Multifocal Visual Performance Study - Seamless Transition With Precision Profile MF Lenses
Phase: NA
Conditions: Presbyopia
Sponsor: Alcon Research



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Investigator Agreement:

I have read the clinical study described herein, recognize its confidentiality, and agree 
to conduct the described trial in compliance with Good Clinical Practice (GCP), the 
ethical principles contained within the Declaration of Helsinki, this protocol, all 
applicable regulatory authority regulations, and conditions of approval imposed by the 
reviewing IRB or regulatory authority.

I will supervise all testing of the device involving human subjects and ensure that the 
requirements relating to obtaining informed consent and IRB review and approval are 
met in accordance with applicable local and governmental regulations.

I have read and understand the appropriate use of the investigational product(s) as 
described in the protocol, current Investigator’s Brochure, product information, or other 
sources provided by the Sponsor.

I understand the potential risks and side effects of the investigational product(s).

I agree to maintain adequate and accurate records in accordance with government 
regulations and to make those records available for inspection.

I agree to comply with all other requirements regarding the obligations of clinical 
Investigators and all other pertinent requirements of the Sponsor and government 
agencies.

I agree to ensure that all associates, colleagues, and employees assisting in the conduct 
of the study are informed of their obligations in meeting the above commitments.
Have you ever been disqualified as an Investigator by any Regulatory Authority?
No        Yes
Have you ever been involved in a study or other research that was terminated?
No        Yes
If yes, please explain here:
Principal Investigator:
Signature
Date
Name and professional 
position:
Address:
 
 
  
  
  
  
 
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Table of Contents
Table of Contents .......................................................................................................................3
List of Tables..............................................................................................................................5
List of Figures............................................................................................................................6
1
GLOSSARY OF TERMS ....................................................................................................7
2
LIST OF ACRONYMS AND ABBREVIATIONS ...........................................................11
3
PROTOCOL SUMMARY.................................................................................................13
4
PROTOCOLAMENDMENTS .........................................................................................20
4.1
Amendments......................................................................................................21
5
INTRODUCTION.............................................................................................................26
5.1
Rationale and Background ................................................................................26
5.2
Purpose of the Study..........................................................................................27
5.3
Risks and Benefits.............................................................................................27
6
STUDY OBJECTIVES......................................................................................................27
6.1
Primary Objective(s) .........................................................................................27
6.2
Secondary Objective(s) .....................................................................................28
6.4
Safety Objective(s)............................................................................................29
7
INVESTIGATIONAL PLAN ............................................................................................29
7.1
Study Design .....................................................................................................29
7.2
Rationale for Study Design ...............................................................................30
7.3
Rationale for Duration of Treatment/Follow-Up...............................................31
7.4
Rationale for Choice of Control Product...........................................................31
7.5
Data Monitoring Committee..............................................................................31
8
STUDY POPULATION ....................................................................................................31
8.1
Inclusion Criteria...............................................................................................31
8.2
Exclusion Criteria..............................................................................................32
8.3
Rescreening of Subjects ....................................................................................33
9
TREATMENTS ADMINISTERED...................................................................................33
 
 
  
  
  
  
 
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9.1
Investigational Product(s)..................................................................................33
9.2
Other Medical Device or Medication Specified for Use During the Study ......36
9.3
Treatment Assignment / Randomization ...........................................................37
9.4
Treatment masking ............................................................................................37
9.5
Accountability Procedures.................................................................................39
9.6
Changes to concomitant medications, treatments/ procedures..........................40
10 STUDY PROCEDURES AND ASSESSMENTS.............................................................40
10.1
Informed Consent and Screening ......................................................................41
10.2
Description of Study Procedures and Assessments...........................................41
10.2.1
Demographics....................................................................................41
10.2.2
Medical History.................................................................................41
10.2.3
Investigational Product compliance ..................................................41
10.2.4
Adverse Event Collection: Safety Assessment..................................42
10.2.5
Slit-Lamp Biomicroscopy: Safety Assessment .................................42
10.2.6
Device Deficiencies: Safety Assessment...........................................42
10.3
Unscheduled Visits ............................................................................................42
10.4
Discontinued Subjects .......................................................................................42
10.4.1
Screen Failures ..................................................................................42
10.4.2
Discontinuations................................................................................43
10.4.3
Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product .............................................................43
10.5
Clinical Study Termination................................................................................43
10.5.1
Follow-up of subjects after study participation has ended ................44
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................44
11.1
General Information ..........................................................................................44
11.2
Monitoring for Adverse Events .........................................................................45
11.3
Procedures for Recording and Reporting ..........................................................46
11.4
Return product analysis .....................................................................................48
11.5
Unmasking of the Study Treatment...................................................................48
11.6
Follow-Up of Subjects with Adverse Events.....................................................48
11.7
Pregnancy in the Clinical Study........................................................................49
12 ANALYSIS PLAN ............................................................................................................49
12.1
Subject Evaluability...........................................................................................49
12.2
Analysis Sets .....................................................................................................49
 
 
  
  
  
  
 
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12.2.1
Safety Analysis Set............................................................................49
12.2.2
Full Analysis Set................................................................................49
12.2.3
Per Protocol Analysis Set ..................................................................50
12.3
Demographic and Baseline Characteristics.......................................................50
12.4
Effectiveness Analyses ......................................................................................50
12.4.1
Analysis of Primary Effectiveness Endpoint(s).................................50
12.4.1.1
Statistical Hypotheses........................................................51
12.4.1.2
Analysis Methods ..............................................................51
12.5
Handling of Missing Data .................................................................................53
12.6
Safety Analyses .................................................................................................53
12.7
Interim Analyses and Reporting........................................................................54
12.8
Sample Size Justification...................................................................................54
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................54
13.1
Subject Confidentiality......................................................................................54
13.2
Completion of Source Documents and Case Report Forms..............................55
13.3
Data Review and Clarifications.........................................................................56
13.4
Sponsor and Monitoring Responsibilities .........................................................56
13.5
Regulatory Documentation and Records Retention ..........................................56
13.6
Quality Assurance and Quality Control.............................................................57
14 ETHICS .............................................................................................................................57
15 REFERENCES ..................................................................................................................59
15.1
References applicable for all clinical studies ....................................................59
15.1.1
US references applicable for clinical studies.....................................59
15.2
References for this clinical study ......................................................................59
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 .............................................18
Table 6–1
Primary Objective(s)........................................................................................27
 
 
  
  
  
  
 
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Table 6–3
Safety Objective(s)...........................................................................................29
Table 9–1
Test Products....................................................................................................34
Table 9–2
Control Product................................................................................................35
Table 9–3
Unmasked Individuals Associated with the Study...........................................38
List of Figures
Figure 7-1
Study Design....................................................................................................30
Figure 11–1
Categorization of All Adverse Events..............................................................44
Figure 11–2
Categorization of All Serious Adverse Events.................................................45
 
 
  
  
  
  
 
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1
GLOSSARY OF TERMS
Names of Test Product(s)
Throughout this document, test product(s) will be referred to 
as:
- AOHG MF
- DT1 MF
- DACP MF
Name of Control Product(s)
Progressive addition lens spectacles (PALs)
Adverse Device Effect
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
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
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.
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 
 
 
  
  
  
  
 
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are conducted and generate outcomes for use in analysis of 
data.
Investigational Product
Is defined as a preventative (vaccine), a therapeutic (drug or 
biologic), device, diagnostic, or palliative used as a test or 
control product in a clinical trial, including a product with a 
marketing authorization when used or assembled 
(formulated or packaged) in a way different from the 
authorized form, or when used for an unauthorized 
indication, or when used to gain further information about 
the authorized form.
Malfunction
Failure of a medical device to meet its performance 
specifications or otherwise perform as intended. 
Performance specifications include all claims made in the 
labeling of the device. The intended performance of the 
device refers to the intended use for which the device is 
labeled or marketed.
Non-serious Adverse Event
Adverse event that does not meet the criteria for a serious 
adverse event.
Postmarketing/Post-
authorization study
Any study conducted within the conditions laid down in 
product labelling and other conditions laid down for the 
marketing of the product or under normal conditions of use. 
A postmarketing study falls either within the definitions of 
an interventional or a non- interventional study and may also 
fall within the definition of a post-approval study.
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.
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:
 
 
  
  
  
  
 
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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.
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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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
ADD
Addition
ADE
Adverse device effect
AE
Adverse event
AOHG MF
AIR OPTIX plus HydraGlyde Multifocal contact lenses
BCVA
Best corrected visual acuity
CFR
Code of Federal Regulations
CL
Contact lens
cm
Centimeter
COL
Clinical Operations Lead
CRF
Case report form
CSM
Clinical Site Manager
D
Diopter(s)
DACP MF
DAILIES AquaComfort Plus Multifocal contact lenses
DT1 MF
DAILIES TOTAL1 Multifocal contact lenses
eCRF
Electronic case report form
EDC
Electronic data capture
FAS
Full analysis set
FDA
US Food and Drug Administration
GCP
Good Clinical Practice
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
IP
Investigational product
IRB
Institutional review board
IRT
Interactive response technology
ISO
International Organization for Standardization
logMAR
Logarithm of the minimum angle of resolution
m
Meter
MF
Multifocal
mm
Millimeter
 
 
  
  
  
  
 
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Abbreviation
Definition
MOP
Manual of procedures
n
Number
N/A
Not applicable
NI
Noninferiority
OD
Right eye
OS
Left eye
OU
Both eyes
PAL
Progressive addition lens spectacles
PP
Per protocol analysis set
SAE
Serious adverse event
SADE
Serious adverse device effect
SD
Standard deviation
US
United States
USADE
Unanticipated serious adverse device effect
VA
Visual acuity
 
 
  
  
  
  
 
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3
PROTOCOL SUMMARY
Investigational 
product type
Device
Study type
Interventional
Investigational 
products
Test Products: 

AIR OPTIX plus HydraGlyde (lotrafilcon B) Multifocal 
(AOHG MF) contact lenses

DAILIES TOTAL1 (delefilcon A) Multifocal (DT1 MF)
contact lenses

DAILIES AquaComfort Plus (nelfilcon A) Multifocal 
(DACP MF) contact lenses
Control Product: 

Progressive addition lens spectacles (PALs)
Purpose and 
rationale
The purpose of this trial is to demonstrate noninferiority in 
functional visual performance of Alcon´s Precision Profile MF 
contact lenses compared to PALs in a presbyopic population.
Objective(s)
The overall objective is to demonstrate noninferiority of multifocal 
(MF) contact lenses versus PALs in the transition time 
 
The primary objective is to demonstrate noninferiority in transition 
time between distance and intermediate vision with MF contact 
lenses compared to PALs.
 
 
 
 
Endpoint(s)
Primary effectiveness endpoint:

Average transition time during alternate distance (4 m) and 
intermediate (80 cm) viewing
 
 
  
  
  
  
 
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Study Design
This is a prospective, randomized, parallel group study measuring 
the average transition time during alternate distance (4 m) and 
intermediate (80 cm) viewing.
Habitual contact lens wearers will be randomized to either AOHG 
MF, DACP MF, or DT1 MF contact lenses. This will be a double-
masked trial for the contact lens group. PAL wearers will not be 
masked.
Subjects will be expected to attend 1or 2 office visits (Visit 2 may 
be performed on the same day immediately following Visit 1). All 
study contact lenses will be dispensed according to the subject’s 
prescription and fitted using the Alcon MF fitting guide. PAL
wearers will wear their habitual spectacles.
Subject population
Presbyopic subjects aged ≥ 38 and ≤ 58 years with normal eyes 
(other than correction for refractive error), whose habitual 
correction is either any MF contact lens (with a preference for 
Alcon Precision Profile Design wearers) with a LO or MED ADD 
(or equivalent to an ADD of max +2.00 D) or progressive addition 
lens spectacles. Wear of habitual correction must be at least 5 days 
per week and at least 6 hours per day.
Planned number of subjects enrolled: ~ 60
Required number of completed subjects: 48 (12 per group)
Key inclusion 
criteria
(See Section 8.1 for a 
complete list of 
inclusion criteria)
Presbyopic subjects aged ≥ 38 and ≤ 58 years with normal eyes 
(other than correction for refractive error), whose habitual 
correction is either any MF contact lens (with a preference for 
Alcon Precision Profile Design wearers) with a LO or MED ADD 
(or equivalent to an ADD of max +2.00 D) or progressive addition 
lens spectacles. Wear of habitual correction must be at least 5 days 
per week and at least 6 hours per day.
Key exclusion 
criteria
(See Section 8.2 for a 
complete list of 
exclusion criteria)
Monocular subjects or subjects fit with only one contact lens.
Known pregnancy or lactating. History of or planned refractive 
surgery or irregular cornea in either eye.
 
 
  
  
  
  
 
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Data analysis and 
sample size 
justification
Planned Analysis
To address the primary effectiveness objective, planned analysis is 
summarized below:
Endpoint
Comparison
Statistical Method
Primary
Average 
transition time 
between distance 
and intermediate
MF lenses vs 
PALs
Generalized linear model
NI margin = 0.5 second
 
 
 
No inferential testing will be performed for the safety analyses.
Sample Size Justification
Sample size calculation for the primary effectiveness endpoint 
(one-sided α = 0.05) is summarized below: 
Primary Endpoint
Assumptions
Power
N/group
Average transition 
time between 
distance and 
intermediate
Common SD = 0.456
NI margin = 0.5
80%
12
Key words
Presbyopic, multifocal
Associated materials
Lubrication/re-wetting drops will not be permitted within 2 hours 
prior to study Visit 2.
 
 
  
  
  
  
 
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Table 3–1
Schedule of Study Procedures and Assessments
ALL 
SUBJECTS
MULTIFOCAL 
CONTACT 
LENS 
WEARERS
PROGRESSIVE 
ADDITION 
LENS
SPECTACLE 
WEARERS
ALL 
SUBJECTS
Visit
Visit 1/
Screening
Visit 2/
Exposure/Exit
Visit 2/
Exposure/Exit
Unscheduled 
Visit
Procedure/Assessment
Day 1
(May be 
performed 
same day as 
Visit 2)
0-14 Days 
from Visit 1
0-14 Days from 
Visit 1
Informed Consent

Demographics

Medical History




Concomitant Medications




Inclusion/Exclusion



Randomize

Habitual correction (type/brand, 
power)


 
 
 
 
 
 
Dispense study contact lenses in 
a masked manner

 
 
 
 
  
  
  
  
 
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ALL 
SUBJECTS
MULTIFOCAL 
CONTACT 
LENS 
WEARERS
PROGRESSIVE 
ADDITION 
LENS
SPECTACLE 
WEARERS
ALL 
SUBJECTS
Visit
Visit 1/
Screening
Visit 2/
Exposure/Exit
Visit 2/
Exposure/Exit
Unscheduled 
Visit
Procedure/Assessment
Day 1
(May be 
performed 
same day as 
Visit 2)
0-14 Days 
from Visit 1
0-14 Days from 
Visit 1
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Transition time during alternate 
distance (4 m) and intermediate 
(80 cm) viewing


 
 
  
  
  
  
 
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ALL 
SUBJECTS
MULTIFOCAL 
CONTACT 
LENS 
WEARERS
PROGRESSIVE 
ADDITION 
LENS
SPECTACLE 
WEARERS
ALL 
SUBJECTS
Visit
Visit 1/
Screening
Visit 2/
Exposure/Exit
Visit 2/
Exposure/Exit
Unscheduled 
Visit
Procedure/Assessment
Day 1
(May be 
performed 
same day as 
Visit 2)
0-14 Days 
from Visit 1
0-14 Days from 
Visit 1
 
 
 
 
 
 
AEs




Device deficiencies


()
Exit form†
()


()
() assessment performed as necessary, eg, decrease of VA by 2 lines or more with investigational product (IP)
*source only; † must be performed as a screening assessment and prior to study exit
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. 
 
 
  
  
  
  
 
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5
INTRODUCTION
5.1
Rationale and Background
Presbyopia is an age-related vision condition in which the crystalline lens gradually loses its 
ability to change shape when acted upon by the ciliary muscle. It typically becomes evident 
by 40 to 45 years of age and it is expressed by a reduction in the ability to define letters or 
objects at near distance. The condition can be corrected by the use of single-vision or bifocal 
spectacles, PALs, or MF contact lenses. 
Alcon manufactures three MF contact lenses (lotrafilcon B, nelfilcon A, and delefilcon A) 
with the same Precision Profile optical design that allows for the same fitting process with all 
three lenses. The AOHG MF soft contact lenses are made of a lens material that is 
approximately 33% water and 67% lotrafilcon B, a fluoro-silicone containing hydrogel which 
is surface-treated. These lenses may be prescribed for daily wear or extended wear for up to 
6 nights of continuous wear with removal for disposal, or cleaning and disinfection prior to 
reinsertion, as recommended by the eye care professional.
The DACP MF daily disposable, soft contact lens is made up of 69% water and 
31% nelfilcon A polymer (polyvinyl alcohol partially acetalized with N-formylmethyl 
acrylamide). DT1 MF (delefilcon A) daily disposable, soft contact lenses feature a unique 
water gradient composition from a silicone-rich highly breathable core (33% water) to an 
ultrasoft hydrophilic surface gel (> 80% water at the lens surface). 
The goal of this study is to demonstrate seamless transition 
 
vision in presbyopes using Precision Profile Design MF contact lenses. 
 
 
  
  
  
  
 
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5.2
Purpose of the Study
The purpose of this postmarket study is to generate ‘real world’ visual performance data to 
demonstrate a fast transition time when reading from digital devices 
 
using Alcon’s 
Precision Profile Design contact lenses. The Alcon MF lenses will be compared to PALs. 
 
 
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
A summary of the known and potential risks and benefits associated with AOHG MF, DACP 
MF, and DT1 MF contact lenses can be found in their respective package inserts. Safety 
information about AOHG MF, DACP MF, and DT1 MF contact lenses may be found in their 
respective product labeling. 
There may also be unknown risks to use of AOHG MF contact lenses, DT1 MF contact 
lenses, or DACP MF contact lenses. Any risk to subjects in this clinical study will be 
minimized by compliance with the eligibility criteria and study procedures, clinical oversight,
and monitoring. In this study, the duration of the planned clinical exposure of the currently 
marketed MF contact lenses is up to 3 hours. Site personnel will educate subjects on proper 
hygiene and lens care, handling, and compliance with use of the study contact lenses, as 
applicable. Site personnel will advise the subjects to remove contact lenses and/or alert site 
staff for prompt follow-up if there are symptoms such as ocular discomfort, foreign body 
sensation, excessive tearing, vision changes, or hyperemia.  
Refer to the product label for additional information.
6
STUDY OBJECTIVES
6.1
Primary Objective(s)
Table 6–1
Primary Objective(s)
Objective(s)
Endpoint(s)
 
 
  
  
  
  
 
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7.3
Rationale for Duration of Treatment/Follow-Up
The duration of exposure to the contact lenses was chosen to address the objective of this 
study, and is aligned with MF fitting guidelines for initial fit assessment following lens 
insertion.
7.4
Rationale for Choice of Control Product
PALs were chosen as the control product to address the study objectives. PALs are an 
alternative to MF contact lenses for the correction of presbyopia. 
7.5
Data Monitoring Committee
Not applicable.
8
STUDY POPULATION
The study population consists of male or female subjects aged ≥ 38 and ≤ 58 with presbyopia. 
The aim is to enroll approximately 60 subjects at approximately 2 sites; 1 in the United 
Kingdom and 1 in the United States (US), with a target of 48 total subjects completed. Each 
site is expected to enroll approximately 30 subjects with a target of 24 completed
(approximately 6 subjects per group at each site). Site-specific targets may vary based upon
individual site capabilities. Estimated time needed to recruit subjects for the study is 
approximately 6 to 8 weeks. Because a 20% screening failure and/or discontinuation rate is 
expected, approximately 60 subjects are expected to be enrolled.
8.1
Inclusion Criteria
Written informed consent must be obtained before any study specific assessment is 
performed. Upon signing informed consent, the subject is considered enrolled in the study.
Subjects eligible for inclusion in this study must fulfill all of the following criteria:
1.
Subject must be able to understand and sign an IRB/IEC approved Informed 
Consent form. 
2.
Willing and able to attend all scheduled study visits as required per protocol.
3.
Subjects must be ≥ 38 and ≤ 58 years of age.
4.
Current contact lens wearers (during the past 3 months for a minimum of 5 days per 
week and 6 hours per day) of any MF contact lens (with a preference for Alcon 
 
 
  
  
  
  
 
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Precision Profile Design wearers) with a LO or MED ADD (or equivalent to an 
ADD of max +2.00 D).
OR
Current PAL wearers (wearing spectacles for a minimum of 5 days per week and 
6 hours per day) with a prescription check in the last 12 months and spectacles up to 
date based on the prescription check with an ADD no higher than +2.00 D and a 
spherical refractive error between -0.50 and -6.50 D.
5.
Contact lens wearers: manifest cylinder (at screening) less than or equal to 0.75 D in 
each eye and a spherical refractive error (vertex distance 10-14mm) between -0.50 
and -6.50 D
6.
Subjects’ BCVA vision with manifest refraction must be  0.1 (logMAR) or better in 
each eye at distance at Visit 2.  
7.
Willing to discontinue artificial tears and rewetting drops within approximately 2 
hours prior to or during study Visit 2. 
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, and/or any infiltrate. 
 
 
  
  
  
  
 
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6.
Current or history of pathologically dry eye in either eye that, in the opinion of the 
Investigator, would preclude contact lens wear. 
7.
Current or history of herpetic keratitis in either eye.
8.
Eye injury in either eye within 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.
Any use of topical ocular medications and artificial tear or rewetting drops that 
would require instillation during contact lens wear.
11.
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.
12.
Participation of the subject in a clinical trial within the previous 30 days or currently 
enrolled in any clinical trial.
13.
Monocular subjects (only one eye with functional vision) or subjects fit with only 
one contact lens.
14.
Known pregnancy or lactating.
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):

AIR OPTIX plus HydraGlyde (lotrafilcon B) 
Multifocal (AOHG MF) contact lens

DAILIES TOTAL1 (delefilcon A) Multifocal 
(DT1 MF) contact lens

DAILIES AquaComfort Plus (nelfilcon A) 
Multifocal (DACP MF) contact lens
Control Product(s) (If applicable):
Progressive addition lens spectacles 
 
 
  
  
  
  
 
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Table 9–1
Test Products
Test Product
AIR OPTIX plus
HydraGlyde 
(lotrafilcon B) 
Multifocal – AOHG 
MF contact lens
DAILIES TOTAL1 
(delefilcon A) 
Multifocal – DT1 MF
contact lens
DAILIES 
AquaComfort Plus 
(nelfilcon A) 
Multifocal – DACP 
MF contact lens
Manufacturer
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134-2099
USA
Indication for 
use and 
intended 
purpose in the 
current study 
The intended use of these contact lenses is for vision correction.
Product 
description 
and 
parameters 
available for 
this study
Material: Lotrafilcon B
Water content: 33%
Power range: 
-0.50 to -6.00 D in 
0.25 D steps
Add: LO, MED
Base curve (mm): 8.6
mm
Diameter (mm): 14.2
mm
Material: Delefilcon A
Water content: 33% 
core, > 80% surface
Power range: 
-0.50 to -6.00 D in 
0.25 D steps
Add: LO, MED
Base curve (mm): 8.5 
mm
Diameter (mm): 14.1 
mm
Material: Nelfilcon A
Water content: 69%
Power range: 
-0.50 to -6.00 D in 
0.25 D steps
Add: LO, MED
Base curve (mm): 8.7 
mm
Diameter (mm): 14.0 
mm
Formulation
Information can be found in the associated package insert
Study Usage
Wear:
Wear:
Wear:
 
 
  
  
  
  
 
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Daily Wear
Bilateral
Replacement period: 
N/A
Exposure: 
approximately 
2-3 hours
Lens Care: N/A
Daily Wear
Bilateral
Replacement period: 
N/A
Exposure: 
approximately 
2-3 hours
Lens Care: N/A
Daily Wear
Bilateral
Replacement period: 
N/A
Exposure: 
approximately 
2-3 hours
Lens Care: N/A
Number/
Amount of 
product to be 
provided to 
the subject
One pair of study lenses will be provided to each subject in the contact 
lens group according to their randomization assignment. Replacement 
lenses will be available if needed. Multiple lenses may be used to fit the 
subject per the Alcon MF Fitting guide or investigator’s discretion.
Packaging 
description
Blister foil pack
Labeling 
description
Commercial labeling
Storage 
conditions
Refer to the package insert
Supply
Each Site will procure study contact lenses. Refer to the MOP,
Section 10.3, for additional details
Table 9–2
Control Product
Control Product(s)
Progressive addition lens spectacles
Manufacturer
N/A
Indication for Use
Subjects will use their habitual progressive addition lens spectacles 
as instructed by their eye care professional.
 
 
  
  
  
  
 
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Product description 
and parameters 
available for this 
study
Progressive addition lens spectacles
Formulation
N/A
Usage
N/A
Number/Amount of 
Product to be 
Provided to the 
subject
N/A
Packaging 
description
N/A
Labeling description
N/A
Storage conditions
N/A
Additional 
identifying 
information
N/A
Supply
Subject will provide their own habitual progressive addition 
spectacles
The study lenses must be maintained within specified environmental condition, per the 
labeling.
More information on the test products can be found in the Package Inserts, Directions for 
Use.
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
Habitual contact lens wearing subjects will be randomized in a 1:1:1 ratio to receive AOHG 
MF, DT1 MF, or DACP MF, respectively. Habitual PALs wearing subjects will not be 
randomized. 
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 IRT system. The 
randomization list will be generated and maintained by the Study Sponsor.
At Visit 2, all eligible subjects in the contact lens group will be randomized via the EDC/IRT 
integration system to one of the treatment arms. The unmasked study coordinator 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 assignment to be dispensed to the subject.
9.4
Treatment masking
The contact lens group in this study is double-masked, with contact lens group subjects 
randomized to use AOHG MF, DT1 MF or DACP MF lenses for the study visit.  
Investigators will be masked to the type and brand of PAL.
 
 
  
  
  
  
 
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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 (including brand/type of PAL). 
The unmasked coordinator will also 
assist with device deficiency and 
adverse event reporting.
The Unmasked Study
Coordinator(s) will be
unmasked to allow for
storage and dispensing, as
well as accountability for all
contact lens 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 
assists 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 any other IP 
related 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, 
The IRT manager is
unmasked to all aspects of 
 
 
  
  
  
  
 
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Unmasked 
Individual
Extent of Unmasking
Rationale
testing, and to allow for technical 
oversight of the system.
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.
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. 
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 IP, the Investigator or delegate must conduct an inventory. During the 
study, Masked Investigator must designate unmasked staff to provide the IP 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
 
 
  
  
  
  
 
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written account must be recorded along with an explanation. All IP 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

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
Subjects will be expected to attend 1-2 office visits. Visit 1/Screening visit procedures may 
be performed the same day as Visit 2 procedures. Visit 2 should occur 0-14 days from Visit 1.
Study randomization for the contact lens group should occur at Visit 2 if it is performed on a 
separate date as the Visit 1/Screening visit. All study contact lenses will be prescribed 
according to the subject’s prescription and fitted using the Alcon MF fitting guide. A 
subject’s participation will be terminated if the subject does not achieve a successful fit with 
 
 
  
  
  
  
 
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the Alcon Precision Profile Design study lenses according to the MF fitting guidelines or at 
the Investigator’s discretion. PAL wearers will wear their habitual spectacles.
 
 Used study contact 
lenses will be removed at the subject’s exit and destroyed by the site.
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. A signed informed consent document defines the point of enrollment.
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.
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.
10.2.3 Investigational Product compliance
Review subject compliance with the IP usage and adjunct product usage and collect all used 
and unused IP and other products that were dispensed.
 
 
  
  
  
  
 
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10.2.4 Adverse Event Collection: Safety Assessment
Assess and record any AEs that are observed or reported, including those associated with 
changes in concomitant medication dosing since the previous visit.
10.2.5 Slit-Lamp Biomicroscopy: Safety Assessment
Slit-lamp examination must be performed in both eyes prior to study exit.
10.2.6 Device Deficiencies: Safety Assessment
Assess and record any device deficiencies that are reported or observed since the previous 
visit. Requirements for reporting device deficiencies in the study can be found in Section 11.
10.3 Unscheduled Visits
If a subject visit occurs between any regularly scheduled visits, this visit must be documented 
as an Unscheduled Visit. During all unscheduled visits, the Investigator must conduct the 
following procedures:

Collect AE and device deficiency information

Assess and record changes in medical condition or concomitant medication

Perform biomicroscopy (assessments with or without lenses as possible)

Perform BCVA (OD, OS, logMAR distance (4 m), intermediate (80 cm), and near (40 
cm) with manifest refraction)
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 and Section 
10.4.3, as possible.
10.4 Discontinued Subjects
10.4.1 Screen Failures
Screen failures are subjects who are excluded from the study after signing the informed 
consent and prior to randomization.
 
 
  
  
  
  
 
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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 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 
N/A. Any subject discontinued from IP will be discontinued from the study.
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.
 
 
  
  
  
  
 
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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:

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 faxed or emailed to the Study Sponsor at
1-817-302-1927 or 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.
 
 
  
  
  
  
 
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Any AEs and device deficiencies for non-study marketed devices/products (ie, habitual 
multifocal contact lenses will be considered and processed as spontaneous (following the 
postmarket 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.
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.
 
 
  
  
  
  
 
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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. 
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.
11.5 Unmasking of the Study Treatment
Masked information on the identity of the assigned medical device should not be disclosed 
during the study (refer to 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). 
 
 
  
  
  
  
 
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All complaints received after this time period will be considered and processed as 
spontaneous (following the postmarket 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 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 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 treatment 
assignment and locking the database, based upon the Deviations and Evaluability Plan.
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 product 
evaluated in this study, except for the lenses used at Visit 2 for the purpose of parameter 
optimization and fitting as they are not intended for the assessment of safety. For treatment-
emergent safety analyses, subjects/eyes will be categorized under the actual study product
exposed.
12.2.2 Full Analysis Set
The full analysis set (FAS) is the set of all subjects assigned to PALs or randomized to the 
contact lens group who are exposed to any study product evaluated in this study, except for 
the lenses used for optimization and fitting. 
 
 
  
  
  
  
 
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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 Deviations and 
Evaluability Plan.
12.3 Demographic and Baseline Characteristics
Demographic and baseline characteristics will be summarized by lens 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, 
 
All effectiveness evaluations will use the FAS as the primary analysis set.
 analyses of the primary 
 will be 
conducted using the PP Analysis Set only if the number of subjects excluded from the PP 
Analysis Set exceeds 5% of the FAS.
A sequential gatekeeping strategy will be used to control testing of multiple effectiveness 
endpoints. Therefore, the overall Type I error will be maintained at one-sided 0.05 with the 
following testing order:
12.4.1 Analysis of Primary Effectiveness Endpoint(s)
The primary objective of this study is to demonstrate noninferiority in transition time 
between distance and intermediate with MF contact lenses compared to PALs. The primary 
endpoint is the average transition time, calculated from a maximum of 3 readings, recorded in 
seconds, during alternate viewing from distance (4 m) to intermediate (80 cm) and vice versa.
 
 
  
  
  
  
 
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12.5 Handling of Missing Data
All data obtained in evaluable subjects/eyes will be included in the analysis. No imputation 
for missing values will be carried out for the primary and secondary effectiveness analyses.
12.6 Safety Analyses
The safety endpoints are:

AEs

Biomicroscopy findings

Device deficiencies
There are no safety hypotheses planned in this study. The focus of the safety analysis will be 
a comprehensive descriptive assessment of occurrence of AEs 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. 
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 
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Two listings for device deficiencies, prior to exposure of study contact 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
Sample size calculation is based on published results regarding response time for distance 
and near visual acuity, with high and low contrast. 
To demonstrate noninferiority (margin = 0.5 seconds) as a one-tailed hypothesis with 
α = 0.05, and using a common standard deviation of 0.456, 80% power can be attained with a 
sample size of 48 (12 per group). For a comparison using a 3:1 ratio, required sample sizes 
for 80% power are 24:8 (test:control).
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 
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 
 
 
  
  
  
  
 
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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
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 
 
 
  
  
  
  
 
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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 
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 
 
 
  
  
  
  
 
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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 
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 
 
 
  
  
  
  
 
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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 
regulations.
 
 
  
  
  
  
 
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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
Not applicable. There are no references.
 
 
  
  
  
  
 
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