Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month
Phase: NA
Conditions: Ametropia
Sponsor: CooperVision, Inc.

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
1  
 
 
 
 
P erf or m a nc e  of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric 
Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
 
S p o ns or St u d y C o d e:  
E X -M K T G - 9 6 
Pr ot oc ol D at e : 
A u g ust ,  2 0 18 
S p o ns or C o m p a n y :   
C o o p er Visi o n, I nc.  
D oc u m e nt T y p e:  
Pr ot oc ol  
St u d y C at e g or y:  
 
P ost M ar k et  
 
 
 
 
Cli nic al Sit e:  
  
 
  
 
Dr. R u b e n V el az q u ez Pri v at e Pr actic e,  
    
  
 
 
  
  
 
   
  
  
  
 
 
  
 
 
Pr ot oc ol S p o ns or:   
  
 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  D at e: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
  
  
  
  
   
  
  
 
 
C o o p er Visi o n I nc.  
  
  
  
  
  
 
Sit e Pri nci p al I n v esti g at or:  _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
D at e: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
  
  
  
  
 
 
Sc h o ol of  O pt o m etr y, N ati o n al A ut o n o m o us U ni v ersit y  
 
R e visi o n Hist or y  
D oc u m e nt n u m b er  
D at e  
C o m m e nts  
 
 
 
 
 
  
  
E X -M K T G -9 6  
A u g ust 2 1, 2 0 1 8  
FI N AL 
 

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
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C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
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C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
4  
T a bl e of C o nt e nt s  
1  
I ntr o d u cti o n ............................................................................................................ 6 
2  
St u d y O bj e cti v e  ...................................................................................................... 6 
3  
St u d y H y p o t h e si s ................................................................................................... 7 
3. 1  
St u d y Hy p ot h esis  ............................................................................................................ 7 
4  
St u d y D e si g n  .......................................................................................................... 7 
5  
I n v e sti g ati o n al Sit e s .............................................................................................. 7 
5. 1  
N u m b er of Sit es  .............................................................................................................. 7 
5. 2  
I n v esti g at or R ecr uit m e nt ................................................................................................ 7 
6  
Et hi c s R e vi e w / St at e m e nt of C o m pli a n c e  ........................................................... 8 
6. 1  
R el e v a nt St a n d ar ds / G ui d eli n es  ..................................................................................... 8 
6. 2  
I nstit uti o n al R e vi e w B o ar d .............................................................................................. 8 
6. 3  
Cli nic al Tri al R e gistr ati o n  ................................................................................................ 8 
6. 4  
I nf or m e d C o ns e nt ........................................................................................................... 8 
7  
P ot e nti al Ri s k s a n d B e n efit s t o H u m a n S u bj e ct s  ................................................ 8 
8  
M at eri al s a n d M et h o d s  .......................................................................................... 9 
8. 1  
P artici p a nts  ..................................................................................................................... 9 
I n cl u si o n crit eri a ...................................................................................................................... 9 
8. 2  
St u d y M at eri als  ............................................................................................................. 1 1  
8. 2. 1  
C o nt act l e ns  .............................................................................................................. 1 1  
8. 2. 2  
C o nt act L e ns c ar e  ...................................................................................................... 1 1  
8. 2. 3  
St or a g e of St u d y M e dic ati o ns/ Tr e at m e nts  .............................................................. 1 1  
8. 2. 4  
Cli nic al S u p pl y I n v e nt or y  ........................................................................................... 1 1  
8. 2. 5  
Dis p os al of C o ns u m a bl es  .......................................................................................... 1 1  
8. 2. 6  
M as ki n g a n d C o ntr ol of St u d y M at eri als  .................................................................. 1 2  
8. 2. 7  
Or d eri n g a n d Acc o u nt a bilit y of St u d y M at eri als  ...................................................... 1 2  
8. 3  
Visit Sc h e d ul e a n d Pr oc e d ur es ...................................................................................... 1 2  
8. 3. 1  
Visit 1: B as eli n e a n d fitti n g visit (scr e e ni n g a n d e nr oll m e nt)  ................................... 1 2  
8. 3. 2  
Visit 2: V ert ex T oric L e ns es  ....................................................................................... 1 3  
8. 3. 3  
Visit 3: 1 -m o nt h f oll o w -u p V ert ex T oric / dis p e ns e A v air a Vit alit y T oric  ................. 1 4  
8. 3. 4  
Visit 4: F oll o w -u p A v air a Vit alit y T oric ( Aft er 2 w e e ks of w e ar)  ............................... 1 5  

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
5  
8. 3. 5  
Visit 5: F oll o w -u p A v air a Vit alit y T oric ( Aft er 1 - m o nt h of w e ar / exit)  .................... 1 6  
9  
A d v er s e R e s p o n s e D efi niti o n s  ........................................................................... 1 7  
9. 1  
Pr oc e d ur es f or A d v ers e E v e nts  ..................................................................................... 1 8  
9. 2  
Disc o nti n u ati o n fr o m t h e St u d y  .................................................................................... 1 9  
9. 3  
R e p orti n g A d v ers e E v e nts  ............................................................................................. 1 9  
1 0  St ati sti c al A n al y si s a n d S a m pl e Si z e  ................................................................. 2 0  
1 0. 1  
St atistic al a n al ysis  ......................................................................................................... 2 0  
1 0. 2  
S a m pl e siz e  .................................................................................................................... 2 0  
1 1  D at a Q u alit y A s s ur a n c e  ....................................................................................... 2 1  
1 1. 1  
St u d y m o nit ori n g  .......................................................................................................... 2 1  
1 1. 2  
R ec or d k e e pi n g  ............................................................................................................. 2 1  
1 1. 3  
R ec or d r et e nti o n  ........................................................................................................... 2 1  
1 1. 4  
D at a E ntr y / D at a M a n a g e m e nt  .................................................................................... 2 1  
1 1. 5  
C o nfi d e nti alit y  ............................................................................................................... 2 1  
1 1. 6  
P u blic ati o n  .................................................................................................................... 2 2  
 
  
  
  
 
 
 
 
 
 
 
 
 

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
6  
1  I ntr o d u cti o n 
T h e  utiliz ati o n  of  s oft  toric  c o nt act l e ns es h as   i ncr e as e d si g nific a ntl y o v er t h e  p ast f e w y e ars. 
T oric  c o ntact l e ns w e a r ers d e m a n d t w o t hi n gs fr o m t h eir c o nt act l ens es,  gr e at  c o mf ort  a nd 
exc ell e nt  visi o n.  C o o p e r Visi o n’s A v air a Vit alit y ™ t oric us es a t hir d g e n er ati o n silic o n e h y dr o g el 
m at eri al  w hic h  m a k es  t h e  l e ns  i n h er e ntl y  w ett a bl e  wit h  n o  s urf ac e  tr e at m e nts,  a n d  us es  
n at ur all y w ett a bl e b uil di n g bl oc ks t o i m pr o v e c o m p ati bilit y b et w e e n silic o n e a n d h y dr o p hilic 
d o m ai ns. T his, c o m bi n e d wit h t h e hi g h er w at er c o nt e nt of A v air a Vit ality ™ t oric e ns ur es a hi g h 
p erf or mi n g, c o mf ort a bl e l e ns.  
V ert ex T oric c o nt act l e ns es ar e p art of a n ol d er g e n er ati o n of a h y dr o g el c o nt act l e ns p ortf oli o 
fr o m C o o p er Visi o n w hic h will b e disc o nti n u e d fr o m t he m ar k et i n t h e n e ar f ut ur e. T h er ef or e, 
C o o p er Visi o n is i nt er est e d i n e v al u ati n g t h e cli nic al p erf or m a nc e of existi n g w e ar ers of V ert ex 
T oric c o nt act l e ns es aft er a r efit wit h A v air a Vit alit y ™ silic o n e h y dr o g el t oric l e ns es o v er 1 -m o nt h 
of d ail y w e ar.  
2  St u d y O bj e cti v e    
T h e  ai m  of  t his  pr os p ecti v e  st u d y  is  t o  ev al u at e  t h e  cli nic al p erf or m a nc e of h a bit u al 
w e ar ers of V ert ex T oric l e ns es aft er a r efit wit h A v air a Vit alit y T oric l e ns es f or 1 -m o nt h of d ail y 
w e ar.  
 
T h e  pri m ar y  v ari a bl es  of  i nte r est ar e:  
•  L e ns fitti n g c h aract e ristics  
T h e  s ec o n d ar y v ari a bl es  of  i nte r est ar e:  
•  W e a ri n g ti me s ( a ve r ag e a n d c o mf o rt a ble) 
  
  
    
 
 
 
 
 
 
 
 
 
   
 
 
  
 
 
  
  
 
   
 
 
  
  
 
 
 
  
 
 
 
  
  
  
 
 
 
 
 
 
  
   
 
    
 
 
 

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
7  
3  St u d y H y p ot h e si s   
3. 1   St u d y H y p ot h e si s   
•  N ull h y p ot h esis ( H o): T h e r e is n o diff er e nc e i n l e ns fitti n g c h ar act eristics b et w e e n t h e 
t w o t oric l e ns es f or t h e k e y v ari a bl es t est e d. 
•  Alt er n ati v e h y p ot h esis ( H 1): T h er e is a diff er e nc e i n l e ns fitti n g c h ar act eristics b et w e e n 
t h e t w o t oric l e ns es f or t h e k e y v ari a bl es t est e d. 
4  St u d y D e si g n  
T his  is  a  pr os p ecti v e,  s u bj ect  m as k e d;  bil at er al,  1 -m o nt h  r efit  st u d y  c o m p ari n g  t h e  fitti n g  
c h ar act eristics of V ert ex T oric h y dr o g el l e ns es, ( m et h afilc o n A) ; a g ai nst A v air a Vit alit y silic o n e 
h y dr o g el T oric  l e ns es (f a nfilc o n  A).  A  t ot al  of  4 0  s u bj ects will b e e nr oll e d  wit h  t h e  ai m of  
c o m pl eti n g 3 4. 
S u bj ect’s will b e e v al u at e d at t h e first visit a n d t h e n fitt e d wit h b ot h st u dy l e ns es t o c o nfir m l e ns 
fit 
  
  
  
    
. At t h e s ec o n d visit, t h e first p air of st u d y l e ns es, ( e. g. 
m et h afilc o n A), will b e dis p e ns e d a n d w or n f or 1 -m o nt h. Aft er 1 -m o nt h of d ail y w e ar wit h t h e 
first p air, s u bj ects will r et ur n f or a t hir d e v al u ati o n a n d t h e n fitt e d wit h t h e s ec o n d p air, ( e. g. 
f a nfilc o n A), of st u d y l e ns es f or 1 -m o nt h. A f o urt h visit will b e sc h e d ul e d aft er 2 -w e e ks of l e ns 
w e ar. A fift h a n d fi n al visit will b e sc h e d ul e d aft er 1 -m o nt h of l e ns w e ar. T h e st u d y ti m eli n e is 
sh o w n i n 
  
5  I n v e sti g ati o n al Sit e s 
5. 1   N u m b er of Sit e s 
T his will b e a si n gl e -c e nt er i n v esti g ati o n al sit e i n M exic o Cit y. ( T ar g et 4 0 s u bj ects, c o m pl et e 3 4).   
5. 2   I n v e sti g at or R e cr uit m e nt  
T his st u d y will b e c o n d uct e d at t h e Sc h o ol of O pt o m etr y Cli nic; N ati o n al A ut o n o m o us U ni v ersit y 
( U N A M) M exic o Cit y. T h e I n v esti g at ors will b e r e q uir e d t o f ulfil t h e f oll o wi n g crit eri a: 
•  Lic e ns e d Opt o m etrist wit h at l e ast t w o y e ars of c o nt act l e ns fitti n g ex p eri e nc e.  
•  Ex p eri e nc e d I n v esti g at ors w h o will b e tr ai n e d i n G o o d Cli nic al Pr actic e ( G C P) b y t h e 
pri nci p al i n v esti g at or.  
•  I n-offic e e m ail or f ax.  
•  Willi n g n ess t o f oll o w t h e st u d y pr ot oc ol a n d t o c o -o p er at e wit h t h e st u d y m o nit ors.  

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
8  
T his cli nic al st u d y is d esi g n e d t o b e i n c o nf or m a nc e wit h t h e et hic al pri nci pl es i n t h e D ecl ar ati o n 
of H elsi n ki, wit h t h e I C H g ui d eli n es f or G o o d Cli nic al Pr actic e ( G C P) a n d all t h e a p plic a bl e l oc al 
g ui d eli n es.  
6  Et hi c s R e vi e w / St at e m e nt of C o m pli a n c e  
6. 1   R el e v a nt St a n d ar d s / G ui d eli n e s 
T his i m pl e m e nt ati o n d oc u m e nt h as b e e n d e v el o p e d i n acc or d a nc e wit h t h e f oll o wi n g:   
•  
I S O 1 4 1 5 5 Cli nic al I nv esti g ati o n of M e dic al D evic es f or H u m a n S u bj ects, P arts 1 & 2, 2 0 1 1. 
•  
I C H H ar m o niz e d Tri p artit e G ui d eli n e f or G o o d Cli nic al Pr actic e E 6, 1 9 9 6. 
•  
D ecl ar ati o n of H elsi n ki  
•  
C O F E P RI S A p plic a bl e G ui d eli n es  
6. 2   I n stit uti o n al R e vi e w B o ar d 
T his st u d y will b e c o n d uct e d i n acc or d a nc e wit h I nstit uti o n al R e vi e w B o ar d r e g ul ati o ns ( U. S. 
2 1 C F R P art 5 6. 1 0 3) or a p plic a bl e I E C r e g ul ati o ns. C o pi es of all I R B/I E C c orr es p o n d e nc e wit h t h e 
i n v esti g at or/s p o ns or will b e k e pt o n fil e. T h e st u d y will c o m m e nc e u p o n a p pr o v al fr o m t h e 
f oll o wi n g Et hics C o m mitt e e: C o mit é d e Étic a M e dic a S ur. Sill ó n d e M e n d oz a # 1 1 0, C ol. T ori ell o 
G u err a, Tl al p a n, C P 1 4 0 5 0, M éxic o, D. F. T el e p h o n e n u m b er 5 4 2 4 7 2 0 0 ext. 4 1 5 7.  
 
6. 3   Cli ni c al Tri al R e gi str ati o n 
T his st u d y will b e r e gist er e d wit h cli nic altri als. g o v i n acc or d a nc e wit h s ecti o n 8 0 1 of t h e F o o d 
a n d Dr u g A d mi nistr ati o n ( F D A) Act w hic h m a n d at es t h e r e gistr ati o n of c ert ai n cli nic a l tri als of 
dr u gs a n d m e dic al d e vic es.  
6. 4   I nf or m e d C o n s e nt 
I nf or m e d  c o ns e nt  s h all  b e  o bt ai n e d  i n  writi n g  fr o m  t h e  s u bj ect  a n d  t h e  pr oc ess  s h all  b e  
d oc u m e nt e d b ef or e a n y pr oc e d ur e s p ecific t o t h e cli nic al i n v esti g ati o n is c arri e d o ut.  
7  P ot e nti al Ri s k s a n d B e n ef it s t o H u m a n S u bj e ct s 
T h er e m a y b e dir ect b e n efits t o t h e s u bj ects i n t his st u d y s uc h as  i m pr o v e d visi o n, c o mf ort, 
c o n v e ni e nc e, a n d c os m etic a d v a nt a g e.   P artici p ati o n i n a st u d y m a y c o ntri b ut e t o sci e ntific 
r es e arc h i nf or m ati o n t h at m a y b e us e d i n t h e d e vel o p m e nt of n e w c o nt act l e ns pr o d ucts. I n 
a d diti o n, s u bj ects will r ec ei v e a n ex a mi n ati o n of t h e fr o nt p art of t h eir ey es a n d m a y h a v e t h e 
o p p ort u nit y t o tr y a diff er e nt t y p e of s oft c o nt act l e ns es a n d/ or diff er e nt l e ns c ar e pr o d ucts at 
n o c ost t o t h e m. T h e  c o nt act l e ns m at eri als us e d i n t his st u d y ar e c o m m erci all y a v ail a bl e as d ail y 

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
9  
or ext e n d e d w e ar. T his st u d y will i n v esti g at e p artici p a nts’ w e ari n g sc h e d ul e i nt e n d e d f or d ail y 
w e ar ( N O T ext e n d e d w e ar) si mil ar t o t h e a v er a g e w e ari n g ti m e of 1 0 -1 6 h o urs f or d ail y w e ar 
l e ns es.  
T his st u d y is c o nsi d er e d t o b e a n o n -si g nific a nt ris k st u d y b as e d o n U nit e d St at e F o o d a n d Dr u g 
a d mi nistr ati o n  ( F D A)  a n d  I nt er n ati o n al  St a n d ar ds  Or g a niz ati o n  (I S O)  g ui d eli n es  b ec a us e  t h e  
st u d y d e vic es us e d as i nt e n d e d i n t his st u d y ( d ail y w e ar) d o n’t r e pr es e nt a p ot e nti al f or s eri o us 
ris k t o t h e h e alt h, s af et y or w elf ar e of t h e s u bj ect, a n d ( 2) it is n ot a n i m pl a nt, ( 3) it is n ot us e d t o 
s u p p ort or s ust ai n h u m a n lif e, ( 4) it is n ot of s u bst a nti al i m p ort a nc e i n di a g n osi n g, c uri n g, 
miti g ati n g or tr e ati n g dis e as e or ot h er wis e pr e v e nts i m p air m e nt of h u m a n h e alt h, ( 5) d o es n ot 
pr es e nt a p ot e nti al f or s eri o us ris k t o t h e h e alt h, s af et y or w elf ar e of t h e s u bj ect  
 
   
C o m plic ati o ns t h at m a y occ ur d uri n g t h e w e ari n g of c o nt act l e ns es i ncl u d e disc o mf ort, dr y n ess, 
ac hi n g or itc hi n g e y es, exc essi v e t e ari n g, disc h ar g e, h y p er e mi a a n d v ari a bl e or bl urr e d visi o n.  
M or e s eri o us ris ks m a y i ncl u d e p h ot o p h o bi a, iritis, c or n e al e d e m a or ey e i nf ecti o n. Alt h o u g h 
c o nt act l e ns-r el at e d i nf ecti o ns ar e v er y i nfr e q u e nt, t h e p ossi bilit y d o es exist.  T h e i nci d e nc e of 
i nf ecti o n d u e t o d a y-w e ar s oft l e ns es is 0. 0 3 5 %. Al m ost al w a ys a n i nf ecti o n will occ ur o nl y i n o n e 
e y e.  T his ris k is ass u m e d b y 3 5 -milli o n A m eric a ns w h o c urr e ntl y w e ar c o nt act l e ns es.  
R o uti n e cli nic al pr oc e d ur es i ncl u di n g a ut o -r efr acti o n, a ut o-k er at o m etr y, vis u al ac uit y, a nt eri or 
oc ul ar h e alt h ass ess m e nt, a n d c o nt act l e ns fitti n g will b e us e d. I n a d diti o n, hi g h m a g nific ati o n 
i m a gi n g of t h e l e ns fit m a y b e m a d e usi n g 3 5 m m or di git al c a m er as, i n vi v o c o nf oc al micr osc o p y, 
a n d/ or s p ec ul ar micr osc o p y . P ati e nts will b e m o nit or e d e v er y t w o w e e ks u ntil t h e e n d of t h e 
st u d y t o r e d uc e if n ot eli mi n at e t h e occ urr e nc e of a d v ers e or p ot e nti al a dv ers e e v e nts. P ati e nts 
will b e gi v e n i nstr ucti o ns fr o m t h eir E C P r e g ar di n g e arl y s y m pt o ms a n d si g ns of a d v ers e e v e nts 
a n d t h eir c o nt act i nf or m ati o n.  
8  M at eri al s a n d M et h o d s  
8. 1   P arti ci p a nt s 
A p pr oxi m at el y 4 0  h a bit u al s oft t oric c o nt act l e ns w e ar ers will b e e nr oll e d. E ac h s u bj ect will b e 
r e q uir e d t o att e n d u p t o fi v e sc h e d ul e d st u d y visits o v er a p eri o d of a p pr oxi m at el y t w o m o nt hs.  
E ac h s u bj ect will b e gi v e n a u ni q u e I D n u m b er. A d diti o n all y, all s u bj ects m ust m e et t h e st u d y 
i ncl usi o n a n d excl usi o n crit eri a list e d b el o w. 
I n cl u si o n crit eri a 
A p ers o n is eli gi bl e f or i ncl u si o n i n t h e st u d y if h e/s h e:  
•  
Is b et w e e n 1 8 a n d 4 0 y e ars of a g e (i ncl usiv e) 
•  
H as h a d a s elf -r e p ort e d vis u al ex a m  i n t h e l ast t w o y e ars 
•  
Is a n a d a pt e d s oft c o nt act l e ns w e ar er     
•  
H as  a c o nt act l e ns s p h eric al pr escri ptio n b et w e e n + 6 . 0 0 t o - 8. 00 (i ncl usi v e)  

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
1 0  
•  
H av e  n o l ess t h a n -0. 7 5 D of a sti g m atis m a n d n o m or e t h a n -2. 2 5  D i n b ot h e y e s.  
•  
C a n ac hi e v e b est c orr ect e d s p ect acl e dist a nc e vis u al ac uit y of 2 0/ 2 5 ( 0. 1 0 l o g M A R ) or b ett er i n 
e ac h ey e.  
•  
C a n ac hi e v e a dist a nc e  vis u al ac uit y of 2 0/ 3 0 (0. 1 8 l o g M A R ) or b ett er i n e ac h ey e wit h t h e st u dy 
c o nt act l e ns es. 
•  
H as cl e ar c or n e as a n d n o acti v e oc ul ar dis e as e  
•  
H as r e a d, u n d erst o o d a n d si g n e d t h e i nf or m ati o n c o ns e nt l ett er.   
•  
P ati e nt c o nt act l e ns r efr acti o n s h o ul d fit wit hi n t h e av ail a bl e p ar a m et ers of t h e st u dy l e ns es.  
•  
Is willi n g t o c o m pl y wit h t h e w e ar sc h e d ul e ( at l e ast 5 d a ys p er w e e k , > 8 h o urs/ d a y ass u mi n g 
t h er e ar e n o c o ntr ai n dic ati o ns f or d oi n g s o). 
•  
Is willi n g t o c o m ply wit h t h e visit sc h e d ul e  
E x cl u si o n Crit eri a  
A p ers o n will b e excl u d e d fr o m t h e st u d y if h e/s h e:  
•  
H as a CL pr escri pti o n o utsi d e t h e r a n g e of t h e a v ail a bl e p ar a m et ers of t h e st u dy l e ns es.  
•  
H as a s p ect acl e c yli n d er l ess t h a n -0. 7 5 D  or m or e t h a n -2. 5 0  D of cyli n d er i n eit h er e y e.  
•  
H as a hist or y of n ot ac hi evi n g c o mf ort a bl e CL  w e ar (5 d a ys p er w e e k; > 8  h o urs/ d a y)  
•  
H as c o nt act l e ns b est c orr ect e d dist a nc e visi o n w ors e t h a n 2 0/ 2 5  ( 0. 1 0 l o g M A R) i n eit h er e y e.  
•  
Pr es e nc e of cli nic all y si g nific a nt ( gr a d e 2 -4) a nt eri or s e g m e nt a b n or m aliti es  
•  
Pr es e nc e of oc ul ar or  syst e mic dis e as e or n e e d of m e dic ati o ns w hic h mi g ht i nt erf er e wit h c o nt act 
l e ns w e ar.  
•  
Slit l a m p fi n di n gs t h at w o ul d c o ntr ai n dic at e c o nt act l e ns w e ar s uc h as:  
o  
P at h ol o gic al dr y ey e or ass oci at e d fi n di n gs  
o  
Pt er y gi u m, pi n g u ec ul a, or c or n e al sc ars wit hi n t h e vis u al axis  
o  
N e o v asc ul ariz ati o n > 0. 7 5 m m i n fr o m of t h e li m b us  
o  
 Gi a nt p a pill ar y c o nj u ncti vitis ( G C P) w ors e t h a n gr a d e 1  
o  
A nt eri or u v eitis or iritis ( p ast or pr es e nt)  
o  
S e b orr h eic ecz e m a, S e b orr h eic c o nj u ncti vitis  
o  
Hist or y of c or n e al ulc ers or f u n g al i nf ecti o ns  
o  
P o or p ers o n al h y gi e n e  
•  
H as a k n o w n hist ory of c or n e al hy p o est h esi a (r e d uc e d c or n e al s e nsitivity)  
•  
H as a p h a ki a, ker at oc o n us or a hi g hl y irr e g ul ar c or n e a .  
•  
H as Pr es by o pi a or h as d e p e n d e nc e o n s p ect acl es f or n e ar w or k ov er t h e c o nt act l e ns es .  
•  
H as u n d er g o n e c or n e al r efr acti v e s ur g ery.  
•  
Is p artici p ati n g i n a ny ot h er t y p e of e y e r el at e d cli nic al or r es e arc h st u dy. 

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
1 2  
8. 2. 6  M a s ki n g a n d C o ntr ol of St u d y M at eri al s  
T h e  st u d y c o nt act l e ns es will b e m as k e d t o  t h e s u bj ect o nl y . St u d y l e ns es will b e tr a nsf err e d, b y 
a n assist a nt,  o ut of t h eir p ac k a gi n g  t o u n m ar k e d n e w c o nt act l e ns c as es fill e d wit h u n pr es er v e d 
st eril e s ali n e j ust pri or t o dis p e nsi n g t o m ai nt ai n s u bj ect m as ki n g of t h e st u d y l e ns es.    
8. 2. 7  Or d eri n g a n d A c c o u nt a bilit y of St u d y M at eri al s  
T h e st u d y l e ns es a n d s ol uti o ns will b e pr o vi d e d by t h e s p o ns or. If a d diti o n al l e ns es ar e r e q uir e d, 
t h e st u d y s p o ns or will r e-s u p pl y t h e i n v esti g at or as r e q u est e d . 
8. 3  Vi sit S c h e d ul e a n d Pr o c e d ur e s  
8. 3. 1  Vi sit 1: B a s eli n e v i sit (B a s eli n e / Fit V ert e x T ori c l e n s e s ) 
T h e f oll o wi n g e v al u ati o ns will b e p erf or m e d t o ass ess eli gi bilit y acc or di n g t o t h e I ncl usi o n a n d 
Excl usi o n Crit eri a at t h e b as eli n e visit o nl y:  
o  T h e s u bj ects s h o ul d att e n d t h e first visit w e ari n g t h eir s p ect acl e l e ns es.  If t h e y ar e n ot 
w e ari n g t h eir s p ect acl e l e ns es, pl e as e r esc h e d ul e t h e visit.  
o  T h e  s u bj ect  will  b e  r e q uir e d  t o  r e a d  a n d  si g n  a n  I nf or m e d  C o ns e nt  F or m  pri or  t o  
e nr ol m e nt. W h e n t h e s u bj ect h as si g n e d t h e c o ns e nt f or m, t h e s u bj ect will b e c o nsi d er e d 
t o b e e nr oll e d o n t o t h e st u d y. 
o  T h e p ers o n ex pl ai ni n g t h e c o ns e nt a n d I n v esti g at or s h o ul d als o si g n t h e c o ns e nt f or m.  
Pr o vi d e t h e s u bj ect wit h a c o p y a n d k e e p t h e ori gi n al i n t h e s u bj ect’s p a p er c h art or sc a n 
i nt o t h e s u bj ect’s el ectr o nic m e dic al r ec or d ( E M R) fil e. 
o  T h e s u bj ect is assi g n e d wit h a S u bj ect I D n u m b er. S u bj ects m ust b e e nr oll e d s e q u e nti all y.   
o  F ull a nt eri or s e g m e nt oc ul ar h e alt h will b e est a blis h e d  
Vi sit 1 a: B a s eli n e S p e ct a cl e L e n s e s  
T h e f oll o wi n g b as eli n e m e as ur e m e nts a n d ass ess m e nts will b e r ec or d e d:  
 
  
  
  
  
 
  
  
  
 
 
 
  
  
  
  
 
  
  
  
 
 
 
  
 
  
  
 
 
 
 
 
 
  
 
  
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
  
  
 
 
  
     
 

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
1 3  
 
  
 
 
 
  
  
•  C o m pl et e t h e eli gi bilit y c h ec klist.  
•  
If at t his p oi nt t h e s u bj ect is f o u n d t o b e i n eli gi bl e, t h e n c o m pl et e a n Exit f or m a n d exit t h e 
s u bj ect fr o m t h e st u dy. 
Vi sit 1 b: Fitti n g V ert e x T ori c l e n s e s  
If s u bj ect is eli gi bl e, c o m pl et e t h e E nr oll m e nt fr o m.  T h e s u bj ects will u n d er g o a tri al fit i n b ot h 
e y es wit h t h e V ert ex T oric a n d A v air a Vit alit y T oric l e ns es, ( acc or di n g t o m a n uf act ur er’s fitti n g 
g ui d es), 
  
 
    
  
  
  
    
  
  
  
 
 
  R e or d e r fi n al l e ns if ap pr o pri at e. If t h e fit 
 
 ar e s atisf act or y sc h e d ul e 
s u bj ects f or visit 2. If t h e l e ns es ar e n ot s uit a bl e t o b e dis p e ns e d t h e n t h e s u bj ect will b e 
disc o nti n u e d a n d a n Exit f or m will b e c o m pl et e d.  
8. 3. 2  Vi sit 2 : Di s p e n s e V ert e x T ori c L e n s e s  
•  D at a is o nl y c oll ect e d o n t h e fi n al p air of st u d y l e ns es dis p e ns e d aft er t h e p o w er h as 
b e e n ass ess e d  a n d if n e e d e d c orr ect e d.  
•  R ec or d  t h e  p ar a m et ers  of  t h e  l e ns es , l e ns  t y p e  a n d  p o w er, o n  t h e  Dis p e nsi n g  C R F  
 
 
•  T h e p erf or m a nc e of t h e l e ns es s h o ul d b e ass ess e d aft er 1 0 -1 5  mi n ut es s ettli n g ti m e a n d 
t h e f oll o wi n g v ari a bl es will b e ass ess e d 
   
 
   
 
  
 
  
 
 
 
 
  
    
   
 
 
 
  
    
   
 
 
 
  
   
 
  
  
 
  
  
  
 
 
 
 
 
  
  
  
 
 
 
 
o  L e ns Fit 
− L e ns c e ntr ati o n (c e nt er e d/sli g htl y d ec e nt er e d /s u bst a nti all y d ec e nt er e d ) 
− C or n e al c o v er a g e [ Y/ N]  
− P ost -bli n k m o v e m e nt ( 0 -5 Li k ert sc al e) 
− L e ns ori e nt ati o n i n pri m ar y p ositi o n of g az e (misl oc ati o n of t h e axis m ar k o n t h e l e ns r el ati v e t o 
t h e 6 o’cl oc k p ositi o n , z er o r ot ati o n, m e as ur e d i n d e gr e es) . 
− O v er all st a bilit y ( 0 – 4 sc al e, w h er e 0 = v er y p o or, 4 = exc ell e nt) .  
− R ot ati o n al r ec o v er y (l e ns a bilit y t o r et ur n t o its ori gi n al p ositi o n m e as ur e d 6 0 s ec o n ds aft er 
m a n u all y r ot ati n g t h e l e ns 4 5 0 d e gr e es t e m p or all y).  
− O v er all fit acc e pt a nc e ( 0  - 4) a n d r e as o n if Gr a d e 2 or l ess.  

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
1 4  
 
    
  
  
  
 
  
    
 
  
  
  
  
   
  
 
    
   
  
 
 
  
  
 
  
    
  
 
  
  
  
 
 
•  L ost or d a m a g e d st u d y l e ns es m a y b e r e pl ac e d. N ot e w hic h l e ns w as r e pl ac e d, d at e of 
r e pl ac e m e nt a n d  r e as o n f or r e pl ac e m e nt o n t h e L e ns R e pl ac e m e nt L o g, 
 
   
•  T h e s u bj ect will b e i nstr uct e d t o w e ar t h e l e ns es o n a d ail y w e ar b asis , ( at l e ast 4 0 h o urs 
p er w e e k) , u ntil t h e 1 -m o nt h f oll o w-u p a p p oi nt m e nt, u nl ess t h e y ex p eri e nc e a pr o bl e m 
w hic h w arr a nts l e ns r e m o v al.  
•  T h e I n v esti g at or or a cli nic al assist a nt will r e vi e w i nstr ucti o ns a n d w ar ni n gs f or l e ns w e ar, 
w h e n t o r e m o v e l e ns es, a n d ot h er i m p ort a nt iss u es wit h t h e p artici p a nt.  
•  P artici p a nts,  w h o a p p e ar u n a bl e or u n w illi n g t o f oll o w i nstr ucti o ns t o a d e gr e e t h at, i n 
t h e I n v esti g at or's o pi ni o n, j e o p ar dis es t h e p artici p a nt's w ell b ei n g  or t h e v ali dit y of t h e 
st u d y, will b e disc o nti n u e d. T h e r e as o n f or disc o nti n u ati o n will b e d oc u m e nt e d.  
•  T h e s u bj ect will b e disc h ar g e d a n d as k e d t o r et ur n f or a f oll o w -u p visit ( V 2) aft er 1 -m o nt h . 
8. 3. 3  Vi sit 3 : 1- m o nt h f oll o w -u p V ert e x T ori c / di s p e n s e A v air a Vit alit y T ori c  
T h e 1 -m o nt h f oll o w -u p visit will b e sc h e d ul e d f o ur w e e ks ( 2 8 + 2 d a ys) fr o m t h e i niti al l e ns 
dis p e nsi n g d at e.  T h e s u bj ect s h o ul d w e ar t h e l e ns es f or a mi ni m u m of 2 h o urs pri or t o t h e 
a p p oi nt m e nt.  If t h e s u bj ect att e n ds wit h o ut l e ns es or wit h l ess t h a n 2 h o urs of l e ns w e ar o n 
t h at d a y a n d t h e y ar e n ot h a vi n g a n y pr o bl e ms wit h t h eir l e ns es, t h e visit s h o ul d b e r esc h e d ul e d, 
if p ossi bl e wit hi n t h e visit wi n d o w. 
Vi sit 3 a: L e n s E v al u ati o n  V ert e x T ori c L e n s e s  
•  T h e f oll o wi n g cli nic al t est v ari a bl es will b e r ec or d e d o n t h e F oll o w -U p Visit C R F:  
o  W e ari n g ti m es:  
− W e ari n g ti m e t o d a y ( h o urs). 
− A v er a g e d ail y w e ari n g ti m e ( h o urs/ d a y)  
− A v er a g e c o mf ort a bl e w e ari n g ti m e ( h o urs/ d a y)  
− N u m b er of d a ys/ w e e k (l e ns es ar e w or n).  
 
 
 
 
  
  
    
 
  
 
  
  
 
  
  
  
  
 
 
  
  
  
  
 
  
    
  
 
  
 
    
  
 
 
 
  
  
  
  
 
  
  
  
    
   
 
 
 
  
  
    
 
 

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
1 5  
 
  
  
 
  
  
 
  
    
   
 
 
 
  
  
  
  
 
  
  
  
 
 
 
  
 
  
 
  
 
 
 
 
 
  
 
  
  
  
 
 
 
 
 
  
  
  
 
 
 
 
 
  
  
 
      
 
 
 
      
 
 
o  L e ns Fit 
˗ 
L e ns c e ntr ati o n (c e nt er e d/sli g htl y d ec e nt er e d/s u bst a nti all y d ec e nt er e d)  
˗ 
C or n e al c o v er a g e [ Y/ N]  
˗ 
P ost -bli n k m o v e m e nt ( 0 -5 Li k ert sc al e)  
˗ 
L e ns ori e nt ati o n i n pri m ar y p ositi o n of g az e ( misl oc ati o n of t h e axis m ar k o n t h e l e ns r el ati v e 
t o t h e 6 o’cl oc k p ositi o n, z er o r ot ati o n, m e as ur e d i n d e gr e es). 
˗ 
O v er all st a bilit y ( 0 – 4 sc al e, w h er e 0 = v er y p o or, 4 = exc ell e nt).   
˗ 
R ot ati o n al r ec o v er y (l e ns a bilit y t o r et ur n t o its ori gi n al p ositi o n m e as ur e d 6 0 s ec o n ds aft er 
m a n u all y r ot ati n g t h e l e ns 4 5 0 d e gr e es t e m p or all y).  
˗ 
O v er all fit acc e pt a nc e ( 0 - 4) a n d r e as o n if Gr a d e 2 or l ess.  
˗ 
R e m o v e st u d y l e ns es a n d p erf or m slit l a m p ex a mi n ati o n  
 
Vi sit 3 b : Di s p e n s e A v air a Vit alit y T ori c   
T h e st u d y s u bj ects will u n d er g o a tri al fit i n e ac h e y e wit h t h e s ec o n d p air of st u d y l e ns es.   
•  T h e p erf or m a nc e of t h e s ec o n d p air of st u d y l e ns es s h o ul d b e ass ess e d aft er 1 0 - 1 5 
mi n ut es s ettli n g ti m e. T h e s a m e v ari a bl es as t h os e c oll ect e d o n visit 2, s ecti o n 8. 3. 2  will 
b e ass ess e d.  
8. 3. 4  Vi sit 4 : F oll o w -u p A v air a Vit alit y T ori c ( Aft er 2 w e e k s of w e ar)  
T h e 2 -w e e k f oll o w -u p visit f or p air 2 will b e sc h e d ul e d t w o w e e ks ( 1 4 + 2 d a ys) fr o m t h e i niti al 
l e ns dis p e nsi n g d at e f or p air 2.  T h e s u bj ect s h o ul d w e ar t h e l e ns es f or a mi ni m u m of 2 h o urs 
pri or t o t h e a p p oi nt m e nt.  If t h e s u bj ect att e n ds wit h o ut l e ns es or wit h l ess t h a n 2 h o urs of l e ns 
w e ar o n t h at d a y a n d t h e y ar e n ot h a vi n g a n y pr o bl e ms wit h t h eir l e ns es, t h e visit s h o ul d b e 

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
1 6  
r esc h e d ul e d,  if  p ossi bl e  wit hi n  t h e  visit  wi n d o w.  T h e  s a m e  v ari a bl es  as  t h os e  c oll ect e d  o n  
s ecti o n 8. 3. 3 (visit 3 a) will b e ass ess e d at t his visit. 
8. 3. 5  Vi sit 5: F oll o w -u p A v air a Vit alit y T ori c ( Aft er 1 - m o nt h of w e ar / e xit)  
T h e 1 -m o nt h f oll o w- u p visit f or p air 2 will b e sc h e d ul e d t w o w e e ks ( 2 8 + 2 d a ys) fr o m t h e i niti al 
l e ns dis p e nsi n g d at e f or p air 2.  T h e s u bj ect s h o ul d w e ar t h e l e ns es f or a mi ni m u m of 2 h o urs 
pri or t o t h e a p p oi nt m e nt.  If t h e s u bj ect att e n ds wit h o ut l e ns es or wit h l ess t h a n 2 h o urs of l e ns 
w e ar o n t h at d a y a n d t h e y ar e n ot h a vi n g a n y pr o bl e ms wit h t h eir l e ns es, t h e visit s h o ul d b e 
r esc h e d ul e d,  if  p ossi bl e  wit hi n  t h e  visit  wi n d o w.  T h e  s a m e  v ari a bl es  as  t h os e  c oll ect e d  o n  
s ecti o n 8. 3. 3 (visit 3 a) will b e ass ess e d at t his visit. I n a d diti o n, a l e ns pr ef er e nc e q u esti o n 
b et w e e n h a bit u al, ( V ert ex T oric), a n d t est l e ns es, ( A v air a Vit alit y T oric), will b e as k e d at t h e e n d 
of t his visit.  
•  T h e St u d y Exit F or m m ust b e c o m pl et e d w h e n a s u bj ect exits t h e st u d y.  T his will occ ur 
eit h er at st u d y c o m pl eti o n, i. e. at Visit 5, or if t h e s u bj ect is disc o nti n u e d fr o m t h e st u d y 
at a n ot h er ti m e.  If t h er e ar e r ec or ds e nt er e d i nt o t h e cli nics o w n p ati e nt c h art s yst e m 
t h e exit d at e s h o ul d b e r ec or d e d o n t h es e s o urc e d oc u m e nts. A St u d y Exit F or m m ust b e 
c o m pl et e d f or all s u bj ects w h o h a v e t a k e n a st u dy I D n u m b er. P ost -st u d y f oll o w-u p visits 
will b e sc h e d ul e d if t h e I n v esti g at or j u d g es t his is n ec ess ar y.  
•  At t h e st u d y Exit Visit t h e f oll o wi n g m e as ur e m e nts ar e t a k e n:  
 R e m o v e  st u d y  l e ns es  
 
  
  
  
   
  
 
  
 
 
 
  
  
  
  
 
  
  
  
 
  
  
    
  
  
    
    
  
  
  
    
  
   
 
  
 
  
  
  
   
  
 
  
  
  
  
    
  
  
  
    
  
 
  
    
    
    
  
  
    
 
  
   
 
o  P ost -st u d y f oll o w-u p r e q uir e m e nt ( Y/ N).  If y es, t h e r e as o n a n d d at e of t h e f oll o w -
visit m ust als o b e r ec or d e d.  
•  
If t h e s u bj ect is b ei n g exit e d d u e t o disc o nti n u ati o n, f urt h er d et ails n e e d t o b e r ec or d e d 
o n t h e exit f or m.   
 
 

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
1 9  
j u d g m e nt of t h e i n v esti g at or t h e s u bj ect m a y b e r ef err e d t o a n o p ht h al m ol o gist f or tr e at m e nt. 
T h e i n v esti g at or will att e m pt t o d et er mi n e w h et h er t h e r e acti o n is r el at e d t o t h e t est d e vic e or a 
r es ult of ot h er f act ors.  
A n A d v ers e E v e nt F or m will b e c o m pl et e d f or e ac h a d v ers e e v e nt. If b ot h e y es ar e i n v ol v e d, a 
s e p ar at e A d v ers e E v e nt F or m will b e c o m pl et e d f or e ac h e y e. W h e n e v er p ossi bl e, t h e a d v ers e 
e v e nt will b e p h ot o -d oc u m e nt e d.  
Ex p e ns es i nc urr e d f or m e dic al tr e at m e nt as p art of st u d y p artici p ati o n will b e p ai d b y t h e 
s p o ns or ( bills a n d pr escri pti o n r ec ei pts k e pt). T h e s u bj ect m ust b e f oll o w e d u ntil r es ol uti o n a n d 
a writt e n r e p ort c o m pl et e d i n dic ati n g t h e s u bs e q u e nt tr e at m e nt a n d r es ol uti o n of t h e c o n diti o n.  
9. 2   Di s c o nti n u ati o n fr o m t h e St u d y  
All disc o nti n u ati o ns will b e f ull y d oc u m e nt e d o n t h e a p pr o pri at e C R F Exit a n d A d v ers e E v e nt 
f or ms as n e e d e d.  P artici p a nts will b e f oll o w e d u ntil r es ol uti o n (i n m ost i nst a nc es) a n d ar e fr e e 
of t h e o p ht h al mic i ns ert r el at e d c o m plic ati o ns or ot h er oc ul ar p at h ol o g y. W h e n p ossi bl e st u d y 
l e ns es i n v ol v e d i n a n A d v ers e E v e nt will b e r et ur n e d t o t h e s p o ns or i n a n e w ti g htl y s e al e d 
c o nt act l e ns c as e, a n d l a b el e d wit h t h e s u bj ect i d e ntific ati o n a n d st or e d i n U nis ol n o n -pr es er v e d 
s ali n e. 
9. 3   R e p orti n g A d v er s e E v e nt s 
All p ot e nti al  S eri o us a n d  U n a ntici p at e d A d v ers e D e vic e Eff ects  t h at ar e r el at e d or p ossi bl y 
r el at e d t o s u bj ect p artici p ati o n i n t h e i n v esti g ati o n will b e r e p ort e d t o t h e Pri nci p al I n v esti g at or 
a n d t h e s p o ns or wit hi n 2 4 h o urs of t h e i n v esti g at or b ec o mi n g a w ar e of t h e e v e nt. T h e Pri nci p al 
I n v esti g at or will r e p ort t h e ev e nt t o t h e E C/I R B as s o o n as p ossi bl e ( b y f ax, m ail/ d eli v er y, p h o n e, 
or e m ail), b ut wit hi n 1 0 b usi n ess d a ys of b ec o mi n g a w ar e of t h e pr o bl e m.  All f at al or lif e 
t hr e at e ni n g ev e nts will b e r e p ort e d i m m e di at ely t o t h e I R B. 
 
Si g nific a nt a n d N o n -Si g nific a nt A d v ers e E v e nts  will b e r e p ort e d t o t h e s p o ns or as s o o n as 
p ossi bl e, b ut n o l at er t h a n 5 w or ki n g d a ys aft er t h e occ urr e nc e.  
  
  
 
 
   
 
    
 
  
 
    
 
 
   
 
 
   
  
 
 
   
 
  
  
  
  
 
 
 
 
 
 

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
2 0  
1 0  St ati sti c al A n al y si s  a n d S a m pl e Si z e   
1 0. 1  St ati sti c al a n al y si s 
S u m m ar y st atistics will b e pr o d uc e d ( e. g. m e a n, st a n d ar d d e vi ati o n). Diff er e nc es b et w e e n l e ns es 
will  b e  c o m p ar e d  usi n g  P air e d  t -t ests.  P air e d  t-t ests  / a n al ysis  of  v ari a nc e  f or  n or m al  
(i nt er v al/c o nti n u o us)  d at a,  Wilc ox o n’s  si g n e d  r a n ks  t est  f or  n o n-n or m al  ( or di n al)  d at a,  c hi - 
s q u ar es  t est  f or  n o mi n al  d at a.   
  
  
  
  
    
  
  
 
 All p artici p a nts w h o w er e e v al u at e d will b e us e d i n t h e a n al ysis. I n t h e e v e nt of 
missi n g d at a, i n di vi d u al d at a p oi nts will b e excl u d e d  i n t h e a n al ysis a n d n ot extr a p ol at e d fr o m 
t h e c oll ect e d d at a.  
1 0. 2  S a m pl e si z e  
A s a m pl e siz e w as c alc ul at e d usi n g d at a fr o m a pr e vi o us st u d y. Ass u mi n g a st a n d ar d d e vi ati o n of 
1. 9 p oi nts, wit h 8 4 % p o w er a n d a n al p h a l e v el of 0. 0 5, a s a m pl e siz e of 3 4 s u bj ects is r e q uir e d  
    
    
  
  
  
  
  
   
  
  
  
 
 
 4 0 s u bj e cts will b e e nr oll e d t o acc o u nt f or p ot e nti al dr o ps o uts or 
disc o nti n u ati o ns.  
Fi g ur e 1. S a m pl e siz e c alc ul ati o n ( Mi nit a b 1 6 St atistics s oft w ar e)  
 

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
2 1  
1 1  D at a Q u alit y A s s ur a n c e  
1 1. 1   St u d y m o nit ori n g  
A sit e visit or disc ussi o n m a y b e c o n d uct e d d uri n g t h e c o urs e of t h e st u dy as a p pr o pri at e. Pri or 
t o fi n al d at a fr e ez e, a cl os e-o ut visit/ disc ussi o n m a y b e w arr a nt e d t o c h ec k f or acc ur acy a n d 
c o m pl et e n ess of r ec or ds. T h e s p o ns or or s p o ns or’s r e pr es e nt ati v es will b e a ut h oriz e d t o g ai n 
acc ess t o t h e s o urc e d oc u m e nt ati o n f or t h e p ur p os es of m o nit ori n g a n d a u diti n g t h e st u d y.  
 
1 1. 2  R e c or d k e e pi n g  
D et ail e d r ec or ds of all st u d y visits will b e m a d e usi n g t h e el ectr o nic C as e R e p ort F or ms ( C R Fs).  
1 1. 3  R e c or d r et e nti o n 
F oll o wi n g st u d y c o m pl eti o n, d at a will b e a v ail a bl e i n el ectr o nic a n d/ or p a p er f or m at f or a u dit, 
s p o ns or us e, or s u bs e q u e nt a n al ysis. T h e ori gi n al cli nic al r a w d at a (i ncl u di n g c o m pl et e d C R Fs a n d 
I nf or m e d C o ns e nt f or ms) will b e r et ai n e d acc or di n g t o g ui d eli n es s et f ort h i n t h e g e n er al w or k 
a gr e e m e nt wit h t h e sit e. T h e S p o ns or will b e n otifi e d a n d c o ns ult e d if ev er t h e fil es ar e t o b e 
d estr o y e d.  I n t h e e v e nt t h at t his i m pl e m e nt at i o n d oc u m e nt is i n dic at e d f or d esi g n v erific ati o n 
a n d  v ali d ati o n  p ur p os es,  as  i n dic at e d  o n  t h e  titl e  p a g e,  all  ori gi n al  r a w  d at a  f or ms  a n d  
c o m pl et e d C R F’s will b e f or w ar d e d t o t h e s p o ns or at c o m pl eti o n of t h e fi n al r e p ort.  
 
1 1. 4  D at a E ntr y / D at a M a n a g e m e nt 
D at a will b e e nt er e d i nt o a n el ectr o nic s pr e a ds h e et. St u d y st aff will o nl y b e a bl e t o m o dif y t h e 
d at a fil e vi a p ass w or d e ntr y. T h e i n v esti g at ors will b e r es p o nsi bl e f or t h e d at a i nt e grit y, a n d 
c o m pl et e d at a e ntr y f or e ac h visit as w ell as t h e t a k e h o m e q u esti o n n air es. T h e i n v esti g at or will 
s e n d t h e d at a  c oll ect e d t o t h e st u d y s p o ns or wit hi n 5 b usi n ess d a ys  aft er t h e l ast  s u bj ect 
c o m pl et es t h e fi n al visit. 
 
1 1. 5  C o nfi d e nti alit y 
T his st u d y is c o nfi d e nti al i n n at ur e. All i nf or m ati o n g at h er e d d uri n g t his st u d y is pr o pr i et ar y a n d 
s h o ul d b e m a d e a v ail a bl e o nl y t o t h os e dir ectl y i n v ol v e d i n t h e st u d y. I nf or m ati o n a n d r e p orts 
arisi n g fr o m t his pr oj ect ar e t h e pr o p ert y of t h e s p o ns or.  
All r ec or ds will als o b e h a n dl e d i n acc or d a nc e wit h HI P A A ( 1 9 9 6).  

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
2 2  
1 1. 6  P u bli c ati o n 
T h e i n v esti g at ors  will  n ot  b e  p er mitt e d  t o  p u blis h  or  pr es e nt  at  sci e ntific  m e eti n gs  r es ults  
o bt ai n e d fr o m t h e cli nic al st u d y wit h o ut pri or writt e n c o ns e nt fr o m t h e s p o ns or.  
 
  
  
  
 
 
  
  
  
 
  
 
  
  
  
  
    
 
  
  
  
  
  
  
  
 
    
  
  
     
 
  
  
  
  
  
  
 
  
    
    
  
 
  
  
  
 
  
    
    
  
    
  
  
  
  
  
  
  
  
  
 
  
  
  
  
    
  
  
 
  
  
  
 
    
 
 
  
  
    
 
  
 
  
  
  
  
 
  
  
  
 
 
 
  
     
    
  
  
  
  
  
  
  
  
  
  
    
 
  
  
  
  
  
   
    
  
  
    
  
  
 
  
 
  
  
  
  
  
  
  
    
    
 
  
    
    
  
 
  
  
 
  
  
  
  
 
  
  
  
    
 
    
  
  
  
  
  
  
    
 
 
 
 
 
     
 
  
 
 
    
 
 
    
 
 
    
 
 
 
    
   
 
  
    
  
  
    
  
 
 
 
 
 
 
 
 
 

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
2 3  
    
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
2 5  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
2 6  
    
 
 
 
 
 
 
 
 
  
  
 
  
 
 
   
  
  
 
  
   
 
 
 
 
 
 
  
 
  
   
 
 
 
 
 
 
 
  
 
 
 
 
  
 
  
   
 
 
 
 
 
 
 
  
 
 
 
 
  
 
  
   
 
 
 
 
 
 
 
  
 
 
 
 
  
 
  
   
 
 
 
 
 
 
 
  
 
 
 
 
  
 
  
   
 
 
 
 
 
 
 
  
 
 
 
 
  
 
  
   
 
 
 
 
 
 
 
  
 
 
 
 
  
 
  
   
 
 
 
 
 
 
 
  
 
 
 
 
  
 
  
   
 
 
 
 
 
 
 
  
 
 
 
 
  
 
  
   
 
 
 
 
 
 
 
  
 
 
 
 
  
 
  
   
 
 
 
 
 
 
 
  
 
 
 
 
  
 
  
   
 
 
 
 
 
 
 
  
 
 
 
 
  
 
  
   
 
 
 
 
 
 
 
  
 
 
 
 
  
 
  
   
 
 
 
 
 
 
 
  
 
 
 
 
  
 
  
   
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 

C o nfi d e nti al  
E X -M K T G - 9 6 P erf or m a nc e of T oric H y dr o g el L e ns es f oll o wi n g A R efit wit h T oric Silic o n e H y dr o g el L e ns es f or 1 M o nt h  
3 0