Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses
Phase: NA
Conditions: Astigmatism, Ametropia, Myopia
Sponsor: Alcon Research

 
 
 
 
 
Clinical Performance of Two Daily Disposable Toric Soft 
Contact Lenses 
 
CLA306‐P002 
 
PROTOCOL v1 
20 Jul 2022 
 
ClinicalTrials.gov ID 
 NCT05483127  
 
 
 
 
 

Document ID: 
V-CLN-0029360 
Status: Approved, Version: 1.0 
Approved Date: 20 Jul 2022 
Page 1 of 64 
 
Alcon – Business Use Only 
 
Device Protocol for CLA306-P002 
Title: Clinical Comparison of Two Daily Disposable Toric Soft Contact 
Lenses  
Protocol Number: 
CLA306-P002 
Clinical Investigation 
Type:  
Postmarket Interventional / Confirmatory 
Test Product: 
PRECISION1™ for Astigmatism (P1fA) 
 
Sponsor Name and 
Address: 
Alcon Research, LLC, and its affiliates (“Alcon”) 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
 
 
 
 
 
 
Property of Alcon 
Confidential 
May not be used, divulged, published, or otherwise disclosed without the consent of 
Alcon 

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

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Table of Contents 
Device Protocol for CLA306-P002 ........................................................................................... 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 
4 
PROTOCOL AMENDMENTS ......................................................................................... 25 
5 
INTRODUCTION ............................................................................................................. 25 
5.1 
Rationale and Background ................................................................................. 25 
5.2 
Purpose of the Study .......................................................................................... 25 
5.3 
Risks and Benefits ............................................................................................. 26 
6 
STUDY OBJECTIVES...................................................................................................... 27 
6.1 
Primary Objective(s) .......................................................................................... 27 
6.2 
Secondary Objective(s) ...................................................................................... 27 
 
 
6.4 
Safety Objective(s) ............................................................................................ 29 
7 
INVESTIGATIONAL PLAN ............................................................................................ 29 
7.1 
Study Design...................................................................................................... 29 
7.2 
Rationale for Study Design................................................................................ 30 
7.2.1 
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations ........................................................................................ 31 
7.3 
Rationale for Duration of Treatment/Follow-Up ............................................... 31 
7.4 
Rationale for Choice of Comparator Product .................................................... 31 
7.5 
Data Monitoring Committee .............................................................................. 31 
8 
STUDY POPULATION .................................................................................................... 31 
8.1 
Inclusion Criteria ............................................................................................... 32 
8.2 
Exclusion Criteria .............................................................................................. 33 
8.3 
Rescreening of Subjects ..................................................................................... 34 
9 
TREATMENTS ADMINISTERED................................................................................... 34 

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9.1 
Investigational Product(s) .................................................................................. 34 
9.2 
Other Medical Device or Medication Specified for Use During the Study ....... 38 
9.3 
Treatment Assignment / Randomization ........................................................... 38 
9.4 
Treatment masking ............................................................................................ 39 
9.5 
Accountability Procedures ................................................................................. 41 
9.6 
Changes to concomitant medications, treatments/ procedures .......................... 41 
10 STUDY PROCEDURES AND ASSESSMENTS ............................................................. 42 
10.1 Informed Consent and Screening ...................................................................... 42 
10.2 Description of Study Procedures and Assessments ........................................... 43 
10.2.1 
Demographics .................................................................................... 43 
10.2.2 
Medical History ................................................................................. 43 
10.2.3 
Investigational Product compliance .................................................. 43 
10.2.4 
Adverse Event Collection: Safety Assessment .................................. 44 
10.2.5 
Slit Lamp Biomicroscopy: Safety Assessment .................................. 44 
10.2.6 
Device Deficiencies: Safety Assessment ........................................... 44 
10.2.7 
Additional Study Assessments .......................................................... 44 
10.3 Unscheduled Visits ............................................................................................ 44 
10.4 Discontinued Subjects ....................................................................................... 45 
10.4.1 
Screen Failures .................................................................................. 45 
10.4.2 
Discontinuations ................................................................................ 45 
10.4.3 
Schedule of Procedures and Assessments for Subjects 
Discontinued from Investigational Product ....................................... 46 
10.5 Clinical Study Termination ................................................................................ 46 
10.5.1 
Follow-up of subjects after study participation has ended ................ 46 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ................................................... 47 
11.1 Monitoring for Adverse Events ......................................................................... 48 
11.2 Procedures for Recording and Reporting .......................................................... 49 
11.3 Return product analysis (as applicable) ............................................................. 51 
11.4 Unmasking of the Study Treatment ................................................................... 51 
11.5 Follow-Up of Subjects with Adverse Events ..................................................... 51 
11.6 Pregnancy in the Clinical Study ........................................................................ 52 
12 ANALYSIS PLAN ............................................................................................................ 52 
12.1 Subject Evaluability ........................................................................................... 52 
12.2 Analysis Sets...................................................................................................... 52 

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12.2.1 
Safety Analysis Set ............................................................................ 52 
12.2.2 
Full Analysis Set ................................................................................ 53 
12.2.3 
Per Protocol Analysis Set .................................................................. 53 
12.3 Demographic and Baseline Characteristics ....................................................... 53 
12.4 Effectiveness Analyses ...................................................................................... 53 
12.4.1 
Analysis of Primary Effectiveness Endpoint(s)................................. 53 
12.4.1.1 
Statistical Hypotheses ........................................................ 53 
12.4.1.2 
Analysis Methods............................................................... 54 
 
 
 
 
 
 
12.5 Handling of Missing Data .................................................................................. 57 
12.6 Safety Analyses.................................................................................................. 57 
12.7 Interim Analyses and Reporting ........................................................................ 58 
12.8 Sample Size Justification ................................................................................... 58 
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ............................... 59 
13.1 Subject Confidentiality ...................................................................................... 59 
13.2 Completion of Source Documents and Case Report Forms .............................. 60 
13.3 Data Review and Clarifications ......................................................................... 61 
13.4 Sponsor and Monitoring Responsibilities.......................................................... 61 
13.5 Regulatory Documentation and Records Retention .......................................... 61 
13.6 Quality Assurance and Quality Control ............................................................. 62 
14 ETHICS ............................................................................................................................. 62 
15 REFERENCES .................................................................................................................. 64 
15.1 Regulations and Standards................................................................................. 64 
 
 
16 APPENDIX A – Protocol Amendments ............................................................................ 64 
 
List of Tables 
Table 2–1 
List of Acronyms and Abbreviations Used in This Protocol ........................... 13 
Table 3–1 
Schedule of Study Procedures and Assessments ............................................. 21 
Table 6–1 
Primary Objective(s) ........................................................................................ 27 

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Table 6–3 
Safety Objective(s)........................................................................................... 29 
Table 9–1 
Test Product ..................................................................................................... 34 
Table 9–2 
Comparator Product ......................................................................................... 36 
 
 
 
List of Figures 
Figure 7-1 
Study Visit Schedule Outline ........................................................................... 30 
Figure 11-1 
Categorization of All AEs ................................................................................ 47 
Figure 11-2 
Categorization of All Serious Adverse Events ................................................. 48 
 
 
 

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1 GLOSSARY OF TERMS 
Names of test product(s) 
Throughout this document, test product(s) will be referred to 
as PRECISION1™ for Astigmatism (verofilcon A) soft 
contact lenses (P1fA) 
 
Name of Comparator 
Product(s) 
MyDay® (stenfilcon A) toric soft contact lenses (MDT) 
 
Adverse Device Effect 
(ADE) 
 
Adverse event related to the use of an investigational 
medical device (investigational product) or comparator 
product. 
Note: This definition includes adverse events resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation; any malfunction; 
and use error or intentional misuse.  
Adverse Event (AE) 
 
Untoward medical occurrence, unintended disease or injury, 
or untoward clinical signs (including abnormal laboratory 
findings) in subjects, users or other persons, whether or not 
related to the investigational medical device (investigational 
product) or comparator and whether anticipated or 
unanticipated.  
Note: This definition includes events related to the 
investigational medical device, comparator, or the 
procedures involved. For users or other persons, this 
definition is restricted to events related to the use of 
investigational medical devices or comparator product. 
Requirements for reporting Adverse Events in the study can 
be found in Section 11. 

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Clinical Investigation Plan 
(CIP) 
 
The document(s) stating the rationale, objectives, design, 
and prespecified analysis, methodology, organization, 
monitoring, conduct, and record-keeping of the clinical 
investigation.  
Note: The protocol and other documents referenced in the 
protocol (for example, the Statistical Analysis Plan, the 
Manual of Procedures, the Deviations and Evaluability 
Plan, and the Protocol Monitoring Plan) comprise the CIP. 
Clinical Investigation 
Report (CIR) / Clinical 
Study Report 
The document describing the design, execution, statistical 
analysis, and results of a clinical investigation. The Clinical 
Investigation Report is synonymous with the Clinical Study 
Report. 
Device Deficiency 
 
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, usability, safety, or 
performance.  
Note: This definition includes malfunctions, use errors, and 
inadequacy in the information supplied by the manufacturer 
including 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. 

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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 
product in a clinical trial, including a product with a 
marketing authorization when used or assembled 
(formulated or packaged) in a way different from the 
authorized form, or when used for an unauthorized 
indication, or when used to gain further information about 
the authorized form. 
Malfunction 
 
Failure of an investigational medical device to perform in 
accordance with its intended purpose when used in 
accordance with the instructions for use or clinical 
investigation plan (CIP), or investigator’s brochure (IB). 
Nonserious Adverse Event 
Adverse event that does not meet the criteria for a serious 
adverse event. 
Post marketing / Post 
authorization study 
 
Any study conducted within the conditions laid down in 
product labelling and other conditions laid down for the 
marketing of the product or under normal conditions of use. 
A 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. 

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Product Complaint 
 
Any oral, electronic, or written communication that alleges 
deficiencies related to the identity (labeling), quality, 
durability, reliability, safety, effectiveness, or performance 
of a marketed product, including failure of the product, 
labeling, or packaging to meet specifications, whether or not 
the product is related to or caused the alleged deficiency. A 
complaint may allege that an adverse event or medical 
device malfunction has occurred. 
Randomized Subject 
Any subject who is assigned a randomized treatment. 
Serious Adverse Device 
Effect (SADE) 
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 

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Serious Adverse Event 
(SAE) 
 
Adverse event that led to any of the following:  
• Death. 
• A serious deterioration in the health of the subject, users 
or other persons as defined by one or more of the 
following:  
a) a life-threatening illness or injury   
Note: Life-threatening means that the individual was 
at immediate risk of death from the event as it 
occurred, i.e., it does not include an event which 
hypothetically might have caused death had it 
occurred in a more severe form. 
b) any potentially sight-threatening event or permanent 
impairment to a body structure or a body function 
including chronic diseases. 
c) inpatient hospitalization or prolonged 
hospitalization. 
 
d) a medical or surgical intervention to prevent a) or b).  
e) any indirect harm as a consequence of incorrect 
diagnostic test results when used within 
manufacturer’s instructions for use. 
• Fetal distress, fetal death, congenital abnormality or 
birth defect including physical or mental impairment. 
Note: Planned hospitalization for a preexisting condition, or 
a procedure required by the CIP, without serious 
deterioration in health, is not considered a serious adverse 
event.  
Refer to Section 11 for additional SAEs. 

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Serious Health Threat 
 
Signal from any adverse event or device deficiency that 
indicates an imminent risk of death or a serious deterioration 
in the health in subjects, users, or other persons, and that 
requires prompt remedial action for other subjects, users, or 
other persons. 
Note: This would include events that are of significant and 
unexpected nature such that they become alarming as a 
potential serious health hazard or possibility of multiple 
deaths occurring at short intervals.  
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. 
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 
BCVA 
Best corrected visual acuity 
CFR 
Code of Federal Regulations 
CI 
Confidence interval 
CIP 
Clinical investigation plan 
CIR 
Clinical investigation report 
COL 
Clinical Operations Lead 
CRF 
Case report form 
CSM 
Clinical Site Manager 
CTT 
Clinical trial team 
D 
Diopter(s) 
DEP 
Deviations and evaluability plan 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
EN 
European Standard 
FAS 
Full analysis set 
FU 
Follow-up 
GCP 
Good Clinical Practice 
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 
MDT 
MyDay toric soft contact lenses 
 
 
 
MOP 
Manual of procedures 
N 
Number of subjects 
NI 
Noninferiority 
N/A 
Not applicable 
OD 
Right eye 
OS 
Left eye 
P1fA 
PRECISION1 for Astigmatism soft contact lenses 
 
PP 
Per protocol 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 
SD 
Standard deviation 

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Abbreviation 
Definition 
SLE 
Slit lamp examination 
SOP 
Standard operating procedure 
 
 
US or USA 
United States of America 
USV 
Unscheduled visit 
VA 
Visual acuity 
 
 
 
 

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3 PROTOCOL SUMMARY 
Investigational 
product type 
Device 
Study type 
Interventional 
Investigational 
products 
Test Product: PRECISION1 for Astigmatism soft contact lenses 
(P1fA) 
 
Comparator Product: MyDay toric soft contact lenses (MDT) 
 
Purpose and 
Scientific Rationale 
for the Study 
To compare the clinical performance of P1fA contact lenses with 
MDT contact lenses 
 
 
 
Objective(s) 
The primary objective of this study is to demonstrate noninferiority 
(NI) in the visual acuity at distance when wearing P1fA contact 
lenses compared to MDT contact lenses. 
 
 
The safety objective is to describe the safety profile of the study 
products. 
Endpoint(s)  
 
Primary Effectiveness 
• 
Distance VA (OD, OS; logMAR) with study lenses at Week 1 
  
 
 
 
 
 
 
 
 
 
 

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Safety 
• 
Adverse events 
• 
Biomicroscopy findings 
• 
Device deficiencies 
Assessment(s)  
Effectiveness 
• 
Distance visual acuity (OD, OS; logMAR) with study lenses 

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Safety 
• 
Adverse Events 
• 
Biomicroscopy 
• 
Device deficiencies 
Study Design 
This is a prospective, randomized, controlled, double-masked, 
bilateral crossover, daily wear, multicenter clinical study.  
Subjects will be expected to attend 4 visits. The total duration of a 
subject’s participation in the study will be up to 28 days. Subjects 
will be expected to wear their study contact lenses daily (except 
between Visits 1 and 2) for at least 10 hours per day. 
 
 
 Subjects will be required 
to wear habitual spectacles or no contact lens wear immediately 
upon completing Visit 1 until returning to Visit 2. 
Subject population 
Volunteer subjects aged 18 or over who are habitual toric soft 
contact lens wearers (excluding current/previous P1fA and MDT 
habitual lens wearers), have at least 3 months of contact lens 
wearing experience, and who wear their habitual lenses at least 5 
days per week and at least 10 hours per day. 
One specific group of subjects will be recruited for this study: 
normal contact lens wearers. 
 
 
 
 

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Planned number of subjects enrolled/consented: ~150 
Planned number of completed subjects: 130 
Sites and Locations 
Planned number of clinical sites: ~ 12  
Planned locations (initial list of locations, which may change during 
start up or conduct according to study needs): US  
Key inclusion 
criteria 
(See Section 8.1 for a 
complete list of 
inclusion criteria) 
• 
Successful wearers of toric soft contact lenses in both eyes 
with at least 3 months wearing experience, with a minimum 
wearing time of 5 days per week and 10 hours per day. 
• 
Able to wear contact lenses within a range of sphere & 
cylinder power and axes (Sphere: -0.75 to -4.00 D in 0.25 D 
steps; Cylinder: -0.75 and -1.25 D; Axis: 10º, 80º, 90º, 100º, 
170º, 180º). 
• 
 
 
• 
Willing to NOT use rewetting/lubricating drops at any time 
during the study. 
Key exclusion 
criteria 
(See Section 8.2 for a 
complete list of 
exclusion criteria) 
• 
Current or previous P1fA and MDT habitual lens wearers. 
• 
Any monovision and multifocal lens wearers. 
• 
Symptomatic subjects as determined using the 
symptomatology questionnaire. 
• 
Participation of the subject in a clinical trial within the 
previous 30 days or currently enrolled in any clinical trial. 
Data analysis and 
sample size 
justification 
Planned Data Analysis 
 
  
Endpoint 
Comparison 
Statistical Model 
Primary 
Distance VA 
P1fA vs MDT 
NI 
Mixed effects repeated measures 
NI margin = 0.05 (logMAR) 

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Sample Size Justification 
Sample size calculation is based on a prior clinical study 
which evaluated performance of P1fA and MDT. 
 
  
Associated materials Lubrication/rewetting drops will not be permitted. 
 

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(✓) assessment performed as necessary, e.g., decrease of VA by 2 lines or more with investigational product (IP) 
* Source only 
€ Option 3 (all ocular and targeted systemic meds/ medical history) 
α Comprehensive details of all AEs will be documented in the source records; however, targeted collection will be utilized in the eCRF. 
 
 
‡ Sites will be provided optional prescreening questionnaire 
 
 

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4 PROTOCOL AMENDMENTS 
Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments must be created by the study sponsor and must be 
approved by the IRB/IEC and global and regional Health Authorities, as applicable, prior to 
implementation except when required to mitigate immediate safety risks or when the changes 
involve only logistical or administrative revisions.  
Amendments may necessitate that the informed consent and other study-related material be 
revised. If the consent form is revised, all subjects currently enrolled in the study must sign 
the approved, revised informed consent (re-consent), as required by the IRB/IEC. 
Refer to Appendix A for detailed description of amendments.  
5 INTRODUCTION 
5.1 Rationale and Background 
In this clinical study, the clinical performance of two commercially available silicone 
hydrogel, toric contact lenses will be evaluated.
 
 
The intended use of this contact lens is vision 
correction; therefore, the measurement of distance VA is planned as the primary 
effectiveness. 
 
 
 
 
 
5.2 Purpose of the Study 
The primary objective of this study is to demonstrate noninferiority in the visual acuity at 
distance when wearing P1fA contact lenses compared to another commercially available, 
silicone hydrogel toric contact lens (MDT). 
 
 
 
At the end of the study, a clinical study report will be prepared in accordance with applicable 
regulatory requirements and standards.  

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Results of the study are intended for publication and the decision whether to publish will be 
made after reviewing the results from this study. 
 
. 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 
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 package inserts 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 the test contact lens are features 
consistent with successful contact lens wear. 
The P1fA and MDT contact lenses are for daily wear use under a daily disposable wear 
modality. 
The P1fA and MDT contact lenses are not intended for use with a cleaning/disinfecting 
solution, and the biocompatibility with lens care solutions and any associated clinical effects 
are unknown. 
A summary of the known potential risks and benefits associated with study contact lenses can 
be found in the package insert of both the investigational products. Risks are minimized by 
compliance with the eligibility criteria and study procedures, and through close supervision 
by a licensed clinician during exposure to the study lenses. 
The site personnel will educate subjects on proper hygiene and lens handling, and compliance 
with the use of contact lenses according to the protocol. Subjects should be instructed not to 
wear contact lenses while sleeping or swimming. The site personnel will also 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. 

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There may also be unknown risks to use of the test products. Any risk to subjects in this 
clinical study will be minimized by compliance with the eligibility criteria and study 
procedures, clinical oversight, and monitoring.  
There may also be unknown risks to use of the comparator. Any risk to subjects in this 
clinical study will be minimized by compliance with the eligibility criteria and study 
procedures, clinical oversight, and monitoring. 
Refer to the package insert for additional information. 
6 STUDY OBJECTIVES 
6.1 Primary Objective(s) 
Table 6–1 
Primary Objective(s) 
Objective(s) 
Endpoint(s) 
To demonstrate noninferiority in the visual 
acuity at distance when wearing P1fA 
contact lenses compared to MDT contact 
lenses 
Distance VA (OD, OS; logMAR) with study 
lenses at Week 1 
 
6.2 Secondary Objective(s) 
Not Applicable. 

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6.4 Safety Objective(s)  
Table 6–3 
Safety Objective(s) 
Objective(s) 
Endpoint(s) 
Describe the safety profile of the study 
products    
• 
Adverse Events 
• 
Biomicroscopy findings 
• 
Device deficiencies 
7 INVESTIGATIONAL PLAN 
7.1 Study Design 
This is a prospective, randomized, controlled, double-masked, bilateral crossover, daily wear, 
multicenter clinical study. Habitual toric soft contact lens wearers will be randomized in 1 of 
the 2 crossover sequences. Subjects and investigators will be masked. An unmasked study 
staff member will prepare the contact lenses for dispensing.   
Subjects will be expected to attend 4 visits. Visit 1 (Screening/Trial lens fitting & 
evaluation), Visit 2 (Baseline/Dispense Lens 1), Visit 3 (Week 1 Follow-up Lens 1/Dispense 
Lens 2), and Visit 4 (Week 1 Follow-up Lens 2/Exit). The total duration of a subject’s 
participation in the study will be up to 28 days. Subjects will be expected to wear their study 
contact lenses daily for at least 10 hours per day.  
 
 Subjects will be required to wear habitual spectacles or no 
contact lens wear immediately upon completing Visit 1 until returning to Visit 2.  

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Figure 7-1 
Study Visit Schedule Outline 
 
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 package insert.  
This study design is justified based upon an evaluation of the results of relevant preclinical 
and clinical testing, as described within the package insert.  
The crossover design will ensure that the same subject is exposed to both the test and 
comparator lens materials; 
 
. The study will include only those 
subjects who are current wearers of habitual toric soft contact lenses in both eyes with at least 
3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours 
per day. 
. 
Furthermore, the subjects will not be permitted to use lubrication/rewetting drops during the 
duration of the study 
. The study will only 
include normal (asymptomatic) contact lens wearers to ensure the subjects participating in 

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this trial represent the average clinic population 
 
The study will exclude any habitual P1fA and MDT contact lens 
wearers in the past 3 months prior to consent in order to reduce potential bias of wearers to 
their habitual contact lenses. The study will also exclude subjects who wish to wear their 
contact lenses in monovision modality during the study and multifocal lens wearers. 
7.2.1 
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations 
 An interim analysis will not be performed.  
7.3 Rationale for Duration of Treatment/Follow-Up 
Subjects will wear each study product bilaterally for approximately 1 week. 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 approximately after 1 week of wearing each study product. 
 
 
 
The duration of use of each study product is in accordance with the respective product 
labeling (see package inserts). 
7.4 Rationale for Choice of Comparator Product 
MyDay toric contact lenses were chosen as the comparator product because these lenses have 
the same wear modality and replacement schedule. 
7.5 Data Monitoring Committee 
Not applicable. 
8 STUDY POPULATION 
The study population consists of male and female subjects (aged 18 or over) who are wearers 
of toric soft contact lenses in both eyes with at least 3 months of wearing experience, with a 
minimum wearing time of 5 days per week and 10 hours per day.  Subjects who are current or 
previous P1fA or MDT habitual lens wearers will be excluded. One specific group of subjects 
will be recruited for this study: normal contact lens wearers. Normal (asymptomatic) subjects 
will be identified using a symptomatology questionnaire, 
 
 

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 It is aimed to enroll (consent) 
approximately 150 subjects in approximately 12 sites in the US, with a target of 130 total 
subjects treated , with 1 (intended minimum) to 25 (maximum) subjects per site. Site-specific 
targets may vary based upon individual site capabilities. Estimated time needed to recruit 
subjects for the study is approximately 3 weeks; however, unanticipated circumstances may 
shorten or lengthen this time and would not require amendment of this protocol. Because a 
~15% screening failure rate is expected, approximately 150 subjects are expected to be 
enrolled. Eligible study population will be representative of the investigational product target 
population. 
8.1 Inclusion Criteria 
Written informed consent must be obtained before any study specific assessment is 
performed. Upon signing informed consent, the subject is considered enrolled in the study. 
Subjects eligible for inclusion in this study must fulfill all of the following criteria: 
1. 
Subject must be able to understand and sign an IRB/IEC approved Informed 
Consent form. 
2. 
Willing and able to attend all scheduled study visits as required per protocol. 
3. 
Subject must be at least 18 years of age. 
4. 
Successful wear of toric soft contact lenses in both eyes for a minimum of 5 days 
per week and 10 hours per day during the past 3 months. 
5.  
Able to wear contact lenses within a range of sphere & cylinder power and axes 
(Sphere: -0.75 to -4.00 D in 0.25 D steps; Cylinder: -0.75 and -1.25 D; Axis: 10º, 
80º, 90º, 100º, 170º, 180º). 
6. 
VA better than or equal to 0.10 (logMAR) in each eye with fitting set lenses (with 
spherical over refraction as needed). 
7. 
BCVA (with manifest refraction) better than or equal to 0.10 (logMAR) in each eye. 
8. 
 
 
 

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9. 
Subject must possess spectacles and be willing to wear habitual spectacles for 
vision correction when study lenses are not worn, as needed. 
10. 
Subject must be willing to stop wearing their habitual contact lenses for the duration 
of study participation. 
11. 
Willing to NOT use rewetting/lubricating drops at any time during the study. 
8.2 Exclusion Criteria 
 Subjects fulfilling any of the following criteria are not eligible for participation in this study. 
1. 
Current or previous P1fA and MDT habitual lens wearers and any current spherical, 
monovision & multifocal lens wearers. 
2. 
Subjects who are symptomatic as determined using the symptomatology 
questionnaire. 
3. 
Any anterior segment infection, inflammation, or abnormality or disease (including 
systemic) that contraindicates contact lens wear, as determined by the Investigator. 
4. 
Any use of systemic or ocular medications for which contact lens wear could be 
contraindicated, as determined by the Investigator. 
5. 
History of refractive surgery or plan to have refractive surgery during the study or 
irregular cornea in either eye. 
6. 
Ocular or intraocular surgery (excluding placement of punctal plugs) within the 
previous 12 months or planned during the study. 
7. 
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. 
8. 
Current or history of pathologically dry eye in either eye that, in the opinion of the 
Investigator, would preclude contact lens wear. 
9. 
Current or history of herpetic keratitis in either eye. 
10. 
Eye injury in either eye within twelve weeks immediately prior to enrollment for this 
trial. 

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11. 
Current or history of intolerance, hypersensitivity, or allergy to any component of the 
study products. 
12. 
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. 
13. 
Any use of topical ocular medications and artificial tear or rewetting drops that 
would require instillation during contact lens wear. 
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): 
 PRECISION1 for Astigmatism soft contact lenses 
 
Comparator Product(s) (If 
applicable): 
 MyDay toric soft contact lenses
 
Table 9–1 
Test Product 
Test Product 
PRECISION1 for Astigmatism soft contact lenses (P1fA) 
 
Manufacturer 
Alcon Laboratories, Inc. 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
USA 
Indication for use 
and intended 
PRECISION1 for Astigmatism (verofilcon A) soft contact lenses 
are indicated for the optical correction of refractive ametropia 

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purpose in the 
current study  
(myopia and hyperopia) in phakic or aphakic persons with non-
diseased eyes with 6.00 diopters (D) or less of astigmatism. 
The lenses are to be prescribed for single use, daily disposable 
wear. The lenses are not intended to be cleaned or disinfected and 
should be discarded after a single use. 
Product description 
and parameters 
available for this 
study 
• Material: verofilcon A  
• Water content: 51% 
• Power range: 
o Sphere: -0.75 to -4.00 D in 0.25 D steps 
o Cylinder: -0.75 and -1.25 D  
o Axis: 10º, 80º, 90º, 100º, 170º, 180º 
• Base curve (mm): 8.5 
• Diameter (mm): 14.5 
Formulation 
Please refer to package insert. 
Usage 
• Wear: 
o Daily Wear 
o Bilateral 
• Replacement period: Daily Disposable 
• Exposure:  
o 16 days total duration (test and comparator) 
▪ Test Product: 8 (-0/+3) days 
▪ Comparator Product: 8 (-0/+3) days 
• Lens Care: N/A 
Number/Amount of 
product to be 
provided to the 
subject 
Subjects will be dispensed study lenses at Visit 2 and Visit 3. No 
spare lenses will be provided to the subject. 
Packaging 
description 
 Blister foil pack 
Labeling description • Lens Foil label includes: 
- 
lens identifier 
- 
base curve 
- 
diameter 
- 
packing solution 
- 
power 
- 
lot number 

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- 
expiration date 
- 
content statement 
- 
investigational device statement 
- 
sponsor information 
- 
country of origin 
 
• Provided in packages of ~11 lenses per power, identified with 
the following: 
- 
a color coded label stating the protocol number 
- 
material identifier 
- 
power 
- 
an investigational use only statement 
- 
tracking number 
Storage conditions 
Stored at room temperature. 
Supply 
Alcon will provide a fitting set and study lenses. 
Refer to the MOP for a detailed description. 
 
Table 9–2 
Comparator Product 
Comparator 
Product(s) 
MyDay toric soft contact lenses (MDT)
 
Manufacturer 
Cooper Vision, Inc 
711 North Road 
Scottsville, New York 14546 
USA 
Indication for Use 
MyDay (stenfilcon A) toric soft contact lenses are indicated for the 
correction of ametropia (myopia or hyperopia with astigmatism) in 
aphakic and non-aphakic persons with non-diseased eyes in powers 
from -20.00 to +20.00 diopters and astigmatic corrections from -
0.25 to -10.00 diopters. 
 
The MyDay (stenfilcon A) toric soft contact lenses are 
indicated for daily wear single use only. The lenses are to be 
discarded upon removal; therefore, no cleaning or disinfection is 
required. 

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Product description 
and parameters 
available for this 
study 
• Material: stenfilcon A 
• Water content: 54% 
• Power range: 
o Sphere: -0.75 to -4.00 D in 0.25 D steps 
o Cylinder: -0.75 and -1.25 D  
o Axis: 10º, 80º, 90º, 100º, 170º, 180º  
• Base curve (mm): 8.6 
• Diameter (mm): 14.5 
Formulation 
Please refer to package insert. 
Usage 
• Wear: 
o Daily Wear 
o Bilateral 
• Replacement period: Daily Disposable 
• Exposure:  
o 16 days total duration (test and comparator) 
▪ Test Product: 8 (-0/+3) days 
▪ Comparator Product: 8 (-0/+3) days 
• Lens Care: < N/A 
Number/Amount of 
Product to be 
Provided to the 
subject 
Subjects will be dispensed study lenses at Visit 2 and Visit 3. No 
spare lenses will be provided to the subject. 
Packaging 
description 
Blister foil pack  
Labeling description Lenses Foil label includes: 
• lens identifier 
• base curve  
• diameter 
• power 
• lot number 
• expiration date 
• content statement 
• investigational device statement 
• sponsor information 
• country of origin 
 

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• Provided in packages of ~11 lenses per power, identified with 
the following: 
- 
a color coded label stating the protocol number 
- 
material identifier 
- 
power 
- 
an investigational use only statement 
- 
tracking number 
Storage conditions 
Stored at room temperature. 
Supply 
Alcon will provide a fitting set and study lenses. 
Refer to the MOP for a detailed description. 
 
More information on the test and comparator products can be found in the respective Package 
Inserts.  
9.2 Other Medical Device or Medication Specified for Use During the 
Study 
No other medical devices or medications are required to be used in conjunction with the 
treatments during the clinical study. 
9.3 Treatment Assignment / Randomization 
Subjects will be randomized in a 1:1 ratio to receive treatment (lens) in crossover sequence: 
Test product then Comparator product or Comparator product then Test product, respectively. 
Sequence 
EDC/randomization integration system 
Lens Name  
Sequence 1 
 
P1fA/MDT 
Sequence 2 
 
MDT/P1fA 
 
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 treatments (lens sequence) to randomization numbers in the specified ratio. 
Subjects will be assigned treatment (lens sequence) according to the randomization list 
uploaded in the randomization system. The randomization list will be generated and 
maintained by the study sponsor. 

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At Visit 1, all eligible subjects will be randomized via the EDC/randomization integration 
system to one of the treatment arms. The investigator or delegate will access the respective 
system after confirming that the subject meets all the eligibility criteria. A randomization 
number will be automatically assigned to the subject according to the subject randomization 
list but will not be communicated to the site user. The EDC/ randomization integration 
system will inform the site user of the treatment (lens sequence) assignment to be dispensed 
to the subject. 
9.4 Treatment masking 
This study is double-masked, with subjects randomized to use PRECISION1 for Astigmatism 
soft contact lenses or MyDay toric soft contact lenses for the duration of 1-week treatment 
period per lens type.  
Table 9–3 
Unmasked Individuals Associated with the Study 
Unmasked Individual 
Extent of Unmasking 
Rationale 
Unmasked Study 
Coordinator(s) 
The Unmasked Study 
Coordinator(s) will obtain the 
treatment assignment from 
the EDC system, manage IP 
inventory, as well as IP 
administration. This 
individual will have access to 
IP supply, accountability 
logs, and other documents or 
supplies pertaining to IP. The 
unmasked coordinator will 
also assist with device 
The Unmasked Study 
Coordinator(s) will be 
unmasked to allow for 
processing of IP shipment, 
storage, and dispensing, as 
well as accountability for all 
IP. 

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. Unmasking 
will occur only after all planned study data have been validated, and the database locked.  
Masked study personnel must avoid seeking information that may compromise masking. 
Unmasked study personnel must not disseminate information that is potentially unmasking to 
any masked personnel. The masked and unmasked site personnel must coordinate all study 
activities as necessary to protect masking and minimize bias during the study.  

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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, masked investigator must designate study staff to 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 
• 
All unused products are available for return to the study sponsor, as directed 
• 
Any study lenses associated with a device deficiency or with any product-related 
adverse event (i.e., ADE or SADE) are returned to the study sponsor for investigation, 
unless otherwise directed by the sponsor. Refer to Section 11 of this protocol for 
additional information on the reporting of device deficiencies and AEs and the return 
of study products associated with these events. 
The investigator is responsible for proper disposition of all unused IPs at the conclusion of 
the study, according to the instructions provided in the MOP. 
9.6 Changes to concomitant medications, treatments/ procedures 
After the subject is enrolled into the study, the investigator must instruct the subject to notify 
the study site about: 
• 
Any new medications  
• 
Alterations in dose or dose schedules for current medications,  

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• 
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 4 office visits, as shown below. 
Visit # 
Visit Type 
Visit Window 
Visit 1 
Screening/Trial lens fitting & evaluation 
N/A 
Visit 2 
Baseline/Dispense Lens 1 
4 (-1/+2) days after Visit 1 
Visit 3 
Week 1 Follow-up Lens 1/Dispense Lens 2 
8 (-0/+3) days after Visit 2 
Visit 4 
Week 1 Follow-up Lens 2/Exit 
8 (-0/+3) days after Visit 3 
Unscheduled Visits and Early Exit Visits are allowed, if necessary. 
Study lenses will be provided to the subjects to take home for daily wear during the course of 
the trial.  
Study randomization will occur at Visit 1 to determine assigned lens sequence. Subjects will 
be provided the assigned lenses to take home at Visit 2 and Visit 3. Study contact lens fitting 
will occur at Visit 1 for both study lenses. If a subject cannot be successfully fit (either study 
lens) according to the study lens fitting guides as determined by the investigator, they will be 
required to exit from the study.  
Lubrication/rewetting drops will not be permitted during this study.  
Study tests, procedures, 
 be conducted as outlined in the MOP. 
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 

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consent from the subject and a witness, if applicable, sign and date the informed consent 
document.  
The investigator or delegate must provide a copy of the signed document to the subject and 
place the original signed document in the subject’s chart, or provide documentation as 
required by local regulations. 
Optional prescreening for eligibility of potential subjects must be done using the using the 
IRB-approved script and symptomatology questionnaire. 
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. 
Medical History and Concomitant Medications will be collected in the eCRF as outlined in 
the MOP. 
10.2.3 Investigational Product compliance 
Review subject compliance with the IP usage and adjunct product usage and collect all used 
and unused study IPs and other products that were dispensed. 

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10.2.4 Adverse Event Collection: Safety Assessment 
Assess and record any adverse events that are observed or reported since the previous visit, 
including those associated with changes in concomitant medication dosing in the subject 
source documents. See Section 11 for further details regarding AE collection and reporting. 
Note: AEs must be recorded for all enrolled subjects from the time of signature of informed 
consent, regardless of subject enrollment status (screen failure or randomized). 
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. 
Device deficiencies on comparator lenses should be reported per the manufacture’s 
guidelines.  Note: Device deficiencies must be recorded for all enrolled subjects from the 
time of signature of informed consent, regardless of subject enrollment status (screen failure 
or randomized). 
10.2.7 Additional Study Assessments 
Additional effectiveness assessments will be conducted throughout the course of the study. 
Refer to the MOP and Table 3-1 for details on each of these assessments. 
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 
• 
Record changes in medical condition or concomitant medication 
• 
Collect device deficiency information 

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• 
Biomicroscopy  
The investigator may perform additional procedures for proper diagnosis and treatment of the 
subject according to the protocol or at their discretion. The investigator must document this 
information in the subject’s case history source documents. 
If during an Unscheduled Visit the subject is discontinuing the IP or discontinuing from the 
study, the investigator must conduct Exit procedures according to Table 3-1 Schedule of 
Study Procedures and Assessments, as possible. 
10.4 Discontinued Subjects 
10.4.1 Screen Failures 
Subjects who were excluded from the study after signing the informed consent and prior to 
randomization to study product assignment and dispensing 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 re-used. 
10.4.2 Discontinuations 
Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the 
study by the investigator after signing the informed consent. 
Subject numbers of discontinued subjects must not be re-used (i.e., subject replacement is not 
allowed). 
Subjects may discontinue from study or study treatment at any time for any reason. Subjects 
may also be discontinued from study treatment at any time if, in the opinion of the 
investigator, continued treatment poses a risk to their health. 
If a subject discontinues from study treatment, every effort must be made to keep the subject 
in the study and to continue with the study assessments as specified in the schedule of study 
procedures and assessments until the final visit. 
For subjects discontinuing from the study, the investigator must complete all Exit procedures 
according to Table 3-1 Schedule of Study Procedures and Assessments and Section 10.4.3, if 
the subject is willing and able, and if in the opinion of the investigator it is safe for the 
subject to do so. 

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The investigator must document the reason for study or treatment discontinuation in the 
subject’s case history source documents. 
To ensure the safety of all subjects who discontinue early, investigators must assess each 
subject and, if necessary, advise them of any therapies and/or medical procedures that may be 
needed to maintain their health. 
10.4.3 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 
 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 AEs 
ADE
Device /
procedure-
related?
Meets 
seriousness 
criteria?
SAE
All AEs
AE
No
No
Yes
Yes
 
 

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Figure 11-2 
Categorization of All Serious Adverse Events 
All SAEs
Device /
procedure 
related?
SAE
SADE
No
Yes
 
Device Deficiencies 
A device deficiency is inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. A device deficiency may or may not be 
associated with patient harm (i.e., ADE or SADE); however, not all ADEs or SADEs are due 
to a device deficiency. The investigator should determine the applicable category listed in the 
Device Deficiency eCRF for the identified or suspect device deficiency and report any patient 
harm separately. Examples of device deficiencies include the following:  
• 
Len missing/folded/fragments/Lens cloudy/dirty 
• 
Lens surface/edge defect  
• 
Torn lens during handling/in pack 
• 
Packaging deficit (e.g., blister strip damage, primary/secondary label mismatch, 
mislabeled product, tampered seal) 
• 
Potential contaminant 
11.1 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: 

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• 
“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?” 
Additionally, changes in any protocol-specific parameters 
 evaluated 
during the study are to be reviewed by the investigator. Any untoward (unfavorable and 
unintended) change in a protocol-specific parameter 
 that is 
clinically relevant, in the opinion of the investigator, is to be reported as an AE. These 
clinically relevant changes will be reported regardless of causality.  
11.2 Procedures for Recording and Reporting 
AEs are collected from the time of informed consent. Any pre-existing medical conditions or 
signs/symptoms present in a subject prior to the start of the study (i.e., before informed 
consent is signed) are not considered AEs in the study and should be recorded in the Medical 
History section of the eCRF. 
In addition, temporary lens awareness or visual changes during the fitting process are not 
considered AEs if the investigator assesses that the symptom(s) can reasonably resolve within 
the anticipated adaptation period.  
For each recorded event, the ADEs and SAEs documentation must include: date of 
occurrence, severity, treatment (if applicable), outcome, and assessments of the seriousness 
and causality. In addition, the investigator must document all device deficiencies reported or 
observed with Test and Comparator products on the Device Deficiency eCRF. The site must 
submit all available information on ADEs, SAEs, and device deficiencies to the study sponsor 
immediately as follows 
• 
All SAEs must be reported immediately (within 24 hours) of the investigator’s or 
site’s awareness.  
• 
ADEs that do not meet seriousness criteria and Device deficiencies must be reported 
within 10 calendar days of the investigator’s or site’s awareness.  
• 
A printed copy of the completed Serious Adverse Event and Adverse Device Effect 
and/or Device Deficiency eCRF must be included with product returns.  
• 
Additional relevant information after initial reporting must be entered into the eCRF as 
soon as the data become available. 
• 
Document all relevant information from Discharge Summary, Autopsy Report, 
Certificate of Death, etc., if applicable, in narrative section of the Serious Adverse 
Event and Adverse Device Effect eCRF. 

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Note: Should the EDC system become nonoperational, the site must complete the appropriate 
paper Serious Adverse Event and Adverse Device Effect and/or Device Deficiency Form. The 
completed form is emailed to the study sponsor at msus.safety@alcon.com according to the 
timelines outlined above; however, the reported information must be entered into the EDC 
system once it becomes operational. 
Any AEs and device deficiencies for non-study marketed devices/products will be considered 
and processed as spontaneous (following the post-market vigilance procedures) and should be 
communicated to the device’s/product’s manufacturer as per local requirements. 
Study sponsor representatives may be contacted for any protocol-related question. 
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 upon 
medical judgment with consideration of any subjective symptom(s), as defined below: 
Intensity (Severity) 
Mild 
An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom. 
Moderate 
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities. 
Severe 
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities. 
For every AE in the study, the investigator must assess the causality (Related or Not Related 
to the medical device or study procedure). An assessment of causality will also be performed 
by study sponsor utilizing the same definitions, as shown below: 
Causality 
Related 
An AE classified as related may be either definitely related or possibly related 
where a direct cause and effect relationship with the medical device or study 

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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 AEs that 
are upgraded from nonserious to serious or from unrelated to related. 
11.3 Return product analysis (as applicable) 
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. These 
products should be returned to the sponsor at the end of the study, unless instructed otherwise 
by the sponsor.  
11.4 Unmasking of the Study Treatment 
Masked information on the identity of the assigned medical device should not be disclosed 
during the study. In the event of a medical emergency where the knowledge of subject 
treatment is required, individual investigator(s) will have the ability to unmask the treatment 
assignment for a specific subject. If time allows, the appropriate study sponsor representative 
should be contacted prior to unmasking. 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. 
11.5 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). 

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Any additional data received up to 1 month after subject discontinuation or exit must be 
documented and available upon the study sponsor’s request. All complaints received after this 
time period will be considered and processed as spontaneous and should be communicated to 
the medical device’s manufacturer as per local requirements. 
The investigator should also report complaints on non-Alcon products directly to the 
manufacturer as per the manufacturer’s instructions or local regulatory requirements. 
11.6 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 form 
in EDC 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 confidence intervals (CIs) or 
confidence limits where applicable. Categorical variables will be summarized with 
frequencies and percentages from each category.  
Any deviations to the analysis plan will be updated during the course of the study as part of a 
protocol amendment or will be detailed in the clinical study report. 
12.1 Subject Evaluability 
Final subject evaluability must be determined prior to breaking the code for masked treatment 
(lens sequence) assignment and locking the database, based upon the 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. 

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12.2.2 Full Analysis Set 
The full analysis set (FAS) is the set of all randomized subjects who are exposed to any study 
lenses 
 
evaluated in this study. 
12.2.3 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 
 1 primary,
 
endpoint
 will use the FAS as the primary analysis set. 
 
 
 
 
 
 
  
12.4.1 Analysis of Primary Effectiveness Endpoint(s) 
The primary objective of this study is to demonstrate noninferiority in the VA at distance 
when wearing P1fA contact lenses compared to MDT contact lenses. The primary endpoint is 
distance VA with study lenses at Week 1, collected for each eye in logMAR. 
12.4.1.1 Statistical Hypotheses 
The null and alternative hypotheses are formulated in terms of the predefined margin of 0.05 
for noninferiority:  

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H0: µ(T) – µ(C) ≥ 0.05  
Ha: µ(T) – µ(C) < 0.05  
where µ(T) and µ(C) denote the mean distance VA at Week 1 for P1ft and MDT, respectively, 
on the logMAR scale. 
12.4.1.2 Analysis Methods 
A mixed effects repeated measures model will be utilized to test these hypotheses. The model 
will include terms for lens, visit, lens by visit interaction, period, and sequence. Within-
subject correlation due to eye and the crossover design will also be accounted for in the 
model. Lens difference (P1fA minus MDT) and the corresponding one-sided 95% upper 
confidence limit will be computed at Week 1. Noninferiority in distance VA will be declared 
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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 
 
 
12.6 Safety Analyses 
The safety endpoints are:  
• 
AEs  
• 
Biomicroscopy findings  
• 
Device Deficiencies  
There are no safety hypotheses planned in this study. The focus of the safety analysis will be 
a comprehensive descriptive assessment of occurrence of adverse events as well as the other 
listed parameters.  
All AEs occurring from the time a subject signs informed consent to study exit will be 
accounted for in the reporting. Safety analyses will be conducted using the safety analysis set 
on a treatment-emergent basis. Descriptive summaries (frequencies and percentages) for 
ocular and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities 
Preferred Terms. AEs leading to study discontinuation and SAEs will be identified. Individual 
subject listings will be provided, as necessary.  

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Individual subject listings will be provided for AEs that occur after signing informed consent 
but prior to exposure to IP.  
Each biomicroscopy parameter will be tabulated by its grade. For each biomicroscopy 
parameter, counts and percentages of eyes that experience an increase of ≥ 2 grades from 
baseline (last assessment prior to study lens exposure) to any subsequent visit within the 
same period will be presented. A supportive listing will be generated which will include all 
biomicroscopy data from all visits within the same period for those eyes experiencing the 
increase.  
Two listings for device deficiencies, prior to exposure to study contact lenses and treatment-
emergent, will be provided. Additionally, each device deficiency category will be tabulated.  
No inferential testing will be conducted for the safety analyses. 
12.7 Interim Analyses and Reporting 
There are no plans to conduct an interim analysis and no criteria by which the study would be 
terminated early based upon statistical determination. 
12.8 Sample Size Justification 
Sample size calculation is based on a prior clinical study 
which evaluated 
performance of P1fA and MDT. 
 
 
Primary Effectiveness  
To demonstrate noninferiority (margin = 0.05 in logMAR; ½ line in Snellen) in distance VA 
as a one-tailed hypothesis with α=0.05, and using a standard deviation of 0.0692 for paired 
differences, 90% power can be attained with a sample size of 18 (9 per sequence).  

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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.  

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

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13.3 Data Review and Clarifications 
A review of CRF data to the subject’s source data will be completed by the site monitor to 
ensure completeness and accuracy. After the CRFs have been completed, additional data 
clarifications and/or additions may be needed as a result of the data cleaning process. Data 
clarifications are documented and are part of each subject’s CRF. 
13.4 Sponsor and Monitoring Responsibilities 
The study sponsor will select principal investigators that are qualified by education, training, 
and experience to assume responsibility for the proper conduct of this clinical trial. 
The study sponsor is financially funding this clinical trial and will compensate the 
investigator and/or the Institution(s) at which the study is conducted in accordance with a 
signed clinical trial agreement. 
The study sponsor will designate a monitor to conduct the appropriate site visits at the 
appropriate intervals according to the study monitoring plan. The clinical investigation will 
be monitored to ensure that the rights and well-being of the subjects are protected, the 
reported data are accurate, complete, and verifiable from the source documents, and the study 
is conducted in compliance with the current approved protocol (and amendments[s], if 
applicable), with current GCP, and with applicable regulatory requirements. 
The site may not screen subjects or perform the informed consent process on any subject until 
it receives a notification from an appropriate study sponsor representative that the site may 
commence conducting study activities. Monitoring will be conducted periodically while the 
clinical study is ongoing. Monitoring methods may include site visits, telephone, written and 
fax correspondence. Close-out visits will take place after the last visit of the last subject at the 
site. 
A coordinating investigator may be identified by the study sponsor to review and endorse the 
final study report. In cases where a coordinating investigator is engaged, the study sponsor 
will select the coordinating investigator based upon their experience, qualifications, active 
study participation, and their willingness and availability to take on this role. 
13.5 Regulatory Documentation and Records Retention 
The investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the study sponsor and the investigator’s files will be reviewed as part of the 
ongoing study monitoring. Financial information is to be kept separately.  

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

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

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15 REFERENCES 
15.1 Regulations and Standards 
The following references may be applicable in whole or in part for this clinical trial. 
• 
ISO 11980:2012 Ophthalmic optics - Contact lenses and contact lens care products - 
Guidance for clinical investigations 
• 
EN ISO 14155:2020 - Clinical Investigation of Medical Devices for Human Subjects - 
Good Clinical Practice 
• 
21 CFR Part 11 - Electronic Records; Electronic Signatures 
• 
21 CFR Part 50 - Protection of Human Subjects 
• 
21 CFR Part 56 - Institutional Review Boards 
• 
21 CFR Part 812 - Investigational Device Exemptions 
• 
21 CFR Part 54 - Financial Disclosure by Clinical Investigators 
• 
The California Bill of Rights, if applicable 
 
 
 
 
16 APPENDIX A – Protocol Amendments 
There are no amendments. This is the first version of the protocol.