A Phase 1/2a Study of LEV102 Topical Gel in Subjects With Acquired Blepharoptosis
Phase: PHASE1
Conditions: Acquired Blepharoptosis
Sponsor: Levation Pharma, Ltd.

Protocol 
 
Study title: A Phase 1/2a Study of LEV102 Topical Gel in Subjects with Acquired Blepharoptosis 
NCT Number:NCT05715346 
Document Date: 25 May 2023 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 1  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
T I T L E P A G E 
C li nic al T ri al P r ot oc ol  
L E V 1 0 2 -C S 0 1  
St u d y Title:   
A  P hase 1/ 2 a St u d y of L E V 1 0 2 T o pical Gel i n S u bjects wit h 
Ac q uire d Ble p har o pt osi s 
St u d y  N u m ber:   
L E V 1 0 2 -C S 0 1  
St u d y P h ase:   
1/ 2a  
Pr o d uct N a me:   
L E V 1 0 2  T o pical G el  
I N D N u m ber:   
1 5 6 8 6 6  
I n dic ati o n:  
Ac q uire d Ble p har o pt osis  
I n vesti g at ors  
M ultice nter  
 
 
S p o ns or:  
Le vati o n P har ma Lt d.  
 
 
S p o ns or C o nt act:  
 
 
 
 
 
 
 
Me dic al M o nit or : 
 
  
 
 
 
 
 
Date  
Ori gi n al  Pr ot oc ol , V 1. 0: 
0 9  A u g ust 2 0 2 2  
A me n d me nt 1, V 2. 0   
3 1  Oct o ber 2 0 2 2  
A me n d me nt 2, V 3. 0   
0 6  Dece m b er 2 0 2 2  
A me n d me nt 3, V 4. 0   
1 7 Ja n uar y  2 0 2 3  
A me n d me nt 4, V 5. 0   
0 6  A pril 2 0 2 3  
A me n d me nt 5, V 6. 0   
2 5  Ma y 2 0 2 3  
 
C o nfi de nti alit y St ate m e nt  
T his d oc u me nt c o ntai ns i nf or mati o n fr o m Le vati o n P har ma Lt d . an d is of c o nfi de ntial, tra de secret, a n d/ or 
pr o prietar y nat ure a n d ma y n ot be discl ose d u nless s uc h discl os ure is re q uire d b y fe deral or state la w or re g ulati o n. 
It is l oa ne d t o y o u f or y o ur c o nfi de ntial re vie w o n be half of Le vati o n P har ma Lt d . onl y a n d is n ot t o be 
p h ot oc o pie d, discl ose d, or tra ns mitte d t o a n y ot her pers o n or part y wit h o ut t he a d va nce writte n a p pr o val of 
Le vati o n P har ma Lt d .  

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 4  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
St u d y P o p ul ati o n:  
T his st u d y is e x pecte d t o e nr oll a p pr o xi matel y 3 0 a d ult s u bjects wit h ac q uire d ble p har o pt osi s. 
Di a g n osis a n d M ai n Criteri a f or I ncl usi o n : 
T he st u d y p o p ulati o n will c o nsist of a d ult s u bjects w h o ha ve ac q uire d ble p har o pt osis. If b ot h e yes q ualif y f or 
t he st u d y, t he e ye wit h t he l o wer M R D 1 val ue at Baseli ne will be desi g nate d as t he st u d y e ye. If M R D 1 val ues 
are t he sa me f or b ot h e yes at Baseli n e, t he ri g ht e ye will be desi g nate d as t he st u d y e ye. Re gar dless of st u d y 
e ye or st u d y q ualificati o n, all e yes i n t his st u d y will recei ve st u d y I P a n d u n der g o st u d y assess me nts.  
 
I ncl usi o n Criteri a:  
S u bjects w h o meet all t he f oll o wi n g i ncl usi o n criteria will be eli gi ble t o partici pate i n t he st u d y. S u bjects m ust:  
1.  B e male or fe male s u bjects 2 5 years of a ge or ol der at t he ti me of Scree ni n g ( Visit 1)  
2.  Ha ve c o m plai nts of aest heticall y u nacce pta ble u p per e yeli d p ositi o n f or b ot h e yes ma ki n g t he m 
desir o us f or ele v ati o n, or ha ve c o m plai nts of s u peri or vis ual fiel d defects i n b ot h e yes t hat i m pact 
acti vities of dail y li vi n g  
3.  P rese nt wit h t he f oll o wi n g at Scree ni n g ( Visit 1):  
a. 
At  least o ne e ye t hat meets b ot h of t he f oll o wi n g criteria: 
i. 
M R D 1 ≤2 . 3 m m ( n o visi ble ce ntral p u pillar y li g ht refle x defa ults t o 0)  
ii. C urre nt c orrecte d  V A , u si n g s u bject’s o w n prescri pti o n e ye glasses, if a p plica ble , i n t he 
q ualif yi n g e ye(s) of + 0. 3  L o g M A R ( L o garit h m of t he Mi ni m u m A n gle of Res ol uti o n) 
or better as assesse d b y E T D R S  
b.  D em o nstrate u p per e yeli d ele vati o n ≥0. 5 m m c ha n ge fr o m baseli ne i n M R D 1 i n b ot h e yes i n 
res p o nse t o a si n gle dr o p of U p nee q ® ( o x y metaz oli ne 0. 1 % o p ht hal mic s ol uti o n) t o eac h e ye 
at Scree ni n g  
N ote: U p nee q ® is preferre d b ut p he n yle p hri ne 2. 5 % o p ht hal mic s ol uti o n ma y be use d 
if U p nee q ® is n ot a vaila ble i n a ti mel y ma n ner.  
4.  I n t he j u d g me nt of t he I n vesti gat or, ha ve n or mal le vat or pal pe brae s u peri oris m uscle f u ncti o n of b ot h 
u p per e yeli d s 
5.  W O C B P m ust a gree t o use a n a p pr o ve d met h o d of birt h c o ntr ol fr o m t he date t he y si g n t he i nf or me d 
c o nse nt f or m ( I C F) u ntil after t he last st u d y visit ( F oll o w -U p Visit)  
6.  Be a ble t o gi ve i nf or me d c o nse nt a n d willi n g t o c o m pl y wit h all st u d y visits a n d e xa mi nati o ns  
 
E xcl usi o n Criteri a : 
S u bjects w h o meet a n y of t he f oll o wi n g e xcl usi o n criteria at Scree ni n g ( Visit 1) or Baseli ne ( Visit 2) will n ot 
be eli gi ble t o partici pate i n t he st u d y. S u bjects m ust n ot:  
Oc ul ar C o n diti o ns:  
1.  Ha v e a n y ot her oc ular pat h ol o g y ot her t ha n pt osis re q uiri n g treat me nt wit h t o pical prescri pti o n 
o p ht hal mic dr o ps i n eit her e ye (e. g., gla uc o ma)  
N ote: S u bjects  w h o use o ver -t he-c o u nter (O T C ) or prescri pti o n  t o pical o p ht hal mic dr o ps  t o treat 
dr y e ye disease ma y be all o we d wit h S p o ns or a p pr o val.  
2.  H ave narr o w a n gles, gla uc o ma, I O P > 2 3 m m H g or dia g n osis of oc ular h y perte nsi o n, c u p -t o-disc rati o 
of > 0. 7 , or hist or y of a n y gla uc o ma e ye s ur ger y i n eit her e ye 
3.  Ha ve a n y acti ve oc ular or peri -oc ular i nfecti o n; a n y hist or y of rec urre nt or c hr o nic i nfecti o n or 
i nfla m mati o n i n eit her e ye 
4.  Ha ve a hist or y of her petic i nfecti o n i n eit her e ye  
5.  Ha ve a hist or y of c or neal disease ot her t ha n mil d t o m o derate dr y e ye or s ur ger y i n eit her e ye  

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 5  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
N ote: S u bjects wit h oc ular refracti ve s ur ger y ( e. g., laser-assiste d i n sit u kerat o mile usis, 
p h ot orefracti ve keratect o m y, s mall i ncisi o n le ntic ule e xtracti o n) ≥9 0 da ys pri or t o Scree ni n g 
( Visit 1) are all o we d. 
6.  Pr ese nt wit h a n y p u pillar y a b n or malit y i n eit her e ye  
7.  Pr ese nt wit h a n y ma nifest stra bis m us i n eit her e ye  
8.  Pr ese nt, i n t he o pi ni o n of t he I n vesti gat or, wit h cli nicall y si g nifica nt br o w pt osis i n eit her e ye  
9.  Ha ve as y m metr y ≥3 . 0 m m i n M R D 1 bet wee n e yes or i nter pal pe bral dista nce bet wee n b ot h e yes 
1 0.  Ha ve a n y a nat o mic a b n or malit y of eit her u p per or l o wer e yeli ds i n eit her e ye  t hat o bsc ures eit her 
u p per or l o wer e yeli d mar gi n  
1 1.  Ha ve a n y  hist or y of pt osis s ur ger y i n eit her e y e 
1 2.  Ha ve a hist or y of a n y u p per or l o wer e yeli d s ur ger y, i ncl u di n g ble p har o plast y , s ki n lesi o n, or ot her 
iss ue wit hi n 3 m o nt h of Scree ni n g ( Visit 1)  i n eit her e ye 
1 3.  Ha ve a hist or y of c hr o nic pr o gressi ve e xter nal o p ht hal m o ple gia, H or ner’s s y n dr o me, m yast he nia 
gra vis, Marc us G u n n ja w wi n ki n g, c o n ge nital pt osis, Kear ns -Sa yre S y n dr o me, der mat oc halasis , 
u nc o ntr olle d ble p har os pas m, Ra msa y H u nt s y n dr o me, or mec ha nical pt osis i n eit her e ye  
N ote:  Der mat oc halasis  (e xcess e yeli d s ki n) sh o ul d n ot be c o nsi dere d e xcl usi o nar y if , i n t he 
o pi ni o n of t he I n vesti gat or, it d oes n ot o bsc ure e yeli d mar gi ns or i nterfere wit h q ualit y i ma ge 
ca pt ur e. 
1 4.  Ha ve mec ha nical pt osis, i ncl u di n g pt osis d ue t o or bital or e yeli d t u m or, cicatricial pr ocesses affecti n g 
t he m o ve me nts of t he u p per e yeli d, a n d e n o p ht hal m os i n eit her e ye 
1 5.  Ha ve e yeli d p ositi o n affecte d b y e yeli d or c o nj u ncti val scarri n g i n eit her e ye  
1 6.  Ha ve a vis ual fiel d l oss fr o m a n y ca use ot her t ha n pt osis i n eit her e ye  
1 7.  Ha ve a hist or y of o ptic ne ur o pat h y i n eit her e ye  
1 8.  Ha ve use d t o pical a p plicati o n of bi mat o pr ost (i.e., Latisse) t o t he e yelas hes wit hi n 7 da ys pri or t o 
Scree ni n g ( Visit 1) a n d d uri n g t he st u d y i n eit her e ye  
1 9.  Ha ve use d t o pical a p plicati o n of pil ocar pi ne (i.e., V uit y) wit hi n 7 da ys pri or t o Scree ni n g ( Visit 1) 
a n d d uri n g t he st u d y i n eit her e ye  
2 0.  Ha ve c o nc urre nt disease i n eit her e ye or t hat c o ul d re q uire me dical or s ur gical i nter ve nti o n d uri n g t he 
st u d y peri od  
2 1.  Be  u n willi n g t o disc o nti n ue t he use of u p per e yeli d/e yelas h ma ke u p a n d  O T C c os metic pr o d ucts 
d uri n g t he S cree ni n g visit a n d o n t he da y of t he st u d y treat me nt a n d assess me nts ( Da y 1), i ncl u di n g 
b ut n ot li mite d t o:  
a. 
E y es ha d o w pri mer  
b.  E y es ha d o w 
c. 
E y eli d m oist urizer  
d.  E y eli ner 
e. 
Fa ke e yelas hes ( gl ue d or ma g netic)  
f. 
S k i n care pr o d ucts a p plie d t o t he e yeli d 
N ote: E n ha nce me nts t hat ca n n ot easil y be re m o ve d s h o ul d n ot be c o nsi dere d e xcl usi o nar y if , i n 
t he o pi ni o n of t he I n vesti gat or, t he y d o n ot o bsc ure e yeli d mar gi ns or i nterfere wit h q ualit y i ma ge 
ca pt ur e. 
N ote : S u bjects weari n g ma ke u p d uri n g t he S cree ni n g visit s h o ul d re m o ve t he ma ke u p o n -site 
bef ore i ma ge ca pt ure.  
2 2.  H ave use d o x y metaz oli ne t o pical e ye dr o ps ( U p nee q ®) f or treat me nt of ble p har o pt osis or as a n oc ular 
dec o n gesta nt ( Visi ne L R) wit hi n 7  da ys pri or t o Scree ni n g ( Visit 1) or pla n ne d use d uri n g t he st u d y 
peri o d i n eit her e ye  

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 6  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
N ote: E ye dr o ps a p plie d d uri n g Scree ni n g ( Visit 1) t o deter mi ne st u d y eli gi bilit y are e xe m pt fr o m 
t his e xcl usi o n. 
2 3.  Ha ve ha d i ntra vitreal i njecti o ns (e. g., L uce ntis, E ylea, A vasti n, Triese nce) wit hi n 7 da ys pri or t o 
Scree ni n g ( Visit 1) or ha ve pla ns f or a n i njecti o n d uri n g t he st u d y i n eit her e ye  
2 4.  Ha ve a hist or y of t h yr oi d e ye disease (i.e., e x o p ht hal m os, u p per e yeli d retracti o n, di pl o pia sec o n dar y 
t o e xtra oc ular m uscle i n v ol ve me nt) i n eit her e ye. H y pert h yr oi dis m t hat is c o ntr olle d o n me dicati o n is 
all o we d  
S yste mic C o n diti o ns:  
2 5.  Ha ve a resti n g heart rate o utsi de n or mal ra n ge of 5 0 -1 1 0 beats per mi n ute w hile sitti n g d uri n g t he 
Scree ni n g visit ( Visit 1)  
2 6.  Ha ve, i n t he o pi ni o n of t he I n vesti gat or, u nc o ntr olle d h y perte nsi o n, u nc o ntr olle d atrial fi brillati o n, or 
hist or y of cli nical car di o vasc ular disease i ncl u di n g str o ke, m y ocar dial i nfarcti o n, or heart fail ure  
2 7.  Ha ve pla ns t o use a n o n -o p ht hal mic α -a dre ner gic a g o nist, i ncl u di n g O T C pr o d ucts (e. g., Afri n), at 
a n y ti me d uri n g t he st u d y  
2 8.  Ha ve use d m o n oa mi ne o xi dase i n hi bit ors ( M A OIs; e. g., is ocar b o xazi d, p he nelzi ne, tra n ylc y pr o mi ne) 
wit hi n 1 4 da ys pri or t o Scree ni n g ( Visit 1) or a ntici pate usi n g M A OIs d uri n g t he st u d y  
2 9.  S u bjects wit h dia betic reti n o pat h y ma y n ot be e nr olle d i n t his st u d y. H o we ver, s u bjects wit h i ns uli n -
de pe n de nt dia betes, dia betes re q uiri n g oral h y p o gl yce mic dr u gs, or diet -c o ntr olle d dia betes are 
all o we d  
3 0.  Ha ve bee n dia g n ose d wit h be ni g n pr ostatic h y pertr o p h y re q uiri n g me dici nal t hera p y; pre vi o us 
pr ostatect o m y is all o we d  
Ge ner al:  
3 1.  Ha ve partici pate d i n ot her i n vesti gati o nal dr u g or de vice cli nical trials wit hi n 3 0 da ys pri or t o 
Scree ni n g ( Visit 1), or be pla n ni n g t o partici pate i n a n y ot her i n vesti gati o nal dr u g or de vice cli nical 
trials wit hi n 3 0 da ys of st u d y c o m pleti o n  
3 2.  Ha ve a hist or y of aller gic reacti o n t o t he i n vesti gati o nal dr u g or a n y of its c o m p o ne nts  
3 3.  Wi t hi n 7 da ys of Scree ni n g ( Visit 1), or a ntici pate d use d uri n g t he st u d y, use of a n y s yste mic, 
i ntra nasal, t o pical der mat ol o gic, or o p ht hal mic α-a dre ner gic a g o nist  (i ncl u di n g bri m o ni di ne) or 
a nta g o nist i ncl u di n g nasal or oc ular or oral dec o n gesta nts i ncl u di n g pse u d oe p he dri ne, o x y metaz oli ne 
t o pical o p ht hal mic s ol uti o n, o x y metaz oli ne t o pical der mat ol o gic crea m 
3 4.  S u bjects w h o are pre g na nt or breast -fee di n g 
3 5.  Ha ve use d U p nee q ® wit hi n 7 da ys of eit her Scree ni n g  ( Visit 1) or Baseli ne  ( Visit 2) 
I n vesti g ati o n al Pr o d uct(s); D ose; a n d M o de of A d mi nist r ati o n:  
•   L E V 1 0 2 T o pical Gel, 2. 0 % ( 1 0 0 µ L)  
•   L E V 1 0 2 T o pical Gel, 1. 0 % ( 1 0 0 µ L)  
Refere nce T her a p y; D ose; a n d M o de of A d mi nistr ati o n:  
•   Ve hicle T o pical Gel ( 1 0 0 µ L)  
D ur ati o n of Tre at m e nt:  
T he d urati o n of t he treat me nt peri o d i n t his st u d y is 1 da y wit h assess me nts t o be c o m plete d at Baseli ne ( bef ore 
I P a d mi nistrati o n), H o ur 0 (after I P a d mi nistrati o n), H o ur 0. 5, H o ur 1, H o ur 2, H o ur 4, H o ur 6, a n d H o ur 8.  
D ur ati o n of St u d y  P artici p ati o n:  
T here are 2  cli nic visits a n d 1  tele p h o ne f oll o w-u p o ver u p t o  5 0 da ys, ( u p to 4 5 da ys f or Scree ni n g  a n d 2 -5 
da ys after t he da y of st u d y treat me nt ). 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 7  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
St atistic al Met h o ds:  
In ge neral, a nal yses i n t his st u d y will e xa mi ne t he differe nces bet wee n i n di vi d ual treat me nt ar ms, as well as 
t he differe nces bet wee n c o m bi ne d ar ms of L E V 1 0 2 T o pical Gel c o m pare d t o ve hicle. C o nti n u o us meas ures 
will be s u m marize d descri pti vel y b y t he mea n, sta n dar d de viati o n ( S D), me dia n, mi ni m u m, a n d ma xi m u m 
val ues. Cate g orical meas ures will be s u m marize d b y t he fre q ue nc y a n d perce nta ge of s u bjects.  
 
F or all e x pl orat or y efficac y a nal yses a n d all safet y a nal yses perf or me d, Baseli ne will be defi ne d as t he 
meas ure me nt o n Da y 1 bef ore I P a d mi nistrati o n a n d n ot fr o m a n y pre vi o us visit. If b ot h e yes q ualif y f or t he 
st u d y, t he e ye wit h t he l o wer M R D 1 val ue at Baseli ne will be desi g nate d as t he st u d y e ye. If M R D 1 val ues are 
t he sa me f or O U at Baseli ne, t he ri g ht e ye will be desi g nate d as t he st u d y e ye. Re gar dless of st u d y e ye or st u d y 
q ualificati o n, all e yes i n t his st u d y will recei ve st u d y I P a n d u n der g o st u d y  assess me nts.  
 
T he sa m ple size of 1 0 s u bjects per ar m ( 3 0 s u bjects t otal f or a t otal of 6 0 e yes) is n ot base d o n f or mal p o wer 
or precisi o n c o nsi derati o ns.  S u bjects will be a nal yze d i n t he gr o u p acc or di n g t o t he I P treat me nt recei ve d. All 
e n d p oi nts will be a nal yze d usi n g t he Safet y A nal ysis Set a n d o nl y o bser ve d data will be i ncl u de d.  
 
S afet y a nal yses will be perf or me d o n all s u bjects i n t he Safet y A nal ysis Set. T he assess m e nt of safet y will be 
base d o n t he s u m mar y of oc ular a n d n o n -oc ular A Es, curre nt c orrecte d V A , I O P, slit la m p bi o micr osc o p y, 
oc ular h y pere mia , ma n ual  p u pill o metr y, i n direct dilate d o p ht hal m osc o p y, vital si g ns, a n d uri ne pre g na nc y test . 
S u m maries will be pr o vi de d b y treat me nt gr o u p, a n d f or oc ular assess me nts se paratel y b y e ye.  
 
S u m mar y statistics f or o bser ve d data a n d c ha n ges fr o m baseli ne ( w here a p pr o priate) f or c urre nt c orrecte d  V A , 
I O P, ma n ual  p u pill o metr y, vital si g ns, a n d t he c o mf ort q uesti o n naire will be prese nte d. A b n or malities i n slit 
la m p bi o micr osc o p y will be s u m marize d b y fre q ue nc y a n d perce nta ge. 
 
S u m mar y statistics f or o bser ve d data , a n d c ha n ges fr o m baseli ne ( w here a p pr o priate) f or M R D 1, L P F T, oc ular 
h y pere mia , a n d s u bject- a n d I nvesti gat or -re p orte d o utc o me q uesti o n naires at p ost-d ose Visit 2, as well as 
c ha n ge fr o m H o ur 2 at H o ur 6 f or L P F T will be prese nte d. S u bjects ac hie vi n g a n i m pr o ve me nt i n M R D 1 fr o m 
baseli ne of 1. 0, 1. 5, 2. 0, a n d 2. 5 m m will be s u m marize d b y ti me p oi nt. S u m mar y statistics f or o bser ve d data 
a n d c ha n ges fr o m baseli ne i n F A C E -Q | Aest hetics q uesti o n naires, as well as t he r es p o nse rates t o i n di vi d ual 
q uesti o ns, will be prese nte d.  
 
A Es will be c o de d usi n g t he Me dical Dicti o nar y f or Re g ulat or y Acti vities ( Me d D R A)  ( m ost c urre nt versi o n) 
a n d cate g orize d b y s yste m or ga n class ( S O C) usi n g preferre d ter ms ( P T). Se parate s u m maries of A Es  relate d 
t o treat me nt a n d b y se verit y will be prese nte d. T he n u m ber of deat hs a n d seri o us a d verse e ve nts (S A E ) will 
als o be prese nte d, a n d e ve nts lea di n g t o disc o nti n uati o n fr o m t he st u d y will be liste d a n d ta b ulate d.  
 
All data c ollecte d i n t his st u d y will be prese nte d i n data listi n gs f or all s u bjects . 
D ate of Ori gi n al Pr ot oc ol:  0 9  A u g ust 2 0 2 2  
D ate of Pre vi o us  Pr ot oc ol A m e n d m e nt: 0 6 A pril 2 0 2 3  
D ate of M ost Rece nt Pr ot oc ol A m e n d me nt: 2 5  Ma y 2 0 2 3  

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T A B L E O F C O N T E N T S  
TI T L E P A G E  .............................................................................................................................1  
S Y N O P SI S  .................................................................................................................................2  
T A B L E O F C O N T E N T S  ...........................................................................................................8  
LI S T O F A B B R E VI A TI O N S A N D D E FI NI TI O N S O F T E R M S  ..........................................1 2  
1  
I N T R O D U C TI O N .................................................................................................1 4  
1. 1  
Bac k gr o u n d  ......................................................................................................1 4  
1. 2  
St u d y Rati o nale  ................................................................................................1 5  
1. 3  
Ris k/ Be nefit Assess me nt  .................................................................................1 5  
1. 3. 1  
K n o w n P ote ntial Ris ks  .........................................................................1 5  
1. 3. 2  
K n o w n P ote ntial Be nefits  ....................................................................1 6  
1. 3. 3  
Assess me nt of Be nefits a n d Ris ks  .......................................................1 6  
2  
S T U D Y O BJ E C TI V E S  ..........................................................................................1 7  
3  
I N V E S TI G A TI O N A L P L A N ................................................................................1 9  
3. 1  
O verall St u d y Desi g n a n d Pla n  ........................................................................1 9  
3. 2  
Rati o nale f or St u d y Desi g n a n d C o ntr ol Gr o u p  ...............................................2 1  
3. 3  
E n d of St u d y Defi niti o n  ...................................................................................2 2  
4  
S T U D Y P O P U L A TI O N S E L E C TI O N  .................................................................2 3  
4. 1  
St u d y P o p ulati o n  ..............................................................................................2 3  
4. 2  
I n cl usi o n Criteria .............................................................................................2 3  
4. 3  
E xcl usi o n Criteria  ............................................................................................2 4  
4. 4  
Scree n/ Baseli ne Fail ures  ..................................................................................2 7  
5  
S T U D Y T R E A T M E N T( S)  ....................................................................................2 8  
5. 1  
Descri pti o n of I n v esti gati o nal Pr o d uct(s)  ........................................................2 8  
5. 1. 1  
D osa ge a n d A d mi nistrati o n ..................................................................2 8  
5. 2  
Pre parati o n/ St ora ge/ H a n dli n g/ Acc o u nta bilit y  .................................................2 8  
5. 2. 1  
Ac q uisiti o n a n d Acc o u nt a bilit y  ...........................................................2 8  
5. 2. 2  
Pr o d uct F or m ulati o n, A p peara n ce, Pac ka gi n g a n d La beli n g  ...............2 9  
5. 2. 3  
Pr o d uct St ora ge a n d Sta bilit y ...............................................................2 9  
5. 3  
Meas ures t o Mi ni mize Bias: Ra n d o mizati o n a n d Mas ki n g  .............................2 9  
5. 4  
C o nc o mita nt T hera p y .......................................................................................3 0  
6  
S T U D Y P R O C E D U R E S  .......................................................................................3 2  
6. 1  
Dis pe nsi n g St u d y Dr u g  ....................................................................................3 2  
6. 2  
A d verse E v e nts Assess me nts  ...........................................................................3 2  
6. 2. 1  
Defi niti o ns ............................................................................................3 2  
6. 2. 2  
Ti mi n g  ..................................................................................................3 3  
6. 2. 3  
Se verit y  ................................................................................................3 3  
6. 2. 4  
Relati o ns hi p  .........................................................................................3 3  

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6. 2. 5  
E x pecte d ness  ........................................................................................3 4  
6. 2. 6  
A d verse E v e nt Re p orti n g Re q uire me nts  ..............................................3 4  
6. 2. 7  
Cli nical La b orat or y A d v erse E ve nts  ....................................................3 5  
6. 2. 8  
Treat me nt -E mer ge nt A d verse E ve nts  ..................................................3 5  
6. 3  
Re m o val of S u bjects fr o m t he St u d y or St u d y Dr u g  .......................................3 5  
6. 4  
L ost t o F oll o w -U p  ............................................................................................3 5  
6. 5  
A p pr o priate ness of Meas ure me nts  ...................................................................3 6  
6. 5. 1  
Safet y Assess me nts  ..............................................................................3 6  
6. 5. 2  
Efficac y Assess me nts ...........................................................................3 6  
6. 5. 3  
Ot her Assess me nts  ...............................................................................3 7  
7  
S T U D Y A C TI VI TI E S  ...........................................................................................3 8  
7. 1  
Scree ni n g Visit ( Visit 1; Da y -4 5 t o Da y -7)  ...................................................3 8  
7. 2  
Baseli ne/ Ra n d o mizati o n ( Visit 2; Treat me nt Peri o d; Da y 1)  ..........................3 9  
7. 2. 1  
Baseli ne Assess me nts ( B ef ore I P A d mi nistrati o n)  ..............................3 9  
7. 2. 2  
I P A d mi nistrati o n a n d H o ur 0 Pr oce d ures ( After I P 
A d mi nistrati o n)  ....................................................................................4 0  
7. 2. 3  
H o ur 0. 5 Pr oce d ures  ( ± 1 0 mi n utes) .....................................................4 0  
7. 2. 4  
H o ur 1 Pr oce d ures ( ± 1 5 mi n utes)  ........................................................4 0  
7. 2. 5  
H o ur 2 Pr oce d ures ( ± 1 5 mi n utes)  ........................................................4 0  
7. 2. 6  
H o ur 4 Pr oce d ures ( ± 1 5 mi n utes)  ........................................................4 1  
7. 2. 7  
H o ur 6 Pr oce d ures ( ± 1 5 mi n utes)  ........................................................4 1  
7. 2. 8  
H o ur 8 Pr oce d ures ( ± 6 0 mi n utes)  ........................................................4 1  
7. 3  
Treat me nt F oll o w -U p P h o ne Call [ Visit 3; Da y 2 t o Da y 5]  ...........................4 2  
7. 4  
St u d y Wit h dra wal/ Earl y Ter mi nati o n Pr oce d ures  ...........................................4 2  
8  
Q U A LI T Y C O N T R O L A N D A S S U R A N C E  .......................................................4 3  
9  
P L A N N E D S T A TI S TI C A L M E T H O D S  ..............................................................4 4  
9. 1  
Ge neral C o nsi derati o ns  ....................................................................................4 4  
9. 2  
Deter mi nati o n of Sa m ple Size  .........................................................................4 4  
9. 3  
A nal ysis P o p ulati o ns  ........................................................................................4 4  
9. 4  
De m o gra p hics a n d Baseli ne C haract eristics  ....................................................4 4  
9. 5  
Safet y A nal ysis  ................................................................................................4 5  
9. 5. 1  
A d verse E v e nts  ....................................................................................4 5  
9. 5. 2  
Ot her Safet y E n d p oi nts  ........................................................................4 5  
9. 5. 3  
Pre g na nc y  .............................................................................................4 5  
9. 6  
E x pl orat or y Effi cac y Assess me nts  ..................................................................4 6  
9. 7  
Ta b ulati o n of I n di vi d ual S u bject Data  .............................................................4 6  
1 0  
A D MI NI S T R A TI V E C O N SI D E R A TI O N S  ..........................................................4 7  
1 0. 1  
St u d y A d mi nistrati ve Str uct ure ........................................................................4 7  

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1 0. 2  
I nstit uti o nal Re vie w B oar d (I R B) A p pr o val ....................................................4 7  
1 0. 3  
Et hical C o n d uct of t he St u d y  ...........................................................................4 8  
1 0. 4  
S u bject I nf or mati o n a n d C o nse nt .....................................................................4 8  
1 0. 5  
S u bject C o nfi de ntialit y  ....................................................................................4 8  
1 0. 6  
St u d y M o nit ori n g  .............................................................................................4 9  
1 0. 7  
Case Re p ort F or ms a n d St u d y Rec or ds  ...........................................................4 9  
1 0. 8  
St u d y Rec or ds Rete nti o n ..................................................................................5 0  
1 0. 9  
Pr ot oc ol De viati o ns  ..........................................................................................5 0  
1 0. 1 0  
Access t o S o urce D oc u m e ntati o n  ....................................................................5 0  
1 0. 1 1  
P u blicati o n P olic y  ............................................................................................5 0  
1 1  
R E F E R E N C E LI S T  ...............................................................................................5 2  
1 2  
A P P E N DI C E S  .......................................................................................................5 3  
1 2. 1  
A p pe n di x 1: Sc he d ule of Visits a n d Pr oce d ures  ..............................................5 3  
1 2. 2  
A p pe n di x 2: C urre nt C orrecte d Vis u al Ac uit y  ................................................5 5  
1 2. 3  
A p pe n di x 3: Pt osis E val uati o n  .........................................................................5 6  
1 2. 4  
A p pe n di x 4: I ntra oc ul ar Press ure (I O P)  ..........................................................5 7  
1 2. 5  
A p pe n di x 5: Leicester Peri p heral Fiel d Test ( L P F T)  ......................................5 8  
1 2. 6  
A p pe n di x 6: F A C E -Q | Aest hetics Q uesti o n naires  ..........................................5 9  
1 2. 7  
A p pe n di x 7:   
 E xter nal P h ot o gra p h y  ...................................................6 0  
1 2. 8  
A p pe n di x 8: I n vesti gat or -Re p orte d O utc o mes  ................................................6 1  
1 2. 9  
A p pe n di x 9: Ma n ual P u pill o metr y ...................................................................6 2  
1 2. 1 0  
A p pe n di x 1 0: Le vat or Pal pe brae S u peri oris F u ncti o n  .....................................6 3  
1 2. 1 1  
A p pe n di x 1 1: Slit La m p Bi o micr osc o p y  .........................................................6 4  
1 2. 1 2  
A p pe n di x 1 2: B ul bar C o nj u ncti val H y pere mia [ Brie n H ol de n Visi o n 
I nstit ute ( B H VI) Gra di n g Scale ( F or merl y K n o w n as t he C C L R U)] ..............6 6  
1 2. 1 3  
A p pe n di x 1 3: I n direct Dilate d O p ht hal m osc o p y  .............................................6 7  
1 2. 1 4  
A p pe n di x 1 4: I n vesti gati o nal Pr o d uct C o mf ort/ T olera bilit y Assess me nt  .......6 9  
1 2. 1 5  
A p pe n di x 1 5: Vital Si g ns  .................................................................................7 0  
1 2. 1 6  
A p pe n di x 1 6: W o me n of C hil d -beari n g P ote ntial ( W O C B P)  .........................7 1  
1 2. 1 7  
A p pe n di x 1 7: C o m plia nce State me nt a n d S p o ns or A p pr o val  .........................7 2  
1 2. 1 8  
A p pe n di x 1 8: I n vesti gat or’s Si g nat ure  ............................................................7 3  
 
 
 
 

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C o nfi de nti al  
 
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T a ble of T a bles  
Ta ble 1  
Me dicati o ns a n d Pr oce d ures N ot Per mitte d  ...............................................3 0  
 
 
T a ble of Fi g ures  
Fi g ure 1  
Cli nical St u d y Dia gra m ..............................................................................2 1  
Fi g ure 2  
M R D 1 Pt osis E val uati o n ............................................................................5 6  
 

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L I S T O F A B B R E VI A TI O N S A N D D E FI NI TI O N S O F T E R M S 
A E  
A d verse e ve nt  
B H VI   
Brie n H ol de n Visi o n I nstit ute  
C C L R U   
C or nea a n d C o ntact L e ns Researc h U nit  
C F R  
C o de of Fe d eral Re g ulati o ns  
C O N S O R T   
C o ns oli date d Sta n dar ds of Re p orti n g Trials  
C R F  
Case re p ort f or m 
e C R F  
E lectr o nic case re p ort f or m  
E D C  
Electr o nic Data Ca pt ure  
E T D R S   
Earl y Treat me nt Dia betic Reti n o pat h y St u d y  
F D A  
U nite d States F o o d a n d Dr u g A d mi nistrati o n  
G C P  
G o o d Cli nical Practice  
G L P  
G o o d La b orat or y Practice  
G M P  
G o o d Ma n ufact uri n g Practice  
HI P A A   
Healt h I ns ura nce P orta bilit y a n d Acc o u nta bilit y A ct  
I B  
I n v esti gat or’s Br oc h ure 
I C F 
Inf or me d c o ns e nt f or m  
I C H 
I nter nati o nal C o u ncil f or Har m o nisati o n 
I O P 
Intr a oc ular press ure  
I P 
In v esti gati o nal pr o d uct  
I R B 
I nstit uti o nal Re vie w B oar d 
L o g M A R   
L o garit h m of t he Mi ni m u m A n gle of Res ol uti o n  
L P F T   
Leicester Peri p heral Fiel d Test  
M A OI   
M o n oa mi ne o xi dase i n hi bit or  
Me d D R A   
Me dical Dicti o nar y f or R e g ulat or y Acti vities  
M R D 1   
M ar gi n refl e x dista nce 1 
O T C  
O ver -t he-c o u nter  
O U  
O c ul us uter q ue ( b ot h e y es) 
P K  
P har mac o ki netics  

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C o nfi de nti al  
 
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P T  
P referre d ter m 
Q C  
Q ualit y c o ntr ol 
S A E  
S eri o us a d verse e ve nt  
S A P  
Statistical A nal ysis Pla n  
S D  
S ta n dar d de viati o n  
S O C  
S yste m or ga n class  
U. S. A.   
U nite d States of A merica  
V A  
V is ual ac uit y  
V A S  
Vis ual A nal o g Scale  
W H O   
W orl d Healt h Or ga nizati o n  
W H O Dr u g   
W orl d Healt h Or ga nizati o n Dr u g Dicti o nar y  
W M A   
W orl d Me dical Ass o ciati o n  
W O C B P   
W o m en of c hil d -b eari n g p ote ntial  
 

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1  
I N T R O D U C TI O N 
1. 1   
B ac k gr o u n d  
B le p har o pt osis, or pt osis, is  a relati vel y c o m m o n, a b n or mal dr o o pi n g of t he u p per e y eli d wit h 
t he e ye hel d i n pri mar y gaze. T his dr o o pi n g ca n affect o ne or b ot h e yes. Base d o n ti me of 
a p peara nce, ble p har o pt osis  is t y picall y classifie d as eit her c o n ge nital or ac q uire d . E sti mates of 
pt osis pre vale nce re p ort rates bet wee n 4. 7 %  a n d 1 3. 5 % i n a d ult p o p ulati o ns, a n d t he i nci de nce 
of pt osis i ncreases wit h a ge. D r o o pi n g of t he u p per e y eli d d ue t o pt osis ca n ne gati vel y i m pact 
patie nt well -bei n g, i ncl u di n g re d uce d i n de pe n d e nce res ulti n g fr o m su peri or vis ual fiel d 
o bstr ucti o n a n d i ncreas e d a p peara n ce -relate d a n xiet y a n d d e pressi o n res ulti n g fr o m pt osis’ 
c haracteristic ‘sl ee p y ’ a p peara n ce . F u ncti o nall y, o bstr ucti o n of t he p u pil as a res ult of pt osis 
ca n lea d t o deficits i n t he s u peri or vis ual fiel d, d etecta ble via vis ual fiel d testi n g a n d  prese nt 
e ve n i n mil d cases, wit h a n o vel static peri metr y test [t he Leicester Peri p heral Fi el d Test 
( L P F T)] detecti n g a vis ual fiel d deficit i n nearl y all pt otic e yes  (H o et al., 2 0 1 1 ). I n lar g e-scale 
st u dies of patie nts wit h u nilateral or bilateral pt osis, i m pr o ve me nt i n t h e s u peri or vis ual fiel d 
f oll o wi n g s ur ger y was ass ociate d wit h si g nifica nt i m pr o ve me nt wit h res pect t o acti vities 
i ncl u di n g perf or mi n g t heir occ u p ati o n, pla yi n g s p orts, a n d wal ki n g wit h o ut assista nce 
(Bac harac h et al., 2 0 2 1 ).  
T he acti ve i n gre die nt i n L E V 1 0 2 T o pical Gel  is o x y metaz oli ne. O x y metaz oli ne is a n α 1- a n d 
α 2 -a dre n oce pt or a g o nist . O x y metaz oli ne was first a p pr o ve d i n t he U nite d States of A merica 
( U. S. A.) i n 1 9 6 4 f or t h e treat me nt of n asal dec o n gesti o n ( Afri n ® Nas al S pra y , 1 9 6 4). 
S u bse q ue ntl y, n u mer o us a d diti o nal o x y metaz oli ne -base d dr u gs ha v e bee n a p pr o ve d b y t he 
U nite d States F o o d a n d Dr u g A d mi nistrati o n ( F D A) f or o p ht hal mic a n d nasal use, i ncl u di n g: 
Oc uclear ® O p ht hal mic S ol uti o n ( 1 9 8 6), Visi ne ® O p ht hal mic S ol uti o n ( 1 9 8 9), K o va n aze ® 
Nasal S pra y ( 2 0 1 6), R h ofa de ® T o pical Crea m ( 2 0 1 7), a n d U p nee q ® E ye dr o ps ( 2 0 2 0). 
O x y metaz oli ne  is als o liste d i n t he F D A’s o ver -t he-co u nter ( O T C) m o n o gra p h f or nasal use 
(F D A, 1 9 9 4 ). 
In a d diti o n t o o x y metaz oli ne’s vas oc o nstrict or effects , w hic h are t hera pe uti c f or t he treat me nt 
of nasal dec o n gesti o n a n d c o nj u ncti val h y pere mi a , o x y metaz oli ne has t hera pe utic effects i n 
t he treat me nt of ac q uir e d ble p har o pt osis i n a d ults. Pres u ma bl y, t his is d ue t o t he sti m ulati o n 
of α -a dre n er gic rece pt or s i n t he s u peri or tarsal m us cle (als o k n o w n as M üller’s m uscle)  ca usi n g 
m uscle c o ntracti o ns  t hat lift t he u p per e y eli d w hile retracti n g t he l o wer e yeli d t o a lesser d e gree 
(Sl o ni m et al., 2 0 2 0 ). 
T he efficac y a n d safet y of a n o x y metaz oli ne 0. 1 % o p ht hal mic s ol uti o n a p pr o ve d f or t he 
treat me nt of ac q uire d ble p har o pt osis i n a d ults ( U p nee qT M , R V L P har mace uticals, I n c., 
Bri d ge water, NJ, U. S. A.) h as b ee n re p orte d. E vi de nce fr o m t w o p hase 3 cli nical trials re veale d 
t hat o nce-dail y use of o x y metaz oli ne 0. 1 % f or 4 2 da ys si g nifica ntl y i m pr o ve d t he s u peri or 
vis ual fiel d a n d u p per e yeli d ele vati o n i n patie nts wit h ac q uire d pt osis a n d acc o m pa n yi n g 

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s u peri or vis ual fiel d deficit. 
Usi n g t he L P F T, t hese st u dies de m o nstrate d si g nifica nt 
i m pr o ve me nts i n t he s u peri or vis ual fiel d wit h ass ociate d i m pr o ve me nts i n mar gi n refle x 
dista nce 1 ( M R D 1 ) meas ure me nts . M R D 1 is a c o m m o nl y use d assess me nt i n patie nts wit h 
pt osis a n d is defi ne d as t he dista nce ( m m) bet w ee n t he u p per e yeli d mar gi n a n d t he c or neal 
refle x w he n t h e e y e is i n t he pri mar y p ositi o n. These st u dies s h o we d t h at o x y metaz oli ne 0. 1 % 
was ass ociat e d wit h relati vel y l o w a d verse e ve nt ( A E) rat es a n d n o tac h y p h yla xis ( Bac harac h 
et al., 2 0 2 1 ). 
1. 2   
St u d y R ati o n ale  
T he p ur p ose of t his st u d y is t o deter mi ne t he oc ular a n d s yste mic safet y a n d t olera bilit y of a 
si n gle a p plicati o n of L E V 1 0 2 T o pical G el o n t he u p per e yeli ds, as well as t o e val uate t he effect 
of a si n gle a p plicati o n of L E V 1 0 2 T o pical G el  o n t he u p per e y eli ds o n s u p eri or vis ual fiel ds 
a n d u p per e y eli d hei g ht as meas ure d b y M R D 1 . 
U p nee q ® is a t o pical o p ht hal mic f or m ulati o n of o x y metaz oli ne  ( o x y metaz oli ne, 0. 1 %) 
a p pr o ve d b y t he F D A f or t he treat me nt of ac q uire d ble p har o pt osis i n a d ults w h o re p ort bl urre d 
visi o n a n d/ or di mi nis he d s u peri or vis ual fiel ds  (U p nee q ® Pac k a ge I ns ert 2 0 2 1 ; Sl o ni m et al., 
2 0 2 0 ). T he mec ha nis m of acti o n of U p nee q ® is pres u ma bl y sti m ulati n g α -a dre ner gic rece pt ors 
i n the s u peri or tarsal m uscle ca usi n g it t o c o ntract a n d t here b y lift t he u p per e yeli d  w hile 
retracti n g t he l o wer e y eli d t o a less er d e gree (Sl o ni m et al., 2 0 2 0 ). As U p nee q ® a n d L E V 1 0 2 
T o pical G el s h are t he sa me acti ve i n gre die nt, U p nee q ® vali dat es t he mec ha nis m of acti o n i n 
L E V 1 0 2 T o pical G el.  
1. 3   
Ris k/ Be nefit Assess me nt  
1. 3. 1   
K n o w n P ote nti al Ris k s 
L E V 1 0 2 T o pical Ge l is a ne w dr u g a n d has n ot bee n a p pr o ve d b y t he F D A f or use i n a n y 
i n dicati o n. T he acti ve i n gre die nt, o x y metaz oli ne, has b ee n us e d f or o p ht hal mic a n d nas al 
i n dicati o ns si nce t he 1 9 6 0s, an d, i n t hat ti me, p har mac ol o g y, p h ar mac o ki netics  ( P K), a n d 
t o xic ol o g y st u dies ha ve bee n c o n d u cte d o n s yste mic, der mal, a n d oc ular o x y metaz oli ne. 
U p nee q ® ( o x y met az oli ne, 0. 1 %) E ye dr o ps utilizes t he sa me acti ve i n gre die nt as L E V 1 0 2 
T o pical Gel  i n a l o wer c o nce ntr ati o n a n d wit h a differe nt met h o d of a d mi nistrati o n.  B ot h 
U p nee q ® a n d L E V 1 0 2 T o pical Gel are i nte n d e d t o treat ac q uire d ble p har o pt osis  i n a d ults. 
U p nee q ® is i nte n de d f or direct  i nstillati o n t o t he e ye, w hereas L E V 1 0 2 T o pical Gel  is i nte n d e d 
f or e xter nal t o pical a p plicati o n t o t he e xter nal u p per e yeli d. T he m ost c o m m o n  A Es  re p orte d 
f or U p nee q ® (i n ci de nce 1-5 %) ar e pu nctate keratitis , co nj u ncti v al h y pere mia , dr y e y e disease, 
bl urr y visi o n , pai n at t he i nstillati o n site, e ye irritati o n, a n d hea dac he.  

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 1 6  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
R h ofa de ® ( o x y metaz oli ne, 1. 0 %) T o pical Crea m a n d L E V 1 0 2 T o pical Gel  b ot h use t he sa me 
acti ve i n gre di e nt a n d are b ot h i nte n de d f or t o pical der mal a p plicati o n  t o t he face. T h e m ost 
c o m m o n A Es  (i nci de nce > 1 %) f or R h ofa de ® are ap plicati o n site der matitis , worse ni n g 
i nfla m mat or y lesi o ns of r osacea, pr uritis  at t he a p plicati o n site, er yt he ma  at t he a p plicati o n 
site, a n d pai n  at t he a p pli cati o n site . 
F or a d diti o nal i nf or mati o n a b o ut t he p ote ntial ris ks ass ociate d wit h L E V 1 0 2 T o pical Gel , 
p lease see t he I n vesti gat or’s Br oc h ure (I B). 
1. 3. 2   
K n o w n P ote nti al Be nefits  
T his is a first-i n-h u ma n cli nical trial of L E V 1 0 2 T o pical Gel  a n d, th eref ore , t here are n o k n o w n 
healt h  be nefits . Base d o n t he k n o w n effects of U p nee q ®, w hic h has t he sa me acti ve i n gre die nt, 
it is h y p ot hesize d t hat su bjects wit h ac q uire d bl e p har o pt osis ma y e x perie nce a n i ncreas e i n 
M R D 1 val ues w hile usi n g L E V 1 0 2 T o pical Gel , wit h res ulti n g im pr o ve me nt i n t he s u peri or 
vis ual fiel d, i ncreas e d i n de pe n de nt f u ncti o ni n g, a n d hi g her q ualit y of life a n d ps yc h os ocial 
f u ncti o ni n g. 
1. 3. 3   
A ssess me nt of Be nefits a n d Ris ks 
It is t he j u d ge me nt of L e vati o n P har ma Lt d. t hat there is a fa v ora bl e be nefit -ris k rati o f or 
s u bjects wit h ac q uir e d bl e p har o pt osis . T he acti ve i n gre die nt i n t he i n vesti gati o nal pr o d uct (I P), 
o x y metaz oli ne, is alrea d y a p pr o ve d b y t he F D A f or use i n h u ma n s u bjects acr oss m ulti ple 
i n dicati o ns. O x y metaz oli ne has b ee n a p pr o ve d a n d i n use si nce t he 1 9 6 0s. T he acti ve 
i n gre die nt is ge nerall y well t olerate d i n h u ma n s u bjects. 
 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 1 9  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
3  
I N V E S TI G A TI O N A L P L A N 
3. 1   
O ver all St u d y Desi g n a n d Pl a n  
T his is a P has e 1/ 2a , m ultice nter, ra n d o mize d, ve hi cle -c o ntr olle d, d o u ble -m as ke d, si n gle-d os e, 
parallel -gr o u p st u d y  c o n d ucte d i n a d ult s u bjects wit h ac q uire d bl e p har o pt osis. S u bjects will 
recei v e a o ne-ti me a p plicati o n of ra n d o mize d, d o u ble -mas ke d I P.  A p pr o xi matel y 3 0 s u bjects 
will be e nr olle d i n t his st u d y. E li gi ble su bjects will be r a n d o mize d t o 1 of t he f oll o wi n g 3 
treat me nt gr o u ps  i n a 1: 1: 1 rati o an d will recei v e a si n gle d ose of d o u ble -mas ke d I P e xt er nall y 
o n t he u p per e y eli d of b ot h e yes ( O U):  
•  L E V 1 0 2 T o pical Gel, 2. 0 % ( 1 0 0 µ L)  
•  L E V 1 0 2 T o pical Gel, 1 . 0 % ( 1 0 0 µ L) 
•  Ve hicle T o pical Gel ( 1 0 0 µ L)  
S cree ni n g Visit ( Visit 1 ; D a y -4 5 t o D a y -7 ) 
A t t he Scree ni n g visit ( Visit 1), s u bjects will r e vie w a n d si g n t he i nf or me d c o nse nt f or m (I C F) 
a n d be gi n was h o ut of pr o hi bite d me dicati o n s/ pr oce d ures not p er mitte d d uri n g  the st u d y . 
S u bjects will c o m plete st u d y i nta ke a n d u n der g o scree ni n g assess me nts, w hic h will i ncl u de 
exter nal p h ot o gr a p h y of O U b ot h bef ore a n d after a d mi nistrati o n of 1 dr o p of si n gle -mas ke d 
U p nee q ® ( o x y metaz oli n e 0. 1 % o p ht h al mic s ol uti o n) O U . (N ote: U p nee q ® is preferre d b ut 
p he n yle p hri ne 2. 5 % o p ht hal mic s ol uti o n ma y be use d if U p nee q ® is n ot a v aila ble i n a ti mel y 
ma n ner .) A  ce ntr al rea di n g ce nter  will re vie w t he i ma ges ca pt ure d d uri n g t he S cree ni n g visit 
t o c o nfir m  st u dy eli gi bilit y . S u bjects weari n g ma ke u p d uri n g t he S cree ni n g visit s h o ul d re m o ve 
t he ma ke u p o n-site bef ore i ma ge ca pt ure.  
S u bjects  s h o ul d be c o nt acte d b y tel e p h o ne o n Da y  -1 , t he da y bef ore Visit 2  (Baseli ne; 
Ra n d o mizati o n; Da y 1),  t o c o nfir m st u d y visit details a n d a p p oi nt me nt ti me, or t o i nf or m 
s u bjects of scree n fail ure. S u bjects w h o re m ai n eli gi ble f or st u d y partici pati o n at t his ti me 
s h o ul d be re mi n de d : 
1.  If t he s u bject n or mall y  w ears c o nt act le nses, t he  s u bject sh o ul d n ot wear c o ntact le nses 
o n  st u d y visit da ys [ Visit 1 ( Scree ni n g); Visit 2 (Baseli ne; Ra n d o mizati o n; Da y 1 )] a n d 
s h o ul d i nstea d wear p res cri pti o n e ye glasses . 
2.  N ot t o a p pl y a n y ma ke u p or  O T C c os metic or t o pical s ki n care pr o d ucts, i ncl u di n g 
s u nscree n or m oist urizer, t o t heir eyeli ds or e yelas hes o n t he da y of st u d y treat me nt 
( Visit 2; Baseli ne; Ra n d o mizati o n; Da y 1). 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 2 0  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
D a y 1/ Tre at me nt Peri o d ( Visit 2)  
Te n  ( 1 0) t o 4 5 cale n dar da ys after t he Scree ni n g visit, eli gi ble su bjects will ret ur n t o t he st u d y 
site f or ra n d o mizati o n t o 1 of 3 treat me nt gr o u ps  i n a 1: 1: 1 rati o. D o u ble -mas ke d I P will be 
dis pe nse d u si n g a p ositi ve-dis place m e nt pi pette a n d will be a p plie d s m o ot hl y wit h a gl o ve d 
fi n ger t o t he e ntire e xter n al s ki n of t he u p per e y eli d of eac h e ye b y trai ne d st u d y staff. 
N ote: T he Da y 1 a p p oi nt me nt arri val ti me m ust be sc he d ule d f or earl y i n t he m or ni n g t o all o w 
s ufficie nt ti me f or t he H o ur 8 st u d y assess me nts. 
S u bjects will u n der g o st u d y assess me nts a n d a ns wer st u d y q uesti o n naires at  Baseli ne , H o ur 1, 
H o ur 4, a n d H o ur 8. E xter nal p h ot o gra p h y of t he e yes will als o be c o n d ucte d at  Baseli ne, H o ur 
0. 5, H o ur 1, H o ur 2, H o ur 4, H o ur 6, a n d H o ur 8. F or t he p ur p oses of d oc u me ntati o n a n d 
a nal ysis, B aseli ne will be defi ne d as t h e  m eas ure me nts c ollecte d at Da y 1 bef ore a d mi nistrati o n 
of d o u ble -mas ke d st u d y I P . 
T ele p h o ne F oll o w -U p ( Visit 3; D a y 2 -5 ) 
S u bjects will be c o ntacte d b y cli nical site staff f or a f oll o w -u p tele p h o ne i nter vie w  2 -5 da ys 
after t he tr eat me nt peri o d t o c ollect data o n A Es e x perie n ce d i n t he da ys f oll o wi n g I P 
a d mi nistrati o n a n d t o c ollect data o n c o n c o mita nt me dicati o ns . 
A  dia gra m of t he st u d y d esi g n is i ncl u de d bel o w at Fi g ure 1 . 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 2 1  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
Fi g ure 1   
Cli nic al St u d y Di a gr a m  
 
•   S u bjects s h o ul d b e c o ntacte d b y st u d y staff via  tele p h o ne bef ore st u d y visits t o be re mi n de d of t he f oll o wi n g: 
1.) I f t he s u bject n or mall y  wears c o ntact le nses, t he s u bject s h o ul d n ot wear c o ntact le nses  o n st u d y visit da ys  
an d s h o ul d i nstea d wear prescri pti o n e ye glasses  a n d 2.) N ot t o a p pl y a n y ma ke u p or  O T C c os metic or t o pical 
s ki n care pr o d ucts, i ncl u di n g s u nscree n or m oist urizer , to t heir e yeli ds or e yelas h es o n t he da y of t he 
S cree ni n g visit or o n t he da y of st u d y treat me nt. 
•   Vi sit 3 will be a re m ote visit c o n d ucte d b y tele p h o ne. 
3. 2   
R ati o n ale f or St u d y Desi g n a n d C o ntr ol Gr o u p  
T his st u d y will assess t he oc ular a n d s yste mic safet y a n d t olera bilit y of a si n gle a p plicati o n of 
L E V 1 0 2 T o pical Gel, 2 %  (1 0 0  µ L ), L E V 1 0 2 T o pical Gel, 1 %  (1 0 0  µ L ), a n d matc hi n g ve hicle 
gel ( 1 0 0 µ L) o n t he u p p er e y eli ds of s u bjects wit h ac q uire d bl e p har o pt osis . The matc hi n g 
ve hicle gel is i de ntical i n f or m ulati o n t o L E V 1 0 2, wit h t he e xce pti o n t hat t h e ve hicle g el d oes 
n ot c o ntai n  a n y acti ve dr u g . 
S u bjects will recei ve 1 dr o p of si n gle-mas ke d U p nee q ® ( o x y metaz oli ne 0. 1 % o p ht hal mic 
s ol uti o n) O U at t he S cree ni n g visit a n d will ha ve p h ot o gra p h y ta ke n of t h eir e yes b ot h bef ore 
a n d aft er si n gle-mas ke d d osi n g . (N ote : U p nee q ® is preferre d b ut p h e n yle p hri ne 2. 5 % 
o p ht hal mic s ol uti o n ma y be use d if U p nee q ® is n ot a vaila ble i n a ti mel y ma n ner .) A ce ntral 
rea di n g ce nter will re vi e w t hese i ma ges t o e ns ure all s u bjects e nr olle d i n t he st u d y are 
o x y metaz oli n e or phe n yl e p hri n e r es p o n ders. 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 2 2  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
S u bjects will recei ve a si n gle d ose of d o u ble -mas ke d I P o n t he u p per e yeli d  O U o n Da y 1 a n d 
will u n der g o st u d y assess me nts at m ulti ple ti me p oi nts o n t hat sa me da y . Do u ble -mas ke d I P 
will be dis pe nse d usi n g a p ositi ve -dis place me nt pi pette a n d will be a p plie d s m o ot hl y wit h a 
gl o ve d fi n ger t o t he e ntire e xter n al s ki n of t he u p p er e y eli d of eac h e y e b y trai ne d st u d y staff . 
T he treat me nt peri o d i n t his st u d y will be  o n Da y 1, a n d s u bjects will be c o nt acte d b y tel e p h o ne 
f or a f oll o w-u p call aft er I P a d mi nistrati o n a n d bef ore bei n g release d fr o m t he st u d y.  
 
 
 
 
 
 T he i nte n de d cli nical d ose of L E V 1 0 2 
T o pical Gel i n t his st u d y will be 1 0 0 µ L per u p per e yeli d at a f or m ulati o n stre n gt h of eit her 
2 % or 1 % . Ass u mi n g d ose pr o p orti o nalit y i n t he s yste mic e x p os ure t o o x y metaz oli ne, the 
esti mate d s yste mic e x p os ure i n h u m a n s u bjects s h o ul d be c o m p ara bl e t o t he s yste mic e x p os ure 
o bser ve d w it h t he mar ket e d pr o d uct, R h ofa d e ®. Th e ma xi m u m d ose of L E V 1 0 2 T o pical Gel 
is calc ulate d as 1 0 0 µ L of 2 % L E V 1 0 2 f or eac h e yeli d ( 20 0 µ L  t otal) = 2  m g per e yeli d or 4  
m g per s u bject f or a si n gle d ose a p plie d t o b ot h u p per e yeli ds. 
B ase d o n  i nf or m ati o n o btai ne d fr o m pu blicl y a vaila ble s o urces a n d t he dat a c ollect e d t o dat e 
o n L E V 1 0 2 T o pical Gel , Le vati o n P har ma Lt d. belie ves t hat t he pr o p ose d d osi n g ( 1 0 0 µ L of 
2 % L E V 1 0 2 a d mi nistere d e xter nall y t o eac h u p per e yeli d, o nce dail y) is wit hi n t he safet y 
ra n ge. Pleas e see t h e I B for a d diti o nal details a b o ut t he n o ncli nical p har mac ol o g y,  t he 
precli nical P K, a n d t o xic ol o g y st u dies  t hat i nf or me d t his e val uati o n of o x y metaz oli n e.  
3. 3   
E n d of St u d y Defi niti o n  
A  s u bject is c o nsi dere d t o ha ve c o m plete d t he st u d y if t he y ha ve bee n ra n d o mize d t o I P , 
u n der g o ne st u d y assess m e nts o n Da y 1, a n d bee n c o ntacte d b y tele p h o ne f or t heir f oll o w -u p 
visit . T h e e n d of t he st u d y is defi ne d as c o m pleti o n of t he last visit or pr oce d ure s h o w n i n t h e 
sc he d ule i n t he st u d y gl o ball y. 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 2 3  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
4  
S T U D Y P O P U L A TI O N S E L E C TI O N  
4. 1   
St u d y P o p ul ati o n  
T he st u d y p o p ulati o n will c o nsist of a d ult s u bjects w h o ha v e ac q uire d ble p har o pt osis . If b ot h 
e yes q ualif y f or t he st u d y, t he e ye wit h t he l o wer M R D 1 val ue at Baseli ne will be desi g nate d 
as t he st u d y e ye . If M R D 1 val ues are t he s a me f or bot h e yes  at Bas eli ne, t h e ri g ht e y e will b e 
desi g nate d as t h e st u d y e ye . Re g ar dless of st u d y e ye or st u d y q ualificati o n, all e yes i n t his 
st u d y will recei ve st u d y I P a n d u n der g o st u d y assess me nts. 
4. 2   
I ncl usi o n Criteria  
S u bjects w h o meet all  t he foll o wi n g i ncl usi o n criteria will be eli gi ble t o partici pate i n t he st u d y. 
S u bjects m ust:  
1.  Be male or fe m ale s u bjects 2 5 years of a g e or ol der at t he ti me of Scree ni n g ( Visit 1)  
2.  Ha ve c o m plai nts of aest heticall y u nacce pta ble u p per e yeli d p ositi o n f or b ot h e yes 
ma ki n g t he m desir o us f or ele vati o n, or h a ve c o m plai nts of s u peri or vis ual fiel d defects 
i n b ot h e yes t hat i m pact acti vities of dail y li vi n g 
3.  Prese nt wit h t he f oll o wi n g at Scree ni n g ( Visit 1):  
a. At least o ne e ye t h at meets b ot h of t he f oll o wi n g criteria:  
i. M R D 1 ≤2 . 3 m m ( n o visi ble ce ntral p u pillar y li g ht refle x d efa ults t o 0)  
ii. C urre nt c orrect e d  V A , usi n g s u bject’s o w n prescri pti o n e ye glasses, if 
a p plica ble, i n t he q u alif yi n g e ye(s) of + 0.3  L o g M A R ( L o garit h m of t he 
Mi ni m u m A n gle of Res ol uti o n) or better as ass esse d b y E T D R S  
b.  De m o nstrate u p p er e yeli d ele vati o n ≥0. 5 m m c h a n ge fr o m baseli ne i n M R D 1 
i n b ot h e yes i n res p o nse t o a si n gle dr o p of U p nee q ® ( o x y metaz oli ne 0. 1 % 
o p ht hal mic s ol uti o n) t o eac h e y e at Scree ni n g  
N ote: U p nee q ® is preferre d b ut p h e n yle p hri ne 2. 5 % o p ht hal mic s ol uti o n 
ma y be use d if U p n ee q ® is n ot a vaila ble i n a ti mel y ma n ner .  
4.  I n t h e j u d g me nt of t he I n vesti gat or, ha ve n or mal le vat or pal p e brae s u peri oris m uscle 
f u ncti o n of b ot h u p per e y eli ds 
5.  W o me n of c hil d -beari n g p ote ntial ( W O C B P) m ust a gree t o use a n a p pr o ve d m et h o d of 
b irt h c o ntr ol as o utli ne d i n A p pe n di x 1 6 : W o men of C hil d -beari n g P ote ntial ( W O C B P)  
fr o m t he date t he y si g n t he I C F u ntil after t he last st u d y visit ( F oll o w -U p Visit ) 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 2 4  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
6.  B e a ble t o gi ve i nf or me d c o nse nt a n d willi n g t o c o m pl y wit h all st u d y visits a n d 
e xa mi nati o ns  
4. 3   
E xcl usi o n Criteri a  
S u bjects w h o meet a n y of t he f oll o wi n g e xcl usi o n criteria at Scree ni n g ( Visit 1) or Baseli ne 
( Visit 2) will n ot be eli gi ble t o partici pate i n t he st u d y. S u bjects m ust n ot: 
O c ul ar C o n diti o ns  
1.  Ha ve a n y ot h er o c ular p at h ol o g y ot her t h a n pt osis re q uiri n g treat me nt wit h t o pical 
prescri pti o n o p ht hal mic dr o ps i n eit her e ye (e. g., gla uc o ma)  
N ote: S u bjects w h o us e O T C or prescri pti o n t o pi cal o p ht hal mic dr o ps t o treat dr y 
e ye diseas e ma y be all o we d wit h S p o ns or a p pr o val.  
2.  Ha ve narr o w a n gles, gla uc o ma, I O P > 2 3 m m H g or dia g n osis of oc ular h y perte nsi o n, 
c u p-t o-disc rati o of > 0. 7, or hist or y of a n y gla uc o ma e ye s ur ger y i n eit her e ye  
3.  Ha ve a n y acti ve oc ul ar or peri -oc ular i nfecti o n; a n y hist or y of rec urre nt or c hr o nic 
i nfecti o n or i nfla m mati o n i n eit her e ye 
 
4.  Ha ve a hist or y of her petic i nfecti o n i n eit her e ye  
5.  Ha ve a hist or y of c or neal disease ot her t ha n mil d t o m o derate dr y e ye or s ur ger y i n 
eit her e ye  
N ote: 
S u bjects 
wit h o c ular refracti ve s ur ger y (e. g., laser -assiste d i n sit u 
kerat o mile usis, p h ot orefracti ve keratect o m y, s mall i ncisi o n le ntic ule e xtracti o n) 
≥9 0 da ys pri or t o Scree ni n g ( Visit 1) are all o we d.  
6.  Prese nt wit h a n y p u pillar y a b n or malit y i n eit her e ye  
7.  Prese nt wit h a n y ma nifest stra bis m us i n eit her e ye  
8.  Prese nt, i n t he o pi ni o n of t he I n v esti gat or, wit h cli nicall y si g nifica nt br o w pt osis i n 
eit her e ye  
9.  Ha ve as y m metr y ≥3. 0 m m i n M R D 1 bet wee n e yes or i nter pal pe bral dista nce bet wee n 
b ot h e yes  
1 0.  Ha ve a n y a n at o mic a b n or malit y of eit her u p per or l o wer e yeli ds i n eit her e ye t hat 
o bsc ures eit her u p per or l o wer e y eli d mar gi n  

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 2 5  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 1.  Ha ve a n y hist or y of pt osis s ur ger y i n eit her e ye  
1 2.  Ha ve a hist or y of a n y u p per or l o wer e yeli d s ur ger y, i ncl u di n g ble p har o plast y, s ki n 
lesi o n, or ot her iss ue wit hi n 3 m o nt h of Scree ni n g ( Visit 1) i n eit her e ye 
1 3.  Ha ve a hist or y of c hr o ni c pr o gressi ve e xter n al o p ht hal m o ple gia, H or ner’s s y n dr o me, 
m yast he nia gra vis, 
Marc us G u n n ja w wi n ki n g, c o n ge nital pt osis, Kear ns -Sa yre 
S y n dr o me, der mat oc halasis, u nc o ntr olle d ble p har os pas m, Ra msa y H u nt s y n dr o me, or 
mec ha nical pt osis  i n eit her e ye 
N ote:  Der mat oc halasis (e xcess e yeli d s ki n) s h o ul d n ot be c o nsi dere d e x cl usi o nar y 
if, i n t he o pi ni o n of t he I n vesti gat or, it d oes n ot o bsc ure e y eli d mar gi ns or i nterfere 
wit h q ualit y i ma ge ca pt ure.  
1 4.  Ha ve m ec ha ni cal pt osis, i ncl u di n g pt osis d ue t o or bital or e y eli d t u m or, cicatricial 
pr ocesses affecti n g t he m o ve me nts of t he u p per e y eli d, a n d e n o p ht hal m os i n eit her e ye  
1 5.  Ha ve e y eli d p ositi o n affecte d b y e yeli d or c o nj u ncti val scarri n g i n eit her e y e  
1 6.  Ha ve a vis ual fiel d l oss fr o m a n y ca us e ot her t ha n pt osis i n eit her e ye  
1 7.  Ha ve a hist or y of o ptic ne ur o pat h y i n eit her e ye  
1 8.  Ha ve use d t o pical a p plicati o n of bi mat o pr ost (i.e., Latisse) t o t he e yelas hes wit hi n 7 
da ys pri or t o Scree ni n g ( Visit 1)  a n d d uri n g t he st u d y i n eit her e ye  
1 9.  Ha ve us e d t o pical a p plicati o n of pil ocar pi ne (i.e., V uit y) wit hi n 7 d a ys pri or t o 
Scree ni n g ( Visit 1) a n d d uri n g t he st u d y i n eit her e ye  
2 0.  Ha ve c o n c urre nt diseas e i n eit her e y e or t hat c o ul d re q uire me di cal or s ur gical 
i nter ve nti o n d uri n g t he st u d y peri o d 
2 1.  Be u n willi n g t o disc o nti n ue t he use of u p per e y eli d/e yelas h ma ke u p a n d O T C c os metic 
pr o d ucts d uri n g t h e S cree ni n g visit a n d o n t he da y of t he st u d y treat me nt a n d 
assess me nts ( Da y 1), i ncl u di n g b ut n ot li mite d t o:  
a. E yes ha d o w pri mer  
b.  E yes ha d o w  
c. E yeli d m oist urizer  
d.  E yeli ner  
e. Fa ke e yelas h es ( gl ue d or ma g netic)  
f. S ki n care pr o d u cts a p plie d t o t he e yeli d  

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 2 6  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
N ote: E n ha n ce me nts t h at ca n n ot easil y be re m o ve d s h o ul d n ot be c o nsi dere d 
e xcl usi o nar y if, i n t he o pi ni o n of t he I n vesti gat or, t he y d o n ot o bsc ure e yeli d 
mar gi ns or i nterfere wit h q ualit y i ma ge ca pt ure.  
N ote : S u bjects weari n g ma ke u p d uri n g t he S cree ni n g visit s h o ul d re m o ve t he 
ma ke u p o n -site bef ore i ma ge ca pt ure. 
2 2.  Ha ve use d o x y met az oli n e t o pical e ye dr o ps ( U p nee q ®) f or treat me nt of ble p har o pt osis 
or as a n o c ular d ec o n gest a nt ( Visi ne L R) wit hi n 7  da ys pri or t o Scree ni n g ( Visit 1) or 
pla n ne d use d uri n g t he st u d y peri o d i n eit her e y e  
N ote: E y e dr o ps a p plie d d uri n g Scree ni n g ( Visit 1) t o deter mi ne st u d y eli gi bilit y 
are e x e m pt fr o m t his e xcl usi o n.  
2 3.  Ha ve ha d i ntra vitreal i njecti o ns (e. g., L uce ntis, E ylea, A vasti n, Triese n ce) wit hi n 7 
da ys pri or t o Scree ni n g ( Visit 1) or ha ve pla ns f or a n i njecti o n d uri n g t he st u d y i n eit her 
e ye  
2 4.  Ha ve a hist or y of t h yr oi d e ye disease (i.e., e x o p ht hal m os, u p per e yeli d retracti o n, 
di pl o pia sec o n dar y t o e xtra oc ular m uscle i n v ol ve me nt) i n eit her e ye. H y pert h yr oi dis m 
t hat is c o ntr olle d o n me dicati o n is all o we d 
S yste mic C o n diti o ns  
2 5.  Ha ve a resti n g heart rate o utsi de n or mal ra n ge of 5 0 -1 1 0 beats per mi n ute w hile sitti n g 
d uri n g t he Scree ni n g visit ( Visit 1)  
2 6.  Ha ve, i n t he o pi ni o n of t he I n vesti gat or, u nc o ntr olle d h y perte nsi o n, u nc o ntr olle d atrial 
fi brillati o n, or hist or y of cli nical car di o vasc ular disease i ncl u di n g str o ke, m y ocar dial 
i nfarcti o n, or heart fail ure 
2 7.  Ha ve pla ns t o use a n o n -o p ht hal mic α -a dre ner gic a g o nist, i ncl u di n g O T C pr o d ucts 
(e. g., Afri n), at a n y ti me d uri n g t he st u d y 
2 8.  Ha ve use d m o n o a mi ne o xi dase i n hi bit ors ( M A OIs; e. g., is ocar b o xazi d, p he nelzi ne, 
tra n ylc y pr o mi ne) wit hi n 1 4 da ys pri or t o Scree ni n g ( Visit 1) or a ntici pate usi n g M A OIs 
d uri n g t he st u d y  
2 9.  S u bjects wit h dia betic reti n o pat h y ma y n ot be e nr olle d i n t his st u d y. H o we ver, s u bjects 
wit h i ns uli n -de pe n de nt dia betes, dia betes re q uiri n g oral h y p o gl yce mic dr u gs, or diet -
c o ntr olle d dia betes are all o we d  

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 2 7  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
3 0.  Ha ve b ee n dia g n ose d wit h be ni g n pr ostatic h y p ertr o p h y re q uiri n g m e dici n al t hera p y; 
pre vi o us pr ostatect o m y is all o we d  
Ge ner al  
3 1.  Ha ve partici pate d i n ot her i n vesti gati o nal dr u g or de vice cli nical trials wit hi n 3 0 da ys 
pri or t o Scree ni n g ( Visit 1), or be pla n ni n g t o partici pate i n a n y ot her i n vesti gati o nal 
dr u g or de vice cli nical tri als wit hi n 3 0 da ys of st u d y c o m pleti o n  
3 2.  Ha ve a hist or y of aller gic reacti o n t o t he i n vesti gati o nal dr u g or a n y of its c o m p o ne nts  
3 3.  Wit hi n 7 da ys of Scree ni n g ( Visit 1), or a ntici pate d use d uri n g t he st u d y, use of a n y 
s yste mic, i ntra nasal, t o pical der mat ol o gic, or o p ht hal mic α-a dre ner gic a g o nist 
(i ncl u di n g bri m o ni di ne) or a nta g o nist i ncl u di n g nasal or oc ular or oral dec o n gesta nts 
i ncl u di n g pse u d oe p he dri ne, o x y metaz oli ne t o pical o p ht hal mic s ol uti o n, o x y metaz oli ne 
t o pical der mat ol o gic crea m 
3 4.  S u bjects w h o are pre g na nt or breast -fee di n g 
3 5.  Ha ve use d U p nee q ® wit hi n 7 da ys of eit her Scree ni n g ( Visit 1) or Baseli ne ( Visit 2)  
4. 4   
S cree n /B aseli ne F ail ures  
S cree n fail ures are defi ne d as s u bjects w h o c o nse nt t o partici pate i n t he cli nical st u d y b ut w h o  
d o n ot meet t he i ncl usi o n criteria at t he Scree ni n g visit  a n d/ or are det er mi ne d u ns uita ble f or 
t he st u d y beca use t he y meet excl usi o n criteria. T his i ncl u des b ut is n ot li mite d t o e val uati o ns 
c o m plete d b y t he ce ntral rea di n g ce nter  of i ma g es ca pt ure d d uri n g t he Scree ni n g visit.  Baseli ne  
fail ures are defi ne d as s u bjects w h o c o nse nt t o partici pate i n t he cli nical st u d y a n d are eli gi ble 
base d o n scree ni n g criteria  b ut are n ot eli gi ble bas e d o n t he Baseli ne criteria  a n d are t heref ore 
n ot r a n d o ml y assi g ne d t o I P. A mi ni mal set of s cree n fail ure i nf or mati o n is re q uire d t o e ns ure 
tra ns pare nt re p orti n g of scree n a n d bas eli ne fail ure s u bjects, t o m eet t he C o ns oli date d 
Sta n dar ds of Re p orti n g Tr ials ( C O N S O R T) p u blis hi n g re q uire me nts, a n d t o res p o n d t o q ueries 
fr o m re g ulat or y a ut h orities. Mi ni mal i nf or mati o n i ncl u des de m o gra p h y, scree n fail ure details, 
eli gi bilit y criteria, a n d a n y seri o us a d verse e v e nts ( S A E).  
R escree ni n g m a y be p er mitte d a ma xi m u m of 1 ti me 2  wee ks after scree n fail ure f or s u bjects 
wit h I O P v al ues at Baseli ne ≥2 3 m m H g. Rescree ni n g ma y be per mitte d a m a xi m u m of 1 ti me 
after a p pr o priate was h o ut peri o ds f or s u bjects w h o prese nte d wit h dis q ualif yi n g me dical 
c o n diti o ns at Baseli ne or pre vi o us/c o nc o mita nt me dicati o ns pr o hi bite d i n  Ta ble 1 . Rescree ni n g 
ma y als o occ ur bas e d u p o n pr ot oc ol a me n d me nts wit h pri or a p pr o val fr o m t he Me dical 
M o nit or a n d S p o ns or . R escree n e d s u bjects s h o ul d be assi g ne d a ne w s u bject n u m ber, a n d t he 
ori gi nal s u bject n u m ber s h o ul d be rec or de d as a scree n fail ure . 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 2 8  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
5  
S T U D Y T R E A T M E N T( S)  
5. 1   
Descri pti o n of I n vesti g ati o n al Pr o d uct(s) 
L E V 1 0 2 T o pical Gel a n d its matc hi n g ve hicle g el ar e 
 ge ls wit h hi g h 
vis ual visc osit y i nte n de d f or e xter n al t o pical a d mi nistrati o n t o t he e xteri or s ki n of s u bjects’ 
u p per e y eli ds. S ta bilit y st u dies of L E V 1 0 2  sh o w n o micr osc o pic c ha n g es of n ote a n d pr o vi de 
n o res ults i n dicati ve of p h ysical i nsta bilit y of t he f or m ulati o n . 
T he I P c o m p o ne nts are ase ptic; h o we ver, it is n ot p ossi ble t o ter mi nall y sterilize  t he I P usi n g 
t he curre nt ma n ufact uri n g met h o d d ue t o l oss of dr u g s u bsta nce a n d/ or c h a n ges i n visc osit y . 
T he matc hi n g ve hicle gel i n t his st u d y is i de ntical i n f or m ulati o n t o L E V 1 0 2 T o pical Gel, wit h 
t he e xce pti o n t hat t he ve hicle gel d oes n ot c o ntai n a n y acti ve dr u g. 
T he acti ve dr u g i n t his st u d y, o x y metaz oli ne, is a c o m merciall y a v aila ble s y m pat h o mi metic. 
 
 
 
5. 1. 1   
D os a ge a n d A d mi nistr ati o n  
E li gi ble s u bjects will be ra n d o mize d t o 1 of 3 p ossi ble treat me nt gr o u ps i n a 1: 1: 1 rati o. Trai ne d 
st u d y staff will dis pe nse d o u ble-mas ke d I P [ L E V 1 0 2 T o pical Gel, 2. 0 % ( 1 0 0 µ L); L E V 1 0 2 
T o pical Gel, 1 . 0 % (1 0 0 µ L); Ve hicle T o pical Gel ( 1 0 0 µ L)] 
 
will a p pl y t he gel s m o ot hl y wit h a gl o ve d fi n ger t o t he e ntire e xter nal s ki n of  eac h 
s u bject’s u p per e yeli ds ( O U). 
T he I P a d mi nistrati o n i n t his st u d y m ust be sc he d ule d f or earl y i n t he m or ni n g i n or der t o 
acc o m m o date t he H o ur 8 st u d y assess me nts. T his is a 1 -da y, s i n gle-d ose st u d y i n w hic h 
s u bjects ra n d o mize d t o I P will recei v e 1 d os e of d o u ble-mas ke d I P gel ( 1 0 0 µ L) per  u p per 
e yeli d f or a t otal of 2 0 0 µ L p er s u bject f or t he d urati o n of t he st u d y . 
5. 2   
Pre p ar ati o n/ St or a ge/ H a n dli n g/ Acc o u nt a bilit y  
5. 2. 1   
Ac q uisiti o n a n d Acc o u nt a bilit y  
D o u ble -mas ke d I P f or t his st u d y will be pr o vi de d t o eac h st u d y site. O nce t he I P has bee n 
deli vere d t o t he site, it will be st ore d i n a li mite d -access area o nl y accessi ble t o trai ne d st u d y 
staff. Use d a n d u n use d I P will be mai ntai ne d at t he site f or acc o u nta bilit y b y t he cli nical st u d y 
m o nit or . 
W he n a ut h orize d b y t he S p o ns or a n d after t he cli nical st u d y m o nit or has verifie d dr u g 
acc o u nta bilit y is c o m plete a n d acc urate, us e d a n d u n use d d o u ble -m as ke d I P will  eit her b e 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 2 9  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
ret ur ne d t o t he S p o ns or or desi g nee,  or will be dis p ose d / destr o ye d b y t he sites i n a cc or da n ce 
wit h t he re q uire me nts of a p plica ble l ocal a ut h orities a n d re g ulat or y b o dies t o e ns ure dis p osal 
of I P d oes n ot e x p ose h u ma n bei n gs t o ris ks fr o m t he dr u g . 
5. 2. 2   
P r o d uct F or m ul ati o n, A p pe ar a nce, P ac k a gi n g a n d L a beli n g  
L E V 1 0 2 T o pical Gel a n d Ve hicle T o pical Gel will be pac ka ge d i n i de ntical 
 
vials a n d la bel e d i n acc or da nce wit h fe d eral re g ulati o ns f or i n vesti gati o nal ne w dr u gs. La bels 
will i ncl u de ver bati m t he f oll o wi n g state me nt: “ C a uti o n: Ne w Dr u g –  Li mite d b y Fe deral la w 
t o i n vesti gati o nal use.” 
A d diti o nal details ma y als o be i ncl u de d o n t he la bel, pr o vi de d t hat t h ese d etails d o n ot p ose a 
ris k t o st u d y mas ki n g. T his ma y i ncl u de b ut is n ot li mite d t o t he pr ot oc ol n u m ber, I P v ol u me 
per c o ntai ner, st ora g e re q uire me nts, ma n ufact urer, a n d l ot n u m ber . 
5. 2. 3   
Pr o d uct St or a ge a n d St a bilit y  
T he d o u ble -mas k e d I P f or t his st u d y will b e st ore d u pri g ht i n a  li mite d-access area accessi ble 
o nl y t o trai ne d st u d y staff a t a c o ntr olle d r o o m t e m perat ure bet w ee n 2 0° C -2 5° C  (6 8° F -7 7° F ) 
a n d pr otecte d fr o m dir ect s u nli g ht. Te m perat ure e xc ursi o ns ex perie n ce d i n ware h o uses a n d 
d uri n g s hi p pi n g [ n ot t o e xcee d 3 0° C (8 6° F )] are p er mitte d . 
O nce a vial of d o u ble -mas ke d I P has bee n o pe ne d,  it m ust o nl y be use d f or d osi n g a si n gle 
s u bject. O pe ne d a n d u n o pe ne d vials will be mai ntai ne d at t he site f or acc o u nta bilit y b y t he 
cli nical st u d y m o nit or.  
5. 3   
Me as ures t o Mi ni mize Bi as: R a n d o miz ati o n a n d M as ki n g  
E li gi ble s u bjects will be ra n d o mize d i n t he el ectr o nic data ca pt ure ( E D C) s yste m i n a 1: 1: 1 
rati o t o d o u ble -mas ke d I P [ L E V 1 0 2 T o pical Gel, 2. 0 % ( 1 0 0 µ L) ; L E V 1 0 2 T o pical Gel, 1 . 0 % 
(1 0 0 µ L) ; V e hicle T o pi cal Gel ( 1 0 0 µ L) ] wit h o ut stratificati o n b y  st u d y site. T he d o u ble -
mas ke d I P will be dis pe nse d a n d a d mi nistere d t o s u bjects b y trai ne d st u d y staff o nl y.  
T he ra n d o mizati o n sc he d ule will be c o m p uter -ge n erate d i n t he E D C, a n d all I P will be mas ke d 
t o t he S p o ns or, st u d y pers o n nel, a n d st u d y s u bjects t hr o u g h o ut t he st u d y u ntil after t he fi nal 
data base has b ee n l oc ke d. A p pr o priate preca uti o ns m ust be ta ke n t o pre ve nt u na ut h orize d 
access t o t he ra n d o mizati o n sc he me. U nless t he s u bject’s safet y re q uires ot her wise a n d if ti me 
per mits, t he d ecisi o n t o u n mas k a treat me nt assi g n me nt is t o be ma de j oi ntl y b y t he I n vesti gat or 
a n d t he st u d y’s me dical m o nit or after c o ns ult ati o n wit h t he S p o ns or . 
If u n mas ki n g is re q uire d d uri n g t he st u d y, t he i nte grit y of t he st u d y assess me nts a n d c ollecte d 
data will be mai ntai ne d b y li miti n g access t o t he u n mas ke d data.  

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 3 2  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
6  
S T U D Y P R O C E D U R E S  
6. 1   
Dis pe nsi n g St u d y Dr u g  
T his is a d o u ble -mas ke d, si n gle -d ose st u d y i n s u bjects wit h ac q uire d ble p har o pt osis. S u bjects 
will n ot ha ve a n y I P dis pe nse d t o t he m . D o u ble -mas ke d I P will be dis pe nse d usi n g a p ositi ve -
dis place me nt pi pette a n d will be a p plie d s m o ot hl y wit h a gl o ve d fi n ger t o t he e ntire e xt er nal 
s ki n of t he u p per e yeli d of eac h e y e b y trai ne d st u d y staff. T he gl o ve d st u d y staff will caref ull y 
r u b t he I P i nt o s u bjects’ u p per e yeli d s ki n u ntil t h e I P h as b ee n f ull y a bs or be d i nt o t he e yeli d 
s ki n. Care will be ta ke n t o e ns ure I P is n ot acci de ntall y i nstille d i nt o s u bjects’ e yes. 
6. 2   
A d verse E ve nts Assess me nts  
A Es will be m o nit ore d t hr o u g h o ut t he st u d y. S u bjects will be e n c o ura g e d t o re p ort a n y a d v erse 
fi n di n gs d uri n g t he st u d y w het her or n ot t he y are relate d t o I P. T hese ca n b e c ollecte d eit her i n 
a n u ns olicite d fas hi o n wit h o ut a n y pr o m pti n g or i n res p o nse t o a g e neral q uesti o n s uc h as: 
“ Ha ve y o u n otice d a n yt hi n g differe nt si nce y o u starte d t he st u d y; be ga n t h e I P, etc.?”  
A ll A Es will be ca pt ure d o n t he a p pr o priate case re p ort f or m ( C R F). I nf or m ati o n t o be c ollecte d 
at mi ni m u m i ncl u des e ve nt descri pti o n, o nset, assess me nt of se verit y, relati o ns hi p t o I P, a n d 
o utc o me . 
6. 2. 1   
Defi niti o ns  
A n A E is a n y u nt o war d me dical occ urre n ce i n a cli nical st u d y s u bject te m p orall y ass ociate d 
wit h t he use of st u d y i nter ve nti o n, w het her or n ot c o nsi dere d relate d t o t he st u d y i nter ve nti o n.  
A n A E ca n t h eref ore b e a n y u nfa v ora ble a n d u ni nte n de d si g n (i ncl u di n g a n a b n or mal 
la b orat or y fi n di n g), s y m pt o m, or disease ( ne w or e xacer bate d) te m p orall y ass ociate d wit h t he 
use of I P. 
A n A E or s us pecte d a d verse reacti o n is c o nsi dere d “seri o us” if, i n t he vie w of eit her t he 
I n v esti gat or or S p o ns or, it res ults i n a n y of t he f oll o wi n g o utc o mes:  
•  De at h  
•  A l ife-t hreate ni n g A E 
•  I n p atie nt h os pitalizati o n or pr ol o n gati o n of e xisti n g h os pitalizati o n  
•  A persiste nt or si g nifica nt i nca pacit y or s u bsta ntial disr u pti o n of t he a bilit y t o c o n d uct 
n or mal life f u ncti o ns  
•  A c o n ge nital a n o mal y or birt h defect  
I m p ort a nt 
me dical e ve nts t hat ma y n ot res ult i n deat h, be life-t hreate ni n g, or re q uire 
h os pitalizati o n ma y be c o nsi dere d s eri o us w he n, base d u p o n a p pr o priate me dical j u d g me nt, 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 3 3  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
t he y ma y je o par dize t he s u bject a n d ma y re q uire me dical or s ur gical i nter ve nti o n t o pre ve nt 
o ne of t he o utc o mes liste d i n t his defi niti o n . 
6. 2. 2   
Ti mi n g  
T he I n vesti gat or will rec or d all A Es wit h start dates occ urri n g a n y ti me after i nf or me d c o nse nt 
is o btai ne d u ntil 7 (f or n o nseri o us A Es) or 3 0 da ys (f or S A Es) after t he last da y of st u d y 
partici pati o n.  At eac h st u d y visit, t he I n vesti gat or will i n q uire a b o ut t he occ urre nce of 
A E/ S A Es si nce t he last visit.  E ve nts will be f oll o we d f or o utc o me i nf or mati o n u ntil res ol uti o n 
or sta bilizati o n . 
A n y me dical c o n diti o n t hat is prese nt at t he ti me t hat t he s u bject is scree ne d will be c o nsi dere d 
as baseli ne a n d n ot re p orte d as a n A E  b ut will be rec or de d as Me dical Hist or y . H o we ver, if t he 
st u d y s u bject’s c o n diti o n deteri orat es at a n y ti me d uri n g t he st u d y, it will be rec or de d as a n 
A E . 
6. 2. 3   
Severity  
T he se verit y of all A Es will be assesse d b y t he I n vesti gat or a n d gra d e d as f oll o ws:  
•  Mil d : Re q uires mi ni mal or n o treat me nt a n d d o es n ot i nterfere wit h t he s u bject’s dail y 
acti vities;  
•  M o der ate:  Res ults i n a l o w le vel of i nc o n ve nie nce or c o n cer n a n d ma y ca use s o me 
i nterfere nce wit h f u ncti o ni n g; 
•  Se vere:  I nt err u pts a s u bject’s us ual dail y acti vit y a n d ma y re q uire s yste mic dr u g 
t hera p y or ot her treat m e nt. Se vere A Es are us uall y p ote ntiall y life-t hreate ni n g or 
i nca pacitati n g. T he t er m “se vere” d o es n ot necess aril y e q uate t o “s eri o us.”  
6. 2. 4   
Rel ati o ns hi p  
A ll A Es m ust ha ve t heir relati o ns hi p t o st u d y i nter ve nti o n assesse d b y t he I n v esti gat or w h o 
e xa mi nes a n d e val uates t he s u bject base d o n te m p oral relati o ns hi p a n d t he I n vesti gat or’s 
cli nical j u d g me nt. T he d e gree of certai nt y a b o ut ca usalit y will be gra de d usi n g t he cate g ories 
bel o w. I n a cli nical st u d y, t he I P m ust al wa ys b e s us pect.  
•  U n rel ate d : N o reas o na bl e p ossi bilit y t hat t he a d mi nistrati o n of t he I P ca use d t he e ve nt, 
n o te m p oral relati o ns hi p bet wee n t he I P a n d e ve nt o nset, or a n alter nate eti ol o g y has 
bee n esta blis he d ; 
•  Re l ate d: Is k n o w n t o occ ur wit h t he I P, is a reas o na ble p ossi bilit y t hat t he I P ca use d 
t he A E, or t here is a te m p oral relati o ns hi p bet wee n t he I P a n d e v e nt. Reas o na ble 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 3 4  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
p ossi bilit y mea ns t hat t here is e vi de nce t o s u g g est a ca usal relati o ns hi p bet wee n t h e I P 
a n d t he A E. 
6. 2. 5   
E x pecte d ness  
A n A E or s us p ecte d a d v erse reacti o n is c o nsi dere d “ u ne x p ecte d” if it is n ot liste d i n t he I B, 
p ac ka g e i nsert, or de vice la beli n g or is n ot liste d at t he s pecificit y or se v erit y t hat has bee n 
o bser ve d; or, if a n  I B is n ot re q uire d or a v aila ble, is n ot c o nsiste nt wit h t he ris k i nf or mati o n 
descri be d i n t he pr ot oc ol, as a me n de d. “ U ne x p ecte d,” as use d i n t his defi niti o n, als o refers t o 
A Es or s us pecte d a d verse reacti o ns t hat are me nti o ne d i n t he I n vesti gat or’s Br oc h ure, pac k a ge 
i nsert, or de vice la beli n g as occ urri n g wit h a cl ass of dr u gs  ( or ot her me dical pr o d ucts) or as 
a ntici pate d fr o m t he p har mac ol o gical pr o perties or ot her c haracteristics of t he I P b ut are n ot 
s pecificall y me nti o ne d as occ urri n g wit h t he partic ular I P u n der i n vesti gati o n . 
T he I n v esti gat or will b e res p o nsi ble f or det er mi ni n g w het her a n A E is u ne x pecte d, i. e., if t he 
nat ure, se verit y, or fre q ue nc y of t he e ve nt is n ot c o nsiste nt wit h t he ris k i nf or mati o n pre vi o usl y 
descri be d f or t he I P . 
6. 2. 6   
A dverse Eve nt Re p orti n g Re q uire me nts  
A cc or di n g t o fe deral re g ulati o ns, a n I n v esti gat or m ust i m me diatel y re p or t (i.e., wit hi n 2 4 
h o urs) t o t he S p o ns or a n y S A E, w het h er or n ot c o nsi dere d dr u g relate d, i ncl u di n g t h ose liste d 
i n t he pr ot oc ol or I B an d m ust i ncl u de a n assess me nt of w het her t here is a reas o na ble p ossi bilit y 
t hat t he I P ca use d t he e ve nt . St u d y e n d p oi nts t hat are S A Es (e. g., all-ca use m ortalit y) m ust be 
re p orte d i n acc or da n ce wit h t he pr ot oc ol u nl ess t here is e vi de nce s u g gesti n g a ca us al 
relati o ns hi p bet wee n t he I P a n d t he e ve nt (e. g. , deat h fr o m a na p h yla xis). I n t hat case, t he 
I n v esti gat or m ust i m me diatel y re p ort t h e e v e nt t o t he S p o ns or ( See 2 1 C o de of Fe deral 
Re g ulati o ns ( C F R ) 3 1 2. 6 4( b)) . 
A cc or di n g t o fe deral re g ulati o ns, t he S p o ns or m ust n otif y t he F D A a n d all partici pati n g 
I n v esti gat ors as s o o n as p ossi ble, b ut i n n o case later t ha n 1 5 cale n dar da ys after t he S p o ns or 
deter mi nes t hat a p ote ntial seri o us ris k arisi n g fr o m a cli nical st u d y q u alifies f or re p orti n g.  T he 
S p o ns or m ust re p ort a n y s us pecte d a d verse reacti o n t hat is b ot h s eri o us a n d u ne x pecte d. T he 
S p o ns or m ust re p ort a n A E as a s us pecte d a d verse reacti o n o nl y if t here is e vi de nce t o s u g gest 
a ca usal relati o ns hi p bet wee n t he dr u g a n d t he a d verse e v e nt ( See 2 1 C F R 3 1 2. 3 2(c)( 1)) . 
F urt her m ore, t he S p o ns or m ust als o n otif y t he F D A of a n y u ne x p ecte d fatal or life -t hreat e ni n g 
s us pecte d a d v erse reacti o n as s o o n as p ossi ble b ut i n n o case later t ha n 7 cale n dar d a ys after 
t he S p o ns or's i nitial recei pt of t he i nf or mati o n ( See 2 1 C F R 3 1 2. 3 2(c)( 2)). 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 3 5  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
6. 2. 7   
C li nic al L a b or at ory A dverse Eve nts 
N ot a p plica ble. Cli nical l a b orat or y tests a n d p har mac o ki netics are n ot bei n g c o n d ucte d f or t his 
st u d y. 
6. 2. 8   
Tre at me nt -E mer ge nt A dverse Eve nts  
T reat me nt-e mer ge nt a d v erse e ve nts  w ill be defi ne d as A Es t hat occ ur i n a s u bject after 
i nf or me d c o nse nt has b ee n si g ne d a n d after t he s u bject has recei ve d I P o n Da y 1.  
6. 3   
Re m o v al of S u bjects fr o m t he St u d y  or St u d y Dr u g  
S u bjects are free t o wit h dra w fr o m p artici pati o n i n t he st u d y at a n y ti me u p o n re q uest. A n 
In v esti gat or ma y disc o nti n ue or wit h dra w a s u bject fr o m  t he st u d y f or a n y of t he f oll o wi n g 
reas o ns: 
•  Pr e g na nc y  
•  Si g nifica nt st u d y treat me nt/i nter ve nti o n n o n -c o m plia nce  
•  If a n y cli nical a d v erse e ve nt, la b orat or y a b n or malit y, or ot her me dical c o n diti o n or 
sit uati o n occ urs s uc h t hat c o nti n ue d partici pati o n i n t he st u d y w o ul d n ot be i n t he best 
i nterest of t he s u bject 
•  T h e S p o ns or or In vesti gat or ter mi nates t he st u d y  
•  T h e s u bject re q u ests t o be disc o nti n ue d fr o m t he st u d y.  
T he reas o n f or s u bject disc o nti n uati o n or wit h dra wal fr o m t he st u d y will be rec or de d o n t he 
C R F . Su bjects w h o si g n t he i nf or me d c o nse nt f or m a n d d o n ot recei ve I P o n Da y 1  ma y be 
re place d. Su bjects w h o si g n t he i nf or me d c o ns e nt f or m , are ra n d o mize d , ha v e bee n  d os e d wit h  
I P o n Da y 1 , a n d s u bse q ue ntl y wit h dra w, or are wit h dra w n or disc o nti n ue d fr o m t he st u d y, 
ma y n ot be re place d.  
6. 4   
L ost t o F oll o w -U p  
A  s u bject will b e c o nsi d ere d l ost t o f oll o w-u p if  t he s u bject fails t o ret ur n t o t he cli nic f or 
sc he d ule d visits  an d i f t he s u bject ca n n ot be co ntacte d b y t he st u d y site staff . S u bjects will 
si milarl y be c o nsi dere d l ost t o f oll o w-u p if t he s u bject d oes n ot  res p o n d t o ph o ne call s f or t he 
Visit 3 tele p h o ne foll o w -u p ( Da y 2 -5) i n a ti mel y ma n ner . 
T he f oll o wi n g acti o ns m ust be ta ke n if a s u bject fails t o ret ur n t o t he cli nic f or a re q uire d st u d y 
visit:  

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 3 6  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
•  T h e site will atte m pt t o c o ntact t he s u bject a n d res c he d ule t he misse d visit  a n d c o u nsel 
t he s u bject o n t he i m p orta nce of m ai ntai ni n g t he assi g ne d visit sc he d ule a n d ascertai n 
if t he s u bject wis hes t o a n d/ or s h o ul d c o nti n ue i n t he st u d y;  
•  Be f ore a s u bject is dee me d l ost t o f oll o w-u p, t he I n v esti gat or or desi g nee will ma ke 
e ver y eff ort t o re gai n c o ntact wit h t he s u bject ( w here p ossi ble, 3 tele p h o n e calls a n d, if 
necessar y, a certifie d letter t o t he s u bject’s last k n o w n maili n g a d dress or l ocal 
e q ui vale nt met h o ds).  T h ese c o ntact atte m pts s h o ul d be d o c u me nte d i n t he s u bject’s 
me dical rec or d or st u d y file . 
S h o ul d t he s u bject c o nti n ue t o be u nreac h a ble, t he s u bject will be c o nsi dere d t o h a ve 
wit h dra w n fr o m t he st u d y wit h a pri mar y reas o n of L ost t o F oll o w -U p.  
6. 5   
A p pr o pri ate ness of Me as ure me nts  
6. 5. 1   
S afet y Assess me nts  
T he safet y assess me nts selecte d f or t his st u d y  are all c o m m o n t o ols wit hi n t he fiel d o f 
o p ht hal m ol o g y a n d are g e nerall y rec o g nize d as relia ble, acc urate, a n d rele va nt  i n assessi n g t he 
healt h a n d safet y of s u bjects’ e yes. S afet y assess m e nts i n t his st u d y i ncl u d e: 
•  A E m o nit ori n g ( oc ular a n d n o n -oc ular)  
•  C urre nt C orrecte d V A  (A p pe n di x 2: C urre nt C orrecte d Vis u al Ac uit y ) 
•  I O P (A p pe n di x 4 : I ntra o c ular Press ure (I O P)) 
•  Ma n ual  P u pill o metr y ( A p pe n di x 9 : Ma n ual  P u pill o metr y ) 
•  Slit La m p E xa mi nati o n ( A p pe n di x 1 1 : Slit La m p Bi o micr osc o p y) 
•  C o nj u ncti val H y pere mia E val uati o n  (A p pe n di x 1 2 : B ul bar C o nj u ncti val H y pere mia  
[Brie n H ol de n Visi o n I nstit ute ( B H VI) G ra di n g S cale (F or merl y  K n o w n as t he 
C C L R U )]) 
•  I ndir ect Dilate d O p ht hal m osc o p y  (A p pe n di x 1 3 : I n direct Dilate d O p ht hal m osc o p y) 
•  V ital Si g ns (A p pe n di x 1 5: Vital Si g ns ) 
•  Ur i ne Pre g n a nc y Test [ o nl y f or 
W O C B P (A p pe n di x 1 6 : 
W o men of C hil d -beari n g 
P ote ntial ( W O C B P) )] 
6. 5. 2   
Effic ac y Assess m e nt s 
T he efficac y assess me nts selecte d f or t his st u d y are  a mi x of co m m o n t o ols wit hi n t he fiel d of 
o p ht hal m ol o g y  ge nerall y r ec o g nize d as relia ble, acc urat e, a n d rele va nt a n d n o vel a p pr oac hes 
t o assessi n g pt osis. Efficac y assess me nts i n t his st u d y i ncl u d e: 
•  Le icester Peri p heral Fiel d Test (A p pe n di x 5 : Leicester Peri p heral Fi el d Test ( L P F T) ) 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 3 7  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
T he L P F T is a n o vel, m o difie d vis ual fiel d test de vel o pe d b y H o et al. ( 2 0 1 1)  t o e val uate 
s u peri or vis ual fiel d defects i n a d va nce of pt osis s ur ger y. T he res ulti n g literat ure 
c o nfir ms t hat pt osis ca n be c o nsi dere d b ot h a f u ncti o nal iss ue  a n d a c os metic iss ue.  T he 
L P F T was s elect e d f or t his st u d y beca use of its F D A -a p pr o ve d use i n cli nical trials f or  
U p nee q ® . 
•  F A C E -Q | 
Aest hetics 
Q uesti o n naires  (A p pe n di x 
6 : F A C E -Q | 
Aest hetics 
Q uesti o n naire s) 
F A C E -Q  is a s u bject-re p orte d o utc o me meas ure t hat has bee n use d s u ccessf ull y in 
n u mer o us cli nical trial setti n gs t o e val uate t he safet y a n d effecti ve n ess of facial  
treat me nts a n d t o i n f or m s u bject care i n cli nical practice . F A C E -Q ca n be use d t o 
meas ur e su bject s atisfacti o n wit h aest hetic facial pr oce d ures a n d pr o d ucts fr o m t he 
s u bjects’ pers pecti ve. 
 
•  In v esti gat or -R e p ort e d O utc o me s (A p pe n di x 8 : I n vesti gat or-Re p orte d O ut c o mes ) 
P ri nci pal I n vesti gat ors will be s u bjecti vel y assessi n g t he  
 p h ot o gra p hs i n a 
ra n d o mize d, mas k e d fas hi o n. 
 
•  E x ter nal P h ot o gra p h y of E yes (A p pe n di x 3: Pt osis E val uati o n ; A p pe n di x 7 :  
 
E xter nal P h ot o gra p h y ) 
I ma ges of s u bjects’ e yes will be ca pt ure d o nsite d uri n g t he cli nic visit a n d s u b mitte d t o 
a ce ntral rea di n g ce nter f or e val uati o n. T hese i ma gi n g assess me nts are c o m m o n t o ols 
wit hi n t he fiel d of o p ht h al m ol o g y a n d are ge nerall y rec o g nize d as relia ble, acc urate, 
a n d rele va nt. Please see t he Ma n ual of Pr oce d ures f or a d diti o nal i nf or mati o n a b o ut t he 
ce ntral r ea di n g ce nter ’s r ole, o perati o ns , a n d q u alificati o ns. 
6. 5. 3   
Ot her Assess m e nts  
T his st u d y will als o i ncl u de a n I P C o mf ort Assess me nt  (A p pe n di x 1 4 : I n v esti gati o nal Pr o d uct 
C o mf ort/ T olera bilit y Assess me nt ). 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 3 8  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
7  
S T U D Y A C TI VI TI E S  
W ritte n i nf or me d c o nse nt a n d Healt h I ns ura n ce P orta bilit y a n d Acc o u nta bilit y Act ( HI P A A) 
a ut h orizati o n will be o btai ne d fr o m all s u bjects bef ore a n y st u d y -relate d pr oce d ures are 
perf or me d. T he pr oce d ures a n d assess m e nts t hat s h o ul d occ ur at eac h st u d y visit  are detaile d 
at A p pe n di x 1 : Sc he d ule of Visits a n d Pr oce d ures.  
U nless ot her wise n ote d, pr oce d ures a n d assess me nts s h o ul d occ ur i n t he or der liste d . T he 
Scree ni n g visit i n v ol ves U p nee q ®  or p he n yl e p hri ne  i nstillati o n a n d use of dilati n g e ye dr o ps. 
S u bjects w h o n or mall y  wear c o ntact le nses s h o ul d i nstea d use prescri pti o n e ye glasses d uri n g 
all st u d y visits. 
7. 1   
S cree ni n g Visit  (Visit 1; D a y  -4 5 t o D a y -7 ) 
•  S u bject pr o vi des i nf or me d c o nse nt a n d HI P A A a ut h orizati o n  
•  C o llect de m o gra p hic i nf or mati o n a n d me dical, oc ular, a n d s ur gical hist ories  
•  Re c or d a n y co nc o mita nt me dicati o ns  
•  Vi tal si g ns 
•  Ur i ne pre g n a nc y test ( W O C B P o nl y) 
•  F A C E -Q | Aest hetics Q uesti o n naires  
•  C urre nt c orrecte d V A  
•  B ul bar C o nj u ncti val H y pere mia - ( B H VI) G ra di n g S cale  
•  L P F T  
•  Sl it la m p e xa mi nati o n a n d e xter nal e ye e x a m  
•  Ma n ual  p u pill o metr y  
•  Le vat or f u n cti o n tes t 
•  1 st  
 e xter nal p h ot o gra p h y of e y es 
•  A d mi nistrati o n of 1 dr o p of U p nee q ® ( o x y metaz oli ne 0. 1 % o p ht hal mic s ol uti o n) O U  
o  N ote : U p nee q ® is preferre d b ut p he n yle p hri ne 2. 5 % o p ht hal mic s ol uti o n ma y 
be use d if U p nee q ® is n ot a vaila ble i n a ti mel y ma n ner . 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 3 9  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
•  W ait 1 2 0 ( ± 3 0)  mi n utes  
•  2 n d  
 e xter nal p h ot o gra p h y of e y es 
•  IO P  
•  A d mi nistrati o n of  d ilatin g e ye dr o ps  
•  Wa it at least 2 0 mi n utes 
•  I ndir ect dilate d o p ht hal m osc o p y  
•  C o nfir m  i nitial st u d y eli gi bilit y base d o n i ncl usi o n a n d e xcl usi o n criteria 
•  Sc he d ule t he Baseli ne visit ( Visit 2) f or at least 5 cale n dar d a ys fr o m t h e Scree ni n g 
v isit t o all o w U p nee q ® or p he n yle p hri n e was h o ut a n d ce ntral rea di n g ce nter pr ocessi n g 
of i ma ges  
7. 2   
B aseli ne / Ra n d o miz ati o n  ( Visit 2; Tre at me nt Peri o d ; D a y 1) 
S u bjects s h o ul d be c o ntacte d b y site st u d y staff via tele p h o ne bef ore t heir Da y 1 visit t o c o nfir m 
st u d y eli gi bilit y as c o nfir me d b y t he ce ntral rea di n g ce nter. S u bjects s h o ul d be re mi n de d d uri n g 
t his call of t he f oll o wi n g: 1.) If t he s u bject n or mall y  wears c o ntact le nses, t he s u bject s h o ul d 
n ot wear c o ntact le ns es o n st u d y visit da ys a n d s h o ul d i nstea d wear pres cri pti o n e ye glasses 
a n d 2.) N ot t o a p pl y a n y ma ke u p or O T C c os metic or t o pical s ki n care pr o d ucts, i ncl u di n g 
s u nscree n or m oist urizer, to t heir e yeli ds or e yel as hes o n t he da y of st u d y treat me nt . 
7. 2. 1   
B aseli ne Assess m e nts ( Bef ore I P A d mi nistr ati o n) 
•  C o llect n e w me dical, oc ular, a n d s ur gical hist ories  
•  Re c or d co n c o mita nt me dicati o ns  
•  Vit al si g ns 
•  Ur i ne pre g n a nc y test ( W O C B P o nl y) 
•  F A C E -Q | Aest hetics Q uesti o n naires  
•  B ul bar C o nj u ncti val H y pere mia - ( B H VI) G ra di n g S cale  
•  C urre nt c orrecte d V A  
•  L P F T  

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 4 0  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
•  Sl it la m p e xa mi nati o n a n d e xter nal e ye e x a m 
•  Ma n ual  p u pill o metr y  
•   
 e xter nal p h ot o gra p h y of e y es (s u b mitte d f or B aseli ne meas ure me nt o nl y, n ot 
f or st u d y eli gi bilit y ) 
•  I OP  
•  C o nfir m c o nti n ue d st u d y eli gi bilit y base d o n i ncl usi o n a n d e xcl usi o n criteria  
7. 2. 2   
I P A d mi nistr ati o n a n d H o ur 0 Pr oce d ures  ( After I P A d mi nistr ati o n)  
•  Ra n d o mizati o n  
•  D o u ble -mas ke d IP a d mi nistrati o n O U  
•  Re c or d A Es (i m me diatel y after I P a d mi nistrati o n)  
7. 2. 3   
H o ur 0. 5 Pr oce d ures  ( ± 1 0 mi n utes) 
•  R ecor d A Es  
•   
 e xter nal p h ot o gra p h y of e y es 
•  B ul bar C o nj u ncti val H y pere mia - ( B H VI) G ra di n g S cale  
7. 2. 4   
H o ur 1 Pr oce d ures  ( ± 1 5 mi n utes) 
•  R ec or d A Es  
•  Vi tal si g ns 
•  Ma n ual  p u pill o metr y  
•   
 e xter nal p h ot o gra p h y of e y es 
•  I OP  
•  I P c o mf ort assess me nt  
•  B ul bar C o nj u ncti val H y pere mia - ( B H VI) G ra di n g S cale  
7. 2. 5   
H o ur 2 Pr oce d ures  ( ± 1 5 mi n utes) 
•  R ec or d A Es  
•  L P F T  

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 4 1  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
•   
 e xter nal p h ot o gra p h y of e y es 
•  B ul bar C o nj u ncti val H y pere mia - ( B H VI) G ra di n g S cale  
7. 2. 6   
H o ur 4 Pr oce d ures  ( ± 1 5 mi n utes) 
•  Re c or d A Es  
•  F A C E -Q | Aest hetics Q uesti o n naires  
•  Ma n ual  p u pill o metr y  
•   
 e xter nal p h ot o gra p h y of e y es 
•  B ul bar C o nj u ncti val H y pere mia - ( B H VI) G ra di n g S cale  
7. 2. 7   
H o ur 6 Pr oce d ures  ( ± 1 5 mi n utes) 
•  Re c or d A Es  
•  L P F T  
•   
 e xter nal p h ot o gra p h y of e y es 
•  B ul bar C o nj u ncti val H y pere mia - ( B H VI) G ra di n g S cale  
7. 2. 8   
H o ur 8 Pr oce d ures  ( ± 6 0 mi n utes) 
•  Re c or d A Es  
•  Re c or d c o n c o mita nt me dicati o ns  
•  Vi tal Si g ns  
•  F A C E -Q | Aest hetics Q uesti o n naires  
•  C urre nt c orrecte d V A  
•  B ul bar C o nj u ncti val H y pere mia - ( B H VI) G ra di n g S cale  
•  Sl it la m p e xa mi nati o n a n d e xter nal e ye e x a m  
•  Ma n ual  p u pill o metr y  
•   
 e xter nal p h ot o gra p h y of e y es 
•  I OP  

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 4 2  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
7. 3   
T re at me nt F oll o w -U p P h o ne C all [ Visit 3; D a y 2 t o D a y 5 ] 
•  Re c or d A Es  
•  Re c or d c o n c o mita nt me dicati o ns  
•  Re lease s u bjects fr o m st u d y 
7. 4   
St u d y Wit h dr a w al/ E arl y Ter mi n ati o n  Pr oce d ures  
T he d urati o n of t he treat me nt peri o d i n t his st u d y is 1 da y  wit h assess me nts t o be c o m plete d at  
Baseli ne, H o ur 0  (after I P a d mi nistrati o n), H o ur 0. 5, H o ur 1, H o ur 2, H o ur 4, H o ur 6, a n d H o ur 
8 . 
Wi n d o ws f or t h ese ti me p oi nts are descri be d in  A p pe n di x 1 : Sc he d ule of Visits a n d 
Pr oce d ure s.  
S u bjects w h o wit h dra w fr o m t he st u d y or w h o are ter mi nate d fr o m t he st u d y bef ore t he 
Tele p h o ne F oll o w -U p ( Visit 3) ma y b e releas e d  after A Es a n d c o nc o mita nt me dicati o ns  ha v e 
bee n assess e d . T he reas o n f or earl y wit h dra wal/ ter mi nati o n will be rec or de d i n t he s u bject’s 
C R F.  

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 4 3  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
8  
Q U A LI T Y C O N T R O L A N D A S S U R A N C E  
E ac h cli nical site will perf or m i nter nal q u alit y ma na ge m e nt of st u d y c o n d uct, dat a a n d 
bi ol o gical s peci me n c ollecti o n, d oc u me ntati o n a n d c o m pleti o n . A n i n di vi d ualize d q ualit y 
ma na ge me nt pla n  ma y b e de vel o pe d t o d escri be a site’s q ualit y ma na ge me nt . 
Q ualit y c o ntr ol  ( Q C) p r oce d ures will c o m me nce wit h t he be gi n ni n g of data e ntr y a n d Q C 
c hec ks o n t he data bas e will be ge nerate d  t hr o u g h o ut t he st u d y. A n y missi n g data or data 
a n o malies will be c o m m u nicate d t o t he site(s) f or clarificati o n/res ol uti o n.   
F oll o wi n g writte n Sta n dar d O perati n g Pr oce d ures , t he st u d y m o nit ors will verif y t hat t he 
cli nical st u d y is c o n d uct e d a n d d ata are g e nerate d a n d bi ol o gical s peci me ns are c ollecte d, 
d oc u me nte d (rec or de d), a n d re p orte d i n c o m plia nce wit h t he pr ot oc ol, I nter nati o nal C o u ncil 
f or 
Har m o nisati o n (I C H) 
G o o d 
Cli nical Practice ( G C P), a n d a p plica ble re g ulat or y 
re q uire me nts [e. g., G o o d La b orat or y Practice (G L P ), G o o d Ma n ufact uri n g Practices ( G M P)]. 
T he i n vesti gati o nal site 
will pr o vi de direct access t o all st u d y-relate d sites, s o urce 
data/ d oc u me nts, a n d re p orts f or t he p ur p ose of m o nit ori n g a n d a u diti n g b y t he S p o ns or  or t heir 
desi g nee , a n d i ns pecti o n b y l ocal a n d re g ul at or y a ut h orities. 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 4 4  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
9  
P L A N N E D S T A TI S TI C A L M E T H O D S  
9. 1   
Ge ner al C o nsi der ati o n s 
C o nti n u o us meas ures will be s u m marize d des cri pti vel y b y t he mea n, sta n dar d de viati o n  ( S D), 
me dia n, mi ni m u m, a n d ma xi m u m val ues. Cate g orical meas ures will be s u m marize d b y t he 
fre q ue n c y a n d p erce nta ge of s u bjects. 
A  se parate Statistical A nal ysis Pla n ( S A P) will be pre p are d bef ore u n mas ki n g of st u d y data. 
A n y a me n d me nts or c h a n ges t o t he pla n ne d a n al yses will be des cri be d i n t he S A P  a n d t he 
la n g ua ge i n t he fi nal S A P will s u perse de t he l a n g ua ge i n t his pr ot oc ol i n t he e ve nt of a 
discre pa n c y . 
In ge n eral, a nal yses will e xa mi ne t he differe nces bet wee n i n di vi d ual treat me nt ar ms , as well 
as t he differe nce s bet wee n c o m bi ne d ar ms of L E V 1 0 2 T o pical Gel  co m pare d t o v e hicle. 
F or all e x pl orat or y efficac y a n al yses a n d all s afet y a nal yses perf or me d, Baseli ne will be 
defi ne d as t he m eas ure me nt o n Da y 1 b ef ore I P a d mi nistrati o n  a n d n ot fr o m a n y pre vi o us  visit . 
If b ot h e y es q ualif y f or t he st u d y, t he e ye wit h t he l o wer M R D 1 v al ue at Baseli ne will be 
desi g nate d as t he st u d y e ye. If M R D 1 v al ues are t he sa me f or  O U at Bas eli ne, t he ri g ht e ye 
will be desi g nat e d as t he st u d y e ye. Re g ar dless of st u d y e ye or st u d y q u alificati o n, all e yes i n 
t his st u d y will recei ve st u d y I P a n d u n d er g o st u d y assess me nts. 
9. 2   
Deter mi n ati o n of S a m ple  Siz e 
T he  sa m ple size of 1 0 s u bjects per ar m  ( 3 0 s u bjects t otal f or a t otal of 6 0 e yes) is n ot base d o n 
f or mal p o wer or precisi o n c o nsi derati o ns . 
9. 3   
A n al ysis P o p ul ati o ns  
T he Safet y A nal ysis Set will i ncl u de all s u bjects w h o  recei v e d at least 1  d ose of I P as i n dicate d 
o n t he d osi n g rec or d. S u bjects will be a n al yze d i n t he gr o u p acc or di n g t o t he I P treat me nt 
recei v e d. All e n d p oi nts will be a n al yze d usi n g t h e Safet y A nal ysis Set a n d o nl y o bser ve d d ata 
will be i ncl u de d . 
9. 4   
De m o gr a p hics a n d B aseli ne C h ar acteristics  
D e m o gra p hic c haracteristics , i ncl u di n g a ge ( years), s e x, race, a n d et h nicit y, will be 
s u m marize d b y treat me nt gr o u p a n d o verall. Me dical hist or y [c o de d usi n g t he m ost rece nt 
versi o n of t h e 
Me dical Dicti o nar y f or Re g ul at or y Acti vities ( Me d D R A)], a n d pri or a n d 
c o nc o mita nt me dicati o ns (c o de d usi n g t he m ost rece nt versi o n of t he 
W H O Dr u g) will be 
s u m marize d b y treat me nt gr o u p a n d o verall.  

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 4 5  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
T he n u m ber of s u bj ects w h o were e nr olle d a n d c o m plete d eac h visit of t he st u d y will be 
pr o vi de d, as well as t he reas o ns f or all e nr oll me nt disc o nti n uati o ns, gr o u pe d b y maj or reas o n 
(e. g., l ost t o f oll o w-u p, a d verse e v e nt, p o or c o m plia nce, res c ue d ue t o lac k of efficac y). A list 
of disc o nti n ue d s u bjects  a n d pr ot oc ol de viati o ns will be pr o vi de d . 
9. 5   
S afet y A n al ysi s 
S afet y a nal ys es will be p erf or me d o n all s u bjects i n t he Safet y A nal ysis Set. T he assess me nt 
of safet y will be bas e d o n t he s u m mar y of oc ular a n d n o n -oc ul ar A Es, c urre nt c orrecte d V A , 
I O P, slit la m p bi o micr osc o p y, oc ular h y pere mia, ma n ual  p u pill o metr y , i n direct dilate d 
o p ht hal m osc o p y, vital si g ns,  a n d uri ne pre g na n c y test . S u m maries will be pr o vi de d b y 
treat me nt gr o u p, a n d f or oc ular assess m e nts se paratel y b y e ye.  
9. 5. 1   
A d verse E ve nts  
A Es will be c o de d usi n g Me d D R A ( m ost c urre nt versi o n) a n d cate g orize d b y s yste m or ga n 
class ( S O C) usi n g preferre d ter ms  ( P T). Se parate s u m maries of A Es rel ate d t o treat me nt a n d 
b y se verit y will be pres e nte d. T he n u m ber of d eat hs a n d S A Es will als o be prese nt e d, a n d 
e ve nts lea di n g t o disc o nti n uati o n fr o m t he st u d y will be liste d a n d ta b ulate d.  
9. 5. 2   
Ot her S afet y E n d p oi nts  
S u m mar y statistics f or o bser ve d data a n d c ha n ges fr o m baseli ne ( w here a p pr o priat e) f or 
c urre nt c orrecte d V A , I O P, ma n ual  p u pill o metr y, vital si g ns, a n d t he c o mf ort  q uesti o n naire  
will be prese nte d. A b n or malities i n slit  la m p bi o micr osc o p y will be s u m marize d b y fre q ue nc y 
a n d perce nta ge.  
9. 5. 3   
Pre g n a nc y  
I n di vi d uals w h o are pre g na nt are n ot per mitte d t o partici pate i n t h e st u d y. All pre g na n cies are 
t o be re p orte d fr o m t he ti me i nf or me d c o nse nt is si g ne d u ntil t he defi ne d f oll o w-u p peri o d.  
If a s u bject bec o mes pre g na nt d uri n g t he st u d y or u p u ntil 3 0 da ys after st u d y c o m pleti o n, t h e 
I nv esti gat or m ust  n otif y  Le vati o n P har ma, Lt d, or t heir p har mac o vi gila nce desi g nee, wit hi n 2 4 
h o urs of lear ni n g its occ urre nce b y  c o m pleti n g a Pre g na nc y R e p ort F or m.  
T he pre g na n c y s h o ul d be f oll o we d u p t o deter mi ne o utc o me, i ncl u di n g s p o nta ne o us or 
v ol u ntar y ter mi nati o n, details of t he birt h, a n d t he prese n ce or a bs e nce of a n y birt h defects, 
c o n ge nital a b n or malities, or mater nal a n d/ or ne w b or n c o m plicati o ns. E ver y eff ort s h o ul d be 
ma de t o gat her i nf or m ati o n re gar di n g t he pre g na n c y o utc o me a n d c o n diti o n of t he i nfa nt. It is 
t he res p o nsi bilit y of t he I n vesti gat or t o o btai n t his i nf or mati o n wit hi n 3 0 cale n dar da ys after 
t he i nitial n otificati o n a n d a p pr o xi matel y 3 0 cal e n dar da ys after deli ver y.  
A n y c o m plicati o ns d uri n g pre g na nc y s h o ul d be rec or de d as a n A E a n d c o m plicati o ns s uc h as 
s p o nta ne o us a b orti o n/ miscarria ge or c o n ge nital a b n or malit y s h o ul d be c o nsi dere d S A Es . A Es 
a n d S A Es  m ust be re p orte d t o Le vati o n P har ma, Lt d, or t heir p har mac o vi gila nce desi g nee, 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 4 6  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
usi n g t he Seri o us A d verse E ve nt F or m  wit hi n 2 4 h o urs of k n o wle d g e of t h e e ve nt.  N ot e: A n 
electi ve a b orti o n is n ot c o nsi dere d a n S A E.  
9. 6   
E x pl or at or y Effic ac y Assess me nts  
S u m mar y statistics f or o bser ve d d ata , a n d c h a n ge s fr o m b aseli ne ( w here a p pr o priate) f or 
M R D 1 , L P F T , oc ular 
h y pere mia , a n d s u bj ect- a n d I nv esti gat or -re p orte d 
o utc o me 
q uesti o n naires  at p ost -d ose Visit 2 , as well as c ha n ge fr o m H o ur 2  at H o ur 6 f or L P F T will be 
prese nte d. S u bjects ac hie vi n g a n i m pr o ve me nt i n M R D 1  fr o m baseli ne of 1. 0, 1. 5, 2. 0, a n d 2. 5  
m m  will be s u m marize d b y ti me p oi nt.  S u m mar y statistics f or o bser ve d data a n d c ha n ges fr o m 
baseli ne i n F A C E -Q | Aest hetics q uesti o n naires , as well as t he res p o nse rates t o i n di vi d ual 
q uesti o ns , will be prese nt e d . 
9. 7   
T a b ul ati o n of I n di vi d u al S u bject D at a  
All data c ollecte d i n t his st u d y will be prese nte d i n data listi n gs f or all s u bjects.  

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 4 8  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 0. 3   
Et hic al C o n d uct of t he St u d y  
T his st u d y  will be c o n d ucte d i n c o m plia nce wit h t he st u d y pr ot oc ol a n d i n acc or da n ce wit h 
G C P, as descri be d i n t he I C H Har m o nize d Tri partite G ui deli ne: G ui deli ne f or G o o d Cli nical 
Practice; t he et hical pri nci ples esta blis he d i n t he 
W orl d 
Me dical Ass ociati o n’s ( W M A) 
D eclarati o n of Helsi n ki; a n d a p plica ble l ocal re g ulati o ns . 
1 0. 4   
S u bject I nf or m ati o n a n d C o nse nt  
Inf or me d c o nse nt is a pr ocess t hat is i nitiate d bef ore s u bjects a gree t o partici pate i n a st u d y, 
a n d t he i nf or me d c o ns e nt pr ocess c o nti n ues t hr o u g h o ut s u bjects’ st u d y partici pati o n. C o nse nt 
f or ms will be a p pr o ve d b y t he I nstit uti o nal Re vie w B oar d (I R B) a n d s u bjects will be as ke d t o 
rea d a n d re vi e w t he d o c u me nt. B ef ore a n y st u d y-s pecific pr oce d ures are perf or me d, t h e 
I n v esti gat or ( or desi g nee) will pr o vi de s u bjects t he I C F a n d e x plai n t he res earc h st u d y t o t he 
s u bject a n d a ns wer a n y q uesti o ns t hat ma y arise. A ver bal e x pla nati o n will be pr o vi de d i n 
ter ms s uite d t o t he s u bjects’ c o m pre he nsi o n of t he p ur p oses, pr oce d ures, a n d p ote ntial ris ks of 
t he st u d y a n d of t heir ri g hts as res earc h s u bjects. S u bjects will ha ve t h e o p p ort u nit y t o caref ull y 
re vie w t h e writte n c o nse nt f or m a n d as k q uesti o ns bef ore si g ni n g it. T he s u bjects s h o ul d ha ve 
t he o p p ort u nit y t o disc uss t he st u d y wit h t heir fa mil y or s urr o g ates or t hi n k a b o ut it b ef ore 
a greei n g t o partici pate  i n t he st u d y. T he s u bject will si g n a n d d ate the I C F a n d  pr o vi d e HI P A A 
a ut h orizati o n  bef ore a n y st u d y -s pecific pr oce d ures are d o ne.  S u bjects will recei ve a c o p y of 
t he f ull y si g ne d a n d date d I C F. 
T he I n v esti gat or ( or desi g nee) will e x plai n t o s u bjects t hat t he y are c o m pletel y free t o ref use 
t o e nter t he st u d y or t o wit h dra w fr o m t he st u d y at a n y ti me, wit h o ut gi vi n g a reas o n . Si milarl y, 
t he I n vesti gat or a n d S p o ns or will be f ree t o wit h dra w s u bjects at a n y ti me f or safet y or 
a d mi nistrati ve reas o ns. Ot her re q uire me nts necess ar y f or t he pr otecti o n of t he h u ma n ri g hts of 
s u bjects will als o be e x plai ne d acc or di n g t o c urre nt I C H G C P g ui deli n es a n d t he W M A 
D eclarati o n of Helsi n ki i n its re vise d e diti o n. T h e c o nte nt of t h e I C F will a d here t o  U. S. A. 
F D A r e g ulati o ns a n d I C H g ui deli nes . Once t he I n v esti gat or ( or desi g nee)  is ass ure d t hat 
s u bjects u n dersta n d  t he i m plicati o ns of st u d y partici pati o n, s u bjects will pr o vi de writte n 
i nf or me d c o nse nt t o partici pate i n t he st u d y . 
1 0. 5   
S u bject C o nfi de nti alit y  
S u bject c o nfi de ntialit y a n d pri vac y will be strictl y hel d i n tr ust b y t he partici pati n g 
I n v esti gat ors, t heir staff, a n d t he S p o ns or(s) a n d t heir i nter ve nti o ns. T his c o nfi de ntialit y will 
be e xte n de d t o c o ver testi n g of bi ol o gical s a m ples a n d g e netic tests i n a d diti o n t o t he cli nical 
i nf or mati o n relati n g t o s u bjects. T heref ore, t he st u d y pr ot oc ol, d oc u me ntati o n, data, a n d all 
ot her i nf or mati o n ge nerate d will be hel d i n strict c o nfi de nce.  N o i nf or mati o n c o ncer ni n g t he 
st u d y or t he data will be release d t o a n y u na ut h ori ze d t hir d part y wit h o ut pri or writte n a p pr o val 
of t he S p o ns or.   

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 4 9  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
All researc h acti vities will be c o n d ucte d i n as pri v ate a setti n g as p ossi ble.   
T he st u d y s u bjects’ c o nt act i nf or mati o n will be sec urel y st ore d at eac h cli nical site f or i nter nal 
use d uri n g t he st u d y.  At t he e n d of t he st u d y, all rec or ds will c o nti n ue t o be ke pt i n a sec ure 
l ocati o n f or as l o n g a p eri o d as dict ate d b y t he re vi e wi n g I R B, I nstit uti o nal p olicies, or S p o ns or 
re q uire me nts.  
St u d y s u bject researc h data, w hic h is f or p ur p oses of statistical a nal ysis a n d scie ntific 
re p orti n g, will be tra ns mitte d t o a n d st ore d at Le xitas P har ma Ser vices, I nc . This will n ot 
i ncl u de t he s u bjects’ c o ntact i nf or mati o n or i de ntif yi n g i nf or mati o n. Rat her, i n di vi d ual 
s u bjects a n d t heir researc h data will be i de ntifie d b y a u ni q ue st u d y i de ntificati o n n u m ber.  T he 
st u d y data e ntr y a n d st u d y ma na ge me nt s yste ms use d b y cli nical sites a n d b y Le xitas P har ma 
Ser vices, I n c. staff will b e sec ure d a n d pass w or d pr otecte d. At t h e e n d of t he st u d y, all st u d y 
data bases will be d e -i de ntifie d a n d arc hi ve d at Le xitas P har ma Ser vices, I n c.  
1 0. 6   
St u d y M o nit ori n g  
L e xitas P har ma Ser vices, I n c . will c o n d u ct t he cli nical m o nit ori n g f or t his st u d y. A cli nical 
m o nit ori n g p la n will be use d  a n d will descri be i n detail w h o will c o n d uct t he m o nit ori n g, at 
w hat fre q ue nc y m o nit ori n g will be d o ne, at w hat le vel of d etail m o nit ori n g will be perf or me d, 
a n d t he distri b uti o n of m o nit ori n g re p orts . 
1 0. 7   
C ase R e p ort F or ms a n d St u d y Rec or ds  
D ata c ollecti o n is t he res p o nsi bilit y of t he cli nical st u d y staff at t he site u n der t he s u per visi o n 
of t he site’s I n v esti gat or . The I n vesti gat or is res p o nsi ble f or ens uri n g t he acc urac y, 
c o m plete ness, le gi bilit y, a n d ti meli ness of t he data re p orte d.   
A ll s o urce d oc u me nts s h o ul d be c o m plete d i n a neat, le gi ble ma n ner t o ens ure acc urate 
i nter pretati o n of dat a. 
C o pies of t he st u d y visit w or ks heets will be pr o vi de d f or use as s o urce d oc u me nt w or ks heets 
f or rec or di n g data f or eac h s u bject e nr olle d i n t he st u d y. Data rec or de d i n t he  e C R F deri ve d 
fr o m s o urce d o c u me nts s h o ul d be c o nsiste nt wit h t he data rec or de d o n t he s o urce d oc u m e nts.  
C li nical data (i ncl u di n g A Es, c o nc o mita nt me dicati o ns, a n d e x pecte d a d v erse reacti o ns dat a) 
a n d a n y cli nical la b orat or y data will be e nt ere d i nt o  IB M Cli nical, a  2 1 C F R Part 1 1 -c o m plia nt 
data ca pt ure s yste m pr o vi de d b y Le xitas P har ma Ser vices, I nc. T he d ata s yste m i ncl u des 
pass w or d pr otecti o n a n d i nter nal q ualit y c hec ks, s uc h as a ut o matic ra n ge c hec ks, t o i de ntif y 
data t hat a p pear i nc o nsiste nt, i nc o m plete, or i nacc urate. Cli nical data will be e ntere d directl y 
fr o m t he s o urce d oc u me nts. 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 5 0  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 0. 8   
St u d y Rec or ds Rete nti o n  
St u d y d oc u me nts s h o ul d be retai ne d f or a mi ni m u m of 2 years after t he last a p pr o val of a 
mar keti n g a p plicati o n i n a n I C H re gi o n a n d u ntil t here are n o pe n di n g or c o nte m plate d 
mar keti n g a p plicati o ns i n a n I C H re gi o n or u ntil at least 2 years ha ve ela pse d si nce t he f or mal 
disc o nti n uati o n of cli nical de vel o p me nt of t he st u d y i nter ve nti o n. T hese d o c u me nts s h o ul d be 
retai ne d f or a l o n ger peri o d, h o we ver, if re q uire d b y l ocal re g ulati o ns. N o rec or ds will be 
destr o ye d wit h o ut t he writte n c o nse nt of t he S p o ns or, if  a p plica ble. It is t h e res p o nsi bilit y of 
t he S p o ns or t o i nf or m t he I n v esti gat or w he n t hese d oc u me nts n o l o n ger nee d t o be retai ne d. 
1 0. 9   
Pr ot oc ol D e vi ati o ns  
A pr ot oc ol de vi ati o n is a n y n o nc o m plia nce wit h t he cli nical trial pr ot oc ol, I C H G C P, or 
Ma n ual of Pr oce d ures re q uire me nts. T he n o n c o m plia nce ma y be eit her o n t he p art of t he 
s u bject, t he I n v esti gat or, or t he st u d y site staff. As a res ult of pr ot oc ol d e viati o ns, c orrecti ve 
acti o ns are t o b e de vel o p e d b y t he site a n d i m ple me nte d pr o m ptl y.   
T hese practices are c o nsiste nt wit h I C H G C P:  
4. 5 C o m plia nce wit h Pr ot oc ol, secti o ns 4. 5. 1, 4. 5. 2, a n d 4. 5. 3  
5. 1 Q ualit y Ass ura nce a n d Q ualit y C o ntr ol, secti o n 5. 1. 1  
5. 2 0 N o nc o m plia nce, secti o ns 5. 2 0. 1, a n d 5. 2 0. 2.  
It is t he res p o nsi bilit y of t he site’s I n vesti gat or t o use c o nti n u o us vi gila nce t o i de ntif y a n d 
re p ort pr ot o c ol de viati o ns. All pr ot oc ol d e viati o ns m ust be a d dresse d i n st u d y s o urce 
d oc u me nts  a n d re p orte d t o t he S p o ns or a n d r e vie wi n g I R B per t heir p olicies.  T he site 
In v esti gat or is res p o nsi ble f or k n o wi n g a n d a d heri n g t o t he re vie wi n g I R B re q uire me nts . 
1 0. 1 0   
Access t o S o urce D oc u me nt ati o n  
T he St u d y M o nit or, ot her a ut h orize d re pres e ntati ves of t he S p o ns or, re prese ntati ves of t he I R B, 
re g ulat or y a g e ncies or p h ar mace utical c o m pa n y s u p pl yi n g st u d y pr o d uct will be a ble t o i ns pect 
all d oc u me nts a n d rec or ds re q uire d t o b e mai ntai ne d b y t he I n v esti gat or, i ncl u di n g b ut n ot 
li mite d t o, me dical rec or ds (i.e., office, cli nic, or h os pital) a n d p h ar mac y rec or ds f or t he 
s u bjects i n t his st u d y. T he cli nical st u d y site will per mit access t o s uc h rec or ds.  Data a n d st u d y 
i nte grit y will be mai ntai ne d b y li miti ng access t o u n mas ke d data.  
1 0. 1 1   
P u blic ati o n P olic y  
T his st u d y will c o m pl y wit h t he Cli nical Trials Re gistrati o n a n d Res ults I nf or m ati o n 
S u b missi o n r ule. As s uc h, t his trial will be re gistere d at Cli nical Trials. g o v, a n d res ults 
i nf or mati o n fr o m t his trial will be s u b mitte d t o Cli nical Trials. g o v. I n a d diti o n, e ver y atte m pt 
will be ma de t o p u blis h res ults i n peer -re vie we d j o ur nals. T he i nstit uti o n a n d I n vesti gat ors 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 5 1  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
partici pati n g i n t his trial s hall ha ve n o ri g ht t o p u blis h or prese nt t he res ults of t his st u d y 
wit h o ut t he pri or writte n c o nse nt of t he S p o ns or . 

Le vati o n P har ma Lt d.  
 
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 5 2  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 1   
R E F E R E N C E LI S T  
B ac harac h J, L ee 
W W, Harris o n A R, Fre d d o T F. A re vie w of ac q uire d ble p har o pt osis: 
pre vale nce, dia g n osis, a n d c urre nt treat me nt o pti o ns. Eye ( L o n d) 2 0 2 1; 3 5  ( 9): 2 4 6 8-2 4 8 1.  
F o o d a n d Dr u g A d mi nistrati o n ( F D A), De part me nt of Healt h a n d H u ma n Ser vices. C ol d, 
C o u g h, Aller g y, Br o nc h o dilat or, a n d A ntiast h matic Dr u g Pr o d ucts f or O ver -t he-C o u nter 
H u ma n Use; Fi nal M o n o gra p h f or O T C Nas al Dec o n gesta nt Dr u g Pr o d ucts. Fe deral Re gister, 
1 9 9 4; 5 9( 1 6 2): 4 3 3 8 6.  
H o S F, 
M ora ws ki A, S a m pat h R, B ur ns J. 
M o difie d vis ual fiel d test f or pt osis s ur ger y 
( Leicester Peri p heral Fi el d Test). Eye ( L o n d)  2 0 1 1; 2 5( 3): 3 6 5 -3 6 9.  
K ua n g A W, D u B ois J, Attar M, A hl u walia G. Cli nical p har mac o ki netics of o x y metaz oli ne 
crea m f oll o wi n g t o pical facial a d mi nistrati o n f or t he treat me nt of er yt he m a ass ociate d wit h 
r osacea. J Dr u gs Der m at ol . 2 0 1 8; 1 7( 2): 2 1 3-2 2 0.  
R h ofa de ® Pac k a ge I ns ert, 2 0 1 7.  
Sl o ni m C B, F oster S, Jar os M, Ka n narr S R, K ore nfel d M S, S m yt h -Me di na R, et al. Ass o ciati o n 
of O x y metaz oli ne H y dr oc hl ori de, 0. 1 %, S ol uti o n A d mi nistrati o n 
Wit h Vis ual Fiel d i n 
Ac q uire d Pt osis: A P o ole d A nal ysis of 2 Ra n d o mize d Cli nical Tri als. J A M A O p ht h al m ol o gy . 
2 0 2 0; 1 3 8( 1 1): 1 1 6 8 -7 5.  
U p nee q ® Pac k a ge I ns ert, 2 0 2 1.  
W oitac h A S. F o o d a n d Dr u g A d mi nistrati o n ( F D A), Ce nter f or Dr u g E val uati o n a n d Researc h . 
C li nical Re vie w: N D A 2 0 8 5 5 2, R h ofa de ( o x y metaz oli ne) Crea m, 1. 0 % . 2 0 1 6. Refere nce I D: 
4 0 3 9 4 7 2 . 
 
 

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 5 3  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 2   
A P P E N D I C E S 
1 2. 1   
A p pe n di x 1 : Sc he d ule of Visits a n d Pr oce d ures 
D a ys/ Wee k s 
Scree ni n g  
( D a y -4 5 t o 
D a y -7 )  
B aseli ne/ R a n d o miz ati o n/ D a y 1  
D a y 2 -5 
( Tele p h o ne 
F oll o w -U p)  
Visit  
1  
2  
3  
Ti m e ( H o urs)  
---  
B aseli ne 1 
H o ur 0  
(I P 
D osi n g)  
0. 5 h o ur  
( ± 1 0 
mi n utes)  
1 h o ur  
( ± 1 5 
mi n utes)  
2 h o urs  
( ± 1 5 
mi n utes)  
4 h o urs  
( ± 1 5 
mi n utes)  
6 h o urs  
( ± 1 5 
mi n utes)  
8 h o urs  
( ± 6 0 
mi n utes)  
 
I nf or me d c o nse nt 
X  
  
  
  
  
  
  
  
 
 
I ncl usi o n/ E x cl usi o n 
criteria  
X   
X  
  
  
  
  
  
  
 
 
Ra n d o mizati o n  
 
 
X 2  
  
  
  
  
  
 
 
IP a d mi nistrati o n O U   
 
  
X 2  
  
  
  
  
  
 
 
De m o gra p hics  
X  
  
  
  
  
  
  
  
 
 
Me dical/ Oc ular/ S ur gical 
hist or y  
X   
X   
  
  
  
  
  
  
 
 
Vital si g ns 3 
X   
X   
  
  
X   
  
  
  
X   
 
Uri ne pre g na nc y test 4  
X   
X   
  
  
  
  
  
  
 
 
C urre nt c orrecte d V A   
X   
X   
  
  
  
  
  
  
X   
 
I O P 
X   
X   
  
  
X   
  
  
  
X   
 
Leicester Peri p heral 
Fiel d Test  
X   
X   
  
  
  
X   
  
X   
 
 
Le vat or f u ncti o n  
X  
  
  
  
  
  
  
  
 
 
 
N ote : A ll o p ht hal mic assess me nts m ust be c o n d ucte d o n b ot h e yes at eac h ti me p oi nt. 
1 Baseli ne assess me nts are t o be perf or me d o n Da y 1 bef ore t he a p plicati o n of IP b y t he st u d y staff. 
2 St u d y -eli gi ble s u bjects o nl y . 
3 Vital si g ns will i ncl u de resti n g heart rate a n d sitti n g bl o o d press ure.  
4 W o me n of c hil d -beari n g p ote ntial o nl y; uri ne pre g na nc y test  

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 5 4  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
D a ys/ Wee k s 
Scree ni n g  
( D a y -4 5 t o 
D a y -7 )  
B aseli ne/ R a n d o miz ati o n/ D a y 1  
D a y 2 -5 
( Tele p h o ne 
F oll o w -U p)  
Visit  
1  
2  
3  
Ti m e ( H o urs)  
---  
B aseli ne 1 
H o ur 0  
(I P 
D osi n g)  
0. 5 h o ur  
( ± 1 0 
mi n utes)  
1 h o ur  
( ± 1 5 
mi n utes)  
2 h o urs  
( ± 1 5 
mi n utes)  
4 h o urs  
( ± 1 5 
mi n utes)  
6 h o urs  
( ± 1 5 
mi n utes)  
8 h o urs  
( ± 6 0 
mi n utes)  
 
F A C E -Q | Aest hetics 
q uesti o n naires  
X   
X   
  
  
  
  
X   
  
X   
 
B H VI  assess me nt  
X   
X   
  
X   
X   
X   
X   
X   
X   
 
 e xter nal 
p h ot o gra p h y of e yes 5 , 6  
X   
X   
  
X   
X   
X   
X   
X   
X   
 
Ma n ual  p u pill o metr y   
X   
X   
  
  
X   
  
X   
  
X   
 
I P c o mf ort assess me nt  
 
  
  
  
X   
  
  
  
 
 
A d mi nistrati o n of 1 dr o p 
of o x y metaz oli ne  O U or 
p he n yle p hri ne  O U  
X  
  
  
  
  
  
  
  
 
 
Slit la m p e xa mi nati o n 
a n d e xter nal e ye e xa m 
X   
X   
  
  
  
  
  
  
X   
 
I n direct dilate d 
o p ht hal m osc o p y  
X  
  
  
  
  
  
  
  
 
 
A E assess me nt  
 
  
X   
X   
X   
X   
X   
X   
X   
X  
Rec or d c o nc o mita nt 
me dicati o ns  
X   
X   
  
  
  
  
  
  
X   
X  
E xit st u d y  
 
  
  
  
  
  
  
  
  
X  
 
5 T o i ncl u de M R D 1 a n d i nter pal pe bral dista nce meas ure me nts b y ce ntral rea di n g ce nter. O nl y M R D 1  val ues at Scree ni n g will be use d f or  deter mi ni n g st u d y 
eli gi bilit y. M R D 1 val ues at Baseli ne will be use d f or assessi n g efficac y . 
6 P h ot o gra p h y will be ta ke n of s u bjects’ e yes d uri n g t he Scree ni n g visit: 1.) Bef ore t he i nstillati o n of o x y metaz oli ne  O U or p he n yle p hri ne  O U a n d 2.) 
A p pr o xi matel y 1 2 0 ( ± 3 0)  mi n utes after t he a d mi nistrati o n of e ye dr o ps. O nl y res p o n ders as defi ne d i n  A p pe n di x 7 :  
E xter nal P h ot o gra p h y  w ill be 
eli gi ble f or c o nti n uati o n i n t he st u d y.  

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 5 5  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 2. 2   
A p pe n di x 2: C urre nt C orrecte d Vis u al Ac uit y  
N ote: Vis ual ac uit y ( V A) testi n g  m ust p rece de a n y e xa mi nati o n re q uiri n g c o ntact wit h t he e ye or 
e yeli d a n d m ust  prece de p u pil dilati o n, i nstillati o n of st u d y d yes, e xter n al p h ot o gra p h y of t h e e y es, 
or a p plicati o n of t o pical gels as detaile d i n t he or d er of ass ess me nts f or t he pr ot oc ol.  
D ista nce V A will be ass esse d O U w it h an  E T D R S c hart  at a 4-meter dista nce  usi n g a L o g M A R 
scale. Dista n ce V A s h o ul d be assesse d c o nsiste ntl y t hr o u g h o ut t he st u d y usi n g t he sa me met h o d, 
e q ui p me nt, a n d li g hti n g c o n diti o ns at eac h site. C urre nt c orrecte d V A testi n g will be perf or me d 
usi n g s u bjects ’ o w n prescri pti o n e ye glasses, if a p plica ble ; s u bjects w h o d o n ot ac hie ve a +0. 0 
L o g M A R sc ore usi n g t heir prescri pti o n e ye glass es , if a p plica ble, will be as ke d t o ma ke t heir best 
eff ort w hile vie wi n g t he E T D R S c hart t hr o u g h a p i n h ole occl u der. 
S u bjects will be i nstr uct e d t o rea d t he letters o n t he E T D R S c hart f r o m t he t o p left-h a n d c or ner 
al o n g eac h r o w, o n e letter at a ti me t h e n d o w n eac h r o w, o n e at a ti me . T here are no n u m bers o n 
t he c hart, o nl y letters. If a s u bject rea ds a n u m ber, t he e xa mi ner s h o ul d re mi n d t he s u bject t hat the 
c hart c o nt ai ns n o n u m bers, a n d t he e x a mi ner s h o ul d t he n re q u est a letter i nstea d of a n u m ber  fr o m 
t he s u bject. S u bjects s h o ul d be e nc o ura ge d t o g uess if a letter a p pears u n clear. If a s u bject i de ntifies 
a letter as 1 of 2 p ossi ble letters, t he e xa mi ner s h o ul d as k t he s u bject t o pic k 1 letter o nl y.  
S u bjects will be i nstr ucte d t o r ea d sl o wl y at a rate of a b o ut 1 letter/s ec o n d. If at a n y p oi nt t he 
s u bject rea ds t o o q uic kl y,  t he e xa mi ner s h o ul d st o p t he s u bject a n d re mi n d t he s u bject t o rea d 
sl o wl y i n or der t o ac hie ve t he best i de ntificati o n of eac h letter. If a su bject l oses  t heir place me nt 
i n t he c hart, t he e xa mi ner s h o ul d as k t he s u bject t o g o bac k t o t he li ne w here t h e place was l ost.  
T he s u bject s h o ul d n ot p r ocee d t o t he ne xt letter u ntil t he y ha ve gi ve n a defi nite res p o nse. If a 
s u bject c ha n g es a res p o nse bef ore m o vi n g o n t o t he ne xt letter, t he e x a mi ner m ust acce pt t he 
c ha n ge.  
A t t he en d of t h e test, t he e xa mi ner will co u nt t he n u m ber of letters i nc orrectl y i de ntifie d  u p t o a n d 
i ncl u di n g t he last li ne rea d an d will rec or d t he res ults o n t he s o urce d o c u me nt. A V A letter sc ore 
will be calc ulate d a n d rec or de d i n t he S o urce D oc u me nt W or ks heets a n d i n t he e C R F. 
Eac h letter has a sc ore val ue of 0. 0 2 l o g u nits. Si nce t here are 5 letters per li ne, t he t otal sc ore f or 
a li ne o n t he L o g M A R c hart re pres e nts a c ha n ge of 0. 1 l o g u nits. T he f or m ula use d i n calc ulati n g 
t he sc ore is: 
C alc ul ati o ns : L o g M A R V A = Baseli ne val ue + ( n X 0. 0 2)   
w here:   
t he baseli ne val ue is t he L o g M A R n u m ber of t he l ast li ne rea d (at least 1 letter rea d 
c orrectl y i n t his li ne), a n d  
“ n” is t he t otal n u m ber of letters misse d u p t o a n d i ncl u di n g t he last li ne rea d, a n d  
“ 0. 0 2” is t he val ue f or eac h letter  

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 5 7  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 2. 4   
A p pe n di x 4 : I ntr a oc ul ar Press ure (I O P) 
IO P will be meas ure d i n m m H g a n d s h o ul d be c o n d ucte d after t h e slit la m p bi o micr osc o p y e x a m 
is c o m plete d a n d bef ore d ilati o n of s u bjects’ e yes.  
IO P meas ure m e nts will be perf or me d utilizi n g i Care or a n ot her t o n o met er t hat d oes n ot re q uire 
t he use of c ol ore d d y es or l ocal a n est hetic, a n d t hat d oes n ot e m pl o y a n air p uff t o meas ure I O P . 
T he sa me met h o d s h o ul d be use d c o nsiste ntl y f or t h e sa m e s u bject f or all visits a n d I O P 
assess me nts. M eas ure me nts will be ta ke n wit h t he s u bject seate d . T w o c o ns ec uti ve meas ure me nts 
will be ta ke n i n eac h e ye  a n d rec or de d i n t he s o urce d oc u me nt. T he mea n of t he t w o meas ure me nts 
will be a ut o maticall y calc ulate d i n E D C. I f t he t w o meas ure me nts differ b y > 1. 0 m m H g, a t hir d 
meas ure me nt will be ta ke n a n d r ec or de d i n t he s o urce d o c u me nt. T he me dia n of t he t hree sc ores 
will t he n be a ut o maticall y calc ulate d i n E D C . 
  
 

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 5 8  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 2. 5   
A p pe n di x 5 : Leicester Peri p her al Fiel d Test ( L P F T)  
 
T he L P F T is a c ust o mize d vis ual fiel d test desi g ne d t o assess pt osis ( H o et al., 2 0 1 1 ). 
T he L P F T will be c o n d u cte d usi n g a H u m p hre y Vis ual Fiel d A nal yzer . C li nical st u d y staff will 
i nstr uct s u bjects t o kee p t heir c hi n a n d f ore hea d a g ai nst t he c hi n a n d f ore h ea d rests, a n d t o e ns ure 
t hat t heir facial feat ur es re mai n f ull y rela xe d d uri n g t he assess me nt. S u bjects will be i nstr ucte d t o 
l o o k at t he ce nter of t he fi xati o n tar get t hr o u g h o ut t he test. C orrecti ve le nses are n ot necessar y wit h 
t he LP F T . 
T he L P F T will be sc ore d base d o n a n eli gi bilit y sc ore a n d a t otal s c ore.  
L P F T Eli gi bilit y Sc ore  = T he t otal n u m ber of p oi nts misse d i n t he t o p 2 r o ws o n t he L P F T  
( mi ni m u m 0; ma xi m u m 1 7) 
L P F T T ot al Sc ore  = T he t otal n u m ber of p oi nts see n i n t he t o p 4 r o ws o n t he L P F T  ( mi ni m u m 0; 
ma xi m u m 3 5 ) 
L P F T assess me nts will be perf or m e d i n b ot h e yes se paratel y. Thirt y -fi ve p oi nts are teste d i n t he 
s u peri or fiel d w hile 1 4 p oi nts are i ncl u de d i n t he i nferi or fiel d . T he i nferi or fiel d test ser ves as a 
refere nce b ut s h o ul d n ot be use d f or t h e a nal ysis. 
 
 

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 5 9  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 2. 6   
A p pe n di x 6 : F A C E -Q | Aest hetics Q uesti o n n aire s  
T he F A C E -Q © is a s u bj ect -re p orte d o ut c o me meas ure t h at ca n be use d t o meas ure o utc o mes of 
facial pr oce d ures a n d pr o d ucts fr o m t he s u bject’s pers pecti ve. T his i nstr u me nt has bee n use d t o 
e val uate t he s afet y a n d effecti ve ness of faci al aest hetic treat me nts i n  n u mer o us cli nical trial 
setti n gs a n d t o i nf or m patie nt care i n cli nical practice. T he F A C E -Q © is c o m p ose d of a s et of 3 9 
i n de pe n de ntl y f u ncti o ni n g scales/c hec klists t hat 
meas ure 3 o verarc hi n g d o mai ns: Facial 
A p peara nce, Healt h -Relate d Q ualit y of Life, a n d A d verse Effects. F or t he p ur p oses of  t his st u d y a 
m o d ular a p pr oac h will be use d  wit h t he m o d ules liste d bel o w . 
T he differe nt q uesti o n naire  m o d ules will be p rese nte d se paratel y, a n d su bjects will n ot ha ve access 
t o t he q uesti o n naires t he y c o m plete d at pre vi o us cli nic visits or at pre vi o us ti me p oi nts . 
F A C E -Q | Aest hetics © Sc ales  ( M o d ul ar A p pr o ac h) 
1.  Satisfacti o n wit h E yes  ( 7 ite ms) 
2.  A p praisal of U p p er E y eli ds  ( 7 ite ms) 
3.  A p praisal of L o wer E y eli ds  ( 7 ite ms) 
 
 

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 6 0  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 2. 7   
A p pe n di x 7 :  
E xter n al P h ot o gr a p h y  
S u bjects will ha ve e xter nal p h ot o gra p hs ta ke n of b ot h e yes via   
 p h ot o gra p h y f or M R D 1 
meas ure me nts  a n d inter pal pe bral dista nce meas ure me nts  b y a  ce ntral rea di n g ce nter at t he 
Scree ni n g visit b ot h bef ore a n d a p pr o xi mat el y  1 2 0 ( ± 3 0)  m i n utes after i nstillati o n of 1 dr o p of 
si n gle-mas ke d o x y metaz oli ne  i n eac h e ye. (N ote : U p nee q ® is preferre d b ut p he n yle p hri ne 2. 5 % 
o p ht hal mic s ol uti o n ma y be use d if U p nee q ® is n ot a vaila ble i n a ti mel y ma n ner .) S u bjects 
weari n g ma ke u p d uri n g t he Scree ni n g visit s h o ul d re m o ve t he ma ke u p o n -site bef ore i ma ge 
ca pt ure. 
T he s u bjects will be as ke d t o mai ntai n a ne utral e x pressi o n t o e ns ure t h at t heir facial feat ures 
re mai n f ull y rel a xe d f or all i ma ge assess me nts. A ce ntral rea di n g ce nter will re vie w t he i ma ges 
ca pt ure d d uri n g t he Scree ni n g visit t o deter mi ne st u d y eli gi bilit y . O nl y s u bjects w h o de m o nstrate 
a p ositi ve s hift i n u p per e yeli d el e vati o n  ( M R D 1) ≥0. 5 m m  i n res p o ns e t o a si n gle dr o p of 
o x y metaz oli ne  o p ht hal mic s ol uti o n or p he n yle p hri ne  o p ht hal mic s ol uti o n will be eli gi ble f or st u d y 
partici pati o n . 
T hr o u g h o ut t he da y of Visit 2 ( Baseli ne; Ra n d o mizati o n; Da y 1; Treat me nt Peri o d), s u bjects will 
ha ve a d diti o nal e xter nal p h ot o gra p hs ta ke n of t heir e yes at Baseli ne (bef ore IP a d mi nistrati o n), 
H o ur 0. 5, H o ur 1, H o ur 2, H o ur 4, H o ur 6, a n d H o ur 8 . 
 
 
 
 
 
 

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 6 1  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 2. 8   
A p pe n di x 8 : I n vesti g at or-Re p orte d O utc o mes  
A fter t he last s u bject h as c o m plete d t h e st u d y, Pri nci pal In vesti gat or s will re vie w b atc he d 
m as ke d/a n o n y mize d   
p h ot o gra p hs of all s u bjects’ e yes as d oc u me nte d at B aseli ne, H o ur 
4 , a n d H o ur 8. 
 p h ot o gra p hs will be pr o vi de d t o t he Pri nci pal In vesti gat ors i n a ra n d o m ma n ner a n d 
s h o ul d n ot be or ga nize d b y site, s u bject, or ti me p oi nt . Eac h In vesti g at or will assess t he 
p h ot o gra p hs bas e d o n  t h eir s u bjecti ve i m pressi o n of v ari o us para meters of s u bjects’ e yes , u p p er 
e yeli ds, an d l o wer e yeli d s. 
A d diti o nal details  f or t his In vesti gat or -re p orte d assess me nt ma y be f o u n d i n t he 
M a n ual of 
Pr oce d ures . 
 

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 6 2  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 2. 9   
A p pe n di x 9 : M a n u al  P u pill o metr y  
T he p u pil size will be meas ure d i n a m bie nt r o o m li g ht . The s u bject s h o ul d be as ke d t o f oc us 
strai g ht a hea d o n a tar get at a dista nce t o a v oi d acc o m m o dati o n w hile seate d i n t he e xa m c hair. 
T he s u bject s h o ul d be i nstr ucte d n ot t o bli n k d uri n g t he meas ure me nt. T he I n vesti gat or s h o ul d t he n 
ta ke t he p u pil meas ure m e nt car d a n d place it directl y bel o w t he p u pil w hile a v oi di n g t he li ne of 
si g ht, a gai n t o a v oi d sti m ulati n g acc o m m o dati o n. T he I n vesti gat or s h o ul d t he n matc h t he p u pil 
size t o t he cir cle size o n t he car d t o deter mi ne t he p u pil size. After a brief rest peri o d, t he pr ocess 
s h o ul d be re p eate d t o m eas ure p u pil dia meter i n t he fell o w e ye. Eac h m eas ure m e nt s h o ul d be 
rec or de d i n t he e C R F. 
If s u bjects’ e yes b ec o m e dr y d uri n g t h e assess me nt, artificial tears ma y be a d mi nistere d a n d 
rec or de d as c o n c o mita nt me dicati o n . 
 

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 6 3  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 2. 1 0   
A p pe n di x 1 0 : Le v at or P al pe br ae S u peri oris F u ncti o n  
L e vat or p al pe brae s u peri oris  f u ncti o n of eac h s u bject will be assesse d b y I n vesti gat ors at t he 
Scree ni n g visit. I n v esti gat ors will place a si n gle fi n ger fir ml y o n t he s u bject’s br o w t o is olate t he 
le vat or m uscle an d n e gat e t he mec h a nical acti vit y of t he fr o ntalis m uscle . 
T he s u bject will be i nstr ucte d t o g aze d o w n war d . I n vesti gat ors will place a r uler at t h e u p per e yeli d 
mar gi n a n d i nstr uct s u bjects t o s hift t heir g aze fr o m stari n g d o w n war d t o stari n g up war d . T he ne w 
p ositi o n of t he u p per e ye li d will be n ote d a n d t he differe n ce b et wee n t he t w o meas ure me nts will 
be rec or de d as t he le v at or pal pe brae s u peri oris f u ncti o n . N or mal le vat or f u ncti o n is t y picall y 1 3 -
1 7 m m .

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 6 4  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 2. 1 1   
A p pe n di x 1 1 : Slit L a m p Bi o micr osc o p y 
T he slit la m p bi o micr osc o p y e xa m s h o ul d be perf or me d wit h t he slit la m p usi n g a bea m wi dt h a n d 
i nte nsit y t hat pr o vi des o pti mal e val uati o n of t he a nteri or s e g me nt. T he slit la m p e xa m s h o ul d be 
perf or me d wit h o ut  fl u orescei n. 
T he slit la m p e xa mi nati o n m ust be perf or me d bef ore a n y pr oce d ures t hat w o ul d re q uire c o ntact 
wit h t he e ye or e yeli ds a n d pri or t o t he i nstillati o n of a n y dilati n g e ye dr o ps or t o pical gels. T he 
I n v esti gat or s h o ul d use t heir sta n dar d e xa mi nati o n tec h ni q ue. This pr oce d ure will be perf or me d i n 
t he sa me ma n ner f or all s u bjects o bser ve d at t he I n vesti gat or’s site. W h e n p ossi ble, t he sa me 
e xa mi ner s h o ul d c o n d uct all slit la m p bi o micr osc o p y e xa mi nati o ns at eac h visit f or a gi ve n s u bject 
t hr o u g h o ut t he st u d y. 
T he  I n vesti gat or must e x a mi ne t he e y eli ds, c o nj u ncti va, c or nea, a nteri or c ha m ber, iris/ p u pil, a n d 
t he le ns of eac h e ye f or e vi de nce of er yt he m a a n d/ or e d e ma, o pacities or ot her si g ns of 
a b n or malities a n d rec or d a gra di n g f or eac h tiss ue/str uct ure as s pecifie d b el o w. O bser va ti o ns will 
be d oc u me nte d o n t he a p pr o priate C R F.  
T he f oll o wi n g as pects of t he e ye will be e v al uate d, a n d c orres p o n di n g data c ollecte d.  
C or ne a:    
I n cl u des all c or neal la y ers 
N or m al:   
A bse nce of acti ve i nfl a m mati o n, i nfecti o n, or str u ct ural c ha n g es/a b n or malities  
A b n or m al:  Prese nce of acti ve i nfla m mati o n, i nfecti o n, or str u ct ural c ha n g es/a b n or malities 
i ncl u di n g f ocal scarri n g a n d fi ne de p ositi o n 
 
Cli nicall y si g nifica nt  
N ot cli nicall y si g nifica nt  
 
A nteri or 
C h a m ber :  I n cl u des A nteri or  C ha m ber  
N or m al:   
A bse nce of acti ve i nfl a m mati o n, i nfecti o n, or str u ct ural c ha n g es/a b n or malities  
A b n or m al:  Prese nce of acti ve i nfla m mati o n, i nfecti o n, or str u ct ural c ha n g es/a b n or malities 
i ncl u di n g f ocal scarri n g a n d fi ne de p ositi o n 
 
Cli nicall y si g nifica nt  
N ot cli nicall y si g nifica nt  
 
Iris/ P u pil:  I n cl u des all Iris a n d P u pil 
N or m al:   
A bse nce of acti ve i nfl a m mati o n, i nfecti o n, or str u ct ural c ha n g es/a b n or malities  
A b n or m al:  Prese nce of acti ve i nfla m mati o n, i nfecti o n, or str u ct ural c ha n g es/a b n or malities 
i ncl u di n g f ocal scarri n g a n d fi ne de p ositi o n 
 
Cli nicall y si g nifica nt  

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 6 5  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
N ot cli nicall y si g nifica nt  
 
E yeli ds:   
I n cl u des e y eli d e de ma a n d e yeli d er yt he ma 
N or m al:  
A bse nce of acti ve i nfl a m mat or y si g ns or si g nifica nt str uct ural 
c ha n ges/a b n or malities or disc har ge  
A b n or m al:  Prese nce of acti ve i nfla m mat or y si g ns or si g nifica nt str uct ural 
c ha n ges/a b n or malities or disc har ge  
 
Cli nicall y si g nifica nt  
N ot cli nicall y si g nifica nt  
C o nj u ncti v a:  I n cl u des peri o c ular tiss ues, a n d t he b ul bar, pal p e bral a n d li m bal c o nj u ncti va  
N or m al:  
A bse nce of acti ve i nfl a m mat or y si g ns or si g nifica nt str uct ural 
c ha n ges/a b n or malities or disc har ge  
A b n or m al:  
Prese nce of acti ve i nfla m mat or y si g ns or si g nifica nt str uct ural 
c ha n ges/a b n or malities or disc har ge  
 
Cli nicall y si g nifica nt  
N ot cli nicall y si g nifica nt  
Le ns  
P ha kic  
  
Pse u d o p ha kic  
  
A p ha kic  
Le ns O p acit y  ( P h a kic o nly) 
N o ne ( 0)   
N o ne prese nt or less t ha n mil d  
Mil d  ( 1)  
Yell o w le ns disc ol orati o n or s mall le ns o pacit y (a xial or peri p heral)  
M o derate  ( 2)  
A m ber le ns disc ol orati o n or me di u m le ns o pacit y (a xial or peri p heral)  
Se vere  ( 3)  
Br u nesce nt le ns disc ol orati o n or c o m plete le ns o pacificati o n ( n o re d refle x)  

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 6 6  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
 
1 2. 1 2   
A p pe n di x 1 2 : B ul b ar C o nj u ncti v al H y pere mi a  [Brie n H ol de n Visi o n I nstit ute 
( B H VI) G r a di n g S c ale (F or merl y  K n o w n as t he C C L R U )] 
I n vesti g at or-R ate d Ass ess m e nt of B ul b ar C o nj u ncti v al H y pere mi a  
In v esti gat ors will rate o verall b ul bar c o nj u ncti val h y pere mia  usi n g t he B rie n H ol de n Visi o n 
I nstit ute ( B H VI) gra di n g scale [f or merl y k n o w n as t h e Cor nea a n d C o ntact Le ns Researc h U nit 
( C C L R U) gra di n g scale]. I n v esti gat or B H VI rati n gs will be rec or de d i n t he e C R F. 
 
Sc ore   
Re d ness  
0   
N o ne  
1   
Ver y Sli g ht  
2   
Sli g ht  
3   
M o derate  
4   
Se vere  
 

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 6 7  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 2. 1 3   
A p pe n di x 1 3 : I n direct Dil ate d O p ht h al m osc o p y 
T his pr oce d ure will occ ur after a p plicati o n of dilati n g e yedr o ps a n d u p o n I n v esti gat or c o nfir mati o n 
wit h a pe n li g ht  O U are f ull y dilate d (rec o m me n d e d ti me of at least 2 0 mi n utes ). As dilati n g dr o ps 
will be a p plie d, i n direct dilate d o p ht hal m osc o p y m ust be perf or me d afte r e xter nal e ye a n d e y eli d 
p h ot o gra p h y, t ests of vis ual ac uit y, a n d I O P ass ess me nts. 
In dir ect d ilate d o p ht hal m osc o p y will i ncl u de assess me nt of t he vitre o us, reti na, mac ula, c h or oi d, 
o ptic ner ve, a n d v ertical o ptic ner ve c u p -t o-dis c rati o. After t he o p ht hal m osc o p y pr oce d ure, t he 
I n v esti gat or will deter mi ne if fi n di n gs are wit hi n n or mal li mits or are a b n or mal. F or a b n or mal 
fi n di n gs at Scree ni n g ( Visit 1), t he I n vesti gat or will deter mi ne  w het her t he a b n or malit y w o ul d 
e xcl u de t he s u bject fr o m st u d y partici pati o n. O bser vati o ns will be d oc u me nte d o n t he a p pr o priat e 
C R F . A b n or malities s h o ul d  be m ar ke d as “cli nicall y si g nifica nt ” or “n ot cli nicall y si g nifica nt .”  
Vitre o us:   
 
N or m al:   
A bse nce of a n y o pacit y  
A b n or m al:  Prese nce of o pacit y  
 
Cli nicall y si g nifica nt  
N ot cli nicall y si g nifica nt  
 
Reti n a:   
 
N or m al:   
A bse nce of acti ve i nfl a m mati o n or si g nifica nt str uct ural c ha n g es 
A b n or m al:  Prese nce of acti ve i nfla m mat or y si g ns or si g nifica nt str uct ural c ha n g es  
 
Cli nicall y si g nifica nt  
N ot cli nicall y si g nifica nt  
 
M ac ul a:   
 
N or m al:   
A bse nce of acti ve i nfl a m mati o n or si g nifica nt str uct ural c ha n g es  
A b n or m al:  Prese nce of acti ve i nfla m mat or y si g ns or si g nifica nt str uct ural c ha n g es  
 
Cli nicall y si g nifica nt  
N ot cli nicall y si g nifica nt  

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 6 8  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
C h or oi d:   
 
N or m al:   
A bse nce of acti ve i nfl a m mati o n or si g nifica nt str uct ural c ha n g es  
A b n or m al:  Prese nce of acti ve i nfla m mat or y si g ns or si g nifica nt str uct ural c ha n g es  
 
Cli nicall y si g nifica nt  
N ot cli nicall y si g nifica nt  
 
O ptic Ner ve:  
 
N or m al:   
A bse nce of a n y da m a ge  
A b n or m al:   
Prese nce of a n y d a ma ge  
 
Cli nicall y si g nifica nt  
N ot cli nicall y si g nifica nt 
 
Vertic al O ptic Ner v e C u p -t o-Disc R ati o:  
_ _. _ _ _ _  
 
Ot her:   
I n dicate a n y ot h er dilate d f u n d us o p ht hal m osc o p y fi n di n gs 
  
N o  
 
Yes  
If yes, s pecif y fi n di n g a n d cli nical si g nifica nce 
 
 

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 6 9  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 2. 1 4   
A p pe n di x 1 4 : I n vesti g ati o n al Pr o d uct C o mf ort/ T oler a bilit y Assess me nt  
S u bjects will be as ke d o n t he da y of st u d y treat me nt t o rate  t he c o mf ort/t olera bilit y of t he st u d y I P 
usi n g a Vis ual A nal o g Scale ( V A S) a fter t he I P has bee n a p plie d t o t h eir up per e y eli ds . This 
assess me nt will be f oc use d o n t he c o mf ort of t he I P itself , a n d s u bjects s h o ul d be i nstr ucte d t o 
t hi n k a b o ut t he c o mf ort of t he I P aft er d osi n g a p pli cati o n a n d  i n de pe n de ntl y fr o m t heir e x p erie n ce 
ha vi n g t he I P a p plie d b y st u d y staf f. 
S u bjects will be as ke d t o place a si n gle v ertical mar k al o n g a h oriz o nt al li ne t o i n dicate  t he le vel 
of c o mf ort/ disc o mf ort t he y e x perie n ce d after I P a d mi nistrati o n . S u bjects will als o be pr o vi de d 
wit h a n e m pt y te xt b o x t o c ollect a n y a d diti o nal n otes t he y w o ul d li ke t o s hare a b o ut t heir 
e x perie n ce wit h t he I P i n re gar ds t o its c o mf ort a n d t olera bilit y.  
 
 
 
 
 
 
 
 
C o m me nts ( O pti o n al ): 
 
Please pr o vi de a n y 
a d diti o nal c o m me nts 
y o u w o ul d li ke t o s hare 
a b o ut y o ur e x perie nce 
t o da y wit h t he 
i n vesti gati o nal pr o d uct 
relate d t o t he pr o d u ct’s 
c o mf ort/t olera bilit y  
 
C o mf orta ble  
U nc o mf orta ble  

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 7 0  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 2. 1 5   
A p pe n di x 1 5: Vit al Si g ns  
S u bject vital si g ns will be assesse d at t he Scree ni n g visit ( Visit 1), Baseli ne ( Visit 2 bef ore I P 
a d mi nistrati o n), a n d d uri n g t he st u d y peri o d after I P a d mi nistrati o n at H o ur 1 a n d H o ur 8. Vital 
si g ns will i ncl u de bl o o d press ure w hile i n a seate d p ositi o n a n d resti n g heart rate.  
 
 
 
 

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 7 1  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 2. 1 6   
A p pe n di x 1 6 : W o men of C hil d -be ari n g P ote nti al ( W O C B P)  
F or t he p ur p oses of t his st u d y, a w o ma n of c hil d -beari n g p ote ntial will be defi ne d as a s u bject wit h  
a uter us w h o is ca pa ble of bec o mi n g pre g n a nt. 
W O C B P m ust a gree t o use o ne of t h e f oll o wi n g met h o ds of birt h c o ntr ol fr o m t he date t he y si g n 
t he I C F u ntil after t h e c o m pleti o n of t he last st u d y visit ( F oll o w-U p Visit):  
a. A b sti ne nce, w he n it is i n li ne wit h t he preferre d a n d us ual lifest yle of t h e s u bj ect, w here 
a bsti ne nce ma y be defi ne d as refrai ni n g fr o m se x u al c o ntact or defi ne d as e n ga gi n g i n 
relati o ns hi ps i n w hic h it is i m p ossi ble f or se x ual c o ntact t o res ult i n pre g na ncy;  
b.  Ma i nte na nce of a m o n o ga m o us relati o ns hi p wit h a male part ner w h o has bee n 
s ur gicall y sterilize d b y vasect o m y ( vasect o m y pr oce d ure m ust ha ve bee n c o n d ucte d at 
least 6 0 da ys pri or t o t he Scree ni n g visit or c o nfir me d via s per m a n al ysis); 
c. Ba rrier met h o d (e. g., c o n d o m or occl usi ve ca p) wit h s per mici dal f oa m/ gel/fil m/crea m 
A N D eit her h or m o nal c o ntrace pti o n ( oral, i m pla nte d or i njecta ble) or a n i ntra uteri ne 
de vice or s yste m.  
N o te: N o n -c hil d-b eari n g p ote ntial  f or t he p ur p oses of t his st u d y is defi ne d as s ur gical sterilizati o n 
(i.e., bilateral o o p h orect o m y, h ysterect o m y, or t u bal li gati o n), p ost me n o pa usal ( defi ne d as n ot 
ha vi n g a me nstr ual peri o d f or at least 1 2 c o ns ec uti ve m o nt hs pri or t o Scree ni n g) , or me di cal 
c o nfir mati o n of i nfertilit y.  
 
 

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 7 2  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 2. 1 7   
A p pe n di x 1 7 : C o m pli a nce St ate me nt a n d S p o ns or A p pr o v al  
St u d y  Title:  
A P hase 1/ 2a St u d y of L E V 1 0 2 T o pical Gel i n S u bjects wit h 
Ac q uire d Ble p har o pt osis  
St u d y  N u m ber:   
L E V 1 0 2 -C S 0 1  
Fi n al  D ate:   
2 5  Ma y 2 0 2 3  
 
T h is st u d y will be c o n d ucte d i n acc or da nce wit h I nt er nati o nal C o u ncil f or Har m o nisati o n G o o d 
Cli nical Practice (I C H G C P), wit h t he U nite d Stat es  of A merica C o de of Fe deral Re g ulati o ns 
( C F R) a p plica ble t o cli nical st u dies ( 4 5 C F R Part 4 6, 2 1 C F R Part 5 0, 2 1 C F R Part 5 6, 2 1 C F R 
Part 3 1 2, a n d/ or 2 1 C F R Part 8 1 2), a n d as sti p ulate d i n t he Declarati o n of Helsi n k i wit h res pect 
t o t he use of h u ma n s u bjects i n cli nical st u dies a n d i n vesti gati o ns. 
S p o ns or’s Re prese nt ati ve:  
 
 
 
 
Na me ( pri nte d)  
C hief Me dical Officer  
Si g nat ure  
Date  
 
Me dic al M o nit or:  
 
 
 
Na me ( pri nte d)  
Si g nat ure  
Date  
 
 

L e vati o n P har ma Lt d.  
L E V 1 0 2 T o pical Gel  
Cli nical Trial Pr ot oc ol  
C o nfi de nti al  
 
Pa ge 7 3  of 7 3  
Cli nical Trial Pr ot oc ol, Versi o n 6 . 0, A me n d me nt 5 , 2 5 Ma y 2 0 2 3  
1 2. 1 8   
A p pe n di x 1 8 : I n vesti g at or’s Si g n at ure 
 
A  P h ase 1/ 2 a St u d y of L E V 1 0 2 T o pic al Gel i n  
S u bjects wit h Ac q uire d Ble p h ar o pt osis  
 
L E V 1 0 2 -C S 0 1  
 
Versi o n N o .: 6 . 0 
Iss u e Date: 2 5  Ma y 2 0 2 3  
I ha v e rea d t he cli nical trial pr ot oc ol a n d u n dersta n d it.  I a gree t o c o n d uct t he st u d y as o utli ne d 
i n t his d oc u me nt a n d i n acc or da n ce wit h G o o d Cli nical Practice G ui deli nes, all l ocal a n d 
fe deral re q uir e me nts a n d re g ulati o ns, a n d i n c o m plia nce wit h t h ose prece pts set f ort h i n t he 
Declarati o n of Helsi n ki wit h res pect t o t he use of h u ma n s u bjects i n cli nical st u d ies a n d 
i n vesti gati o ns.  
T he I n v esti gat or will ass ure t hat n o de viati o n fr o m, or c ha n ges t o t he pr ot oc ol will ta ke place 
wit h o ut pri or a gree me nt fr o m t he S p o ns or a n d d oc u me nte d a p pr o val fr o m t he I R B, e x ce pt 
w here necessar y t o eli mi nate a n i m me diate hazar d(s) t o t he st u d y s u bjects. All pers o n nel 
i n v ol ve d i n t he c o n d uct of t his st u d y ha ve c o m plete d H u ma n S u bjects Pr otecti o n a n d I C H G C P 
Trai ni n g.  
T he pr ot oc ol, i nf or me d c o nse nt f or m(s), recr uit me nt materials, a n d all s u bject materials will 
be s u b mitte d t o t he I R B f or re vie w a n d a p pr o val.  A p pr o val of b ot h t he pr ot oc ol a n d t he c o ns e nt 
f or m m ust be o btai ne d b ef ore a n y s u bject is e nr olle d. A n y a me n d me nt t o t he pr ot oc ol will 
re q uire re vi e w a n d a p pr o val b y t he I R B bef ore t he c ha n ges are i m ple me nte d t o t he st u d y. All 
c ha n ges t o t he c o nse nt f or m will be I R B a p pr o ve d; a deter mi nati o n will be ma de re gar di n g 
w het her a n e w c o ns e nt nee ds t o be o btai ne d fr o m s u bje cts w h o pr o vi de d c o nse nt, usi n g a 
pre vi o usl y a p pr o ve d c o nse nt f or m.  
F urt her, I a gree t o mai nt ai n t he c o nfi de ntialit y of all i nf or mati o n recei ve d or de vel o pe d i n 
c o n necti o n wit h t his pr ot oc ol.  
 
Si g n at ure of I n vesti g at or:  
 
 
 
Na me ( pri nte d)  
Si g nat ure  
Date