Comparison of Two Daily Disposable Lenses
Phase: NA
Conditions: Refractive Ametropia, Myopia
Sponsor: Alcon Research



Page 2 of 61
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
Table of Contents .......................................................................................................................3
List of Tables..............................................................................................................................6
List of Figures............................................................................................................................6
1
GLOSSARY OF TERMS ....................................................................................................7
2
LIST OF ACRONYMS AND ABBREVIATIONS ...........................................................12
3
PROTOCOL SUMMARY.................................................................................................13
4
PROTOCOL AMENDMENTS .........................................................................................20
4.1
Amendments......................................................................................................21
5
INTRODUCTION.............................................................................................................23
5.1
Rationale and Background ................................................................................23
5.2
Purpose of the Study..........................................................................................23
5.3
Risks and Benefits.............................................................................................24
6
STUDY OBJECTIVES......................................................................................................24
6.1
Primary Objective(s) .........................................................................................24
6.2
Secondary Objective(s) .....................................................................................24
6.4
Safety Objective(s)............................................................................................25
7
INVESTIGATIONAL PLAN ............................................................................................25
7.1
Study Design .....................................................................................................25
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
9
TREATMENTS ADMINISTERED...................................................................................28
 
 
  
  
  
  
 
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9.1
Investigational Product(s)..................................................................................28
9.2
Other Medical Device or Medication Specified for Use During the Study ......31
9.3
Treatment Assignment / Randomization ...........................................................32
9.4
Treatment masking ............................................................................................32
9.5
Accountability Procedures.................................................................................35
9.6
Changes to concomitant medications, treatments/ procedures..........................36
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
Digital Use Questionnaire .................................................................37
10.2.2
Symptomatology Questionnaire ........................................................37
10.2.3
Computer Vision Syndrome Questionnaires (CVS-Q)......................37
10.2.4
Demographics....................................................................................37
10.2.5
Medical History and Concomitant Medications................................37
10.2.6
Investigational Product compliance ..................................................37
10.2.7
VA Assessment (logMAR).................................................................38
10.2.8
Subjective Refraction ........................................................................38
10.2.9
BCVA (logMAR)...............................................................................38
10.2.10 Slit-Lamp Biomicroscopy .................................................................38
10.2.11 Study Lens Fitting Assessment..........................................................38
10.2.12 Adverse Event Collection..................................................................38
10.2.13 Device Deficiencies...........................................................................38
10.3
Unscheduled Visits ............................................................................................40
10.4
Discontinued Subjects .......................................................................................40
10.4.1
Screen Failures ..................................................................................40
10.4.2
Discontinuations................................................................................40
10.4.3
Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product .............................................................41
10.5
Clinical Study Termination................................................................................41
 
 
  
  
  
  
 
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10.5.1
Follow-up of subjects after study participation has ended ................42
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................42
11.1
General Information ..........................................................................................42
11.2
Monitoring for Adverse Events .........................................................................43
11.3
Procedures for Recording and Reporting ..........................................................43
11.4
Return product analysis .....................................................................................45
11.5
Unmasking of the Study Treatment...................................................................46
11.6
Follow-Up of Subjects with Adverse Events.....................................................46
11.7
Pregnancy in the Clinical Study........................................................................46
12 ANALYSIS PLAN ............................................................................................................47
12.1
Subject Evaluability...........................................................................................47
12.2
Analysis Sets .....................................................................................................47
12.2.1
Safety Analysis Set............................................................................47
12.2.2
Full Analysis Set................................................................................47
12.2.3
Per Protocol Analysis Set ..................................................................47
12.3
Demographic and Baseline Characteristics.......................................................47
12.4
Effectiveness Analyses ......................................................................................48
12.4.1
Analysis of Primary Effectiveness Endpoint(s).................................48
12.4.1.1
Statistical Hypotheses........................................................48
12.4.1.2
Analysis Methods ..............................................................49
12.5
Handling of Missing Data .................................................................................53
12.6
Safety Analyses .................................................................................................53
12.7
Safety Analyses .................................................................................................54
12.8
Sample Size Justification...................................................................................55
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................56
13.1
Subject Confidentiality......................................................................................56
13.2
Completion of Source Documents and Case Report Forms..............................57
13.3
Data Review and Clarifications.........................................................................58
13.4
Sponsor and Monitoring Responsibilities .........................................................58
13.5
Regulatory Documentation and Records Retention ..........................................58
13.6
Quality Assurance and Quality Control.............................................................59
 
 
  
  
  
  
 
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14 ETHICS .............................................................................................................................59
15 REFERENCES ..................................................................................................................61
15.1
References applicable for all clinical studies ....................................................61
15.1.1
US references applicable for clinical studies.....................................61
15.2
References for this clinical study ......................................................................61
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
Table 6–1
Primary Objective(s)........................................................................................24
Table 9–1
Test Product .....................................................................................................28
Table 9–2
Control Product................................................................................................30
Table 9–3
Unmasked Individuals Associated with the Study...........................................33
List of Figures
Figure 11–1
Categorization of All Adverse Events..............................................................42
Figure 11–2
Categorization of All Serious Adverse Events.................................................42
 
 
  
  
  
  
 
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1
GLOSSARY OF TERMS
Names of test product(s)
Throughout this document, test product(s) will be referred to 
as DACP FreshTech (or DACP FreshTech contact lenses) 
Name of Control Product(s)
Throughout this document, control product(s) will be 
referred to as DACP (or DACP contact lenses or DACP 
sphere)
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.
 
 
  
  
  
  
 
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Requirements for reporting Device Deficiencies in the study 
can be found in Section 11.
Enrolled Subject
Any subject who signs an informed consent form for 
participation in the study.
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.
 
 
  
  
  
  
 
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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 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.
 
 
  
  
  
  
 
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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.
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.
 
 
  
  
  
  
 
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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
BI
Prism base in
BO
Prism base out
CFR
Code of Federal Regulations
cm
Centimeter
CI
Confidence intervals
COL
Clinical Operations Lead
CRF
Case report form
CSM
Clinical Site Manager
CVS-Q
Computer Vision Syndrome Questionnaire
D
Diopter
DACP or DACP 
contact lenses or 
DACP sphere
DAILIES AquaComfort Plus (nelfilcon A) Soft Contact Lenses
DACP FreshTech 
or DACP 
FreshTech contact 
lenses
DAILIES AquaComfort Plus (nelfilcon A) FreshTech Soft Contact 
Lenses
DEF
Digital Eye Fatigue
DEP
Deviations and evaluability plan
eCRF
Electronic case report form
EDC
Electronic data capture
FAS
Full analysis set
FDA
US Food and Drug Administration
GCP
Good Clinical Practice
GPCMS
Global Product Complaint Management System
HIV
Human immunodeficiency virus
ICF
Informed consent form
ICH
International Council for Harmonization of Technical Requirements 
for Pharmaceuticals for Human Use
IEC
Independent ethics committee
IIT
Investigator initiated trial
IP
Investigational product
IRB
Institutional review board
IRT
Interactive response technology
ISO
International Organization for Standardization
 
 
  
  
  
  
 
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Abbreviation
Definition
LID
Lens identification
logMAR
Logarithm of the minimum angle of resolution
m
Meter
mm
Millimeter
MOP
Manual of procedures
N
Number of subjects
NI
Non-inferiority
N/A
Not applicable
OD
Right eye
OS
Left eye
OU
Both eyes
PP
Per protocol
SADE
Serious adverse device effect
SAE
Serious adverse event
SD
Standard deviation
SOP
Standard operating procedure
UCL
Upper confidence limit
US
United States
USADE
Unanticipated serious adverse device effect
VA
Visual acuity
3
PROTOCOL SUMMARY
Investigational 
product type
Device
Study type
Interventional
Investigational 
products
Test Product: DACP FreshTech contact lenses
Control Product: DACP contact lenses
Purpose and 
rationale
The purpose of this study is to demonstrate noninferiority in 
distance VA of DACP FreshTech when compared to DACP contact 
lenses. 
The rationale for this study to compare the clinical performance of 
the new DACP FreshTech contact lenses to an already marketed 
daily disposable contact lens (DACP).
 
 
  
  
  
  
 
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Objective(s)
The primary objective is to demonstrate noninferiority in distance 
visual acuity (VA) of DACP FreshTech compared to DACP at the 
Week 1 follow-up visit. 
 
 
 
 
 
 
Endpoint(s) 
Primary Effectiveness

Mean VA with study lenses (OU; logMAR; distance[4m])
 
 
 
 
 
 
 
  
  
  
  
 
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Safety

AEs 

Biomicroscopy findings

Device deficiencies
Assessment(s) 
Effectiveness

VA with study lenses (OD, OS, OU; logMAR; distance [4m])
 
 
 
 
 
 
  
  
  
  
 
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Safety

AEs

Biomicroscopy 

Device deficiencies
Study Design
This is a prospective, randomized, double-masked, bilateral 
crossover, single site, of 3 weeks in duration, with 1-week 
exposure each to optimized habitual, test and control lenses. 
Follow-up visits are planned after 1 week wearing optimized 
habitual lenses as well as each study lens.
Subject population
Habitual soft contact lens wearers aged 18 to 35 years with normal 
eyes and a spherical distance contact lens prescription between -
1.00 and -6.00D (inclusive).  The subjects must be symptomatic, 
which means they have self-reported eye fatigue, use their digital 
devices for ≥ 4 hours/5 days a week, and score ≥ 6 on the 
Computer Vision Syndrome Questionnaire (CVS-Q). 
Planned to enroll: ~72
Target to complete: 66
Sample size reassessment is planned
Key inclusion 
criteria
(See Section 8.1 for a 
Volunteer subjects 18 to 35 years of age. Subjects must have at 
least 3 months of soft contact lens wearing experience and wear 
their habitual lenses at least 5 days per week and at least 8 hours 
per day. Subjects must be symptomatic (self-reported eye fatigue) 
 
 
  
  
  
  
 
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complete list of 
inclusion criteria)
who use digital devices ≥4 hours a day/5 days a week, and score 
≥6 on the Computer Vision Syndrome Questionnaire (CVS-Q). 
Key exclusion 
criteria
(See Section 8.2 for a 
complete list of 
exclusion criteria)
Wearing habitual contact lenses in an extended wear modality 
(routinely sleeping in lenses for at least 1 night per week) over the 
last 3 months prior to enrollment.
Data analysis and 
sample size 
justification
Planned Analysis
To address the primary and key exploratory effectiveness 
objectives, planned analyses are summarized below:
Endpoint
Comparison
Statistical Method
Primary
Distance VA 
DACP digital vs DACP
Noninferiority
Mixed effects 
repeated measures 
NI margin = 0.05 
(logMAR)
 
 
 
 
Sample Size Justification
Sample size calculations for distance VA 
 at 80% power, are summarized below:
Endpoint
Assumptions
Type I error
N
 
 
  
  
  
  
 
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Primary
Distance VA
SD (paired difference) = 0.075
NI margin = 0.05
One-sided 
0.05
16
 
 
 
Key words
Contact lens, vision correction, visual acuity, daily disposable 
contact lens, eye fatigue, digital devices, CVS-Q
Associated materials
Habitual lens care and rewetting/lubricating drops as applicable 
will be used during the wear of habitual lenses.
No lens care will be needed during daily disposable study lens (test 
and control) exposure.  Artificial tears and re-wetting drops will 
not be permitted to be used with study lenses (test and control). 
 
 
  
  
  
  
 
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Table 3–1
Schedule of Study Procedures and Assessments
Procedure/ Assessment
Pre-screening
VISIT 1
VISIT 2
VISIT 3
VISIT 4
Unscheduled Visit
Early Exit
Day 1
1 Week
(7±2 Days)
from V1
1 Week
(7±2 Days)
from V2
1 Week
(7±2 
Days)
from V3
Screening / Fitting / 
Dispense 
Optimized Habitual
Week 1 Follow-up 
and Baseline with 
Optimized Habitual 
Dispense Study 
Product 1
Week 1 Follow-up 
Study Product 1
Dispense Study 
Product 2
Week 1 Follow-up
Study Product 2 /
Exit
Digital Use Time

-

-

-

-
-
Symptomatology Question

-

-
-
-
-
-
-
CVS-Q

-

-

-

-
-
Informed Consent
-

-
-
-
-
-
-
-
Demographics
-

-
-
-
-
-
-
-
Habitual Lens (brand and 
wear schedule), Lens Care, 
Drops
-

-
-
-
-
-
-
-
Medical History
-


-

-



Concomitant Medications
-


-

-

()

Inclusion/Exclusion
-


-
-
-
-
-
-
VA (OD, OS,OU logMAR 
distance with habitual 
contact lenses)
-

-
-
-
-

-
()
Subjective (manifest) 
refraction*
-

()
()
()
()
()
(
)
()
BCVA (OD, OS, OU, 
logMAR distance with 
manifest refraction)*
-

()
()
()
()
()
(
)
()
Habitual contact lens power 
optimization (if needed)
-

-
-
-
-
-
-
-
Biomicroscopy
-


-

-

(
)

Dispense new (optimized) 
habitual contact lenses 
-

-
-
-
-
-
-
-
VA (OD, OS, OU logMAR 
distance with new 
-


-
-
-
-
-
-
 
 
  
  
  
  
 
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5
INTRODUCTION
5.1
Rationale and Background
Increasing numbers of contact lens wearers use digital devices for prolonged and demanding 
periods throughout the day and suffer from Digital Eye Fatigue (DEF).  Near universal use of 
digital devices, and time spent on them, is becoming a growing short-term problem and a 
concern for long-term vision health.  Currently, there are few products addressing DEF, and 
mostly in spectacle form.  
 
 
 
 
 
  The targeted population is pre-presbyopic (< 40 years of age) with 
heavier usage of digital devices.  
5.2
Purpose of the Study
The purpose of this post-approval market support study is to demonstrate the benefit of the 
DACP FreshTech lens in non-presbyopic contact lens wearers with symptoms of eye fatigue
as compared to the DACP (sphere) design.  The primary objective is to demonstrate 
noninferiority in distance visual acuity of DACP FreshTech compared to DACP at the 1-week 
follow-up visit. 
 
 
 
 
 
 
 
 
  
 
 
  
  
  
  
 
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At the end of the study, a clinical study report will be prepared in accordance with applicable 
regulatory requirements and standards. Results of the study may be offered for publication.
5.3
Risks and Benefits
There are no known risks to use of the test DACP FreshTech product.  
 
 
 
 
 
There may be unknown risks to use of the test DACP FreshTech product. Any risk to subjects 
in this clinical study will be minimized by compliance with the eligibility criteria and study 
procedures, clinical oversight and monitoring.  The potential harms associated with on-eye 
exposure to the new lens design include blurred vision and ocular discomfort.  In general, the 
risks with this new contact lens are anticipated to be similar to other marketed daily 
disposable soft contact lenses.
Refer to the product labeling for additional information. 
6
STUDY OBJECTIVES
6.1
Primary Objective(s)
The primary objective of this study is to demonstrate noninferiority in distance visual acuity 
of DACP FreshTech contact lenses compared to DACP contact lenses.  
Table 6–1
Primary Objective(s)
Objective(s)
Endpoint(s)
Demonstrate noninferiority of DACP 
FreshTech in distance visual acuity when 
compared to DACP
Mean VA with study lenses (OU; logMAR 
[4m])
6.2
Secondary Objective(s)
Not Applicable 
 
 
  
  
  
  
 
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6.4
Safety Objective(s)
Table 6–3
Safety Objective(s)
Objective(s)
Endpoint(s)
Describe the safety profile of investigational 
products based on evaluation of safety 
endpoints

AEs

Biomicroscopy findings

Device deficiencies
7
INVESTIGATIONAL PLAN
7.1
Study Design
This is a prospective, randomized, double-masked, bilateral crossover, single site study, 
comparing 2 daily disposable contact lenses. The expected duration of subjects participation 
in the study is 16-28 days, with 4 scheduled visits. The study is expected to be completed in 
approximately 11 weeks. 
7.2
Rationale for Study Design 
This study design was selected to include symptomatic subjects as the appropriate population 
for this trial.  Subjects will be fitted with their optimal habitual prescription and wear for 
approximately one week before wearing the test and control lenses.  They will then be 
questioned again for symptoms of digital eye fatigue, with further assurance that any fatigue 
related symptoms are not related to a wrong prescription or old lenses that may have deposits 
or poor surface and thus inclusion in the study is appropriate.  
 
 
 
 
  
  
  
  
 
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  The age of the study population is necessary to avoid 
confounding with the natural lessening of accommodation with an early presbyopic 
population.  The remaining aspects of the study design are well established.  
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 exposure of test and control for each subject 
 
  
 
 
7.4
Rationale for Choice of Control Product
The control product, DACP, was chosen to compare the effects of a spherical design versus 
the aspherical low plus design of the test product and to avoid any confounding factors 
related to lens material.
7.5
Data Monitoring Committee
Not applicable
8
STUDY POPULATION
The study population consists of male and female subjects 18 to 35 years of age with normal 
eyes (other than correction for refractive error). Subjects must be symptomatic (self-reported 
eye fatigue) who use digital devices ≥4 hours a day/5 days a week, and score ≥6 on the 
Computer Vision Syndrome Questionnaire (CVS-Q). It is aimed to enroll (consent)
approximately 72 subjects in one site in the US. Estimated time needed to recruit subjects for 
the study is approximately 11 weeks.
8.1
Inclusion Criteria
1. Subject must be  18 to 35 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).
 
 
  
  
  
  
 
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3. Current wearers of commercial spherical soft daily wear lenses with at least 3 months 
wearing experience, with a minimum wearing time of 5 days per week and 8 hours per 
day
4. Requiring spherical contact lens distance correction in each eye within the range of      
-1.00 to -6.00 D in 0.25 D steps
5. Currently using digital devices (computer, tablet, and/or smart phone) for an average 
of 4 hours per day 
6. Self-reported “eye fatigue” at least once per week attributable to digital device use 
with habitual lenses (at pre-screening) and with optimized habitual lenses 
7. Subjects must score ≥ 6 on the Computer Vision Syndrome Questionnaire (CVS-Q) 
with habitual lenses (at pre-screening) and with optimized habitual lenses (at Visit 2) 
8. Astigmatism less than or equal to 0.75 D (as determined by manifest refraction at 
screening)
9. Best corrected distance visual acuity greater than or equal to 0.10 or 20/25 in each eye 
(as determined by manifest refraction at screening)
10. Willing to NOT use rewetting/lubricating drops during the period of study product 
exposures  
11. Willing to NOT use any near aid (eg, reading glasses) at any time during the study
12. Mobile digital device with active data and text plan, able to receive email and text 
messages
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 self-reported accommodative, binocular vision issues, or issues of eye alignment
2. Any anterior segment infection, inflammation, disease, or abnormality that 
contraindicates contact lens wears as determined by the Investigator
3. Any use of systemic medications or ocular medications for which contact lens wear 
could be contraindicated, as determined by the Investigator, including use of any 
topical ocular medications and lubrication drops that would require instillation during 
contact lens wear
4. History of refractive surgery or irregular cornea
 
 
  
  
  
  
 
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5. Ocular or intraocular surgery within the previous 12 months (excluding placement of 
punctal plugs) or during the study
6. 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 at screening
7. Current or history of pathologically dry eye in either eye
8. Current or history of herpetic keratitis in either eye
9. Eye injury within 12 weeks immediately prior to enrollment for the study
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. Monocular subjects (only one eye with functional vision
12. Known pregnancy at time of enrollment
13. Concurrent participation of the subject in a contact lens or contact lens care product 
clinical trial or within the previous 30 days
14. The Investigator, his/her staff, family members of the Investigator, family members of 
the Investigator’s staff, or individuals living in the households of the aforementioned 
persons may not participate in the study
8.3
Rescreening of Subjects
Rescreening of subjects is not allowed in this study.
9
TREATMENTS ADMINISTERED
9.1
Investigational Product(s)
Test Product(s):
DACP FreshTech
Control Product:
DACP
Table 9–1
Test Product
Test Product
DACP FreshTech
Manufacturer
Alcon Research, LLC
6201 South Freeway
 
 
  
  
  
  
 
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Fort Worth, Texas 76134-2099
USA
Indication for use 
and intended 
purpose in the 
current study 
DACP FreshTech contact lenses are indicated for daily wear for the 
optical correction of refractive ametropia (myopia and hyperopia) in 
non-aphakic persons with non-diseased 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: nelfilcon A

Water content: 69%

Power range: -1.00 to -6.00 D in 0.25 D steps

Base curve (mm): 8.7

Diameter (mm): 14.0
Formulation
Please see the package insert 
Usage

Wear:
o
Daily Wear
o
Bilateral

Replacement period: Daily Disposable

Exposure: At least 8 hours per day, 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

LID Number

power

an investigational use only statement

tracking number
Packaging 
description
Blister foil pack
Labeling description

Lens Foil label includes:
-
lens identifier
 
 
  
  
  
  
 
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-
base curve
-
diameter
-
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)
DACP
Manufacturer
Alcon Research, LLC
6201 South Freeway
Fort Worth, Texas 76134-2099
USA
Indication for Use
DACP contact lenses are indicated for daily wear for the optical 
correction of refractive ametropia (myopia and hyperopia) in non-
aphakic persons with non-diseased 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: nelfilcon A

Water content: 69%

Power range: -1.00 to -6.00 D in 0.25 D steps

Base curve (mm): 8.7

Diameter (mm): 14.0
Formulation
Please see the package insert
 
 
  
  
  
  
 
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Usage

Wear:
o
Daily Wear
o
Bilateral

Replacement period: Daily Disposable

Exposure: At least 8 hours per day, 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

LID Number

power

an investigational use only statement

tracking number
Packaging 
description
Blister foil pack
Labeling description

Lens Foil label includes:
-
lens identifier
-
base curve
-
diameter
-
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
During the clinical study, the following additional medical devices are required:
 
 
  
  
  
  
 
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
Habitual optimized lenses will be optimized for power
o
Contact lenses will not be over labeled (subjects know they are wearing 
their habitual lenses)
o
Subjects will be instructed by site personnel to use their habitual lenses 
according to the instructions for use
o
Subjects will be provided with 1 to 10 habitual optimized lenses per eye, 
depending on replacement schedule 
o
Subjects will be instructed to wear lenses each day for at least 8 hours per 
day over the study treatment duration (7±2 days)
o
Subjects will continue to use their habitual lens care products when 
wearing the optimized habitual lenses
9.3
Treatment Assignment / Randomization
Subjects will be randomized in a 1:1 ratio to receive treatment (lens) in crossover sequence 
DACP FreshTech then DACP or DACP then DACP FreshTech, 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 sequences to randomization numbers in the specified ratio. Subjects 
will be assigned treatment according to the randomization list uploaded in the IRT system. 
The randomization list will be generated and maintained by the Study Sponsor.
At Visit 2, all eligible subjects will be randomized via the EDC/IRT integration system to one 
of the 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 DACP FreshTech and 
DACP (in a crossover fashion) for approximately 7 days for each period. Subjects, the 
Investigator, and masked study personnel (site and Sponsor) will be masked to the 
assigned treatment sequence.
 
 
  
  
  
  
 
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Table 9–3
Unmasked Individuals Associated with the Study
Unmasked Individual
Extent of Unmasking
Rationale
Unmasked Study 
Coordinator(s)
The Unmasked Study 
Coordinator(s) will manage 
IP inventory, as well as IP 
administration. This 
individual will have access 
to IP supply, accountability 
logs, and other documents or 
supplies pertaining to IP. 
The unmasked coordinator 
will also assist with device 
deficiency and AE 
reporting.
The Unmasked Study 
Coordinator(s) will be 
unmasked to allow for 
storage and dispensing, as 
well as accountability for all 
IP.
Clinical Operations Lead 
(COL)
The COL will have access to 
IP supply, accountability 
logs, and other documents or 
supplies pertaining to IP. 
This individual assist with 
masked and unmasked data 
reviews.
The COL will be unmasked 
to allow for oversight of the 
CSM, in conjunction with 
all IP accountability tasks.
Clinical Site Manager 
(CSM)
CSM will have access to IP 
supply, accountability logs, 
and other documents or 
supplies pertaining to IP 
accountability. This 
individual monitors 
unmasked and masked 
study data.
The CSM will be unmasked 
to allow for performance of 
IP accountability, 
management of device 
deficiencies and related AE 
lens returns, and other IP 
related tasks.
 
 
  
  
  
  
 
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Clinical Supplies 
Coordinator
The Clinical Supplies 
Coordinator will have access 
to the IP inventory, 
accountability logs and other 
documents or supplies for 
management and 
reconciliation of the IP.
The Clinical Supplies 
Coordinator will be 
unmasked to allow for 
storage, management, and 
distribution of IP inventory 
and other IP related 
products/tasks.
Unmasked Data Manager(s)
The Unmasked Data 
Manager(s) will have access 
to restricted fields in EDC 
that would contain 
unmasking data.
The Unmasked Data 
Manager(s) will be 
unmasked to allow for 
review of all restricted data.
IRT Manager
The IRT Manager will be 
unmasked to allow for 
system programming, 
testing, and to allow for 
technical oversight of the 
system.
The IRT manager is 
unmasked to all aspects of 
the trial for system 
development purposes.
Randomization Specialist
The Randomization 
Specialist will be unmasked 
to allow for generation of 
the randomization list and 
uploading of that list into the 
IRT system.
Generates and therefore has 
full knowledge of treatment 
codes but otherwise is 
operationally not associated 
with the Clinical Trial Team 
or any decision-making 
aspects related to clinical 
trial design, execution, or 
reporting.
Unmasked Statistician
The Unmasked Statistician 
will be unmasked to 
treatment sequence 
assignment at time of 
sample size reassessment.
The Unmasked Statistician 
will be unmasked to allow 
for reassessment of sample 
size at the planned interim 
analysis.
 
 
  
  
  
  
 
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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. 
Unmasking will also occur at the time of the interim analysis intended for sample size 
reassessment, with treatment-related information being revealed only to designated personnel 
as listed in the table above.
Masked study personnel must avoid seeking information that may compromise masking. 
Unmasked study personnel must not disseminate information that is potentially unmasking to 
any masked personnel. The masked and unmasked site personnel must coordinate all study 
activities as necessary to protect masking and minimize bias during the study. 
In the event of a medical emergency where the knowledge of subject treatment is required, an 
individual Investigator will have the ability to unmask the treatment assignment for a specific 
subject after contacting an appropriate Study Sponsor representative if time allows. 
Unmasking must be done according to the instructions provided for the study IRT system.
Refer to Section 11.5. 
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
 
 
  
  
  
  
 
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
Any study lenses associated with a device deficiency or with any product-related adverse 
event AE (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

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
Pre-screening activities include questions of digital use time and symptomatology and also 
administering the CVS-Q.  Subjects must also have use of a mobile digital device with active 
data and text plan, able to receive email and text messages. 
The Investigator or delegate must explain the purpose and nature of the study, and have the 
subject read, sign, and date the IRB/IEC-approved informed consent document. The subject 
must sign the ICF BEFORE any study-specific procedures or assessments can be performed, 
including study-specific screening procedures. Additionally, have the individual obtaining 
consent from the subject and a witness, if applicable, sign and date the informed consent 
document. 
The Investigator or delegate must provide a copy of the signed document to the subject and 
place the original signed document in the subject’s chart, or provide documentation as 
required by local regulations.
 
 
  
  
  
  
 
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10.2 Description of Study Procedures and Assessments
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 Digital Use Questionnaire
Administer the digital use questionnaire at pre-screening and with details of digital use 
experiences at Visit 2-4 (follow-up visits). Subjects must answer at least 4 hours per day at 
pre-screening to qualify to participate in the study.
 
 
10.2.3 Computer Vision Syndrome Questionnaires (CVS-Q)
Administer the CVS-Q at pre-screening and Visit 2-4 (follow-up visits). Subjects total score 
must be ≥6 points at pre-screening and again at Visit 2 to qualify to participate in the study.
10.2.4 Demographics
Obtain demographic information including age, race, ethnicity, and sex. Collect at Visit 1.
10.2.5 Medical History and Concomitant Medications
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 each study 
visit.
10.2.6 Investigational Product compliance
Review subject compliance with the IP usage and adjunct product usage and collect all used 
and unused study IPs.
 
 
  
  
  
  
 
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10.2.7 VA Assessment (logMAR)
Perform logMAR VA, distance only (4m), OD, OS and OU, with habitual contact lenses at 
Visit 1 and 4; with optimized habitual contact lenses at Visit 1 and 2; with study lenses at 
Visits 2-4, and with habitual lenses at Exit.
10.2.8 Subjective Refraction
Perform subjective (manifest) refraction. Required for Visit 1. Assessment should be 
performed at any other study visit if necessary (ie, decrease of VA by 2 lines or more). 
Capture data in source only.
10.2.9 BCVA (logMAR)
Perform BCVA (logMAR) at distance (4m) with manifest refraction, OD, OS, OU. Required 
for Visit 1. Assessment should be performed at any other study visit if necessary (ie, decrease 
of VA by 2 lines). Capture data in source only.
10.2.10Slit-Lamp Biomicroscopy
Perform biomicroscopy examination of the cornea, adnexa and anterior segment of the eye
must be performed, OD and OS, without contact lenses, and before instillation of any 
diagnostic eye drops, at each study visit. 
10.2.11Study Lens Fitting Assessment 
Evaluate the study lenses at each scheduled study visit by performing the following 
assessments: Lens movement (overall fit) and Lens position (centration). Capture data in 
source only at dispensing.
10.2.12Adverse Event Collection
Assess and record any AEs that are observed or reported at each study visit, including those 
associated with changes in concomitant medication dosing since the previous visit.
10.2.13 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 
 
 
  
  
  
  
 
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signature of informed consent, regardless of subject enrollment status (screen failure or 
randomized).
  
 
 
 
   
 
 
   
 
 
 
   
 
 
.
  
 
  
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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 the 
following procedures: 

Collect AE information

Record changes in medical condition or concomitant medication

Assess and record VAs

Collect device deficiency 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.
If during an Unscheduled Visit the subject is discontinuing the IP or discontinuing from the 
study, the Investigator must conduct Exit procedures according to Table 3-1 Schedule of 
Study Procedures and Assessments, as possible.
10.4 Discontinued Subjects
10.4.1 Screen Failures
Subjects who were excluded from the study after signing the informed consent and prior to
randomization and 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.
 
 
  
  
  
  
 
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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.
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.
 
 
  
  
  
  
 
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For each recorded event, the ADEs and SAEs documentation must include: date of 
occurrence, severity, treatment (if applicable), outcome, and assessments of the seriousness 
and causality. In addition, the Investigator must document all device deficiencies reported or 
observed with test and 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:

All SAEs must be reported immediately (within 24 hours) of the Investigator’s or site’s 
awareness. 

ADEs that do not meet seriousness criteria and device deficiencies must be reported 
within 10 calendar days of the Investigator’s or site’s awareness. 

A printed copy of the completed Serious Adverse Event and Adverse Device Effect 
and/or Device Deficiency eCRF must be included with product returns.

Additional relevant information after initial reporting must be entered into the eCRF as 
soon as the data become available.

Document any changes to concomitant medications on the appropriate eCRFs.

Document all relevant information from Discharge Summary, Autopsy Report, Certificate 
of Death etc., if applicable, in narrative section of the Adverse Device Effect (for related 
AEs) and Serious Adverse Event eCRF.
Note: Should the EDC system become 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 at 
msus.safety@alcon.com according to the timelines outlined above; however, the reported 
information must be entered into the EDC system once it becomes operational.
Any AEs and device deficiencies for non-study marketed devices/products (i.e., habitual 
contact lenses and contact lens care products) will be considered and processed as 
spontaneous following the post-market vigilance procedures and should be communicated to 
the device’s/product’s manufacturer as per local requirements.
Study Sponsor representatives may be contacted for any protocol related question and their 
contact information is provided in the Manual of Procedures that accompanies this protocol.
Further, depending upon the nature of the AE or device deficiency being reported, the Study 
Sponsor may request copies of applicable portions of the subject’s medical records. The 
Investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC.
 
 
  
  
  
  
 
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Intensity and Causality Assessments
Where appropriate, the Investigator must assess the intensity (severity) of the AE based on 
medical judgment with consideration of any subjective symptom(s), as defined below:
Intensity (Severity)
Mild 
An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom.
Moderate 
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities.
Severe 
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities.
For every AE in the study, the Investigator must assess the causality (Related or Not Related 
to the medical device or study procedure). An assessment of causality will also be performed 
by Study Sponsor utilizing the same definitions, as shown below:
Causality
Related
An AE classified as related may be either definitely related or possibly related 
where a direct cause and effect relationship with the medical device or study 
procedure has not been demonstrated, but there is a reasonable possibility that 
the AE was caused by the medical device or study procedure.
Not Related 
An AE classified as not related may either be definitely unrelated or simply 
unlikely to be related (ie, there are other more likely causes for the AE).
The Study Sponsor will assess the AEs and may upgrade the Investigator’s assessment of 
seriousness and/or causality. The Study Sponsor will notify the Investigator of any AEs that 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 Manual of 
Procedures that accompanies this protocol.
 
 
  
  
  
  
 
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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).
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 (i.e., 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). 
All complaints received after this time period will be considered and processed as 
spontaneous (following the post-market vigilance procedures) and should be communicated 
to the medical device’s manufacturer as per local requirements.
The Investigator should also report complaints on non-Alcon products directly to the 
manufacturer as per the manufacturer’s instructions or local regulatory requirements.
11.7 Pregnancy in the Clinical Study
Pregnancy should be included in the Medical History section of the eCRF if a woman 
becomes pregnant during the study. Pregnancy is not reportable as an AE; however, 
 
 
  
  
  
  
 
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complications may be reportable and will be decided on a case–by-case basis. An Alcon form 
will be utilized to capture all pregnancy-related information until birth of the child.
12 ANALYSIS PLAN
Continuous variables will be summarized using the number of observations, mean, 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 this analysis plan will be updated during the course of the study as part of a 
protocol amendment or will be detailed in the clinical study report.
12.1 Subject Evaluability
Final subject evaluability must be determined prior to breaking the code for masked treatment 
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 
(DACP FreshTech or DACP) evaluated in this study. The optimized habitual lenses and trial-
fit lenses are not considered study lenses for the purpose of safety evaluation. 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) will include all randomized subjects who are exposed to any 
study lenses evaluated in this study, not including the optimized habitual and trial-fit lenses.
12.2.3 Per Protocol Analysis Set
The Per Protocol (PP) analysis set is a subset of FAS and excludes all data/subjects that have 
met any of the critical deviation or evaluability criteria identified in the DEP.
12.3 Demographic and Baseline Characteristics
Demographic and baseline characteristics will be summarized by lens sequence and overall.
 
 
  
  
  
  
 
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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, 
 
endpoints. 
 
 
 
 
 
 
 
 
 
12.4.1 Analysis of Primary Effectiveness Endpoint(s)
The primary objective of this study is to demonstrate noninferiority in mean distance visual 
acuity of DACP FreshTech compared to DACP sphere at the Week 1 Follow-up visit. 
The primary endpoint is the mean distance VA with study lenses. The corresponding 
assessment is collected bilaterally (OU) in logMAR, at the Dispense and Week 1 Follow-up 
visits.
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 logMAR VA for DACP FreshTech and DACP, 
respectively, at Week 1 Follow-up.
 
 
  
  
  
  
 
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
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 non-serious AEs, and 
SAEs will be identified. Individual subject listings will be provided, as necessary.
Individual subject listings will be provided for AEs that occur after signing informed consent 
but prior to exposure to IP.
Each biomicroscopy parameter will be tabulated by its grade. For each biomicroscopy 
parameter, 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 Safety Analyses
 
 
 
 
 
 
  
  
  
  
 
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Actions to be taken following the communication of the new sample size will depend on the 
new sample size, as detailed below: 
New Sample Size
Action
Smaller than or equal to 66
No changes and complete the study with the 
originally planned sample size of 66 completers
Larger than 66 but smaller or 
equal than 90
Update and complete the study as per new sample 
size requirement 
Larger than 90
No changes and complete the study with the 
originally planned sample size of 66 completers
12.8 Sample Size Justification
Sample size calculations are based on prior clinical study (CLD523-C001) which evaluated 
performance of DACP Digital and DACP sphere, preliminary results from IIT #42145213, as 
well as other publications.
Primary Effectiveness
To demonstrate noninferiority (margin = 0.05 in logMAR; ½ line in Snellen) in mean 
distance VA as a one-tailed hypothesis with α=0.05, and using a standard deviation of 0.075 
for paired differences based on CLD523-C001, 80% power can be attained with a sample size 
of 16 (8 per sequence).
 
 
 
 
  
  
  
  
 
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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)

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
 
 
  
  
  
  
 
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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.
13.5 Regulatory Documentation and Records Retention
The Investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the Study Sponsor and the Investigator’s files will be reviewed as part of the 
ongoing study monitoring. Financial information is to be kept separately. 
 
 
  
  
  
  
 
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Additionally, the Investigator must keep study records and source documents consistent with 
the terms of the clinical study agreement with the Study Sponsor. If the Investigator retires, 
relocates, or for any other reason withdraws from responsibility of keeping the study records, 
then the Study Sponsor must be notified and suitable arrangements made for retention of 
study records and source documents needed to comply with national and international 
regulations.
13.6 Quality Assurance and Quality Control
The Study Sponsor will secure agreement from all involved parties to ensure direct access to 
all study related sites, source data and documents, and reports for the purpose of monitoring 
and auditing by the Study Sponsor, and inspection by domestic and foreign regulatory
authorities. Quality control will be applied to each stage of data handling to ensure that all 
data are reliable and have been processed correctly. Agreements made by the Study Sponsor 
with the Investigator/Institution and any other parties involved in the clinical study will be 
provided in writing as part of the protocol or as a separate agreement.
14 ETHICS
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 
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 
 
 
  
  
  
  
 
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be approved by an IRB/IEC. The Investigator must provide documentation of the IRB/IEC
approval to the Study Sponsor. The approval must be dated and must identify the applicable 
protocol, amendments (if any), informed consent form, assent form (if any), all applicable 
recruiting materials, written information for subject, and subject compensation programs. The 
IRB/IEC must be provided with a copy of the 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. 
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 
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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
Orsborn G, Vega JA, Chamberlain P. Assessment of a new lens design to improve symptoms
of eye fatigue in users of digital devices. Presented at: Annual Global Specialty Lens 
Symposium; 2016 Jan 21-24; Las Vegas, Nevada. 
Tilia D, Sha J, Yeotikar N, et al. Visual performance, accommodative function and digital eye 
strain with digital zone optics contact lenses. Optom Vis Sci. 2018;95:E-abstract 180017.
 
 
  
  
  
  
 
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