DD T2 Daily Disposable Registration Trial
Phase: NA
Conditions: Myopia, Refractive Errors
Sponsor: Alcon Research

Page 1 of 52
Title
DD T2 Daily Disposable Registration Trial
Protocol Number:
Development Stage of 
Project:
Sponsor Name and 
Address:
Test Product:
Investigator Agreement:
CLE383-C005 / NCT03305770
Development
Alcon Research, Ltd. and its affiliates (“Alcon”)
6201 South Freeway
Fort Worth, Texas 76134-2099
DD T2
I have read the clinical study described herein, and recognize its 
confidentiality. I agree to conduct this study in accordance with 
the ethical principles contained within the Declaration of 
Helsinki, and the described study in compliance with the 
protocol, Good Clinical Practice (GCP), ISO 14155, 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 Study Sponsor.
Principal Investigator:
Signature
Date
Name and professional 
position:
Address:
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Table of Contents
Table of Contents .......................................................................................................................2
List of Tables..............................................................................................................................4
List of Figures............................................................................................................................5
1
GLOSSARY OF TERMS ....................................................................................................6
2
LIST OF ACRONYMS AND ABBREVIATIONS ...........................................................10
3
PROTOCOL SUMMARY.................................................................................................12
4
PROTOCOL AMENDMENTS .........................................................................................18
4.1
Amendments......................................................................................................18
5
INTRODUCTION.............................................................................................................18
5.1
Rationale and Background ................................................................................18
5.2
Purpose of the Study..........................................................................................19
5.3
Risks and Benefits.............................................................................................19
6
STUDY OBJECTIVES......................................................................................................20
6.1
Primary Objective..............................................................................................20
6.2
Secondary Objective..........................................................................................20
20
6.4
Safety Objective(s)............................................................................................20
7
INVESTIGATIONAL PLAN ............................................................................................21
7.1
Study Design .....................................................................................................21
7.2
Rationale for Study Design ...............................................................................22
7.3
Rationale for Duration of Treatment/Follow-Up...............................................23
7.4
Rationale for Choice of Control Product...........................................................23
7.5
Data Monitoring Committee..............................................................................23
8
STUDY POPULATION ....................................................................................................23
8.1
Inclusion Criteria...............................................................................................23
8.2
Exclusion Criteria..............................................................................................24
8.3
Rescreening of Subjects ....................................................................................25
9
TREATMENTS ADMINISTERED...................................................................................25
9.1
Investigational Product(s)..................................................................................25
9.2
Other Medical Device or Medication Specified for Use During the Study ......28
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9.3
Treatment Assignment / Randomization ...........................................................29
9.4
Treatment masking ............................................................................................29
9.5
Accountability Procedures.................................................................................31
9.6
Changes to concomitant medications, treatments/ procedures..........................32
10 STUDY PROCEDURES AND ASSESSMENTS.............................................................32
10.1
Informed Consent and Screening ......................................................................33
10.2
Description of Study Procedures and Assessments...........................................33
10.2.1
Demographics....................................................................................33
10.2.2
Medical History.................................................................................33
10.2.3
Investigational Product compliance ..................................................34
10.2.4
Adverse Event Collection: Safety Assessment..................................34
10.2.5
Slit-Lamp Biomicroscopy: Safety Assessment .................................34
10.2.6
Device Deficiencies: Safety Assessment...........................................34
10.2.7
Additional Study Assessments: Effectiveness and Safety Assessments
...........................................................................................................34
10.3
Unscheduled Visits ............................................................................................35
10.4
Discontinued Subjects .......................................................................................35
10.4.1
Screen Failures ..................................................................................35
10.4.2
Discontinuations................................................................................35
10.4.3
Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product .............................................................36
10.5
Clinical Study Termination................................................................................36
10.5.1
Follow-up of subjects after study participation has ended ................37
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................37
11.1
General Information ..........................................................................................37
11.2
Monitoring for Adverse Events .........................................................................40
11.3
Procedures for Recording and Reporting ..........................................................40
11.4
Return product analysis .....................................................................................42
11.5
Unmasking of the Study Treatment...................................................................42
11.6
Follow-Up of Subjects with Adverse Events.....................................................43
11.7
Pregnancy in the Clinical Study........................................................................43
12 ANALYSIS PLAN ............................................................................................................43
12.1
Subject Evaluability...........................................................................................43
12.2
Analysis Sets .....................................................................................................44
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12.3
Demographic and Baseline Characteristics.......................................................44
12.4
Effectiveness Analyses ......................................................................................44
12.4.1
Analysis of Primary Effectiveness Endpoint.....................................44
12.4.1.1
Statistical Hypotheses........................................................45
12.4.1.2
Analysis Methods ..............................................................45
45
......................45
46
12.5
Handling of Missing Data .................................................................................46
12.6
Safety Analyses .................................................................................................46
12.7
Interim Analyses and Reporting........................................................................46
46
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................47
13.1
Subject Confidentiality......................................................................................47
13.2
Completion of Source Documents and Case Report Forms..............................47
13.3
Data Review and Clarifications.........................................................................48
13.4
Sponsor and Monitoring Responsibilities .........................................................48
13.5
Regulatory Documentation and Records Retention ..........................................49
13.6
Quality Assurance and Quality Control.............................................................49
14 ETHICS .............................................................................................................................50
15 REFERENCES ..................................................................................................................51
15.1
References applicable for all clinical studies ....................................................51
15.1.1
US references applicable for clinical studies.....................................51
15.2
References for this clinical study ......................................................................52
List of Tables
Table 2–1
List of Acronyms and Abbreviations Used in This Protocol ...........................10
Table 3–1
Schedule of Study Procedures and Assessments .............................................16
20
Table 6–2
Safety Objective(s)...........................................................................................20
Table 9–1
Test Product .....................................................................................................25
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Table 9–2
Control Product................................................................................................27
Table 9–3
Unmasked Individuals Associated with the Study...........................................29
Table 10-1
Study Visits......................................................................................................32
List of Figures
Figure 7–1
Flowchart of Study Visits.................................................................................22
Figure 11–1
Categorization of All Adverse Events..............................................................37
Figure 11-2
Categorization of All Serious Adverse Events.................................................38
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1
GLOSSARY OF TERMS
Names of test product
Throughout this document, Test product will be referred to 
as DD T2.
Name of Control Product
Alcon DAILIES TOTAL1® (delefilcon A) (DT1)
Adverse Device Effect
AEs 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.
Adverse Event (AE)
Any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal 
laboratory findings) in subjects, users or other persons, 
whether or not related to the investigational medical device 
(test product). Note: For subjects, this definition includes 
events related to the test product, the control product, or the 
procedures involved. For users or other persons, this 
definition is restricted to events related to the test product.
Requirements for reporting AEs 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 
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Pa ge 7 of 5 2
partici pati o n i n t he st u d y.
I nter ve nti o nal Cli nical Trial
A researc h trial t hat pr os pecti vely assi g ns, w het her 
ra n d o ml y or n ot, h u ma n partici pa nts or gr o u ps of h u ma ns t o 
o ne or m ore healt h -relate d i nter ve nti o ns t o e val uate t he 
eff ects o n healt h o utc o mes, a n d/ or a researc h trial i n w hic h 
dia g n ostic or m o nit ori n g pr oce d ures be y o n d sta n dar d of care 
are c o n d ucte d a n d ge nerate o utc o mes f or use i n a nal ysis of 
data.
I n vesti gati o nal Pr o d uct
Is defi ne d as a pre ve ntati ve ( vacci ne), a t hera pe utic ( dr u g or 
bi ol o gic), de vice, dia g n ostic, or palliati ve use d as a test or 
c o ntr ol pr o d uct i n a cli nical trial, i ncl u di n g a pr o d uct wit h a 
mar keti n g a ut h orizati o n w he n use d or asse m ble d 
(f or m ulate d or packa ge d) i n a wa y  differe nt fr o m t he 
a ut h orize d f or m, or w he n use d f or a n u na ut h orize d 
i n dicati o n, or w he n use d t o gai n f urt her i nf or mati o n a b o ut 
t he a ut h orize d f or m.
Malf u ncti o n
Fail ure of a me dical de vice t o meet its perf or ma nce 
s pecificati o ns or ot her wise perf or m as i nte n de d. 
Perf or ma nce s pecificati o ns i ncl u de all clai ms ma de i n t he 
la beli n g of t he de vice. T he i nte n de d perf or ma nce of t he 
de vice refers t o t he i nte n de d use f or w hic h t he de vice is 
la bele d or mar kete d.
N o n -seri o us A d verse E ve nt
A E t hat d oes n ot meet t he criteria f or a S A E .
Ra n d o mize d S u bjects
A n y  s u bject w h o is assi g ne d a ra n d o mize d treat me nt.
Seri o us A d verse De vice 
Ef fect ( S A D E)
A d verse de vice ef fect t hat has res ulte d i n a n y of t he 
c o nse q ue nces c haracteristic of a S A E .
Seri o us A d verse E ve 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.
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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7

Pa ge 8 of 5 2
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 urre 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 
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 
tre 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 pro 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 ar e A E s. If a c o mplic ati o n 
pr ol 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 aliz ati o n ” 
occ urr e 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.
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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7

Page 9 of 52
Refer to Section 11 for additional SAEs.
Significant Non-Serious 
Adverse Event
Is a symptomatic, device-related, non-sight threatening AE
that warrants discontinuation of any contact lens wear for 
greater than or equal to 2 weeks.
Refer to Section 11 for additional Significant Non-Serious 
AEs.
Unanticipated Serious 
Adverse Device Effect 
(USADE)
Serious adverse device effect which by its nature, incidence, 
severity or outcome has not been identified in the risk 
management file.
Use Error
Act or omission of an act that results in a different medical 
device response than intended by manufacturer or expected 
by user. Note: This definition includes slips, lapses, and 
mistakes. An unexpected physiological response of the 
subject does not in itself constitute a use error.
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2
LIST OF ACRONYMS AND ABBREVIATIONS
Table 2–1
List of Acronyms and Abbreviations Used in This Protocol
Abbreviation
Definition
ADE 
Adverse device effect
AE 
Adverse event
BCVA 
Best corrected visual acuity
CFR 
Code of Federal Regulations
CRF
Case report form
CSM
Clinical site manager
CTT
Clinical trial team
D 
Diopter(s)
D/C
Discontinue
DD 
Daily disposable
DD T2 
Daily Disposable T2 Soft Contact Lenses
DT1
DAILIES TOTAL1 Daily Disposable Contact Lenses
DS
Diopters sphere
eCRF 
Electronic case report form
EDC 
Electronic data capture
FDA 
US Food and Drug Administration
GCP 
Good Clinical Practice
GPCMS
Global Product Complaint Management System
 
IB 
Investigator’s brochure
ICF 
Informed consent form
ICH
International Council for Harmonisation of Technical Requirements 
for Pharmaceuticals for Human Use
IEC 
Independent ethics committee
IP 
Investigational product
IRB 
Institutional review board
IRT
Interactive response technology
ISO 
International Organization for Standardization
LCSM
Lead clinical site manager
LID
Lens identification 
LogMAR 
Logarithm of the minimum angle of resolution
mm 
Millimeter
MOP
Manual of procedures
n
Number
N/A 
Not applicable
O/R
Over refraction
OU 
Both eyes
pt 
Point
SAE 
Serious adverse event
SADE 
Serious adverse device effect
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Abbreviation
Definition
SiHy 
Silicone hydrogel
SLE
Slit-lamp examination
SOP
Standard operating procedure
US / USA
United States of America
USADE 
Unanticipated serious adverse device effect
USAN
United States Adopted Name
USV
Unscheduled visit
VA 
Visual acuity
vs
Versus 
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Page 12 of 52
3
PROTOCOL SUMMARY
This will be a prospective, randomized 
, controlled, 
double-masked, parallel-group clinical trial.
Approximately 6 sites in the US will enroll approximately 99 subjects. Subjects will be
randomized to wear either the test DD T2 lenses in both eyes or the control DT1 lenses in 
both eyes for 3 months. Approximately 66 subjects will be assigned to wear the test lenses 
and 33 the control lenses, following the 2:1 subject allocation ratio as recommended by ISO 
11980:2012 and the US FDA 510(k) guidance document.
Subjects will be expected to attend 7 office visits: Baseline, Dispense, 1-week follow-up, 2-
week follow-up, 1-month follow-up, 2-month follow-up and 3-month follow-up/Exit.
Following randomization at the Baseline visit, study lenses will be trial fit using the fitting set 
supplied by the Sponsor, and the correct contact lens power for the individual subject will be
determined. The Sponsor will send investigational lenses for each subject to the site after 
receiving an order from the Investigator. Between the Baseline and Dispense visits, subjects 
will be allowed to wear their habitual lenses. Biomicroscopy will be repeated at the Dispense 
visit.
 
 
 
 
 
 
Investigational 
product type
Device
Study type
Interventional
Investigational 
products
Test Product: DD T2 soft contact lenses
Control Product: DT1 (delefilcon A) soft contact lenses
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Pa ge 1 3 of 5 2
P ur p ose a n d 
r ati o n ale
T he p ur p ose of t his cli nical trial is t o e val uate t he perf or ma nce of 
t he i n vesti gati o nal D D T 2 le ns c o m pare d t o t he c o m merciall y 
a vaila ble D T 1 le ns, b y assessi n g vis ual ac uit y as t he pri mar y 
varia ble.
O bjecti ves
T he pri mar y  o bjecti ve is t o de m o nstrate effecti ve ness a n d safet y of 
t he D D T 2 s oft c o ntact le ns w he n w or n f or daily dis p osa ble wear 
as c o m pare d t o D T 1 s oft c o ntact le ns.
E n d p oi nt s
Pri mar y  Effecti ve ness

Dista nce V A ( S nelle n)
Safet y

A E s

De vice deficie ncies

Bi o micr osc o p y
Assess me nt s
Effecti ve ness

V A  ( S nelle n dista nce) wit h I P


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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7

Pa ge 1 4 of 5 2

 

 





Safet y

A E s 

De vice deficie ncies

Bi o micr osc o p y
St u d y Desi g n
T his will be a pr os pecti ve, ra n d o mize d, stratifie d, c o ntr olle d, 
d o u ble -mas ke d, parallel -gr o u p cli nical trial. S u bject partici pati o n 
i n t he st u d y will be a p pr o xi matel y 1 5 wee ks wit h a p pr o xi matel y 3 
m o nt hs of e x p os ure t o I P.
S u bject p o p ul ati o n
V ol u nteer s u b jects a ge d 1 8 or o ver w h o are s oft c o ntact le ns 
wearers, e xcl u di n g D T 1 ha bit ual 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 ys per wee k a n d at least 8 h o urs per da y. 
S u bjects m ust re q uire c o ntact le nses i n a p o wer ra n ge fr o m - 1. 0 0 
t o - 6. 0 0 D S. 
 
 
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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7

Pa ge 1 5 of 5 2
Ke y i ncl usi o n 
criteri a
( See Secti o n 8. 1 f or a 
c o m plete list of 
i ncl usi o n criteria)

S uccessf ul wear of s p herical s oft c o ntact le nses f or dista nce 
c orrecti o n i n b ot h e yes d uri n g t he past 3 m o nt hs f or a 
mi ni m u m of 5 da y s per wee k a n d 8 h o urs per da y.

Best c orrecte d V A 2 0/ 2 5 or better i n eac h e ye.
Ke y e xcl usi o n 
criteri a
( See Secti o n 8. 2 f or a 
c o m plete list of 
e xcl usi o n criteria)

A n y  c urre nt or pri or wear e x perie nce wit h D T 1 le nses.

We ari 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.
D at a a n al ysis a n d 
s a m ple size 
j ustific ati o n
I n a d here nce t o t he re p orti n g f or mat as s pecifie d i n t he IS O a n d 
F D A 5 1 0( k) g ui da nce d oc u me nts, effecti ve ness a n d safet y data 
will be prese nte d se paratel y  base d u p o n s u bject st u d y  stat us of 
C o m plete d or Disc o nti n ue d. 
 
 
 
 
 
Sa m ple size is base d u p o n I S O a n d F D A 5 1 0( k) re q uire me nts a n d 
rec o m me n dati o ns of at least 5 0 s u bjects i n t he Test gr o u p , i n a 2: 1 
Test t o C o ntr ol rati o.
Ke y w or ds
D D T 2, D T 1, dail y dis p osa ble , re gistrati o n
Ass oci ate d m ateri als
L u bricati o n/re -wetti n g dr o ps pr o vi de d b y  Alc o n will be per mitte d 
as nee de 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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7

Pa ge 1 6 of 5 2
Ta ble 3 – 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,
B aseli ne/
Scree ni n g
( D a y 0 )
Visit 2, 
Dis pe nse 
st u d y 
le nses
Visit 3, 
Wee k 1
f oll o w-
u p
Visit 4, 
Wee k 2 
f oll o w-
u p
Visit 5, 
1- m o nt h
f oll o w-
u p
Visit 6, 
2- m o nt h
f oll o w-
u p
Visit 7,
3- m o nt h
f oll o w-
u p/ e xit
U S V
U p t o 
4 da ys 
after le ns 
or der
( Da y 1 
of le ns 
wear)
7 da ys
(-1/ + 2 
da ys) 
fr o m t he 
Dis pe nse 
visit
1 5 da ys 
(-1/ + 3 
da ys) 
fr o m t he 
Dis pe nse 
visit
3 0 da ys 
(-2 da ys 
/ + 5 da ys) 
fr o m t he 
Dis pe nse 
visit
6 0 da ys 
(-2 da ys 
/ + 5 da ys) 
fr o m t he 
Dis pe nse 
visit
9 5 da ys 
(-2 da ys 
/ + 5 da ys) 
fr o m t he 
Dis pe nse 
visit
I nf or me d C o nse nt

- 
- 
- 
- 
- 
-
-
D e 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 
i nf or mati o n 
( bra n d / 
ma n ufact urer, 
m o dalit y, p o w er, 
wear s uccess ) 

- 
- 
- 
- 
- 
-
-
V A w/ ha bit ual 
c orrecti o n
( S nelle n dista nce)
 

- 
- 
- 
-

()
Bi o micr osc o p y
 
 
 
 
 
 

()
Or der s u bject’s 
st u d y le nses 

- 
- 
- 
- 
- 
-
-
Dis pe nse or 
pr o visi o n of st u d y 
le nses
-

- 
-
 

-
()
V A w/ st u d y 
le nses ( S nelle n 
dista nce)
 
 
 
 
 
 

()
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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7

Pa ge 1 7 of 5 2
Pr oce d ure/ 
Assess me nt
Visit 1,
B aseli ne/
Scree ni n g
( D a y 0)
Visit 2, 
Dis pe nse 
st u d y 
le nses
Visit 3, 
Wee k 1
f oll o w-
u p
Visit 4, 
Wee k 2 
f oll o w-
u p
Visit 5, 
1- m o nt h
f oll o w-
u p
Visit 6, 
2- m o nt h
f oll o w-
u p
Visit 7,
3- m o nt h
f oll o w-
u p/ e xit
U S V
U p t o 
4 da ys 
after le ns 
or der
( Da y 1 
of le ns 
wear)
7 da ys
(-1/ + 2 
da ys) 
fr o m t he 
Dis pe nse 
visit
1 5 da ys 
(-1/ + 3 
da ys) 
fr o m t he 
Dis pe nse 
visit
3 0 da ys 
(-2 da ys 
/ + 5 da ys) 
fr o m t he 
Dis pe nse 
visit
6 0 da ys 
(-2 da ys 
/ + 5 da ys) 
fr o m t he 
Dis pe nse 
visit
9 5 da ys 
(-2 da ys 
/ + 5 da ys) 
fr o m t he 
Dis pe nse 
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 vis ual ac uit y  b y 2 li nes or m ore wit h i n vesti gati o nal pr o d ucts.
U S V = U nsc he d ule d Visit
ǂ
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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7
 
 
 

Page 18 of 52
4
PROTOCOL AMENDMENTS
Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments must be created by the Study Sponsor and must be 
approved by the IRB/IEC and global and regional Health Authorities, as applicable, prior to 
implementation except when required to mitigate immediate safety risks or when the changes 
involve only logistical or administrative revisions. 
Amendments may necessitate that the informed consent and other study-related material be 
revised. If the consent form is revised, all subjects currently enrolled in the study must sign 
the approved, revised informed consent (re-consent), as required by the IRB/IEC.
4.1
Amendments
There are no amendments. This is the first version of the protocol.
5
INTRODUCTION
5.1
Rationale and Background
Daily disposable (DD) lenses are worn for a full day, during waking hours, and then 
discarded after usage. This type of contact lens eliminates the requirement for lens cleaning 
and disinfection and has been shown to have higher compliance rates with lens replacement 
schedules compared to other lens wearing modalities (Dumbleton 2009). Silicone hydrogel 
contact lenses provide superior oxygen transmissibility over contact lenses made with 
conventional materials.
A new DD SiHy lens, known here as DD T2, has been developed that combines high oxygen 
transmissibility with a low modulus of elasticity.
In this clinical trial, the performance of the investigational DD T2 lens will be compared to 
the commercially available DT1 (delefilcon A) lens in a parallel-group design with 3 months 
of exposure. The intended use of this contact lens is for vision correction. Therefore, the 
objective measurement of VA is planned as the primary variable for the comparison with the 
DT1 lens. 
 
 
 
 
 The recommendations of ISO 11980:2012 and FDA (510(k)) 
Guidance Document for Daily Wear Contact Lenses in regard to variables to assess were 
considered.
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Page 19 of 52
5.2
Purpose of the Study
The purpose of this clinical trial is to evaluate the performance of the investigational DD T2 
lens compared to the commercially available DT1 lens, by assessing VA as the primary 
variable. The study is designed to follow the 2:1 subject allocation ratio as recommended by 
ISO 11980:2012 and the US FDA 510(k) guidance document. At the end of the study, a 
clinical study report will be prepared in accordance with applicable regulatory requirements 
and standards.
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.
5.3
Risks and Benefits
Contact lenses may offer improved peripheral vision and the convenience of not wearing 
spectacles. Material properties and design characteristics of DD T2 are features consistent 
with successful contact lens wear. Based upon nonclinical testing and documented rationale 
for applicability of test results, DD T2 are assessed to be non-toxic and biocompatible for 
on-eye use. 
DT1 lenses are for daily wear use under a DD wear modality; further details on any known 
potential risks and benefits can be found in the package insert.
DD T2 and DT1 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 DD T2 can be found in 
the IB. Risks are minimized by compliance with the eligibility criteria and study procedures, 
and through close supervision by a licensed clinician during exposure to the study lenses. The 
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 DD T2 are 
anticipated to be similar to other marketed DD soft contact lenses.
There may also be unknown risks with the use of DD T2. Risks to subjects in this clinical 
study will be minimized by compliance with the eligibility criteria and study procedures, 
clinical oversight, and monitoring. 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 due to 
increased risk of infection. Site personnel should advise the subjects to remove contact lenses 
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Page 20 of 52
and return for prompt follow-up of symptoms such as ocular discomfort, foreign body 
sensation, excessive tearing, vision changes, or hyperemia. 
Refer to the IB for additional information. 
6
STUDY OBJECTIVES
6.1
Primary Objective
The primary objective is to demonstrate the effectiveness and safety of the DD T2 soft 
contact lens when worn for daily disposable wear as compared to the DT1 soft contact lens. 
6.2
Secondary Objective
Not applicable.
6.4
Safety Objective(s)
Safety endpoints are as follows:
Table 6–2
Safety Objective(s)
Objective(s)
Endpoint(s)
To assess duty of care and demonstration of 
safety.
AEs
Device Deficiencies
Biomicroscopy
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Page 21 of 52
7
INVESTIGATIONAL PLAN
7.1
Study Design
This will be a prospective, randomized, 
 controlled, double-masked, parallel-group 
clinical trial.
Approximately 6 sites in the US will enroll approximately 99 subjects and with 
approximately 15-18 subjects per site. Subjects will be randomized to wear either the test DD 
T2 lenses in both eyes or the control DT1 lenses in both eyes.
Subjects will be expected to attend 7 office visits. The total expected duration of the subject’s 
participation is approximately 3 months. 
The study is expected to take approximately 4 months for completion. The study outline is 
provided in Figure 7-1 (below):
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Page 22 of 52
Figure 7–1
Flowchart of Study Visits
7.2
Rationale for Study Design 
In this clinical trial, the performance of the investigational DD T2 lens will be compared to 
the commercially available DT1 (delefilcon A) lens in a double-masked, parallel-group 
design with approximately 3 months of exposure. The study is designed following the 
recommendations for registration from ISO 11980:2012 and the US FDA 510(k) guidance 
document.
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Effective Date:  
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Page 23 of 52
7.3
Rationale for Duration of Treatment/Follow-Up
The duration of exposure as well as the schedule of follow-up visits follow the recommended 
guidance from ISO 11980:2012 and the US FDA 510(k) guidance document.
7.4
Rationale for Choice of Control Product
DT1 contact lenses were chosen as the control product because this lens is a proper predicate 
device to compare to DD T2 in regards to effectiveness and safety. Both DD T2 and DT1 are 
silicone hydrogel lenses and are to be prescribed for single use, daily disposable wear. The 
DT1 spherical soft contact lenses are indicated for the optical correction of refractive 
ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes. The 
lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
7.5
Data Monitoring Committee
Not applicable.
8
STUDY POPULATION
The study population consists of adult male and female subjects (aged 18 or over), with non-
diseased eyes, who require optical correction for refractive ametropia.
 
 
 
The intended study population consists of volunteer subjects aged 18 or over who are soft 
contact lens wearers, excluding DT1 habitual wearers, who have at least 3 months of contact 
lens wearing experience, and who wear their habitual lenses at least 5 days per week and at 
least 8 hours per day. Subjects must require contact lenses in a power range from -1.00 
to -6.00 DS. 
 
 
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 at least 18 years of age and must be able to understand and sign an 
IRB/IEC approved informed consent form. 
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2.
Willing and able to attend all scheduled study visits as required per protocol.
3.
Successful wear of spherical soft contact lenses for distance correction in both eyes 
during the past 3 months for a minimum of 5 days per week and 8 hours per day.
4.
Manifest cylinder ≤ 0.75 D in each eye.
5.
Best spectacle corrected visual acuity 20/25 or better in each eye.
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 ocular or intraocular surgery, including refractive surgery and/or irregular 
cornea.
4.
Biomicroscopy findings at baseline that are moderate (grade 3) or higher and/or 
corneal vascularization that is mild (grade 2) or higher.
5.
Current or history of pathologically dry eye in either eye that, in the opinion of the 
Investigator, would preclude contact lens wear.
6.
Current or history of herpetic keratitis in either eye.
7.
Eye injury in either eye within 12 weeks immediately prior to enrollment for this 
trial.
8.
Any current or prior wear experience with DT1 lenses.
9.
Wearing habitual contact lenses in an extended wear modality (routinely sleeping in 
lenses for at least 1 night per week) over the last 3 months prior to enrollment
10.
History of intolerance or hypersensitivity to any component of the study lenses.
11.
Enrollment of site staff or family/household members of the site staff who are listed 
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Pa ge 2 5 of 5 2
o n t he st u d y  pers o n nel l o g as ha vi n g a r ole i n t he e xec uti o n of t his st u d y.
1 2 .
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 ys or c urre ntly 
e nr olle d i n a n y cli nical trial.
8. 3
Rescree ni n g of S u bjects
Rescree ni n g of s u bjects is n ot all o we d i n t his st u d y.
9
T R E A T M E N T S A D MI NI S T E R E D
9. 1
I n vesti g ati o n al Pro d uct(s)
Te st Pro d uct:
D D T 2 dail y dis p osa ble s oft c o ntact le nses
C o ntr ol Pr o d uct:
D T 1 ( delefilc o n A) dail y  dis p osa ble s oft c o ntact 
le nses
Ta ble 9 – 1
Te st Pro d uct
Te st Pr o d uct
D D T 2 dail y dis p osa ble s oft c o ntact le nses
( LI D 0 0 6 8 4 1)
Ma n ufact urer
Alc o n La b orat ories, I nc.
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
U S A
I n dicati o n f or use 
a n d i nte n de d 
p ur p ose i n t he 
c urre nt st u d y 
T he i nte n de d use of t his c o ntact le ns is f or visi o n c orrecti o n. 
Pr o d uct descri pti o n 
a n d para meters 
a vaila ble f or this 
st u d y

Material: 

Wa ter c o nte nt: 5 1 %

P o wer ra n ge: - 1. 0 0 D t o - 6. 0 0 D, 0. 2 5 D ste ps

Base c ur ve ( m m): 8. 3

Dia meter ( m m): 1 4. 2

A d diti o nal details ca n be f o u n d i n t he I B.
F or m ulati o n
Silic o ne H y dr o gel. A d diti o nal details ca n be f o u n d i n t he I B f or D D 
T 2. 
Usa ge

We ar:
o
Dail y  Wear
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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7

Pa ge 2 6 of 5 2
o
Bilateral

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 a n d at least ~ 5 da y s per 
wee k o ver a 3 m o nt h e x p os ure peri o d.

Le ns Care: N/ A

A d diti o nal details ca n be f o u n d i n t he M O P 
N u m ber/ A m o u nt of 
pr o d uct t o be 
pr o vi de d t o t he 
s u bject
A cart o n c o ntai ni n g ~ 4 0 le nses ( per e ye) will be pr o vi de d t o t he 
s u bject at t he f oll o wi n g st u d y visits:

Vi sit 2 ( Dis pe nse)

Vi sit 5 ( 1 m o nt h f oll o w-u p)

Vi sit 6 ( 2 m o nt h f oll o w- u p)
Pac ka gi n g 
descri pti o n
Blister f oil pac k
La beli n g descri pti o n

Le ns F oil la bel i ncl u des:
-
material na me 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 nal de vice state me nt
-
S p o ns or i nf or mati o n

Pr o vi de d i n b o xes of ~ 4 0 le nses per p o wer per b o x, i de ntifie d 
wit h t he f oll o wi n g:
-
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 nal use o nl y state me nt
-
trac ki n g n u m ber
St ora ge c o n diti o ns
St ore d at r o o m te m perat ure.
S u p pl y

Fitti n g sets will be pr o vi de d b y  t he S p o ns or bef ore t he start of 
t he trial t o be use d d uri n g Visit 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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7

Pa ge 2 7 of 5 2

St u d y  le nses will be pr o vi de d t o t he site f or eac h s u bject as per 
t he i n vesti gat or’s or der f or m. T he site will dis pe nse t he st u d y  
le nses t o t he s u bject at Visit 2 a n d pr o vi de m o nt hl y  s u p plies at 
Visit 5 a n d 6.
Ta ble 9 – 2
C o ntr ol Pr o d uct
C o ntr ol Pr o d uct
D AI LI E S T O T A L 1 
( LI D 0 0 6 9 6 1)
Ma n ufact urer  
Alc o n La b orat ories, I nc.
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
U S A
I n dicati o n f or Use
T he i nte n de d use of t his c o ntact le ns is f or visi o n c orrecti o n.
Pr o d uct descri pti o n 
a n d para meters 
a vaila ble f or t his 
st u d y

Material: delefilc o n A

Water c o nte nt : 3 3%

P o wer ra n ge: - 1. 0 0 D t o - 6. 0 0 D, 0. 2 5 D ste ps

Base c ur ve ( m m): 8. 5

Dia meter ( m m): 1 4. 1
F or m ulati o n
Silic o ne H y dr o gel. A d diti o nal details ca n be f o u n d i n t he D T 1
pac ka ge i nsert .
Usa ge

Wear:
o
Dail y  Wear
o
Bilateral

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 a n d at least ~ 5 da y s per 
wee k o ver a 3 m o nt h e x p os ure peri o d.

Le ns Care: N/ A

A d diti o nal details ca n be f o u n d i n t he M O P
N u m ber/ A m o u nt of 
Pr o d uct t o be 
Pr o vi de d t o t he 
s u bject
A cart o n c o ntai ni n g ~ 4 0 le nses ( per e ye) wil l be pr o vi de d t o t he 
s u bject at t he f oll o wi n g st u d y visits:

Visit 2 ( Dis pe nse)

Visit 5 ( 1 m o nt h f oll o w - u p)

Visit 6 ( 2 m o nt h f oll o w - u p)
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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7

Pa ge 2 8 of 5 2
Pac ka gi n g 
descri pti o n
C o ntr ol pr o d uct pac ka gi n g is i de ntical t o Test pr o d uct, see 
Ta ble 9- 1 f or details.
La beli n g descri pti o n

Le ns F oil la bel i ncl u des:
-
material na me 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

Pr o vi de d i n b o xes of ~ 4 0 le nses per p o wer per b o x, i de ntifie d 
wit h t he f oll o wi n g:
-
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 nal use o nl y state me nt
St ora ge c o n diti o ns
S t ore d at r o o m te m perat ure.
S u p pl y

Fitti n g sets will be pr o vi de d b y t he S p o ns or bef ore t he start of 
t he trial t o be use d d uri n g Visit 1.

St u d y  le nses will be pr o vi de d t o t he site f or eac h s u bject as per 
t he i n vesti gat or’s or der f or m. T he site will dis pe nse t he st u d y 
le nses t o t he s u bject at Visit 2 a n d pr o vi de m o nt hl y  s u p plies at 
Visit 5 a n d 6.
9. 2
Ot her Me dic al De vice or Me dic ati o n S pecifie d f or Use 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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7
D uri n g t he cli nical st u d y S p o ns or pr o vi de d re wetti n g dr o ps ma y be use d, if necessar y.  

Page 29 of 52
9.3
Treatment Assignment / Randomization
Subjects will be randomized in a 2:1 ratio to receive either DD T2 or DT1 soft contact lenses, 
respectively. 
 
Only after signing the ICF, a subject will be assigned a subject number by the electronic data 
capture system. 
A randomization list will be generated using a validated system that automates the random 
assignment of treatment arms to randomization numbers in the specified ratio
 
. Subjects will be assigned treatment according to the randomization list 
uploaded in the iMedidata BALANCE system. The randomization list will be generated and 
maintained by the Study Sponsor.
At Visit 1, all eligible subjects will be randomized via the EDC/IRT integration system to one 
of the treatment arms. The Investigator or delegate will access the respective system after 
confirming that the subject meets all the eligibility criteria. A randomization number will be 
automatically assigned to the subject according to the subject randomization list but will not 
be communicated to the site user. The EDC/IRT integration system will inform the site user 
of the treatment assignment to be dispensed to the subject.
9.4
Treatment masking
This study is double-masked, with subjects randomized to use DD T2 or DT1 soft contact 
lenses for the duration of the 3-month treatment period.
Table 9–3
Unmasked Individuals Associated with the Study
Unmasked Individual
Extent of Unmasking
Rationale
Unmasked Study 
Coordinator(s)
The Unmasked Study 
Coordinator(s) will manage IP 
inventory, as well as IP 
administration. This individual 
will have access to IP supply, 
accountability logs, and other 
documents or supplies 
pertaining to IP. The 
unmasked coordinator will 
also assist with device 
The Unmasked Study 
Coordinator(s) will be 
unmasked to allow for 
processing of IP shipment, 
storage, and dispensing, as 
well as accountability for all 
IP.
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Page 30 of 52
Unmasked Individual
Extent of Unmasking
Rationale
deficiency and adverse event 
reporting.
LCSM
The LCSM 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 LCSM will be unmasked 
to allow for oversight of the 
CSM, in conjunction with all 
IP accountability tasks.
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 RAVE that 
would contain unmasking 
data.
The Unmasked Data 
Manager(s) will be unmasked 
to allow for review of all 
restricted data.
IRT Manager
The IRT manager will be 
unmasked to allow for system 
programming, testing, and to 
allow for technical oversight 
of the system.
The IRT manager is 
unmasked to all aspects of the 
trial for system development 
purposes.
Randomization Specialist
The Randomization Specialist 
will be unmasked to allow for 
generation of the 
randomization list and 
uploading of that list into the 
IRT system.  
Generates and therefore has 
full knowledge of treatment 
codes but otherwise is 
operationally not associated 
with the CTT or any decision-
making aspects related to 
clinical trial design, 
execution, or reporting.
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Pa ge 3 1 of 5 2
T his le vel of mas ki n g will be mai ntai ne d t hr o u g h o ut t he c o n d uct of t he st u d y . U n mas ki n g 
will occ ur o nl y  after all pla n ne d st u d y data ha ve bee n vali date d a n d t he data base l oc ke d. 
Mas ke d st u d y  pers o n nel m ust a v oi d see ki n g i nf or mati o n t hat ma y c o m pr o mise mas ki n g. 
U n mas ke d st u d y  pers o n nel m ust n ot disse mi nate i nf or mati o n t hat is p ote ntiall y u n mas ki n g t o 
a n y mas ke d pers o n nel. T he mas ke d a n d u n mas ke d site pers o n nel m ust c o or di nate all st u d y  
acti vities as necessar y t o pr otect mas ki n g a n d mi ni mize bias d uri n g t he st u d y. 
I n t he e ve nt of a me dical e mer ge nc y w here t he k n o wle d ge of s u bject treat me nt is re q uire d, a n 
i n di vi d ual In vesti gat or will ha ve t he a bilit y  t o u n mas k t he treat me nt assi g n me nt f or a s pecific 
s u bject after c o ntacti n g a n a p pr o priate St u dy S p o ns or re prese ntati ve if ti me all o ws. 
U n mas ki n g m ust be d o ne acc or di n g t o t he i nstr ucti o ns pr o vi de d f or t he st u d y I RT s yste m.
9. 5
Acc o u nt a bilit y Pr oce d ures
U p o n recei pt of t he I Ps, t he I n vesti gat or or dele gate m ust c o n d uct a n i n ve nt or y . D uri n g t he 
st u d y, u n mas ke d desi g nate d st u d y  staff m ust pr o vi de t he IPs t o t he s u bjects i n acc or da nce 
wit h t heir ra n d o mizati o n assi g n me nt. T hr o u g h o ut t he st u d y, t he I n vesti gat or or dele gate m ust 
mai ntai n rec or ds of I P  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 I P  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. All I Ps se nt t o t he I n vesti gat or m ust be 
acc o u nte d f or b y St u d y S p o ns or pers o n nel, a n d i n n o case be use d i n a n u na ut h orize d 
sit uati 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:

All 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

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 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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7
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 E (ie, 
A D E or S A D E) are ret ur ne d t o t he St u d y  S p o ns or f or i n vesti gati o n, u nless ot her wise 
directe d b y t he S p o ns or. Refer t o Secti o n 11 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.
T he I n vesti gat or is res p o nsi ble f or pr o per dis p ositi o n of all u n use d I Ps at t he c o ncl usi o n of 
t he st u d y, acc or di n g t o t he i nstr ucti o ns pr o vi de d i n t he M O P.

Pa ge 3 2 of 5 2
9. 6
C h a n ges t o c o nc o mit a nt me dic ati o ns, tre at me nts/ pr oce d ures
C ha n ges i n c o nc o mita nt treat me nts after Vi sit 1 are n ot all o we d u nless nee de d f or t he pr o per 
me dical care a n d treat me nt of t he s u bject f or a s pecific me dical c o n diti o n.
After t he s u bject is e nr olle d i nt o t he st u d y, t he I n vesti gat or m ust i nstr uct t he s u bject t o n otif y 
t he st u d y site a b o ut:

A n y  ne w me dicati o ns 

Alterati o ns i n d ose or d ose sc he d ules f or c urre nt me dicati o ns, 

A n y  me dical pr oce d ure or h os pitalizati o n t hat occ urre d or is pla n ne d

A n y  n o n-dr u g t he ra pies (i ncl u di n g p h ysical t hera p y a n d bl o o d tra nsf usi o ns). 
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.
1 0 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
S u bjects will be e x pecte d t o atte n d 7 of fice visits, as s h o w n i n Ta ble 1 0 - 1: 
Ta ble 1 0 - 1
St u d y Vi sits
Vi sit
Vi sit 1: Baseli ne/ Scree ni n g ( Da y 0)
Vi sit 2: Dis pe nse st u d y le nses ( Da y 1)
Vi sit 3: We e k 1 f oll o w- u p
Vi sit 4: We e k 2 f oll o w- u p
Vi sit 5: 1-m o nt h f oll o w - u p
Vi sit 6: 2-m o nt h f oll o w - u p
Vi sit 7: 3-m o nt h f oll o w -u p/e xit
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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7
U nsc he d ule d V isits a n d Early Te r mi nati o n Vi sits are all o we d, if necessar y.
At t he Baseli ne visit, st u d y  le nses will be trial fit usi n g t he fitti n g set s u p plie d b y t he S p o ns or, 
a n d t he c orrect c o ntact le ns p o wer f or t he i n di vi d ual s u bject will be deter mi ne d. T he S p o ns or 
will se n d i n ves ti gati o nal le nses f or eac h s u bject t o t he site after recei vi n g a n or der fr o m t he 
In vesti gat or. Bet wee n t he Baseli ne a n d Dis pe nse visits, s u bjects will be all o we d t o wear t heir 
ha bit ual le nses. Bi o micr osc o p y  will be re peate d at t he Dis pe nse visit.

Page 33 of 52
 
 
 
 
 
 
10.1 Informed Consent and Screening
The Investigator or delegate must explain the purpose and nature of the study, and have the 
subject read, sign, and date the IRB/IEC-approved informed consent document. The subject 
must sign the ICF BEFORE any study-specific procedures or assessments can be performed, 
including study-specific screening procedures. Additionally, have the individual obtaining 
consent from the subject and a witness, if applicable, sign and date the informed consent 
document. 
The Investigator or delegate must provide a copy of the signed document to the subject and 
place the original signed document in the subject’s chart, or provide documentation as 
required by local regulations.
10.2 Description of Study Procedures and Assessments
Detailed descriptions of assessments and procedures are provided in the MOP. The 
Investigator is responsible for ensuring responsibilities for all procedures and assessments are 
delegated to appropriately qualified site personnel.
10.2.1 Demographics
Obtain demographic information including age, race, ethnicity, and sex.
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.
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Pa ge 3 4 of 5 2
1 0. 2. 3 I n vesti g ati o n al Pr o d uct c o m pli a nce
Re vie w s u bject c o m plia nce wit h t he I P  usa ge a n d a dj u nct pr o d uct usa ge a n d c ollect all use d 
a n d u n use d st u d y IPs a n d ot her pr o d ucts t hat were dis pe nse d.
1 0. 2. 4 A d verse E ve nt C ollecti o n: S afet y Assess me nt
Assess a n d rec or d a n y A E s t hat are o bser ve d or re p orte d, 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 si nce t he pre vi o us visit.
1 0. 2. 5 Slit -L a m p Bi o micr osc o p y: S afet y Assess me nt
S L E of t he c or nea, iris/a nteri or c ha m ber , a n d le ns m ust be perf or me d i n b ot h e yes bef ore 
i nstillati o n of a n y dia g n ostic e ye dr o ps.
1 0. 2. 6 De vice Deficie ncies: S afet y Assess me nt
Assess a n d rec or d a n y de vice deficie ncies t hat are re p orte d or o bser ve d, 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 si nce t he pre vi o us visit. 
Re q uire me nts f or re p orti n g de vice deficie ncies i n t he st u d y ca n be f o u n d i n Secti o n 1 1.
1 0. 2. 7 A d diti o n al St u d y Assess me nt s: Effecti ve ness a n d S afet y 
Assess me nt s
T he f oll o wi n g are a d diti o nal st u d y  assess me nts. Refer t o t he M O P f or f urt her details.

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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7
V A  ( S nelle n dista nce) wit h I P

Pa ge 3 5 of 5 2
1 0. 3 U nsc he d ule d Vi sits
If a s u bject visit occ urs bet wee n a n y re g ularl y sc he d ule d visits , t his visit m ust be d oc u me nte d 
as a n U nsc he d ule d Visit. D uri n g all u nsc he d ule d visits, t he In 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 i nf or mati o n, as a p plica ble

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

C ollect De vice Deficie nc y  i nf or mati o n, as a p plica ble

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 a p plica 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 I P 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 3- 1 Sc he d ule of 
St u d y  Pr oce d ures a n d Assess me nts , as p ossi ble.
1 0. 4 Disc o nti n ue d S u bjects
1 0. 4. 1 Scree n F ail ures
S u bjects w h o were e xcl u de d 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, n ot meeti n g 
t he i ncl usi o n/e xcl usi o n criteria, a n d pri or t o ra n d o mizati o n t o pr o d uct/ dis pe nse of st u d y 
pr o d uct.
T he I n vesti gat or m ust d oc u me nt t he reas o n f or scree n fail ure i n t he s u bject’ s case hist or y 
s o urce d oc u me nts.
S u bject n u m bers m ust n ot be re- use d.
1 0. 4. 2 Disc o nti n u ati o ns
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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7
Disc o nti n ue d s u bjects are i n di vi d uals w h o v ol u ntaril y wit h dra w or are wit h dra w n fr o m t he 
st u d y b y t he I n vesti gat or 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 bject n u m bers of disc o nti n ue d s u bjects m ust n ot be re -use d.

Pa ge 3 6 of 5 2
S u bject s ma y disc o nti n ue fr o m st u d y or st u d y treat me nt at a n y ti me f or a ny reas o n. S u bjects 
ma y  als o be disc o nti n ue d fr o m st u d y treat me nt at a n y ti me if, i n t he o pi ni o n of t he 
I n vesti gat or, c o nti n ue d treat me nt p oses a ris k t o t heir healt h.
F or s u bjects disc o nti n u i n g fr o m t he st u d y, t he I n vesti gat or m ust c o m plete all E xit pr oce d ures 
acc or di n g t o Ta ble 3- 1, Sc he d ule of St u d y Pr oce d ures a n d Assess me nts, if t he s u bject is 
willi n g a n d a ble, a n d if i n t he o pi ni o n of t he I n vesti gat or it is safe f or t he s u bject t o d o s o.
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.
To  e ns ure t he safety 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 necessar y, a d vise t he m of a n y t hera pies a n d/ or me dical pr oce d ures t hat ma y  be 
nee de d t o mai ntai n t heir healt h.
1 0. 4. 3 Sc he d ule of Pr oce d ures a n d Assess me nts f or S u bjects Disc o nti n ue d 
fr o m I n vesti g ati o n al Pr o d uct 
Ot her t ha n scree n fail ures, i f a s u bject disc o nti n ues fr o m t he st u d y the s u bject s h o ul d u n der g o 
a n Earl y E xit visit . Refer t o T a ble 3 -1 Sc he d ule of St u d y  Pr oce d ures a n d Assess me nts.
1 0. 5 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.
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
I m 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 nstructi o ns f or st u d y  ter mi nati o n.
o
I nf 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. 

T he I n vesti gat or m ust:
o
Pr o m ptl y  n otif y t he I RB/I E C 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
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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7
Pr o vi de s u bject s 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.

Page 37 of 52
The Investigator may terminate the site’s participation in the study for reasonable cause.
10.5.1 Follow-up of subjects after study participation has ended 
Following this study, the subject will return to their eye care professional for their routine eye 
care.
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES
11.1 General Information
An AE is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, 
whether or not related to the investigational medical device (test article). Refer to the 
Glossary of Terms and figures below for categories of AEs and SAEs.
Figure 11–1
Categorization of All Adverse Events
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Pa ge 3 8 of 5 2
Fi g ur e 11 - 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 ng 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 pres u me d i nfecti o us ulcer wit h a n y 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

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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7
H y p o p y o n

Pa ge 3 9 of 5 2

H y p he ma

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 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 
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 Si g nifica nt N o n- Seri o us 
A d verse E ve nt:

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 n ts

C or neal stai ni n g sc ore greater t ha n or e q ual t o G ra de 3 ( Refer t o M O P f or gra di n g scales) 
[ Gra di n g scale is base d u p 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 G ra de 2 ( Refer t o M O P f or gra di n g 
scales) [ Gra di n g scale is base d u p 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]
T he a b ove eve nts ar e b ase d u p o n t he c ate g ories pr ovi de d i n t he I S O 11 9 8 0 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.
Device Deficie ncies
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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7
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 
D e 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: 

Pa ge 4 0 of 5 2

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 )

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, mis la bele d pr o d uct)

S us pect pr o d uct c o nta mi nati o n

Lac k of perf or ma nce
1 1. 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?”
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 oc 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. 
1 1. 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 ditio 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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7
e C R F wit hi n 2 4 h o urs of 
t he In vesti gat or ’s or site’s a ware ness.

Pa ge 4 1 of 5 2

A pri nte d c o p y of t he c o m plet e 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 secti 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 
F T W . me dical _safety @ alc o n.c o m 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 ntati ves 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 gator 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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 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 sy 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 42 of 52
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.
11.4 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 
(GPCMS).
11.5 Unmasking of the Study Treatment
Masked information on the identity of the assigned medical device should not be disclosed 
during the study. 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 requirements.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0054027
Protocol - Clinical
24-Aug-2017

Page 43 of 52
11.6 Follow-Up of Subjects with Adverse Events 
The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study. 
The Investigator should provide the Study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (ie, database lock). 
Any additional data received up to 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 (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
Women of childbearing potential or women who are pregnant at the time of study entry are 
not excluded from participation. Pregnancy should be included in the Medical History section 
of the eCRF when a pregnant woman enters the study or if a woman becomes pregnant 
during the study. Pregnancy is not reportable as an AE; however, complications may be 
reportable and will be decided on a case–by-case basis. 
12 ANALYSIS PLAN
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.
All analyses will be conducted according to the applicable statistical analysis plan.
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.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0054027
Protocol - Clinical
24-Aug-2017

Pa ge 4 4 of 5 2
1 2. 2 A n al ysis Sets
Fi ve a nal y sis sets will be defi ne d:
a)
All E nr olle d – all s u bjects si g ni n g t he inf or me d co nse nt for m
b)
E nr olle d Dis pe nse d – s u bjects/e yes fr o m All E nr olle d w h o ha ve bee n e x p ose d t o st u d y  
le nses
c)
E nr olle d N ot Dis pe nse d – s u bjects/e yes fr o m All E nr olle d w h o ha ve n ot bee n e x p ose d 
t o st u d y le nses
d)
C o m plete d – E nr olle d Dis pe nse d s u bjects c o m pleti n g t he st u d y
e)
Disc o nti n ue d – E nr olle d Dis pe nse d w h o di d n ot c o m plete t he st u d y
1 2. 3 De m o gr a p hic a n d B aseli ne C h ar acteristics
De m o gra p hic i nf or mati o n, 
 
 a n d ha bit ual le ns inf or mati o n will be prese nte d b y le ns gr o u p a n d o verall f or 
t he All E nr olle d set.
 
1 2. 4 Effecti ve ness A n al yses
F o r eac h of t he pri mar y 
effecti ve ness e n d p oi nts, se parate s u m mar y  ta bles 
will be pre pare d f or t he C o m plete d a n d t he Disc o nti n ue d sets as f oll o ws:

C o m plete d C o ntr ol (e y es/s u bjects)

C o m plete d Te st (e yes/s u bjects)

Disc o nti n ue d C o ntr ol (e yes/s u bj ects)

Disc o nti n ue d T est (e yes/s u bjects)
 
 
 
1 2. 4. 1 A n al ysis of Pri m ar y Effecti ve ness E n d p oi nt
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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7
T he pri mar y  o bjecti ve of t his st u d y is t o de m o nstrate t he effecti ve ness a n d safety of D D T 2 
c o m pare d t o D T 1. 

Pa ge 4 5 of 5 2
T he pri mar y  e n d p oi nt is V A wit h st u d y  le nses, c ollecte d by e ye .
1 2. 4. 1. 1
St atistic al H y p ot heses
N o h y p ot hesis testi n g of t he pri mar y  effecti ve ness e n d p oi nt is pla n ne d.
1 2. 4. 1. 2
A n al ysis Met h o ds
S u m mar y  statistics will be pr o vi de d. 
A d diti o nall y , t he f oll o wi n g will be prese nte d:

S hift ta ble c o m pari n g V A at dis pe nse vs s u bse q ue nt visits

Fre q ue nc y  a n d perce nt f or V A  of 2 0/ 3 0 or better, fi nal V A  wit hi n 1 li ne of Dis pe nse , fi nal 
V A  w orse t ha n 1 li ne of Dis pe nse

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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7
Listi n g f or V A c ha n ges fr o m Dis pe nse of 2 or m ore li nes d uri n g t he st u d y

Pa ge 4 6 of 5 2
1 2. 5 H a n dli n g of Missi n g D at a
All data o btai ne d i n e val ua ble s u bjects/e y es will be use d. N o i m p utati o n f or missi n g val ues 
will be carrie d o ut. 
I nci de nce a n d reas o ns f or disc o nti n uati o n b y  le ns gr o u p will be ta b ulate d at eac h visit a n d 
o verall.
1 2. 6 S afet y A n al ys es
T he safet y e n d p oi nts are: 

A E s

De vice Deficie ncies

Bi o micr osc o p y
T here are n o safet y h y p ot heses pla n ne d i n t his st u d y. T he f oc us of t he safet y a nal ys is will be 
a c o m pre he nsi ve descri pti ve assess me nt of occ urre nce of A E as well as t he ot her liste d 
para meters.
Descri pti ve s u m maries (c o u nts a n d perce nta ges) f or oc ular a n d n o n oc ular A Es will be 
prese nte d b y M e dical Dicti o nar y f or Re g ulat or y Acti vities Preferre d Ter ms, f or C o m plete d 
a n d Disc o nti n ue d sets. A listi n g c o ntai ni n g details of t he A Es w ill als o be pr o vi de d.
Eac h bi o micr osc o p y para meter will be ta b ulate d b y its gra de, o n C o m plete d a n d 
Disc o nti n ue d sets.
Fre q ue nc y  f or eac h de vice deficie nc y cate g or y will be prese nte d a n d a s u p p orti n g listi n g will 
be pr o vi de d.
1 2. 7 I nteri m A n al yses a n d Re p orti 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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7
T here are n o pla ns t o c o n d uct a n i nteri m a nal ys is.

Page 47 of 52
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 
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. 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
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Print Date:  
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At a mi ni m u m, s o urce d oc u me nts 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 nicity)

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 visits

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 he 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

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
It is re q uire d t hat t he a ut h or of a n e ntr y i n t he s o urce d oc u me nts be i de ntifia ble. Direct access 
t o s o urce d oc u me ntati o n ( me dical rec or ds) m ust be all o we d f or t he p ur p ose of verif yi n g t hat 
t he data rec or de d o n t he C R F are c o nsiste nt wit h t he ori gi nal s o urce data.
O nl y  desi g nate d i n di vi d uals at t he site will c o m plete t he C R Fs. T he C R Fs m ust be c o m plete d 
at re g ular i nter vals f oll o wi n g t he cli nical st u d y  visit sc he d ule. It is e x pecte d t hat all data 
re p orte d ha ve c orres p o n di n g e ntries i n t he s o urce d oc u me nts. T he Pri nci pal I n vesti gat or is 
res p o nsi ble f or re vie wi n g a n d certif yi n g t hat t he C R Fs are acc urate a n d c o m plete. T he o nl y 
s u bject i de ntifiers rec or de d o n t he C R Fs will be s u bject n u m ber, a n d s u bject de m o gra p hic 
i nf or mati o n.
1 3. 3 D at a Re vie w a n d Cl arific ati o ns
A re vie w of C R F data t o t he s u bject’s s o urce data will be c o m plete d b y t he site m o nit or t o 
e ns ure c o m plete ness a n d acc urac y. After t he C R Fs ha ve bee n c o m plete d, a d diti o nal data 
clarificati o ns a n d/ or a d diti o ns ma y  be nee de d as a res ult of t he data clea ni n g process. Data 
clarificati o ns are d oc u me nte d a n d are part of eac h s u bject’s C R F.
1 3. 4 S p o ns or a n d M o nit ori n g Res p o nsi bilities
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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7
T he St u d y  S p o ns or will desi g nate a m o nit or t o c o n d uct t he a p pr o priate site visits at t he 
a p pr o priate i nter vals acc or di n g t o t he st u d y m o ni t ori n g pla n. T he cli nical i n vesti gati o n will 
be m o nit ore d t o e ns ure t hat t he ri g hts a n d well -bei n g of t he s u bjects are pr otecte d, t he 

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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 
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.
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Pa ge 5 0 of 5 2
1 4 E T HI C S
T his cli nical st u d y  m ust be c o n d ucte d i n acc or da nce wit h t he et hical pri nci ples c o ntai ne d 
wit hi n: 

T he D eclarati o n of H elsi n ki, a n d i n c o m plia nce wit h t he I C H E 6 G C P  C o ns oli date d 
G ui deli ne, I S O 1 4 1 5 5: 2 0 1 1, a n d t he a p plica ble U S F D A 2 1 C o de of Fe deral Re g ulati o ns. 

S O Ps of t he St u d y  S p o ns or a n d c o ntract researc h or ga nizati o ns partici pati n g i n t he 
c o n d uct of t he cli nical st u d y a n d all ot her a p plica ble re g ulati o ns. 

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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7
N otificati o ns a n d ti meli nes f or re p orti n g pr ot oc ol de viati o ns s h o ul d be base d u p o n
a p plica ble Et hics C o m mittee re q uire me nts
T he I n vesti gat or m ust e ns ure t hat all pers o n nel i n v ol ve d i n t he c o n d uct of t he st u d y  are 
q ualifie d t o perf or m t heir assi g ne d res p o nsi bilities t hr o u g h rele va nt e d ucati o n, trai ni n g, a n d 
e x perie nce. T he I n vesti gat or a n d all cli nical st u d y staf f m ust c o n d uct t he cli nical st u d y i n 
c o m plia nce wit h t he pr ot oc ol. De viati o ns fr o m t his pr ot oc ol, re g ulat or y  re q uire me nts, a n d/ or 
G C P m ust be rec or de d a n d re p orte d t o t he S p o ns or pri or t o data base l oc k. If nee de d, 
c orrecti ve a n d pre ve nti ve acti o n s h o ul d be i de ntifie d, i m ple me nte d, a n d d oc u me nte d wit hi n 
t he st u d y rec or ds. Use of wai vers t o de viate fr o m t he cli nical pr ot oc ol is pr o hi bited.
Bef ore cli nical st u d y  i nitiati o n, t his pr ot oc ol, t he i nf or me d c o nse nt f or m, a n y ot her writte n 
i nf or mati o n gi ve n t o s u bjects, a n d a ny a d vertise me nts pla n ne d f or s u bject recr uit me nt m ust 
be a p pr o ve d b y a n I R B/I E C. T he I n vesti gat or m ust pr o vi de d oc u me ntati o n of t he I R B/I E C 
a p pr o val t o t he St u d y S p o ns or. T he a p pr o val m ust be date d a n d m ust i de ntif y t he a p plica ble 
pr ot oc ol, a me n d me nts (if a n y ), i nf or me d c o nse nt f or m, asse nt f or m (if a n y), all a p plica ble 
recr uiti n g materials, writte n i nf or mati o n f or s u bject, an d s u bject c o m pe nsati o n pr o gra ms. T he 
I RB/I E C m ust be pr o vi de d wit h a c o p y of t he I B, a n y peri o dic safety u p dates, a n d all ot her 
i nf or mati o n as re q uire d b y l ocal re g ulati o n a n d/ or t he IR B/I E C. At t he e n d of t he st u d y , t he 
I n vesti gat or m ust n otif y t he IR B/I E C a b o ut t he st u d y ’s c o m pleti o n. T he I RB/I E C als o m ust 
be n otifie d if t he st u d y  is ter mi nate d pre mat urel y. Fi nall y, t he I n vesti gat or m ust re p ort t o t he 
I RB/I E C o n t he pr o gress of t he st u d y  at i nter vals sti p ulate d b y t he I R B/I E C.
Vo l u ntar y i nf or me d c o nse nt m ust be o btai ne d i n writi n g fr o m e ver y s u bject a n d t he pr ocess 
s hall be d oc u me nte d bef ore a ny pr oce d ure s pecific t o t he cli nical i n vesti gati o n is a p plie d t o 
t he s u bject. T he I n vesti gat or m ust ha ve a defi ne d pr ocess f or o btai ni n g c o nse nt. S pecificall y , 
t he I nvesti gat or , or t heir dele gate, m ust e x plai n t he cli nical st u d y  t o eac h p ote ntial s u bject a n d 
t he s u bject m ust i n dicate v ol u ntar y c o nse nt b y si g ni n g a n d dati n g t he a p pr o ve d i nf or me d 
c o nse nt f or m. T he s u bject m ust be pr o vi de d a n o p p ort u nit y t o as k q uesti o n s of t he 
I n vesti gat or, a n d if re q uire d b y l ocal re g ulati o n, ot her q ualifie d pers o n nel. T he I n vesti gat or 

Pa ge 5 1 of 5 2
m ust pr o vi de t he s u bject wit h a c o p y of t he c o nse nt f or m writte n i n a la n g ua ge t he s u bject 
u n dersta n ds. T he c o nse nt d oc u me nt m ust meet all a p plica ble l o cal la ws a n d pr o vi de s u bjects 
wit h i nf or mati o n re gar di n g t he p ur p ose, pr oce d ures, re q uire me nts, a n d restricti o ns of t he 
st u d y, al o n g wit h a n y k n o w n ris ks a n d p ote ntial be nefits ass ociate d wit h t he I P a n d t he st u d y, 
t he a vaila ble c o m pe nsati o n, a n d t he esta blis he d pr o visi o ns f or mai ntai ni n g c o nfi de ntialit y of 
pers o nal, pr otecte d healt h i nf or mati o n. S u bjects will be t ol d a b o ut t he v ol u ntar y  nat ure of 
partici pati o n i n t he st u d y  a n d 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 uesti 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 by 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 py of t he c o nse nt (file i n 
s u bject’s me dical rec or ds) a n d m ust pr o vi de a d u 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. 
T he St u d y  S p o ns or ass ures t hat t he ke y desi g n ele me nts of t his pr ot oc ol will be re gistere d o n 
w w w .cli nicaltrials. g o v as re q uire d by c urre nt re g ulati o ns a n d, if a p plica ble, ot her p u blic 
data bases as re q uire d b y l ocal c o u ntr y re g ulati o ns. In a d diti o n, res ults of t his st u d y  will be 
ma de p u blicl y  a vaila ble o n w w w.cli nicaltrials. g o v re gar dless of o utc o me as re q uire d by 
c urre nt re g ulati o ns a n d, if a p plica ble, i n ot her p u blic data bases as re q uire d b y  l ocal c o u ntr y 
re g ulati o ns.
1 5 R E F E R E N C E S
1 5. 1 Refere nces a p plic a ble f or all cli nic al st u dies

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 1 1 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 5. 1. 1 U S refere nces a p plic a ble f or cli nic al st u dies

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

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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7
T he Calif or nia Bill of Ri g hts

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1 5. 2 Refere nces f or t his cli nic al st u d y

Pre mar ket N otificati o n ( 5 1 0( k)) G ui da nce D oc u me nt f or Dail y Wear C o ntact Le nses

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 1 1 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

D u m blet o n K, W o o ds C, J o nes L , F o n n D, Sar wer D. Patie nt a n d Practiti o ner C o m plia nce 
wit h Silic o ne H y dr o gel a n d Dail y  Dis p osa ble Le ns Re place me nt i n t he U nite d States. Eye 
C o nt act Le ns
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 0 2 7
P r o t o c o l  -  C l i n i c a l
2 4- A u g- 2 0 1 7
. 2 0 0 9: 3 5( 4): 1 6 4-1 7 1.

                                                                                                                
                                                                                     
Date/Time 
(mm/dd/yyyy GMT):
Signed by:
Justification:
08/24/2017 13:43:11
08/23/2017 17:49:11
08/23/2017 17:36:08
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Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0054027
Protocol - Clinical
24-Aug-2017