Clinical Evaluation of MucoPEG™ for Xerostomia
Phase: NA
Conditions: Dry Mouth, Xerostomia
Sponsor: SunBio, Inc.

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Protocol Title 
Clinical Evaluation of MucoPEG for Xerostomia 
 
 
Sponsor 
 
SunBio, Inc. 
95 Sanbon-ro 
Gunpo-si, Gyeonggi-do 
South-Korea 
Protocol Number:   
SB-MU-001   
Version Number:  
1.1 
 
November 08, 2021 
 
Confidentiality Statement 
2TThis document is confidential and may not be disclosed without prior written consent of SunBio, 
Inc.  This study will be performed in accordance with all stipulations of the protocol and in 
compliance with all applicable SunBio, Inc. Policies and Procedures.   
2TStudy conduct will comply with US FDA Regulations, applicable state and local regulations, and 
the Good Clinical Practice guidelines.  
 
 

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PROTOCOL APPROVAL PAGE 
Protocol Title:  Clinical Evaluation of MucoPEG for Xerostomia 
 
Protocol Number: SB-MU-001   
 
 
 
Date:   
 
 
 
We the undersigned, have read and approve the clinical investigational plan specified above and 
agree on its content: 
 
 
 
 
 
 
 Kwang Nho, CEO, SunBio, Inc. 
 
 
 
Date 
 
 
 
______________________________________________ 
Min-jung Ahn, Director, SunBio, Inc. 
 
 
 
 
Date 
 
 
 
______________________________________________ 
Yuseung Ha, Strategy & Developing Sr. Manager, Rudacure 
Corporation 
 
 
 
 
Date 
 
 
 

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INVESTIGATOR STATEMENT OF COMPLIANCE 
 
I have read this protocol(s) and agree to conduct and/or supervise the study(ies) in accordance 
with the relevant, current protocol(s); in accordance with accepted good clinical practice 
principles and will only make changes in a protocol after notifying 2TSunBio, Inc. . 
 
I agree to obtaining the written and dated approval/waiver of an Institutional Review Board 
(IRB) prior to initiation of the performance evaluation study and ensure prompt reporting to the 
IRB of any changes in research activity.  
 
I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the 
study(ies) are informed about their obligations in meeting the above commitments. 
 
I agree to maintain adequate and accurate records and to make those records available for 
inspection to both 2TSunBio, Inc.  2T and regulatory bodies. 
 
I agree to disclose to 2TSunBio, Inc. 2Taccurate financial information as required by FDA regulations 
(21 CFR 54). 
 
I agree to maintain the confidentiality of this study, all study related documents and data; and 
will not publish or disclose any content without prior written consent. 
 
The signature below attests that I have read and understand the contents of this protocol 
(or revisions to the protocol) and will adhere to the study protocol requirements as 
presented including all statements regarding confidentiality, and according to local legal 
and regulatory requirements and applicable U.S. Federal Regulations and Good Clinical 
Practice guidelines. 
 
 
Investigator Printed Name: 
 
 
_____________________________________ 
 
Investigator Signature: 
 
 
_____________________________________ 
 
Date (dd/mmm/yyyy): 
 
 
_____________________________________ 
 
 
 
 
 

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PROTOCOL REVISION HISTORY  
 
 
Version 
Date 
Description of Change 
Brief 
Rationale 
1 
August 2021 
Initial Release 
Initial Release 
1.1 
November 2021 
Section 2 Contact Information 
Section 10.3.3 Device/Product Return Procedure 
8.1 Scale 
1st 
Amendment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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TABLE OF CONTENTS 
INVESTIGATOR STATEMENT OF COMPLIANCE ....................................................................................................... 3 
TABLE OF CONTENTS .............................................................................................................................................. 5 
1 
LIST OF ABBREVIATIONS ............................................................................................................................... 8 
2 
CONTACT INFORMATION .............................................................................................................................. 9 
2.1 
SPONSOR CONTACT INFORMATION .......................................................................................................................... 9 
3 
STUDY SYNOPSIS ........................................................................................................................................ 10 
4 
INTRODUCTION .......................................................................................................................................... 13 
4.1 
BACKGROUND AND RATIONALE ............................................................................................................................. 13 
5 
INVESTIGATIONAL DEVICE DESCRIPTION .................................................................................................... 13 
5.1 
INTENDED USE ................................................................................................................................................... 14 
5.2 
DOSAGE ........................................................................................................................................................... 14 
5.3 
LABELS ............................................................................................................................................................. 14 
5.4 
COMPARATOR INFORMATION ............................................................................................................................... 14 
6 
STUDY PURPOSE ......................................................................................................................................... 15 
6.1 
RISK AND BENEFIT ASSESSMENT ............................................................................................................................ 15 
6.1.1 
Risk Minimization ................................................................................................................................. 15 
6.1.2 
Benefits ................................................................................................................................................ 15 
7 
STUDY OBJECTIVES AND ENDPOINTS .......................................................................................................... 16 
7.1 
PRIMARY OBJECTIVE: .......................................................................................................................................... 16 
7.2 
SECONDARY OBJECTIVE(S): .................................................................................................................................. 16 
7.3 
STUDY ENDPOINTS.............................................................................................................................................. 16 
8 
STUDY DESIGN ............................................................................................................................................ 16 
8.1 
SCALE .............................................................................................................................................................. 17 
8.2 
ENROLLMENT .................................................................................................................................................... 17 
8.3 
INCLUSION CRITERIA ........................................................................................................................................... 17 
8.4 
EXCLUSION CRITERIA ........................................................................................................................................... 18 
8.5 
STUDY DURATION............................................................................................................................................... 18 
9 
STUDY PROCEDURES ................................................................................................................................... 18 
9.1 
STUDY SCHEDULE OF EVENTS ................................................................................................................................ 18 
9.2 
VISIT 1 (SCREENING VISIT) ................................................................................................................................... 20 
9.3 
VISIT 2 (BASELINE VISIT) ...................................................................................................................................... 20 
9.4 
VISIT 3 ............................................................................................................................................................. 21 
9.5 
VISIT 4 ............................................................................................................................................................. 23 
9.6 
VISIT 5 ............................................................................................................................................................. 24 
9.7 
VISIT 6 ............................................................................................................................................................. 25 
9.8 
VISIT 7 ............................................................................................................................................................. 26 
9.9 
WASHOUT PERIOD ............................................................................................................................................. 27 
9.10 PATIENT DIARY .................................................................................................................................................. 27 
9.11 INTRA-ORAL PHOTOGRAPH .................................................................................................................................. 27 
9.12 CONCOMITANT MEDICATIONS .............................................................................................................................. 28 
10 
TRAINING, STORAGE AND ACCOUNTABILITY .............................................................................................. 28 
10.1 TRAINING REQUIREMENTS ................................................................................................................................... 28 

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10.2 CLINICAL STUDY MATERIALS AND CLINICAL STUDY-SPECIFIC EQUIPMENT ...................................................................... 28 
10.3 STUDY DEVICE/PRODUCT TRACEABILITY.................................................................................................................. 28 
10.3.1 
Supply of Devices/Products ............................................................................................................. 28 
10.3.2 
Device Storage and Accountability .................................................................................................. 28 
10.3.3 
Device/Product Return Procedures ................................................................................................. 28 
11 
PATIENT ACCOUNTABILITY AND WITHDRAWAL .......................................................................................... 29 
11.1 PATIENT WITHDRAWALS AND DISCONTINUATION ..................................................................................................... 29 
11.2 LOSS TO FOLLOW-UP .......................................................................................................................................... 29 
12 
SAFETY CONSIDERATIONS........................................................................................................................... 29 
12.1 INVESTIGATOR RESPONSIBILITIES ........................................................................................................................... 29 
12.2 ADVERSE EVENT AND DEVICE EFFECT DEFINITIONS ................................................................................................... 30 
12.3 RECORDING AND REPORTING ................................................................................................................................ 31 
12.4 FOLLOW-UP OF UNRESOLVED EVENTS .................................................................................................................... 31 
13 
CLINICAL SITE MONITORING ....................................................................................................................... 31 
14 
REGULATORY AND ADMINISTRATIVE REQUIREMENTS ............................................................................... 32 
14.1 RESPONSIBILITY OF INVESTIGATOR ......................................................................................................................... 32 
14.2 RESPONSIBILITY OF SPONSOR ................................................................................................................................ 32 
14.3 AUDITING ......................................................................................................................................................... 32 
14.4 PROTOCOL DEVIATIONS ....................................................................................................................................... 32 
14.5 CHANGES TO PROTOCOL ...................................................................................................................................... 33 
14.6 RECONCILIATION OF STUDY MATERIAL, SUPPLIES AND SAMPLES .................................................................................. 33 
15 
STATISTICAL CONSIDERATIONS ................................................................................................................... 33 
15.1 SAMPLE SIZE DETERMINATION .............................................................................................................................. 33 
15.2 RANDOMIZATION ............................................................................................................................................... 34 
15.3 STATISTICAL METHODS ........................................................................................................................................ 34 
15.4 ANALYSIS OF CLINICAL DATA................................................................................................................................. 35 
16 
SOURCE DOCUMENTS ................................................................................................................................. 35 
17 
ETHICAL CONSIDERATIONS ......................................................................................................................... 36 
17.1 INSTITUTIONAL REVIEW BOARD (IRB) .................................................................................................................... 36 
17.2 INFORMED CONSENT PROCESS .............................................................................................................................. 36 
17.3 PATIENT CONFIDENTIALITY ................................................................................................................................... 36 
18 
TERMINATION OF THE CLINICAL INVESTIGATION ....................................................................................... 37 
18.1 EARLY TERMINATION OF THE CLINICAL INVESTIGATION .............................................................................................. 37 
19 
DATA MANAGEMENT ................................................................................................................................. 37 
19.1 DATA COLLECTION METHODS ............................................................................................................................... 37 
19.2 COMPLETION OF CASE REPORT FORMS ................................................................................................................... 37 
19.3 REVIEW AND RETURN OF COMPLETED DOCUMENTATION ........................................................................................... 38 
19.4 RETENTION ....................................................................................................................................................... 38 
20 
INVESTIGATOR/INVESTIGATION SITE SELECTION ........................................................................................ 38 
20.1 INVESTIGATOR SELECTION CRITERIA ....................................................................................................................... 38 
20.2 SITE SELECTION CRITERIA ..................................................................................................................................... 38 
21 
PUBLICATIONS AND COMMUNICATIONS .................................................................................................... 39 
21.1 CLINICAL INVESTIGATION REPORT .......................................................................................................................... 39 

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21.2 PUBLICATIONS ................................................................................................................................................... 39 
22 
MISCELLANEOUS......................................................................................................................................... 39 
22.1 STATEMENT REGARDING THE FUNDING OF THE STUDY ............................................................................................... 39 
22.2 CLINICAL INVESTIGATION AGREEMENT .................................................................................................................... 39 
23 
LITERATURE REFERENCES............................................................................................................................ 39 
APPENDIX A: VAS QUESTIONNAIRES ........................................................................................................ 41 
APPENDIX B: DRY MOUTH RELIEF QUESTIONNAIRE ........................................................................... 42 
APPENDIX C: DRY MOUTH INVENTORY QUESTIONNAIRE .................................................................. 43 
APPENDIX D: PPAQ & PPUQ QUESTIONNAIRE ........................................................................................ 45 
APPENDIX E: THE CHALLACOMBE SCALE .............................................................................................. 49 
 
 
 
 
 
 
 

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1 
LIST OF ABBREVIATIONS 
TERM 
DEFINITION 
ADE 
Adverse device effect 
AE 
Adverse event 
CDMS 
Clinical Data Management System  
IRB 
Institutional Review Board 
CRF 
Case Report Form 
CRO 
Contract research organization 
CTA 
Clinical Trial Agreement 
DD 
Device deficiency 
DMI 
Dry Mouth Inventory 
DMP 
Data Management Plan 
DMRQ 
Dry Mouth Relief Questionnaire 
eCRF 
Electronic Case report form 
FAS 
Full analysis set  
FSFV 
First patient first visit 
GCP 
Good clinical practice 
ICH 
International Conference on Harmonization 
IFU 
Instructions for Use 
ISF 
Investigator’s site file 
ISO 
International Organization for Standardization 
PI 
Principal investigator 
PPAQ 
Product Performance and Attributes Questionnaire 
PPUQ 
Post-Product Use Questionnaire  
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SAS 
Statistical Analysis System software 
SD 
Standard deviation 
SOP 
Standard operating procedure 
USADE 
Unanticipated serious adverse device effect 
VAS 
Visual Analog Scale    
 
 
 
 
 
 

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2 
CONTACT INFORMATION 
2.1 
Sponsor Contact Information 
Sponsor:  
 
SunBio, Inc. 
95 Sanbon-ro 
Gunpo-si, Gyeonggi-do 
 South Korea 
Tel : +82-31-423-5467 
Fax : +82-31-423-5430 
 
CRO: 
North American Science Associates Inc. 
400 Highway 169 South, Suite 500 
Minneapolis, MN 55426 

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3 
STUDY SYNOPSIS 
Study Number 
SB-MU-001   
Full Title 
Clinical Evaluation of MucoPEG for Xerostomia 
Short Title 
CEMPEG 
Protocol Number 
SB-MU-001 
Protocol Version 
Version 1.1 
Study Sponsor 
SunBio, Inc. 
95 Sanbon-ro, Gunpo-si, Gyeonggi-do, South Korea 
Study Purpose 
This study will compare the effect of MucoPEG™ to that of 
Biotène®  Dry Mouth Gentle Oral Rinse and  evaluate its temporal 
change in a population of patients with dry mouth symptoms. 
Investigational 
Material/Product 
MucoPEG 
Comparative device 
Biotène®  Dry Mouth Gentle Oral Rinse 
Study Objectives 
 
Primary Objective: 
To evaluate the effect of MucoPEG in relieving xerostomia, 
relative to that of Biotène®  Dry Mouth Gentle Oral Rinse. Effectof 
both products will be assessed using the Visual Analogue Scale 
(VAS) and Dry Mouth Relief Questionnaire. 
Secondary Objectives: 
 To evaluate the effect of MucoPEG, measured using the Visual 
Analogue Scale, relative to that of Biotene Dry Mouth Gentle 
Oral Rinse after two hours and one week of use. 
 To compare the effect of MucoPEG in treating symptoms of 
dry mouth to that of Biotene. Effect will be assessed using dry 
mouth Product Performance and Attributes Questionnaire 
(PPAQ) and Post-Product Use Questionnaire (PPUQ) 
 To evaluate the clinical safety of MucoPEG™ 
 To examine change in the symptoms of xerostomia using the 
Dry Mouth Inventory (DMI) 
 
Study Design 
The proposed study will be an open-label randomized cross-over 
design.  
Patients will be randomly assigned to receive either the 
MucoPEG  or the Biotène®  Dry Mouth Gentle Oral Rinse in the 
first period. Patients will use the assigned oral rinse two times a 
day for two weeks. Patients will switch to the other treatment after 
a wash-out period of one week. 

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Inclusion Criteria 
1. Must have read, understood and signed an informed consent 
prior to entering the study. 
2. Must be 18 years of age or older 
3. Good general and mental health with, in the opinion of the 
investigator or their medically qualified designee, no clinically 
relevant or significant abnormalities found on examination of 
the oral cavity or in their medical history. 
4. Participant with a Challacombe Scale score of 1 or higher 
5. Participant agrees not to eat, drink, chew tobacco, chew gum, 
smoke, brush or floss their teeth for 2 hours prior to study visits 
6. Participant agrees not to use any oral care products or any type 
of breath mint or lozenges for 2 hours prior to study visits 
7. Participant agrees not to consume any food or liquid during the 
study visits, except for what is provided by the study research 
staff (e.g., water, MucoPEG and Biotène®  Dry Mouth Gentle 
Oral Rinse during evaluation periods) 
8. Participant agrees to using clinical oral care supplies provided 
by the investigators and no other products during the entire 
study 
9. Understands and is willing and able to comply with all study 
procedures and restrictions 
 
Exclusion Criteria 
1. Women who are pregnant or intending to become pregnant over 
the course of the study, or who have verbally confirmed they 
are pregnant at the Screening Visit 
2. Women who are breast-feeding 
3. Participant is currently undergoing radiotherapy and/or 
chemotherapy.  
4. Any condition the investigator identifies that  may impede the 
participant's ability to properly participate in the study. For 
example, Alzheimer's Disease 
5. Participant with untreated oral mucosal disease which in the 
opinion of the investigator could interfere with the study. For 
example, presence of oral ulceration. 
6. Evidence of gross intra-oral neglect or need for extensive dental 
therapy 
7. Denture wearer (complete dentures)  
8. Participant on systemic parasympathetic medications (e.g. 
pilocarpine) for treating dry mouth, but the dose requirement of 
which is unstable 
9. Known or suspected intolerance or hypersensitivity to the study 
materials (or closely related compounds) or to any of their 
stated ingredients 

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10. Participation in another clinical study (including studies of 
cosmetic products) or in receipt of an investigational drug 
within 14 days of the screening visit 
11. Previous participation in this study 
12. Recent history (within one year prior to screening visit) of 
alcohol or other substance abuse 
Target Population/ 
Sample Size 
42 adults in total for the entire study, males and females 
 
Number of site(s) 
Up to 2 sites in the United States 
Study Duration 
Approximately six months 
Participant Duration 
The study duration for each participant is expected to be 
approximately 42 days. 
Statistical Methods 
Descriptive summaries will be produced for the primary endpoints 
and the secondary endpoints using data from the intent-to-treat 
analysis population. 
 
Hypothesis testing for the primary endpoints will be carried out 
using data from the intent-to-treat analysis population and, as a 
sensitivity analysis, from the per protocol analysis population. 
Hypothesis tests will be carried out using data on: 
 the difference in the mean change in VAS for dry mouth 
 the difference in the proportion of patients rating the relief 
of dry mouth as “very good” or “excellent” in the Dry 
Mouth Relief Questionnaire (DMRQ). 
 
 
 
 

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4 
INTRODUCTION 
4.1 
Background and Rationale 
Xerostomia is a common oral health problem, affecting up to 50% of the population (Furness et 
al. 2011). Xerostomia is a subjective feeling of dryness of the mouth and can present with or 
without reduced saliva production (Furness et al. 2011, Villa et al. 2015, Jose et al. 2016). Dry 
mouth may be associated with other conditions such as diabetes and hypertension. Dry mouth is 
also a common side effect of many different drugs, such as anti-hypertensives, anti-depressants, 
decongestants (Tan et al. 2018). 
 
Mouth dryness is commonly associated with other symptoms such as taste disturbances, bad breath 
and painful mouth ulcers. Dry mouth may also affect speech, chewing and swallowing (Dawes 
1987, Furuta et al. 2013). 
 
Current management strategies include symptom relieving measures such as topical saliva 
substitutes, oral moisturizers, saliva stimulants, and also frequent sips of water. However, the 
evidence in favour of any particular topical therapy was weak (Jose et al. 2016, Villa et al.2015). 
Other products (e.g., Biotène® , Hydris™) have became available for treating dry mouth in recent 
years, but there is an increasing demand for more effective dry-mouth relief products.  
 
Polyethylene glycol (PEG) is a polyether compound with low toxicity, and it is used in a variety 
of products (Sheftel VO 2000). PEG in general is well-known for its moisturizing effect when 
formulated in aqueous liquid, due to its excellent ability to retain water. PEG is a polymer with 
repeating units of ethylene glycol, as depicted -(CHR2
RCHR2
RO)n-, where each repeating unit has 
molecular weight of 44 Da. The repeating unit has one oxygen, it is around this oxygen where 
water molecules bind via hydrogen bond established between the hydrogen of water and the 
oxygen of the PEG. It is known that 2 ~ 3 molecules of water bind to each oxygen of 
PEG.(Antonsen, Kris P. et al. 1992).  
 
SunBio, Inc.  has developed MucoPEG™ for the treatment of dry mouth, and is intended to relieve 
dry mouth symptoms in persons with xerostomia. 
 
The main ingredient of MucoPEG™ is a polyethylene glycol (PEG) derivative. The MucoPEG™ 
PEG derivative also naturally exhibits the hydrophilic characteristic of PEG. The                        
MucoPEG™ PEG derivative has a molecular weight of 10,000 daltons (Da). The MucoPEG™ 
PEG derivative has functional groups, which under aqueous conditions of neutral pH, may assist 
the PEG to stay in contact with the mucosal surface. Once in contact with the mucosa, the 
hydrophilic ability of PEG, to retain water, helps to moisturize and lubricate the oral mucosa to 
help alleviate oral dryness. 
 
5 
INVESTIGATIONAL DEVICE DESCRIPTION 
 
MucoPEG™ received FDA clearance on November 5, 2019 with the 510(k) number K190144. 
MucoPEG™ is an artificial saliva. The main ingredient of MucoPEG™ is a polyethylene glycol 
(PEG) derivative. This PEG derivative forms a covalent bond with the oral epithelial cell. The 

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additives to MucoPEG™ are mint (for flavor) and sodium bicarbonate (for pH maintenance when 
dissolved in water).  
 
MucoPEG™ is available by prescription for home use. It is formulated as a powder and 
packaged in a single-use packet, which should be kept in a dry environment and stored in the 
freezer between -4 ± 9 Po
PF. The shelf-life is expected to be one year under the prescribed 
environment. MucoPEG™ is not sterile and conforms with ISO 10993-1 for cytotoxicity, 
sensitization, and irritation. 
5.1 
Intended Use 
The device intended use is to relieve the symptoms and discomfort of dry mouth, refresh, 
moisturize/hydrate, clean, soothe oral irritation, and lubricate oral dryness.  
5.2 
Dosage 
The content of a single dose containing 1 g powder of MucoPEG™ is dissolved in 20 mL 
(approximately .67 fluid oz) of water using the accessory bottle and shaken well for about 10 
seconds for complete mixing. When completely mixed, the solution is gargled and swished inside 
the oral cavity for 30 - 60 seconds and then spat out. This is followed by rinsing the oral cavity 
with drinking water to remove any residual product. Users are recommended not to eat or drink 
for 30 minutes after treatment. MucoPEG™  should be used twice a day, once after breakfast and 
once before bedtime. 
5.3 
Labels  
The sponsor will label, package and ship the study materials to the research facility. 
Each experimental material will be labeled with the following minimum information: 
 
For use in Study SB-MU-001 only 
SunBio, Inc. 
Identifying lot or control number 
Study Material name or code designation 
Quantity of contents 
Expiration date: 
“Use as directed” 
Storage conditions as indicated in the IFU 
Contact details of the site 
 
5.4 
Comparator Information  
Biotène®  Dry Mouth Gentle Oral Rinse is specially formulated to clean, refresh, and relieve 
dryness and helps soothe oral tissues. Biotène®  Dry Mouth Gentle Oral Rinse contains a 
combination of moisturizers and lubricants to provide immediate and long-lasting dry mouth 
symptom relief for up to 4 hours, as measured in a 7 day clinical study. 
The manufacturers suggests using approximately 15 mL (one tablespoon) of Biotène®  Dry 
Mouth Gentle Oral Rinse, gargle for 30 seconds and then spat out. Biotène®  Dry Mouth Gentle 
Oral Rinse can be used as needed up to 2~3 times a day. 
 

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Since Biotène®  Dry Mouth Gentle Oral Rinse is a commercially available product, it will be 
labeled for study use only. Labels will contain the following information:  
 
For use in Study SB-MU-001 only 
Identifying lot or control number 
Study Material name or code designation 
Quantity of contents 
Expiration date: 
“Use as directed” 
Storage conditions as indicated in the IFU 
Contact details of the site 
 
6 
STUDY PURPOSE 
 
The purpose of this clinical trial is to compare the effect of using MucoPEG™ and its temporal 
change to those of the Biotène®  Dry Mouth Gentle Oral Rinse in patients with xerostomia. 
This study will also gather data on patient reported outcomes on the safety and performance of the 
product, mouth-feel qualities and any changes in dry mouth. 
 
6.1 
Risk and Benefit Assessment 
6.1.1 Risk Minimization 
There may be unknown risks for patients participating in this study, however efforts to minimize 
risks to study patients will be made with the following approaches: 
 Conformity with ISO 10993-1 for cytotoxicity, sensitization, and irritation  
 Selection of an investigator who is an experienced dental clinician 
 Clearly defined inclusion and exclusion criteria will be used to ensure only appropriate 
patients are enrolled 
 Monitoring of investigational sites and patients 
 Review of reported Adverse Events 
Based on the risk assessment report, the side effects of using the experimental device include:  
 Allergic reaction  
 Unpleasantness 
 Foreign-body sensation  
6.1.2 Benefits 
There may be no benefit to patients participating in this study, however the data collected in this 
study may benefit future patients.   

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7 
STUDY OBJECTIVES AND ENDPOINTS 
7.1 
Primary Objective: 
To evaluate the effect of MucoPEG™ in relieving xerostomia, relative to that of Biotène®  Dry 
Mouth Gentle Oral Rinse. Effect will be assessed using the Visual Analogue Scale (VAS) and 
Dry Mouth Relief Questionnaires (DMRQ). 
7.2 
Secondary Objective(s): 
The secondary objectives are as follows:  
 To evaluate the effect of MucoPEG, measured using the Visual Analogue Scale, relative to 
that of Biotene Dry Mouth Gentle Oral Rinse after two hours and one week of use.  
 To compare the effect of MucoPEG in treating symptoms of dry mouth to that of Biotene. 
Effect will be assessed using dry mouth Product Performance and Attributes Questionnaire 
(PPAQ) and Post-Product Use Questionnaire (PPUQ) 
 To evaluate the clinical safety of MucoPEG™ 
 To examine change in symptoms of xerostomia using the Dry Mouth Inventory (DMI) 
7.3 
Study Endpoints 
 
The primary endpoint is the difference in the change in the rating of mouth dryness between 
MucoPEG and Biotene Dry Mouth Gentle Oral Rinse. The rating of mouth dryness is assessed 
using the Visual Analogue Scale. Its change is the difference between the assessment before 
using any of the products, on the first day of a treatment period (on Visit 2 and Visit 5), and after 
the last dose of a product, on the final day of a treatment period (on Visit 4 and 7). 
 
Patients will also be asked to rate the relief of discomfort of dry mouth using the Dry Mouth 
Relief Questionnaire. The difference in the proportion of patients giving a response of “4 – Very 
Good” or “5 – Significant/Excellent” between MucoPEG  and Biotène®  Dry Mouth Gentle 
Oral Rinse will be examined. 
 
The secondary endpoints include examination of the temporal changes in the effect of MucoPEG 
relative to Biotene, measured using the Visual Analogue Scale, after using the products for two 
hours (at Visit 2 and Visit 5) and one week (at Visit 3 and Visit 6). Other secondary endpoints 
include assessment of mouth dryness using Product Performance and Attributes Questionnaire 
(PPAQ - 4 parts), and Post-Product Use Questionnaire (PPUQ) and the Dry Mouth Inventory 
(DMI). 
Data from these sources will be summarised descriptively. 
 
8 
STUDY DESIGN 
The study is a randomized, open-labelled crossover trial. Each patient receives both the 
MucoPEG  and Biotène®  Dry Mouth Gentle Oral Rinse treatments. 
Patients will be randomly assigned to one of the two groups. Patients in group A will begin with 
two weeks of treatment (period 1) with MucoPEG, followed by a wash-out period of one week, 
and then two weeks of treatment (period 2) with Biotène®  Dry Mouth Gentle Oral Rinse. Patients 

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in group B will receive Biotène®  Dry Mouth Gentle Oral Rinse in period 1 and MucoPEG in 
period 2. 
8.1 
Scale 
This study will be conducted at up to 2 clinics in the United States. At least 42 patients meeting 
the eligibility criteria will be enrolled into the study and followed for approximately 42 days.  
 
8.2 
Enrollment 
Patients are considered enrolled in the study once they have signed the informed consent. The 
appropriate Electronic Case Report Form (eCRF) will be completed to document adherence to the 
inclusion and exclusion criteria.  
If a patient fails to meet the inclusion and exclusion criteria, this will be documented and their 
signed consent form and completed record of inclusion/exclusion criteria will be retained by the 
Principal Investigator. The patient will not be advanced any further into this clinical investigation. 
When a patient is considered eligible for this  study, the patient will be assigned an investigational 
number (patient ID number). This number will be a unique identifier of the patient and documented 
on the eCRF and all other documentation relating to that patient. 
The Principal Investigator (PI) at each site will maintain a master log that will map each patient 
ID number to the patient’s name. This log will remain at the study site and will be confidential. 
 
8.3 
Inclusion Criteria 
Individuals must meet all of the inclusion criteria and none of the exclusion criteria to be eligible 
to participate in the study. 
The inclusion criteria are: 
1. Must have read, understood and signed an informed consent prior to entering the study 
2. Must be 18 years of age or older 
3. Good general and mental health with, in the opinion of the investigator or their medically 
qualified designee, no clinically relevant or significant abnormalities found on 
examination of the oral cavity or in their medical history 
4. Participant with a Challacombe Scale  score of 1 or higher 
5. Participant agrees not to eat, drink, chew tobacco, chew gum, smoke, brush or floss their 
teeth for 2 hours prior to study visits 
6. Participant agrees not to use any oral care products or any type of breath mint or lozenges 
for 2 hours prior to study visits 
7. Participant agrees not to consume any food or liquid during the study visits, except for 
what is provided by the study research staff (e.g., water, MucoPEGand Biotène®  Dry 
Mouth Gentle Oral Rinse during evaluation periods) 
8. Participant agrees to using clinical oral care supplies provided by the investigators and no 
other products during the entire study 
9. Understands and is willing and able to comply with all study procedures and restrictions 

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8.4 
Exclusion Criteria 
If a patient meets the exclusion criteria, s/he will not be able to participate in the study.  
The exclusion criteria are: 
1. Women who are pregnant or intending to become pregnant over the course of the study, 
or who have verbally agreed that they are pregnant at the Screening Visit 
2. Women who are breast-feeding 
3. Participant is currently undergoing radiotherapy and/or chemotherapy.  
4. Any condition the investigator identifies that  may impede the participant's ability to 
properly participate in the study. For example, Alzheimer's Disease 
5. Participant with untreated oral mucosal disease which in the opinion of the investigator 
could interfere with the study. For example, presence of oral ulceration. 
6. Evidence of gross intra-oral neglect or need for extensive dental therapy 
7. Denture wearer (complete dentures)  
8. Participant on systemic parasympathetic medications (e.g. pilocarpine) for treating dry 
mouth, but the dose requirement of which is unstable 
9. Known or suspected intolerance or hypersensitivity to the study materials (or closely 
related compounds) or to any of their stated ingredients 
10. Participation in another clinical study (including studies of cosmetic products) or in 
receipt of an investigational drug within 14 days of the screening visit 
11. Previous participation in this study 
12. Recent history (within  one year prior to screening visit) of alcohol or other substance 
abuse 
 
8.5 
Study Duration 
 
The overall study is expected to last around six months and each patient’s participation is 
expected to last around 42 days. Each patient’s involvement in the study will last approximately 
3 to 5 hours per study visit with a total time commitment expected to be around 30 hours for 
each patient. 
9 
STUDY PROCEDURES 
9.1 
Study Schedule of Events 
Table 1 on the next page consists of the scheduled assessments for each study visit.  
 

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Table 1: Schedule of Events 
 
 
First Treatment 
2 times a day for 2 weeks 
 
Second Treatment 
2 times a day for 2 weeks 
Assessment 
Visit 1  
 
Wash-
out 
period* 
(7 Days) 
Visit 2 
(Day 1 +  
2 Days) 
Visit 3 
(Day 7 ±  
2 Days) 
Visit 4 
(Day 14 ±  
2 Days) 
Wash-out 
period* 
(7 Days) 
Visit 5 
(Day 22 + 
2 Days) 
Visit 6  
(Day 28 ± 
2 Days) 
Visit 7 
(Day 35 ±  
2 Days) 
Informed Consent 
X 
 
 
 
 
 
 
 
 
Inclusion/Exclusion 
X 
 
 
 
 
 
 
 
 
Demographics/Medical 
History 
X 
 
 
 
 
 
 
 
 
VAS Measurements 
 
 
X 
X 
X 
 
X 
X 
X 
Dry Mouth Relief 
Questionnaire 
 
 
X 
X 
X 
 
X 
X 
X 
Oral Tissue Exam using 
theChallacombe Scale Score 
X 
 
X 
X 
X 
 
X 
X 
X 
Dry Mouth Inventory 
 
 
X 
X 
X 
 
X 
X 
X 
Patient Diary 
 
 
X 
X 
X 
 
X 
X 
X 
Intra-Oral Photo ** 
 
 
X 
X 
X 
 
X 
X 
X 
PPAQ1 
 
 
X 
X 
X 
 
 X 
X 
X 
PPAQ2 
 
 
X 
X 
X 
 
X 
X 
X 
PPAQ3 
 
 
X 
X 
X 
 
X 
X 
X 
PPAQ4 
 
 
 
X 
X 
 
 
X 
X 
PPUQ 
 
 
 
 
X 
 
 
 
X 
Concomitant medication 
X 
 
X 
X 
X 
 
X 
X 
X 
Adverse Events 
 
 
X 
X 
X 
 
X 
X 
X 
* Patients must undergo a washout period of at least 7 days prior to using either treatment 
**Patients that opt in/consent to having a picture of their mouth taken. Photo must be taken as a pre-use measurement. 
For details of the Study Questionnaires, see Appendix A, B, C, D and E. 
 

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9.2 
Visit 1 (Screening Visit) 
Patients interested in participating the study will be consented and enrolled at Visit 1. Patients 
will be consented prior to conducting any study assessments.  
 
The following will be completed at Visit 1: 
 
 Obtain Informed Consent from the patient  
 Verify Inclusion criteria has been met and no Exclusion Criteria has been met 
 Collect Demographics 
 Collect Medical History 
 Collect Concomitant Medications 
 Conduct the Oral Tissue Exam using the Challacombe Scale Score 
 Schedule patient for future study visits 
To ensure an effective washout period, the study product will not be provided to the patient during 
Visit 1 to avoid the patient starting the treatment before obtaining baseline data at Visit 2 (Baseline 
Visit). Patients should be reminded to not to use any oral rinse products during the washout 
period, as described in Section 9.9. 
9.3 
Visit 2 (Baseline Visit) 
The second visit will be the Baseline Visit and should occur 1 (+2) days after screening visit and 
could last up to 4 hours as it will collect pre-use and post-use information at multiple timepoints 
(5 min, 30 min, 60 min, 120 min, and 240 min). 
 
Before starting any treatment, the following Upre-use measurementsU must be assessed by the 
UInvestigator or designated study staff U: 
 
 
Visual Analogue Scale (VAS) 
 
Oral Tissue Exam using the Challacombe Scale Score 
 
Intra-Oral Photo 
Before starting any treatment, the following Upre-use measurementU must be completed by the 
UpatientU: 
 
 
Dry Mouth Inventory (DMI) 
Patients will not be allowed to eat or drink during the study visit except for when directed 
by study staff.  
 
Once the VAS, DMI, the Oral Tissue Exam and Intra-Oral photo have been completed, the sealed 
envelope will be opened, and treatment order noted. The patient will then self-administer the first 
dose of the treatment into their mouth using the first sample assigned based on the randomization 
card.  
 
The Upost-use measurementsU will include the following at the appropriate timepoints: 

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 5 (+ 5) minutes after 1Pst
P dose: PPAQ1 (Questions 1-3; completed while patient is in clinic) 
 30 (± 10) minutes after 1Pst
P dose: PPAQ2 (Questions 1-11; completed while patient is in 
clinic) 
 60 (± 10) minutes after 1Pst
P dose: PPAQ3 (Questions 12-14; completed while patient is in 
clinic) 
 120 (± 10) minutes after 1Pst
P dose: VAS, Dry Mouth Relief Questionnaire (DMRQ), and 
PPAQ3 (Questions 12-14; completed while patient is in clinic) 
 240 (± 10) minutes after 1Pst
P dose: PPAQ3 (Questions 12-14; completed while patient is in 
clinic or completed at home) 
 
Other Assessments/Schedule of Events that must be completed during Visit 2 include: 
 Provide the patient with a patient diary and instructions as indicated below 
 Review any changes in concomitant medications 
 Review any side effects/adverse events 
 Provide the patient with instructions to use the product at home 
 Schedule the next follow-up visit (Visit 3) and instruct patients NOT to take the product 
the morning of Visit 3 
 
Prior to sending the patient home, the patient will be instructed to self-administer the second daily 
dose into their mouth before bedtime. Patients will be also given a patient diary and instructed to 
record storage location of the product (i.e. was the MucoPEG  stored in the freezer as indicated 
and was the Biotene stored at room temperature as indicated), the hours of use, and any side 
effects and/or adverse events they experience while using their assigned study product. Patients 
will be asked anopen question in their diary about how their mouth feels after using the product.  
 
Patients will be instructed to call the clinic if they experience any adverse side effects and/or 
adverse events.  
 
Patients will be instructed to use the product at home for 7 days, self-administering 2 doses per 
day depending on the treatment. They will be scheduled to return to the clinic with their product 
container and patient diary.   
 
9.4 
Visit 3  
The third visit should occur 7 (± 2) days after the baseline visit and could last up to 4 hours as it 
will collect pre-use and post-use information at multiple timepoints (5 min, 30 min, 60 min, 120 
min, 240 min). 
 
Before starting any treatment, the following Upre-use measurementsU must be assessed by the 
UInvestigator or designated study staffU: 
 
 
Visual Analogue Scale (VAS) 
 
Dry Mouth Relief Questionnaire (DMRQ) 
 
Oral Tissue Exam using the Challacombe Scale Score 
 
Intra-Oral Photo 

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Before starting any treatment, the following Upre-use measurementU must be completed by the 
UpatientU: 
 
 
PPAQ4 (Questions 15 -23; completed while patient is in clinic) 
 
Dry Mouth Inventory (DMI) 
Patients will not be allowed to eat or drink during the study visit except for when directed 
by study staff.  
 
The patient will then self-administer the first dose of the treatment into their mouth using the first 
sample assigned based on the randomization card.  
 
The Upost-use measurementsU will include the following at the appropriate timepoints: 
 5 (+ 5) minutes after 1Pst
P dose: PPAQ1 (Questions 1-3; completed while patient is in clinic) 
 30 (± 10) minutes after 1Pst
P dose:PPAQ2 (Questions 1-11; completed while patient is in 
clinic) 
 60 (± 10) minutes after 1Pst
P dose: PPAQ3 (Questions 12-14; completed while patient is in 
clinic) 
 120 (± 10) minutes after 1Pst
P dose: VAS, Dry Mouth Relief Questionnaire (DMRQ), and 
PPAQ3 (Questions 12-14; completed while patient is in clinic) 
 240 (± 10) minutes after 1Pst
P dose: PPAQ3 (Questions 12-14; completed while patient is in 
clinic or completed at home) 
 
Other Assessments/Schedule of Events that must be completed during Visit 3 include: 
 Provide the patient with a patient diary and instructions as indicated below 
 Review any changes in concomitant medications 
 Review any side effects/adverse events 
 Provide the patient with instructions to use the product at home 
 Schedule the next follow-up visit (Visit 4) and instruct patients NOT to take the product 
the morning of Visit 4 
 
Prior to sending the patient home, the patient will be instructed to self-administer the second daily 
dose into their mouth before bedtime. Patients will be also given a patient diary and instructed to 
record storage location of the product (i.e. was the MucoPEG  stored in the freezer as indicated 
and was the Biotene stored at room temperature as indicated), the hours of use, and any side 
effects and/or adverse events they experience while using their assigned study product. Patients 
will be asked a general question in their diary about how their mouth feels after using the product.  
 
Patients will be instructed to call the clinic if they experience any adverse side effects and/or 
adverse events.  
 
Patients will be instructed to use the product at home for 7 days, self-administering 2 doses per 
day depending on the treatment. They will be scheduled to return to the clinic with their product 
container and patient diary. 
 

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9.5 
Visit 4 
The fourth visit should occur 14 (± 2) days after the baseline visit and could last up to 4 hours as 
it will collect all the pre-use and post-use information at multiple timepoints (5 min, 30 min, 60 
min, 120 min, 240 min). 
 
Before starting any treatment, the following Upre-use measurementsU must be assessed by the 
UInvestigator or designated study staffU: 
 
 
Visual Analogue Scale (VAS) 
 
Dry Mouth Relief Questionnaire (DMRQ) 
 
Oral Tissue Exam using the Challacombe Scale Score 
 
Intra-Oral Photo 
Before starting any treatment, the following Upre-use measurementU must be completed by the 
UpatientU: 
 
 
PPAQ4 (Questions 15 -23; completed while patient is in clinic) 
 
Dry Mouth Inventory (DMI) 
Patients will not be allowed to eat or drink during the study visit except for when directed 
by study staff.  
 
The patient will then self-administer the first dose of the treatment into their mouth using the first 
sample assigned based on the randomization card.  
 
The Upost-use measurementsU will include the following at the appropriate timepoints: 
 5 (+ 5) minutes after 1Pst
P dose: PPAQ1 (Questions 1-3; completed while patient is in clinic) 
 30 (± 10) minutes after 1Pst
P dose:PPAQ2 (Questions 1-11; completed while patient is in 
clinic) 
 60 (± 10) minutes after 1Pst
P dose: PPAQ3 (Questions 12-14; completed while patient is in 
clinic) 
 120 (± 10) minutes after 1Pst
P dose: VAS, Dry Mouth Relief Questionnaire (DMRQ), and 
PPAQ3 (Questions 12-14; completed while patient is in clinic) 
 240 (± 10) minutes after 1Pst
P dose: PPAQ3 (Questions 12-14) and PPUQ (completed while 
patient is in clinic) 
 
Other Assessments/Schedule of Events that must be completed during Visit 4 include: 
 Collect the patient diary from the patient 
 Review any changes in concomitant medications 
 Review any side effects/adverse events 
 Schedule the next follow-up visit (Visit 5) and instruct patients NOT to use any product as 
indicated in the Washout Period 
 
After all assessments are completed for Visit 4, the first treatment phase will be considered 
complete and patients will be instructed to follow the one-week wash-out period, as described in 
Section 9.9. 

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9.6 
Visit 5 
The fifth visit should occur 22 (+ 2) days after the baseline visit and could last up to 4 hours as it 
will collect all the pre-use and post-use information at multiple timepoints (5 min, 30 min, 60 min, 
120 min, 240 min). 
 
Before starting any treatment, the following Upre-use measurementsU must be assessed by the 
UInvestigator or designated study staffU: 
 
 
Visual Analogue Scale (VAS) 
 
Oral Tissue Exam using the Challacombe Scale Score 
 
Intra-Oral Photo 
Before starting any treatment, the following Upre-use measurementU must be completed by the 
UpatientU: 
 
 
Dry Mouth Inventory (DMI) 
Patients will not be allowed to eat or drink during the study visit except for when directed 
by study staff.  
 
Once the VAS, DMI, the Oral Tissue Exam and Intra-oral photo have been completed, the patient 
will then self-administer the first dose of the treatment into their mouth using the second sample 
assigned. If the patient’s randomized first sample was the MucoPEG then the second sample 
assigned to the patient should be the Biotène®  Dry Mouth Gentle Oral Rinse and vice versa. 
 
The Upost-use measurementsU will include the following at the appropriate timepoints: 
 5 (+ 5) minutes after 1Pst
P dose: PPAQ1 (Questions 1-3; completed while patient is in clinic) 
 30 (± 10) minutes after 1Pst
P dose: PPAQ2 (Questions 1-11; completed while patient is in 
clinic) 
 60 (± 10) minutes after 1Pst
P dose: PPAQ3 (Questions 12-14; completed while patient is in 
clinic) 
 120 (± 10) minutes after 1Pst
P dose: VAS, Dry Mouth Relief Questionnaire (DMRQ), and 
PPAQ3 (Questions 12-14; completed while patient is in clinic) 
 240 (± 10) minutes after 1Pst
P dose: PPAQ3 (Questions 12-14; completed while patient is in 
clinic or completed at home) 
 
Other Assessments/Schedule of Events that must be completed during Visit 5 include: 
 Provide the patient with a patient diary and instructions as indicated below 
 Review any changes in concomitant medications 
 Review any side effects/adverse events 
 Provide the patient with instructions to use the product at home 
 Schedule the next follow-up visit (Visit 6) and instruct patients NOT to take the product 
the morning of Visit 6 
 

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Prior to sending the patient home, the patient will be instructed to self-administer the second daily 
dose into their mouth before bedtime. Patients will be also given a patient diary and instructed to 
record storage location of the product (i.e. was the MucoPEG  stored in the freezer as indicated 
and was the Biotene stored at room temperature as indicated), the hours of use, and any side 
effects and/or adverse events they experience while using their assigned study product. Patients 
will be asked a general question in their diary about how their mouth feels after using the product.  
 
Patients will be instructed to call the clinic if they experience any adverse side effects and/or 
adverse events.  
 
Patients will be instructed to use the product at home for 7 days, self-administering 2 doses per 
day depending on the treatment. They will be scheduled to return to the clinic with their product 
container and patient diary.  
9.7 
Visit 6 
The sixth visit should occur 28 (± 2) days after the baseline visit and could last up to 4 hours as it 
will collect pre-use and post-use information at multiple timepoints (5 min, 30 min, 60 min, 120 
min, 240 min). 
 
Before starting any treatment, the following Upre-use measurementsU must be assessed by the 
UInvestigator or designated study staff U: 
 
 
Visual Analogue Scale (VAS) 
 
Dry Mouth Relief Questionnaire (DMRQ) 
 
Oral Tissue Exam using the Challacombe Scale Score 
 
Intra-Oral Photo 
Before starting any treatment, the following Upre-use measurementU must be completed by the 
UpatientU: 
 
 
PPAQ4 (Questions 15 -23; completed while patient is in clinic) 
 
Dry Mouth Inventory (DMI) 
Patients will not be allowed to eat or drink during the study visit except for when directed 
by study staff.  
 
The patient will then self-administer the first dose of the treatment into their mouth using the 
second sample assigned.  
 
The Upost-use measurementsU will include the following at the appropriate timepoints: 
 5 (+ 5) minutes after 1Pst
P dose: PPAQ1 (Questions 1-3; completed while patient is in clinic) 
 30 (± 10) minutes after 1Pst
P dose:PPAQ2 (Questions 1-11; completed while patient is in 
clinic) 
 60 (± 10) minutes after 1Pst
P dose: PPAQ3 (Questions 12-14; completed while patient is in 
clinic) 

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 120 (± 10) minutes after 1Pst
P dose: VAS, Dry Mouth Relief Questionnaire(DMRQ), and 
PPAQ3 (Questions 12-14; completed while patient is in clinic) 
 240 (± 10) minutes after 1Pst
P dose: PPAQ3 (Questions 12-14; completed while patient is in 
clinic or completed at home) 
 
Other Assessments/Schedule of Events that must be completed during Visit 6 include: 
 Provide the patient with a patient diary and instructions as indicated below 
 Review any changes in concomitant medications 
 Review any side effects/adverse events 
 Provide the patient with instructions to use the product at home 
 Schedule the next follow-up visit (Visit 7) and instruct patients NOT to take the product 
the morning of Visit 7 
 
Prior to sending the patient home, the patient will be instructed to self-administer the second daily 
dose into their mouth before bedtime. Patients will be also given a patient diary and instructed to 
record storage location of the product (i.e. was the MucoPEG  stored in the freezer as indicated 
and was the Biotene stored at room temperature as indicated), the hours of use, and any side 
effects and/or adverse events they experience while using their assigned study product. Patients 
will be asked a general question in their diary about how their mouth feels after using the product.  
 
Patients will be instructed to call the clinic if they experience any adverse side effects and/or 
adverse events.  
 
Patients will be instructed to use the product at home for 7 days, self-administering 2 doses per 
day depending on the treatment. They will be scheduled to return to the clinic with their product 
container and patient diary. 
9.8 
Visit 7 
The seventh visit should occur 35 (± 2) days after the baseline visit and could last up to 4 hours as 
it will collect all the pre-use and post-use information at multiple timepoints (5 min, 30 min, 60 
min, 120 min, 240 min). 
 
Before starting any treatment, the following Upre-use measurementsU must be assessed by the 
UInvestigator or designated study staff U: 
 
 
Visual Analogue Scale (VAS) 
 
Dry Mouth Relief Questionnaire (DMRQ) 
 
Oral Tissue Exam using the Challacombe Scale Score 
 
Intra-Oral Photo 
Before starting any treatment, the following Upre-use measurementU must be completed by the 
UpatientU: 
 
 
PPAQ4 (Questions 15 -23; completed while patient is in clinic) 
 
Dry Mouth Inventory (DMI) 

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Patients will not be allowed to eat or drink during the study visit except for when directed 
by study staff.  
 
The patient will then self-administer the first dose of the treatment into their mouth using the 
second sample assigned.  
 
The Upost-use measurementsU will include the following at the appropriate timepoints: 
 5 (+ 5) minutes after 1Pst
P dose: PPAQ1 (Questions 1-3; completed while patient is in clinic) 
 30 (± 10) minutes after 1Pst
P dose:PPAQ2 (Questions 1-11; completed while patient is in 
clinic) 
 60 (± 10) minutes after 1Pst
P dose: PPAQ3 (Questions 12-14; completed while patient is in 
clinic) 
 120 (± 10) minutes after 1Pst
P dose: VAS, Dry Mouth Relief Questionnaire (DMRQ), and 
PPAQ3 (Questions 12-14; completed while patient is in clinic) 
 240 (± 10) minutes after 1Pst
P dose: PPAQ3 (Questions 12-14); and PPUQ (completed while 
patient is in clinic) 
 
Other Assessments/Schedule of Events that must be completed during Visit 7 include: 
 Collect the patient diary from the patient 
 Review any changes in concomitant medications 
 Review any side effects/adverse events and resolve if appropriate 
 
After all assessments are completed for Visit 7, the second treatment phase will be considered 
complete and the subject’s participation in the study will be complete. 
9.9 
Washout Period 
Patients will be required to undergo a washout period twice during the study. The first washout 
period should occur after the subject signs consent and will last until the baseline visit (Visit 2). 
The second washout period will start after the end of Visit 4 and last until the beginning of Visit 
5. A washout period is necessary to ensure patients proceed to a new treatment period without 
carrying over any residual effects from previous treatment. During the washout period patients 
will be instructed not to use any over the counter or prescription products for dry mouth. Patients 
will be allowed to only use water to rinse their mouth during the washout period. If a patient uses 
any type of oral rinse to treat dry mouth during the washout period it will be considered a protocol 
deviation. 
9.10 Patient Diary 
Patients will be given a patient diary at Visit 2 and instructed to record storage location of the 
product (i.e. was the MucoPEG  stored in the freezer as indicated and was the Biotene stored 
at room temperature, as indicated), the hours of use, and any side effects and/or adverse events 
they experience while using their assigned study product. Patients will also be asked an open 
question about how their mouth feels after using the product.  
9.11 Intra-Oral Photograph 
An intra-oral photograph of the mouth will be taken if patients have consented to have their 
photo taken.  The intra-oral photo must be taken prior to administering any study product to the 

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patient. A total of 5 pictures should be taken as follows: 1) upper side – hard plate 2) tongue 3) 
buccal mucosa: right side 4) buccal mucosa: left side 5) floor of mouth. Intra-oral photographs 
will be taken at the designated visits as described in Table 1. 
9.12 Concomitant Medications 
Concomitant medications are prescription medications, over-the-counter (OTC) drugs or dietary 
supplements taken by a patient. Concomitant medications should be collected at Visit 1 and should 
include any medications that, in the opinion of the Investigator, could contribute to dry mouth. 
 
10 TRAINING, STORAGE AND ACCOUNTABILITY 
10.1 Training Requirements 
Prior to investigation site activation or subsequent involvement in clinical study activities, the 
Sponsor or designated CRO will provide clinical study training relevant and pertinent to the 
involvement of personnel conducting clinical study activities.  
10.2 Clinical Study Materials and Clinical Study-Specific Equipment 
The sponsor or designated CRO will provide study documentation (e.g. Investigator Site File, 
eCRF access, Study Worksheets, etc.) and study devices to the site personnel. 
The site personnel are responsible to send an acknowledgment of receipt to the sponsor or 
designee after receiving the study devices (via email or fax). 
Where applicable, computer and internet access may be a pre-requisite for site participation. 
10.3 Study Device/Product Traceability 
10.3.1 Supply of Devices/Products 
The study sponsor will have the product shipped directly to the investigational site. 
10.3.2 Device Storage and Accountability 
Full tracking must be performed as soon as the device/product is received by the 
investigator/investigation site. Devices/products received by the Site will be confirmed on the 
shipping documents. The MucoPEGPTM
P provided by the Sponsor will be traced during the clinical 
study by assigning specific lot numbers, batch numbers, or serial numbers to each 
device/product.  
All information for the use, storage and handling of the investigational device/product as 
indicated in the Instructions for Use must be taken into account. 
10.3.3 Device/Product Return Procedures 
The vendor of products manufactured by SunBio Inc., will collect the returned and any 
malfunction device/product. 
 

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11 PATIENT ACCOUNTABILITY AND WITHDRAWAL 
11.1 Patient Withdrawals and Discontinuation 
During this study, patients may choose to discontinue / leave the study for any of the following 
reasons: 
 
Patient’s withdrawal of consent.   
 
Any unexpected adverse effect which, in the opinion of the Principal Investigator, is related 
to the device and will endanger the well being of the patient if the treatment is continued. 
 
The deterioration of any underlying illness(es), infection or condition(s) that might interfere 
with the Clinical Investigation Plan. 
 
Any problem deemed by the Principal Investigator and/ SunBio, Inc.  to be sufficient to cause 
discontinuation.   
 
Patients who are withdrawn from the study because of an unexpected adverse event will be treated 
until its resolution. The Principal Investigator will clearly document the date and reason(s) for 
patient withdrawal in his/her eCase Report Form (eCRF) or EDC system and the monitor must be 
notified.  
Patients have the right to withdraw from the study at any time and for any reason without prejudice 
to their future medical care. If a patient decides to withdraw, all study tests and procedures will be 
stopped and the cause of withdrawal will be documented. The investigative site must account for 
and document all patients enrolled in the study, including those withdrawn from the study or lost 
to follow-up. If a patient withdraws from the clinical investigation, the reason(s) shall be reported 
on the eCRF. 
 
Additional study data may no longer be collected after a patient’s withdrawal. Data collected up 
to the point of withdrawal will be used for analysis. Patients who are withdrawn will not be 
replaced if they have received any of MucoPEG or Biotène®  Dry Mouth Gentle Oral Rinse 
doses. Patients will be replaced if they are withdrawn prior to receiving the first dose on Visit 2. 
11.2 Loss to Follow-Up 
The minimum effort to obtain follow-up information includes 3 attempts to contact the patient (or 
their legally authorized representative) by telephone, and if not successful, a certified letter sent to 
the patient’s last known address. All contact efforts to obtain follow-up information must be 
documented in both the patient’s medical records and on the eCRFs.  
12  
SAFETY CONSIDERATIONS 
12.1 Investigator Responsibilities 
The Investigator is responsible for identifying adverse events throughout the study and follow-up 
period. An adverse event can occur at any time during the conduct of the study, in any phase of 
the study or after the study is completed. An adverse event can be identified by the Investigator or 
reported by the patient.  
 
Note: The Federal Privacy Rule (HIPAA) specifically permits the use and disclosure of protected 
health information “without written authorization of the individual” when used for public health 

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activities such as reporting adverse events, tracking FDA-related products, enabling recalls, repairs, 
replacements, lookbacks, or conducting post-market surveillance [45 CFR 164.512]. This use and 
disclosure is patient to the minimum necessary standard, i.e. “the minimum necessary to 
accomplish the intended use, disclosure, or request” [45 CFR 164.502].  
12.2 Adverse Event and Device Effect Definitions  
The principal measures of safety will be the incidence of adverse events reported during the study. 
Adverse events will be collected until the subject has exited/withdrawn from the study. Only 
treatment-emergent adverse event will be collected and reported.  
 
Examples of anticipated adverse events are:  
• Temporary and mild, mouth or tongue sensations such as: 
o Numbness  
o Burning sensation  
o Tingling sensations  
o Taste alteration  
 
The following are definitions related to safety: 
 
Adverse event (AE) means any undesirable clinical occurrence in a patient, whether or not it is 
considered to be device- or drug-related.  
 
Device-related adverse event (i.e., adverse device effect) is an AE considered by the Investigator 
to have a reasonable likelihood of being associated with the experimental device or device under 
study.  
 
Serious adverse event is an adverse event or suspected adverse reaction which, in the view of 
either the investigator or sponsor, results in any of the following outcomes: Death, a threat to life, 
inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant 
incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital 
anomaly/birth defect. Important medical events that may not result in death, be life- threatening, 
or require hospitalization may be considered serious when, based upon appropriate medical 
judgment, they may expose the patient to an increased risk of such outcomes and may require 
medical or surgical intervention to prevent one of the outcomes listed in this definition.  
 
Serious adverse device effect is a device effect that has a serious adverse effect on the health or 
safety of study participants, causing hospitalization , or is life threatening or causes death.  
 
Unanticipated adverse device effect is any serious adverse device effect on the health or safety 
of study participants or any life-threatening problem or death, that is caused by or associated with 
a device. That effect, problem or death and its nature, severity or degree of incidence was not 
previously identified in the investigational plan or application. This also included any other 
unanticipated serious problem which may be associated with a device  and is related to the rights, 
safety and welfare of patients.  

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12.3 Recording and Reporting  
The Investigator records each device-related adverse event on an Adverse Event eCRF. Each 
record includes the description, severity, seriousness, date of onset and resolution, relationship to 
the experimental material, action taken and outcome.  
The Investigator must promptly report an adverse device effects/adverse events to the Sponsor 
using the appropriate eCRF in the EDC system. If the Investigator is not able to report the adverse 
event or adverse device effect through the EDC system, the Investigator must notify the site 
monitor or Clinical Study Manager. If the adverse device effect/adverse event is considered by the 
Investigator to be serious and/or unanticipated, the Investigator must report it to the IRB as soon 
as possible and within IRB requirements.  
 
A serious AE involving the comparative device is reported to the study monitor and IRB.  
 
12.4 Follow-up of Unresolved Events 
All serious adverse events, serious adverse device effects and/or unexpected adverse device effects 
will be followed up until: 
 Thirty days after the onset of the event 
 Resolution of the event 
 Reaching a stable condition if its effect is a permanent impairment 
 The end of a patient’s participation in the study 
 
13 CLINICAL SITE MONITORING 
Clinical site monitoring is conducted to ensure that the study is implemented in accordance 
to the protocol and/or other operating procedures, and that the quality and integrity of study 
data and data collection methods are maintained. The monitor will evaluate study processes and 
documentation based on the Good Clinical Practice guidelines (GCP). Clinical Monitoring for this 
study may be performed with a combination of on-site visits and remote sessions. Site monitoring 
will be conducted under the direction of a separate Clinical Monitoring Plan.  
 
The monitor will be responsible for securing the compliance of the Principal Investigators to the 
signed agreement, the Clinical Study Protocol, Good Clinical Practice guidelines (GCP), or 
conditions of approval imposed by the reviewing ethics committee or regulatory authorities.   
 
The Principal investigator will permit a representative from SunBio, Inc. to inspect all eCase 
Report Forms and corresponding portions of the patient’s clinic records and/or original hospital 
medical records, either on-site or remotely, at regular intervals throughout the clinical investigation.  
These inspections are for the purpose of verifying adherence to the Clinical Study Protocol and 
the completeness and accuracy of the data being entered on the eCase Report Forms.  
The extent of source data verification is detailed in the monitoring plan. Source data is defined as 
all the information in the original records, certified copies of the original records of clinical 
findings, observations, or other activities in a clinical investigation, necessary for the 
reconstruction and evaluation of the clinical investigation. Source document are defined as printed, 
optical or electronic document containing source data, e.g. Hospital records, laboratory notes, 

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device accountability records, photographic negatives, radiographs, records kept at the 
investigation site, at the laboratories and at the medico-technical departments involved in the 
clinical investigation. 
A Principal Investigator found not to be in compliance with the study procedures will receive 
telephone and/or written notification of the deficiency, which will include a request that deviation 
be corrected immediately.  If the corrections are not made, shipment of products to the institution 
will be suspended.  A request will be made to the Principal Investigator that any products still in 
his/her possession are returned to SunBio, Inc.   
 
Monitoring for this study will be performed by an appointed CRA from the CRO NAMSA.  
 
14 REGULATORY AND ADMINISTRATIVE REQUIREMENTS 
14.1 Responsibility of Investigator  
The Principal Investigator is responsible for the proper conduct of the study at their site(s).  The 
investigator will ensure that the study is conducted in compliance with GCP, the protocol, the 
Clinical Study Agreement,  and applicable regulations in 21 CFR Part 812, and any other 
applicable regulatory requirements.   
14.2 Responsibility of Sponsor 
The sponsor has the overall responsibility for the conduct of the study, including assurance that 
the study meets the FDA regulations and other regulatory requirements as applicable.   
The sponsor’s study-related duties and functions may be transferred to a Contract Research 
Organization (CRO). 
14.3 Auditing 
During the running of the clinical investigation, SunBio, Inc.  may appoint Quality Assurance 
(QA) personnel to provide audit of the administration and conduct of the clinical investigation, 
both at the investigation site and at SunBio, Inc. .  
The relevant Regulatory Authority also has the right to conduct an audit of the clinical 
investigation, that the clinical investigations were, in fact, performed at stated investigation sites 
and that the data reported to the authority in support of a marketing application accurately 
reflects the data in the records of the Principal Investigator.  The authority also inspects such 
studies to verify that the clinical investigations were conducted in accordance with Government 
regulations relating to the Institutional Review Board and Informed Consent.  It is the joint 
responsibility of the Sponsor and the Principal Investigator to ensure the clinical investigation 
has been conducted in line with all government regulations. 
In the event the regulatory authority desires to inspect this clinical investigation, the Principal 
Investigator will permit authorized inspectors to inspect all facilities and records relating to the 
clinical investigation and aid the Inspector to perform the audit in a timely fashion.  
14.4 Protocol Deviations 
A protocol deviation is failure to comply with the requirements specified within the clinical 
study protocol, ICH GCP, Manual of Operations or IRB requirements. Investigators are not 

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allowed to deviate from the protocol except when a deviation is necessary to protect patient’s 
rights and well-being, or the scientific integrity of the study (ISO 14155). The noncompliance 
may be on the part of the patient, the investigator, or study staff. As a result of deviations, 
corrective actions are to be developed by the study staff and implemented promptly. 
 
All deviations from the protocol must be addressed in study source documents and promptly 
reported to SunBio, Inc., or the designated CRO and the local IRB/IEC, according to their 
requirements. The site PI/study staff is responsible for knowing and adhering to their IRB 
requirements.  
 
In the event that a procedural variation occurs, the SunBio, Inc. should be notified 
immediately to discuss the required follow-up. Protocol deviations or violations must be 
documented on the appropriate case report form after discussion with the study monitor. 
 
Data must not be invalidated, eliminated or discarded by the site. All results must be 
accounted for study source documents.   
14.5 Changes to Protocol 
In the event the study protocol is amended, the sponsor will provide the Principal Investigator 
with the protocol amendment(s) and a revised protocol. It is the responsibility of the 
Principal Investigator to determine if the protocol amendment(s) should be submitted for 
IRB approval. 
 
Protocol amendments that affect the patient rights, safety, or welfare must be submitted 
to the IRB for approval. The Sponsor must be notified of the approval, in writing, prior 
to implementation. 
14.6 Reconciliation of Study Material, Supplies and Samples 
The Sponsor, via its distributor, will supply sufficient quantities of study materials, supplies and 
samples to enable the site to complete the study. The site is required to maintain the inventory of 
these materials provided and document the reconciliation of these materials. 
 
At the completion of this clinical study, all unused materials, supplies, and samples must 
be returned to the Sponsor or disposed of according to provided instructions. If materials are 
disposed at the study site, the Investigator must provide the Sponsor with a signed record of 
disposition. 
 
15 STATISTICAL CONSIDERATIONS 
15.1 Sample Size Determination 
The primary endpoint is the difference between MucoPEG  and Biotène®  Dry Mouth Gentle 
Oral Rinse in the reduction of mouth dryness, assessed using the Visual Analogue Scale (VAS),  
for each patient after using each product for two weeks. 
  
The hypotheses are as follows: 

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Null hypothesis: 
Change in VAS after MucoPEG  minus change in VAS after Biotène®  Dry Mouth Gentle Oral 
Rinse  ≤ 0 
Alternative hypothesis: 
Change in VAS after MucoPEG  minus change in VAS after Biotène®  Dry Mouth Gentle Oral 
Rinse > 0 
 
The change in VAS associated with each product for the first treatment period will be calculated 
as the value of VAS at two hours after the final dose at Visit 4 minus the value of VAS before 
the first dose at Visit 2. The change in VAS for the second treatment period will be calculated in 
a similar way using values measured at Visit 5 and 7. 
 
Assuming the average difference between randomization groups is -1.25 with a common 
standard deviation of 1.50 and a Type I error of 0.05, an effective sample size of 38 patients will 
provide 80% power to reject the null hypothesis of no difference between the two devices 
(MucoPEG  vs Biotène®  Dry Mouth Gentle Oral Rinse). 
 
For comparing the percentage of patients giving a response of “Very Good” or “Significant / 
Excellent” in the Dry Mouth Relief Questionnaire (DMRQ), an effective sample size of 32 
patients will provide 80% power to demonstrate theeffect of MucoPEG is greater than 
Biotène®  Dry Mouth Gentle Oral Rinse. We assumed a difference in percentages of 0.20 with a 
standard deviation of 0.45 and a Type I error rate of 0.05. 
 
Since the effective sample size for the VAS scale analysis is greater than that of the Dry Mouth 
Relief Questionnaire analysis, and effective sample size of 38 patients will be used.  Assuming a 
10% loss to follow-up, total enrollment for this study is approximately 42 patients. 
15.2 Randomization 
Patients will be randomly allocated to either group A or group B in this crossover study in a 1:1 
ratio. Patients in group A will begin using MucoPEG  from Visit 2 for two weeks (period 1). 
This is followed by a washout period of one week. They will switch to using Biotène®  Dry Mouth 
Gentle Oral Rinse from Visit 5 for another two weeks (period 2). Patients in group B will follow 
the same pattern except they receive Biotène®  Dry Mouth Gentle Oral Rinse in period 1 and 
MucoPEG  in period 2. 
 
Because of differences in the package of the two products, blinding of treatment allocation in 
patients is not possible. Study assessors administrating the questionnaires, data entry staff and the 
statistician may be blinded to the product used at each period. 
 
15.3 Statistical Methods 
Data will be summarised descriptively as tables and/or graphs. Continuous variables such as 
patient’s assessment of mouth dryness using the Visual Analogue Scale (VAS) are to be 
summarised as mean, standard deviation, number of non-missing observations, median, 
minimum and maximum by the product used (MucoPEG or Biotène®  Dry Mouth Gentle Oral 
Rinse) and period (1 – before washout or 2 – after washout). Discrete variables such as ordinal 

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responses or binary responses (yes or no) from the Dry Mouth Relief Questionnaire, the Product 
Performance and Attributes Questionnaire, etc. are to be summarised as frequency counts and 
percentages by product and period. 
 
Measurements of symptom severity will be tested in a Student’s t test for the difference between 
MucoPEG and Biotène®  Dry Mouth Gentle Oral Rinse in their mean changes in Visual 
Analogue Scale for each treatment period. Changes between Visit 2 and Visit 4 and between 
Visit 5 and 7 will be tested for the primary endpoint and changes between Visit 2 and Visit 3, 
between Visit 5 and Visit 6, within Visit 2 (before the first dose and two hours after the first 
dose) and Visit 5 (before the first dose and two hours after the first dose) will be tested for the 
secondary endpoint. Confidence intervals will be presented with significance probability of the 
difference between the mean values. 
 
Data on other secondary endpoints will be summarised descriptively.  
15.4 Analysis of Clinical Data 
The intent-to-treat (ITT) analysis population is define as all patients enrolled in the study.  Patients 
in this analysis population will be analyzed according to the group to which they were randomized. 
The per protocol (PP) analysis population is a subset of the ITT population and excludes those 
patients with a protocol deviation that could affect the measurement of the primary endpoint.  For 
example, a patient who uses over the counter products for dry mouth during the course of the study. 
 
Descriptive summaries will be produced for the primary endpoints and the secondary endpoints 
using data from the intent-to-treat analysis population. 
 
Hypothesis testing for the primary endpoints will be carried out using data from the intent-to-treat 
analysis population and, as a sensitivity analysis, from the per protocol analysis population. The 
change in VAS associated for each product will be estimated as the value of VAS at the end of a 
treatment period minus the value of VAS before the first dose in the same period. The difference 
in mean change in VAS for dry mouth between MucoPEG  and Biotène®  Dry Mouth Gentle 
Oral Rinse will be tested in a Student’s t-test. The difference in the proportion of patients rating 
the relief of dry mouth as “Very Good” or “Significant / Excellent” will be tested in a binomial 
test of difference between two proportions. We will consider using statistical methods that are 
more suitable for smaller sample sizes (for example: exact binomial test, bootstrapping) if they are 
applicable. 
 
16 SOURCE DOCUMENTS  
Study staff will maintain appropriate study records for this study, in compliance with GCP, 
and regulatory and institutional requirements for the protection of confidentiality 
of patients. Study staff will permit authorized representatives the Sponsor and regulatory 
agencies to examine (and when required by applicable law, to copy) research records for the 
purposes of quality assurance reviews, audits, and evaluation of the study safety, progress 
and data validity. 
 

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17 ETHICAL CONSIDERATIONS 
17.1 Institutional Review Board (IRB) 
Prior to the initiation of this clinical investigation, the Principal Investigator must submit the 
Clinical Investigation Plan, the Informed Consent Form and any other study documents, as 
required, to the appropriate IRB for review and approval.  The Principal Investigator, and any other 
member of the investigative team, must not participate in the IRB review of this clinical study.  A 
signed and dated letter granting approval must be provided to SunBio, Inc. or the designated CRO 
prior to the initiation of the clinical investigation.  A list of the voting members of the IRB 
reviewing this Clinical Investigation Plan may be requested. 
 
17.2 Informed Consent Process 
Informed consent is a process that is initiated prior to the patient’s agreement to participate in the 
study and continues throughout the study participation. The Principal Investigator, or designee 
must explain to each patient the nature of the clinical investigation, including any risks and benefits, 
its purpose and procedures, and expected duration of involvement in the clinical investigation.  
Each patient must be informed that participation in the clinical investigation is voluntary and non-
participation will not affect his / her right to the treatment the patient is entitled to receive or affect 
the doctor/clinician-patient relationship. Each patient must be given sufficient time to decide 
whether they wish to participate and have all their questions addressed prior to signing the IRB-
approved consent form(s). A copy of the signed consent form(s) must be provided to the patient. 
Study specific procedures will not be initiated until the patient has signed the appropriate consent 
forms(s). Patients have full rights to withdraw from the clinical investigation at any time, 
irrespective of their initial consent.  
 
Each patient must also give their permission for representatives of the Sponsor, auditor and 
regulatory authorities to review their hospital records for the purposes of source data verification. 
 
Informed consent from the patient must be obtained in writing before any clinical investigation 
related procedures are performed.  
17.3 Patient Confidentiality 
Confidentiality of patient data will be maintained at all times and all documentation relating to a 
patient will be kept in a secure location. 
 
Study participant’s research data will be transmitted to the sponsor. This will not include 
participant’s contact or identifying information. Rather, samples will be de-identified using a study 
specific number at the time of enrollment.  All study forms will be labeled with the study number. 
No identifiable patient information will be provided to the sponsor or CRO.  
 
Study documents provided to the sponsor will be stored in a secure location with access given to 
only those that require study access.  None of the stored documents will contain any personal 
identifying information or direct identifiers. 
 

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Study files will be made available to the IRB, regulatory authorities, Sponsor (or designee) 
and/or clinical study staff should they request access for auditing purposes.  
 
18 TERMINATION OF THE CLINICAL INVESTIGATION 
In case of a study close-out, the Investigators will be notified by the Sponsor or designated CRO. 
Appropriate notification/report to IRB will be provided, as required per 21CFR812. After study 
close-out, the follow-up treatment and medical care of the patients will continue to be as per routine 
practice of the site. 
18.1 Early Termination of the Clinical Investigation 
This study may be suspended or prematurely terminated by the sponsor or the investigator 
immediately upon notice for any cause. Written notification via email or post, documenting the 
reason for study suspension or termination, will be provided by the suspending or terminating 
party. If the study is prematurely terminated or suspended, the Principal Investigator will promptly 
inform the IRB/IEC and will provide the reason(s) for suspension or termination. 
 
Circumstances that may warrant termination include, but are not limited to: 
• Insufficient adherence to protocol requirements. 
• Data that are not sufficiently complete and/or evaluable. 
• Determination of futility 
 
19 DATA MANAGEMENT   
19.1 Data Collection Methods 
Electronic Case Report Forms (eCRFs) will be used to capture data for performance and safety 
analysis. The clinical database will reside on a production server hosted by iMedNet. Instructions 
and training for use of the EDC system and proper completion of the forms will be provided to 
the clinical sites. All changes made to the data will be in an electronic audit trail and available 
for review. The database will be subject to quality control checks according to the study specific 
Data Management Plan and NAMSA’s standard procedures. 
Data collection and accurate documentation are the responsibility of the study staff under the 
supervision of the investigator or designee. Unanticipated problems must be reviewed by the 
investigator or designee.  
19.2 Completion of Case Report Forms 
Source data will be transcribed into the eCRFs of the database. The completed eCRFs must be 
reviewed and signed by the Investigator. Monitors will review the study database to ensure the 
validity of the study data relative to the available source documentation.  
 
Once all the patient data has been collected, the analysis and reporting will be conducted. Any data 
existing for patients who have not received treatment, will not be used in the analysis. Details of 
these patients will, however, be referenced in the final report. 
 

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Any data existing for patients who have received the investigational device/study product, who 
withdraw voluntarily or who are withdrawn from the clinical investigation, will be used in the final 
analysis.  The inclusion of partial data will be documented in the final report. The final report will 
be the responsibility of SunBio, Inc. or the designated CRO. 
19.3 Review and Return of Completed Documentation 
Throughout the clinical study and at the conclusion of the clinical investigation, the electronic case 
report forms must be signed by the Principal Investigator. 
 
19.4 Retention  
The Principal Investigator will retain all copies of the records as directed by SunBio, Inc. for a 
period of at least 2 years after the latter of the following two dates: the date on which the 
study is terminated or completed, or the date that the records are no longer required for purposes 
of supporting FDA clearance of the product and/or required by local regulations. In all cases, the 
Principal Investigator must obtain written consent from the Sponsor prior to disposing of any 
records related to the clinical investigation.  Included in records to be maintained are signed 
Clinical Investigation Plan, copies of the Case Report Forms, signed consent forms, IRB approval 
letters, product accountability records, correspondence concerning the clinical study and any other 
documents to identify the patients.  
 
In addition, if the Principal Investigator moves/retires, etc., s/he should provide the Sponsor with 
the name and address of the person/company that will be responsible for the clinical investigation 
related records. 
 
20 INVESTIGATOR/INVESTIGATION SITE SELECTION 
20.1 Investigator Selection Criteria 
The role of the Principal Investigator is to implement and manage the day-to-day conduct of the 
clinical study as well as ensure data integrity and the rights, safety and well-being of the patients 
involved in the clinical study. Investigators selected to participate in this study should have 
previous clinical study experience and must have past experience in the therapy being studied. 
20.2 Site Selection Criteria 
The following requirements will be evaluated for each investigation site considered for 
participation in the clinical study: 
 Past experience of site staff in conducting clinical studies 
 Adequate resources (including study nurse or coordinator), facilities and administrative 
support for the total study duration  
 Site has the capacity to recruit enough patients for the study.  
 Computer with access to EDC system 
 

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21 PUBLICATIONS AND COMMUNICATIONS 
21.1 Clinical Investigation Report 
The final report will be compiled by NAMSA, reviewed by SunBio, Inc.  and reviewed, approved 
and signed off by the Principal Investigator.  
21.2 Publications 
Details of publications will be addressed in each Clinical Trial Agreement. 
 
22 MISCELLANEOUS 
22.1 Statement Regarding the Funding of the Study 
This Clinical Investigation is a 100% Sponsor funded Investigation. 
 
22.2 Clinical Investigation Agreement 
A Clinical Investigation Agreement shall be in place, signed by the participating investigation site 
and returned to the Sponsor or designated CRO prior to the commencement of any clinical study 
activities. The investigator is indicating approval of the Clinical Investigation Plan and subsequent 
amendments, by a fully executed agreement. Amendments to this Clinical Investigation Plan shall 
be agreed upon between Sponsor and investigator(s) and be recorded with a justification for the 
amendments. Furthermore, each Investigator(s) should provide signed Financial Disclosure Forms 
to disclose a Conflict of Interest. 
 
23 LITERATURE REFERENCES 
 
Furness, S., Worthington, H. V., Bryan, G., Birchenough, S., & McMillan, R. (2011). 
Interventions for the management of dry mouth: topical therapies. Cochrane Database of 
Systematic Reviews, (12). 
 
Jose, A., Siddiqi, M., Cronin, M., DiLauro, T. S., & Bosma, M. L. (2016). A randomized clinical 
trial in subjects with dry mouth evaluating subjective perceptions of an experimental oral gel, an 
oral rinse and a mouth spray compared to water. American journal of dentistry, 29(1), 58-64. 
 
Villa, A., Connell, C. L., & Abati, S. (2015). Diagnosis and management of xerostomia and 
hyposalivation. Therapeutics and clinical risk management, 11, 45. 
 
Tan, E. C., Lexomboon, D., Sandborgh‐Englund, G., Haasum, Y., & Johnell, K. (2018). 
Medications that cause dry mouth as an adverse effect in older people: A systematic review and 
metaanalysis. Journal of the American Geriatrics Society, 66(1), 76-84. 
 
Dawes, C. (1987). Physiological factors affecting salivary flow rate, oral sugar clearance, and the 
sensation of dry mouth in man. Journal of dental research, 66(2_suppl), 648-653. 
 

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Furuta, M., & Yamashita, Y. (2013). Oral health and swallowing problems. Current physical 
medicine and rehabilitation reports, 1(4), 216-222. 
 
Sheftel, V. O. (2000). Indirect food additives and polymers: migration and toxicology. CRC 
Press. 
 
Shahdad, S. A., Taylor, C., Barclay, S. C., Steen, I. N., & Preshaw, P. M. (2005). A double‐
blind, crossover study of Biotene Oralbalance and BioXtra systems as salivary substitutes in 
patients with post‐radiotherapy xerostomia. European journal of cancer care, 14(4), 319-326. 
 
KRIS P. ANTONSEN and ALLAN S. HOFFMAN (1992) Water Structure of PEG Solutions by 
Differential Scanning Calorimetry Measurements. Poly(Ethylene Glycol) Chemistry/ 
Biotechnical and Biomedical Applications, Chapter 2. 15-28 
 
S Osailan et al “Investigating the relationship between hyposalivation and mucosal 
wetness“ (2011) Oral Diseases volume 17, Issue 1, Pages: 109–114 

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APPENDIX A: VAS Questionnaires 
Visual Analogue Scale  
The Visual Analogue Scale questionnaire will be provided to the patient and the patient will be instructed 
to rate the dryness of their mouth and tongue by placing a single mark on the line. 
 
1. Rate the dryness of your mouth 
 
      0        1        2        3        4        5        6        7        8        9       10 
Not dry at all  
 
 
 
     
 
 Very dry 
 
2. Rate the dryness of your tongue 
 
      0        1        2        3        4        5        6        7        8        9       10 
Not dry at all  
 
 
 
     
 
 Very dry 
 
 
 

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APPENDIX B: Dry Mouth Relief Questionnaire 
Dry Mouth Relief Questionnaire 
 
The Dry Mouth Relief Questionnaire is given to the patient and they must answer the following  q
uestion: 
 
Does the product relieve the discomfort of dry mouth? 
 
Please check only one response: 
 
 
 None / (No relief) (1) 
 Not enough (2)  
 Some/Good (3) 
 Very Good (4)  
 Significant / Excellent (5)  
 
 

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APPENDIX C: Dry Mouth Inventory Questionnaire 
Dry Mouth Inventory (DMI) 
 
The Dry Mouth Inventory questionnaire is given to the patient and they must answer the             
following  question: 
  
Please check only one response to each of the following questions: 
 
1. My mouth feels dry 
 Disagree (0) 
 Agree a little (1) 
 Agree (2)  
 Strongly agree (3) 
2. I have difficulty in eating dry foods 
 Disagree (0) 
 Agree a little (1) 
 Agree (2)  
 Strongly agree (3) 
3. I get up at night to drink 
 Disagree (0) 
 Agree a little (1) 
 Agree (2)  
 Strongly agree (3) 
4. My mouth feels dry when eating a meal 
 Disagree (0) 
 Agree a little (1) 
 Agree (2)  
 Strongly agree (3) 
5. I sip liquids to aid in swallowing food 
 Disagree (0) 
 Agree a little (1) 
 Agree (2)  
 Strongly agree (3) 
6. I suck sweets or cough lollies to relieve dry mouth 
 Disagree (0) 
 Agree a little (1) 
 Agree (2)  
 Strongly agree (3) 

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7. My lips stick to the teeth 
 Disagree (0) 
 Agree a little (1) 
 Agree (2)  
 Strongly agree (3) 
8. My tongue sticks to the roof of mouth 
 Disagree (0) 
 Agree a little (1) 
 Agree (2)  
 Strongly agree (3) 
 
 
 
 
 

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APPENDIX D: PPAQ & PPUQ Questionnaire 
The PPAQ (Product Performance and Attributes Questionnaire) and PPUQ (Post-Product Use 
Questionnaire) are included below : 
 
PPAQ1: The PPAQ1 Questionnaire is given to the patient 5 (+ 5) minutes after the product is 
administered. The patient must answer questions 1-3 below while in clinic. 
 
No. 
Question item 
Answer 
1 
Relieving the discomfort of dry mouth 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
2 
Effectively moistens your mouth 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
3 
Effectively lubricates your mouth 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
 
PPAQ2: The PPAQ2 Questionnaire is given to the patient 30 (± 10) minutes after the product is 
administered. The patient must answer questions 1-11 below while in clinic. 
 
No. 
Question item 
Answer 
1 
Relieving the discomfort of dry mouth 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
2 
Effectively moistens your mouth 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
3 
Effectively lubricates your mouth 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
4 
Feeling comfortable in the mouth 
 Poor (1) 
 Fair (2) 
 Good (3) 

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 Very Good (4)  
 Excellent (5) 
5 
Soothing your mouth 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
6 
Allowing you to speak without difficulty 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
7 
Helping to freshen your breath 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
8 
Protecting your mouth from drying out 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
9 
Providing whole mouth comfort 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
10 
Helping you to swallow without difficult 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
11 
Helping mouth feel ‘normal’ 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
 
PPAQ3: The PPAQ3 Questionnaire is given to the patient at three (3) different timepoints (60,120 and 
240 minutes).  
The first one is given 60 (± 10) minutes after the product is administered and must be completed in clinic.  
The second one is given to the patient 120 (± 10) minutes after the product is administered and must be 
completed in clinic. The third one is given to the patient 240 (± 10) minutes after the product is 
administered and must be completed in clinic or at home. For PPAQ3, the patient must answer questions 
12-14 below at each timepoint.  
 
No. 
Question item 
Answer 
12 
Having a long-lasting dry mouth relief 
 Poor (1) 

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 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
13 
Having a long-lasting lubricating effect 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
14 
Having a long-lasting moisturizing effect 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
 
 
PPAQ4: The PPAQ4 Questionnaire is only given to the patient at Visits 3, 4, 6 and 7. UThe patient mustU 
Uanswer questions 15-23 prior to using any study product because it is a pre-use measurement U. This 
questionnaire must be completed while the patient is in clinic. 
 
No. 
Question item 
Answer 
15 
Providing relief all night 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
16 
Reducing the number of times you wake up from 
dry mouth 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
17 
Feeling less parched when you wake up 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
18 
Having a long-lasting dry mouth relief 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
19 
Having a long-lasting lubricating effect 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
20 
Having a long-lasting moisturizing effect 
 Poor (1) 
 Fair (2) 

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 Good (3) 
 Very Good (4)  
 Excellent (5) 
21 
Having an overall dry mouth relief 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
22 
Having an overall lubrication effect 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
23 
Having an overall moisturizing effect 
 Poor (1) 
 Fair (2) 
 Good (3) 
 Very Good (4)  
 Excellent (5) 
 
 
PPUQ: The PPUQ Questionnaire is given to the patient only at Visits 4 and 7, 240 (± 10) minutes after 
the product is administered. UThe patient must answer question 24 below while in clinic. 
 
No. 
Question item 
Answer 
24 
Would you continue use of the product?  
 Yes 
 No 
 
 

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APPENDIX E: The Challacombe Scale 
The Challacombe Scale will be provided in a separate document. The Principal Investigator or designee 
will complete the Challacombe Scale. Per (S Osailan et al, 2011), the Challacombe Scale was developed 
from research conducted at King’s College London Dental Institute under the supervision of Professor 
Stephen Challacombe. The purpose of this scale is to be able to visually identify and quantify whether 
your patient has xerostomia (dry mouth) and if so, how it changes over time and the most appropriate 
therapy options. This scale is applicable whatever your profession. The Challacombe Scale works as an 
additive score of 1 to 10 : 1 being the least and 10 being the most severe. Each feature scores 1 and 
symptoms will not necessarily progress in the order shown, but summated scores indicate likely patient 
needs. Score changes over time can be used to monitor symptom progression or regression. 
 
The Challacombe Scale Score may include the following assessments: 
 
1. Mirror sticks to buccal mucosa 
2. Mirrors sticks to tongue 
3. Saliva frothy 
An additive score of 1 - 3 indicates mild 
dryness. May not need treatment or 
management. Sugar-free chewing gum 
for 15 mins, twice daily and attention 
to hydration is needed. Many drugs will 
cause mild dryness. Routine checkup 
monitoring required. 
4. No saliva pooling in floor of mouth 
5. Tongue shows generalized shortened 
papillae (mild depapillation) 
6. Altered gingival architecture (i.e. smooth) 
An additive score of 4 - 6 indicates 
moderate dryness. Sugar-free chewing 
gum or simple sialogogues may be 
required. Needs to be investigated further 
if reasons for dryness are not clear. 
Saliva substitutes and topical fluoride 
may be helpful. Monitor at regular intervals 
especially for early decay and symptom 
change. 
7. Glassy appearance of oral mucosa, 
especially palate 
8. Tongue lobulated/fissured 
9. Cervical caries (more than two teeth) 
10. Debris on palate or sticking to teeth 
An additive score of 7 - 10 indicates 
severe dryness. Saliva substitutes and 
topical fluoride usually needed. Cause 
of hyposalivation needs to be ascertained 
and Sjögrens Syndrome excluded. 
Refer for investigation and diagnosis. 
Patients then need to be monitored 
for changing symptoms and signs, 
with possible further specialist input if 
worsening.