A Range of Contact Lenses and Care System Combinations
Phase: NA
Conditions: Contact Lens Solutions
Sponsor: CooperVision, Inc.



E ur o le n s  R e s e ar c h  (C 1 7 -6 3 5 ,E X -M K T G -9 5)  
P r oto c o l v 1  
J u n e  1 8 , 2 0 1 8  
2  
C o nfi d e nti al  ( T 3) 
 
 
 
 
C o nt e nt s  
D o c u m e n t c o n tro l  
3  
S tu d y  s u m m a r y 
S e c tio n  1 . 
O v e rv ie w   
5  
1. 1  
B a c k g ro u n d   
5  
1. 2  
P e rs o n n e l  
5  
1. 3  
S tu d y  o b je c tiv e s   
5  
1. 4  
S tu d y  d e s ig n   
5  
1. 5  
S ta tis tic a l  c o n s id e ra tio n s   
5  
1. 6  
R is k  a n a ly s i s  
6  
S e c tio n  2 . 
R e s o u rc e s   
7  
2. 1  
S u b je c t s e le c tio n   
7  
2. 2  
S u b je c t  d is c o n tin u a tio n   
8  
2. 3  
S a fe t y p a ra m e te rs , a d v e rs e  e v e n t s a n d  c o n c u rre n t illn e s s e s   
9  
2. 4  
S tu d y  te rm in a tio n   
9  
2. 5  
P ro to c o l d e v ia tio n s   
9  
2. 6  
S tu d y  re s o u rc e s   
1 0  
2. 7  
S tu d y  c o n tro l  
1 1  
2. 8  
D o c u m e n ta tio n   
1 1  
2. 9  
D a t a c o lle c tio n  a n d  a n a ly s i s  
1 1  
2. 1 0  S tu d y  c o m p le tio n   
1 1  
2. 1 1  C o n fid e n tia lit y  
1 2  
2. 1 2  S tu d y  m o n ito rin g   
1 2  
2. 1 3  C lin ic a l tria l re g is tra tio n   
1 2  
S e c tio n  3 . 
S u b je c t  m a n a g e m e n t  
1 3  
3. 1  
V is it s c h e d u lin g   
1 3  
3. 2  
V is it c o n d u c t  
1 3  
3. 3  
M o n ito rin g  s u b je ct  c o m p lia n c e   
1 9  
3. 4  
M i s sin g , u n u s e d  a n d  s p u rio u s  d a t a  
1 9  
S e c tio n  4 . 
S tu d y  c o -o rd in a tio n   
2 0  
4. 1  
D o c u m e n t p ro c e s s in g   
2 0  
4. 2  
D is c lo s u r e  
2 0  
4. 3  
P e rs o n n e l  
2 0  
 
 
 
A p p e n d ic e s  
A  A d v e rs e  e v e n t s 
B  R a n d o m is a tio n  ta b l e 
C  P a rtic ip a n t fo rm s , gr a d in g  s c a le s , q u e sti o n n a ire s  

E ur o le n s  R e s e ar c h  (C 1 7 -6 3 5 ,E X -M K T G -9 5)  
P r oto c o l v 1  
J u n e  1 8 , 2 0 1 8  
5  
C o nfi d e nti al  ( T 3) 
 
 
 
 
S e cti o n  1.  O v er v i e w 
 
 
1. 1  
B a c k g ro u n d  
V a rio u s  re p o rt s i n th e  lite ra tu r e h a v e  re p o rte d  s ig n ific a n t le v e l s o f c o rn e a l s ta in in g  w it h 
c e rta i n c o m b in a tio n s  o f c o n ta c t le n s  ty p e s  a n d  c a r e s y s te m s . T h i s p h e n o m e n o n  h a s  b e e n  
a ttrib u te d  t o th e  b in d in g  o f p o ly h e x a m e th y le n e  b ig u a n id e  t o lip id s  o n t h e s u rfa c e  o f a c o n ta c t 
le n s , a n d  th e  s u b s e q u e n t re le a s e  o f th e  p re s e rv a tiv e  a t th e  o c u la r s u rfa c e;  a lth o u g h  th i s 
th e o r y h a s  n o t b e e n  c o n v in c in g l y p ro v e n . T h e  p re c is e  s ig n ific a n c e  o f s u c h  c o rn e a l 
s ta in in g  i s n o t g e n e ra ll y a g re e d . T h i s p ro je c t s e e k s t o e x a m in e t h e  b io m ic ro s c o p i c 
re s p o n s e  a n d  o th e r s h o rtte r m c lin ic a l re s p o n s e s  a fte r a p p ro x im a te l y tw o  h o u r s e x p o s u r e 
t o a  ra n g e  o f c o n ta c t le n s e s  a n d  s o lu tio n  c o m b in a tio n s . 
 
1. 2  
P e rs o n n e l 
T h i s w o r k w ill b e  c o n d u c te d  a t E u ro le n s  R e s e a rc h , T h e  U n iv e rs it y o f M a n c h e s te r 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
1. 3  
S tu d y  o b je c tiv e s  
 
T h e  o b je c tiv e  o f th i s s tu d y  i s t o c o m p a r e th e  s h o rt-te r m c lin ic a l re s p o n s e  t o a ll 
c o m b in a tio n s  o f tw o  le n s  ty p e s : A v a ir a V ita lit y a n d  B io fin it y w it h tw o  c a r e s y s te m s : H y - 
C a r e a n d  L ite.  
 
T h e  p rim a r y v a ria b l e s o f in te re s t a r e s h o rt-te r m b io m ic ro s c o p y  s ig n s . O th e r v a ria b le s  o f 
in te re s t in c lu d e  s u b je c tiv e  re s p o n s e  
 
 
. 
 
1. 4  
S tu d y  d e s ig n  
T h i s c lin ic a l s tu d y  w ill b e  a  ra n d o m is e d , d o u b le -m a s k e d , c o n tra la te ra l s tu d y , c o n tro lle d  b y  
c ro s s -c o m p a ris o n  w h e r e th e  s h o rt te r m c lin ic a l re s p o n s e  t o e a c h  le n s /c a r e s y s te m  
c o m b in a tio n  w ill b e  a s s e s s e d  a t a  s in g l e s tu d y  s ite . 2 8  s u b je c t s w ill w e a r le n s e s  fo r 
a p p ro x im a te l y 2  h o u r s o n  tw o  d a y s . 
 
1. 5  
S ta tis tic a l  c o n s id e ra tio n s  
T h e  p rin c ip a l h y p o th e s i s t o b e  te s te d  i n th i s w o r k i s th a t b io m ic ro s c o p y  s c o re s  w ill n o t b e  
d iffe re n t b e tw e e n  th e  le n s /s o lu tio n  c o m b in a tio n s  e v a lu a te d.  
 
 
 
 
, b io m i cro s c o p y  
 
 a n d  s u b je c tiv e  re s p o n s e s  w ill 
g e n e ra t e d a t a th a t a r e lik e l y t o b e  c o n tin u o u s  a n d  n o rm a ll y d is trib u te d . A s  s u c h , th e s e  w ill 
b e  c o m p a re d  u s in g  lin e a r re g re s s io n  m o d e l s o r o th e r p a ra m e tri c m e th o d s . 

E ur o le n s  R e s e ar c h  (C 1 7 -6 3 5 ,E X -M K T G -9 5)  
P r oto c o l v 1  
J u n e  1 8 , 2 0 1 8  
6  
C o nfi d e nti al  ( T 3) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 D e v ia tio n s  fro m  th i s s ta tis tic a l p la n  w ill b e  d is c u s s e d  i n th e  fin a l re p o rt. 
D e v ia tio n s  m a y  b e  n e c e s s a r y d u e  t o d iffe re n c e s  b e tw e e n  th e  a c tu a l d a t a d is trib u tio n  
c o m p a re d  w it h th e  a n tic ip a te d  d a t a d is trib u tio n . 
 
1 .5 . 1 
P o w e r a n a ly s i s 
T h e  p rin c ip a l o u tc o m e  v a ria b l e t o b e  te st e d  i n th i s w o r k i s c o rn e a l st a in in g . If 2 2  s u b je c t s 
c o m p le t e th e  w o rk , th e  p o w e r o f th e  s tu d y  t o d e te c t a  d iffe re n c e  o f 5  u n it s fo r ‘e x te n t o f 
c o rn e a l s ta in in g ’ o n  a  0 -1 0 0  s c a l e fo r c o rn e a l s ta in in g  (a s s u m in g  a n  a lp h a  o f 0 .0 5 , a  tw o - 
ta ile d  p a ire d  a n a ly si s  a n d  a  st a n d a r d d e v ia tio n  o f in tra -s u b je c t d iffe re n c e s  o f 8  u n its ) i s 
0 .8 0 .  T o  c a te r fo r a n y  s u b je c t d is c o n tin u a tio n s , 2 8  s u b je c t s w ill b e  re c ru ite d  fo r th e  w o rk . 
 
 
1. 6  
R is k  a n a ly s i s 
T h i s s tu d y  i s c o n s id e re d  t o b e  a  n o n -s ig n ific a n t ris k  s tu d y  b a s e d  o n  U n ite d  S ta t e F o o d  
a n d  D ru g  a d m in is tra tio n  (F D A ) a n d  In te rn a tio n a l S ta n d a rd s  O rg a n iz a tio n  (IS O ) g u id e lin e s  
d u e  t o th e  d a il y w e a r n a tu r e o f th e  s tu d y .  W it h th e  p o te n tia l b e n e fit o f th i s s tu d y , th e  w o r k 
i s c o n s id e re d  t o b e  e th ic a ll y ju s tifia b le .  E th ic a l a p p ro v a l w ill b e  s o u g h t fro m  th e  U n iv e rs it y 
o f M a n c h e s te r S e n a t e C o m m itte e  o n  th e  E th ic s  o f R e s e a rc h  o n  H u m a n  B e in g s  (h e re a fter  
re fe rre d  t o a s  M a n c h e s te r U R E C ). T h e  w o r k w h e r e p ra c tic a l w ill b e  c o n d u c te d  i n 
a c c o rd a n c e  w it h th e  IC H  G o o d  C lin ic a l P ra c tic e  G u id e lin e s  a n d  th e  in te rn a tio n a l s ta n d a r d 
B S  E N  IS O  1 4 1 5 5 :2 0 1 1  ‘C lin i ca l in v e s tig a tio n  o f m e d i ca l d e v i ce s  fo r h u m a n  s u b je c ts ’. 

E ur o le n s  R e s e ar c h  (C 1 7 -6 3 5 ,E X -M K T G -9 5)  
P r oto c o l v 1  
J u n e  1 8 , 2 0 1 8  
7  
C o nfi d e nti al  ( T 3) 
 
 
 
 
 
S e cti o n  2.  R e s o ur c e s  
 
 
2. 1  
S u b je c t s e le c tio n  
I n th i s w o r k 2 8  s u b je c t s w ill b e  e n ro lle d , w it h a n  a i m t o c o m p le t e 2 2  s u b je c ts . 
 
 
2. 1. 1  
S u b je c t w ith d ra w a l a n d  re p la c e m e n t 
T h i s s tu d y  in c lu d e s  fo u r c lin ic a l v is its .  O n c e  th e  s tu d y  c o n s e n t fo r m i s s ig n e d , th e  s u b je c t 
i s c o n s id e re d  t o b e  e n ro lle d  o n  th e  s tu d y . S u b je c t s w h o  h a v e  s ig n e d  th e  c o n s e n t fo rm , 
b u t w h o  h a v e  n o t c o m p le te d  th e  d is p e n si n g  v is it w ill u s u a ll y b e  re p la c e d . A ll s u b je c t d a t a 
w ill b e  in c lu d e d  i n th e  fin a l a n a ly s e s  u n le s s  th e r e a r e s tro n g  g ro u n d s  fo r e x c lu s io n ; s u c h  
g ro u n d s  w ill b e  d e ta ile d  i n th e  fin a l re p o rt. A t th e  e n d  o f th e  st u d y,  a ll s u b je ct s  w ill s ig n  a  
s tu d y  e x it fo rm . 
 
2. 1. 2  
S u b je c t re c ru itm e n t 
S u b je c t s w ill b e  re c ru ite d  b y  o n e  o r m o r e o f fo llo w in g  m e a n s : 
 
1.  C o n ta c tin g  v o lu n te e r s  o n  th e  E u ro le n s  R e s e a rc h  d a ta b a s e  o f  v o lu n te e r s  u s in g  
e m a il, p h o n e  a n d  S M S . 
2.  P o s tin g  s tu d y  d e ta il s  o n  T h e  U n iv e rs it y  o f  M a n c h e s te r’ s  ‘R e s e a r c h  V o lu n te e r s’ 
w e b s ite . 
3.  A d v e rtis in g  th ro u g h  a  v a rie t y  o f  m e d i a  v i a  a  fo rm a t  s e p a ra te l y  a p p ro v e d  b y  
M a n c h e st e r U R E C . 
 
2. 1. 3  
In c lu s io n  c rite ri a 
S u b je c t s w ill o n l y b e  e lig ib l e fo r th e  s tu d y  if: 
 
1.  T h e y  a r e o f le g a l a g e  (1 8 ) a n d  c a p a cit y  t o v o lu n te e r. 
 
2.  T h e y  u n d e rs ta n d  th e ir rig h t s a s  a  re s e a rc h  s u b je c t a n d  a r e w illin g  a n d  a b l e t o s ig n  a  
S ta te m e n t o f In fo rm e d  C o n s e n t. 
3.  T h e y  a r e w illin g  a n d  a b l e t o fo llo w  th e  p ro to c o l. 
 
4.  T h e y  a g re e  n o t t o p a rtic ip a t e i n o th e r c lin ic a l re s e a rc h  fo r th e  d u ra tio n  o f th i s s tu d y . 
 
5.  T h e y  c a n  b e  s a tis fa c to ril y fitte d  w it h th e  s tu d y  le n s  fo r a  p e rio d  o f a p p ro x im a te l y 2  
h o u rs . 
6.  T h e y  c a n  a tta i n a t le a s t 0 .2 0  lo g M A R  d is ta n c e  h ig h  c o n tra s t v is u a l a c u it y i n e a c h  
e y e  w it h th e ir h a b itu a l s p e ct a cl e s.  
7.  T h e y  c u rre n tl y w e a r d a il y  d is p o s a b l e s o ft c o n ta ct  le n s e s  o r h a v e  d o n e  s o  i n th e  
p re v io u s  s i x m o n th s . 
8.  T h e y  a r e w illin g  t o c o m p l y w it h th e  w e a r s c h e d u l e (a p p ro x im a te l y 2  h o u r s o n  tw o  
d iffe re n t d a y s ) 
9.  T h e y  o w n  a  w e a ra b l e p a ir o f s p e c ta c le s  a n d  a g re e  t o b rin g  th e s e  t o s tu d y  v is its . 

E ur o le n s  R e s e ar c h  (C 1 7 -6 3 5 ,E X -M K T G -9 5)  
P r oto c o l v 1  
J u n e  1 8 , 2 0 1 8  
8  
C o nfi d e nti al  ( T 3) 
 
 
 
 
2. 1. 4  
E x c lu s io n  c rite ri a 
S u b je c t s w ill n o t b e  e lig ib l e t o ta k e  p a rt i n th e  s tu d y  if: 
 
1.  T h e y  h a v e  a n  o c u la r d is o rd e r w h ic h  w o u l d n o rm a ll y c o n tra -in d i ca t e c o n ta c t le n s  
w e a r. 
2.  T h e y  h a v e  a  s y s te m i c d is o rd e r w h ic h  w o u l d n o rm a ll y c o n tra -in d i ca t e c o n ta c t le n s  
w e a r. 
3.  T h e y  c u rre n tl y w e a r re u s a b l e s o ft c o n ta c t le n s e s  i n b o t h e y e s.  
 
4.  T h e y  a r e u s in g  a n y  to p ic a l m e d ic a tio n  s u c h  a s  e y e  d ro p s  o r o in tm e n t. 
 
5.  T h e y  h a v e  h a d  c a ta ra c t s u rg e ry . 
 
6.  T h e y  h a v e  h a d  c o rn e a l re fra c tiv e  s u rg e ry . 
 
7.  T h e y  h a v e  a n y  c o rn e a l d is to rtio n  re s u ltin g  fro m  p re v io u s  h a r d o r rig i d le n s  w e a r o r 
h a v e  k e ra to c o n u s.  
8.  T h e y  a r e p re g n a n t o r b re a s t-fe e d in g.  
 
9.  T h e y  h a v e  a n y  o c u la r a b n o rm a lit y w h ic h  w o u ld , i n th e  o p in io n  o f th e  in v e sti g a to r, 
n o rm a ll y c o n tra in d ic a t e c o n ta c t le n s  w e a r. 
1 0.  T h e y  h a v e  T y p e  2  o r g re a te r c o rn e a l s ta in in g  p rio r t o le n s  a p p lic ati o n  a t V i sit 1  o r 2  
 
1 1.  T h e y  h a v e  c o rn e a l s ta in in g  c o v e rin g  g re a te r th a n  2 0 %  i n  a n y  c o rn e a l re g io n  at  
V is it 1 a  o r 2 a  
 
1 2.  T h e y  h a v e  a n y  in fe c tio u s  d is e a s e  w h ic h  w o u ld , i n th e  o p in io n  o f th e  in v e s tig a to r, 
c o n tra in d ic a t e c o n ta c t le n s  w e a r o r p o s e  a  ris k  t o s tu d y  p e rs o n n e l; o r th e y  h a v e  
a n y  im m u n o s u p p re s s iv e  d is e a s e  (e .g . H IV ), o r a  h is to r y o f a n a p h yl a x i s o r s e v e r e 
a lle rg i c re a c tio n.  
1 3.  T h e y  h a v e  t a k e n  p a rt i n  a n y  o th e r c o n ta c t le n s  o r c a r e  s o lu tio n  c lin ic a l tria l o r 
re s e a rc h , w ith i n tw o  w e e k s  p rio r t o s ta rtin g  th i s s tu d y . 
 
2. 2  
S u b je c t  d is c o n tin u a tio n  
I n g e n e ra l, s u b je ct s  s h o u l d b e  d i s co n tin u e d  a t a n y  tim e , if it i s i n th e ir b e s t in te re s ts , a s  
ju d g e d  b y  th e  in v e s tig a to r. R e a s o n s  fo r th i s m a y  in c lu d e  c lin ic a l s ig n s  o f g ra d e  3  o r m o re , 
la c k  o f m o tiv a tio n , d i sc o m fo rt, re p e a te d  re fu s a l t o fo llo w  in s tru c tio n s  o r th e  u s e  o f n o n - 
s tu d y  p ro d u c t s s u c h  a s  s o lu tio n s  o r le n s e s . S u b je c t s w ill b e  d is c o n tin u e d  if  a  s e rio u s  
a d v e rs e  e v e n t o c c u r s o r if th e y  m is s  tw o  o r m o r e p la n n e d  c o n s e c u tiv e  v is its . S u b je c t s w h o  
fa il t o m e e t a ll th e  in cl u si o n  a n d  e x cl u si o n  crit e ri a a t th i s tim e  w ill u s u a ll y b e  d i s co n tin u e d  
a n d  re p la c e d . If i n th e  o p in io n  o f th e  in v e sti g a to r, th e  s u b je ct  m a y  b e  e lig ib l e a t a  la te r 
d a te , th e  s u b je c t m a y  b e  b ro u g h t b a c k  fo r u p  t o o n e  re p e a t v is it o f th i s ty p e . S u b je c t s m a y  
c h o o s e  t o le a v e  th e  s tu d y  a t th e ir o w n  re q u e s t. A ll d is c o n tin u a tio n s  w ill  b e  c a re fu ll y 
re c o rd e d . 

E ur o le n s  R e s e ar c h  (C 1 7 -6 3 5 ,E X -M K T G -9 5)  
P r oto c o l v 1  
J u n e  1 8 , 2 0 1 8  
9  
C o nfi d e nti al  ( T 3) 
 
 
 
 
2. 3  
S a fe t y p a ra m e te rs , a d v e rs e  e v e n t s a n d  c o n c u rre n t illn e s s e s  
T h e  k e y  s a fe t y p a ra m e te r s a r e th e  s e rio u s  a n d  s ig n ific a n t a d v e rs e  e v e n t s lis te d  i n 
 (a d v e rs e  e v e n t s a r e c la s s ifie d  a s  ‘ s e rio u s ’, ‘s ig n ific a n t’ o r  ‘n o n -s ig n ific a n t’). 
C lin ic a l a s s e s s m e n t i s m a d e  a t th e  s tu d y  v is it(s ) fo r th e s e  p a ra m e te rs . T h e  p re s e n c e  o f 
a n y  o c u la r a d v e rs e  e v e n t w ill b e  n o te d  o n  th e  e C R F  a n d  re p o rte d  t o th e  S p o n s o r u s in g  
C V I re p o rt fo rm s  a n d  th o s e  o c u la r a d v e rs e  e v e n t s d e s c rib e d  a s  ‘s e rio u s ’ o r ‘s ig n ific a n t’ 
w ill b e  d e ta ile d  i n th e  fin a l re p o rt. S im ila rly , a n y  c o n c u rre n t illn e s s  w ill b e  n o te d  o n  th e  
e C R F  a n d  c o m m e n t a d d e d  if i s li ke l y t o im p a c t o n  th e  re le v a n c e  a n d  q u a lit y  o f  th e  
c a p tu re d  d a ta . 
 
2. 3. 1  
In v e s tig a to r  o b lig a tio n s  
A t a ll tim e s  th e  in v e s tig a to r w ill a c t i n th e  b e s t in te re s t o f th e  s u b je c t. R e fe rra l o r tre a tm e n t 
o f a n  a d v e rs e  e v e n t o r o th e r c lin ic a l fin d in g  s h o u l d b e  in itia te d  i n th e  b e s t c lin ic al  
ju d g e m e n t o f th e  in v e sti g a to r, irre s p e cti v e  o f th e  p a rti cip a tio n  i n th e  cli n i ca l st u d y . 
 
2. 3. 2  
R e p o rtin g  o b lig a tio n s  
N o n -s ig n ific a n t o c u la r a d v e rs e  e v e n t s s h o u l d b e  re p o rte d  t o th e  In d u stri a l C o n ta c t P e rs o n  
w ith i n 5  w o rk in g  d a y s . I n th e  c a s e  o f a  ‘ se rio u s’  o r ‘ sig n ific a n t’ a d v e rs e  o c u la r e v e n t, th e  
P rin c ip a l In v e s tig a to r a n d  th e  In d u stri a l C o n ta ct  P e r so n  w ill b e  n o tifie d  w ith i n 2 4  h o u rs . 
M a n c h e st e r U R E C  a n d  a n y  re g u la to r y a u th o ritie s  w ill b e  in fo rm e d  a s  re q u ire d . 
 
2. 4  
S tu d y  te rm in a tio n  
If it b e c o m e s  n e c e s s a r y t o te rm in a t e th e  st u d y  e a rlie r th a n  p la n n e d , th e  In d u stri a l C o n ta ct  
P e rs o n  w ill n o tif y th e  P rin c ip a l In v e s tig a to r w h o  w ill e n d  th e  s tu d y  w it h th e  c o o p e ra tio n  o f 
o th e r s ta ff m e m b e rs . M a n c h e s te r U R E C  w ill b e  in fo rm e d.  
 
2. 5  
P ro to c o l d e v ia tio n s  
A n y  d e v ia tio n s  fro m  th i s p ro to c o l w ill b e  re c o rd e d  o n  th e  e C R F , a n d  re p o rte d  t o  th e  
In d u stri a l C o n ta c t P e rs o n  a s  a p p ro p ria te . M a n c h e s te r U R E C  w ill b e  in fo rm e d  a s  
n e c e s s a ry . D e v ic e  d e fic ie n c ie s  w ill b e  re c o rd e d  o n  th e  e C R F  a n d  re p o rte d  t o th e  
In d u stri a l C o n ta ct  P e r so n  a s  a p p ro p ria te . 
 
2. 5. 1  
P ro to c o l  a m e n d m e n t s 
A n y  a m e n d m e n t s w ill b e  a g re e d  b e tw e e n  th e  In d u s tria l C o n ta c t P e rs o n  a n d  th e  P rin c ip a l 
In v e sti g a to r w it h th e  c o o p e ra tio n  o f o th e r st a ff m e m b e r s. A m e n d m e n t s w ill b e  re c o rd e d , 
id e n tifie d  a n d  d i strib u te d . A p p ro v a l  fro m 
 M a n c h e s te r  U R E C  w ill  b e  o b ta in e d  a s  
n e c e s s a ry . 

E ur o le n s  R e s e ar c h  (C 1 7 -6 3 5 ,E X -M K T G -9 5)  
P r oto c o l v 1  
J u n e  1 8 , 2 0 1 8  
1 1  
C o nfi d e nti al  ( T 3) 
 
 
 
 
2. 6. 4  
In v e n to r y c o n trol  
A ll s tu d y  le n s e s  a n d  s tu d y  s o lu tio n s  w ill b e  s u p p lie d  b y  C o o p e rV is io n  In c.  W o r n le n s e s  w ill 
u s u a ll y b e  d is c a rd e d,  a n d  a n y  o p e n e d  b o ttle s  o f s o lu tio n  d i sp o s e d  o f. W h e r e p o s s ib le , 
le n s e s  a s s o c ia te d  w it h d e v ic e  d e fic ie n c ie s  w ill b e  re ta in e d  (s to re d  i n s te ril e s a lin e ), a n d  
re tu rn e d  t o th e  S p o n s o r u n le s s  o th e rw is e  d ire c te d . 
 
 
A ll u n u s e d  m a te ria l s w ill b e  re tu rn e d  t o th e  S p o n s o r a t th e  e n d  o f th e  s tu d y  u n le s s  th e  s it e 
i s o th e rw i s e d ire c te d  b y  th e  S p o n s o r: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
2. 6. 5  
C lin ic a l e q u ip m e n t 
C lin ic a l e q u ip m e n t i s re g u la rl y m a in ta in e d  a n d  c a lib ra te d  a s  re q u ire d . S ta n d a r d o p e ra tin g  
p ro c e d u re s  a n d  in te rn a tio n a l s ta n d a rd s  a r e u s e d  w h e r e a p p ro p ria te.  
 
2. 7  
S tu d y  c o n tro l 
T h i s s tu d y  i s  c o n tro lle d  b y  c ro s s -c o m p a ris o n . B ia s  w ill b e  m in im iz e d  b y  m a s ki n g  a n d  
ra n d o m iz in g  th e  o rd e r o f a s s e s s m e nt . M a s ki n g  m a y  b e  ‘b ro k e n ’ if d e e m e d  n e c e s s a r y, b y  
th e  P rin ci p a l In v e sti g a to r o r In d u stri a l C o n ta ct  P e r so n . 
 
2. 8  
D o c u m e n ta tio n  
D o c u m e n t s re la te d  t o th i s w o r k th a t re q u ir e a rc h iv in g  w ill b e  k e p t b y  E u ro le n s  R e s e a rc h  
fo r a  p e rio d  o f 1 0  y e a r s a fte r c o m p le tio n  o f th e  fin a l re p o rt. T h e  S p o n s o r’ s p e rm i s sio n  w ill 
b e  s o u g h t b e fo r e th e  d o c u m e n t s a r e d e s tro y e d.  
 
2. 9  
D a t a c o lle c tio n  a n d  a n a ly s i s 
D a t a c o lle c te d  i n th i s w o r k w ill b e  re c o rd e d  o n  a  c u s to m -d e v e lo p e d  d a ta b a s e  (e C R F ) a n d  
a n  e s ta b lis h e d  d a t a tra il. D a t a h a n d lin g  w ill in c lu d e  e x p o rt o f th e  s tu d y  in fo rm a tio n  fro m  
th e  cli n i ca l d a ta b a s e  in t o s p re a d s h e e t fo rm a t fo r m a ni p u la tio n , fo llo w e d  b y  e x p o rt in t o a  
s ta tis tic a l p a c k a g e  fo r a n a ly s is . M o s t c lin ic a l d a t a w ill b e  e n te re d  d ire c tl y o n t o th e  
e le c tro n i c c a s e  re p o rt fo r m a n d  i s c o n s id e re d  t o b e  s o u rc e  d a ta.  
 
2. 1 0  
S tu d y  c o m p le tio n  
T h e  c lin ic a l p h a s e  o f th e  s tu d y  w ill b e  c o n s id e r ed  a s  c o m p le te  w h e n  a ll s u b je c ts  h a v e  
re c e iv e d * a n d /o r s ig n e d  th e  e x it s ta te m e n t. (*I n th e  e v e n t th a t a  s u b je c t i s lo s t t o fo llo w -u p .) 

E ur o le n s  R e s e ar c h  (C 1 7 -6 3 5 ,E X -M K T G -9 5)  
P r oto c o l v 1  
J u n e  1 8 , 2 0 1 8  
1 2  
C o nfi d e nti al  ( T 3) 
 
 
 
 
2. 1 1  
C o n fid e n tia lit y 
A ll m a tte r s re la te d  t o th i s w o r k w ill re m a i n c o n fid e n tia l w ith i n  E u ro le n s  R e s e a rc h ,  th e  
fu n d in g  c o m p a n y  a n d  a n y  re g u la to r y a u th o rit y (e .g . M a n c h e s te r U R E C ). E u ro le n s  
R e s e a rc h  w ill ta k e  a ll re a s o n a b l e s te p s  t o e n s u r e th a t s p e c ifi c le n s -re la te d  in fo rm a tio n  i s 
n o t p a s s e d  o n  t o s tu d y  p a rtic ip a n t s u n le s s  th i s i s re q u ire d  fo r c lin ic a l m a n a g e m e n t o f a n  
a d v e rs e  e v e n t. P e r so n a l s u b je ct  in fo rm a tio n  w ill n o t b e  m a d e  a v a ila b le . T o  c a te r fo r th i s, 
s u b je c t s w ill o n l y b e  re fe rre d  b y  th e ir u n iq u e  id e n tit y n u m b e r i n th e  s tu d y  re p o rt. T h e  d a t a 
a c tiv itie s  o f E u ro le n s  R e s e a rc h  a r e re g is te re d  w it h th e  d a t a p ro te c tio n  o ffic e r at  T h e  
U n iv e rs it y o f M a n c h e s te r. 
 
2. 1 2  
S tu d y  m o n ito rin g  
I n o rd e r t o p ro v id e  q u a lit y c o n tro l a n d  q u a lit y a s s u ra n c e  a s  p a rt o f th i s w o r k, th e  st u d y  
m o n ito r w ill: 
1.  L ia is e  c lo s e l y w it h th e  P rin c ip a l In v e s tig a to r. 
 
2.  M o n ito r a n d  e n s u r e th e  s a fe t y o f th e  s u b je ct s.  
 
3.  E n s u r e th a t th e  in v e s tig a tio n  i s b e in g  c o n d u ct e d  a c c o rd in g  t o th e  p ro to c o l. 
 
4.  M o n ito r a n d  re v ie w  (o r o v e r se e  re v ie w  o f) th e  st u d y  re c o rd s  t o e n s u r e a c c u ra c y . 
 
5.  D o c u m e n t  th e ir  o b s e rv a tio n s  a n d  m a k e  th e m  a v a ila b l e  t o  re le v a n t  a u th o riz e d  
p a rtie s  (e .g . M a n c h e s te r U R E C ). 
6.  Im p le m e n t 
th e  E u ro le n s  
R e s e a r c h 
cli n i ca l 
m o n ito rin g  
st a n d a r d 
o p e ra tin g  
p ro c e d u re.  
 
2. 1 3  
C lin ic a l tria l re g is tra tio n  
 
T h i s s tu d y  w ill b e  re g is te re d  w it h c lin ic a ltria ls .g o v  i n a c c o rd a n c e  w it h s e c tio n  8 0 1  o f th e  
F o o d  a n d  D ru g  A d m in is tra tio n  (F D A ) A c t w h ic h  m a n d a te s  th e  re g i stra tio n  o f c e rta i n cli n i ca l 
tria l s o f d ru g s  a n d  m e d i ca l d e v i ce s.  

E ur o le n s  R e s e ar c h  (C 1 7 -6 3 5 ,E X -M K T G -9 5)  
P r oto c o l v 1  
J u n e  1 8 , 2 0 1 8  
1 5  
C o nfi d e nti al  ( T 3) 
 
 
 
 
b e  d is c o n tin u e d  a n d  re p la c e d . If i n th e  o p in io n  o f th e  in v e s tig a to r, th e  s u b je c t m a y  
b e  e lig ib l e a t a  la te r d a te , th e  s u b je c t m a y  b e  b ro u g h t b a c k  fo r u p  t o o n e  re p e at  
v i sit o f th i s ty p e , w h i c h m a y  in cl u d e  s o m e  o r a ll o f th e  s c h e d u le d  a s s e s s m e n ts . 
In fo rm e d  c o n s e n t w ill n o t b e  re p e a te d.  
6.  S tu d y  le n s e s  w ill b e  fitte d  a c c o rd in g  t o  th e  ra n d o m iz a tio n   ta b l e  a n d  a llo w e d  t o 
s e ttl e fo r fiv e  m in u te s.  B o t h in v e sti g a to r a n d  s u b je ct  a r e m a s k e d  fro m  th e  le n s e s  
a n d  c a r e s y s te m  u s e d , s o  th e  le n s e s  w ill b e  p ro v id e d  i n le n s  c a s e s  w h ic h  d o  n ot  
d e ta il le n s  o r c a r e s y s te m  in fo rm a tio n . If a  le n s  fa il s t o s e ttl e w ith i n th e  firs t fiv e  
m in u te s,  e g  e x c e s si v e  d i s co m fo rt, o r a  s u s p i cio n  th a t th e  le n s  i s in v e rte d , th e n  th e  
le n s  m a y  b e  r em o v e d  a n d  a  n e w  le n s  re a p p li ed.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0.  T h e  s u b je c t w ill b e  a s k e d  t o s c o r e th e  fo llo w in g  s u b je c tiv e  s c o re s , w it h re fe re n c e  
t o a p p ro p ria t e v e rti ca l a n a lo g u e  s c a le s  
 
• 
C o m fo rt 
 
 
 
 
 
  
 
 
• 
O v e ra ll s c o r e 
 
1 1.  T h e  s u b je c t w ill th e n  b e  d i sc h a rg e d  a n d  a s k e d  t o re tu r n a p p ro x im a te l y 2  h o u r s 
la te r. 
 
3. 2. 3  
V is it 1 b  (fo llo w -u p)  
T h e  fo llo w in g  p ro c e d u re s  w ill b e  p e rfo rm e d : 
 
1.  T h e  s u b je c t w ill b e  a s k e d  t o s c o r e th e  fo llo w in g  re a c tio n s : 
 
• 
C o m fo rt b e fo r e re m o v a l 
 
• 
D ry n e s s  
 
 
 
 
 
 
 
 
 
 
• 
O v e ra ll s c o r e 
 
 
 
 
 
 
 
 
 
 
 

E ur o le n s  R e s e ar c h  (C 1 7 -6 3 5 ,E X -M K T G -9 5)  
P r oto c o l v 1  
J u n e  1 8 , 2 0 1 8  
1 6  
C o nfi d e nti al  ( T 3) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5.  T h e  le n s e s  w ill b e  re m o v e d  a n d  d is c a rd e d . 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.  A  c o m p le t e b io m ic ro s c o p i c e x a m in a tio n  w ill b e  c o n d u c te d  a s  o u tlin e d  i n V is it 1 . 
 
8.  T h e  s u b je c t w ill th e n  b e  d is c h a rg e d  a n d  a s k e d  t o re tu r n fo r V is it 2 . S u b je c t s a r e 
re m in d e d  t o a tte n d  w e a rin g  s p e c ta c le s , a n d  n o t t o w e a r h a b itu a l c o n ta c t le n s e s  o n  
th e  d a y  o f th e  v i sit. 
 
 
 
3. 2. 4  
V is it 2  
T h e  fo llo w in g  p ro c e d u re s  w ill b e  p e rfo rm e d  (a n y  o c u la r m e a s u re m e n t p ro c e d u re s  o u tlin e d  
b e lo w  w ill b e  c a rrie d  o u t o n  e a c h  e y e ): 
1.  M e d i ca l a n d  o c u la r h is to r y s in c e  th e  la s t v is it w ill b e  re c o rd e d . 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.  S lit la m p  B io m ic ro s c o p y  w ill b e  c a rrie d  o u t fo r th e  s ig n s  o u tlin e d  i n T a b l e 5  a n d  i n 
a c c o rd a n c e  w it h th e  c u rre n t E u ro le n s  R e s e a rc h  S ta n d a r d O p e ra tin g  P ro c e d u r e 
‘E x a m in a tio n  o f th e  a n te rio r s e g m e n t u s in g  s lit la m p  B io m i cro s c o p y ’. G ra d e s  w ill 
b e  s c o re d  t o th e  n e a re s t 0 . 1 u n it i n th e  b e st  ju d g e m e n t o f th e  in v e sti g a to r u si n g  
E fro n  G ra d in g  S c a le s . C o rn e a l s ta in in g  w ill b e  g ra d e d  fo r fiv e  re g io n s  a s  d e s c rib e d  
i n 
 

E ur o le n s  R e s e ar c h  (C 1 7 -6 3 5 ,E X -M K T G -9 5)  
P r oto c o l v 1  
J u n e  1 8 , 2 0 1 8  
1 8  
C o nfi d e nti al  ( T 3) 
 
 
 
 
9.  T h e  s u b je c t w ill th e n  b e  d is c h a rg e d  a n d  a s k e d  t o re tu r n a p p ro x im a te l y 2  h o u r s 
la te r. 
 
3. 2. 5  
V is it 2 b  (fo llo w -u p)  
T h e  fo llo w in g  p ro c e d u re s  w ill b e  p e rfo rm e d : 
 
1.  T h e  s u b je c t w ill b e  a s k e d  t o s c o r e th e  fo llo w in g  re a c tio n s : 
 
• C o m fo rt b e fo r e re m o v a l 
 
• D ry n e s s  
 
 
 
 
 
 
 
 
 
 
• O v e ra ll s c o r e 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.  T h e  le n s e s  w ill b e  re m o v e d  a n d  d is c a rd e d . 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.  A  c o m p le t e b io m ic ro s c o p i c e x a m in a tio n  w ill b e  c o n d u c te d  a s  o u tlin e d  i n V is it 1 . 
 
9.  T h e  s u b je c t w ill th e n  b e  d is c h a rg e d  a n d  a s k e d  t o re tu r n fo r V is it 2 . S u b je c t s a r e 
re m in d e d  t o a tte n d  w e a rin g  s p e c ta c le s , a n d  n o t t o w e a r h a b itu a l c o n ta c t le n s e s  o n  
th e  d a y  o f th e  v i sit. 
A t th e  fin a l v is it (o r w h e n  th e  s u b je c t i s d is c o n tin u e d  a t a n  e a rlie r v is it) th e  s u b je c t w ill 
s ig n  a n  e x it  s ta te m e n t  a c k n o w le d g in g  th a t  th e  w o r k  i s  c o m p le te ,  a lth o u g h  th e y  m a y  

E ur o le n s  R e s e ar c h  (C 1 7 -6 3 5 ,E X -M K T G -9 5)  
P r oto c o l v 1  
J u n e  1 8 , 2 0 1 8  
1 9  
C o nfi d e nti al  ( T 3) 
 
 
 
 
h a v e  b e e n  a s k e d  b y  th e  in v e s ti ga to r t o a tte n d  a  p o s t-s tu d y  fo llo w -u p  v is it, a n d  th a t th e y  
s h o u l d c o n tin u e  t o u s e  th e ir le n s e s  a n d  s o lu tio n s  a s  a d v is e d , a n d  s e e k  a fte rc a r e fo r 
th e ir c o n ta ct  le n s e s.  A  c o p y  o f th i s si g n e d  fo r m w ill b e  i s su e d  t o th e  s u b je ct.  T h e  
s u b je c t w ill b e  is s u e d  w it h th e ir p a y m e n t a n d  d is c h a rg e d.  
 
3. 2. 6  
P o s t-s tu d y  fo llo w -u p  v is it 
I n th e  c a s e  o f a  s u b je ct  w h o  e x it s th e  st u d y  w it h si g n ifi ca n t o c u la r c lin ic a l s ig n s  o r 
s y m p to m s , th e  in v e s tig a to r m u s t u n d e rta k e  t o e x a m in e  th e  s u b je c t a t in te rv a l s h e /s h e  
d e te rm in e s  t o b e  c lin ic a ll y a p p ro p ria t e u n til th e  s ig n  o r s y m p to m  h a s  re s o lv e d  o r re tu rn e d  
t o a  le v e l th a t i s c o n si d e re d  t o b e  cli n i ca ll y a c c e p ta b le . D e ta il s fro m  th e s e  v i sit s w ill b e  
re c o rd e d  o n  a  p o s t-s tu d y  fo llo w -u p  v is it fo rm . 
 
3. 3  
M o n ito rin g  s u b je c t c o m p lia n c e  
S u b je c t s a r e re q u ire d  t o a d h e r e t o th e  in s tru c tio n s  p ro v id e d  d u rin g  th i s  c lin ic al  
in v e s tig a tio n . T h i s w ill b e  c o n firm e d  a t th e  s tu d y  v i sit s b y  v e rb a l q u e s tio n in g  o f th e  s u b je c t 
b y  th e  in v e s tig a to r. 
 
3. 4  
M is s in g , u n u s e d  a n d  s p u rio u s  d a t a 
T h e  a b s e n c e  o f a n y  d a t a w ill b e  c a re fu ll y a n d  c ritic a ll y c o n s id e re d . If a p p ro p ria te , p a rtial  
d a ta s e t s w ill b e  in c lu d e d  i n th e  fin a l a n a ly s is . A n y  d a t a m is s in g  fro m  a  s u b je c t v is it w ill b e  
o u tlin e d  i n th e  re p o rt b y  in d ic a tin g  th e  n u m b e r  o f  s u b je c t s  in c lu d e d  fo r  e a c h  a n a ly s is . 
D a t a th a t a r e u n u s e d  o r c o n s id e re d  t o b e  s p u rio u s  w ill b e  d e ta ile d  a n d  d is c u s s e d  i n th e  
re p o rt. 

E ur o le n s  R e s e ar c h  (C 1 7 -6 3 5 ,E X -M K T G -9 5)  
P r oto c o l v 1  
J u n e  1 8 , 2 0 1 8  
2 0  
C o nfi d e nti al  ( T 3) 
 
 
 
 
 
S e cti o n  4.  S tu d y  c o -or di n ati o n  
 
 
4. 1  
D o c u m e n t  p ro c e s s in g  
A ll c a s e  re p o rt fo rm s  w ill b e  p ro c e s s e d  a n d  e v a lu a te d  b y  E u ro le n s  R e s e a rc h , w h o  w ill 
p ro d u c e  th e  fin a l re p o rt w it h fu ll s ta tis tic a l a n a ly s i s. A d ra ft re p o rt w ill b e  s e n t t o th e  
In d u stri a l C o n ta ct  P e r so n  i n o rd e r t o m a k e  c o m m e n t s a n d  a s k  fo r re -d ra fts . If n o  
c o m m e n t s a r e re c e iv e d  fro m  th e  In d u s tria l C o n ta c t P e rs o n  w ith i n  e ig h t  w e e k s ,  a  fin a l 
re p o rt w ill b e  re le a s e d  w it h a  s e p a ra t e d o c u m e n t c o n tro l p a g e  (i n d u p lic a te ), re q u e s tin g  
th e  In d u stri a l C o n ta ct  P e r so n  t o si g n  b o t h c o p ie s , o n e  t o k e e p  a n d  th e  o th e r  t o  b e  
re tu rn e d  t o E u ro le n s  R e s e a rc h . 
 
4. 2  
D is c lo s u r e 
A ll m a tte r s re la tin g  t o th i s c lin ic a l s tu d y  a r e c o n fid e n tia l a n d  s h o u l d o n l y b e  d is c lo s e d  t o 
re le v a n t a u th o riz e d  p a rtie s . M o r e p re c is e  d e ta il s re la tin g  t o d is c lo s u r e a r e o u tlin e d  i n th e  
R e s e a rc h  A g re e m e n t. N o n e  o f th e  in v e s tig a to r s in v o lv e d  i n th i s w o r k o w n s  e q u it y i n th e  
fu n d in g  c o m p a n y .