Clinical Comparison of 4 Daily Disposable Soft Contact Lenses
Phase: NA
Conditions: Refractive Error
Sponsor: Alcon Research

Page 1 of 38
___________________________________________________________________________
Title:
Clinical Comparison of 4 Daily Disposable Soft Contact Lenses
Protocol Number:
Sponsor Name and 
Address:
Test Product(s):
Investigator Agreement:
CLE383-C004 / NCT03349632
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 76134-2099
Daily Disposable T2 Soft Contact Lenses (DD T2 Contact 
Lenses)
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, and all applicable regulatory requirements. 
Additionally, I will comply with all procedures for data 
recording and reporting, will permit monitoring, auditing, and 
inspection of my research center, and will retain all records until 
notified by the Sponsor.
Principal Investigator:
Signature
Date
Name:
Address:
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0054506
Protocol - Clinical
02-Nov-2017

Pa ge 2 of 3 8
1
P R O T O C O L  S Y N O P SI S
Trial S p o ns or
Alc o n Researc h, Lt d.
6 2 0 1 S o ut h Free wa y
F ort W ort h, Te xas 7 6 1 3 4- 2 0 9 9
Na me of Test Pr o d uct
D D T 2
Na me of C o ntr ol 
Pr o d ucts

A C U V U E O A S Y S ® Bra n d C o ntact Le nses 1- D a y  wit h 
H y dra L u xe ™Tec h n ol o g y  ( Oas ys 1- D a y )

C o o per Visi o n ® M y Da y ® ( M yD a y )

1- D a y  A C U V U E® M OI S T ( M oist)
Title of Trial
Cli nical C o m paris o n of 4 Dail y  Dis p osa ble S oft C o ntact Le nses
Pr ot oc ol N u m ber
C L E 3 8 3 -C 0 0 4
N u m ber of Sites
C o u ntr y
~ 3
U S
Pla n ne d D urati o n of 
E x p os ure 
~ 2 0 da y s t otal d urati o n
•
Test Pr o d uct: 8 da y s (-1/ + 2 da y s)
•
C o ntr ol Pr o d uct s: 8 da ys (-1/ + 2 da y s)
N u m ber of S u bjects  
Tar get t o c o m plete: 6 0 ( 2 0 per eac h parallel gr o u p)
Pla n ne d t o e nr oll: ~ 6 6 ( ~ 2 2 per eac h parallel gr o u p)
St u d y  P o p ulati o n
V ol u nteer s u bjects a ge d 1 8 or o ver w h o are s oft dail y  dis p osa ble 
c o ntact le ns wearers (e xcl u di n g c urre nt Oas ys  1-Da y , My D a y, a n d 
M oist wearers), ha ve at least 3 m o nt hs of c o ntact le ns weari n g 
e x perie nce, a n d w h o wear t heir ha bit ual le nses at least 5 da y s per wee k 
a n d at least 8 h o urs per da y.  
O bjecti ves
T he pri mar y  o bjecti ve of t his st u d y is t o e val uate t he o verall 
perf or ma nce of D D T 2 le nses w he n c o m pare d t o Oas ys  1-Da y , My Da y,
a n d M oist le nses.
E n d p oi nts
Pri mar y  Effecti ve ness

O verall q ualit y of visi o n
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7

Pa ge 3 of 3 8
Safet y

A Es

Bi o micr osc o p y fi n di n gs

De vice deficie ncies
Assess me nts
Effecti ve ness
-
V A ( S nelle n dista nce)
-
O verall q ualit y of visi o n
Safet y
-
A Es
-
Bi o micr osc o p y
-
De vice deficie ncies
St u d y  Desi g n
Pr os pecti ve
Si n gle -mas ke d 
(trial s u bject)
Si n gle -mas ke d (I n vesti gat or)
D o u ble- mas ke d
O pe n -la bel
Ot her
Si n gle gr o u p
Parallel gr o u p
Cr oss o ver
Ot her 
C o ntralateral
Bilateral
M o n oc ular le ns wear
Ra n d o mize d
T his is a 3 -ar m, parallel, cr osso ver gr o u p st u d y  desi g n. I n eac h ar m, t he 
test le ns will be e val uate d c o m pare d t o o ne of 3 c h ose n c o ntr ol le nses.  
A p pr o xi matel y  2 2 s u bjects will be ra n d o mize d t o 1 of t he 6 le ns 
se q ue nces c o nsisti n g of 2 cr oss o ver se q ue nces of test vs . c o ntr ol wit hi n 
eac h of t he 3 parallel gr o u ps .  S u bjects will wear t he assi g ne d st u dy 
Le ns 1 bilaterall y f or a p pr o xi matel y  1 wee k bef ore cr ossi n g o ver i nt o 
t he assi g ne d st u d y Le ns 2 bilaterall y f or a p pr o xi matel y 1 wee k.  T his 
sa me desi g n will be sc he d ule d f or eac h of t he 3 ar ms.
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7

Page 4 of 38
Study Visits:  
1. Baseline/Dispense Lens 1
2. Day 8 (-1/+2 days) follow-up Lens 1/Dispense Lens 2
3. Day 8 (-1/+2 days) follow-up Lens 2/Exit
Test Product Details
Primary component/material
Product Name
DD T2
LID Number
LID 006841
Manufacturer
Alcon
Other 
The lenses will be available in 
-1.00 D to -6.00 D (0.25 D steps)
Control Product 1 
Details
Primary component/material
senofilcon A
Product Name
Oasys 1-Day
LID Number
LID 009601
Manufacturer
Johnson and Johnson Vision
Other
The lenses will be available in 
-1.00 D to -6.00 D (0.25D steps)
Control Product 2
Details
Primary component/material
stenfilcon A
Product Name
MyDay
LID Number
LID 009602
Manufacturer
CooperVision
Other 
The lenses will be available in 
-1.00 D to -6.00 D (0.25 D steps)
Control Product 3
Details
Primary component/material
etafilcon A
Product Name
Moist
LID Number
LID 009603
Manufacturer
Johnson and Johnson Vision
Other 
The lenses will be available in 
-1.00 D to -6.00 D (0.25 D steps)
Inclusion Criteria
1. Subject must be at least 18 years of age. 
2. Subject must be able to understand and must sign an ICF that has 
been approved by an IRB.
3. Successful wear of daily disposable spherical soft contact lenses in 
both eyes for a minimum of 5 days per week and 8 hours per day 
during the past 3 months.
4. Manifest cylinder ≤ 0.75 D in each eye.
5. BCVA 20/25 or better in each eye.
6. Subject must be willing to stop wearing their habitual contact 
lenses for the duration of study participation.  
Exclusion Criteria
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.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
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1.0; CURRENT; Most-Recent; Effective
TDOC-0054506
Protocol - Clinical
02-Nov-2017

Pa ge 5 of 3 8
4.
Oc ular or i ntra oc ular s ur ger y  (e xcl u di n g place me nt of p u nctal 
pl u gs) wit hi n t he pre vi o us 1 2 m o nt hs or pla n ne d d uri n g t he st u d y.
5.
Bi o micr osc o p y fi n di n gs at scree ni n g t hat are m o derate ( Gra de 3) or 
hi g her a n d/ or c or neal vasc ularizati o n t hat is mil d ( Gra de 2) or 
hi g her.
6.
C urre nt or hist or y  of pat h ol o gically dr y e ye i n eit her e ye t hat, i n t he 
o pi ni o n of t he I n vesti gat or, w o ul d precl u de c o ntact le ns wear.
7.
C urre nt or hist or y  of her petic keratitis i n eit her e ye.
8.
E y e i nj ur y i n eit her e ye wit hi n 1 2 wee ks i m me diatel y  pri or t o 
e nr oll me nt f or t his trial.
9.
C urre nt or hist or y  of i nt olera nce, hy perse nsiti vit y , or aller g y  t o a ny 
c o m p o ne nt of t he st u d y pr o d ucts.
1 0.
Weari n g ha bit ual c o ntact le nses i n a n e xte n de d wear m o dalit y 
(r o uti nel y slee pi n g i n le nses f or at least 1 ni g ht per wee k) o ver t he 
last 3 m o nt hs pri or t o e nr oll me nt.
1 1. A n y  use of t o pical oc ular me dicati o ns a n d artificial tear or 
re wetti n g dr o ps t hat w o ul d re q uire i nstillati o n d uri n g c o ntact le ns 
wear.
1 2. T he I n vesti gat or, his/ her staff, fa mil y me m bers of t he I n vesti gat or, 
fa mil y me m bers of t he I n vesti gat or’s staff, or i n di vi d uals li vi n g i n 
t he h o use h ol ds of t he af ore me nti o ne d pers o ns ma y n ot partici pate 
i n t he st u d y. 
1 3. Partici pati o n of t he s u bject i n a cli nical trial wit hi n t he pre vi o us 3 0 
da y s or c urre ntly e nr olle d i n a n y cli nical trial.
1 4. C urre ntl y  weari n g Oasys  1-Da y , My Da y , or M oist c o ntact le nses.
1 5. Ha bit uall y  weari n g m o n o visi o n or m ultif ocal le nses d uri n g t he last 
3 m o nt hs.
Ass ociate d Materials
L u bricati o n/re -wetti n g dr o ps will n ot be per mitte d.
Ta ble 1 – 1 
Sc he d ule of St u d y Pr oce d ur es a n d Assess me nts
Pr oce d ure/ Assess me nt
Visit 1, D a y 1: 
Baseli ne/
Dis pe nse 
Le ns 1
Visit 2, Wee k 1:
Da y  8 of le ns 
wear
(-1/ + 2 da ys) 
F oll o w - u p Le ns 1/
Dis pe nse Le ns 2
Visit 3, Wee k 2:
Da y  8 of le ns 
wear
(-1/ + 2 da ys) 
F oll o w - u p Le ns 2/
E xit
U nsc he d ule d
Visit
I nf or me d C o nse nt

-
-
-
De m o gra p hics

-
-
-
Me dical Hist or y

-
-
-
C o nc o mita nt Me dicati o ns

()
()
()
I ncl usi o n/
E xcl usi o n

-
-
-
Ha bit ual le ns
( bra n d, p o wer)*

-
-
-
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7

Pa ge 6 of 3 8
Pr oce d ure/ Assess me nt
Visit 1, D a y 1: 
Baseli ne/
Dis pe nse 
Le ns 1
Visit 2, Wee k 1:
Da y  8 of le ns 
wear
(-1/ + 2 da ys) 
F oll o w - u p Le ns 1/
Dis pe nse Le ns 2
Visit 3, Wee k 2:
Da y  8 of le ns 
wear
(-1/ + 2 da ys) 
F oll o w - u p Le ns 2/
E xit
U nsc he d ule d
Visit
V A w/ ha bit ual c orrecti o n
(O D, O S, S nelle n
dista nce) *

-

()
Bi o micr osc o p y




Dis pe nse st u d y  le nses


-
-
V A w/ st u d y le nses (O D, 
O S, S nelle n dista nce )



()
S u bjecti ve rati n g wit h 
st u d y le nses: 
•
•
 
•
•
•
o verall q ualit y of visi o n
•
•
-

( F oll o w- u p 
Le ns 1)


A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7

Pa ge 7 of 3 8
Pr oce d ure/ Assess me nt
Visit 1, D a y 1: 
Baseli ne/
Dis pe nse 
Le ns 1
Visit 2, Wee k 1:
Da y  8 of le ns 
wear
(-1/ + 2 da ys) 
F oll o w - u p Le ns 1/
Dis pe nse Le ns 2
Visit 3, Wee k 2:
Da y  8 of le ns 
wear
(-1/ + 2 da ys) 
F oll o w - u p Le ns 2/
E xit
U nsc he d ule d
Visit
A E s 




De vice deficie ncies 




E xit F or m
()
()
()
()
() assess me nt perf or me d as necessar y, e g, decrease of VA b y 2 li nes or m ore wit h i n vesti gati o nal pr o d uct (I P)
* S o urce o nl y
ᵼC o m me nts, o pti o nal
1. 1
A b bre vi ati o ns
Ta ble 1 – 2
Ta ble of A b br e vi ati o ns
A b br e vi ati o n
Defi niti o n
A D E
A d verse de vice ef fect
A S A D E
A ntici pate d seri o us a d verse de vice ef fect
A E
A d verse e ve nt
B C V A
Best c orrecte d vis ual ac uit y
C F R
C o de of Fe deral Re g ulati o ns
D
Di o pter
D D
Dail y  Dis p osa ble
e C R F
Electr o nic case re p ort f or m
E D C
Electr o nic data ca pt ure
F D A
U S F o o d a n d Dr u g A d mi nistrati o n
G C P
G o o d Cli nical Practice
I B
I n vesti gat or’s br oc h ure
I CF
I nf or me d c o nse nt f or m
I P
I n vesti gati o nal pr o d uct
I RB
I nstit uti o nal re vie w b oar d
I S O
I nter nati o nal Or ga nizati o n f or Sta n dar dizati o n
m m
Milli meter
M O P
Ma n ual of pr oce d ures
N/ A
N ot a p plica ble
O D
Ri g ht e y e
O S
Left e y e
O U
B ot h e y es
S A E
Seri o us a d verse e ve nt
S A D E
Seri o us a d verse de vice effect
U S
U nite d States
U S A D E
U na ntici pate d seri o us a d verse de vice ef fect
V A
Vi s ual ac uit y
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7

Page 8 of 38
2
TABLE OF CONTENTS
1
PROTOCOL SYNOPSIS ....................................................................................................2
Clinical Comparison of 4 Daily Disposable Soft Contact Lenses.............................................2
1.1
Abbreviations ......................................................................................................7
2
TABLE OF CONTENTS.....................................................................................................8
List of Tables............................................................................................................................10
List of Figures..........................................................................................................................10
3
INTRODUCTION.............................................................................................................11
3.1
Study Rationale and Purpose.............................................................................11
3.2
Trial Objective...................................................................................................11
3.3
Risks and Benefits.............................................................................................11
3.4
Subject Population.............................................................................................12
3.5
Outline of Study ................................................................................................12
4
TREATMENTS ADMINISTERED...................................................................................12
4.1
Identity of Study Treatments .............................................................................13
4.2
Accountability Procedures.................................................................................14
5
STUDY PROCEDURES AND ASSESSMENTS.............................................................15
5.1
Visits and Examinations ....................................................................................15
5.1.1
Visit 1 (Day 1) – Baseline/Dispense Lens 1......................................15
5.1.2
Visit 2, Week 1 [Day 8 (-1/+2 Days)] – Follow-Up Lens 1/Dispense 
Lens 2 ................................................................................................17
5.1.3
Visit 3, Week 2 [Day 8 (-1/+2 Days)] – Follow-Up Lens 2/Exit.......19
5.2
Unscheduled Visits ............................................................................................21
5.3
Discontinued Subjects .......................................................................................21
5.4
Clinical Study Termination................................................................................22
6
ANALYSIS PLAN ............................................................................................................22
6.1
Subject Evaluability...........................................................................................23
6.2
Analysis Data Sets.............................................................................................23
6.2.1
Safety Analysis Set............................................................................23
6.3
Demographic and Baseline Characteristics.......................................................23
6.4
Effectiveness Analyses ......................................................................................23
6.4.1
Primary Effectiveness........................................................................23
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Effective Date:  
Document:  
Version:  
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TDOC-0054506
Protocol - Clinical
02-Nov-2017

Page 9 of 38
6.4.1.1
Statistical Hypotheses........................................................23
6.4.1.2
Analysis Methods ..............................................................23
6.4.2
Secondary Effectiveness....................................................................24
24
24
24
6.5
Subgroup Analyses ............................................................................................25
6.6
Handling of Missing Data .................................................................................25
6.7
Multiplicity........................................................................................................25
6.8
Safety Analysis ..................................................................................................25
6.9
Interim Analyses................................................................................................26
26
7
ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................26
7.1
General Information ..........................................................................................28
7.2
Monitoring for Adverse Events .........................................................................31
7.3
Procedures for Recording and Reporting ..........................................................31
7.4
Return product analysis .....................................................................................33
7.5
Follow-Up of Subjects with Adverse Events.....................................................33
7.6
Pregnancy in the Clinical Study........................................................................34
8
CONFIDENTIALITY, BIAS, AND MASKING...............................................................34
8.1
Subject Confidentiality and Methods Used to Minimize Bias..........................34
8.2
Unmasking of the Study Treatment...................................................................35
9
DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................35
9.1
Completion of Source Documents and Case Report Forms..............................35
9.2
Data Review and Clarifications.........................................................................36
9.3
Regulatory Documentation and Records Retention ..........................................36
10 ETHICS AND COMPLIANCE.........................................................................................36
10.1
Compliance........................................................................................................37
10.2
Institutional Review Board (IRB) .....................................................................37
11 PROTOCOL AMENDMENT HISTORY..........................................................................38
12 REFERENCES ..................................................................................................................38
12.1
References applicable for all clinical trials .......................................................38
12.1.1
US references applicable for clinical trials........................................38
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TDOC-0054506
Protocol - Clinical
02-Nov-2017

Page 10 of 38
12.2
References for this clinical trial.........................................................................38
List of Tables
Table 1–1
Schedule of Study Procedures and Assessments ...............................................5
Table 1–2
Table of Abbreviations.......................................................................................7
Table 4–1
Description of Test and Control Products........................................................13
Table 7-1
Terms and Definitions......................................................................................26
List of Figures
Figure 7–1
Categorization of All AEs................................................................................28
Figure 7-2
Categorization of All Serious Adverse Events.................................................29
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Effective Date:  
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Version:  
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TDOC-0054506
Protocol - Clinical
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Page 11 of 38
3
INTRODUCTION
3.1
Study Rationale and Purpose
The purpose of this study is to obtain on-eye performance data to inform contact lens product 
development and to further evaluate product performance in the intended population. The 
primary endpoint was selected to fulfil the primary objective of the study. Procedures for 
measurement of these endpoints were selected based on common practice for these 
assessments. The design of this study is justified based upon preclinical and clinical testing, 
as described within the Investigator’s Brochure. Oasys 1-Day, MyDay, and Moist contact 
lenses were chosen as the control products because these lenses have the same wear modality.
The new contact lens in development is intended for the optical correction of refractive 
myopia in persons with non-diseased eyes.
There are no immediate plans to submit the results of this study for publication; however, the 
results may be offered for publication if they are of scientific interest, or if the results relate 
to a product that is subsequently approved or cleared for marketing.
3.2
Trial Objective
The primary objective of this study is to evaluate the overall performance of DD T2 lenses 
when compared to Oasys1-Day, MyDay, and Moist lenses.
3.3
Risks and Benefits
Contact lenses may offer improved peripheral vision and the convenience of not wearing 
spectacles. Material properties and design characteristics of the contact lens in development 
are features consistent with successful contact lens wear.
Based upon non-clinical testing and/or documented rationale for applicability of test results 
to the IP, the new contact lens in development is assessed to be non-toxic and biocompatible 
for on-eye use. 
The new contact lens in development and the 3 control contact lenses are not intended for use 
with a cleaning/disinfecting solution, and the biocompatibility with lens care solutions and 
any associated clinical effects are unknown.
A summary of the known potential risks and benefits associated with the new contact lens in 
development can be found in the Investigator’s Brochure. There may also be unknown risks 
with the use of the new contact lens. Risks are minimized by compliance with the eligibility 
criteria and study procedures, and through close supervision by a licensed clinician during 
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Page 12 of 38
exposure to the study lenses. The potential harms associated with on-eye exposure to the new 
lens materials include toxicity response, blurred vision and ocular discomfort. In general, the 
risks with the new contact lens in development are anticipated to be similar to other marketed 
daily disposable soft contact lenses.
The site personnel will educate subjects on proper hygiene and lens handling, and compliance 
with the use of contact lenses according to the protocol. Subjects should be instructed not to 
wear contact lenses while sleeping or swimming. The site personnel will also advise the 
subjects to remove contact lenses and return for prompt follow-up of symptoms, such as 
ocular discomfort, foreign body sensation, excessive tearing, vision changes, or hyperemia.
3.4
Subject Population
The study population includes approximately 66 volunteer subjects to be enrolled at 
approximately 3 sites, with approximately 22 subjects enrolled per site. The study population 
will consist of subjects with normal eyes (other than the need for optical correction for 
myopia), and who are adapted, existing wearers of daily disposable soft contact lenses in both 
eyes.
Subjects must be screened according to the full list of inclusion/exclusion criteria in Section 1
of this protocol. Rescreening of subjects is not allowed in this study.
3.5
Outline of Study
This will be a multi-site, prospective, randomized, parallel crossover, double-masked study 
comparing 4 contact lenses. The expected duration of subject participation in the study is 
approximately 20 days, with 3 scheduled visits. The study is expected to be completed in 
approximately 7 weeks.
4
TREATMENTS ADMINISTERED
This is a 3-arm, parallel, crossover group study design. In each arm, the test lens will be 
evaluated compared to 1 of 3 chosen control lenses.  Subjects will be randomized to 1 of the 
6 lens sequences, as described below:
Sequence 1: DD T2 →Oasys 1-Day 
Sequence 2: Oasys 1-Day →DD T2 
Sequence 3: DD T2 →MyDay 
Sequence 4: MyDay →DD T2 
Sequence 5: DD T2 →Moist 
Sequence 6: Moist →DD T2
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0054506
Protocol - Clinical
02-Nov-2017

Pa ge 1 3 of 3 8
4. 1
I de ntit y of St u d y Tr e at me nts
Ta ble 4 – 1
Descri pti o n of Te st a n d C o ntrol Pr o d ucts
Te st Le ns
C o ntr ol 1 L e ns
C o ntr ol 2 L e ns
C o ntr ol 3 L e ns
LI D N u m ber
LI D 0 0 6 8 4 1
LI D 0 0 9 6 0 1
LI D 0 0 9 6 0 2
LI D 0 0 9 6 0 3
Le ns
D D T 2
Oas ys  1-Da y
M y D a y
M oist
Material
sen o filc o n A
ste nfilc o n A
etafilc o n A
Wa ter C o nte nt
3 8 %
5 4 %
5 8 %
Base C ur ve
( m m)
8. 3
8. 5
8. 4
8. 5
Dia meter
( m m)
1 4. 2
1 4. 3
1 4. 2
1 4. 2
R x p o wers t o 
be a vaila ble i n 
t his st u d y
-1. 0 0 t o - 6. 0 0 D 
( 0. 2 5 D ste ps)
- 1. 0 0 t o - 6. 0 0 D
( 0. 2 5 ste ps)
-1. 0 0 t o - 6. 0 0 D 
( 0. 2 5 D ste ps)
-1. 0 0 t o - 6. 0 0 D
( 0. 2 5 D ste ps)
Pac ka gi n g, 
La beli n g, a n d 
S u p pl y

Blister f oil
pac k

F oil la bel 
i ncl u des at a 
mi ni m u m:
- material 
na me a n d/ or 
i de ntifier
- base c ur ve
- dia meter
- ma n ufact uri n
g pr ot oc ol 
n u m ber
- pac ki n g 
s ol uti o n
- p o wer
- l ot n u m ber
- e x pirati o n 
date
- c o nte nt 
state me nt
- i n vesti gati o na
l de vice 
state me nt
- S p o ns or 
i nf or mati o n
- c o u ntr y of 
ori gi n

Pr o vi de d i n 
b o xes of 1 2 
le nses per 

Blister f oil 
pac k

F oil la bel 
i ncl u des at a 
mi ni m u m:
- material 
na me 
a n d/ or 
i de ntifier
- base c ur ve
- dia meter
- pac ki n g 
s ol uti o n
- p o wer
- l ot n u m ber
- e x pirati o n 
date
- c o nte nt 
state me nt
- i n vesti gati o
nal de vice 
state me nt
- S p o ns or 
i nf or mati o n
- c o u ntr y of 
ori gi n

Pr o vi de d i n 
b o xes of 1 2 
le nses per 
p o wer per 
b o x,  

Blister f oil 
pac k 

F oil la bel 
i ncl u des at a 
mi ni m u m:
- material 
na me a n d/ or 
i de ntifier
- base c ur ve
- dia meter
- pac ki n g 
s ol uti o n
- p o wer
- l ot n u m ber
- e x pirati o n 
date
- c o nte nt 
state me nt
- i n vesti gati o
nal de vice 
state me nt
- S p o ns or 
i nf or mati o n
- c ou ntr y of 
ori gi n

Pr o vi de d i n 
b o xes of 1 2 
le nses per 
p o wer per 
b o x,  
i de ntifie d wit h 

Blister f oil 
pac k 

F oil la bel 
i ncl u des at a 
mi ni m u m:
- material 
na me a n d/ or 
i de ntifier
- base c ur ve
- dia meter
- pac ki n g 
s ol uti o n
- p o wer
- l ot n u m ber
- e x pirati o n 
date
- c o nte nt 
state me nt
- i n vesti gati o
nal de vice 
state me nt
- S p o ns or 
i nf or mati o n
- c o u ntr y of 
ori gi n

Pr o vi de d i n 
b o xes of 1 2 
le nses per 
p o wer per 
b o x,  
i de ntifie d wit h 
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7

Pa ge 1 4 of 3 8
p o wer per b o x, 
i de ntifie d wit h 
t he f oll o wi n g 
at a mi ni m u m:
- a c ol or c o de d 
la bel stati n g 
t he pr ot oc ol 
n u m ber
- material 
i de ntifier
- p o wer
- a n 
i n vesti gati o na
l use o nl y 
state me nt
- trac ki n g 
n u m ber

Le nses s h o ul d 
be st ore d at 
r o o m 
te m perat ure.
i de ntifie d 
wit h t he 
f oll o wi n g at a 
mi ni m u m:
- a c ol or 
c o de d la bel 
stati n g t he 
pr ot oc ol 
n u m ber
- material 
na me or 
i de ntifier
- p o wer
- a n 
i n vesti gati o
nal use o nl y 
state me nt
- trac ki n g 
n u m ber

Le nses s h o ul d 
be st ore d at 
r o o m 
te m perat ure.
t he f oll o wi n g 
at a mi ni m u m:
- a c ol or 
c o de d la bel 
stati n g t he 
pr ot oc ol 
n u m ber
- material 
na me or 
i de ntifier
- p o wer
- a n 
i n vesti gati o
nal use o nl y 
state me nt
- trac ki n g 
n u m ber

Le nses s h o ul d 
be st ore d at 
r o o m 
te m perat ure.
t he f oll o wi n g 
at a mi ni m u m:
- a c ol or 
c o de d la bel 
stati n g t he 
pr ot oc ol 
n u m ber
- material 
na me or 
i de ntifier
- p o wer
- a n 
i n vesti gati o
nal use o nl y 
state me nt
- trac ki n g 
n u m ber

Le nses s h o ul d 
be st ore d at 
r o o m 
te m perat ure.
Usa ge

Wear: 
o
Dail y  wear 
o
Bilateral, parallel cr oss o ver gr o u p 

Re place me nt peri o d: Dail y  Dis p osa ble

E x p os ure: At least 8 h o urs per da y , at least 5 da ys per wee k o ver t he 
st u d y treat me nt d urati o n.

Le ns Care: N/ A
4. 2
Acc o u nt a bilit y Pr oce d ures
U p o n recei pt of t he st u d y le nses, t he I n vesti gat or or dele gate will c o n d uct a n i n ve nt or y . 
Desi g nate d st u d y staff will pr o vi de t he st u d y le nses t o t he s u bjects i n acc or da nce wit h t heir 
ra n d o mizati o n sc he d ule. T hr o u g h o ut t he st u dy,  t he I n vesti gat or or dele gate m ust mai ntai n 
rec or ds of st u d y treat me nt dis pe nsati o n a n d c ollecti o n f or eac h s u bject. T his rec or d m ust be 
ma de a vaila ble t o t he st u d y  m o nit or f or t he p ur p oses of verif yi n g t he acc o u nti n g of cli nical 
s u p plies. A n y discre pa ncies a n d/ or deficie ncies bet wee n t he o bser ve d dis p ositi o n a n d t he 
writte n acc o u nt m ust be rec or de d al o n g wit h a n e x pla nati o n. 
It is t he I n vesti gat or’s res p o nsi bilit y t o e ns ure t hat:

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7
A ll st u d y pr o d ucts are acc o u nte d f or a n d n ot use d i n a n y u na ut h orize d ma n ner

Pa ge 1 5 of 3 8

All use d f oils a n d u n use d s u p plies are ret ur ne d b y eac h s u bject

All u n use d pr o d ucts are a vaila ble f or ret ur n t o t he St u d y  S p o ns or, as directe d

A n y  st u d y le nses ass ociate d wit h a de vice deficie nc y  or wit h a n y pr o d uct-relate d 
a d verse e ve nt [ie, A D E or S A D E] are ret ur ne d t o t he St u d y  S p ons or f or i n vesti gati o n. 
Refer t o Secti o n 7. 3 of t his pr ot oc ol f or a d diti o nal i nf or mati o n o n t he re p orti n g of 
de vice deficie ncies a n d A Es a n d t he ret ur n of st u d y  pr o d ucts ass ociate d wit h t hese 
e ve nts.
5
S T U D Y  P R O C E D U R E S A N D A S S E S S M E N T S
5. 1
Vi sits a n d E x a mi n ati o ns
5. 1. 1
Vi sit 1 ( D a y 1 ) – B aseli ne/ Dis pe nse Le ns 1
1
E x plai n t he p ur p ose a n d nat ure of t he st u d y, a n d ha ve t he s u bject rea d, si g n, a n d date 
t he IR B -a p pr o ve d i nf or me d c o nse nt d oc u me nt. A d diti o nall y , ha ve t he i n di vi d ual 
o btai ni n g c o nse nt fr o m t he s u bject a n d a wit ness, if a p plica ble, si g n a n d date t he 
i nf or me d c o nse nt d oc u me nt. Pr o vi de a p h ot oc o py of t he si g ne d d oc u me nt t o t he 
s u bject a n d place t he ori gi nal si g ne d d oc u me nt i n t he s u bject’s c hart. After si g ni n g 
t he IC F , a s u bject will be assi g ne d a s u bject n u m ber b y t he E D C s yste m. A si g ne d 
i nf or me d c o nse nt d oc u me nt defi nes t he p oi nt of e nr oll me nt.
2
O btai n de m o gra p hic i nf or mati o n a n d me dical hist or y, i ncl u di n g i nf or mati o n o n all 
me dicati o ns use d wit hi n t he past 3 0 da y s. I ncl u de her bal t hera pies, vita mi ns, a n d all 
o ver -t he-c o u nter as well as prescri pti o n me dicati o ns.
3
4 
Perf or m S nelle n V A wit h ha bit ual c orrecti o n.
O D , O S, dista nce o nl y,  c o ntact le nses
O ver -refracti o n ( o nly nee de d if V A is re d uce d)
Rec or d ha bit ual le ns i nf or mati o n ( bra n d, p o wer).
5
6
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7

Pa ge 1 6 of 3 8
7
Perf or m slit -la m p bi o micr osc o py ( wit h o ut c o ntact le nses) t o e val uate t he f oll o wi n g:

Li m bal h y pere mia

B ul bar h y p ere mia

C or neal stai ni n g

C o nj u ncti val stai ni n g

Pal pe bral c o nj u ncti val o bser vati o ns

C or neal e pit helial e de ma

C or neal str o mal e de ma

C or neal vasc ularizati o n

C o nj u ncti val c o m pressi o n/i n de nti o n

C he m osis

C or neal i nfiltrates

Ot her fi n di n gs
8
 
9
Re vie w i ncl usi o n/ e xcl usi o n criteria t o deter mi ne if t he s u bject q ualifies t o be
ra n d o mize d i nt o t he st u d y. If s u bject q ualifies, re q uest ra n d o mizati o n. If s u bject does 
n ot q ualif y , e xit t he s u bject fr o m t he st u d y as a scree n fail ure.
1 0 
Base d u p o n t he ra n d o mize d treat me nt se q ue nce assi g n me nt, ha ve t he s u bject i nsert 
t he a p pr o priate st u d y le nses.

Kee p all li d di n g f oils of le nses use d d uri n g le ns fit pr ocess f or st u dy le ns 
acc o u nt a bility.

F oll o w pr oce d ures t o m ai nt ai n m aski n g. 
1 1
 
1 2
E val uate t he st u d y le nses b y  perf or mi n g t he f oll o wi n g:

S nelle n V A wit h st u d y  le nses ( O D a n d O S, at dista nce) *

O ver -refracti o n if necessar y t o deter mi ne t he best c o ntact le ns-c orrecte d V A 
a n d fi nal st u d y le ns p o wer(s)
* V A w/st u dy le nses m ust be 2 0/ 4 0 O U or better f or s u bject t o le av e t he office
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7

Pa ge 1 7 of 3 8
1 3
1 4
Assess a n d rec or d a n y A Es a n d de vice deficie ncies re p orte d or o bser ve d d uri n g t he 
st u d y visit.
N ote: A Es a n d device deficie ncies m ust be rec or de d f or all e nr olle d s u bjects fr o m t he ti me of 
si g n at ure of i nf or me d c o nse nt i ncl u di n g t h ose t h at scree n f ail.
1 5
Dis pe nse st u d y  le nses ( Le ns 1). Pr o vi de t he s u bject wit h writte n a n d ver bal
i nstr ucti o ns o n le ns wear.
1 6 
Sc he d ule Visit 2 t o ta ke place o n D a y  8 (-1/ + 2 da y s) of le ns wear ( Le ns 1).
1 7
N ote: If f or s o me re as o n a s u bject is u n a ble t o we ar a st u dy le ns f or t he d ur ati o n of t his visit 
wi n d o w , i nstr uct t he s u bject t o ret ur n t o t he site f or a n U nsc he d ule d Visit as well as le ns 
re m ov al o n site, if p ossi ble. T he s u bject s h o ul d t he n be sc he d ule d t o ret ur n t o t he cli nic f or 
Visit 2 (if p ossi ble) or exite d fr o m t he st u dy.
5. 1. 2
Vi sit 2, We e k 1 [D a y 8 (-1/ + 2 D a ys) ] – F oll o w -U p Le ns 1/ Dis pe nse 
Le ns 2
1
O btai n i nf or mati o n o n a n y  c ha n ges i n me dical healt h a n d/ or t he use of c o nc o mita nt 
me dicati o ns.
2
Rec or d a n y de vice deficie ncies or A Es i ncl u di n g t h ose ass ociate d wit h c ha n ges i n 
c o nc o mita nt me dicati o n d os i n g, w hic h are o bser ve d or re p orte d si nce t he pre vi o us 
visit (s).
3
Re vie w s u bject c o m plia nce wit h le ns wear a n d a dj u nct pr o d uct usa ge . 
4
A d mi nister S u bjecti ve Q uesti o n naire t o assess: 





S u bjecti ve o verall q ualit y  of visi o n, O U


A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7

Pa ge 1 8 of 3 8
5
E val uate t he st u d y le nses b y perf or mi n g t he f oll o wi n g:

S nelle n V A wit h st u d y le nses ( O D a n d O S, at dista nce)
6
7
Perf or m slit -la m p bi o micr osc o py ( wit h o ut c o ntact le nses) t o e val uate t he f oll o wi n g:

Li m bal h y pere mia

B ul bar h y p ere mia

C or neal stai ni n g

C o nj u ncti val stai ni n g

Pal pe bral c o nj u ncti val o bser vati o ns

C or neal e pit helial e de ma

C or neal str o mal e de ma

C or neal vasc ularizati o n

C o nj u ncti val c o m pressi o n /i n de nti o n

C he m osis

C or neal i nfiltrates

Ot her fi n di n gs
8
Base d u p o n t he ra n d o mize d treat me nt se q ue nce assi g n me nt, ha ve t he s u bject i nsert 
t he Le ns 2 st u d y le nses t o be e val uate d.
N ote: Kee p all li d di n g f oils of le nses use d d uri n g le ns fit pr ocess f or st u dy le ns 
acc o u nt a bility.
9
 
1 0
E val uate t he st u d y le nses b y perf or mi n g t he f oll o wi n g:

S nelle n V A wit h st u d y  le nses ( O D a n d O S, at dista nce) *

O ver -refracti o n if necessar y t o deter mi ne t he best c o ntact le ns-c orrecte d V A
a n d fi nal st u d y le ns p o wer(s)
* V A w/st u dy le nses m ust be 2 0/ 4 0 O U or better f or s u bject t o le ave t he office
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7

Pa ge 1 9 of 3 8
1 1
1 2
Assess a n d rec or d a n y A Es a n d de vice deficie ncies re p orte d or o bser ve d d uri n g t he 
st u d y visit.
N ote: A Es a n d device deficie ncies m ust be r ec orde d f or all e nr olle d s u bjects fr o m 
t he ti me of si g n at ure of i nf or me d c o nse nt re g ardless of t heir e nr oll me nt st at us
(scree n f ail ure or r a n d o mize d).
1 3
Dis pe nse st u d y  le nses ( Le ns 2). Pr o vi de t he s u bject wit h writte n a n d ver bal
i nstr ucti o ns o n le ns wear.
1 4 
Sc he d ule Visit 3 t o ta ke place D a y  8 (-1/ + 2 da y s) of le ns wear ( Le ns 2).
1 5
N ote: If f or s o me re as o n a s u bject is u n a ble t o we ar a st u dy le ns f or t he d ur ati o n of t his 
visit wi n d o w, i nstr uct t he s u bject t o ret ur n t o t he site f or a n U nsc he d ule d Visit as well as 
le ns re m ov al o n site, if p ossi ble. T he s u bject s h o ul d t he n be sc he d ule d t o ret ur n t o t he cli nic 
f or Visit 3 (if p ossi ble) or exite d fr o m t he st u dy.
5. 1. 3
Vi sit 3, We e k 2 [D a y 8 (-1/ + 2 D a ys) ] – F oll o w -U p Le ns 2/ E xit 
1
O btai n i nf or mati o n o n a n y  c ha n ges i n me dical healt h a n d/ or t he use of c o nc o mita nt 
me dicati o ns.
2
Rec or d a n y de vice deficie ncies or A Es i ncl u di n g t h ose ass ociate d wit h c ha n ges i n 
c o nc o mita nt me dicati o n d osi n g, w hic h are o bser ve d or re p orte d si nce t he pre vi o us 
visit (s).
3
Re vie w s u bject c o m plia nce wit h le ns wear a n d a dj u nct pr o d uct usa ge. 
4  
A d mi nister S u bjecti ve Q uesti o n naire t o assess: 





S u bjecti ve o verall q ualit y  of visi o n, O U



A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7

Pa ge 2 0 of 3 8
5
E val uate t he st u d y le nses b y perf or mi n g t he f oll o wi n g:

S nelle n V A wit h st u d y  le nses ( O D a n d O S, at dista nce)
6
7
Perf or m slit -la m p bi o micr osc o py ( wit h o ut c o ntact le nses) t o e val uate t he f oll o wi n g:

Li m bal h y pere mia

B ul bar h y p ere mia

C or neal stai ni n g

C o nj u ncti val stai ni n g

Pal pe bral c o nj u ncti val o bser vati o ns

C or neal e pit helial e de ma

C or neal str o mal e de ma

C or neal vasc ularizati o n

C o nj u ncti val c o m pressi o n/i n de nti o n

C he m osis

C or neal i nfiltrates

Ot her fi n di n gs
8
Assess a n d rec or d a n y A Es a n d de vice deficie ncies re p orte d or o bser ve d d uri n g t he 
st u d y visit.
N ote: A Es a n d de vice deficie ncies m ust be rec or de d f or all e nr olle d s u bjects fr o m 
t he ti me of si g nat ure of i nf or me d c o nse nt re gar dless of t heir e nr oll me nt stat us 
(scree n fail ure or ra n d o mize d).
9
Perf or m S nelle n V A wit h ha bit ual c orrecti o n.

O D, O S, dista nce o nl y, c o ntact le nses
N ote: If t his V A wit h h a bit u al c orr ecti o n s h o ws a decre ase of 2 li nes or m ore vers us
Vi sit 1 b aseli ne VA wit h h a bit u al c orr ecti o n, t he n B C VA wit h M R is r e q uire d t o 
c o nfir m a p ote nti al l os s i n VA f or A E r e p orti n g re q uire me nts (see Secti o n 7 ).
1 0
E xit t he s u bject fr o m t he st u d y .
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7

Pa ge 2 1 of 3 8
5. 2
U nsc he d ule d Vi sits
A n y  visit t hat occ urs bet wee n re g ularly sc he d ule d visits is a n U nsc he d ule d V isit. If a s u bject 
re q uires a n U nsc he d ule d Visit, he/s he m ust be a d vise d t o ret ur n t o t he office weari n g t he 
st u d y le nses, if at all p ossi ble ( u nless he/s he is e x perie nci n g a si g n or s y m pt o m [as i n dicate d 
i n Secti o n 3. 3 Ris ks a n d Be nefits]). D uri n g all u nsc he d ule d visits, t he I n vesti gat or m ust 
c o n d uct t he f oll o wi n g pr oce d ures: 

C ollect A E a n d d e vice d eficie nc y i nf or mati o n

Assess a n d rec or d c ha n ges i n me dical c o n diti o n or c o nc o mita nt me dicati o n 

Assess a n d rec or d V As

Perf or m bi o micr osc o p y (assess me nts wit h or wit h o ut le nses, as p ossi ble)
I n a d diti o n, all pr oce d ures f or Visit 3 ( F oll o w-u p Le ns 2 / E xit) s h o ul d be c o m plete d (as 
p ossi ble). T he I n vesti gat or ma y perf or m a d diti o nal pr oce d ures f or pr o per dia g n osis a n d 
treat me nt of t he s u bject. T he I n vesti gat or m ust d oc u me nt t his i nf or mati o n i n t he s u bject’ s 
case hist or y s o urce d oc u me nts.
If d uri n g a n U nsc he d ule d Visit t he s u bject is disc o nti n ui n g t he st u d y le nses or disc o nti n ui n g 
fr o m t he st u d y, t he I n vesti gat or m ust c o n d uct E xit pr oce d ures acc or di n g t o Ta ble 1 -1:
Sc he d ule of St u d y  Pr oce d ures a n d Assess me nts , as p ossi ble.
5. 3
Disc o nti n ue d S u bjects
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7
Disc o nti n ue d s u bjects are t h ose w h o wit h dra w or are wit h dra w n fr o m t he st u d y  after si g ni n g 
t he i nf or me d c o nse nt, i ncl u di n g scree n fail ures. S u bjects ma y  disc o nti n ue fr o m t he st u d y at 
a n y ti me f or a n y reas o n. S u bjects ma y als o be disc o nti n ue d fr o m t he st u d y at a n y ti me if, i n 
t he o pi ni o n of t he I n vesti gat or, t heir c o nti n ue d partici pati o n p oses a ris k t o t heir healt h. 
Disc o nti n ue d s u bjects will n ot be re place d (ie, t heir s u bject n u m bers will n ot be 
re-assi g ne d/re -use d).
S h o ul d a s u bject e x hi bit a n y  cli nicall y rele va nt si g ns, sy m pt o ms, or ot her cli nical 
o bser vati o ns t hat p ossi bl y  c o ul d be ass ociate d wit h s us pecte d se nsiti vit y or i nt olera nce t o o ne 
of t he st u d y  treat me nts, t he I n vesti gat or m ust d oc u me nt t h ose o bser vati o ns o n a n A E F or m.
A n y  s u bject w h o e xits earl y fr o m t he st u d y (e xcl u di n g scree n fail ures) m ust u n der g o all 
pr oce d ures o utli ne d at Visit 3 , as a p plica ble .

Pa ge 2 2 of 3 8
T he I n vesti gat or m ust d oc u me nt t he reas o n f or st u d y  or treat me nt disc o nti n uati o n i n t he 
s u bject’s case hist or y s o urce d oc u me nts.
T o e ns ure t he safet y of all s u bjects w h o disc o nti n ue earl y,  In vesti gat ors m ust assess eac h 
s u bject a n d, if necessary,  a d vise t he m of a ny t hera pies a n d/ or me dical pr oce d ures t hat m a y be 
nee de d t o mai ntai n t heir healt h.
5. 4
Cli nic al St u d y Te r mi n ati o n
T he St u d y  S p o ns or reser ves t he ri g ht t o cl ose t he i n vesti gati o nal site or ter mi nate t he st u d y i n 
its e ntiret y at a n y ti me, f or reas o na ble ca use.
If t he cli nical st u dy is pre mat urel y ter mi nate d or s us pe n de d b y  t he St u d y S p o ns or:

T he St u d y  S p o ns or m ust :
o
Im me diatel y  n otif y t he I n vesti gat or(s) a n d s u bse q ue ntl y pr o vi de i nstr ucti o ns f or 
st u d y ter mi nati o n.
o
Inf or m t he I n vesti gat or a n d t he re g ulat or y a ut h orities of t he 
ter mi nati o n/s us pe nsi o n a n d t he reas o n(s) f or t he ter mi nati o n/s us pe nsi o n, as 
a p plica ble.

T he I n vesti gat or m ust:
o
P r o m ptl y n otif y t he I RB of t he ter mi nati o n or s us pe nsi o n a n d of t he reas o ns. 
o
Pr o vi de s u bjects wit h rec o m me n dati o ns f or p ost -st u d y treat me nt o pti o ns as 
nee de d.
T he I n vesti gat or ma y  ter mi nate a site’s partici pati o n i n t he st u d y f or reas o na ble ca use.
6
A N A L Y SI S P L A N
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7
C o nti n u o us varia bles will be s u m marize d usi n g t he n u m ber of o bser vati o ns, mea n, sta n dar d 
de viati o n , me dia n, mi ni m u m, a n d ma xi m u m. Cate g orical varia bles will be s u m marize d wit h 
c o u nts a n d perce nta ges fr o m eac h cate g or y. A n y de viati o ns t o t his a nal y sis pla n will be 
u p date d d uri n g t he c o urse of t he st u d y as part of a pr ot oc ol a me n d me nt or will be detaile d i n 
t he cli nical st u d y re p ort.

Page 23 of 38
6.1
Subject Evaluability
The final subject evaluability will be determined prior to breaking the code for masked 
treatment sequence assignment and locking the database, based on the Deviations and 
Evaluability Plan.
6.2
Analysis Data Sets
6.2.1
Safety Analysis Set
Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. 
As such, the safety analysis set will include all subjects/eyes exposed to any study lenses
evaluated in this study. For treatment-emergent safety analyses, subjects/eyes will be 
categorized under the actual study lenses exposed. 
6.3
Demographic and Baseline Characteristics
Demographic information (age, sex, ethnicity, race) will be summarized on the Safety 
Analysis Set Baseline data pertaining to habitual lens 
 
 will be summarized on the Safety Analysis Set as well.
6.4
Effectiveness Analyses
This study defines one primary endpoint 
 Data for DD T2 
will be summarized according to the crossover control worn per each parallel group. The 
Safety Analysis Set will serve as the primary set for all effectiveness analyses.
6.4.1
Primary Effectiveness
The primary objective of this study is to evaluate the overall performance of DD T2 lenses 
when compared to Oasys 1-Day, MyDay and 1-Day Acuvue Moist. The primary endpoint is 
the subjective rating on overall quality of vision, collected binocularly on a scale of 1 (Poor) 
to 10 (Excellent).
6.4.1.1
Statistical Hypotheses
No inferences are to be made on the primary effectiveness endpoint/s, therefore no 
hypotheses are formulated.
6.4.1.2
Analysis Methods
Descriptive statistics will be provided. 
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Page 24 of 38
6.4.2
Secondary Effectiveness
No secondary objective or endpoint is defined for this study.
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Page 25 of 38
6.5
Subgroup Analyses
It is not expected that demographic or baseline characteristics will have an impact on the 
study results in this study. No subgroup analyses are planned.
6.6
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 analysis.
6.7
Multiplicity
No multiplicity adjustment needs to be considered for the effectiveness endpoints since no 
formal hypothesis testing will be conducted.
6.8
Safety Analysis
The safety endpoints for this study are AEs, biomicroscopy findings, and device deficiencies. 
Data for DD T2 will be summarized according to the crossover control worn per each parallel 
group.
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 study lenses. 
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 (Visit 1) to any subsequent visit will be presented. A supportive listing will be 
generated which will include all biomicroscopy data from all visits for these eyes 
experiencing the increase.
Two listings (prior to exposure of study lenses and treatment-emergent) of device 
deficiencies, as recorded on the Device Deficiency Form, will be provided. Additionally, each 
device deficiency category will be tabulated. 
No inferential testing will be done for safety analysis. 
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Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
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1.0; CURRENT; Most-Recent; Effective
TDOC-0054506
Protocol - Clinical
02-Nov-2017

Page 26 of 38
6.9
Interim Analyses
There are no plans to conduct an interim analysis and no criteria by which the study would be 
terminated early based upon statistical determination. 
7
ADVERSE EVENTS AND DEVICE DEFICIENCIES
Table 7-1
Terms and Definitions
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.
Adverse device effect 
(ADE)
AE related to the use of an investigational medical device (test 
product) or control product. 
Note: This definition includes AEs 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.
Anticipated serious 
adverse device effect 
(ASADE)
Serious ADE 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.
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 
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Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
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1.0; CURRENT; Most-Recent; Effective
TDOC-0054506
Protocol - Clinical
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Pa ge 2 7 of 3 8
de vice is la bele d or mar kete d.
N o n -seri o us ad verse 
eve nt
A E t hat d oes n ot meet t he criteria f or a n S A E.
Seri o us ad verse eve nt 
( S A E)
A E t hat le d t o a n y of t he f oll o wi n g:

Deat h.

A seri o us deteri orati o n i n t he healt h of t he s u bject t hat eit her 
res ulte d i n:
a)
a life-t hreate ni n g ill ness or i nj ur y.
N ote: Life -t hre ate ni n g me a ns t h at t he i n divi d u al w as at 
i m me di ate risk of de at h fro m t he eve nt as it occ urr e d, ie, it 
d oes n ot i ncl u de a n eve nt w hic h hy p ot hetic ally mi g ht h ave 
c a use d de at h h a d it occ urre d i n a m ore severe f or m.
b)
a n y p ote ntiall y si g ht-t hreate ni n g e ve nt or per ma ne nt 
i m pair me nt t o a b o d y str uct ure or a b o d y f u ncti o n.
c)
i n-patie nt h os pitalizati o n or pr ol o n ge d h os pitalizati o n.
N ote: Pl a n ne d h os pit aliz ati o n f or a pr e-existi n g c o n diti o n, 
wit h o ut seri o us deteri or ati o n i n he alt h, is n ot c o nsi der e d 
a n S A E. I n ge ner al, h os pit aliz ati o n si g nifies t h at t he 
i n divi d u al re m ai ne d at t he h os pit al or e merge ncy w ar d f or 
o bserv ati o n a n d/ or tr e at me nt ( us u ally i nv olvi n g a n 
over ni g ht st ay) t h at w o ul d n ot h ave bee n a p pr o pri ate i n t he 
p hysici a n's office or a n o ut - p atie nt setti n g. C o m plic ati o ns 
t h at occ ur d uri n g h os pit aliz ati o n are a dverse eve nts. If a 
c o m plic ati o n prol o n gs h os pit aliz ati o n or f ulfills a ny ot her 
seri o us criteri a, t he eve nt is seri o us. Whe n i n d o u bt as t o 
w het her “ h os pit al iz ati o n ” occ urre d, t he eve nt s h o ul d be 
c o nsi dere d seri o us.
d)
a me dical or s ur gical i nter ve nti o n t o pre ve nt a) or b). 
e)
a n y i n direct har m as a c o nse q ue nce of i nc orrect dia g n ostic 
test res ults w he n use d wit hi n ma n ufact urer’s i nstr ucti o ns 
f or use.

Fetal distress , fetal deat h, or a c o n ge nital a b n or malit y or birt h 
defect.
Refer t o Secti o n 7. 1 f or a d diti o n al S A Es.
Seri o us ad verse 
d e vice effect ( S A D E)
A D E t hat has res ulte d i n a n y  of t he c o nse q ue nces c haracteristic of 
a n S A E.
Si g nifica nt n o n-
A si g nifica nt n o n-seri o us A E is a sy m pt o matic, de vice -relate d, 
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7

Page 28 of 38
serious adverse event
non-sight threatening AE that warrants discontinuation of any 
contact lens wear for greater than or equal to 2 weeks.
Refer to Section 7.1 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.
7.1
General Information
An AE is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, 
whether or not related to the investigational medical device (test article).
Figure 7–1
Categorization of All AEs
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Pa ge 2 9 of 3 8
Fi g ur e 7- 2
C ate g oriz ati o n of All Seri o us A d verse E ve nts
Seri o us A dverse Eve nts 
I n a d diti o n t o re p orti n g all A Es (seri o us a n d n o n -seri o us) meeti n g t he defi niti o ns, t he 
I n vesti gat or m ust re p ort a n y occ urre nce of t he f oll o wi n g as a n S A E:

A n oc ular i nfecti o n i ncl u di n g a p res u me d i nfecti o us ulcer wit h a ny of t he f oll o wi n g 
c haracteristics: 
o
Ce ntral or parace ntral l ocati o n
o
Pe netrati o n of B o w ma n’ s me m bra ne
o
I nfiltrates > 2 m m dia meter
o
Iritis
o
I ncrease i n i ntra oc ular press ure
o
C ult ure p ositi ve f or micr o or ga nis ms
o
I ncreasi n g size or se verit y at s u bse q ue nt visits

A n y  ce ntral or parace ntral c or neal e ve nt (s uc h as ne o vasc ularizati o n) t hat res ults i n 
per ma ne nt o pacificati o n

H y p o p y o n

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7
H y p he ma

Pa ge 3 0 of 3 8

Ne o vasc ularizati o n wit hi n t he ce ntral 6 m m of t he c or nea

Per ma ne nt visi o n l oss as defi ne d b y l oss of 2 or m ore li nes of B C VA fr o m e nr oll me nt 
visit t hat fails t o res ol ve

U veitis (a nteri or , i nter me diate, or p osteri or)

C or neal a brasi o n affecti n g ≥ 5 0 % of c or neal s urface area
Si g nific a nt N o n -Seri o us A dverse Eve nts
A si g nifica nt n o n-seri o us A E is a sy m pt o ma tic, de vice-relate d, n o n-si g ht t hreate ni n g A E t hat 
warra nts disc o nti n uati o n of a n y c o ntact le ns wear f or greater t ha n or e q ual t o 2 wee ks. I n 
a d diti o n, t he In vesti gat or m ust re p ort a n y  occ urre nce of t he f oll o wi n g as a Si g nifica nt 
N o n - Seri o us A E:

Peri p heral n o n- pr o gressi ve n o n- i nfecti o us ulcers

All s y m pt o matic c or neal i nfiltrati ve e ve nts

C or neal stai ni n g sc ore greater t ha n or e q ual t o Gra de 3 ( Refer t o M O P f or gra di n g 
scales) [ Gra di n g scale is base d o n I S O 1 1 9 8 0: 2 0 1 2 u nless s pecifie d differe ntl y i n 
M O P]

Te m p orar y  visi o n l oss as defi ne d b y l oss of 2 or m ore li nes of B C VA fr o m e nr oll me nt 
visit t hat persists f or 2 or m ore wee ks

Ne o vasc ularizati o n sc ore greater t ha n or e q ual t o Gra de 2 
T he a b ove eve nts ar e b ase d u p o n t he c ate g ories provi de d i n t he I S O 11 9 8 0 : 2 0 1 2 a n d t he U S 
F D A Pr e m arket N otific ati o n ( 5 1 0(k)) G ui d a nce D oc u me nt f or D aily We ar C o nt act Le nses 
a n d C o nt act Le ns C ar e Pro d ucts. 
Device Deficie ncies
A de vice deficie nc y  is i na de q uac y of a me dical de vice wit h res pect t o its i de ntit y, q ualit y, 
d ura bilit y, relia bilit y, safet y, or perf or ma nce. A de vice deficie nc y  ma y or ma y n ot be 
ass ociate d wit h patie nt har m (ie, A D E or S A D E); h o we ver , n ot all A D Es or S A D Es are d ue 
t o a de vice deficie nc y. T he I n vesti gat or s h o ul d deter mi ne t he a p plica ble cate g or y liste d i n t he 
De vice Deficie nc y  e C R F f or t he i de ntifie d or s us pect de vice deficie nc y a n d re p ort a ny patie nt 
har m se paratel y. E xa m ples of de vice deficie ncies i ncl u de t he f oll o wi n g: 

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7
Fail ure t o meet pr o d uct s pecificati o ns (e g, i nc orrect le ns p o wer/ dia meter/ base 
c ur ve/c ol or)

Pa ge 3 1 of 3 8

Le ns cl o u d y

Le ns s urface/e d ge defect 

To r n le ns d uri n g ha n dli n g/i n pac k

Pac ka gi n g deficit (e g, misla bele d pr o d uct, ta m pere d seal, lea ki n g b ottle/c o ntai ner)

S us pect pr o d uct c o nta mi nati o n

Lac k of perf or ma nce
7. 2
M o nit ori n g f or A d verse E ve nts
At eac h visit, after t he s u bject has ha d t he o p p ort u nit y  t o s p o nta ne o usly me nti o n a n y 
pr o ble ms, t he I n vesti gat or s h o ul d i n q uire a b o ut A Es b y  as ki n g t he sta n dar d q uesti o ns:

“ Ha ve y o u ha d a n y healt h pr o ble ms si nce y o ur last st u d y  visit?”

“ Ha ve t here bee n a n y c ha n ges i n t he me dici nes y o u ta ke si nce y o ur last st u d y  visit?”
A d diti o nall y , c ha n ges i n a ny pr ot oc ol -s pecific p ar a meters a n d/ or q uesti o n n aires e val uate d 
d uri n g t he st u d y are t o be re vie we d b y t he I n vesti gat or. A n y u nt o war d ( u nfa v ora ble a n d 
u ni nte n de d) c ha n ge i n a pr ot o c ol-s pecific p ar a meter or q uesti o n n aire res p o nse t hat is 
cli nicall y rele va nt, i n t he o pi ni o n of t he In vesti gat or , is t o be re p orte d as a n A E. T hese 
cli nicall y rele va nt c ha n ges will be re p orte d re gar dless of ca usalit y. 
7. 3
Pr oce d ures f or Rec or di n g a n d Re p orti n g
A Es are c ollecte d fr o m t he ti me of i nf or me d c o nse nt. A n y pre -e xisti n g me dical c o n diti o ns or 
si g ns/s ym pt o ms prese nt i n a s u bject pri or t o t he start of t he st u d y  (ie, bef ore i nf or me d 
c o nse nt is si g ne d) are n ot c o nsi dere d A Es i n t he st u d y  a n d s h o ul d be rec or de d i n t he Me dical 
Hist or y  secti o n of t he e C R F.
I n a d diti o n, te m p orar y le ns a ware ness or vis ual c ha n ges d uri n g t he fitti n g pr ocess are n ot 
c o nsi dere d A Es if t he I n vesti gat or assesses t hat t he s y m pt o m(s) ca n reas o na bl y  res ol ve wit hi n 
t he a ntici pate d a da ptati o n peri o d. 

A D Es or S A Es are d oc u me nte d o n t he Seri o us A dverse Eve nt a n d A dverse Device 
Effect e C R F wit hi n 2 4 h o urs of t he I n vesti gat or ’s or site’s a ware ness. 

De vice deficie ncies are d oc u me nte d o n t he Device Deficie ncy 
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7
e C R F wit hi n 2 4 h o urs 
of t he I n vest i gat or ’s or site’s a ware ness. 

Pa ge 3 2 of 3 8

A pri nte d c o p y of t he c o m plete d Seri o us A dverse Eve nt a n d A dverse Device Effect 
a n d/ or Device Deficie ncy e C R F m ust be i ncl u de d wit h pr o d uct ret ur ns.

A d diti o nal rele va nt i nf or mati o n after i nitial re p orti n g m ust be e ntere d i nt o t he e C R F as 
s o o n as t he data bec o me a vaila ble.

D oc u me nt a n y c ha n ges t o c o nc o mita nt me dicati o ns o n t he a p pr o priate e C R Fs.

D oc u me nt all rele va nt i nf or mati o n fr o m Disc har ge S u m mar y , A ut o ps y  Re p ort,

Certificate of Deat h, etc, if a p plica ble, i n narrati ve sect i o n of t he Seri o us A dverse 
Eve nt a n d A dverse Device Effect e C R F.
N ote: S h o ul d t he E D C s yste m bec o me n o n -o perati o nal, t he site m ust c o m plete t he 
a p pr o priate pa per Seri o us A dverse Eve nt a n d A dverse Device Effect a n d/ or Device Deficie ncy
F or m. T he c o m plete d f or m is e maile d t o t he St u d y  S p o ns or at 
 
acc or di n g t o t he ti meli nes o utli ne d a b o ve; h o we ver, t he re p orte d i nf or mati o n m ust be e ntere d 
i nt o t he E D C s yste m o nce it bec o mes o perati o nal.
A n y  A Es a n d de vice deficie ncies f or n o n-st u d y mar kete d de vices/ pr o d ucts will be c o nsi dere d 
a n d pr ocesse d as s p o nta ne o us (f oll o wi n g t he p ost mar ket vi gila nce pr oce d ures) a n d s h o ul d be 
c o m m u nicate d t o t he de vice’s/ pr o d uct’s ma n ufact urer as per l ocal re q uire me nts.
St u d y  S p o ns or re prese ntatives ma y  be c o ntacte d f or a n y pr ot oc ol relate d q uesti o n a n d t heir
c o ntact i nf or mati o n is pr o vi de d i n t he M O P t hat acc o m pa nies t his pr ot oc ol .
F urt her , de pe n di n g u p o n t he nat ure of t he A E or de vice deficie nc y  bei n g re p orte d, t he St u d y 
S p o ns or ma y  re q uest c o pies of a p plica ble p orti o ns of t he s u bject’s me dical rec or ds. T he 
I n vesti gat or m ust als o re p ort all A Es a n d de vice deficie ncies t hat c o ul d ha ve le d t o a S A D E 
acc or di n g t o t he re q uire me nts of re g ulat or y  a ut h orities or IR B/I E C.
I nte nsit y a n d C a us alit y Assess me nts
W here a p pr o priate, t he I n vesti gat or m ust assess t he i nte nsit y  (se verity) of t he A E base d u p o n 
me dical j u d g me nt wit h c o nsi derati o n of a n y s u bjecti ve s y m pt o m(s), as defi ne d bel o w:
I nte nsity ( Severity)
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7
Mil d
A n A E is mil d if t he s u bject is a ware of b ut ca n easil y t olerate t he si g n or 
s ym pt o m.
M o derate  
A n A E is m o derate if t he si g n or s y m pt o m res ults i n disc o mf ort si g nifica nt 
e n o u g h t o ca use i nterfere nce wit h t he s u bject’s us ual acti vities.

Page 33 of 38
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 
are upgraded from non-serious to serious or from unrelated to related.
7.4
Return product analysis
Alcon products associated with device deficiencies and/or product related AEs should be 
returned and must include the Complaint # which will be provided by Study Sponsor after the 
case is entered in the Study Sponsor’s Global Product Complaint Management System. These 
products should be returned to the Sponsor at the end of the study, unless instructed otherwise 
by the Sponsor. 
7.5
Follow-Up of Subjects with Adverse Events
The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study. 
The Investigator should provide the Study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (ie, database lock).
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Any additional data received up to 1 month after subject discontinuation or exit must be 
documented and available upon the Study Sponsor’s request. All complaints received after
this time period will be considered and processed as spontaneous and should be 
communicated to the medical device’s manufacturer as per local requirements.
The Investigator should also report complaints on non-Alcon products directly to the 
manufacturer as per the manufacturer’s instructions or local regulatory requirements.
7.6
Pregnancy in the Clinical Study
Women of childbearing potential or women who are pregnant at the time of study entry are 
not excluded from participation. Pregnancy should be included in the Medical History section 
of the eCRF when a pregnant woman enters the study or if a woman becomes pregnant 
during the study. Pregnancy is not reportable as an AE; however, complications may be 
reportable and will be decided on a case–by-case basis.
8
CONFIDENTIALITY, BIAS, AND MASKING
8.1
Subject Confidentiality and Methods Used to Minimize Bias
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 Sponsor will collect a copy of the 
enrollment log without any identifying subject information. All documents submitted to the 
Sponsor will identify the subjects exclusively by number and demographic information. No 
other personally identifying information should be transmitted to the Sponsor.
This study is double-masked with subjects randomized to use both DD T2 and the assigned 
control product (in a randomized sequence) for the duration of the treatment period. The 
Investigator and Sponsor personnel (other than site monitors, lead clinical site manager, 
person responsible for generating the randomization schedule, and unmasked clinical data 
managers) involved in reporting, obtaining, and/or reviewing the clinical evaluations will be 
masked to the identity of the contact lens being administered. 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 trial.
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Pa ge 3 5 of 3 8
8. 2
U n m as k i n g of t he St ud y Tr e at me nt
Mas ke d i nf or mati o n o n t he i de ntit y  of t he assi g ne d me dical de vice s h o ul d n ot be discl ose d 
d uri n g t he st u d y. If t he treat me nt c o de nee ds t o be br o ke n i n t he i nterest of s u bject safet y, t he 
I n vesti gat or is e nc o ura ge d t o c o ntact a n a p pr o priate Stu d y  S p o ns or re prese ntati ve pri or t o 
u n mas ki n g t he i nf or mati o n if t here is s ufficie nt ti me. De pe n de nt u p o n t he i n di vi d ual 
circ u msta nces (ie, me dical e mer ge nc y ), t he c o de ma y be br o ke n pri or t o c o ntact wit h t he 
St u d y  S p o ns or. T he St u d y S p o ns or m ust be i nf or me d of all cases i n w hic h t he c o de was 
br o ke n a n d of t he circ u msta nces i n v ol ve d. A d diti o nall y , t he St u d y S p o ns or ma y be re q uire d 
t o u n mas k t he i nf or mati o n i n or der t o f ulfill e x pe dite d re g ulat or y re p orti n g re q uire me nts.
9
D A T A  H A N D LI N G A N D A D MI NI S T R A TI V E R E Q U I R E M E N T S
9. 1
C o m pleti o n of S o ur ce D oc u me nts a n d C ase Re p ort F or ms
T he nat ure a n d l ocati o n of all s o urce d oc u me nts will be i de ntifie d t o e ns ure t hat ori gi nal data 
re q uire d t o c o m plete t he e C R Fs e xist a n d are accessi ble f or verificati o n b y t he site m o nit or, 
a n d all discre pa ncies s hall be a p pr o priatel y  d oc u me nte d via t he q uer y res ol uti o n pr ocess. 
St u d y  m o nit ors are a p p oi nte d b y t he St u d y S p o ns or a n d are i n de pe n de nt of st u d y site staff. If 
electr o nic rec or ds are mai ntai ne d, t he met h o d of verificati o n m ust be deter m i ne d i n a d va nce 
of starti n g t he st u d y.  
At a mi ni m u m, s o urce d oc u me nts s h o ul d i ncl u de t he f oll o wi n g i nf or mati o n f or eac h s u bject:

S u bject i de ntificati o n ( na me, se x, race/et h nicit y)

D oc u me ntati o n of s u bject eli gi bilit y

Date of i nf or me d c o nse nt

Dates of visi ts

D oc u me ntati o n t hat pr ot oc ol s pecific pr oce d ures were perf or me d

Res ults of st u d y  para meters, as re q uire d by t he pr ot oc ol

I P acc o u nta bilit y rec or ds

D oc u me ntati o n of A Es a n d ot her safet y para meters (if a p plica ble)

Rec or ds re gar di n g me dical hist ories a n d t h e use of c o nc o mita nt t hera pies pri or t o a n d 
d uri n g t he st u d y

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7
Date of st u d y c o m pleti o n a n d reas o n f or earl y disc o nti n uati o n, if a p plica ble

Page 36 of 38
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 eCRF are consistent with the original source data.
Only designated individuals may complete the eCRFs. The eCRFs will be submitted at 
regular intervals following the clinical study visit schedule. It is expected that all data 
reported will have corresponding entries in the source documents. The Principal Investigator 
is responsible for reviewing and certifying that the eCRFs are accurate and complete. The 
only subject identifiers recorded on the eCRFs will be subject number, and subject 
demographic information.
9.2
Data Review and Clarifications
Upon completion of the eCRFs, a targeted review of the eCRF data to the subject’s source 
data will be completed by the site monitor to ensure completeness and accuracy. 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 eCRFs.
9.3
Regulatory Documentation and Records Retention
The Investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the Sponsor and the Investigator’s files will be reviewed as part of the ongoing 
study monitoring. Financial disclosure is not subject to regulatory inspection and should be 
kept separately. 
Additionally, the Investigator must keep study records and source documents until the 
Sponsor provides written approval for their destruction. If the Investigator retires, relocates, 
or for any other reason withdraws from responsibility of keeping the study records, the 
Sponsor must be notified and suitable arrangements made for retention of study records and 
source documents needed to comply with national and international regulations (generally 
2 years after discontinuing clinical development or after the last marketing approval).
10 ETHICS AND COMPLIANCE
This trial will be conducted in accordance with the ethical principles that have their origin in 
the Declaration of Helsinki and the referenced directives, regulations, guidelines, and/or 
standards.
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10.1 Compliance
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.
10.2 Institutional Review Board (IRB)
This trial requires IRB approval prior to initiation. This protocol, subject informed consent, 
and subsequent amendments will be reviewed and approved by an IRB.
Before clinical study initiation, this protocol, the ICF (and assent form, if applicable), any 
other written information given to subjects, and any advertisements planned for subject 
recruitment must be approved by an IRB. The Investigator must provide documentation of 
the IRB approval to the Study Sponsor. The approval must be dated and must identify the 
applicable protocol, amendments (if any), ICF, assent form (if any), all applicable recruiting 
materials, written information for subject, and subject compensation programs. The IRB must 
be provided with a copy of the Investigator’s Brochure, any periodic safety updates, and all 
other information as required by local regulation and/or the IRB. At the end of the study, the 
Investigator must notify the IRB about the study’s completion. The IRB also must be notified 
if the study is terminated prematurely. Finally, the Investigator must report to the IRB on the 
progress of the study at intervals stipulated by the IRB.
Voluntary informed consent must be obtained from every subject (and/or legal representative, 
as applicable) prior to the initiation of any screening or other study-related procedures. The 
Investigator must have a defined process for obtaining consent. Specifically, the Investigator, 
or 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, 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 
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Pa ge 3 8 of 3 8
m ust be pr o vi de d wit h c o ntact i nf or mati o n f or t he a p pr o priate i n di vi d uals s h o ul d q ues ti o ns or 
c o ncer ns arise d uri n g t he st u d y. T he s u bject als o m ust be t ol d t hat t heir rec or ds ma y be 
accesse d b y a p pr o priate a ut h orities a n d S p o ns or -desi g nate d pers o n nel. T he I n vesti gat or m ust 
kee p t he ori gi nal, si g ne d c o p y  of t he c o nse nt a n d m ust pr o vi de a du plicate c o p y  t o eac h 
s u bject acc or di n g t o l ocal re g ulati o ns. F oll o wi n g t his st u d y, t he s u bject will ret ur n t o t heir 
e ye care pr ofessi o nal f or t heir r o uti ne e ye care a n d c o ntact le nses.
1 1 P R O T O C O L  AM E N D M E N T HI S T O R Y
Versi o n
Brief Descri pti o n a n d R ati o n ale
1
I nitial Versi o n of t his d oc u me nt
1 2 R E F E R E N C E S
1 2. 1 Refere nces a p plic a ble f or all cli nic al tri als

I S O 11 9 8 0: 2 0 1 2 O p ht hal mic o ptics - C o ntact le nses a n d c o ntact le ns care pr o d ucts -
G ui da nce f or cli nical i n vesti gati o ns

I S O 1 4 1 5 5: 2 0 11 Cli nical i n vesti gati o n of me dical de vices f or h u ma n s u bjects - G o o d 
cli nical practice
1 2. 1. 1 U S refere nces a p plic a ble f or cli nic al tri als

2 1 C F R Part 1 1 - Electr o nic Rec or ds; Electr o nic Si g nat ures

2 1 C F R Part 5 0 - Pr otecti o n of H u ma n S u bjects

2 1 C F R Part 5 6 - I nstit uti o nal Re vie w B oar ds

2 1 C F R Part 8 1 2 - I n vesti gati o nal De vice E xe m pti o ns

2 1 C F R Part 5 4 - Fi na ncial Discl os ure b y Cli nical I n vesti gat ors

T he Calif or nia Bill of Ri g hts .
1 2. 2 Refere nces f or t his cli nic al tri al
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 4 5 0 6
P r o t o c o l  -  C l i n i c a l
0 2- N o v- 2 0 1 7
N ot a p plica ble.

                                                                                                                
                                                                                     
Date/Time 
(mm/dd/yyyy GMT):
Signed by:
Justification:
11/02/2017 13:25:44
10/31/2017 20:07:40
10/31/2017 19:36:06
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