a life-threatening illness or injury   
Note: Life-threatening means that the individual was 
at immediate risk of death from the event as it 
occurred, i.e., it does not include an event which 
hypothetically might have caused death had it 
occurred in a more severe form. 
b) any potentially sight-threatening event or permanent 
impairment to a body structure or a body function 
including chronic diseases. 
c) inpatient hospitalization or prolonged 
hospitalization. 
d) a medical or surgical intervention to prevent a) or b).  
e) any indirect harm as a consequence of incorrect 
diagnostic test results when used within 
manufacturer’s instructions for use. 
• Fetal distress, fetal death, congenital abnormality, or 
birth defect including physical or mental impairment. 

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Note: Planned hospitalization for a preexisting condition, or 
a procedure required by the CIP, without serious 
deterioration in health, is not considered a serious adverse 
event.  
Refer to Section 11 for additional SAEs. 
Serious Health Threat 
 
Signal from any adverse event or device deficiency that 
indicates an imminent risk of death or a serious deterioration 
in the health in subjects, users, or other persons, and that 
requires prompt remedial action for other subjects, users, or 
other persons. 
Note: This would include events that are of significant and 
unexpected nature such that they become alarming as a 
potential serious health hazard or possibility of multiple 
deaths occurring at short intervals.  
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 
Adverse event 
ASADE 
Anticipated serious adverse device effect 
 
 
CI 
Confidence interval 
CIP 
Clinical investigation plan 
CIR 
Clinical investigation report 
cm 
Centimeters 
COL 
Clinical operation lead 
CRF 
Case report form 
CSM 
Clinical site manager 
CTT 
Clinical trial team  
D 
Diopter 
DEP 
Data evaluability plan 
EC 
European Commission 
ECP 
Eye care professional 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
FAS 
Full analysis set 
FDA 
United States Food and Drug Administration 
GCP 
Good Clinical Practice 
GPCMS 
Global Product Complaint Management System 
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 
LID 
Lens identification 
LID233309 
Alcon serafilcon A Multifocal contact lenses. 
LO 
Low  
logMAR 
Logarithm of the minimum angle of resolution 
m 
Meter 
MED 
Medium 
MF 
Multifocal 
mm 
Millimeters 

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Abbreviation 
Definition 
MOP 
Manual of procedures 
n 
Number of subjects 
N/A 
Not applicable 
Oasys MF 
ACUVUE® OASYS MULTIFOCAL with PUPIL OPTIMIZED 
DESIGN contact lenses (senofilcon A). 
OD 
Oculus dexter (right eye) 
OS 
Oculus sinister (left eye) 
OU 
Oculus uterque (both eyes) 
PI 
Principal investigator 
PP 
Per protocol 
PR # 
Project record number 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 
SD 
Standard deviation 
SLE 
Slit lamp examination 
SOP 
Standard operating procedure 
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: LID233309 
Comparator Product: ACUVUE® OASYS MULTIFOCAL with 
PUPIL OPTIMIZED DESIGN (Oasys MF) 
Purpose and 
Scientific Rationale 
for the Study 
The study aims to evaluate the on-eye clinical performance of 
investigational LID233309 contact lenses, with Alcon’s Precision 
Profile® Multifocal Design, to support contact lens product 
development and to evaluate product performance in the intended 
population.  
 
 
The Oasys MF contact lenses have been chosen as the comparator 
product because these lenses have a comparable wear modality 
and same indication for correction of presbyopia. 
Brief Summary of 
the Protocol 
The overall objective of this study aims to evaluate the on-eye 
multifocal clinical performance of investigational LID233309 
contact lenses and Oasys MF contact lenses in a daily wear 
dispensing trial. Volunteer subjects aged 40 or over who are 
habitual MF soft contact lens wearers, have at least 6 months of 
contact lens wearing experience (excluding any Oasys MF habitual 
lens wearers and daily disposable lens wearers), and who wear 
their habitual lenses at least 5 days per week and at least 10 hours 
per day, will be included. This is a prospective, randomized, 
bilateral, crossover, double-masked (study lenses), dispensing, 
multicenter study. The outcomes of this study will be used to 
support contact lens product development. 
 
 
 
 
 

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Objective(s) 
• The primary objective of this study is to evaluate binocular 
visual acuity at distance of LID233309 lenses and Oasys MF 
lenses. 
 
 
 
  
• The safety objective is to describe the safety profile of the 
study products 
Endpoint(s)  
 
Primary Effectiveness:  
• 
Binocular high contrast/high illumination (HC/HI) visual 
acuity (VA; logMAR) at distance (4 m) at Week 1 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 

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Safety 
• 
Adverse events 
• 
Biomicroscopy findings 
• 
Device deficiencies 
Assessment(s)  
Effectiveness 
• 
Binocular HC/HI logMAR VA at distance (4 m), 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Safety 
• 
Biomicroscopy 
• 
Adverse events 
• 
Device deficiencies 
Study Design 
This is a prospective, randomized, bilateral, crossover, double-
masked (study lenses), dispensing trial comparing LID233309 and 
Oasys MF contact lenses. Subjects will be expected to attend 7 
office visits and will be dispensed study lenses (test and 
comparator lenses) for a 14-day duration of bilateral wear each 
(total of approximately 28 days of lens wear). Between Visits 1 
and 2, a washout period (wearing spectacles) of 2 [at least 48 
hours] - 4 days after the end of Visit 1 will be required, and 
between Visits 4 and 5, a washout period (wearing spectacles) of 2 
[at least 48 hours] - 4 days after the end of Visit 4 will be required. 
Subject population 
Planned number of subjects enrolled/consented: ~96 
Planned number of completed subjects: 92 

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• The subject population consists of volunteer subjects aged ≥ 40 
years, frequent replacement soft multifocal contact lens 
wearers (excluding habitual Oasys MF and habitual daily 
disposable lens wearers) for at least past 6 months and wear 
their habitual lenses at least 5 days per week and at least 10 
hours per day,
 
 
• 
 
 
 
 
 
 
  
 
 
 
 
 
 
Sites and Locations 
Planned number of clinical sites: ~ 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) 
• Current wearer of biweekly/monthly replacement multifocal 
soft contact lenses in both eyes for a minimum of 5 days per 
week and 10 hours per day during the past 6 months. 
• Subjects must have a manifest cylinder ≤ 0.75 D in each eye. 
• Subjects must be able to wear contact lenses within a range 
of -0.50 D to -4.00 D (in 0.25 D steps), -5.00 D, -6.00 D 
& -8.00 D, +1.00 D to +3.00 D (in 0.25 D steps) +5.00 D and 
+6.00 D and requiring a near ADD of +0.75 D to +2.50 D in 
each eye 
• Subject must be willing to wear contact lenses for at least 16 
hours per day on the day prior to week 1 and week 2 follow-up 
visits for both test and comparator lenses. 
Key exclusion 
criteria 
(See Section 8.2 for a 
complete list of 
exclusion criteria) 
• Currently pregnant or lactating 
• Any history of amblyopia, strabismus, or binocular vision 
abnormalities 
• Habitual Oasys MF contact lens wearers or daily disposable 
contact lens wearers 

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• Monovision contact lens wearers and wearers of contact lens in 
one eye only. 
 
Data analysis and 
sample size 
justification 
Planned Data Analysis 
To address the primary effectiveness objective, descriptive 
statistics will be provided along with a two-sided 95% confidence 
interval (CI) at Week 1. Additionally, descriptive statistics and 
two-sided 95% CI will be presented at Dispense and Week 2. No 
inferences are to be made. 
 
   
 
 
 
  
 
Sample Size Justification 
Degree of precision achieved with a sample size of 92 is as 
follows: 
  
Visual Acuity: with an assumed standard deviation (SD) of 0.12, a 
two-sided 95% CI for the mean of distance visual acuity based on 
t-statistics, coverage probability of 0.85, will extend 0.027 (~1 
Snellen letter) from the observed mean. 
 
 
 
. 
Associated materials • CLEAR CARE® Cleaning & Disinfecting Solution 
• Lubrication/rewetting drops will not be permitted during lens 
wear. However, habitual lubrication/rewetting drop usage is 
allowed up to 10 minutes prior to lens insertion and any time 
after lens removal.  
• No lubrication/rewetting drop use will be allowed during clinic 
visits. 
• 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 (reconsent), as required by the IRB/IEC. 
Refer to Appendix A for detailed description of amendments.  
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 could be corrected with single-
vision, bifocal or progressive spectacles, progressive addition lenses, monovision contact 
lenses or multifocal contact lenses.  
To address the growing needs of presbyopic population, LID233309 soft contact lenses, a 
new weekly replacement water gradient contact lens has been developed. These multifocal 
lenses use the center-near aspheric Unique Precision Profile® Multifocal design, which has 
been successfully adopted for DAILIES® Total1® MF, DAILIES® AquaComfort® Plus MF, 
and AIR OPTIX® plus HydraGlyde® MF contact lenses.  
LID233309 soft contact lenses are indicated for the optical correction of presbyopia, with or 
without refractive ametropia (myopia and hyperopia) in persons with nondiseased eyes. The 
lenses are to be used for daily wear with removal for disposal, or cleaning and disinfection 
(chemical, not heat) prior to reinsertion, as recommended by the eye care professional. 
Lenses should be discarded and replaced with a new pair each week or more often, if 
recommended by an eye care professional. 

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5.2 Purpose of the Study 
The study aims to evaluate the on-eye clinical performance of investigational LID233309 
contact lenses, Alcon’s Precision Profile Multifocal Design, to support contact lens product 
development and to evaluate product performance in the intended population. 
 
. 
Volunteer subjects aged 40 or over who are habitual MF soft contact lens wearers, have at 
least 6 months of contact lens wearing experience (excluding Oasys MF habitual lens wearers 
and habitual daily disposable lens wearers), and who wear their habitual lenses at least 5 days 
per week and at least 10 hours per day, will be included. This is a prospective, randomized, 
bilateral, crossover, controlled, double-masked (study lenses), multicenter clinical study. The 
Oasys MF contact lenses have been chosen as the comparator product because these lenses 
have the comparable wear modality and same indication for correction of presbyopia.  
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.  
Alcon reserves the right of prior review of any publication or presentation of information 
related to the study. The author(s) of the publication will be the individual with substantial 
contribution to the conception or design of the work, OR the acquisition, analysis, or 
interpretation of data. Additionally, the author will draft the work or revise it critically for 
important intellectual content; provide final approval of the version to be published; and 
agree to be accountable for all aspects of the work, ensuring that questions related to the 
accuracy or integrity of any part of the work are appropriately investigated and resolved. 
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, 

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including risks associated with use of device and methods and procedures for application of 
device, are defined in the investigator’s brochure and/or product labeling and are managed 
through review of safety assessments outlined in this protocol.  
Contact lenses may offer improved peripheral vision and the convenience of not wearing 
spectacles. Material properties and design characteristics of serafilcon A contact lenses are 
features consistent with successful contact lens wear. Based upon nonclinical testing and 
documented rationale for applicability of test results, LID233309 contact lenses, which are 
made of the same material as Alcon serafilcon A sphere contact lenses, are assessed to be 
nontoxic and biocompatible for on-eye use. 
In the US, Oasys MF contact lenses have approved indications for use for both daily wear 
and extended wear for up to 6 continuous nights. Further details on any known potential risks 
and benefits can be found in the product package insert. 
A summary of the known potential risks and benefits associated with LID233309 contact 
lenses can be found in the IB. The potential harms associated with on-eye exposure to the 
new lens materials include toxicity response, blurred vision, and ocular discomfort. In 
general, when worn for daily wear, the risks with LID233309 contact lenses are anticipated to 
be similar to other marketed soft contact lenses worn for daily wear. 
There may also be unknown risks to use of LID233309. Any risk to subjects in this clinical 
study will be minimized by compliance with the eligibility criteria and study procedures, 
clinical oversight, and monitoring. Site personnel will educate subjects on proper hygiene and 
lens handling, and compliance with the use of contact lenses for daily wear according to the 
protocol. Subjects should be instructed not to wear contact lenses while swimming due to 
increased risk of infection or while sleeping. Site personnel should advise the subjects to 
remove contact lenses and return for prompt follow-up of symptoms such as ocular 
discomfort, foreign body sensation, excessive tearing, vision changes, or hyperemia. 
Refer to the IB for additional information. 

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6 STUDY OBJECTIVES 
6.1 Primary Objective(s) 
Table 6–1 
Primary Objective(s) 
Objective(s) 
Endpoint(s) 
To evaluate binocular visual acuity at 
distance of LID233309 lenses and Oasys 
MF lenses. 
 
Binocular HC/HI VA (logMAR) at distance 
(4 m) at Week 1  
6.2 Secondary Objective(s) 
Not Applicable  

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6.4 Safety Objective(s)  
Table 6–3 
Safety Objective(s) 
Objective(s) 
Endpoint(s) 
To describe the safety profile of the study 
products. 
• Adverse events 
• Biomicroscopy findings 
• Device deficiencies 
7 INVESTIGATIONAL PLAN 
7.1 Study Design 
This is a prospective, randomized, bilateral, crossover, double-masked (study lenses), 
dispensing, multicenter study comparing the LID233309 lenses and Oasys MF contact lenses. 
Subjects will be randomized 
 and exposed to both test and 
comparator lenses for bilateral wear. Subjects will be expected to attend 7 office visits and 
will be dispensed study lenses (test and comparator lenses) for a 14-day duration of bilateral 
wear each (total of approximately 28 days of lens wear). Between Visits 1 and 2, a washout 
period (wearing spectacles) of 2 [at least 48 hours] - 4 days after the end of Visit 1 will be 
required, and between Visits 4 and 5, a washout period (wearing spectacles) of 2 [at least 48 
hours] - 4 days after the end of Visit 4 will be required. Subjects will be expected to wear 
their study contact lenses for at least 10 hours per day, over a 14-day period per study lens. 
Subjects will be asked to wear study lenses for 16 hours on the days prior to each Follow-up 
Visit (Visit 3, 4, 6 & 7). 
In this trial, as both test and comparator lenses have manufacture specific fitting guides, the 
PI may become aware of the identity of the lens during fitting. However, the PI must remain 
masked to the complete randomized sequence which includes study lenses. The investigator 
will be masked to the dispensed study lenses. The subjects will be masked to both fitting and 
dispensed study lenses. An unmasked site coordinator will prepare the lenses for both lens 
fitting and dispensing. 
All study contact lenses will be prescribed according to the subject’s prescription. CLEAR 
CARE Cleaning & Disinfecting Solution will be provided for use during the duration of the 
study. 

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Figure 7-1 
Study Design 
 
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.  
The bilateral, crossover study design will ensure that the same subject is exposed to both the 
test and comparator lens materials during the study visits and wearing period; therefore, 
 assessments can be obtained for both lenses from the same subject. 
The study will include only those subjects who are successful wearers of soft multifocal 
contact lenses in both eyes during the past 6 months for a minimum of 5 days per week and 
10 hours per day. This will avoid confounding safety responses in nonadapted subjects. The 
study will exclude subjects who are habitual Oasys MF contact lens wearers, daily disposable 
contact lens wearers and monovision contact lens, and wearers of contact lens in 1 eye only.  
Lubrication/rewetting drops will not be permitted during study lens wear or at study visits, 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 visual acuity results. 
7.3 Rationale for Duration of Treatment/Follow-Up 
Subjects will wear each study product bilaterally for their respective wear cycles on a daily 
wear modality. The wear cycle for the LID233309 contact lens is 7 days, and that for the 

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marketed Oasys MF contact lens is 14 days. 
 
 
 
 
 
.  
7.4 Rationale for Choice of Comparator Product 
The Oasys MF contact lenses have been chosen as the comparator product because these 
lenses have a comparable wear modality and same indication for correction of presbyopia.  
7.5 Data Monitoring Committee 
Not applicable. 
8 STUDY POPULATION 
The study population consists of volunteer subjects, of at least 40 years of age who are 
habitual biweekly or monthly soft multifocal contact lens wearers have at least 6 months of 
contact lens wearing experience, and who wear their habitual lenses at least 5 days per week 
and at least 10 hours per day. It is aimed to enroll (consent) approximately 96 subjects in 
approximately 8 sites in the United States, with a target of 92 total subjects completed, with 7 
(intended minimum) to 16 (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.  

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This protocol allows enrollment of the following vulnerable population(s), with associated 
justification for each population:  
Elderly – It is appropriate to include elderly subjects in this clinical trial, as Presbyopia and 
associated gradual loss of accommodation is part of the aging process and worsens with 
increasing age is common to this population. Multifocal contact lenses are a commonly used 
correction option for this condition. The contact lens under study is intended to alleviate this 
condition. It is necessary to include elderly subjects in this clinical trial to gain data regarding 
the safety and effectiveness of the LID233309 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 
protocol. 
3. 
Subject must be at least 40 years of age. 
4. 
Subject must be willing to stop wearing their habitual contact lenses for the duration 
of study participation. 

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5. 
Current wearer of biweekly/monthly replacement multifocal soft contact lenses in 
both eyes for a minimum of 5 days per week and 10 hours per day during the past 6 
months. 
6. 
Manifest cylinder ≤ 0.75 D in each eye. 
7. 
BCVA distance (as determined by manifest refraction at screening) 0.1 logMAR or 
better in each eye. 
8. 
Subject must be able to wear contact lenses within a range of -0.50 D to -4.00 D in 
0.25 D steps, -5.00 D, -6.00 D & -8.00 D, +1.00 D to +3.00 D (in 0.25 D steps) 
+5.00 D and +6.00 D and requiring a near ADD of +0.75 D to +2.50 D in each eye. 
9. 
Subject must be willing to wear the study contact lenses as defined for the full 
duration of the study. 
10. 
Subject must possess spectacles and be willing to wear habitual spectacles for 
vision correction when study lenses are not worn, as needed. 
11. 
Subject must be willing to not use readers while wearing study contact lenses for 
duration of the study. 
12. 
Subject must be willing to wear contact lenses for at least 16 hours per day on the 
day prior to week 1 and week 2 follow-up visits for both test and comparator lenses. 
13. 
Subject must be willing to NOT use rewetting/lubricating drops at any time during 
study lens wear.   
8.2 Exclusion Criteria 
Subjects fulfilling any of the following criteria are not eligible for participation in this study. 
1. 
Currently pregnant or lactating, as stated at Screening. 
2. 
Any anterior segment infection, inflammation, or abnormality or disease (including 
systemic) that contraindicates contact lens wear, as determined by the Investigator. 
3. 
Any use of systemic or ocular medications for which contact lens wear could be 
contraindicated, as determined by the Investigator. 
4. 
History of refractive surgery or planning to have refractive surgery during the study, 
or irregular cornea in either eye. 
5. 
Ocular or intraocular surgery (excluding placement of punctal plugs) within the 
previous 12 months or planned during the study. 

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6. 
Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or 
corneal vascularization that is mild (Grade 2) or higher, and/or any infiltrate. 
7. 
Current or history of pathologically dry eye in either eye that, in the opinion of the 
Investigator, would preclude contact lens wear. 
8. 
Current or history of herpetic keratitis in either eye. 
9. 
Eye injury in either eye within 12 weeks immediately prior to enrollment for this 
trial. 
10. 
Current or history of intolerance, hypersensitivity, or allergy to any component of the 
study products. 
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. 
Habitual Oasys MF contact lens wearers and daily disposable contact lens wearers. 
14. 
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. 
15. 
Participation of the subject in a clinical trial within the previous 15 days or currently 
enrolled in any clinical trial. 
16. 
Monovision contact lens wearers and wearers of contact lens in 1 eye only. 
 
 
 
18. 
Wearing habitual contact lenses in an extended wear modality (routinely sleeping in 
lenses for at least 1 night per week) over the last 6 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): 
LID233309   
Comparator Product(s) (If 
applicable): 
Oasys MF 
Table 9–1 
Test Product 
Test Product 
Serafilcon A Multifocal contact lenses (LID233309) 
Manufacturer 
Alcon Laboratories, Inc. 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
USA 
Indication for use 
and intended 
purpose in the 
current study  
The investigational frequent replacement multifocal contact lens is 
indicated for the optical correction of presbyopia with or without 
refractive ametropia (myopia and hyperopia) persons with 
nondiseased eyes.  
The lenses are intended for daily wear (less than 24 hours while 
awake), with removal for cleaning and disinfection (chemical, not 
heat) prior to reinsertion. 
Product description 
and parameters 
available for this 
study 
• Material: Serafilcon A 
• Water content: 55% 
Power range: Limited lens parameters will be available for use in this 
study:  
o -0.50 D to -4.00 D in 0.25 D steps, -5.00 D, -6.00 D, 
and -8.00 D with ADD of LO, MED, or HI (as available) 
o +1.00 D to +3.00 D in 0.25 D steps, +5.00 D and 
+6.00 D with ADD of LO, MED, or HI (as available) 
• Base curve (mm): 8.4 (Target) 
• Diameter (mm): 14.2 (Target) 
Formulation 
Refer to IB 
Usage 
• Wear: 
o Daily Wear 

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o Bilateral 
• Replacement period:  
o Replaced weekly for ~14 days 
o The unmasked staff must maintain the subject and 
investigator masking to the study product being used. 
• Exposure: Study lenses are to be worn during typical contact 
lens wearing hours, on all days during the study lens wearing 
period, at least 10 hours per day, over each wear cycle (7 days [-
0/+1] according to randomization assignment). Subjects will be 
asked to wear their study lenses for 16 hours on the days prior to 
each Follow-up Visit (Visit 3, 4, 6, & 7). 
• Lens Care: Cleaned and disinfected with CLEAR CARE 
Cleaning & Disinfecting Solution after each use 
• Replacement lenses will not be provided to the subject. In the 
event a lens needs to be replaced, the subject must return to the 
site for a replacement lens. Until the replacement lens is 
obtained, the subject must store the study lenses as instructed. 
Refer to MOP for detailed instructions. 
Number/Amount of 
product to be 
provided to the 
subject 
Subjects will be provided a pair of test lenses at the applicable visit 
as per randomization. Lenses (to be used for fitting and study lens 
wear) will be provided in bulk by the sponsor before the start of the 
trial. (Any additional lenses needed can be requested by the site to 
the sponsor). 
Packaging 
description 
Blister foil pack 
Labeling description • Lens foil label includes: 
o material name and identifier 
o base curve 
o diameter 
o manufacturing protocol number (for the following 
parameters: -0.50 HI, -0.75 HI, +1.00 HI, +1.25 HI, 
+1.50 HI) 
o packing solution 
o power 
o lot number 
o expiration date 

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o content statement 
o investigational device statement 
o sponsor information 
• Lens inventory will be provided in packages and identified with 
the following: 
o a color-coded label stating the study protocol number 
o LID Number 
o power 
o an investigational use only statement 
o 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  
Additional 
information 
N/A 
Supply 
• Lenses will be provided in bulk by the sponsor  
• CLEAR CARE Cleaning & Disinfecting Solution supplied by 
sponsor to be provided to the subject 
• LacriPure saline will be permitted for rinsing the lens(es) after 
removal and prior to insertion, if required 
Refer to the MOP for a detailed description 
 
Table 9–2 
Comparator Product 
Comparator 
Product(s) 
ACUVUE® OASYS MULTIFOCAL with PUPIL OPTIMIZED 
DESIGN (Oasys MF) contact lenses (senofilcon A) 
Manufacturer 
Johnson & Johnson 
Indication for Use 
These comparator multifocal 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 nondiseased eyes.  

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Product description 
and parameters 
available for this 
study 
Commercial description for Product:  
• Material: Senofilcon A  
• Water content: 38% 
• Base curve (mm): 8.4 mm 
• Diameter (mm): 14.3 mm 
Power range: Limited lens parameters will be available for use in this 
study:  
o -0.50 D to -4.25 D in 0.25 D steps, -5.25 D, -6.25 D, 
and -8.25 D with ADD of LO, MID, or HI (as available) 
o +0.75 D to +3.00 D in 0.25 D steps, +4.75 D and +5.75 
D with ADD of LO, MID, or HI (as available) 
 
Formulation 
Refer to package insert 
Usage 
• Wear: 
o Daily wear 
o Bilateral 
• Replacement period:  
o Replaced biweekly for ~14 days 
o The unmasked staff must maintain the subject and 
investigator masking to the study product being used 
• Exposure: Study lenses are to be worn during typical contact 
lens wearing hours, on all days during the study lens wearing 
period, at least 10 hours per day, over the wear cycle (total ~14 
days of 7 days [-0/+1] in each follow-up, according to 
randomization assignment). Subjects will be asked to wear their 
study lenses for 16 hours on the days prior to each Follow-up 
Visit (Visit 3, 4, 6, & 7). 
• Lens Care: Cleaned and disinfected with CLEAR CARE 
Cleaning & Disinfecting Solution after each use 
• Replacement lenses will not be provided to the subject. In the 
event a lens needs to be replaced, the subject must return to the 
site for a replacement lens. Until the replacement lens is 
obtained, the subject must store the study lenses as instructed. 
Refer to MOP for detailed instructions. 
Number/Amount of 
Product to be 
Subjects will receive 1 pair of comparator lenses as per 
randomization, in parameters as determined during trial. 

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Provided to the 
subject 
Packaging 
description 
Provided in Commercial Packaging  
Labeling description Commercial foil 
Training and/or 
experience 
requirements for 
device 
No additional training or experience is required to administer the 
comparator. 
Storage conditions 
Lenses are to be stored at room temperature 
Additional 
identifying 
information 
N/A 
Supply 
• Each site will procure their own comparator lenses, to be used 
for lens fitting and study lenses wear  
• CLEAR CARE Cleaning & Disinfecting Solution supplied by 
sponsor to be provided to the subject 
• LacriPure saline will be permitted for rinsing the lens(es) after 
removal and up to 10 minutes prior to insertion, if required 
Refer to the MOP for a detailed description 
9.2 Other Medical Device or Medication Specified for Use During the 
Study 
No other medical devices or medications are required to be used in conjunction with the 
treatments during the clinical study. 
9.3 Treatment Assignment / Randomization 

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Only after signing the ICF, a subject will be assigned a subject number by the electronic data 
capture system.  
A randomization list will be generated using a validated system that automates the random 
assignment of treatment arms to randomization numbers in the specified ratio. Subjects will 
be assigned treatment (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 
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 LID233309 or 
Oasys MF for the duration of the 2-week treatment period. 
 
 
 
 
 The subjects will be masked to both fitting and dispensed study 
lenses. An unmasked site coordinator will prepare the lenses for both lens fitting and 
dispensing.  

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This level of masking will be maintained throughout the conduct of the study. Unmasking 
will occur only after all planned study data have been validated, and the database locked.  
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.  
9.5 Accountability Procedures 
Upon receipt of the IPs, the investigator or delegate must conduct an inventory. During the 
study, unmasked delegate 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 used lenses and supplies from subjects. 
It is the investigator’s responsibility to ensure that: 
• 
All study products are accounted for and not used in any unauthorized manner 
• 
All unused products are available for return to the study sponsor, as directed 

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• 
Any study lenses associated with a device deficiency or with any product-related 
adverse event (i.e., ADE or SADE) are returned to the study sponsor for investigation, 
unless otherwise directed by the sponsor. Refer to Section 11 of this protocol for 
additional information on the reporting of device deficiencies and AEs and the return 
of study products associated with these events. 
The investigator is responsible for proper disposition of all unused IPs at the conclusion of 
the study, according to the instructions provided in the MOP. 
9.6 Changes to Concomitant Medications, Treatments/Procedures 
After the subject is enrolled into the study, the investigator must instruct the subject to notify 
the study site about: 
• 
Any new medications  
• 
Alterations in dose or dose schedules for current medications  
• 
Any medical procedure or hospitalization that occurred or is planned 
• 
Any nondrug therapies (including physical therapy and blood transfusions)  
The investigator must document this information in the subject’s case history source 
documents. 
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. 
 
 
 
  

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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. 
10.2.2 Medical History 
Collect medical history information for the past year, including information on all 
medications used within the past 30 days. Include herbal therapies, vitamins, and all over-the-
counter as well as prescription medications. Throughout the subject’s participation, obtain 
information on any changes in medical health and/or the use of concomitant medications. 
Targeted medical history and concomitant medications will be collected in the eCRF as 
outlined in the MOP. 
10.2.3 Lens Fitting 
During Visit 1, the investigator should determine if a subject meets the qualification of 
inclusion criteria #8 based upon their habitual contact lens prescription and screening 
manifest refraction, indicating that a subject could be fit within the available study lens 
parameters. In this trial, lens fitting assessments are performed after screening and 
confirmation of inclusion/exclusion criteria, and after a subject is randomized. If a subject 
meets inclusion criteria #8 during screening, but at the time of lens fitting, is determined by 
the PI to be unable to wear study lenses in the available parameters (for either test  or 
comparator), the subject should be discontinued from the study as an Early Exit, and NOT 
indicate screen failure as the reason for exit. 
 
 
10.2.4 Worn Lens Collection 
Worn study lenses will be collected and returned. Refer to MOP for details. 

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10.2.7 Habitual Lens Information 
At Visit 1, the subject’s habitual contact lens information will be collected. Refer to MOP for 
details.  
10.2.8 Keratometry 
Keratometry is required at Visit 1. Refer to MOP for details.  
10.2.9 VA with Habitual Correction 
VA (logMAR distance and near; OD, OS) with the subject’s habitual correction (spectacles or 
habitual contact lenses) will be collected at Visit 1 and at the Exit Visit (Visit 7 or Early Exit) 
and is optional for unscheduled visit. Refer to MOP for details.  
Note: At Visit 7/ Early Exit, PI to ensure the subject wears the same habitual correction worn 
at Visit 1. 

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10.2.13 Worn Lens Collection 
Worn lenses will be collected and returned. Refer to MOP for details. 
10.2.15 Adverse Event Collection: Safety Assessment 
Assess and record any adverse events that are observed or reported since the previous visit, 
including those associated with changes in concomitant medication dosing. 
10.2.16 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. 
10.2.17 Device Deficiencies: Safety Assessment 
Assess and record any device deficiencies that are reported or observed since the previous 
visit. Requirements for reporting device deficiencies in the study can be found in Section 11. 
10.3 Unscheduled Visits 
If a subject visit occurs between any regularly scheduled visit and the visit is conducted by 
study personnel, this visit must be documented as an Unscheduled Visit. If the subject seeks 
medical attention outside the clinic (for example, at an emergency room) or at the clinic but is 
seen by nonstudy personnel, the investigator is to capture adverse event-related information 
on the adverse event form upon becoming aware. 

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During all unscheduled visits, the investigator must conduct the following procedures:  
• 
Collect adverse event information  
• 
Collect device deficiency information, as applicable 
• 
Record changes in medical condition or concomitant medication 
• 
Perform slit lamp biomicroscopy exam 
The investigator may perform additional procedures for proper diagnosis and treatment of the 
subject. The investigator must document this information in the subject’s case history source 
documents. 
If during an Unscheduled Visit the subject is discontinuing the IP or discontinuing from the 
study, the investigator must conduct Exit procedures according to Table 3-1 Schedule of 
Study Procedures and Assessments and Section 10.5.3, as possible. 
Do not complete an Unscheduled Visit if a subject is exiting between scheduled study visits. 
An Early Exit Visit should be completed instead. 
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 re-used. 
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. 

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Subject numbers of discontinued subjects must not be re-used (i.e., subject replacement is not 
allowed). 
Subjects may discontinue from study or study treatment at any time for any reason. Subjects 
may also be discontinued from study treatment at any time if, in the opinion of the 
investigator, continued treatment poses a risk to their health. 
If a subject discontinues from study treatment, every effort must be made to keep the subject 
in the study and to continue with the study assessments as specified in the schedule of study 
procedures and assessments until the final visit. 
For subjects discontinuing from the study, the investigator must complete all Exit procedures 
according to Table 3-1 Schedule of Study Procedures and Assessments and Section 10.5.3, 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, as possible. Refer to Table 3–1 and the MOP for details. 
10.6 Clinical Study Termination 
The study sponsor reserves the right to suspend or close the investigational site or suspend or 
terminate the study in its entirety at any time. 
If the clinical study is prematurely terminated or suspended by the study sponsor:  
• 
The study sponsor must: 
o Immediately notify the investigator(s) and subsequently provide 
instructions for study termination. 

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o Inform the investigator and the regulatory authorities of the 
termination/suspension and the reason(s) for the termination/suspension.  
• 
The investigator must: 
o Promptly notify the IRB/IEC of the termination or suspension and of the 
reasons.  
o Provide subjects with recommendations for poststudy treatment options as 
needed. 
The investigator may terminate the site’s participation in the study for reasonable cause. 
Breaking of the masked treatment codes will be done after locking the database. 
10.6.1 Follow-up of Subjects after Study Participation has Ended  
Following this study, the subject will return to their eye care professional for their routine eye 
care. 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
11.1 General Information 
An AE is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, 
whether or not related to the investigational medical device (test product). Refer to the 
Glossary of Terms and figures below for categories of AEs and SAEs. 
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
 

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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: 
• 
An ocular infection including a presumed infectious ulcer with any of the following 
characteristics:  
o Central or paracentral location 
o Penetration of Bowman’s membrane 
o Infiltrates > 2 mm diameter 
o Iritis 
o Increase in intraocular pressure 
o Culture positive for microorganisms 

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o Increasing size or severity at subsequent visits 
• 
Any central or paracentral corneal event (such as neovascularization) that results in 
permanent opacification 
• 
Hypopyon 
• 
Hyphema 
• 
Neovascularization within the central 6 mm of the cornea 
• 
Permanent vision loss as defined by loss of 2 or more lines of BCVA (e.g., with 
manifest refraction or habitual correction) from enrollment visit that fails to resolve 
• 
Uveitis (anterior, intermediate, or posterior) 
• 
Corneal abrasion affecting ≥ 50% of corneal surface area 
Significant Nonserious Adverse Events 
A significant nonserious AE is a device-related, nonsight threatening adverse event that 
warrants discontinuation of any contact lens wear for greater than or equal to 2 weeks. In 
addition, the investigator must report any occurrence of the following as a significant 
nonserious adverse event: 
• 
Peripheral nonprogressive noninfectious ulcers 
• 
All symptomatic corneal infiltrative events 
• 
Corneal staining score greater than or equal to grade 3 (Refer to MOP for grading 
scales) 
• 
Temporary vision loss as defined by loss of 2 or more lines of BCVA (e.g., with 
manifest refraction or habitual correction) from enrollment visit that persists for 2 or 
more weeks 
• 
Neovascularization score greater than or equal to grade 2 (Refer to MOP for grading 
scales) 
The above events are based on the categories provided in the ISO 11980 and the US FDA 
Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses and 
Lens Care. 
Device Deficiencies 
A device deficiency is inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. A device deficiency may or may not be 

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associated with patient harm (i.e., ADE or SADE); however, not all ADEs or SADEs are due 
to a device deficiency. The investigator should determine the applicable category listed in the 
Device Deficiency eCRF for the identified or suspect device deficiency and report any patient 
harm separately. Examples of device deficiencies include the following:  
• 
Failure to meet product specifications (e.g., incorrect lens power/diameter/base 
curve/color) 
• 
Lens/solution cloudy 
• 
Lens surface/edge defect  
• 
Torn lens during handling/in pack  
• 
Packaging deficit (e.g., mislabeled product, tampered seal, leaking bottle/container) 
• 
Suspect product contamination 
11.2 Monitoring for Adverse Events 
At each visit, after the subject has had the opportunity to spontaneously mention any 
problems, the investigator should inquire about AEs by asking the standard questions shown 
below and report as applicable: 
• 
“Have you had any health problems since your last study visit?” 
• 
“Have there been any changes in the medicines you take since your last study visit?” 
In addition, changes in any protocol-specific parameters 
 evaluated 
during the study are to be reviewed by the investigator. Any untoward (unfavorable and 
unintended) change in a protocol-specific parameter 
 that is 
clinically relevant, in the opinion of the investigator, is to be reported as an AE. These 
clinically relevant changes will be reported regardless of causality.  
11.3 Procedures for Recording and Reporting 
AEs are collected from the time of informed consent. Any preexisting medical conditions or 
signs/symptoms present in a subject prior to the start of the study (i.e., before informed 
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.  

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For each recorded event, the ADEs and SAEs documentation must include date of 
occurrence, severity, treatment (if applicable), outcome, and assessments of the seriousness 
and causality. In addition, the investigator must document all device deficiencies reported or 
observed with test and comparator products on the Device Deficiency eCRF. The site must 
submit all available information on ADEs, SAEs, and device deficiencies to the study sponsor 
immediately as follows: 
• 
ADEs or SAEs are documented on the Adverse Device Effect and Serious Adverse 
Event eCRF within 24 hours of the investigator’s or site’s awareness. 
• 
Device deficiencies are documented on the Device Deficiency eCRF within 24 hours 
of the investigator’s or site’s awareness.  
• 
Additional relevant information after initial reporting must be entered into the eCRF as 
soon as the data become available. 
• 
Document any changes to relevant concomitant medications on the narrative section of 
the corresponding Adverse Device Effect (for related AEs) and Serious Adverse Event 
eCRF. 
• 
Document all relevant information from Discharge Summary, Autopsy Report, 
Certificate of Death, etc., if applicable, in narrative section of the Adverse Device 
Effect (for related AEs) and Serious Adverse Event eCRF. 
Note: Should the EDC system become nonoperational, the site must complete the 
appropriate paper Serious Adverse Event and Adverse Device Effect and/or Device 
Deficiency Form. The completed form is emailed to the study sponsor at 
msus.safety@alcon.com, for US, according to the timelines outlined above; however, 
the reported information must be entered into the EDC system once it becomes 
operational. 
Study sponsor representatives may be contacted for any protocol-related question and their 
contact information is provided in the manual of procedures that accompanies this protocol. 
Further, depending upon the nature of the AE or device deficiency being reported, the study 
sponsor may request copies of applicable portions of the subject’s medical records. The 
investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC. 

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Intensity and Causality Assessments 
Where appropriate, the investigator must assess the intensity (severity) of the AE based on 
medical judgment with consideration of any subjective symptom(s), as defined below: 
Intensity (Severity) 
Mild  
An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom. 
Moderate  
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities. 
Severe  
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities. 
For every AE in the study, the investigator must assess the causality (related or not related to 
the medical device or study procedure). An assessment of causality will also be performed by 
study sponsor utilizing the same definitions, as shown below: 
Causality 
Related 
An AE classified as related may be either definitely related or possibly related 
where a direct cause and effect relationship with the medical device or study 
procedure has not been demonstrated, but there is a reasonable possibility that 
the AE was caused by the medical device or study procedure. 
Not Related  An AE classified as not related may either be definitely unrelated or simply 
unlikely to be related (i.e., there are other more likely causes for the AE). 
The study sponsor will assess the AEs and may upgrade the investigator’s assessment of 
seriousness and/or causality. The study sponsor will notify the investigator of any AE that is 
upgraded from nonserious to serious or from unrelated to related. 
11.4 Return Product Analysis  
Study sponsor representatives and their contact information are provided in the MOP that 
accompanies this protocol.  
Alcon study products associated with device deficiencies and/or product related AEs should 
be returned and must include the PR #, which will be provided by study sponsor after the 

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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 code needs to be broken in the interest of subject safety, the 
investigator is encouraged to contact an appropriate study sponsor representative prior to 
unmasking the information if there is sufficient time. Dependent upon the individual 
circumstances (i.e., medical emergency), the assigned treatment can be unmasked prior to 
contact with the study sponsor. The study sponsor must be informed of all cases in which 
unmasking occurred and of the circumstances involved. Additionally, the study sponsor may 
be required to unmask the information in order to fulfill expedited regulatory reporting 
requirements. 
11.6 Follow-Up of Subjects with Adverse Events 
The investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study.  
The investigator should provide the study sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ongoing at time of subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (i.e., database lock).  
All complaints received after this time period will be considered and processed as 
spontaneous (following the post market vigilance procedures) and should be communicated 
to the medical device’s manufacturer as per local requirements. 
The investigator should also report complaints on non-Alcon products (i.e., Oasys MF, 
CLEAR CARE Cleaning & Disinfecting Solution, and LacriPure saline) 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 or lactating (as stated by subject) at the time of study entry are 
excluded from participation. However, pregnancy should be included in the Pregnancy eCRF 
if a woman becomes pregnant (as stated by the subject) during the study. Subjects who 
become pregnant during the study will not be discontinued; however data will be excluded 

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from the effectiveness analyses because pregnancy can alter refraction and visual acuity 
results. 
Pregnancy is not reportable as an AE; however, complications may be reportable and will be 
decided on a case-by-case basis. 
12 ANALYSIS PLAN 
Continuous variables will be summarized using the number of observations, mean, SD, 
median, minimum, and maximum, as well as CIs or confidence limits 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 
(lens sequence) assignment and locking the database, based upon the data evaluability plan 
(DEP). 
12.2 Analysis Sets 
12.2.1 Safety Analysis Set 
Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. 
As such, the safety analysis set will include all subjects/eyes exposed to any study lens 
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. 

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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,
 
 
 the FAS as the primary analysis set. 
 
 
  
 
 
 
 
12.4.1 Analysis of Primary Effectiveness Endpoint(s) 
The primary objective of this study is to evaluate the binocular VA at distance of LID233309 
lenses and Oasys MF contact lenses at Week 1. 
The primary endpoint is binocular HC/HI distance (4 m) VA with study lenses at Week 1, 
collected for each eye, on the logMAR scale. 

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12.4.1.1 Statistical Hypotheses 
No inferences are to be made on the primary effectiveness endpoint; therefore, no hypotheses 
are formulated. 
12.4.1.2 Analysis Methods 
At Week 1, descriptive statistics will be provided as number of observations, mean, SD, 
median, minimum, and maximum, along with a two-sided 95% confidence interval. 
Similarly, for Dispense and Week 2.  

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12.5 Handling of Missing Data 
All data obtained in evaluable subjects/eyes will be included in the analysis. No imputation 
for missing values will be carried out for the primary and key exploratory effectiveness 
analyses. 
12.6 Safety Analyses 
The safety endpoints are:  
• AEs  
• Biomicroscopy findings  
• Device deficiencies  
There are no safety hypotheses planned in this study. The focus of the safety analysis will be 
a comprehensive descriptive assessment of occurrence of AEs as well as the other listed 
parameters.  
All AEs occurring from the time a subject signs 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.  
Separate individual subject listings will be provided for AEs that occur after signing informed 
consent but prior to exposure to study lenses, and for AEs that occur during the washout 
periods.  
Each biomicroscopy parameter will be tabulated by its grade. For each biomicroscopy 
parameter, counts and percentages of eyes that experience an increase of ≥ 2 grades from 
baseline (last assessment prior to study lens) to any subsequent visit within the same period 
will be presented. A supportive listing will be generated which will include all biomicroscopy 
data from all visits within the same period for those eyes experiencing the increase.  
Two listings (prior to exposure to study lenses and treatment-emergent) of device deficiencies 
will be provided. Additionally, each device deficiency category will be tabulated.  
No inferential testing will be conducted for the safety analyses. 

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12.7 Interim Analyses and Reporting 
There are no plans to conduct an interim analysis and no criteria by which the study would be 
terminated early based upon statistical determination. 
12.8 Sample Size Justification 
Although inferential testing is not planned for the primary and effectiveness endpoints, 
expected precision of the observed results is provided for the chosen sample size of 92,
 
 
Visual Acuity 
With the assumed standard deviation of 0.12, a two-sided 95% CI for the mean of distance 
visual acuity based on t-statistics, coverage probability of 0.85 will extend 0.027 (~1 Snellen 
letter) from the observed mean. 
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS 
13.1 Subject Confidentiality 
The investigator must ensure that the subject’s identity is kept confidential throughout the 
course of the study. In particular, the investigator must keep an enrollment log with 
confidential identifying information that corresponds to the subject numbers and initials of 
each study participant. The study sponsor may collect a copy of the enrollment log without 
any directly identifying subject information.  
The study sponsor may share patient-level data collected in this trial with qualified 
researchers to help facilitate product development or enhancements in research that is not 
directly related to the study objectives. The informed consent explains this to the study 
subject.  
13.2 Completion of Source Documents and Case Report Forms 
The nature and location of all source documents will be identified to ensure that original data 
required to complete the CRFs exist and are accessible for verification by the site monitor, 

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

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13.4 Sponsor and Monitoring Responsibilities 
The study sponsor will select principal investigators who 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 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. 
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 

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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 Good Clinical Practices; 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.  
• 
The SOPs of the study sponsor and contract research organizations participating in the 
conduct of the clinical study and all other applicable regulations shall apply.  
• 
Notifications and timelines for reporting protocol deviations should be based upon 
applicable Ethics Committee requirements. 
The investigator must ensure that all personnel involved in the conduct of the study are 
qualified to perform their assigned responsibilities through relevant education, training, and 
experience. The investigator and all clinical study staff must conduct the clinical study in 
compliance with the protocol. The investigator is not allowed to deviate from the protocol 
except to protect the rights, safety, and well-being of human subjects under emergency 
circumstances. Emergency deviations may proceed without prior approval of the sponsor and 
the IRB/EC, but shall be documented and reported to the sponsor and the IRB/EC 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 

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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 
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. 

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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. 
• 
ISO 11980 Ophthalmic optics - Contact lenses and contact lens care products - 
Guidance for clinical investigations 
• 
EN ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects - Good 
Clinical Practice 
• 
21 CFR Part 11 - Electronic Records; Electronic Signatures 
• 
21 CFR Part 50 - Protection of Human Subjects 
• 
21 CFR Part 56 - Institutional Review Boards 
• 
21 CFR Part 812 - Investigational Device Exemptions 
• 
21 CFR Part 54 - Financial Disclosure by Clinical Investigators 
• 
The California Bill of Rights, if applicable 
15.2 Scientific and Other References 
Young G, Chalmers RL, Napier L, Hunt C, Kern J. Characterizing contact lens-related 
dryness symptoms in a cross-section of UK soft lens wearers. Contact Lens Anterior Eye. 
2011; 34:64–70. 

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Status: Approved, Version: 3.0 
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Document ID: 
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Status: Approved, Version: 3.0 
Approved Date: 31 Jul 2024 
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Signature Page for V-CLN-0196000 v3.0