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

 
 
 
 
 
Clinical Performance Evaluation of Two Frequent 
Replacement  
Silicone Hydrogel Toric Contact Lenses 
 
STUDY ID 
CLN109-C001 
 
PROTOCOL 
 
 
NCT05959200 

Document ID: 
V-CLN-0040694 
Status: Approved, Version: 3.0 
Approved Date: 06 Sep 2023 
Page 1 of 81 
 
Alcon – Business Use Only 
 
Device Protocol for CLN109-C001 
Title: Clinical Performance Evaluation of Two Frequent Replacement 
Silicone Hydrogel Toric Contact Lenses 
Protocol Number: 
CLN109-C001 
Clinical Investigation 
Type:  
Pivotal 
Test Product: 
Alcon Serafilcon A Toric Contact Lenses (LID226397) 
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 

Document ID: 
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Status: Approved, Version: 3.0 
Approved Date: 06 Sep 2023 
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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 (PI): 
 
Signature 
 
 
 
 
 
Date 
Name and professional 
position: 
 
Address: 
Phone Number:  
Off-hours Emergency 
Phone Number: 
 
 
 

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Status: Approved, Version: 3.0 
Approved Date: 06 Sep 2023 
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Table of Contents 
Device Protocol for CLN109-C001 ........................................................................................... 1 
Title: Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel 
Toric Contact Lenses ........................................................................................................... 1 
Table of Contents ....................................................................................................................... 3 
List of Tables .............................................................................................................................. 5 
List of Figures ............................................................................................................................ 6 
1 
GLOSSARY OF TERMS .................................................................................................... 7 
2 
LIST OF ACRONYMS AND ABBREVIATIONS ........................................................... 13 
3 
PROTOCOL SUMMARY ................................................................................................. 15 
 
 
5 
INTRODUCTION ............................................................................................................. 29 
5.1 
Rationale and Background ................................................................................. 29 
5.2 
Purpose of the Study .......................................................................................... 30 
5.3 
Risks and Benefits ............................................................................................. 31 
6 
STUDY OBJECTIVES...................................................................................................... 32 
6.1 
Primary Objective(s) .......................................................................................... 32 
6.2 
Secondary Objective(s) ...................................................................................... 32 
 
 
6.4 
Safety Objective(s) ............................................................................................ 34 
7 
INVESTIGATIONAL PLAN ............................................................................................ 35 
7.1 
Study Design...................................................................................................... 35 
7.2 
Rationale for Study Design................................................................................ 36 
7.2.1 
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations ........................................................................................ 37 
7.3 
Rationale for Duration of Treatment/Follow-Up ............................................... 37 
7.4 
Rationale for Choice of Comparator Product .................................................... 38 
7.5 
Data Monitoring Committee .............................................................................. 38 
8 
STUDY POPULATION .................................................................................................... 38 
8.1 
Inclusion Criteria ............................................................................................... 39 
8.2 
Exclusion Criteria .............................................................................................. 40 

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8.3 
Rescreening of Subjects ..................................................................................... 41 
9 
TREATMENTS ADMINISTERED................................................................................... 41 
9.1 
Investigational Product(s) .................................................................................. 41 
9.2 
Other Medical Device or Medication Specified for Use During the Study ....... 46 
9.3 
Treatment Assignment/Randomization ............................................................. 46 
9.4 
Treatment Masking ............................................................................................ 47 
9.5 
Accountability Procedures ................................................................................. 49 
9.6 
Changes to Concomitant Medications, Treatments/Procedures ........................ 50 
10 STUDY PROCEDURES AND ASSESSMENTS ............................................................. 50 
10.1 Informed Consent and Screening ...................................................................... 51 
10.2 Description of Study Procedures and Assessments ........................................... 51 
10.2.1 
Demographics .................................................................................... 51 
10.2.2 
Medical History ................................................................................. 51 
10.2.3 
Investigational Product Compliance .................................................. 52 
10.2.4 
Adverse Event Collection: Safety Assessment .................................. 52 
10.2.5 
Slit Lamp Biomicroscopy: Safety Assessment .................................. 52 
10.2.6 
Device Deficiencies: Safety Assessment ........................................... 52 
10.3 Unscheduled Visits ............................................................................................ 52 
10.4 Discontinued Subjects ....................................................................................... 53 
10.4.1 
Screen Failures .................................................................................. 53 
10.4.2 
Discontinuations ................................................................................ 53 
10.4.3 
Schedule of Procedures and Assessments for Subjects 
Discontinued from Investigational Product ....................................... 54 
10.5 Clinical Study Termination ................................................................................ 54 
10.5.1 
Follow-up of Subjects after Study Participation has Ended .............. 54 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ................................................... 55 
11.1 General Information .......................................................................................... 55 
11.2 Monitoring for Adverse Events ......................................................................... 58 
11.3 Procedures for Recording and Reporting .......................................................... 58 
11.4 Return Product Analysis .................................................................................... 60 
11.5 Unmasking of the Study Treatment ................................................................... 60 
11.6 Follow-Up of Subjects with Adverse Events ..................................................... 61 
11.7 Pregnancy in the Clinical Study ........................................................................ 61 

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12 ANALYSIS PLAN ............................................................................................................ 61 
12.1 Subject Evaluability ........................................................................................... 62 
12.2 Analysis Sets...................................................................................................... 62 
12.2.1 
Safety Analysis Set: ........................................................................... 62 
12.2.2 
The Full Analysis Set ......................................................................... 62 
12.2.3 
Per Protocol Analysis set ................................................................... 62 
12.3 Demographic and Baseline Characteristics ....................................................... 62 
12.4 Effectiveness Analyses ...................................................................................... 62 
12.4.1 
Analysis of Primary Effectiveness Endpoint(s)................................. 63 
12.4.1.1 
Statistical Hypotheses ........................................................ 63 
12.4.1.2 
Analysis Methods............................................................... 64 
 
 
 
 
 
 
12.5 Handling of Missing Data .................................................................................. 68 
12.6 Safety Analyses.................................................................................................. 68 
12.7 Interim Analyses and Reporting ........................................................................ 69 
 
 
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ............................... 70 
13.1 Subject Confidentiality ...................................................................................... 70 
13.2 Completion of Source Documents and Case Report Forms .............................. 70 
13.3 Data Review and Clarifications ......................................................................... 71 
13.4 Sponsor and Monitoring Responsibilities.......................................................... 71 
13.5 Regulatory Documentation and Records Retention .......................................... 72 
13.6 Quality Assurance and Quality Control ............................................................. 73 
14 ETHICS ............................................................................................................................. 73 
15 REFERENCES .................................................................................................................. 75 
15.1 Regulations and Standards................................................................................. 75 
15.2 Scientific and Other References ........................................................................ 75 
 
 
List of Tables 
Table 2–1 
List of Acronyms and Abbreviations Used in This Protocol ........................... 13 

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Table 3–1 
Schedule of Study Procedures and Assessments ............................................. 23 
Table 6–1 
Primary Objective(s) ........................................................................................ 32 
 
 
Table 6–3 
Safety Objective(s)........................................................................................... 34 
Table 9–1 
Test Product ..................................................................................................... 41 
Table 9–2 
Comparator Product ......................................................................................... 44 
 
 
 
List of Figures 
  
 
Figure 11-1 
Categorization of All Adverse Events .............................................................. 55 
Figure 11-2 
Categorization of All Serious Adverse Events ................................................. 56 
 
 
 
 

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1 GLOSSARY OF TERMS 
Names of Test Product(s) 
Throughout this document, test product(s) Alcon Serafilcon 
A Toric Contact Lenses 
 
 will be referred to as LID226397. 
Name of Comparator 
Product(s) 
ACUVUE® OASYS for ASTIGMATISM with 
HYDRACLEAR®  PLUS (AOfAHP) 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. 
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 

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

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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. 
Postapproval Study (PAS) 
 
A study required by the FDA or other health authority at the 
time of approval of a premarket approval (PMA), 
humanitarian device exemption (HDE), or product 
development protocol (PDP) application. Postapproval 
studies are conducted to provide patients, health care 
professionals, the device industry, the FDA and other 
stakeholder’s information on the continued safety and 
effectiveness (or continued probable benefit, in the case of 
an HDE) of approved medical devices. 
Postmarketing / 
Postauthorization study 
Any study conducted within the conditions laid down in 
product labelling and other conditions laid down for the 
marketing of the product or under normal conditions of use. 

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A post-marketing study falls either within the definitions of 
an interventional or a noninterventional study and may also 
fall within the definition of a post-approval study. 
Product Complaint 
 
Any oral, electronic, or written communication that alleges 
deficiencies related to the identity (labeling), quality, 
durability, reliability, safety, effectiveness, or performance 
of a marketed product, including failure of the product, 
labeling, or packaging to meet specifications, whether or not 
the product is related to or caused the alleged deficiency. A 
complaint may allege that an adverse event or medical 
device malfunction has occurred.  
Randomized Subject 
Any subject who is assigned a randomized treatment. 
Serious Adverse Device 
Effect (SADE) 
 
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
Serious Adverse Event 
(SAE) 
 
Adverse event that led to any of the following:  
• Death. 
• A serious deterioration in the health of the subject, users 
or other persons as defined by one or more of the 
following:  
a) a life-threatening illness or injury   
Note: Life-threatening means that the individual was 
at immediate risk of death from the event as it 
occurred, i.e., it does not include an event which 
hypothetically might have caused death had it 
occurred in a more severe form. 
b) any potentially sight-threatening event or permanent 
impairment to a body structure or a body function 
including chronic diseases. 
c) inpatient hospitalization or prolonged 
hospitalization. 
d) a medical or surgical intervention to prevent a) or b).  
e) any indirect harm as a consequence of incorrect 
diagnostic test results when used within 

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manufacturer’s instructions for use. 
• Fetal distress, fetal death, congenital abnormality or 
birth defect including physical or mental impairment. 
Note: Planned hospitalization for a preexisting condition, or 
a procedure required by the CIP, without serious 
deterioration in health, is not considered a serious adverse 
event.  
Refer to Section 11 for additional SAEs. 
Serious Public Health 
Threat 
 
Signal from any adverse event or device deficiency that 
indicates an imminent risk of death or a serious deterioration 
in the health in subjects, users, or other persons, and that 
requires prompt remedial action for other subjects, users, or 
other persons. 
Note: This would include events that are of significant and 
unexpected nature such that they become alarming as a 
potential serious health hazard or possibility of multiple 
deaths occurring at short intervals.  
Significant Nonserious 
Adverse Event 
A symptomatic, device-related, nonsight-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 
ADE  
Adverse device effect 
AE 
Adverse event 
AOfAHP 
ACUVUE OASYS for ASTIGMATISM with HYDRACLEAR PLUS 
contact lenses   
ASADE 
Anticipated serious adverse device effect 
BCVA 
Best corrected visual acuity 
CFR 
Code of Federal Regulations 
CI 
Confidence interval 
CIP 
Clinical Investigation Plan 
CIR 
Clinical Investigation Report 
COL 
Clinical Operation Lead 
CRF 
Case report form 
CSM 
Clinical Site Manager 
CTT 
Clinical Trial Team 
D 
Diopter  
D/C 
Discontinue 
DEP 
Deviations and evaluability plan 
ECP 
Eye Care Practitioner 
EDC 
Electronic Data Capture 
eCRF 
Electronic case report form 
FAS 
Full analysis set 
FDA 
US Food and Drug Administration 
GCP 
Good Clinical Practice 
GPCMS 
Global Product Complaint Management System 
HDE 
Humanitarian Device Exemption 
 
 
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 
 
 
LogMAR 
Logarithm of the minimum angle of resolution 
min 
Minutes 
MOP 
Manual of procedures 
 
 
N/A 
Not applicable 
OD 
Right Eye 
 

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Abbreviation 
Definition 
OS 
Left Eye 
OU 
Both Eye 
PAS 
Postapproval Study 
PDP 
Product development protocol 
PI 
Principal investigator 
PMA 
Premarket approval 
PP 
Per protocol 
SAE 
Serious adverse effect 
SADE 
Serious adverse device event 
SD 
Standard Deviation 
SiHy 
Silicone Hydrogel 
SLE 
Slit lamp examination 
SOP 
Standard operating procedure 
US 
United States 
USADE 
Unanticipated serious adverse device effect 
UV 
Ultraviolet 
VA 
Visual acuity 
 
 
 
 

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3 PROTOCOL SUMMARY 
Investigational 
product type 
Device 
Study type 
Interventional  
Investigational 
products 
Test Product: LID226397 
Comparator Product: ACUVUE OASYS for ASTIGMATISM 
with HYDRACLEAR  PLUS (AOfAHP) contact lenses  
Purpose and Scientific 
Rationale for the 
Study 
• For performance confirmation purposes, the study will 
evaluate the on-eye clinical performance of investigational 
LID226397 contact lenses to support contact lens product 
development/launch and to evaluate product performance in 
the intended population. 
 
 
 
 
 
 
  
Brief Summary of the 
Protocol 
The overall objective of this study aims to evaluate the on-eye 
toric clinical performance of investigational LID226397 contact 
lenses and AOfAHP contact lenses in a daily wear dispensing 
trial. Volunteer subjects aged 18 or over who are habitual soft 
toric contact lens wearers, have at least 3 months of contact lens 
wearing experience (excluding AOfAHP 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, 
multicenter clinical study.  
Objective(s) 
The primary objective is to evaluate the percentage of 
LID226397 contact lenses with axis orientation within 
±30 degrees from the 90º axis (ideal location), 10 min after lens 
insertion at dispense visit. 
 
 
 

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The safety objective is to describe the safety profile of the study 
products. 
Endpoint(s)  
 
Primary Effectiveness  
• Percent of lenses with axis orientation within 
±30 degrees from the intended axis, 10 min after 
insertion  

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Safety 
• Adverse events  
• Biomicroscopy findings 
• Device deficiencies 
Assessment(s)  
Effectiveness 
• Axis orientation (degrees, as deviation from 90° axis), at 
 10 min after lens insertion 

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Safety 
• Adverse events 
• Biomicroscopy 
• Device deficiencies 
 
Study Design 
This will be a prospective, randomized 
, bilateral, 
crossover, controlled, double-masked, multicenter clinical study. 
Subjects will be expected to attend 7 visits including screening 
visit. The total duration of a subject’s participation in the study 
will be approximately 40 days. Subjects will be exposed to each 
lens for bilateral wear for approximately 14 days and will be 
followed up weekly. 
 
 
 
Subjects will be 
 and randomized 1:1 to one of two 
sequences: 
 
Sequence 1 = LID226397/AOfAHP 
Sequence 2 = AOfAHP/LID226397 
Subject population 
Volunteer subjects aged 18 or over who are habitual soft toric 
contact lens wearers (excluding AOfAHP habitual lens wearers 
and habitual daily disposable lens wearers) with normal eyes 
(other than correction for refractive error). Subjects should have 

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at least 3 months wearing experience, wear these lenses at least 
5 days per week and at least 10 hours per day. 
Planned number of subjects enrolled/consented: ~92 
Planned number of completed subjects: 80 
Sites and Locations 
Planned number of clinical sites: ~ 6 
Planned locations (initial list of locations, which may change 
during start up or conduct according to study needs): United 
States 
Key inclusion criteria 
(See Section 8.1 for a 
complete list of 
inclusion criteria) 
• Successful wearers of any commercial soft toric contact 
lenses (except AOfAHP and daily disposable lenses) in both 
eyes with at least 3 months wearing experience, with a 
minimum wearing time of 5 days per week and 10 hours per 
day. 
• Subjects must be able to fit and wear contact lenses within a 
range of sphere & cylinder power and axes available (Sphere: 
-0.25 to -4.00 D in 0.25 D steps, -5.50 D, -6.50 D, -5.00 to -
10.00 D (in 1D steps), +1.00 D to +8.00 D (in 1D steps); 
Cylinder: -0.75 D and -1.25 D; Axis: 10º, 90º, 170º, 180º as 
available). 
• Best corrected distance visual acuity greater than or equal to 
20/25 Snellen (0.10 logMAR) in each eye (as determined by 
manifest refraction at screening) 
 
 
 
 
Key exclusion criteria 
(See Section 8.2 for a 
complete list of 
exclusion criteria) 
• Wearing habitual contact lenses in an extended wear 
modality (routinely sleeping in lenses for at least 1 night per 
week) over the last 3 months prior to enrollment. 
• Habitual AOfAHP contact lens wearers and habitual daily 
disposable lens wearers (worn within last 3 months). 
Data analysis and 
sample size 
justification 
Planned Data Analysis 
To address the primary effectiveness, 
 
 

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only descriptive statistics will be provided.
 
 
 No inferential 
testing will be performed. 

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Associated materials 
The use of marketed rewetting drops will not be permitted 
during clinical study. 
Subjects will be provided with CLEAR CARE® Cleaning & 
Disinfecting Solution to use with the study lenses.  
LacriPure saline will be permitted for rinsing the lens(es) after 
removal and prior to insertion, if required. 
 

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Lens 1 (Period 1) 
Lens 2 (Period 2) 
 
 
Procedure/ 
Assessment 
Pre-
screening 
Visit 1 
Screening/ 
Baseline/ 
Trial fit 
 
Visit 2 
Dispense Lens 
1 
(3 - 4 days after 
Visit 1 
[Washout 
period with 
habitual 
spectacles only 
after Visit 1]) 
Visit 3 
Week 1 
Follow-
up Lens 
1 
(7 -0/+1 
days 
after 
Visit 2) 
Visit 4 
Week 2 
Follow- up 
Lens 1 
(7 -0/+1 
days after 
Visit 3) 
Visit 5 
Dispense Lens 
2 
(2 [at least 48 
hours] - 4 days 
after Visit 4 
[Washout 
period with 
habitual 
spectacles only 
after Visit 4]) 
Visit 6 
Week 1 
Follow-
up 
Lens 2 
(7 -0/+1 
days 
after 
Visit 5) 
Visit 7 
Week 2 
Follow-
up Lens 
2/Exit 
(7 -0/+1 
days after 
Visit 6) 
Early 
Exit 
Unscheduled 
Visit 

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4 PROTOCOL AMENDMENTS 
Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments must be created by the study sponsor and must be 
approved by the IRB/IEC and global and regional Health Authorities, as applicable, prior to 
implementation except when required to mitigate immediate safety risks or when the changes 
involve only logistical or administrative revisions.  
Amendments may necessitate that the informed consent and other study-related material be 
revised. If the consent form is revised, all subjects currently enrolled in the study must sign 
the approved, revised informed consent (re-consent), as required by the IRB/IEC. 
  
5 INTRODUCTION 
5.1 
Rationale and Background 
LID226397 contact lenses are indicated for the optical correction of refractive ametropia 
(myopia or hyperopia, with astigmatism) in persons with nondiseased eyes. The LID226397 
contact lenses are a frequent replacement silicone hydrogel (SiHy) contact lenses being 
developed in an effort to maintain prolonged on-eye performance by utilizing an inherently 
wettable core lens material. These SiHy lenses have a water content of 55%, contain a UV 
blocker, High Energy Visible Light (HEVL) filter, and light blue handling tint. LID226397 
contact lenses use the Precision Balance 8|4™ ballasted toric design concept, successfully 

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adopted for AIR OPTIX™ for Astigmatism. A front-curve orientation feature will consist of a 
fiducial mark at 6 o’clock for on-eye assessment of lens rotation. 
 
In order for the toric contact lenses to perform effectively, they must maintain the correcting 
cylindrical axis in appropriate and stable orientation. Therefore, it is critical to have timely 
lens orientation to ideal axis, minimal lens rotation, and lens oscillation to achieve optimal 
performance and stable correction of astigmatism with minimal visual blur. For performance 
confirmation purpose, the study aims to evaluate the on-eye clinical performance of 
investigational LID226397 contact lenses to support contact lens product development and to 
evaluate product performance in the intended population. 
 
 
  
The AOfAHP contact lenses have been chosen as the comparator product because these 
lenses have the comparable wear modality and same indication for correction of astigmatism. 
5.2 Purpose of the Study 
The overall objective of this study aims to evaluate the on-eye toric clinical performance of 
investigational LID226397 contact lenses and AOfAHP contact lenses in a daily wear 
dispensing trial. Volunteer subjects aged 18 or over who are habitual toric soft contact lens 
wearers, have at least 3 months of contact lens wearing experience (excluding AOfAHP 
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, 
multicenter clinical study. The outcomes of this study will be used to support contact lens 
product development 
 
  

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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, 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 for successful contact lens wear. Based upon nonclinical testing and 
documented rationale for applicability of test results, LID226397 contact lenses, which is 
made of the same material as Alcon serafilcon A sphere contact lens, are assessed to be 
nontoxic and biocompatible for on-eye use. 
 
In the US, Acuvue Oasys 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. 
 

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A summary of the known potential benefits and risks associated with LID226397 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 LID226397 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 LID226397 contact lenses. 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. 
6 STUDY OBJECTIVES 
6.1 Primary Objective(s) 
Table 6–1 
Primary Objective(s) 
Objective(s) 
Endpoint(s) 
To evaluate the percentage of LID226397 
contact lenses with axis orientation within ± 
30 degrees from the 90º axis (ideal 
location), 10 min after lens insertion at 
dispense visit. 
Percent of lenses with axis orientation 
within ± 30 degrees from the intended axis, 
10 min after insertion  
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 

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7 INVESTIGATIONAL PLAN 
7.1 Study Design 
This is a prospective, randomized 
 bilateral, crossover, controlled, double-masked, 
multicenter clinical study, evaluating the LID226397 and AOfAHP contact lenses, to be 
conducted at approximately 6 sites.  
Subjects will be randomized to 1 of 2 crossover sequences, 
 
 and exposed to test and comparator lenses for bilateral wear. Subjects will 
be expected to complete all 7 scheduled visits. Subjects will be asked to wear their habitual 
spectacles only (no contact lens wear) during the washout periods for 3 to 4 days after Visit 1, 
and for 2 (at least 48 hours) to 4 days after Visit 4. All study contact lenses will be prescribed 
according to subject’s prescription and fitted using the manufacturers fitting instructions. 
Investigator will insert the contact lenses with scribe mark in the direction of the intended 6 
o’clock position (90º axis), 
 
. 
 
This is a double masked study design where both the investigator and the subjects will be 
masked to the details of the study products and assigned treatment (lens) sequences. 
Differences in scribe marks and lens thickness profile between the study lenses could result in 
potential inadvertent unmasking of investigator. 
 
 
 
 
 
  
 
Subjects will be provided with CLEAR CARE Cleaning & Disinfecting Solution to use with 
the study lenses for the duration of study. LacriPure saline will be permitted for rinsing the 
lens(es) after removal and prior to insertion, if required. 

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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 investigational contact lens is intended for the optical correction of refractive ametropia 
(myopia or hyperopia, with astigmatism) in persons with non-diseased eyes. 
The purpose of this study is to evaluate the on-eye clinical performance of investigational 
LID226397 contact lenses to support contact lens product development and to evaluate 
product performance in the intended population. 
 
 
 
The primary and 
 endpoints were selected to fulfill the primary 
 objectives of the study. Procedures for measurement of these endpoints 
were selected based on common practice for these assessments. The design of this study is 
justified based upon preclinical and clinical testing, as described within the investigator’s 
brochure. 
 
 AOfAHP contact lenses were chosen as the comparator product 

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because these lenses also are reusable contact lenses and have the comparable wear modality 
and same indication for correction of astigmatism (see Package Insert for AOHP contact 
lenses).  
The intended use of this contact lens is vision correction in astigmatism; therefore, the 
measurement of lens axis orientation, 10 min after insertion is planned as the primary 
effectiveness endpoint. 
 
 
 
 
  
The crossover design will ensure that the same subject is exposed to both the test and 
comparator lens materials; therefore, 
objective assessments 
 
will be obtained for both lenses from the same subject. 
 
 
 The study will exclude any current/habitual 
AOfAHP lens and daily disposable contact lens wearers, and any previous wearers of 
AOfAHP or daily disposable contact lenses in the past 3 months prior to consent in order to 
reduce potential bias of wearers to their habitual contact lenses. There are no immediate plans 
to submit the results of this pivotal 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.  
7.2.1 
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations 
Interim analyses will not be performed.  
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 lenses will be provided by a qualified 
unmasked study staff member in such a manner that the subject and the investigator remain 
masked to the lens type. The primary 
 endpoints will be assessed on dispense 
visits 
 respectively. 
 
 

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 The duration of use of each study 
product is in accordance with the respective product labeling (see package inserts for AOHP 
contact lenses and IB for LID226397 contact lenses). 
7.4 Rationale for Choice of Comparator Product 
AOfAHP contact lenses were chosen as the comparator product because these lenses also are 
reusable contact lenses (see Package Insert for AOHP contact lenses) and have similar 
indications for correction of astigmatism. 
7.5 Data Monitoring Committee 
Not applicable.  
8 STUDY POPULATION 
The study population consists of male and female subjects aged 18 or over and who wear any 
commercial soft toric contact lenses (excluding AOfAHP habitual lens wearers and habitual 
daily disposable lens wearer) in both eyes with at least 3 months wearing experience, with a 
minimum wearing time of 5 days per week and 10 hours per day.  

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The study population will include approximately 92 volunteer subjects to be enrolled 
(consented) at approximately 6 sites within the US, with a target of 80 total completed 
subjects. Site-specific targets may vary based upon individual site capabilities. Estimated 
time needed to recruit subjects for the study is approximately 4 weeks; however, 
unanticipated circumstances may shorten or lengthen this time and would not require 
amendment of this protocol. A 15% screening failure rate is expected requiring approximately 
92 subjects are expected to be enrolled. 
8.1 Inclusion Criteria 
Written informed consent must be obtained before any study specific assessment is 
performed. Upon signing informed consent, the subject is considered enrolled in the study. 
Subjects eligible for inclusion in this study must fulfill all of the following criteria: 
1.  
Subject must be at least 18 years of age. 
2. 
Subject must be able to understand and must sign an informed consent form (ICF) 
that has been approved by an Institutional Review Board (IRB/IEC).  
3. 
Successful wearers of any commercial toric soft contact lenses (except AOfAHP 
and daily disposable lenses) in both eyes with at least 3 months wearing experience, 
with a minimum wearing time of 5 days per week and 10 hours per day. 
4. 
BCVA distance (as determined by manifest refraction at screening) 20/25 or better 
in each eye with a sphero-cylindrical refractive error within the available study lens 
parameter range in the study. 
Note: Study lens parameters available in this study are: 
-0.75 D and -1.25 D cylinder power with: 
(a) -0.25 to -4.00 D (in 0.25 D steps) spherical power in 10°, 90°, 170° and 180° 
axis as available 
(b) -5.00 to -10.00 D (in 1 D steps), -5.50 D & -6.50 D spherical power in 90° and 
180° axis as available 
(c) +1.00 to +8.00 D (in 1 D steps) spherical power 90° and 180° axis as available 
 
5. 
Distortion-free keratometric readings at screening 

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6. 
Subject must possess spectacles (with 0.3 logMAR or better vision OU) and be 
willing to wear habitual spectacles for vision correction when study lenses are not 
worn, as needed. 
7. 
Subject must be willing to stop wearing their habitual contact lenses for the duration 
of study participation. 
 
 
 
 
9. 
Willing to NOT use rewetting/lubricating drops at any time during the study.   
10. 
Subjects must be willing and able to attend all scheduled visits. 
8.2 Exclusion Criteria 
Subjects fulfilling any of the following criteria are not eligible for participation in this study. 
1. 
Any anterior segment infection, inflammation, or abnormality or disease (including 
systemic) that contraindicates contact lens wear, as determined by the investigator 
2. 
Any use of systemic or ocular medications for which contact lens wear could be 
contraindicated, as determined by the investigator. 
3. 
History of refractive surgery or irregular cornea in either eye. 
4. 
Ocular or intraocular surgery (excluding placement of punctal plugs) within the 
previous 12 months. 
5. 
Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or 
corneal vascularization that is mild (Grade 2) or higher; presence of corneal 
infiltrates. 
6. 
Current or history of pathologically dry eye in either eye that, in the opinion of the 
investigator, would preclude contact lens wear. 
7. 
Current or history of herpetic keratitis in either eye. 
8. 
Eye injury in either eye within twelve weeks immediately prior to enrollment for this 
trial. 

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9. 
Current or history of intolerance, hypersensitivity or allergy to any component of the 
study products. 
10. 
Any use of topical ocular medications and artificial tear or rewetting drops that 
would require instillation during contact lens wear. 
11. 
Wearing habitual contact lenses in an extended wear modality (routinely sleeping in 
lenses for at least 1 night per week) over the last 3 months prior to enrollment. 
12. 
Habitual AOfAHP contact lens wearers and habitual daily disposable lens wearers 
(worn within last 3 months). 
 
 
 
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 30 days or currently 
enrolled in any clinical trial. 
8.3 Rescreening of Subjects 
Rescreening of subjects is not allowed in this study. 
9 TREATMENTS ADMINISTERED 
9.1 Investigational Product(s) 
Test Product(s): 
LID226397 
Comparator Product(s) (If 
applicable): 
ACUVUE OASYS for ASTIGMATISM with 
HYDRACLEARPLUS (AOfAHP) contact lenses 
(senofilcon A).  
 
Table 9–1 
Test Product 
Test Product 
LID226397 
Manufacturer 
Alcon Laboratories, Inc. 
6201 South Freeway 

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Fort Worth, Texas 76134-2099 
USA 
Indication for use and 
intended purpose in the 
current study  
The investigational LID226397 contact lenses are indicated 
for the optical correction of ametropia (myopia or 
hyperopia, with astigmatism) in persons with non-diseased 
eyes. 
The lenses are intended for daily wear (less than 24 hours 
while awake), with removal for cleaning and disinfection 
(chemical, not heat) prior to reinsertion, or for disposal, as 
recommended by the eye care professional. 
 
 
 
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: 
• -0.75 D cylinder power with  
(a) -0.25 to -4.00 D (in 0.25 D steps) spherical power in 
10°, 90°, 170° and 180° axis as available  
(b) -5.00 to -10.00 D (in 1 D steps), -5.50 D & -6.50 D 
spherical power 90° and 180° axis as available   
(c) +1.00 to +8.00 D (in 1 D steps) spherical power 90° 
and 180° axis as available   
 
• -1.25 D cylinder power with  
a) -0.25 to -4.00 D (in 0.25 D steps) spherical power in 
10°, 90°, 170° and 180° axis as available  
b) -5.00 to -10.00 D (in 1 D steps), -5.50 & -6.50 D 
spherical power 90° and 180° axis as available   
c) +1.00 to +8.00 D (in 1 D steps) spherical power 90° 
and 180° axis as available   
• Base curve (mm): 8.6 mm (Target) 
• Diameter (mm): 14.5 mm (Target) 
Formulation 
Details are present in the IB for CLN109-C001 V3.0 
Usage 
• Wear: 
o Daily Wear  

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o Bilateral 
• 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 
both study lenses in the provided lens care solution and 
wear their habitual spectacles. 
• 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 treatment period (7 days [-0/+1] according to 
randomization assignment). 
 
 
 
 
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, in parameters as 
determined during trial fitting as per the investigator’s 
assessment. Fitting and Test Lenses 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: 
- 
material name and identifier 
- 
base curve 
- 
diameter  
- 
packing solution 
- 
power 
- 
lot number 
- 
expiration date 
- 
content statement 
- 
investigational device statement 
- 
sponsor information 
- 
country of origin 

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Provided in packages of ~ 18 lenses per power, identified 
with the following: 
- 
 a color-coded label stating a protocol 
number 
- 
material identifier 
- 
power 
- 
an investigational use only statement 
- 
tracking number 
Training and/or experience 
requirements for device 
No additional training or experience is required to 
administer the test product. 
Storage conditions 
Lenses stored at room temperature. 
Lens Care 
• Cleaned and disinfected with CLEAR CARE Cleaning 
& Disinfecting Solution after each use. 
• LacriPure saline will be permitted for rinsing the 
lens(es) after removal and prior to insertion, if 
required. 
 
Table 9–2 
Comparator Product 
Comparator Product(s) 
ACUVUE OASYS for ASTIGMATISM with 
HYDRACLEAR PLUS (AOfAHP) contact lenses 
(senofilcon A)  
Manufacturer 
Johnson & Johnson Vision Care, Inc. 
Indication for Use 
The ACUVUE OASYS Brand Contact Lenses for 
ASTIGMATISM are indicated for the optical correction 
of refractive ametropia (myopia or hyperopia, with 
astigmatism) in persons with non-diseased eyes. 
Product description and 
parameters available for this 
study 
• Material: Senofilcon A 
• Water content: 38% 
• Power range: 
Available power range for the comparator lenses: 
• -0.75 D cylinder power with  
(a) -0.25 to -4.00 D (in 0.25 D steps) spherical power 
in 10°, 90°, 170° and 180° axis as available  
(b) -5.00 to -9.00 D (in 1 D steps), -5.50 D & -6.50 D 
spherical power 90° and 180° axis as available   

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(c) +1.00 to +6.00 D (in 1 D steps) spherical power 
90° and 180° axis as available   
 
• -1.25 D cylinder power with  
(a) -0.25 to -4.00 D (in 0.25 D steps) spherical power 
in 10°, 90°, 170° and 180° axis as available  
(b) -5.00 to -9.00 D (in 1 D steps), -5.50 D & -6.50 D 
spherical power 90° and 180° axis as available   
(c) +1.00 to +6.00 D (in 1 D steps) spherical power 
90° and 180° axis as available   
• Base curve (mm): 8.6 mm 
• Diameter (mm): 14.5 mm 
Formulation 
See package Insert for AOHP contact lenses 
Usage 
• Wear: 
o Daily Wear  
o Bilateral 
• 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 both study lenses in the provided lens 
care solution and wear their habitual spectacles. 
• 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 treatment period (7 days [-0/+1] according 
to randomization assignment). 
 
 
 
 
Number/Amount of Product to 
be Provided to the subject 
Subjects will receive 1 pair of comparator lenses as per 
randomization, in parameters as determined during trial. 
Packaging description 
Provided in commercial packaging  

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Labeling description 
Commercial foil  
Training and/or experience 
requirements for device 
No additional training or experience is required to 
administer the test product.  
Storage conditions 
Store at room temperature  
Lens Care  
Cleaned and disinfected with CLEAR CARE Cleaning 
& Disinfecting Solution after each use. 
LacriPure saline will be permitted for rinsing the 
lens(es) after removal and prior to insertion, if required. 
Additional identifying 
information 
N/A 
Supply 
• Each site will procure their own comparator lenses 
• CLEAR CARE Cleaning & Disinfecting Solution 
will be supplied by sponsor to be provided to 
subject. 
• LacriPure saline will be procured by the sites. 
Refer to the MOP for a detailed description. 
 
9.2 Other Medical Device or Medication Specified for Use During the 
Study 
During the clinical study, additional medical devices and/or medications that are required in 
conjunction with the treatment include the following: 
• Subjects will be provided with CLEAR CARE Cleaning & Disinfecting Solution to 
use with the study lenses.  
• Lubrication/rewetting drops will not be permitted. 
9.3 Treatment Assignment/Randomization 

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Eligible subjects will be randomized in a 1:1 ratio to receive treatment (lens) in one of the 
following crossover sequences:  
• Sequence 1: LID226397/AOfAHP 
• Sequence 2: AOfAHP/LID226397 
 
Only after signing the ICF, a subject will be assigned a subject number by the electronic data 
capture system.  
A randomization list will be generated using a validated system that automates the random 
assignment of treatment arms to randomization numbers in the specified ratio. Subjects will 
be assigned treatment according to the randomization list uploaded in the randomization 
system. The randomization list will be generated and maintained by the study sponsor 
At Visit 1 all eligible subjects will be randomized via the EDC/randomization integration 
system to 1 of the treatments (lens sequences). The investigator’s delegate will access the 
respective system after confirming that the subject meets all the eligibility criteria. A 
randomization number will be automatically assigned to the subject according to the subject 
randomization list but will not be communicated to the site user. The EDC/randomization 
integration system will inform the site user of the treatment (lens sequence) assignment be 
dispensed to the subject. The same randomization assignment will be followed for lens 
fitting. 
9.4 Treatment Masking 
This study is double-masked (subject and the investigator), with subjects randomized to wear 
LID226397 and AOfAHP for the duration of the 2-week per treatment period. 
 
 
   

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This level of masking will be maintained throughout the conduct of the study. Unmasking 
will occur only after all planned study data have been validated, and the database locked.  
In the event of a medical emergency where the knowledge of subject treatment is required, an 
individual investigator will have the ability to unmask the treatment assignment for a specific 
subject after contacting an appropriate study sponsor representative if time allows.  
9.5 Accountability Procedures 
Upon receipt of the IPs, the investigator or delegate must conduct an inventory. During the 
study, designated study staff must provide the IPs to the subjects in accordance with their 
randomization assignment. Throughout the study, the investigator or delegate must maintain 
records of IP dispensation and collection for each subject. This record must be made available 
to the study monitor for the purposes of verifying the accounting of IP supplies. Any 
discrepancies and/or deficiencies between the observed disposition and the written account 
must be recorded along with an explanation. All IPs sent to the investigator must be 
accounted for by study sponsor personnel, and in no case be used in an unauthorized 
situation. 
The investigator should make every effort to collect unused lenses, foils, and supplies from 
subjects. 
It is the investigator’s responsibility to ensure that: 
• All study products are accounted for and not used in any unauthorized manner 

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• All unused products are available for return to the study sponsor, as directed 
• Any study lenses, solutions associated with a device deficiency or with any product-
related adverse event (i.e., ADE or SADE) are returned to the study sponsor for 
investigation, unless otherwise directed by the sponsor. Refer to Section 11 of this 
protocol for additional information on the reporting of device deficiencies and AEs, 
and the return of study products associated with these events. 
The investigator is responsible for proper disposition of all unused IPs at the conclusion of 
the study, according to the instructions provided in the MOP. 
9.6 Changes to Concomitant Medications, Treatments/Procedures 
After the subject is enrolled into the study, the investigator 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 
Subjects will be expected to attend 7 office visits, as shown below. 
Visit # Visit Type 
Lens (Period) 
Visit Window 
Visit 1 Screening/ Baseline 
N/A 
N/A 
Visit 2 Dispense Lens 1  
Lens 1 (Period 1) 
3 - 4 days after Visit 1 
(Washout period with 
habitual spectacles only after 
Visit 1) 
Visit 3 Week 1 Follow-up Lens 1 
Lens 1 (Period 1) 
7 -0/+ 1 days after Visit 2 
Visit 4 Week 2 Follow- up Lens 
1 
Lens 1 (Period 1) 
7 -0/+ 1 days after Visit 3 

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Visit # Visit Type 
Lens (Period) 
Visit Window 
Visit 5 Dispense Lens 2  
Lens 2 (Period 2) 
2 (at least 48 hours) - 4 days 
after Visit 4 (Washout 
period with habitual 
spectacles only after Visit 4) 
Visit 6 
Week 1 Follow-up Lens 
2 
Lens 2 (Period 2) 
7 -0/+ 1 days after Visit 5 
Visit 7 
Week 2 Follow-up Lens 
2 /Exit 
Lens 2 (Period 2) 
7 -0/+ 1 days after Visit 6 
 
10.1 Informed Consent and Screening 
The investigator or delegate must explain the purpose and nature of the study, and have the 
subject read, sign, and date the IRB/IEC-approved informed consent document. The subject 
must sign the ICF BEFORE any study-specific procedures or assessments can be performed, 
including study-specific screening procedures. Additionally, have the individual obtaining 
consent from the subject and a witness, if applicable, sign and date the informed consent 
document.  
10.2 Description of Study Procedures and Assessments 
Study-specific procedures and assessments described here may include standard of care; 
other standard of care procedures performed in the clinical management of the subject are not 
excluded. 
Detailed descriptions of assessments and procedures are provided in the MOP. The 
investigator is responsible for ensuring responsibilities for all procedures and assessments are 
delegated to appropriately qualified site personnel. 
10.2.1 Demographics 
Obtain demographic information including age, race, ethnicity, and sex. 
10.2.2 Medical History 
Collect medical history information, including information on all medications used within the 
past 30 days. Include herbal therapies, vitamins, and all over-the-counter as well as 
prescription medications. Throughout the subject’s participation, obtain information on any 
changes in medical health and/or the use of concomitant medications. 

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Medical History and Concomitant Medications will be collected in the eCRF as outlined in 
the MOP.  
10.2.3 Investigational Product Compliance 
Review subject compliance with the IP usage and adjunct product usage and collect all used 
and unused study IPs and other products that were dispensed. 
10.2.4 Adverse Event Collection: Safety Assessment 
Assess and record any adverse events that are observed or reported since the previous visit, 
including those associated with changes in concomitant medication dosing. See Section 11 
for further details regarding AE collection and reporting. 
10.2.5 Slit Lamp Biomicroscopy: Safety Assessment 
SLE of the cornea, iris/anterior chamber, and lens must be performed in both eyes before 
instillation of any diagnostic eye drops. 
10.2.6 Device Deficiencies: Safety Assessment 
Assess and record any Device Deficiencies that are reported or observed since the previous 
visit. Requirements for reporting device deficiencies in the study can be found in Section 11.  
10.3 Unscheduled Visits 
If a subject visit occurs between any regularly scheduled visit and the visit is conducted by 
study personnel, this visit must be documented as an Unscheduled Visit. If the subject seeks 
medical attention outside the clinic (for example, at an Emergency Room) or at the clinic but 
is seen by nonstudy personnel, the investigator is to capture adverse event-related information 
on the Adverse Event form upon becoming aware. 
During all unscheduled visits, the investigator must conduct the following procedures:  
• Collect Adverse Event information 
• Collect Device Deficiency information 
• Record changes in medical condition or concomitant medication 

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• Biomicroscopy  
• Review lens wear calendar 
The investigator may perform additional procedures for proper diagnosis and treatment of the 
subject. The investigator must document this information in the subject’s case history source 
documents. 
If during an Unscheduled Visit the subject is discontinuing the IP or discontinuing from the 
study, the investigator must conduct Exit procedures according to Table 3–1 Schedule of 
Study Procedures and Assessments and Section 10.4.3, as possible. 
10.4 Discontinued Subjects 
10.4.1 Screen Failures 
Subjects who were excluded from the study after signing the informed consent and prior to 
randomization to product/dispense of study product.  
The investigator must document the reason for screen failure in the subject’s case history 
source documents. 
Subject numbers must not be reused. 
10.4.2 Discontinuations 
Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the 
study by the investigator after informed consent form, including screen failures. 
Subject numbers of discontinued subjects must not be reused (i.e., subject replacement is not 
allowed). 
Subjects may discontinue from study or study treatment at any time for any reason. Subjects 
may also be discontinued from study treatment at any time if, in the opinion of the 
investigator, continued treatment poses a risk to their health. 
For subjects discontinuing from the study, the investigator must complete all Exit procedures 
according to Table 3–1 Schedule of Study Procedures and Assessments and Section 10.4.3, if 
the subject is willing and able, and if in the opinion of the investigator it is safe for the 
subject to do so. 
The investigator must document the reason for study or treatment discontinuation in the 
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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. 
10.4.3 Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product  
Other than screen failures, if a subject discontinues from the study, the subject should 
undergo an early exit visit. Refer to Table 3–1 and the MOP for details. 
10.5 Clinical Study Termination 
The study sponsor reserves the right to suspend or close the investigational site or suspend or 
terminate the study in its entirety at any time. 
If the clinical study is prematurely terminated or suspended by the study sponsor:  
• The study sponsor must: 
o Immediately notify the investigator(s) and subsequently provide 
instructions for study termination. 
o Inform the investigator and the regulatory authorities of the 
termination/suspension and the reason(s) for the termination/suspension.  
• The investigator must: 
o Promptly notify the IRB/IEC of the termination or suspension and of the 
reasons.  
o Provide subjects with recommendations for 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. 
10.5.1 Follow-up of Subjects after Study Participation has Ended  
Following this study, the subject will return to their eye care professional for their routine eye 
care. 

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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 
o Increasing size or severity at subsequent visits 
• Any central or paracentral corneal event (such as neovascularization) that results in 

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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. 
 
Device Deficiencies 
 
A device deficiency is inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. A device deficiency may or may not be associated 
with patient harm (i.e., ADE or SADE); however, not all ADEs or SADEs are due to a device 
deficiency. The investigator should determine the applicable category listed in the Device 

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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 and/or questionnaires evaluated 
during the study are to be reviewed by the investigator. Any untoward (unfavorable and 
unintended) change in a protocol-specific parameter or questionnaire response 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.  
For each recorded event, the ADEs and SAEs documentation must include date of 
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and causality. In addition, the investigator must document all device deficiencies reported or 
observed with test and comparator products on the Device Deficiency eCRF. The site must 
submit all available information on ADEs, SAEs, and device deficiencies to the study sponsor 
immediately as follows: 
• ADEs or SAEs are documented on the Serious Adverse Event and Adverse Device 
Effect eCRF within 24 hours of the investigator’s or site’s awareness. 
• Device deficiencies are documented on the Device Deficiency eCRF within 24 hours 
of the investigator’s or site’s awareness. Additional relevant information after initial 
reporting must be entered into the eCRF as soon as the data become available. 
• Document any changes to concomitant medications on the appropriate eCRFs. 
• Document all relevant information from Discharge Summary, Autopsy Report, 
Certificate of Death, etc., if applicable, in narrative section of the 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. 
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 
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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 products associated with device deficiencies and/or product related AEs should be 
returned and must include the Complaint #, which will be provided by study sponsor after the 
case is entered in the study sponsor’s Global Product Complaint Management System 
(GPCMS), if applicable. 
11.5 Unmasking of the Study Treatment 
Masked information on the identity of the assigned medical device should not be disclosed 
during the study. If the treatment code needs to be broken in the interest of subject safety, the 
investigator is encouraged to contact an appropriate study sponsor representative prior to 
unmasking the information if there is sufficient time. Dependent upon the individual 
circumstances (i.e., medical emergency), the code may be broken prior to contact with the 

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study sponsor. The study sponsor must be informed of all cases in which the code was broken 
and of the circumstances involved. Additionally, the study sponsor may be required to 
unmask the information in order to fulfill expedited regulatory reporting requirements. 
11.6 Follow-Up of Subjects with Adverse Events 
The investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study.  
The investigator should provide the study sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ongoing at time of subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (i.e., database lock).  
All complaints received after this time period will be considered and processed as 
spontaneous (following the post market vigilance procedures) and should be communicated 
to the medical device’s manufacturer as per local requirements. 
The investigator should also report complaints on non-Alcon products (i.e., ACUVUE 
OASYS for ASTIGMATISM with HYDRACLEAR PLUS) directly to the manufacturer as 
per the manufacturer’s instructions or local regulatory requirements. 
11.7 Pregnancy in the Clinical Study 
Women of childbearing potential or women who are pregnant at the time of study entry are 
not excluded from participation. Pregnancy should be included in the Pregnancy eCRF when 
a pregnant woman enters the study or if a woman becomes pregnant during the study. 
Pregnancy is not reportable as an AE; however, complications may be reportable and will be 
decided on a case-by-case basis. 
12 ANALYSIS PLAN 
Continuous variables will be summarized using the number of observations, mean, standard 
deviation (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. 

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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 Deviations and 
Evaluability Plan (DEP). 
12.2 Analysis Sets 
12.2.1 Safety Analysis Set:  
Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. 
As such, the safety analysis set will include all subjects/eyes exposed to any study lenses 
evaluated in this study. 
 
 
 
 
 
For treatment-emergent safety analyses, subjects/eyes will be categorized under the actual 
study lenses exposed in the corresponding lens sequence. 
12.2.2 The 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, except for lenses used for lens fitting at Visit 1. 
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 
 
 Unless otherwise specified, effectiveness evaluations will use the FAS as the 

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primary analysis set, except for those relating to lens fitting. 
 
 
 
12.4.1 Analysis of Primary Effectiveness Endpoint(s) 
The primary objective is to evaluate the percentage of LID226397 contact lenses with axis 
orientation within ± 30 degrees from the 90º axis (ideal location), 10 min after lens insertion, 
at the dispense visit. 
The primary endpoint is the percentage of LID226397 contact lenses with axis orientation, 
recorded as deviations from 90° axis, between -30 and +30 degrees, inclusive, assessed at the 
dispense visit, 10 min after lens insertion. 
12.4.1.1 Statistical Hypotheses 
No inferences are to be made on the primary effectiveness endpoint; therefore, no hypotheses 
are formulated. 

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12.4.1.2 Analysis Methods 
Frequencies and percentages will be provided, 
 
 
. 

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12.5 Handling of Missing Data 
All data obtained in evaluable subjects/eyes will be included in the analysis. No imputation 
for missing values will be carried out for effectiveness analyses.  
12.6 Safety Analyses 
The safety endpoints are: 
• AEs 
• Biomicroscopy findings 
• Device Deficiencies 

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

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

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• 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. 
13.4 Sponsor and Monitoring Responsibilities 
The study sponsor will select principal investigators that are qualified by education, training, 
and experience to assume responsibility for the proper conduct of this clinical trial. For this 
study, the principal investigator and sub-investigators must be eye care professionals 
appropriately licensed to diagnose and treat subjects with the condition under study and be 
able to dispense contact lenses. 
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. 

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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. 
The sponsor must be supervised by the investigator or designee to ensure the sponsor 
presence or activities do not bias the outcome of the study, affect the quality of the research 
data, and/or compromise the rights and welfare of the subject. The sponsor will not intervene 
with the standard of care provided to study subjects or make safety-related decisions or 
assessments. 
13.5 Regulatory Documentation and Records Retention 
The investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the study sponsor and the investigator’s files will be reviewed as part of the 
ongoing study monitoring. Financial information is to be kept separately.  
Additionally, the investigator must keep study records and source documents consistent with 
the terms of the clinical study agreement with the study sponsor. If the investigator retires, 
relocates, or for any other reason withdraws from responsibility of keeping the study records, 
then the study sponsor must be notified, and suitable arrangements made for retention of 
study records and source documents needed to comply with national and international 
regulations. 

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13.6 Quality Assurance and Quality Control 
The study sponsor will secure agreement from all involved parties to ensure direct access to 
all study related sites, source data and documents, and reports for the purpose of monitoring 
and auditing by the study sponsor, and inspection by domestic and foreign regulatory 
authorities. Quality control will be applied to each stage of data handling to ensure that all 
data are reliable and have been processed correctly. Agreements made by the study sponsor 
with the investigator/institution and any other parties involved in the clinical study will be 
provided in writing as part of the protocol or as a separate agreement. 
14 ETHICS 
• Investigations are conducted in compliance with Good Clinical Practices; international 
and national regulations, laws and guidelines; 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/IEC but shall be documented and reported to the sponsor and the IRB/IEC as soon as 
possible. Deviations from this protocol, regulatory requirements, and/or GCP must be 
recorded and reported to the Sponsor prior to database lock. If needed, corrective and 
preventive action should be identified, implemented, and documented within the study 
records. Failure to implement identified corrective and preventative actions may result in site 
closure by the sponsor. Use of waivers to deviate from the clinical protocol is prohibited. 
Before clinical study initiation, this protocol, the informed consent form, any other written 
information given to subjects, and any advertisements planned for subject recruitment must 
be approved by an IRB/IEC. The investigator must provide documentation of the IRB/IEC 
approval to the study sponsor. The approval must be dated and must identify the applicable 
protocol, amendments (if any), informed consent form, assent form (if any), all applicable 

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recruiting materials, written information for subject, and subject compensation programs. The 
IRB/IEC must be provided with a copy of the IB will be provided for test product and 
Package Insert for the control product, 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. 
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.  

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The study sponsor assures that the key designs of this protocol will be registered on public 
databases where required by current regulations, and, as applicable, results will be posted.   
15 REFERENCES 
15.1 Regulations and Standards 
The following references may be applicable in whole or in part for this clinical trial. 
• ISO 11980:2012 Ophthalmic optics - Contact lenses and contact lens care products - 
Guidance for clinical investigations 
• EN ISO 14155:2020 - Clinical Investigation of Medical Devices for Human Subjects - 
Good Clinical Practice 
• US FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact 
Lenses 
• 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 
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 Apr;34(2):64-70.  
• Investigator’s Brochure for Mercury Toric Contact Lenses for Daily Wear. IB for 
CLN109-C001 V3.0. V-CLN-0042048. 
• US FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact 
Lenses 
• Acuvue Oasys Brand Contact Lenses Package Insert. Package Insert for CLN109-
C001 V1.0. V-CLN-0176412 
 
 

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