Performance Assessment of a Modified Daily Disposable Contact Lens
Phase: NA
Conditions: Refractive Errors, Myopia, Hyperopia
Sponsor: Alcon Research

Page 1 of 50
Title
Performance Assessment of a Modified Daily Disposable Contact Lens
Protocol Number:
Development Stage of 
Project:
Sponsor Name and 
Address:
Test Product:
CLP691-C002 / NCT03762668
Development
Alcon Research, Ltd. and its affiliates (“Alcon”) 
6201 South Freeway
Fort Worth, Texas 76134-2099
Modified delefilcon A  Contact Lens
Property of Alcon Laboratories
Confidential
May not be used, divulged, published, or otherwise disclosed without the consent of 
Alcon Laboratories
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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:
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Table of Contents
Performance Assessment of a Modified Daily Disposable Contact Lens..................................1
Table of Contents .......................................................................................................................3
List of Tables..............................................................................................................................6
List of Figures............................................................................................................................6
1
GLOSSARY OF TERMS ....................................................................................................7
2
LIST OF ACRONYMS AND ABBREVIATIONS ...........................................................11
3
PROTOCOL SUMMARY.................................................................................................13
4
PROTOCOL AMENDMENTS .........................................................................................18
4.1
Amendments......................................................................................................18
5
INTRODUCTION.............................................................................................................19
5.1
Rationale and Background ................................................................................19
5.2
Purpose of the Study..........................................................................................19
5.3
Risks and Benefits.............................................................................................19
6
STUDY OBJECTIVES......................................................................................................21
6.1
Primary Objective(s) .........................................................................................21
6.2
Secondary Objective(s) .....................................................................................21
6.4
Safety Objective(s)............................................................................................21
7
INVESTIGATIONAL PLAN ............................................................................................22
7.1
Study Design .....................................................................................................22
7.2
Rationale for Study Design ...............................................................................22
7.2.1
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations........................................................................................22
7.3
Rationale for Duration of Treatment/Follow-Up...............................................22
7.4
Data Monitoring Committee..............................................................................22
8
STUDY POPULATION ....................................................................................................22
8.1
Inclusion Criteria...............................................................................................23
8.2
Exclusion Criteria..............................................................................................23
8.3
Rescreening of Subjects ....................................................................................24
9
TREATMENTS ADMINISTERED...................................................................................24
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9.1
Investigational Product(s)..................................................................................24
9.2
Other Medical Device or Medication Specified for Use During the Study ......27
9.3
Treatment Assignment / Randomization ...........................................................28
9.4
Treatment masking ............................................................................................28
9.5
Accountability Procedures.................................................................................29
9.6
Changes to concomitant medications, treatments/ procedures..........................29
10 STUDY PROCEDURES AND ASSESSMENTS.............................................................30
10.1
Informed Consent and Screening ......................................................................30
10.2
Description of Study Procedures and Assessments...........................................30
10.2.1
Demographics....................................................................................30
10.2.2
Medical History.................................................................................30
10.2.3
Investigational Product compliance ..................................................30
10.2.4
Habitual VA Assessment (logMAR)..................................................31
10.2.5
Manifest Refraction...........................................................................31
10.2.6
BCVA (logMAR)...............................................................................31
10.2.7
Adverse Event Collection..................................................................31
10.2.8
Slit-Lamp Biomicroscopy .................................................................31
10.2.9
Device Deficiencies...........................................................................31
10.2.10 High Contrast VA Assessment (logMAR).........................................31
10.3
Unscheduled Visits ............................................................................................32
10.4
Discontinued Subjects .......................................................................................33
10.4.1
Screen Failures ..................................................................................33
10.4.2
Discontinuations................................................................................33
10.4.3
Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product .............................................................33
10.5
Clinical Study Termination................................................................................34
10.5.1
Follow-up of subjects after study participation has ended ................34
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................34
11.1
General Information ..........................................................................................34
11.2
Monitoring for Adverse Events .........................................................................37
11.3
Procedures for Recording and Reporting ..........................................................38
11.4
Return Product Analysis....................................................................................40
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11.5
Unmasking of the Study Treatment...................................................................40
11.6
Follow-Up of Subjects with Adverse Events.....................................................40
11.7
Pregnancy in the Clinical Study........................................................................41
12 ANALYSIS PLAN ............................................................................................................41
12.1
Subject Evaluability...........................................................................................41
12.2
Analysis Sets .....................................................................................................41
12.2.1
Safety Analysis Set............................................................................41
12.2.2
Full Analysis Set................................................................................41
12.2.3
Per Protocol Analysis Set ..................................................................42
12.3
Demographic and Baseline Characteristics.......................................................42
12.4
Effectiveness Analyses ......................................................................................42
12.4.1
Analysis of Primary Effectiveness Endpoint(s).................................42
12.4.1.1
Statistical Hypotheses........................................................42
12.4.1.2
Analysis Methods ..............................................................42
12.5
Handling of Missing Data .................................................................................44
12.6
Safety Analyses .................................................................................................44
12.7
Interim Analyses and Reporting........................................................................45
12.8
Sample Size Justification...................................................................................45
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................45
13.1
Subject Confidentiality......................................................................................45
13.2
Completion of Source Documents and Case Report Forms..............................46
13.3
Data Review and Clarifications.........................................................................47
13.4
Sponsor and Monitoring Responsibilities .........................................................47
13.5
Regulatory Documentation and Records Retention ..........................................48
13.6
Quality Assurance and Quality Control.............................................................48
14 ETHICS .............................................................................................................................48
15 REFERENCES ..................................................................................................................50
15.1
References applicable for all clinical studies ....................................................50
15.1.1
US references applicable for clinical studies.....................................50
15.2
References for this clinical study ......................................................................50
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List of Tables
Table 2–1
List of Acronyms and Abbreviations Used in This Protocol ...........................11
Table 3–1
Schedule of Study Procedures and Assessments .............................................17
Table 6–1
Primary Objective(s)........................................................................................21
Table 9–1
Test Product .....................................................................................................24
Table 9–2
Control Product................................................................................................26
Table 9–3
Unmasked Individuals Associated with the Study...........................................28
List of Figures
Figure 11–1
Categorization of All Adverse Events..............................................................35
Figure 11–2
Categorization of All Serious Adverse Events.................................................35
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1
GLOSSARY OF TERMS
Names of test product(s)
Modified delefilcon A Contact Lens (MDACL)
Name of Control Product(s)
Delefilcon A Contact Lens (DACL)
Adverse Device Effect
(ADE)
Adverse event related to the use of an investigational 
medical device (test product) or control 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 of the test product or 
control product.
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 
(test product). Note: For subjects, this definition includes 
events related to the test product, the control product, or the 
procedures involved. For users or other persons, this 
definition is restricted to events related to the test product.
Requirements for reporting Adverse Events in the study can 
be found in Section 11.
Anticipated Serious 
Adverse Device Effect
(ASADE)
Serious adverse device effect which by its nature, incidence, 
severity, or outcome has been identified in the risk 
management file.
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 
inadequate labeling.
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 perform in accordance with its 
intended purpose when used in accordance with the 
instructions for use or clinical investigation plan.
Non-serious 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.
Randomized Subjects
Any subject who is assigned a randomized treatment.
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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 that 
either resulted in:
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, ie, 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.
c. in-patient hospitalization or prolonged 
hospitalization.
Note: Planned hospitalization for a pre-
existing condition, 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.
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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 Public Health 
Threat
Any event type which results in imminent risk of death, 
serious deterioration in state of health, or serious illness that 
requires prompt remedial action. This would include: Events 
that are of significant and unexpected nature such that they 
become alarming as a potential public health hazard, eg, 
human immunodeficiency virus (HIV) or Bird Flu.
Significant Non-Serious 
Adverse Event
Is a symptomatic, device-related, non-sight threatening 
adverse event that warrants discontinuation of any contact 
lens wear for greater than or equal to 2 weeks.
Refer to Section 11 for additional Significant Non-Serious 
AEs.
Unanticipated Serious 
Adverse Device Effect 
(USADE)
Serious adverse device effect which by its nature, incidence, 
severity, or outcome has not been identified in the risk 
management file.
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
ASADE
Anticipated serious adverse device effect
BCVA
Best corrected visual acuity
CFR
Code of Federal Regulations
CI
Confidence intervals
CRF
Case report form
D
Diopter
D/C
Discontinue
DAILIES 
TOTAL1, DT1 or 
DT1 Contact Lens
DAILIES TOTAL1 Water Gradient silicon hydrogel daily disposable 
Contact Lenses
DACL
Delefilcon A Contact Lens (DACL)
DEP
Deviations and evaluability plan
eCRF
Electronic case report form
EDC
Electronic data capture
EN
European Standard
EOD
End of Day
FAS
Full analysis set
FDA
US Food and Drug Administration
GCP
Good Clinical Practice
GPCMS
Global Product Complaint Management System
HDE
Humanitarian device exemption
HIV
Human immunodeficiency virus
IB
Investigator’s brochure
ICF
Informed consent form
ICH
International Council for Harmonization of Technical Requirements 
for Pharmaceuticals for Human Use
IEC
Independent ethics committee
IP
Investigational product
IRB
Institutional review board
IRT
Interactive response technology
ISO
International Organization for Standardization
LID
Lens identification
LogMAR
Logarithm of the minimum angle of resolution
MDACL
Modified delefilcon A Contact Lens
mm
Millimeter
MOP
Manual of procedures
N/A
Not applicable
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Abbreviation
Definition
OD
Right eye
OS
Left eye
OU
Both eyes
PP
Per protocol
RMF
Risk Management File
SADE
Serious adverse device effect
SAE
Serious adverse event
SiHy
Silicone hydrogel
SOP
Standard operating procedure
US
United States
USADE
Unanticipated serious adverse device effect
VA
Visual acuity
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3
PROTOCOL SUMMARY
This is a prospective, multi-site, randomized, bi-lateral cross-over, double-masked study 
comparing 2 Daily Disposable Contact Lenses. The expected duration of subject participation 
in the study is approximately 2 weeks, with 3 scheduled visits. The study is expected to be 
completed in approximately 5 weeks. 
Investigational 
product type
Device
Study type
Interventional
Investigational 
products
Test Product: Modified delefilcon A Contact Lens (MDACL)
(LID016029)
Control Product: Delefilcon A Contact Lens (DACL) (LID006961)
Purpose and 
rationale
To demonstrate noninferiority of VA 
 of 
MDACL compared to the current DACL. 
 
 
Objective(s)
The primary objective is to demonstrate that VA with MDACL is 
noninferior to that with the current DACL.
 
 
Endpoint(s)
Primary Effectiveness

High Contrast Distance VA (LogMAR)
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Safety

Adverse Events

Biomicroscopy findings

Device deficiencies
Assessment(s) 
Effectiveness

High Contrast Distance VA (LogMAR)
 
 
Safety

Adverse Events

Biomicroscopy

Device deficiencies
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Study Design
This study will be a prospective, randomized, double-masked, bi-
lateral crossover of two weeks in duration, with 1-week exposure 
to both test and control lenses. Follow-up visits are planned after 1
week wearing of each device.
Subject population
Adapted DT1 contact lens wearers with normal eyes 
willing and able to be fit with the study lenses 
and comply with the visit and wearing schedule.  
Planned to enroll: ~60
Target to complete: 54
Key inclusion 
criteria
(See Section 8.1 for a 
complete list of 
inclusion criteria)
Volunteer subjects aged 18 or older who are current wearers of 
commercial DAILIES TOTAL1 Contact Lenses in both eyes. 
Wearers must have at least 3 months wearing experience in their 
current DT1 correction, with a minimum wearing time of 5 days 
per week and 8 hours per day.
Key exclusion 
criteria
(See Section 8.2 for a 
complete list of 
exclusion criteria)

Any anterior segment infection, inflammation, or abnormality 
or disease (including systemic) that contraindicates contact 
lens wear, as determined by the Investigator.

History of refractive surgery or irregular cornea.

Ocular or intraocular surgery within the previous 12 months 
(excluding placement of punctal plugs) or during the study.

Biomicroscopy findings at screening that are moderate (Grade 
3) or higher and/or corneal vascularization that is mild (Grade 
2) or higher in either eye.

Current or history of herpetic keratitis in either eye.

Eye injury in either eye within 12 weeks immediately prior to 
enrollment for this trial.

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.

Monocular subjects (only one eye with functional vision).
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Data analysis and 
sample size 
justification
To address the primary 
effectiveness 
endpoints, planned analyses are summarized below:
Endpoint
Comparison
Statistical Method
Primary
High contrast 
distance VA
(logMAR)
MDACL vs. DACL 
Noninferiority 
(margin = 0.05)
Mixed effect 
repeated measures 
model
 
 
 
 
 
A sequential gatekeeping strategy will be implemented to control 
multiplicity, thereby controlling the overall type I error at one-
sided 0.05.
No inferential testing will be carried out for safety endpoints.
Sample size calculation for primary 
effectiveness endpoints is summarized below:
Endpoint
Assumptions
Power
N per 
sequence
Primary
Distance VA
Paired 
differences 
SD = 0.0383
80% 
(one-sided α = 0.05)
4
 
 
 
 
Key words
Contact lens, vision correction, visual acuity, high contrast,
 
Associated materials
Not applicable
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Table 3–1
Schedule of Study Procedures and Assessments
Procedure/ Assessment
Visit 1
Visit 2
Visit 3
Unscheduled Visit
Early Exit
Day 1 
Baseline / 
Dispense 
Lens 1 
Day 7
(± 2 days) Follow-
up  Lens 1 / 
Dispense Lens 2
Day 7
(± 2 days) 
Follow-up
Lens 2 / Exit
Informed Consent

-
-
-
-
-
Demographics

-
-
-
-
-
Medical/Ocular History

-
-
-
-
-
Concomitant Medications

()
-
()
()
()
Inclusion/Exclusion

-
-
-
-
-
VA w/ habitual correction
(logMAR distance)*

-
-
-
()

Manifest refraction*

()
()
()
()
()
BCVA (logMAR distance with 
manifest refraction)*

()
()
()
()
()
AEs  (Both reported and 
observed)





Biomicroscopy





Device deficiencies





Randomize subject

-
-
-
-
-
IP Dispense

-

-
-
-
High contrast VA w/IP 
(logMAR distance)




()
()
 
 
 
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Procedure/ Assessment
Visit 1
Visit 2
Visit 3
Unscheduled Visit
Early Exit
Day 1 
Baseline / 
Dispense 
Lens 1 
Day 7
(± 2 days) Follow-
up  Lens 1 / 
Dispense Lens 2
Day 7
(± 2 days) 
Follow-up
Lens 2 / Exit
       
      
 
 
 
 
 
 
Exit Form
()
()
()
()
()

 
* Source only
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.
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5
INTRODUCTION
5.1
Rationale and Background
 
 
 
 
 
5.2
Purpose of the Study
The purpose of the study is demonstrate noninferiority of VA
 of 
MDACL compared to the current DACL.
 
At the end of the study, a clinical study report will be prepared in accordance with applicable 
regulatory requirements and standards.
 
 
5.3
Risks and Benefits
The benefits specific to the DACL include:
Refractive Benefits:

Correction of ametropia

Improved peripheral (side) vision
Comfort Benefits:

Sustained comfort with contact lens over wearing period

Freedom from spectacles including comfort 
Ocular Health Benefits:

Alternative to invasive refractive surgery

Non-permanent device application

Highest oxygen transmissibility compared to currently marketed daily disposable contact 
lenses
Lifestyle Benefits:
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
Convenience of daily disposable modality (no need for lens cleaning, disinfection,
storage, and conditioning)

Perceived improvement in cosmetic appearance
Risks:
Potential hazardous situations associated with the use of DACL Soft Contact Lens Family 
have been analyzed in accordance with European Standard (EN) International Organization 
for Standardization (ISO) 14971:2012 and managed in such a way that all associated risks 
have been reduced to or maintained at acceptable levels. During the risk assessment, no new 
hazards were introduced.
Harm is defined as physical injury or damage to the health of people, or damage to property 
or environment. The Risk Management File 
 
 identifies 19 types of harms such as:
Negligible harms that may be associated with temporary user discomfort:

Blurred vision

Eye redness

Ocular discomfort

Visual disturbance – minor

Pain-no intervention required
Moderate harms that may cause injury or impairment requiring professional medical 
intervention:

Allergic response-hypersensitivity

Corneal abrasion

Inflammation
Serious harms that may cause injury or impairment with partial loss of function despite 
professional medical intervention:

Decreased vision-permanent (Severe)

Microbial infection – serious

Ulcerative keratitis (corneal ulcer) – non-infectious
Refer to the IB-0164, Investigator’s Brochure for MDACL for additional information. 
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6
STUDY OBJECTIVES
6.1
Primary Objective(s)
The primary objective is to demonstrate that visual acuity with MDACL is noninferior to that 
with DACL.
Table 6–1
Primary Objective(s)
Objective(s)
Endpoint(s)
Demonstrate noninferiority of 
MDACL when compared to the current 
DACL, in evaluating VA
High Contrast VA with IP (logMAR
distance) at each study Visit.
6.2
Secondary Objective(s)
Not applicable
 
 
 
 
 
 
6.4
Safety Objective(s)
Table 6–3
Objective(s)
Endpoint(s)
Describe the safety profile of the 
investigational products

Adverse Events (AEs)

Biomicroscopy findings

Device Deficiencies (DDs)
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7
INVESTIGATIONAL PLAN
7.1
Study Design
This is an interventional, prospective, multi-site, randomized, bi-lateral cross-over, double-
masked study comparing 2 Daily Disposable Contact Lenses. The expected duration of 
subject participation in the study is approximately 2 weeks, with 3 scheduled visits. The 
study is expected to be completed in approximately 5 weeks. 
7.2
Rationale for Study Design
 
 
 
 
 
7.2.1
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations
Not applicable
7.3
Rationale for Duration of Treatment/Follow-Up
One week of exposure to each product is sufficient 
 
Both, test and control lenses have the same wearing modality (daily disposable) 
 
7.4
Data Monitoring Committee
Not applicable
8
STUDY POPULATION
The study population consists of male and female subjects aged or older. . It is aimed to 
enroll (consent) approximately 60 subjects in approximately 5 sites within the US, with a 
target of approximately 12 subjects with a maximum of 18 subjects per site per site. Site-
specific targets may vary based upon individual site capabilities. Estimated time needed to 
recruit subjects for the study is approximately 2 weeks. 
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8.1
Inclusion Criteria
1. Subject must be at least 18 years of age
2. Subject must be able to understand and sign an IRB/IEC approved Informed Consent 
form
3. Current wearers of commercial DAILIES TOTAL1 in both eyes. Wearers must have at 
least 3 months wearing experience in their current DAILIES TOTAL1 correction, with 
a minimum wearing time of 5 days per week and 8 hours per day. 
 
5. Manifest cylinder ≤ 0.75 D in each eye (at Screening)
6. BCVA 20/25 or better in each eye (as determined by manifest refraction at screening)
7. Subject must be willing and able to attend all scheduled study visits as required per 
protocol
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.
8.2
Exclusion Criteria
Subjects fulfilling any of the following criteria are not eligible for participation in this study.
1. Any anterior segment infection, inflammation, or abnormality or disease (including 
systemic) that contraindicates contact lens wear, as determined by the Investigator.
2. Any use of systemic or ocular medications for which contact lens wear could be 
contraindicated, as determined by the Investigator.
3. History of refractive surgery or plan to have refractive surgery during the study or 
irregular cornea in either eye.
4. Ocular or intraocular surgery (excluding placement of punctal plugs) within the 
previous 12 months or planned during the study.
5. Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or 
corneal vascularization that is mild (Grade 2) or higher.
6. Current or history of pathologically dry eye in either eye that, in the opinion of the 
Investigator, would preclude contact lens wear.
7. Current or history of herpetic keratitis in either eye.
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8. Eye injury in either eye within 12 weeks immediately prior to enrollment for this trial.
9. Current or history of intolerance, hypersensitivity, or allergy to any component of the 
study products.
10. 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.
11. Any use of topical ocular medications that would require instillation during contact 
lens wear.
12. 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. 
13. Participation of the subject in a clinical trial within the previous 30 days or currently 
enrolled in any clinical trial.
14. Monocular subjects (only one eye with functional vision).
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. Pregnancy is not reportable as an AE; however, complications may be 
reportable and will be decided on a case–by-case basis.
8.3
Rescreening of Subjects
Rescreening of subjects is not allowed in this study.
9
TREATMENTS ADMINISTERED
9.1
Investigational Product(s)
Test Product:
MDACL 
Control Product (If applicable):
DACL 
Table 9–1
Test Product
Test Product
MDACL  
Manufacturer
Alcon Laboratories, Inc.
6201 South Freeway
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Fort Worth, Texas 76134-2099
USA
Indication for use 
and intended 
purpose in the 
current study 
delefilcon A spherical soft contact lenses are indicated for the 
optical correction of refractive ametropia (myopia and hyperopia) in 
phakic or aphakic persons with non-diseased eyes with up to 
approximately 1.50 diopters (D) of astigmatism that does not 
interfere with visual acuity.
Product description 
and parameters 
available for this 
study

Material: delefilcon A

LID Number: LID016029
Formulation
Please see the IB-0164
Usage

Wear:
o
Daily Wear
o
Bilateral

Replacement period: Daily Disposable

Exposure: At least 8 hours per day, 5 days per week, over the 
study treatment duration (7±2 days)

Lens Care: N/A
Number/Amount of 
product to be 
provided to the 
subject
Lenses will be provided in packages of (10) lenses per power, 
identified with the following:

a color coded label stating the protocol number

material identifier or LID Number

power

an investigational use only statement

tracking number
Packaging 
description
Blister foil pack
Labeling description
Blister foil label includes at a minimum:

Lens Foil label includes:
-
material name or identifier
-
base curve
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-
diameter
-
manufacturing protocol number
-
packing solution
-
power
-
lot number
-
expiration date
-
content statement
-
investigational device statement
-
Sponsor information
Storage conditions
Lenses should be stored at room temperature. 
Supply
Test product will be shipped to the site by Alcon. 
Table 9–2
Control Product
Control Product(s)
DACL  
Manufacturer
Alcon
Indication for Use
delefilcon A spherical soft contact lenses are indicated for the 
optical correction of refractive ametropia (myopia and hyperopia) in 
phakic or aphakic persons with non-diseased eyes with up to 
approximately 1.50 diopters (D) of astigmatism that does not 
interfere with visual acuity.
Product description 
and parameters 
available for this 
study

Material: delefilcon A

LID Number: LID006961

Water content: 33%

Base curve (mm): 8.5

Diameter (mm): 14.1
Formulation
Please see the package insert 
Usage

Wear:
o
Daily Wear
o
Bilateral

Replacement period: Daily Disposable
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
Exposure: At least 8 hours per day, 5 days per week, over the 
study treatment duration (7±2 days)

Lens Care: N/A
Number/Amount of 
Product to be 
Provided to the 
subject

Lenses will be provided in packages of (10) lenses per power, 
identified with the following:
-
a color coded label stating the protocol number
-
material identifier or LID Number
-
power
-
an investigational use only statement
-
tracking number
Packaging 
description
Blister foil pack
Labeling description
Blister foil label includes at a minimum:

Lens Foil label includes:
-
material name  or identifier
-
base curve
-
diameter
-
manufacturing protocol number
-
packing solution
-
power
-
lot number
-
expiration date
-
content statement
-
investigational device statement
-
Sponsor information
Storage conditions
Lenses should be stored at room temperature. 
Supply
Test product will be shipped to the site by Alcon. 
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.
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9.3
Treatment Assignment / Randomization
Subjects will be randomized in a 1:1 ratio to receive treatment (lens) in crossover sequence 
MDACL then DACL or DACL then MDACL, respectively.
Only after signing the ICF, a subject will be assigned a subject number by the electronic data 
capture system. 
A randomization list will be generated using a validated system that automates the random 
assignment of treatment arms to randomization numbers in the specified ratio. Subjects will 
be assigned treatment according to the randomization list uploaded in the iMedidata 
BALANCE 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/IRT integration system to one 
of the lens treatment sequences. The Investigator or delegate will access the respective 
system after confirming that the subject meets all the eligibility criteria. A randomization 
number will be automatically assigned to the subject according to the subject randomization 
list but will not be communicated to the site user. The EDC/IRT integration system will 
inform the site user of the treatment sequence assignment to be dispensed to the subject.
9.4
Treatment masking
This study is double-masked, with subjects randomized to use MDACL and DACL (in a 
crossover fashion) for approximately 7 days for each period.
Table 9–3
Unmasked Individuals Associated with the Study
Unmasked Individual
Extent of Unmasking
Rationale
Clinical Site Monitor, 
Clinical Operations Lead, 
Randomization Specialist,  
Clinical Data Manager 
Unmasked monitor for IP 
accountability purposes, 
unmasked Investigator for 
IP administration.
Knowledge of subject 
treatment is required in the 
event of a medical 
emergency. 
This level of masking will be maintained throughout the conduct of the study. Unmasking 
will occur only after all planned study data have been validated, and the database locked. 
Masked study personnel must avoid seeking information that may compromise masking. 
Unmasked study personnel must not disseminate information that is potentially unmasking to 
any masked personnel. The masked and unmasked site personnel must coordinate all study 
activities as necessary to protect masking and minimize bias during the study. 
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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. 
Unmasking must be done according to the instructions provided for the study IRT system.
9.5
Accountability Procedures
Upon receipt of the IPs, the Investigator or delegate must conduct an inventory. During the 
study, unmasked designated study staff must provide the IPs to the subjects in accordance 
with their randomization assignment. Throughout the study, the Investigator or delegate must 
maintain records of IP dispensation and collection for each subject. This record must be made 
available to the study monitor for the purposes of verifying the accounting of IP supplies. 
Any discrepancies and/or deficiencies between the observed disposition and the written 
account must be recorded along with an explanation. All IPs sent to the Investigator must be 
accounted for by Study Sponsor personnel, and in no case be used in an unauthorized 
situation.
It is the Investigator’s responsibility to ensure that:

All study products are accounted for and not used in any unauthorized manner

All used foils and unused supplies are returned by each subject

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 (ie, ADE or SADE) are returned to the Study Sponsor for investigation, unless 
otherwise directed by the Sponsor. Refer to Section 11 of this protocol for additional 
information on the reporting of device deficiencies and AEs and the return of study 
products associated with these events.
The Investigator is responsible for proper disposition of all unused IPs at the conclusion of 
the study, according to the instructions provided in the MOP.
9.6
Changes to concomitant medications, treatments/ procedures
After the subject is enrolled into the study, the Investigator must instruct the subject to notify 
the study site about:

Any new medications 

Alterations in dose or dose schedules for current medications, 

Any medical procedure or hospitalization that occurred or is planned
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
Any non-drug therapies (including physical therapy and blood transfusions). 
The Investigator must document this information in the subject’s case history source 
documents.
10 STUDY PROCEDURES AND ASSESSMENTS
10.1 Informed Consent and Screening
The Investigator or delegate must explain the purpose and nature of the study, and have the 
subject read, sign, and date the IRB/IEC-approved informed consent document. The subject 
must sign the ICF BEFORE any study-specific procedures or assessments can be performed, 
including study-specific screening procedures. Additionally, have the individual obtaining 
consent from the subject and a witness, if applicable, sign and date the informed consent 
document. 
The Investigator or delegate must provide a copy of the signed document to the subject and 
place the original signed document in the subject’s chart, or provide documentation as 
required by local regulations.
10.2 Description of Study Procedures and Assessments
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. Collect at Visit 1.
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. Collect at Visit 1.
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 Habitual VA Assessment (logMAR)
Perform logMAR high contrast VA, distance only, OD and OS, with habitual correction (at 
Visit 1 and upon exit). Capture data in source only. 
10.2.5 Manifest Refraction
Perform manifest refraction. Required for Visit 1. Assessment should also be performed at 
any other study visit if necessary 
 
10.2.6 BCVA (logMAR)
Perform high contrast distance BCVA (logMAR) with manifest refraction, OD and OS. 
Required for Visit 1. Assessment should be performed at any other study visit if necessary 
10.2.7 Adverse Event Collection
Assess and record any adverse events that are observed or reported at each study visit, 
including those associated with changes in concomitant medication dosing since the previous 
visit.
10.2.8 Slit-Lamp Biomicroscopy
Slip-lamp examination of the cornea, adnexa and anterior segment of the eye must be 
performed, OD and OS, before instillation of any diagnostic eye drops.
10.2.9 Device Deficiencies 
Assess and record any Device Deficiencies that are reported or observed at each study visit, 
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. 
Note: AEs and 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).
10.2.10 High Contrast VA Assessment (logMAR)
Perform logMAR VA, distance only, OD and OS, with IP at all scheduled study visits. 
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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, at a 
minimum, the following procedures: 

Collect adverse event information

Record changes in medical condition or concomitant medication

Assess and record VAs

Collect device deficiencies information

Perform biomicroscopy
The Investigator may perform additional procedures for proper diagnosis and treatment of the 
subject. The Investigator must document this information in the subject’s case history source 
documents.
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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.
10.4 Discontinued Subjects
10.4.1 Screen Failures
Subjects who were excluded from the study after signing the informed consent and prior to 
randomization to product/dispense of study product. 
The Investigator must document the reason for screen failure in the subject’s case history 
source documents.
Subject numbers must not be 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, including screen failures.
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, 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 
Not applicable
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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.
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 post-study treatment options 
as needed.
The Investigator may terminate the site’s participation in the study for reasonable cause.
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
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 article). Refer to the 
Glossary of Terms and figures below for categories of AEs and SAEs.
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Figure 11–1
Categorization of All Adverse Events
Figure 11–2
Categorization of All Serious Adverse Events
.
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Serious Adverse Events
In addition to reporting all AEs (serious and non-serious) meeting the definitions, the 
Investigator must report any occurrence of the following as an SAE:

An ocular infection including a presumed infectious ulcer with any of the following 
characteristics: 
o
Central or paracentral location
o
Penetration of Bowman’s membrane
o
Infiltrates > 2 mm diameter
o
Iritis
o
Increase in intraocular pressure
o
Culture positive for microorganisms
o
Increasing size or severity at subsequent visits

Any central or paracentral corneal event (such as neovascularization) that results in 
permanent opacification

Hypopyon

Hyphema

Neovascularization within the central 6 mm of the cornea

Permanent vision loss as defined by loss of 2 or more lines of BCVA from enrollment 
visit that fails to resolve

Uveitis (anterior, intermediate, or posterior)

Corneal abrasion affecting ≥50% of corneal surface area
Significant Non-Serious Adverse Events
A significant non-serious AE is a device-related, non-sight threatening adverse event that 
warrants discontinuation of any contact lens wear for greater than or equal to 2 weeks. In 
addition, the Investigator must report any occurrence of the following as a Significant 
Non-Serious Adverse Event:

Peripheral non-progressive non-infectious ulcers

All symptomatic corneal infiltrative events
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
Corneal staining score greater than or equal to Grade 3 (Refer to MOP for grading scales) 
[Grading scale is based on ISO 11980:2012 unless specified differently in MOP]

Temporary vision loss as defined by loss of 2 or more lines of BCVA from enrollment 
visit that persists for 2 or more weeks

Neovascularization score greater than or equal to Grade 2 (Refer to MOP for grading 
scales) [Grading scale is based on ISO 11980:2012 unless specified differently in MOP]
The above events are based on the categories provided in the ISO 11980 and the US FDA 
Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses.
Device Deficiencies
A device deficiency is inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. A device deficiency may or may not be 
associated with subject harm (ie, 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 
subject harm separately. Examples of device deficiencies include the following: 

Failure to meet product specifications (eg, incorrect lens power/diameter/base 
curve/color)

Lens/solution cloudy

Lens surface/edge defect 

Torn lens during handling/in pack

Packaging deficit (eg, mislabeled product, tampered seal, leaking bottle/container)

Suspect product contamination

Lack of performance
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:

“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?”
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) 
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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 pre-existing medical conditions or 
signs/symptoms present in a subject prior to the start of the study (ie, 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 control articles on the Device 
Deficiency eCRF. The site must submit all available information on ADEs, SAEs, and device 
deficiencies to the Study Sponsor immediately as follows:

ADEs or SAEs are documented on the Serious Adverse Event and Adverse Device Effect 
eCRF within 24 hours of the Investigator’s or site’s awareness. 

Device deficiencies are documented on the Device Deficiency eCRF within 24 hours of 
the Investigator’s or site’s awareness. 

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 any changes to concomitant medications on the appropriate eCRFs.

Document all relevant information from Discharge Summary, Autopsy Report, Certificate 
of Death, etc, if applicable, in narrative section of the Serious Adverse Event and Adverse 
Device Effect eCRF.
Note: Should the EDC system become non-operational, 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 
(msus.safety@alcon.com) according to the timelines outlined above; however, the 
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reported information must be entered into the EDC system once it becomes 
operational.
Study Sponsor representatives may be contacted for any protocol related question and their 
contact information is provided in the Manual of Procedures that accompanies this protocol.
Further, depending upon the nature of the AE or device deficiency being reported, the Study 
Sponsor may request copies of applicable portions of the subject’s medical records. The 
Investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC.
Intensity and Causality Assessments
Where appropriate, the Investigator must assess the intensity (severity) of the AE based on 
medical judgment with consideration of any subjective symptom(s), as defined below:
Intensity (Severity)
Mild
An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom.
Moderate
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities.
Severe
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities.
For every AE in the study, the Investigator must assess the causality (Related or Not Related 
to the medical device or study procedure). An assessment of causality will also be performed 
by Study Sponsor utilizing the same definitions, as shown below:
Causality
Related
An AE classified as related may be either definitely related or possibly related 
where a direct cause and effect relationship with the medical device or study 
procedure has not been demonstrated, but there is a reasonable possibility that 
the AE was caused by the medical device or study procedure.
Not Related
An AE classified as not related may either be definitely unrelated or simply 
unlikely to be related (ie, there are other more likely causes for the AE).
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The Study Sponsor will assess the AEs and may upgrade the Investigator’s assessment of 
seriousness and/or causality. The Study Sponsor will notify the Investigator of any AEs that is 
upgraded from non-serious to serious or from unrelated to related.
11.4 Return Product Analysis
Study Sponsor representatives and their contact information are provided in the MOP that 
accompanies this protocol.
Alcon products associated with device deficiencies and/or product related AEs should be 
returned and must include the Complaint # which will be provided by Study Sponsor after the 
case is entered in the Study Sponsor’s Global Product Complaint Management System 
(GPCMS), as applicable.
11.5 Unmasking of the Study Treatment
Masked information on the identity of the assigned medical device should not be disclosed 
during the study (see Section 9.4). If the treatment code needs to be broken in the interest of 
subject safety, the Investigator is encouraged to contact an appropriate Study Sponsor 
representative prior to unmasking the information if there is sufficient time. Dependent upon 
the individual circumstances (ie, medical emergency), the code may be broken prior to 
contact with the Study Sponsor. The Study Sponsor must be informed of all cases in which 
the code was broken and of the circumstances involved. Additionally, the Study Sponsor may 
be required to unmask the information in order to fulfill expedited regulatory reporting 
requirements.
11.6 Follow-Up of Subjects with Adverse Events
The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study. 
The Investigator should provide the Study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (ie, database lock). 
Any additional data received up to 3 months 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 (following the postmarket 
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vigilance procedures) and should be communicated to the medical device’s manufacturer as 
per local requirements.
11.7 Pregnancy in the Clinical Study
Women of childbearing potential or women who are pregnant at the time of study entry are 
not excluded from participation. Pregnancy should be included in the Medical History section 
of the eCRF when a pregnant woman enters the study or if a woman becomes pregnant 
during the study. Pregnancy is not reportable as an AE; however, complications may be 
reportable and will be decided on a case–by-case basis. 
12 ANALYSIS PLAN
Continuous variables will be summarized using the number of observations, mean, standard 
deviation (SD), median, minimum, and maximum, as well as confidence intervals (CIs) or 
confidence limits where applicable. Categorical variables will be summarized with counts 
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 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.
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12.2.3 Per Protocol Analysis Set
The per protocol (PP) analysis set is a subset of FAS and excludes all data/subjects which 
have met any of the critical deviation or evaluability criteria identified in the DEP.
12.3 Demographic and Baseline Characteristics
Demographic and baseline characteristics will be summarized by lens sequence and overall. 
Counts and percentages will be presented for categorical variables such as sex, age group, 
race, and ethnicity. Number of observations, mean, SD, median, minimum, and maximum 
will be presented for continuous variables such as age.
12.4 Effectiveness Analyses
This study defines 1 primary, 
 effectiveness 
endpoints. All effectiveness evaluations 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 that the high contrast visual acuity with 
Test is noninferior to that with Control. The primary endpoint is high contrast distance VA 
with study lenses, collected in logMAR, for each eye. 
12.4.1.1 Statistical Hypotheses
The null and alternative hypotheses are formulated in terms of the predefined margin of 0.05 
in logMAR 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 high contrast distance VA, in logMAR, for Test and 
Control, respectively.
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 the crossover will also be accounted for in the model. Lens 
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difference (Test minus Control) and the corresponding one-sided 95% upper confidence limit 
will be computed. Noninferiority in VA will be declared if upper confidence limit is less than 
0.05.
 
 
 
 
 
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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 (counts and percentages) for ocular 
and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities 
Preferred Terms. AEs leading to study discontinuation, significant nonserious AEs, and SAEs 
will be identified. Individual subject listings will be provided, as necessary. 
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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 of study lenses and 
treatment-emergent, will be provided. Additionally, each device deficiency category will be 
tabulated. 
No inferential testing will be done for safety analysis.
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
 
To demonstrate noninferiority (margin=0.05 logMAR) as a one-tailed hypothesis with 
α=0.05, and using a standard deviation of 0.0383 for paired differences, 80% power can be 
attained with a sample size of 8 (4 per sequence group).
To demonstrate noninferiority (margin=0.75) as a one-tailed hypothesis with α=0.05, and 
using a standard deviation of 2.17 for paired differences, 80% power can be attained with a 
sample size of 54 (27 per sequence group).
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. 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. At the end of the clinical study, the Study Sponsor will collect a copy 
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of the enrollment log without any identifying subject information. All documents submitted 
to the Study Sponsor will identify the subjects exclusively by number and demographic 
information. No other personally identifying information will be transmitted to the Study 
Sponsor.
The Study Sponsor may release anonymized study data to external researchers for purposes 
of future research directly related to the study objectives, or future research that is beyond the 
scope of the current study objectives. The Informed Consent Form explains this to study 
subjects. Anonymization means that all identifiable information will be removed from the 
dataset and all links to the subjects in the study will be removed. Anonymization of the data 
will maintain confidentiality of the subjects who participate in the study so that they cannot 
be identified by external researchers. The anonymized data set will contain records from all
of the subjects in the current study, but the anonymization process might change the data set 
in some ways, so external researchers will be informed that they might not be able to 
duplicate some of the results from this study.
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)
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
Records regarding medical histories and the use of concomitant therapies prior to and 
during the study

Date of study completion and reason for early discontinuation, if applicable
It is required that the author of an entry in the source documents be identifiable. Direct access 
to source documentation (medical records) must be allowed for the purpose of verifying that 
the data recorded on the CRF are consistent with the original source data.
Only designated individuals at the site will complete the CRFs. The CRFs must be completed 
at regular intervals following the clinical study visit schedule. It is expected that all data 
reported have corresponding entries in the source documents. The Principal Investigator is 
responsible for reviewing and certifying that the CRFs are accurate and complete. The only 
subject identifiers recorded on the CRFs will be subject number, and subject demographic 
information. 
13.3 Data Review and Clarifications
A review of CRF data to the subject’s source data will be completed by the site monitor to 
ensure completeness and accuracy. After the CRFs have been completed, additional data 
clarifications and/or additions may be needed as a result of the data cleaning process. Data 
clarifications are documented and are part of each subject’s CRF.
13.4 Sponsor and Monitoring Responsibilities
The Study Sponsor will 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 
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Sponsor will select the Coordinating Investigator based upon their experience, qualifications, 
active study participation, and their willingness and availability to take on this role.
13.5 Regulatory Documentation and Records Retention
The Investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the Study Sponsor and the Investigator’s files will be reviewed as part of the 
ongoing study monitoring. Financial information is to be kept separately. 
Additionally, the Investigator must keep study records and source documents consistent with 
the terms of the clinical study agreement with the Study Sponsor. If the Investigator retires, 
relocates, or for any other reason withdraws from responsibility of keeping the study records, 
then the Study Sponsor must be notified and suitable arrangements made for retention of 
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
This clinical study must be conducted in accordance with the ethical principles contained 
within: 

The Declaration of Helsinki, and in compliance with the ICH E6 GCP Consolidated 
Guideline, ISO 14155:2011, and the applicable US FDA 21 CFR Regulations. 

SOPs of the Study Sponsor and contract research organizations participating in the 
conduct of the clinical study and all other applicable regulations. 

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 
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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 
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 and the process 
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 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. 
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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.
15 REFERENCES
15.1 References applicable for all clinical studies

ISO 11980:2012 Ophthalmic optics - Contact lenses and contact lens care products -
Guidance for clinical investigations

ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good 
clinical practice
15.1.1 US references applicable for clinical studies

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
15.2 References for this clinical study
Not applicable. There are no references.
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Date/Time 
(mm/dd/yyyy GMT):
Signed by:
Justification:
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