Clinical Comparison of Two Daily Disposable Contact Lenses
Phase: NA
Conditions: Refractive Errors
Sponsor: Alcon Research



Document ID: 
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Status: Approved, Version: 1.0 
Approved Date: 10 Apr 2021 
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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 Practice (GCP), the 
ethical principles contained within the Declaration of Helsinki, this protocol, all 
applicable regulatory authority regulations, and conditions of approval imposed by the 
reviewing IRB or regulatory authority. 
• 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: 
 
 
 

Document ID: 
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Table of Contents 
Device Protocol for CLE383-P005 ............................................................................................ 1 
Table of Contents ....................................................................................................................... 3 
List of Tables.............................................................................................................................. 5 
List of Figures ............................................................................................................................ 6 
1 
GLOSSARY OF TERMS .................................................................................................... 7 
2 
LIST OF ACRONYMS AND ABBREVIATIONS ........................................................... 12 
3 
PROTOCOL SUMMARY ................................................................................................. 14 
4 
PROTOCOL AMENDMENTS ......................................................................................... 21 
4.1 
Amendments ...................................................................................................... 21 
5 
INTRODUCTION ............................................................................................................. 21 
5.1 
Rationale and Background ................................................................................ 21 
5.2 
Purpose of the Study.......................................................................................... 21 
5.3 
Risks and Benefits ............................................................................................. 22 
6 
STUDY OBJECTIVES ..................................................................................................... 23 
6.1 
Primary Objective(s) ......................................................................................... 23 
6.2 
Secondary Objective(s) ..................................................................................... 23 
 
 
6.4 
Safety Objective(s) ............................................................................................ 24 
7 
INVESTIGATIONAL PLAN ............................................................................................ 24 
7.1 
Study Design ..................................................................................................... 24 
7.2 
Rationale for Study Design ............................................................................... 25 
7.2.1 
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations ........................................................................................ 26 
7.3 
Rationale for Duration of Treatment/Follow-Up............................................... 26 
7.4 
Rationale for Choice of Control Product ........................................................... 26 
7.5 
Data Monitoring Committee ............................................................................. 26 
8 
STUDY POPULATION .................................................................................................... 26 
8.1 
Inclusion Criteria ............................................................................................... 26 
8.2 
Exclusion Criteria .............................................................................................. 27 
8.3 
Rescreening of Subjects .................................................................................... 28 

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9 
TREATMENTS ADMINISTERED .................................................................................. 29 
9.1 
Investigational Product(s).................................................................................. 29 
9.2 
Other Medical Device or Medication Specified for Use During the Study ...... 32 
9.3 
Treatment Assignment / Randomization ........................................................... 32 
9.4 
Treatment masking ............................................................................................ 33 
9.5 
Accountability Procedures ................................................................................ 35 
9.6 
Changes to concomitant medications, treatments/ procedures .......................... 35 
10 STUDY PROCEDURES AND ASSESSMENTS ............................................................. 36 
10.1 Informed Consent and Screening ...................................................................... 36 
10.2 Description of Study Procedures and Assessments ........................................... 37 
10.2.1 
Demographics .................................................................................... 37 
10.2.2 
Medical History and Concomitant Medications ................................ 37 
10.2.3 
Investigational Product compliance .................................................. 37 
10.2.4 
Adverse Event Collection: Safety Assessment .................................. 37 
10.2.5 
Slit Lamp Biomicroscopy: Safety Assessment .................................. 38 
10.2.6 
Device Deficiencies: Safety Assessment ........................................... 38 
 
 
10.3 Unscheduled Visits ............................................................................................ 38 
10.4 Discontinued Subjects ....................................................................................... 39 
10.4.1 
Screen Failures .................................................................................. 39 
10.4.2 
Discontinuations ................................................................................ 39 
10.4.3 
Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product ............................................................. 39 
10.5 Clinical Study Termination................................................................................ 40 
10.5.1 
Follow-up of subjects after study participation has ended ................ 40 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ................................................... 40 
11.1 General Information .......................................................................................... 40 
11.2 Monitoring for Adverse Events ......................................................................... 42 
11.3 Procedures for Recording and Reporting .......................................................... 42 
 
 
11.5 Unmasking of the Study Treatment ................................................................... 44 
11.6 Follow-Up of Subjects with Adverse Events .................................................... 45 
11.7 Pregnancy in the Clinical Study ........................................................................ 45 
12 ANALYSIS PLAN ............................................................................................................ 45 

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12.1 Subject Evaluability .......................................................................................... 46 
12.2 Analysis Sets ..................................................................................................... 46 
12.2.1 
Safety Analysis Set ............................................................................ 46 
12.2.2 
Full Analysis Set ................................................................................ 46 
12.2.3 
Per Protocol Analysis Set .................................................................. 46 
12.3 Demographic and Baseline Characteristics ....................................................... 46 
12.4 Effectiveness Analyses ...................................................................................... 46 
12.4.1 
Analysis of Primary Effectiveness Endpoint(s) ................................ 47 
12.4.1.1 
Statistical Hypotheses ........................................................ 47 
12.4.1.2 
Analysis Methods .............................................................. 47 
 
 
 
 
 
 
12.5 Handling of Missing Data ................................................................................. 50 
12.6 Safety Analyses ................................................................................................. 50 
12.7 Interim Analyses and Reporting ........................................................................ 51 
 
 
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ............................... 52 
13.1 Subject Confidentiality ...................................................................................... 52 
13.2 Completion of Source Documents and Case Report Forms .............................. 53 
13.3 Data Review and Clarifications ......................................................................... 54 
13.4 Sponsor and Monitoring Responsibilities ......................................................... 54 
13.5 Regulatory Documentation and Records Retention .......................................... 54 
13.6 Quality Assurance and Quality Control............................................................. 55 
14 ETHICS ............................................................................................................................. 55 
 
 
 
 
 
 
 
 
List of Tables 
Table 2–1 
List of Acronyms and Abbreviations Used in This Protocol ........................... 12 
Table 3–1 
Schedule of Study Procedures and Assessments ............................................. 19 

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Table 6–1 
Primary Objective(s) ........................................................................................ 23 
 
 
Table 6–3 
Safety Objective(s) .......................................................................................... 24 
Table 9–1 
Test Product ..................................................................................................... 29 
Table 9–2 
Control Product ................................................................................................ 31 
 
 
 
List of Figures 
Figure 7-1 
Flowchart of Study Visits ................................................................................ 25 
Figure 11–1 
Categorization of All Adverse Events .............................................................. 41 
Figure 11–2 
Categorization of All Serious Adverse Events ................................................. 41 
 
 
 

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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 (or PRECISION1 soft contact lenses) 
Name of Control Product(s) Throughout this document, test product(s) will be referred to 
as Clariti 1-Day (or Clariti 1-Day soft contact lenses) 
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 of the test product or comparator. 
Adverse Event (AE) 
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 
or comparator. 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 events related to the 
use of investigational medical devices. 
Requirements for reporting Adverse Events in the study can 
be found in Section 11. 
Device Deficiency 
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, 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. 

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Enrolled Subject 
Any subject who signs an informed consent form for 
participation in the study. 
Interventional Clinical Trial A research trial that prospectively assigns, whether 
randomly or not, human participants or groups of humans to 
one or more health-related interventions to evaluate the 
effects on health outcomes, and/or a research trial in which 
diagnostic or monitoring procedures beyond standard of care 
are conducted and generate outcomes for use in analysis of 
data.  
Investigational Product 
Is defined as a preventative (vaccine), a therapeutic (drug or 
biologic), device, diagnostic, or palliative used as a test or 
control 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 a medical device to meet its performance 
specifications or otherwise perform as intended. 
Performance specifications include all claims made in the 
labeling of the device. The intended performance of the 
device refers to the intended use for which the device is 
labeled or marketed. 
Nonserious Adverse Event 
Adverse event that does not meet the criteria for a serious 
adverse event. 
Product Complaints 
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. 

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Randomized Subjects 
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. 

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c. in-patient hospitalization or prolonged 
hospitalization. 
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. In general, 
hospitalization signifies that the 
individual remained at the hospital or 
emergency ward for observation and/or 
treatment (usually involving an overnight 
stay) that would not have been 
appropriate in the physician's office or an 
out-patient setting. Complications that 
occur during hospitalization are adverse 
events. If a complication prolongs 
hospitalization or fulfills any other 
serious criteria, the event is serious. 
When in doubt as to whether 
“hospitalization” occurred, the event 
should be considered serious. 
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, or a congenital abnormality or 
birth defect. 
Refer to Section 11 for additional SAEs. 
Serious Health Threat 
Signal from any adverse event or device deficiency that 
indicates an imminent risk of death or a serious deterioration 
in the health in subjects, users or other persons, and that 
requires prompt remedial action for other subjects, users or 
other persons.  

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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. 
Use Error 
Act or omission of an act that results in a different medical 
device response than intended by manufacturer or expected 
by user. Note: This definition includes slips, lapses, and 
mistakes. An unexpected physiological response of the 
subject does not in itself constitute a use error. 
 
 
 

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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 
Clariti 1-Day or 
Clariti 1-Day 
contact lenses 
CooperVision® Clariti® 1 day  
 
 
 
 
 
 
 
 
D  
Diopter(s) 
 
 
  
 
EDC  
Electronic data capture 
FAS 
Full analysis set 
FDA  
US Food and Drug Administration 
GCP  
Good Clinical Practice 
ICF  
Informed consent form 
ICH 
International Council for Harmonisation of Technical Requirements 
for Pharmaceuticals for Human Use 
IEC 
Independent ethics committee 
IP  
Investigational product 
IRB  
Institutional review board 
  
 
 
 
LID 
Lens identification 
logMAR 
Logarithm of the minimum angle of resolution 
  
 
 
 
N 
Number 
N/A  
Not applicable 
NI 
Noninferiority 
OD 
Right eye 
OS 
Left eye 
PRECISION1 or 
PRECISION1 
contact lenses 
PRECISION1 (verofilcon A) Soft Contact Lenses  

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Abbreviation 
Definition 
 
 
SADE  
Serious adverse device effect 
SAE  
Serious adverse event 
SD 
Standard deviation 
SLE 
Slit lamp examination 
 
 
 
 
US / USA 
United States of America 
VA  
Visual acuity 
 
 
vs 
Versus  
 
 
 
 

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3 PROTOCOL SUMMARY 
Investigational 
product type 
Device 
Study type 
Interventional 
Investigational 
products 
Test Product: PRECISION1 soft contact lenses (PRECISION1) 
 
Control Product: Clariti 1-Day soft contact lenses (Clariti 1-Day) 
 
Purpose and 
rationale 
To compare the clinical performance of PRECISION1 contact lenses 
with Clariti 1-Day contact lenses using visual acuity (VA) 
 
 
 
 
Objective(s) 
The primary objective of this study is to demonstrate noninferiority 
(NI) in the visual acuity at distance when wearing PRECISION1 
contact lenses compared to Clariti 1-Day contact lenses.  
 
 
  
Endpoint(s) 
Primary Effectiveness  
• 
Distance VA (logMAR) with study lenses  
  
 
 
 
 
  
 
  
 
 
 
 
 
 
 

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Safety 
• 
Adverse events 
• 
Biomicroscopy findings 
• 
Device deficiencies 
Assessment(s)  
Effectiveness 
• 
Distance VA (logMAR) with study lenses 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Safety 
• 
Adverse events 
• 
Biomicroscopy findings 
• 
Device deficiencies  

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Study Design 
This is a prospective, randomized, controlled, double-masked, 
bilateral crossover, daily wear, multicenter clinical study.  
Subjects will be expected to attend 3 visits. The total duration of a 
subject’s participation in the study will be up to 22 days. Subjects 
will be expected to wear their study contact lenses daily 
 
 for at least 10 hours per day. The day prior to visits 
2 and 3, subjects will be expected to wear the study lenses for at least 
16 hours. 
 
 
 
Subject 
population 
Volunteer subjects aged 18 or over who are habitual spherical soft 
contact lens wearers (excluding current/previous PRECISION1, 
Clariti 1-Day and DAILIES TOTAL1® 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. 
 
 
 
 
  
Planned number of subjects enrolled/consented: ~173 
Planned number of completed subjects: 150 
Key inclusion 
criteria 
(See Section 8.1 
for a complete list 
of inclusion 
criteria) 
• 
Successful wearers of spherical soft contact lenses with at least 
3 months wearing experience, with a minimum wearing time of 
5 days per week and 10 hours per day. 
• 
 
 subject must possess 
spectacles and willing to wear habitual spectacles for vision 
correction when study lenses are not worn, as needed. 
• 
Willing to wear contact lenses for at least 16 hours on one of the 
days (day prior to each week 1 visit). 
Key exclusion 
criteria 
(See Section 8.2 
for a complete list 
• 
Participation of the subject in a clinical trial within the previous 
15 days or currently enrolled in any clinical trial. 
• 
Habitual PRECISION1, Clariti 1-Day, and DAILIES TOTAL1 
contact lens wearers. 
• 
Any monovision and multifocal lens wearers. 

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of exclusion 
criteria) 
 
 
 
Data analysis
 
 
 
Planned Data Analysis  
To address the primary 
 objectives, 
planned analyses are summarized below: 
Endpoint 
Comparison 
Statistical Method 
Primary 
Distance VA 
PRECISION1 vs 
Clariti 1-Day 
Noninferiority 
Mixed effect repeated 
measures  
NI margin = 0.05 (logMAR) 

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Key words 
PRECISION1, Clariti 1-Day, daily wear, visual acuity, Visual 
Analog Scales, Likert 
Associated 
materials 
Lubrication/re-wetting drops will not be permitted. 
 

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Table 3–1 
Schedule of Study Procedures and Assessments 
Procedure / Assessment 
Prescreening 
(optional) 
Visit 1 
Screening/Baseline/ 
Dispense Lens 1 
 
 
Visit 2 
Week 1 Follow-up 
Lens 1 / Dispense 
Lens 2  
Visit 3 
Week 1 Follow-up 
Lens 2 / Exit 
Unscheduled 
Visit / Early 
Exit 
 
 
 
 
 
 
 
 
 
8 
days after Visit 1 
 
 
 
 
 
 
8 
 days after 
Visit 2 
N/A 
Informed Consent 
- 
✓ 
- 
- 
- 
Demographics 
- 
✓ 
- 
- 
- 
Medical History ‡ 
- 
✓ 
✓ 
✓ 
✓ 
Concomitant Medications ‡ 
- 
✓ 
✓ 
✓ 
✓ 
Inclusion/Exclusion 
- 
✓ 
- 
- 
- 
Habitual lens information (brand,  power) 
- 
✓ 
- 
- 
- 
VA with habitual contact lens correction 
(OD, OS, LogMAR distance)* 
- 
✓ 
- 
✓ (Exit 
procedure) 
(✓) 
BCVA with manifest refraction (OD, OS, 
logMAR distance) 
- 
✓ 
(✓) 
(✓) 
(✓) 
Biomicroscopy 
- 
✓ 
✓ 
✓ 
✓ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomize 
- 
✓ 
- 
- 
- 
Dispense (provide) study lenses 
- 
✓ 
✓ 
- 
(✓) 
VA (logMAR distance) with study lenses, 
OD, OS 
- 
- 
✓ 
✓ 
- 

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Procedure / Assessment 
Prescreening 
(optional) 
Visit 1 
Screening/Baseline/ 
Dispense Lens 1 
 
 
Visit 2 
Week 1 Follow-up 
Lens 1 / Dispense 
Lens 2  
Visit 3 
Week 1 Follow-up 
Lens 2 / Exit 
Unscheduled 
Visit / Early 
Exit 
 
 
 
 
 
 
 
 
 
8 
 days after Visit 1 
 
 
 
 
 
 
8 
 days after 
Visit 2 
N/A 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
AEs 
- 
✓ 
✓ 
✓ 
✓ 
Device Deficiencies 
- 
✓ 
✓ 
✓ 
✓ 
Exit Form 
- 
(✓) 
(✓) 
(✓) 
(✓) 
(✓) assessment performed as necessary, 
 
* source only  
 
  
   
 
 
 

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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. 
4.1 Amendments 
There are no amendments. This is the first version of the protocol. 
5 INTRODUCTION 
5.1 Rationale and Background 
It is estimated that soft contact lenses account for over 90% of lens fits. Furthermore, it was 
reported that almost 32% of soft contact lenses were prescribed in a daily disposable 
modality. PRECISION1 is a new daily disposable silicone hydrogel contact lens with a 
material that combines high oxygen transmissibility with a low modulus of elasticity. 
PRECISION1 contact lenses are intended for the optical correction of refractive ametropia in 
persons with nondiseased eyes requiring subjects to wear spectacles for vision correction. 
The unique properties of PRECISION1 contact lenses provide precise vision, long lasting 
comfort and excellent handling. 
5.2 Purpose of the Study 
The purpose of this study is to evaluate the overall clinical performance of PRECISION1 
contact lenses when compared to another commercially available daily disposable contact 
lens, Clariti 1-Day.  

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5.3 Risks and Benefits 
Contact lenses may offer improved peripheral vision and the convenience of not wearing 
spectacles. Material properties and design characteristics of the contact lens in development 
are features consistent with successful contact lens wear.  
PRECISION1 and Clariti 1-Day contact lenses are for daily wear use under a daily 
disposable wear modality; further details on any known potential risks and benefits can be 
found in the package insert.  
PRECISION1 and Clariti 1-Day 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 PRECISION1 can be 
found in the package insert. 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.  
There may also be unknown risks to use of these study 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.  
 

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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 
PRECISION1 contact lenses compared to 
Clariti 1-Day contact lenses. 
Distance VA with study lenses (OD, OS; 
logMAR) 
6.2  Secondary Objective(s) 
Not Applicable. 
6.3  Exploratory Objective(s) 

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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 
• AEs 
• Biomicroscopy findings 
• Device deficiencies 
7 INVESTIGATIONAL PLAN 
7.1  Study Design 
This is a prospective, randomized, controlled, double-masked bilateral crossover, daily wear, 
multi-center clinical study. Habitual 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 3 visits: Screening/Baseline/Dispense Lens 1, Week 1 
Follow-up Lens 1, Week 1 Follow-up Lens 2/Exit. The total duration of a subject’s 
participation in the study will be up to 22 days. Subjects will be expected to wear their study 
contact lenses daily for at least 10 hours per day.  
On the day prior to visits 2 and 3, subjects will be instructed to wear the study lenses at least 
16 hours. 
 
  

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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 
 variable  
will be assessed on approximately after 1 week of wearing each study product
 
 
 
7.4 Rationale for Choice of Control Product 
Clariti 1-Day contact lenses were chosen as the control 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 spherical soft contact lenses in both eyes with a least 3 months wearing experience, with a 
minimum wearing time of 5 days per week and 10 hours per day. Subjects who are current or 
previous PRECISION1, Clariti 1-Day, and DAILIES TOTAL1 habitual lens wearers will be 
excluded
 
 
 
 
 This study aims to enroll (consent) approximately 173 subjects in 
approximately 10 sites in the US, with a target of 150 completed subjects.   
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: 

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1. 
Subjects must be ≥ 18 years of age.   
2. 
Subjects 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. 
Current wearers of any commercial spherical soft contact lenses with at least 
3 months wearing experience, with a minimum wearing time of 5 days per week 
and 10 hours per day. 
 
 
 
 
 
 
 
 
  
7. 
Subject must be willing to wear contact lenses for at least 16 hours of lens per day 
on one of the days (day prior to each week 1 visit). 
8. 
Subject must possess spectacles and willing to wear habitual spectacles for vision 
correction when study lenses are not worn, as needed. 
 
 
   
8.2  Exclusion Criteria 
Subjects fulfilling any of the following criteria are not eligible for participation in this study. 
1. 
Current/previous PRECISION1, Clariti 1-Day, and DAILIES TOTAL1 habitual lens 
wearers and any monovision & multifocal lens wearers. 
 
 
 
 
 
 
 
 
 

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8.3  Rescreening of Subjects 
Rescreening of subjects is not allowed in this study. 

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9 TREATMENTS ADMINISTERED 
9.1  Investigational Product(s) 
Test Product(s): 
PRECISION1 soft contact lenses 
 
Control Product(s) (If applicable): Clariti 1-Day soft contact lenses 
 
Table 9–1 
Test Product 
Test Product 
PRECISION1 soft contact lenses 
 
Manufacturer 
Alcon Laboratories, Inc. 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
USA 
Indication for use 
and intended 
purpose in the 
current study  
Precision1 spherical soft contact lenses are indicated for the optical 
correction of refractive ametropia (myopia and hyperopia) in phakic 
or aphakic persons with nondiseased eyes with up to approximately 
1.50 D of astigmatism that does not interfere with visual acuity. 
Product description 
and parameters 
available for this 
study 
• Material: verofilcon A 
• Water content: 51% 
• Power range: -1.00 to -6.00 D in 0.25 D steps 
• Base curve (mm): 8.3 
• Diameter (mm): 14.2 
Formulation 
Please see the package insert 
Usage 
• Wear: 
o Daily Wear 
o Bilateral 
• Replacement period: Daily Disposable 
• Exposure:  
o 16 days total duration (test and control) 
▪ Test Product: 8 
days 
▪ Control Product: 8 
days 
• Lens Care: N/A 

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Table 9–2 
Control Product 
Control Product(s) 
Clariti 1-Day soft contact lenses 
 
Manufacturer 
Cooper Vision 
711 North Road 
Scottsville, New York 14546 
USA 
Indication for Use 
Clariti 1-Day soft contact lenses are indicated for the optical 
correction of refractive ametropia (myopia and hyperopia) in phakic 
or aphakic persons with nondiseased eyes that may exhibit 
astigmatism up to 2.00 D that does not interfere with visual acuity. 
Product description 
and parameters 
available for this 
study 
• Material: somofilcon A 
• Water content: 56% 
• Power range: -1.00 to -6.00 D in 0.25 D steps 
• Base curve (mm): 8.6 
• Diameter (mm): 14.1 
Formulation 
Please see the package insert 
Usage 
• Wear: 
o Daily Wear 
o Bilateral 
• Replacement period: Daily Disposable 
• Exposure:  
o 16 days total duration (test and control) 
▪ Test Product: 8 
 days 
▪ Control Product: 8 
 days 
• Lens Care: N/A 

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More information on the test and control 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 with Test product then Control 
product or Control product then Test product, respectively.  

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Only after signing the ICF, a subject will be assigned a subject number by the electronic data 
capture system.  
A randomization list will be generated using a validated system that automates the random 
assignment of 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. 
At Visit 1, all eligible subjects will be randomized via the EDC/randomization integration 
system to one of the treatments (lens sequence). The investigator or delegate will access the 
respective system after confirming that the subject meets all the eligibility criteria. 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 the PRECISION1 contact 
lenses and the Clariti 1-Day contact lenses for the duration 1-week treatment period, per lens 
type. 
 
 

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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.  

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9.5 Accountability Procedures 
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. 
 
 
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: 

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• 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 3 office visits, as shown below. 
Visit # 
Visit Type 
Visit Window 
Visit 1 
Screen/Baseline/Dispense Lens 1 
N/A 
Visit 2 
Week 1 Follow-up Lens 1 
8 
 days after Visit 1 
Visit 3 
Week 1 Follow-up Lens 2/Exit 
8 
days after Visit 2 
 
Unscheduled Visits and Early Termination 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 with assigned lenses provided to take home at 
Visit 1 and Visit 2. 
 
 
  
Lubrication/rewetting drops will not be permitted during this study.  
 
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 
 All study 
procedures and assessments are to be performed according to the table of procedures 
(Table 3-1). 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 and Concomitant Medications 
Collect medical history information, including information on all medications used within the 
past 30 days. 
 
 
 
. 
10.2.3 Investigational Product compliance 
Review subject compliance with the IP usage 
 
 
10.2.4 Adverse Event Collection: Safety Assessment 
Assess and record any adverse events that are observed or reported, including those 
associated with changes in concomitant medication dosing since the previous visit in the 
subject source documents. See Section 11 for further details regarding AE collection and 
reporting. 

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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, including those 
associated with changes in concomitant medication dosing 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 manufacturer’s 
guidelines.   
 
 
 
10.3 Unscheduled Visits 
If a subject visit occurs between any regularly scheduled visits, this visit must be documented 
as an Unscheduled Visit. 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 
• 
Biomicroscopy 
The investigator may perform additional procedures for proper diagnosis and treatment of the 
subject according to Table 3-1 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 and Section 10.4.3, as possible. 

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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. 
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 
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. 

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10.5 Clinical Study Termination 
The study sponsor reserves the right to close the investigational site or terminate the study in 
its entirety at any time. 
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. 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
Comprehensive adverse event data will be collected in the subject source records. All AEs 
will be reported in the eCRF, however adverse event details collected will be determined 
based on the type of AE (ocular or systemic), if serious criterion is met, relationship to the IP, 
or if a subject discontinues due to the AE.
 
  
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 for categories of AEs and SAEs. 

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Figure 11–1 
Categorization of All Adverse Events 
ADE
Device /
procedure-
related?
Meets 
seriousness 
criteria?
SAE
All AEs
AE
No
No
Yes
Yes
 
 
Figure 11–2 
Categorization of All Serious Adverse Events 
All SAEs
Device /
procedure 
related?
SAE
SADE
No
Yes
 
 
Device Deficiencies  
A device deficiency may or may not be associated with subject harm (i.e., ADE or SADE); 
however, not all ADEs or SADEs are due to a device deficiency. The investigator should 

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determine the applicable category for the identified or suspect device deficiency and report 
any subject harm separately. 
• 
Event 1 
• 
Event 2 
• 
Event 3, etc. 
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.  
 
 
  
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 control 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: 

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• 
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.  

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11.5 Unmasking of the Study Treatment  
Masked information on the identity of the assigned medical device should not be disclosed 
during the study (see Section 9.4). 
 
 
 
 
 

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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.  
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 Medical History section 
of the eCRF when a pregnant woman enters the study or if a woman becomes pregnant 
during the study. 
 
 
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. 

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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 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. 
12.3 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,
 
 All effectiveness evaluations will use the FAS as the primary analysis set. 
 
 
  

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12.4.1 Analysis of Primary Effectiveness Endpoint(s) 
The primary objective of this study is to demonstrate noninferiority in distance VA when 
wearing PRECISION1 contact lenses compared to Clariti 1-Day contact lenses. The primary 
endpoint is distance VA with study lenses, 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:  
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 for PRECISION1 and Clariti 1-Day, 
respectively, on the logMAR scale. 
12.4.1.2 Analysis Methods 
A mixed effect 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 (PRECISION1 minus Clariti 1-Day) and the corresponding one-sided 
95% upper confidence limit will be computed. Noninferiority in distance VA will be declared 
if upper confidence limit is less than 0.05. 

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12.5 Handling of Missing Data 
All data obtained in evaluable subjects/eyes will be included in the analysis. No imputation 
for missing values will be carried out for the primary and key exploratory effectiveness 
analyses. 
12.6 Safety Analyses 
The safety endpoints are:  
• AEs  
• Biomicroscopy findings  
• Device Deficiencies  
 
There are no safety hypotheses planned in this study. The focus of the safety analysis will be 
a comprehensive descriptive assessment of occurrence of 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 

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Preferred Terms. AEs leading to study discontinuation, significant nonserious AEs, and SAEs 
will be identified. Individual subject listings will be provided, as necessary.  
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 anonymity is maintained throughout the 
course of the study. 
 
 
 
 
 
 
 
 
 
 

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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.  

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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 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. 
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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13.6 Quality Assurance and Quality Control 
 
 
 
. Quality control will be applied to each stage of data handling to ensure that all 
data are reliable and have been processed correctly.
 
 
 
14 ETHICS 
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. 

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Voluntary informed consent must be obtained in writing from every subject and the process 
shall be documented before any procedure specific to the clinical investigation is applied to 
the subject. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
The study sponsor assures that the key design elements of this protocol will be registered on 
www.clinicaltrials.gov as 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 as required by 
current regulations and, if applicable, in other public databases as required by local country 
regulations. 

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