Conditions: Dry Eye
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 257
Healthy volunteers: no

Brief summary:
The objective of this study is to compare the safety and efficacy of YP-P10 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

Detailed description:
The clinical hypotheses for this study is that 0.3% YP-P10 Ophthalmic Solution twice daily (BID) and 1.0% YP-P10 Ophthalmic Solution BID are superior to YP-P10 Placebo Ophthalmic Solution (vehicle) for the primary endpoints of signs and symptoms of dry eye, as follows:

* Sign: Total corneal fluorescein staining score of the study eye using the modified NEI grading scale, measured by mean change from baseline (Visit 2, Pre- Controlled Adverse Environment \[CAE®\]) to Visit 6
* Symptom: Ocular discomfort score of both eyes using the Visual Analog Scale (VAS) Ocular Discomfort Scale, measured by mean change from baseline (Visit 2, Pre-CAE®) to Visit 6

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: 0.3% YP-P10 Ophthalmic Solution intervention 2: 1% YP-P10 Ophthalmic Solution intervention 3: YP-P10 Placebo Ophthalmic Solution (vehicle)
Intervention descriptions: intervention 1: Drug: YP-P10 Ophthalmic Solution intervention 2: Drug: YP-P10 Ophthalmic Solution intervention 3: Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Protocol document:
Prot_000.pdf: 
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Document History
SignNow E-Signature Audit Log
All dates expressed in MM/DD/YYYY (US)

SAP_001.pdf: 
 
 
 
 
STATISTICAL ANALYSIS PLAN 
 
A Phase 2, Multi-center, Randomized, Double-Masked and 
Placebo-Controlled Study Evaluating the Efficacy and Safety 
of YP-P10 Ophthalmic Solution Compared to Placebo in 
Subjects with Dry Eye 
 
 
Sponsor: 
Yuyu Pharma, Inc. 
Yuyu Building, 
197 Dongho-ro, 
Jung-gu, 
Seoul, South Korea 
 
 
 
 
Protocol Number: 
YPP10-001 
 
 
 
 
Author: 
Xiaofei Quinn 
 
Sr Principal Biostatistician 
Statistics & Data Corporation 
 
 
Date: 
09MAR2023 
 
Version: 
1.0 




09MAR2023 
Confidential & Proprietary 
Page 3 of 46 
 
 
 
 
Protocol YPP10-001 SAP, Version 1.0 
 
 
 
 
Table of Contents 
1. 
Introduction ......................................................................................................................................... 7 
2. 
Study Objectives ................................................................................................................................. 7 
3. 
Study Design and Procedures. ........................................................................................................... 7 
3.1 
General Design ............................................................................................................................ 7 
3.2 
Schedule of Visits and Measurements ......................................................................................... 8 
4. 
Study Endpoints .................................................................................................................................. 8 
4.1 
Efficacy Endpoints ....................................................................................................................... 8 
4.1.1 
Primary Efficacy Endpoints .................................................................................................... 8 
4.1.2 
Secondary Efficacy Endpoints ............................................................................................. 11 
4.2 
Safety Endpoints ........................................................................................................................14 
5. 
Study Treatments ............................................................................................................................. 14 
5.1 
Methods of Assigning Subjects to Treatment Groups ................................................................ 14 
5.2 
Masking and Unmasking ........................................................................................................... 15 
6. 
Sample Size and Power Considerations .......................................................................................... 15 
7. 
Data Preparation ............................................................................................................................... 15 
7.1 
Input Data ................................................................................................................................... 15 
7.2 
Output Data ................................................................................................................................ 16 
8. 
Analysis Populations .........................................................................................................................16 
8.1 
Intent-to-Treat Population ...........................................................................................................16 
8.2 
Per Protocol Population ............................................................................................................. 16 
8.3 
Safety Population ...................................................................................................................... 17 
9. 
Missing Data Handling ......................................................................................................................17 
10. 
Statistical Methods ........................................................................................................................... 18 
10.1 
Unit of Analysis........................................................................................................................... 18 
10.2 
Definition of Baseline ..................................................................................................................18 
10.3 
Data Analysis Conventions .........................................................................................................18 
10.4 
Adjustments for Multiplicity ........................................................................................................ 19 
11. 
Disposition of Subjects ..................................................................................................................... 20 
12. 
Demographic and Pretreatment Variables ........................................................................................ 21 
12.1 
Demographic Variables ..............................................................................................................21 
12.2 
Baseline Disease Characteristics ............................................................................................... 22 
12.2.1 
Corneal Fluorescein Staining (Ora Calibra Scale) ............................................................... 22 
12.2.2 
Ocular Discomfort during the CAE (Ora Calibra Scale)........................................................ 23 
12.2.3 
Ocular Discomfort & 4-Symptom Questionnaire (Ora Calibra Scale) ................................... 23 


09MAR2023 
Confidential & Proprietary 
Page 4 of 46 
 
Protocol YPP10-001 SAP, Version 1.0 
13. 
Medical History and Concomitant Medications ................................................................................. 23 
13.1 
Medical History ...........................................................................................................................23 
13.2 
Concomitant Medications ...........................................................................................................23 
14. 
Dosing Compliance and Treatment Exposure .................................................................................. 24 
14.1 
Dosing Compliance ....................................................................................................................24 
14.2 
Treatment Exposure ...................................................................................................................25 
15. 
Efficacy Analyses ..............................................................................................................................25 
15.1 
Primary Efficacy Endpoints ........................................................................................................ 25 
15.1.1 
Primary Analyses of Primary Efficacy Endpoints ................................................................. 25 
15.1.2 
Sensitivity Analyses of the Primary Efficacy Endpoints ........................................................ 26 
15.1.3 
Figures. ................................................................................................................................ 26 
15.2 
Analyses of Secondary Efficacy Endpoints ................................................................................ 26 
16. 
Safety Analyses ................................................................................................................................27 
16.1 
Adverse Events .......................................................................................................................... 27 
16.2 
Visual Acuity (ETDRS)............................................................................................................... 29 
16.3 
Slit-Lamp Biomicroscopy Examination ....................................................................................... 30 
16.4 
Intraocular Pressure (IOP) ..........................................................................................................30 
16.5 
Dilated Fundoscopy Examination............................................................................................... 30 
17. 
Subgroup Analyses ...........................................................................................................................30 
17.1 
Subgroup Analyses by Demographic Characteristics ................................................................. 30 
17.2 
Subgroup Analysis by Japanese Subgroup ............................................................................... 31 
17.2.1 
Demographic and Baseline Disease Characteristics ........................................................... 31 
17.2.2 
Medical History and Concomitant Medications .................................................................... 31 
17.2.3 
Primary Efficacy Endpoints Analyses .................................................................................. 31 
17.2.4 
Secondary Efficacy Endpoints Analyses .............................................................................. 32 
17.2.5 
Safety Analyses ...................................................................................................................32 
17.3 
Subgroup Analysis by Two Stratification Factors ....................................................................... 32 
18. 
Interim Analyses ............................................................................................................................... 32 
19. 
Changes from Protocol-Stated Analyses ...........................................................................................32 
20. 
References ....................................................................................................................................... 32 
21. 
Revision History ................................................................................................................................33 
22. 
Potential Impact of COVID-19 .......................................................................................................... 33 
23. 
Tables ............................................................................................................................................... 33 
24. 
Listings ............................................................................................................................................. 41 
25. 
Figures.............................................................................................................................................. 43 
Appendix 1. Schedule of Visits and Assessments ...................................................................................... 46 


Protocol YPP10-001 SAP, Version 1.0 
 
List of Abbreviations 
ADaM 
Analysis Data Model 
AE 
Adverse Event 
ANOVA 
Analysis of Variance 
ATC 
Anatomical Therapeutic Chemical 
BID 
Bis in die (Twice Daily) 
CAE® 
Controlled Adverse Environment® 
CI 
Confidence Interval 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CS 
Clinically Significant 
CSR 
Clinical Study Report 
DED 
Dry Eye Disease 
eCRF 
Electronic Case Report Form 
ETDRS 
Early Treatment of Diabetic Retinopathy Study 
IB 
Investigator’s Brochure 
ICH 
International Conference on Harmonisation 
IOP 
Intraocular Pressure 
IP 
Investigational Product 
ITT 
Intent-to-Treat 
IWRS 
Intractive Web Response System 
LOCF 
Last Observation Carried Forward 
logMAR 
Logarithm of the Minimum Angle of Resolution 
LS 
Least Squares 
MedDRA 
Medical Dictionary for Regulatory Activities 
MCMC 
Markov Chain Monte Carlo 
mm 
Millimeters 
mmHg 
Millimeters of Mercury 
MMRM 
Mixed-Effect Model for Repeated Measures 
NC 
Not Calculable 
NCS 
Not Clinically Significant 
NEI 
National Eye Institute 
OSDI© 
Ocular Surface Disease Index 
PDF 
Portable Document Format 
PP 
Per Protocol 
PT 
Preferred Term 
RTF 
Rich Text Format 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SAS® 
Statistical Analysis System® 
SD 
Standard Deviation 
SDC 
Statistics & Data Corporation 
SDTM 
Study Data Tabulation Model 
SE 
Standard Error 
 
 
09MAR2023 
Confidential & Proprietary 
Page 5 of 46 




09MAR2023 
Confidential & Proprietary 
Page 7 of 46 
 
 
 
 
Protocol YPP10-001 SAP, Version 1.0 
 
1. Introduction 
The purpose of this statistical analysis plan (SAP) is to describe the planned analyses and reporting in 
detail for the efficacy and safety assessments, as well as relevant data collected in protocol YPP10-001, 
version 5.0 dated 03MAR2023. 
This SAP is being written with due consideration of the recommendations outlined in the most recent 
International Conference on Harmonisation (ICH) E9 Guideline entitled Guidance for Industry: Statistical 
Principles for Clinical Trials, the most recent ICH E3 Guideline, entitled Guidance for Industry: Structure 
and Content of Clinical Study Reports, and the most recent ICH E9 (R1) addendum on estimands and 
sensitivity analysis in clincal trials to the guideline on statistical principles for clinical trials. 
The statistical analysis methods presented in this document will supersede the statistical analysis methods 
described in the clinical protocol. If additional analyses are required to supplement the planned analyses 
described in this SAP, they may be completed and will be identified in the clinical study report. 
2. Study Objectives 
The objective of this study is to compare the safety and efficacy of YP-P10 Ophthalmic Solution to placebo 
for the treatment of the signs and symptoms of the dry eye. 
3. Study Design and Procedures 
 
3.1 
General Design 
This study is a randomized, double-masked, placebo-controlled, and multi-center study to compare the 
efficacy and safety of YP-P10 Ophthalmic Solution to YP-P10 Placebo Ophthalmic Solution (vehicle) for 
treating dry eye. Approximately
 subjects will be randomized with a ratio of 
 into one of the three 
groups at Visit 2 (Day 1): 
1) 0.3% YP-P10 Ophthalmic Solution (low dose, N = 
) 
 
2) 1% YP-P10 Ophthalmic Solution (high dose, N =
 ) 
 
3) YP-P10 Placebo Ophthalmic Solution (placebo, N = 
) 
 
Subjects will be instructed to administer study drug one drop in each eye, twice daily (BID) for 12 weeks. 
 
Of the 
 randomized subjects, approximately 
 subjects will be of first, second, or third generation 
Japanese descent, verified by review of subject’s family tree, government-approved ID (e.g., birth 
certificate), and affirmative response to a Japanese lifestyle questionnaire. Inclusion of Japanese subjects 
will only be applicable at one site (Aesthetic Eye Care Institute, CA). 
Subjects, Sponsor, Contract Research Organization (CRO), and site personnel will be masked to treatment 
assignment. During the 7-day run-in period prior to randomization, all subjects will receive vehicle in each 
eye BID. During the screening period, two 90-minute exposures to the Controlled Adverse Environment 
(CAE®) will be conducted to ascertain eligibility to enter the study at Visit 1 (Day -7) and Visit 2 (Day 1). 










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o 
Corneal fluorescein staining on the 
 will be assessed for each eye at all 
visits, including pre-CAE® of Visit 1 (Day -7) and Visit 2 (Day 1), and Visit 3 (Day 15) through 
Visit 6 (Day 85) 
• 
Lissamine green staining of the conjunctiva on the 
 by region: 
 
 
 
 
o 
Lissamine green staining using 
 will be assessed for each eye at all 
visits, including pre-CAE® of Visit 1 (Day -7) and Visit 2 (Day 1), and Visit 3 (Day 15) through 
Visit 6 (Day 85) 
o 
The conjunctival sum will be calculated as the sum of grading score of six regions 
 
 for study 
eye, ranging from
 per eye 
• 
Mean change from baseline to each follow-up visit in conjunctival redness (Ora Calibra® 
Conjunctival Redness Scale) 
o 
Conjunctival redness using Ora Calibra® Scale will be assessed in each eye at both pre- 
and post-CAE® of Visit 1 (Day -7) and Visit 2 (Day 1), and Visit 3 (Day 15) through Visit 6 
(Day 85) 
o 
The scale ranges from 
 
 
 
• 
Mean change from baseline to each follow-up visit in Unanesthetized Schirmer’s Test in the study 
eye 
• 
Unanesthetized Schirmer’s Test will be assessed in each eye at pre-CAE® of Visit 1 (Day 
-7) and Visit 2 (Day 1), and Visit 3 (Day 15) through Visit 6 (Day 85) 
• 
Proportion of subjects demonstrating 
 increase from baseline to each follow-up visit in the 
Unanesthetized Schirmer’s Test 
o 
Change from baseline in the Unanesthetized Schimer’s Test will be dichotomized to 
 
 
 
• 
Mean change from baseline to each follow-up visit in Tear Film Break-Up Time (TFBUT) in the 
study eye 
o 
TFBUT will be assessed in each eye at all visits including Pre-CAE® and Post-CAE® of 
Visit 1 (Day -7) and Visit 2 (Day 1), and Visit 3 (Day 15) through Visit 6 (Day 85). 
• 
Mean change from baseline to each follow-up visit in Ocular Surface Disease Index© (OSDI©) 
o 
OSDI is assessed at pre-CAE® of Visit 1 (Day -7) and Visit 2 (Day 1), and Visit 3 (Day 15) 
through Visit 6 (Day 85) 






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The site staff will dispense kit(s) required at each visit. Both the randomization number and the dispensed 
study drug kit number(s) will be recorded on the subject’s source document and electronic case report form 
(eCRF). Subjects, Sponsor, CRO, and site personnel will be masked to treatment assignment. 
 
5.2 
Masking and Unmasking 
All subjects, investigators, and study personnel, including Yuyu Pharma, Inc., Statistics & Data Corporation 
(SDC), and Ora, Inc. site personnel involved with the conduct of the study, data quality assurance, and 
statistical analyses will be masked with regard to treatment assignments until database lock. When 
medically necessary, the investigator may need to determine what treatment group has been assigned to 
a subject. When possible (i.e., in non-emergent situations), Ora, Inc. and Yuyu Pharma, Inc. personnel 
should be notified before unmasking study drug. Ora, Inc. and Yuyu Pharma, Inc. must be informed 
immediately about any unmasking event. 
If an investigator identifies a medical need for unmasking the treatment assignment of a subject, they should 
contact Ora, Inc. and/or the medical monitor prior to unmasking the identity of the investigational product 
(IP), if possible. Ora, Inc. will ask the site to complete and send them the Unmasking Request Form. Ora, 
Inc. will notify Yuyu Pharma, Inc. and jointly will determine if the unmasking request should be granted. 
They may consult the medical monitor as needed. The result of the request will be documented on the 
Unmasking Request Form. The investigator will unmask the subject’s treatment assignment using IWRS 
upon approval of the request. The investigator will complete the Unmasking Memo form and include it in 
the subject’s study file and provide a copy for the Trial Master File. For each unmasked request, the reason, 
date, signature, and name of the person who unmasked the subject must be noted in the subject’s study 
file. 
Unmasked subjects will be discontinued from the study. Unmasked subjects will be followed for safety 
monitoring until resolution of the AE or study completion, whichever occurs last. 
6. Sample Size and Power Considerations 
This study is expected to enroll a total of 
 randomized subjects, with 
subjects in each group. Of the 
 randomized subjects, approximately 
 subjects will be of first, second, or third generation Japanese 
descent, verified by review of subject's family tree, government-approved ID (e.g., birth certificate), and 
subject’s affirmative response to a Japanese lifestyle questionnaire. Approximately 
 subjects will be 
screened to enroll 
 randomized subjects. Assuming approximately 10% drop out rate, 
 subjects per 
group are expected to complete the study. A sample size of 
 subjects per group will provide 80% power 
to detect a statistically significant standardized treatment effect size of 
 between YP-P10 Ophthalmic 
Solution and placebo at the two-sided significance level of 
 for each primary endpoint. 
7. Data Preparation 
 
7.1 
Input Data 
Study data will primarily be recorded on the eCRFs supplied by SDC using iMednet v2020.1.0. 














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Age (years) will be summarized by treatment group and overall, using continuous descriptive statistics. Age 
will also be categorized as follows: < 65 years and ≥ 65 years. Age will be reported in years and calculated 
using the following formula: 
 
 
The number and percentage of subjects will be presented by treatment group and overall, for age category, 
sex, race, ethnicity, and iris color (OD and OS). 
A subject listing that includes all demographic variables will be provided. 
 
12.2 
Baseline Disease Characteristics 
Baseline disease characteristics will be summarized by treatment group for the study eye when appropriate 
for the following assessments: 
• 
Total Corneal Fluorescein Staining 
 
• 
Ocular Discomfort 
 
• 
Fluorescein Staining (
 
• 
Lissamine Green Staining 
 
• 
Conjunctival Redness (Ora Calibra Scale) 
• 
Unanesthetized Schirmer’s Test 
• 
TFBUT 
• 
OSDI 
• 
Burning/stinging, Itching, Foreign body sensation, Blurred vision, Photophobia, Pain, Eye Dryness 
as measured by 
 
 
 
 
 
 
 
 
 
 
 
12.2.1 CORNEAL FLUORESCEIN STAINING (ORA CALIBRA SCALE) 
At Visit 1 (Day -7) and Visit 2 (Day 1), both Pre-CAE® and Post-CAE®, grading of the 
 
 
 
 
 










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• 
Change from baseline to each follow-up visit in Ocular Surface Disease Index© (OSDI©) 
• 
Change from baseline to each follow-up visit in symptom assessment by 
 
 
• 
Drop comfort (Ora Calibra® Drop Comfort Scale and Questionnaire) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
. 
Subject listings will be provided for all secondary efficacy endpoint assessments for all randomized 
subjects. 
 
 
 
 
For drop comfort assessment, separate listings will be produced for the Ora Calibra® Drop Comfort Scale 
and the Ora Calibra® Drop Comfort Questionnaire. 
16. Safety Analyses 
All safety analyses will be conducted using the Safety population. 
 
16.1 
Adverse Events 
An AE is defined as any untoward medical occurrence associated with the use of an IP in humans, whether 
or not considered IP-related. An AE can be any unfavorable and unintended sign (e.g., an abnormal 
laboratory finding), symptom, or disease temporally associated with the use of an IP, without any judgment 
about causality. Any pre-existing medical condition that worsens after first administration of the IP will also 






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16.3 
Slit-Lamp Biomicroscopy Examination 
The results will be summarized using 
 
 
 
. A subject listing of the slit-lamp 
biomicroscopy parameters will also be produced. 
 
16.4 
Intraocular Pressure (IOP) 
The IOP values and changes from baseline for each eye (study eye and fellow eye) will be summarized 
using 
 
 
 
 
 
 
 
A subject listing of IOP will also be produced. 
 
16.5 
Dilated Fundoscopy Examination 
The results will be summarized using 
 
 
 
 A subject listing of the dilated 
fundoscopy parameters will also be produced. 
17. Subgroup Analyses 
Subgroup analyses will be performed in selected subgroups on the ITT population with the observed data 
only. If the number of subjects in a subgroup is 
, it may be combined with other subgroups for the 
subgroup analyses. 
 
17.1 
Subgroup Analyses by Demographic Characteristics 
The demographic characteristics subgroups are the following: 
 
• 
Age Group: <65 years, ≥65 years 
• 
Sex: Female, Male 
• 
Race: White, Black or African American, Asian, or Other (including American Indian or Alaska 
Native, Native Hawaiian or other Pacific Islander, and other) 
• 
Ethnicity: Hispanic or Latino, Not Hispanic or Latino 


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Subgroup analysis of the primary efficacy endpoints will be performed in the demographic subgroups based 
on the ITT population with the observed data only. The primary efficacy endpoint will be analyzed using the 
similar methods described for the primary analysis of the primary efficacy endpoints by the ANOVA model. 
LS means and their respective SEs of the change from baseline for each treatment group and LS mean 
differences comparing active treatment (low dose and high dose) to placebo, respectively, will be presented 
from the model with SEs, two-sided 95% CIs, and two-sided p-values. 
 
17.2 
Subgroup Analysis by Japanese Subgroup 
The Japanese subgroups are the following: 
 
• 
Japanese, non-Japanese 
 
17.2.1 DEMOGRAPHIC AND BASELINE DISEASE CHARACTERISTICS 
Demographic variables will be summarized by Japanese subgroups on the ITT and Safety populations. 
 
The number and percentage of subjects will be presented by Japanese subgroups and overall, further by 
treatment group, for age category, sex, race, ethnicity, and iris color (OD and OS). 
Baseline disease characteristics will be summarized by Japanese subgroup, further by treatment group for 
the study eye when appropriate for the following assessments: 
• 
Total Corneal Fluorescein Staining 
 
• 
Ocular Discomfort 
 
• 
Fluorescein Staining 
 
• 
Lissamine Green Staining 
 
• 
Conjunctival Redness (Ora Calibra Scale) 
• 
Unanesthetized Schirmer’s Test 
• 
TFBUT 
• 
OSDI 
• 
Burning/stinging, Itching, Foreign body sensation, Blurred vision, Photophobia, Pain, Eye Dryness 
as measured by 
 
17.2.2 MEDICAL HISTORY AND CONCOMITANT MEDICATIONS 
Ocular and non-ocular medical history will be summarized separately at the subject level by Japanese 
subgroups and overall, and by SOC and PT using the ITT population. 
Concomitant medications will be summarized separately for ocular and non-ocular concomitant 
medications by Japanese subgroups and overall, and by ATC and preferred name using the ITT population. 
17.2.3 PRIMARY EFFICACY ENDPOINTS ANALYSES 
Subgroup analyses of the primary efficacy endpoints will be performed in the Japanese subgroups based 
on the ITT population with the observed data only. The primary efficacy endpoint will be analyzed using the 






























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Protocol YPP10-001 SAP, Version 1.0 
 
 
SP,Tl51 cs & DATA Co11,oaA110N 
 
Appendix 1. Schedule of Visits and Assessments