Clinical trial NCT05816070
Conditions: Acute Bacterial Conjunctivitis
Sponsor: IVIEW Therapeutics Inc.
Start date: 2023-01-05; Completion date: 2024-10-12
Enrollment: 129 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase 2, Multi-center, Randomized, Parallel Controlled Study to Evaluate the Clinical Efficacy and Safety of IVIEW-1201 (1.0% Povidone-Iodine) Gel Forming Ophthalmic Solution Compared to Ofloxacin Eye Drops in the Treatment of Acute Bacterial Conjunctivitis

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: IVIEW-1201 intervention 2: Ofloxacin Eye Drops
Intervention descriptions: intervention 1: Four times per day for day 1-2 and three times per day for day 3-7 intervention 2: Four times per day for day 1-2 and three times per day for day 3-7

Protocol documents:
Prot_SAP_000.pdf: 
IVIEW-1201-BAC-II 
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1
Drug Name 
IVIEW-1201 
(1.0% Povidone Iodine Ophthalmic Gel Forming Sterile Solution) 
 Protocol 
IVIEW-1201-BAC-II 
Version 
2.0 
Date 
Oct 10th 2022 
A Phase II, Multi-Center, Randomized, Parallel-Controlled Study to 
Evaluate the Clinical Efficacy and Safety of IVIEW-1201 (1.0%PVP-I) 
Gel Forming Ophthalmic Sterile Solution Compared to Ofloxacin Eye 
Drops in the Treatment of Acute Bacterial Conjunctivitis 
Clinical Study Protocol：IVIEW-1201-BAC-II 
Title 
A Phase II, Multi-Center, Randomized, Parallel-Controlled Study to Evaluate 
the Clinical Efficacy and Safety of IVIEW-1201 (1.0%PVP-I) Gel Forming 
Ophthalmic Sterile Solution Compared to Ofloxacin Eye Drops in the Treatment 
of Acute Bacterial Conjunctivitis. 
Investigational Product 
IVIEW-1201(1.0% Povidone Iodine Ophthalmic Gel Forming Sterile Solution) 
Sponsor 
IVIEW Therapeutics, Inc. 
Address 
5 Cedar Brook Drive, Cranbury, New Jersey 08512 
Domestic Clinical Trial 
Execution Agency 
IVIEW Pharmaceutical (Zhuhai) CO., LTD 
Address 
Phase 
II 
Project Leader 
 
Contact 
Confidentiality Statement 
The information contained in this document contains trade secrets and commercial information that are privileged or 
confidential and may not be disclosed unless such disclosure is required by federal or state law or regulations. In the event of 
any disclosure, persons to whom the information is disclosed must be informed that the information is privileged or 
confidential and may not be further disclosed by them. These restrictions on disclosure will apply equally to all future 
information supplied.
NCT05816070


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SIGNATURE PAGE 
Sponsor 
We will be responsible for initiating, applying for, organizing, funding and auditing this clinical trial in 
accordance with the "Good Clinical Practice for Drugs" and other regulations. And conscientiously 
perform the responsibilities of the applicant unit in accordance with the "Drug Registration Management 
Measures" and other relevant regulations, and provide relevant information, research drugs, trial funds, 
etc. in accordance with the clinical trial agreement. 
Sponsor     IVIEW Therapeutics, Inc. ；IVIEW Pharmaceutical (Zhuhai) CO., LTD 
Project Leader (Signature)：                    Date： YYMMDD


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SIGNATURE PAGE 
Investigator 
I have read this protocol and I agree to conduct this clinical trial in accordance with the design and 
provisions of this protocol. I will conscientiously perform my duties as a researcher in accordance with 
the "Good Clinical Practice for Drugs" and other regulations. I will ensure the accuracy, authenticity, 
completeness and reliability of the trial data, and accept the audit and inspection by monitors and auditors 
assigned by the contract research organization/sponsor and the drug supervision and administration 
department. 
I agree to keep confidential all information related to this clinical study (including this clinical study plan) 
provided by the sponsor IVIEW Therapeutics, Inc. and IVIEW Pharmaceuticals (Zhuhai) Co., Ltd. I 
declare that there is no financial interest relationship between myself, my family, this research unit and the 
sponsor. 
Site  Eye Hospital Affiliated to Shandong First Medical University (Shandong Eye Hospital) 
Principle Investigator (Signature)：                                                           Date： YYMMDD 


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SIGNATURE PAGE 
Central Laboratory 
I have read this study plan and agree to its contents. I will conduct the study in strict accordance with the 
study plan and the Good Clinical Practice for Drugs and other regulations, and conscientiously perform 
my biological sample testing duties.I agree to keep confidential all information received or obtained 
during the trial related to this project. 
Central Laboratory  Suzhou Xishan Biotechnology Co., Ltd. 
Person in Charge(Signature)：                    Date： YYMMDD 


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SIGNATURE PAGE 
Contract Research Organization (CRO) 
I have read this protocol. I will appoint a qualified monitor in accordance with the Good Clinical Practice 
for Drugs and other regulations, and require the monitor to perform the corresponding duties, including 
ensuring that the rights and interests of the subjects in the clinical trial are protected, and that the data in 
the research records and reports are true, accurate, complete and correct. Ensure that the study complies 
with the approved protocol and relevant regulations. I agree to keep confidential all information related to 
this protocol received or obtained during the trial. 
CRO  Proswell Medical  
Person in Charge(Signature)：          
 Date： YYMMDD 


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Table of Contents 
SYNOPSIS ......................................................................................................................................................... 8 
ABBREVIATIONS ........................................................................................................................................... 15 
1.    Introduction ................................................................................................................................................ 16 
1.1 Background .......................................................................................................................................... 16 
1.2 IVIEW-1201(1.0% Povidone Iodine Ophthalmic Gel Forming Sterile Solution) .......................................... 16 
1.3 IVIEW-1201 (1.0% Povidone Iodine Ophthalmic Gel Forming Sterile Solution) Phase II Clinical Trial for the 
Treatment of Acute Bacterial Conjunctivitis .................................................................................................. 18 
2 ．Objectives and Endpoints ............................................................................................................................. 19 
2.1  Objectives ........................................................................................................................................... 19 
2.2 Endpoints ............................................................................................................................................. 19 
3. Trial Design .................................................................................................................................................. 19 
3.1 Overall Design ..................................................................................................................................... 19 
3.2  Choice of Comparator Drug .................................................................................................................. 20 
3.3  Treatment of Newly Infected Eyes ......................................................................................................... 20 
3.4  Number of Subjects .............................................................................................................................. 20 
3.5  Blinding .............................................................................................................................................. 21 
4. Selection of Subject ....................................................................................................................................... 21 
4.1 Inclusion Criteria .................................................................................................................................. 21 
4.2 Exclusion Criteria ................................................................................................................................. 21 
4.3 Number of Cases and Allocation of Cases ............................................................................................... 22 
5. Drug Information .......................................................................................................................................... 22 
5.1 Investigational Drug Information ............................................................................................................ 22 
5.2 Control Drug Information ...................................................................................................................... 22 
5.3 Package ............................................................................................................................................... 23 
5.4 Study Drug Administration .................................................................................................................... 23 
5.5 Prohibited Drugs or Treatments: ............................................................................................................. 23 
6. Process and Indicators .................................................................................................................................... 23 
6.1 Study Procedures/Visit 1 (screening/baseline Day 1) ................................................................................ 23 
6.2  Study Procedures Visit 2 (D3) and Visit 3 (Day 6) (treatment period) ........................................................ 24 
6.3 Visit 4 (D8 ± 1 day) End of Treatment .................................................................................................... 24 
6.4 End of Study period: Visit 5 (D14 ± 1) End of Study ................................................................................ 25 
6.5 Indicators ............................................................................................................................................. 25 
7. Assessment of Efficacy .................................................................................................................................. 27 
7.1 Clinical Efficacy Assessment ................................................................................................................. 27 
7.2 Biological Sample Test Indicators .......................................................................................................... 27 
8. Compliance ................................................................................................................................................... 28 
9. Assessment of Safety ..................................................................................................................................... 29 
9.1 Adverse Events (AE) ............................................................................................................................. 29 
9.2 Serious Adverse Events (SAE) ............................................................................................................... 29 
9.3 Suspected Unexpected Serious Adverse Reaction ..................................................................................... 30 
9.5 Severity of Adverse Events .................................................................................................................... 31 
9.6 Recording of Adverse Event .................................................................................................................. 31 
9.7 Name of Adverse Event ......................................................................................................................... 31 
9.8 Start and End Time of the Adverse Event ................................................................................................ 31 
9.9 Outcome of adverse events .................................................................................................................... 32 
9.10 Reporting Process of Serious Adverse Events ........................................................................................ 32 
9.11 Pregnancy .......................................................................................................................................... 32 
10. Data Management and Statistical Analysis ...................................................................................................... 33 
10.1 Randomization .................................................................................................................................... 33 
10.2 Data Management ............................................................................................................................... 33 
10.3 Statistical Analysis .............................................................................................................................. 35 
11. Trial Management ........................................................................................................................................ 36 
11.1 Subject Withdrawal Criteria ................................................................................................................. 36 
11.2 Trial Termination ................................................................................................................................ 36 


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11.3 Ethics ................................................................................................................................................ 37 
11.4 Quality Control and Quality Assurance of Trials .................................................................................... 37 
11.5 Study Drug Handling ........................................................................................................................... 37 
11.6 Data Retention .................................................................................................................................... 37 
11.7 Duties ................................................................................................................................................ 38 
11.8 Protocol Amendment ........................................................................................................................... 38 
12. Publication .................................................................................................................................................. 38 
13. Reference .................................................................................................................................................... 38 
14. Appendix .................................................................................................................................................... 40 
Appendix 1: Symptom Scoring Criteria ........................................................................................................ 40 
Appendix 2: Evaluation criteria of comprehensive efficacy ............................................................................. 40 


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SYNOPSIS 
Title 
A Phase II, Multi-Center, Randomized, Parallel-Controlled Study to Evaluate the Clinical 
Efficacy and Safety of IVIEW-1201 (1.0%PVP-I) Gel Forming Ophthalmic Sterile Solution 
Compared to Ofloxacin Eye Drops in the Treatment of Acute Bacterial Conjunctivitis. 
Sponsor 
IVIEW Therapeutics, Inc. 
Domestic Clinical Trial 
Execution Agency 
IVIEW Pharmaceutical (Zhuhai) CO., LTD 
Purpose 
To explore the efficacy and safety of IVIEW-1201 (1.0% Povidone Iodine Ophthalmic Gel 
Forming Sterile Solution) in the treatment of acute bacterial conjunctivitis to provide a basis for 
the Phase III clinical trial. 
Study Design 
Mult-center, randomized, parallel-group, positive-controlled. 
Criteria 
Inclusion Criteria: 
Potential study subjects must meet all of the following inclusion criteria to be enrolled in this 
study. 
1.Volunteered to participate in the study and signed the Informed Consent Form after receiving
a verbal and written explanation of this clinical trial.  In cases where the subject is unable to
sign the Informed Consent Form, his/her guardian may sign in accordance with relevant
regulations.
2.Aged above 15 (inclusive), male or female.
3.A diagnosis of acute bacterial conjunctivitis based on clinical observations: a) a score of ≥1
for bulbar conjunctival congestion and ≥1 for conjunctival secretion/exudation in at least one
eye (same eye); and b) increased purulent, mucopurulent or mucopurulent secretions are
observed in the conjunctival sac of the affected eye in all patients.
Willing to cooperate in the completion of all procedures and visits required for the trial.
Exclusion Criteria: 
Subjects are excluded from the study if any of the following exclusion criteria are met. 
1. Patients with systemic or ocular diseases, or functional disorders with comorbidities, or
structural abnormalities that, in the judgment of the investigator, could adversely affect the
course or results of the trial (e.g. hyperthyroidism, hepatitis, acute and chronic renal
insufficiency).
2. Those who have a history of allergy or serious adverse reactions to any component of
IVIEW-1201 (1.0% povidone-iodine ophthalmic gel sterile solution) and Ofloxacin Eye Drops; 
have a history of allergy or serious adverse reactions to quinolones; or have a cumulative total
of three or more allergies to other drugs, food and environment; or who are prone to allergic
symptoms such as rash and urticaria;
3. Symptoms or signs of bacterial conjunctivitis for more than 72 hours prior to screening;


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4. Suspected fungal, viral or acanthamoeba infections based on clinical observations;
5. Those with severe keratitis or corneal opacity affecting the study results;
6. Active inflammation of the cornea, iris, or anterior chamber;
7. Corrected visual acuity of less than 0.2 in either eye;
8. History of eye surgery within 3 months prior to screening;
9. Those who have a history of acute or chronic dacryocystitis;
10. Those who need to wear corneal contact lenses during the trial;
11. Those who have used antibiotic eye drops or glucocorticoid eye drops within 14 days, and
oral or intravenous antibiotics within 72 hours prior to screening;
12. Systemic use of steroidal drugs within 14 days prior to screening. Local use of eye steroidal 
drugs or nonsteroidalanti-inflammatory drugs (NSAIDs) within 7 days before enrollment
(nasally or bronchially inhaled steroidal drugs are not allowed during the study);
13. Those with co-infections requiring treatment with other anti-infective drugs in the study;
14. Those who are using other drugs that may interfere with the efficacy or safety evaluation of
the drug;
15. Participation in other interventional clinical trials within 30 days prior to the study;
16. Pregnant or lactating women, women with positive pregnancy tests and those planning to
become pregnant (including male subjects); subjects who do not take effective contraceptive
measures within 1 month before enrollment, or subjects (including male subjects) who are
unwilling to take effective contraceptive measures within the next 6 months.
17. Other conditions or illnesses judged by the clinical investigator to be unsuitable for
enrollment.
Sample Size 
120 cases, 60 cases in the treatment group and 60 cases in the control group. 
Investigational Drug 
IVIEW-1201 (1.0% Povidone Iodine Ophthalmic Gel Forming Sterile Solution): usually a 
reddish brown thick liquid or gel, which becomes a brown uniform transparent solution after 
shaking. Specification: 5g: 5mg (based on I2), Bio-Concept Laboratorie (USA) 
Comparator Drug 
Ofloxacin Eye Drops (Tarivid®) Slightly yellowish green clear solution, specification: 
5ml:15mg, Santen Pharmaceutical (China) Co., Ltd. 
Administration Method 
IVIEW-1201 
Shake well before use, 1 drop/eye/time in the affected eye. The drug shall be administered once 
at the study site on Day 1, and then at least once every 3 hours until bedtime, up to a maximum 
of 4 doses; The drug shall be administered 4 doses on Day 2, with an interval of at least 3 
hours; The drug shall be administered 3 doses a day from Day 3 to Day 7, with an interval of at 
least 3 hours, with duration of administration of 7 days. 
Ofloxacin Eye Drops (Tarivid®) 
Shake well before use, 1 drop/eye/time in the affected eye. The drug shall be administered once 
at the study site on Day 1, and then at least once every 3 hours until bedtime, up to a maximum 
of 4 doses; The drug shall be administered 4 doses on Day 2, with an interval of at least 3 


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hours; The drug shall be administered 3 doses a day from Day 3 to Day 7, with an interval of at 
least 3 hours, with duration of administration of 7 days. 
Administration Route 
Sit or lie on back, tilt head back slightly, look up, place the test drug bottle mouth close to the 
eyelid of the affected eye, drop 1 drop, then gently close eyes and press the inner canthus of the 
eye with fingers for 1 to 2 minutes, then rest for about 5 minutes. If the test drug is not 
completely dropped into the eye during administration, add one drop. Among them, the test 
group needs to gently shake the drug solution before instilling it before use. 
Treatment of Newly 
Infected eyes 
If a subject suffers from monocular disease at Visit 1 and the other healthy eye becomes 
infected and develops bacterial conjunctivitis after Visit 1 during the study, the newly infected 
eye shall be treated with the investigational drug of the subject's group, following the 
prescribed administration regimen for the group, i.e. "the drug shall be administered once in the 
study site on Day 1, and then at least once every 3 hours until bedtime, up to a maximum of 4 
doses; the drug shall be administered 4 doses on Day 2, with an interval of at least 3 hours; the 
drug shall be administered 3 doses a day from Day 3 to Day 7, with an interval of at least 3 
hours, with duration of administration of 7 days", until Visit 5. At Visit 5, if the investigator 
determines that the newly infected eye still requires continued treatment based on the subject's 
signs and symptoms, the investigator will determine the specific treatment regimen after the 
subject is removed from the study, but the use of IVIEW-1201 (1.0% povidone-iodine 
ophthalmic gel sterile solution) should be discontinued. Newly infected eyes are not included in 
the group test, but normal secretions are taken for bacterial culture. 
Visits 
This study will be divided into 5 visit phases, namely Visit 1 (screening/baseline period, Day 
1), Visit 2 (Day 3), Visit 3 (Day 6), Visit 4/End of Treament(EOT) (Day 8 ±1 day) and Visit 
5/End of Study(EOS) (Day 14±1 day). 
Efficacy Evaluation 
Primary outcomes 
Clinical cure rate: The proportion of subjects with a score of 0 (on a 3-point scale) for bulbar 
conjunctival congestion and 0 (on a 3-point scale) for conjunctival secretion/exudation at Visit 
4 (Day 8±1 day) and Visit 5 (Day 14±1 day). 
Secondary outcomes 
Clearance rate: The clearance rate of each major pathogenic bacteria at Visit 2, 3, 4 and 5: 
Stratified analysis shall be conducted according to the type of pathogenic bacteria and the visit 
time point, and the clearance rate of each kind of bacteria by the investigational drug at 
different times shall be calculated. Bacterial clearance is defined as positive bacterial culture at 
baseline and negative bacterial culture at the last visit. Bacterial clearance rate = (number of 
subjects cleared + number of subjects assumed to be cleared) / total number of subjects 
enrolled × 100%. 
Exploratory outcomes 
Mean clinical improvement rate at Visit 2, 3, 4 and 5: 
Clinical improvement rate = (pre-treatment score - post-treatment score) / pre-treatment score x 


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100%. The score of symptoms and signs is the sum of the scores for pain, foreign body 
sensation, photophobia, tearing, conjunctival congestion, conjunctival secretion/exudation and 
conjunctival edema. 
Total effective rate (%) at Visit 2, 3, 4 and 5:  
Total effective rate (%) = (number of subjects cured+ number of subjects markedly effective) / 
total number of subjects available for evaluation of efficacy × 100%. Comprehensive efficacy 
evaluation: defined as cured, markedly effective, effective and ineffective; Calculate the total 
effective rate; See Appendix 2 for judgment criteria. 
Safety Evaluation 
Including adverse events/serious adverse events, clinically significant changes in ocular and 
systemic symptoms and signs before and after treatment. 
Statistical analysis method 
Selection of statistical analysis data set 
Full Analysis Set (FAS): All subjects randomized and for whom the data of at least one post-
dose efficacy indicator is collected. Only the following randomized subjects are excluded: 
Subjects who violates key eligibility criteria, who are not treated with the investigational drug, 
and who have no observed data after randomization.  
Per Protocol Set (PPS): A subset of the FAS, excluding subjects with significant protocol 
violations that may affect the primary efficacy evaluation based on the FAS.  
Safety Set (SS): All subjects who have used the study drug at least once. 
The efficacy analysis is mainly based on the FAS, but also on the PPS; the SS is used for safety 
analysis. 
Statistical analysis method 
This study will use SAS software version 9.4 or above for statistical analysis. 
The statistical description of quantitative indicators will calculate the number of subjects, 
mean, standard deviation, median, minimum and maximum (25% quantile Q1, 75% quantile 
Q3 where necessary), the statistical description of categorical indicators will calculate the 
number of subjects and percentage. 
The T-test or non-parametric comparison is used for inter-group comparison of quantitative 
indicators, and the chi-square test or Fisher's exact probability method is used for inter-group 
comparison of categorical indicators. 
Statistical analysis and methods 
Efficacy analysis 
Statistical analysis of the primary efficacy indicators and secondary indicators for comparison 
between groups is performed based on the FAS and PPS respectively. 
Primary efficacy indicators: The clinical cure rate of each group is counted and compared using 
the χ2 test or Fisher's exact probability method. 
Secondary efficacy indicators: fungal clearance and change in best-corrected visual acuity will 
be calculated based on the target eye. In addition, pain improvement and clinical effective rate 
will be described and compared between groups. 


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Safety analysis 
Adverse event: Treatment-Emergent Adverse Event (TEAEs) should be focused on, i.e. 
treatment-emergent adverse events. The χ2 test or Fisher's exact probability method is used to 
compare the incidence of adverse events in each group and the incidence of adverse events 
related to the study drug. All adverse events will be coded using the Medical Dictionary for 
Regulatory Activities (MedDRA) and the number of cases, incidence and frequency of each 
type of adverse event occurring during the trial will be summarized by SOC/PT. The adverse 
events occurring in this trial will be tabulated and described. 


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Overview of study flow chart of IVIEW 1201 
1.Demographic information: date of birth, gender, ethnicity, height, weight.
2.Medical history collection: including past medical history, surgical history, current medical history (time of onset, cause, etc.),
comorbidities, medication history, etc. Any clinically significant examination results other than the research disease found during
the screening period should be recorded as medical history.
3.Symptom scoring: Four symptoms (pain, foreign body sensation, photophobia, and tearing) were scored using a 3-point scale
(0 = none, 1 = mild, 2 = moderate, 3 = severe). Under the guidance of the researchers, the subjects scored according to the actual
situation on the day before the visit and checked in the record form.
Visit schedule 
Visit 1 
Visit 2 
Visit 3 
Visit 4/ 
EOT 
Visit 5/ EOS 
Test stage 
Screening/Baseline/Day 1 
Day 3 
Day 6 
Day 8 
Day 14/ 
Early 
withdrawal 
Visit window period 
(± 1 days) 
(± 1 days) 
Signing of Informed Consent 
Form 
X 
Inclusion and exclusion 
criteria 
X 
Randomization 
X 
Demographic data1 
X 
History taking2 
X 
Subjective Symptoms Score3 
X 
X 
X 
X 
X 
Objective Clinical Score4 
X 
X 
X 
X 
X 
Collection of conjunctival 
sac secretion5 
X 
X 
X 
X 
X 
Vital signs6 
X 
X 
X 
X 
X 
Pregnancy Test7 
X 
X 
Corneal endothelial cell 
count 
X 
X 
Best-corrected visual acuity 
X 
X 
X 
X 
X 
Corneal fluorescein staining 
X 
X 
X 
X 
X 
Slit-lamp examination 
X 
X 
X 
X 
X 
Intraocular pressure 
measurement 
X 
X 
X 
X 
X 
Fundus examination 
X 
X 
12-lead ECG examination
X 
Drug allocation9 
X 
Study drug administration10 
X 
X 
X 
Drug compliance assessment 
X 
X 
X 
Recoding of concomitant 
medications 
X 
X 
X 
X 
X 
Adverse events11 
X 
X 
X 
X 
X 
Check of diary card 
X 
X 
X 
Return of drugs 
X 
X 


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4.Sign scoring: The three signs (conjunctival congestion, conjunctival secretion/exudation, and conjunctival edema) were scored
using a 3-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe); the researchers examined and recorded them.
5. Collection of conjunctival sac secretions: Preparation before sampling: Collect bacterial culture tubes and sterile swabs
provided by the central laboratory. When sampling, fully expose the bulbar conjunctiva and fornix conjunctiva, and use a sterile
swab moistened with sterile 0.9% sodium chloride solution to gently swab the surface of the conjunctival sac 4 times from the
inner canthus from the inside to the outside (pay attention not to miss the inner canthus, and collect the dense secretions), avoid
contact with eyelashes and eyelid margins, and use eyelid openers and other instruments when necessary. After sampling, place
the specimen in a sterile transport tube, mark it, and send it to the hospital laboratory for bacterial culture. All subjects need to
take secretions from both eyes for bacterial culture, and indicate the subject number and eye type.
6.Vital signs: including body temperature, heart rate, blood pressure, etc.
7.Pregnancy test: For women of childbearing age, blood/urine pregnancy test can be accepted (blood pregnancy test is the main
method, if it is not met, urine pregnancy test can be selected).
8.The investigators will determine whether mydriasis is required for fundus examination. If mydriasis is required, mydriasis
should be applied after secretions are collected for relevant examinations. Fundus examination or fundus photography can be
accepted.
9.Medication distribution: According to the medication plan, the drugs will be distributed to the subjects. These drugs will be
taken by the patients themselves or with the help of caregivers or the trial team for 7 days from D1 to D7.
10.After randomization of the subjects who meet the criteria at Visit 1, the staff of the Clinical Research Center will distribute
the study drugs, and then start to instruct the subjects on the topical eye drops as soon as possible and supervise the first
administration. After that, the subjects will self-administer the drugs according to the dosing regimen. On the day of Visit 2 and
Visit 3, the study drugs shall not be used within 1 hour before the visit.
11.Adverse events refer to all adverse medical events that occur to subjects after the first medication. However, in order to
protect the rights and interests of the subjects, the recording of adverse events in this study starts from the signing of the
informed consent form.
12. After completing Visit 4, IVIEW-1201 (1.0% povidone-iodine eye gel sterile solution) needs to be discontinued. If the
investigator determines that treatment is still needed based on the subject's symptoms and signs, the specific treatment plan will
be determined by the investigator, and the subject needs to continue in the group until Visit 5 (Day 14±1).


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ABBREVIATIONS 
AE 
Adverse Event 
TEAE 
Treatment-Emergent Adverse Event 
CTCAE 
Common Terminology Criteria for Adverse Events 
CRF 
Case Report Form 
D 
Day 
EC 
Ethics Committee 
EDC 
Electronic Data Capture System 
eCRF 
Electronic Case Report Form 
EOS 
End of Study 
EOT 
End of Treatment 
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
MedDRA 
Medical Dictionary for Regulatory Activities 
NSAID 
Nonsteroidal Anti-inflammatory Drugs 
PVP-I 
Povidone Iodine 
PPS 
Per Protocol Set 
Q1 
25% quantile 
Q3 
75% quantile 
SAE 
Serious Adverse Event 
SS 
Safety Set 
VAS 
Visual Analogue Scale 
BCVA 
Best-corrected visual acuity 
MRSA 
Methicillin-resistant Staphylococcus aureus 
IWRS 
Interactive Web Response System 
ETDRS 
Early Treatment Diabetic Retinopathy Study 


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1.
Introduction
1.1 Background 
Acute conjunctivitis (also known as "pink eye") is the most common and contagious ocular infection in 
the United States, Asia and Europe and is a major cause of ocular morbidity, epidemic eye infections, loss 
of productivity and discomfort in patients. The primary causes are bacterial (mainly gram-positive and 
gram-negative), fungal, and viral (mainly adenovirus) infections[1]. Acute bacterial conjunctivitis can 
occur in people of different ages, genders, regions, and social strata. 
The main clinical manifestations of acute bacterial conjunctivitis are eyelid swelling, conjunctival 
congestion and purulent secretions on the conjunctival surface. The secretions are mucous at first and then 
purulent. Acute bacterial conjunctivitis usually does not cause permanent vision loss and eye structure 
damage, and has obvious self-limiting properties. Even without treatment, it can be cured within 10 to 14 
days. 
At present, acute bacterial conjunctivitis is mainly treated with topical antibiotics and broad-spectrum 
antibiotics. However, due to irrational use of antibiotics in clinical practice, some pathogenic bacteria 
develop resistance to related antibiotics. Under such circumstances, treatment with antibiotics cannot 
achieve the desired therapeutic effect, and the best timing for treatment will be missed, thereby indirectly 
increasing the medical burden of patients. 
1.2 IVIEW-1201(1.0% Povidone Iodine Ophthalmic Gel Forming Sterile Solution) 
1.2.1  Introduction 
IVIEW-1201 is a brownish aqueous clear solution for ophthalmic administration, containing 1.0% (by 
weight) povidone-iodine for topical administration ，After shaking, it becomes a brown, uniform, 
transparent solution. The active ingredient is povidone-iodine, whose chemical name is a complex of 1-
vinyl-2-pyrrolidone homopolymer and iodine, and has in vitro antibacterial effects on a variety of 
bacteria, yeasts, fungi and human adenoviruses. 
Povidone-iodine gradually releases iodine in the solvent and can release 1.4 to 2.4 ppm of free iodine in 
water. The powerful bactericidal mechanism of free iodine is to oxidize the active groups of pathogen 
protoplasmic proteins and combine with the amino groups of proteins to denature them, thereby 
effectively killing bacteria and other pathogens. It has the characteristics of low irritation, light yellowing, 
easy cleaning and no allergic reaction. It can quickly kill hundreds of bacteria including Staphylococcus 
aureus, Escherichia coli, Pseudomonas aeruginosa, Neisseria gonorrhoeae, Candida albicans, etc.
Povidone-iodine is a commercially available iodine tincture that is routinely used in ophthalmic and general 
surgical procedures. A single drop of PVP-I (5% to 10%) is used as an eye disinfectant before ophthalmic 
surgery and is approved by the FDA for this indication. Povidone-iodine has been used for the acute and 
chronic treatment of a variety of human indications. Povidone-iodine solutions have been shown to be 
effective before eye surgery (5% PVP-I)[2,3] and before/after eye surgery (1.25% PVP-I, 2.5% PVP-I, 5% PVP-
I)[4,5]. It is also effective in treating neonatal ophthalmia (2.5% PVP-I)[6,7] and acute ocular infection (1.25% 
PVP-I)[8]. It has been clearly demonstrated in the literature that PVP-I is, in fact, tolerated and non-toxic 
at concentrations below 2% (w/w)[9-11]. According to the ophthalmic literature, the active antimicrobial 


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drug povidone-iodine [10-14] has been shown to be well tolerated in low concentrations in animals and has 
low toxicity. 
In a large clinical trial of 459 pediatric patients[8], povidone-iodine solution was safe and effective in the 
treatment of acute conjunctivitis when administered as a single dose as well as repeated doses. At the 
same time, it is routinely used to prevent and treat eye infections in adults[3-6] and infants[7,15]. In a 
placebo-controlled trial of 1.25% PVP-I in 459 children for the treatment of bacterial, viral, and 
chlamydial conjunctivitis, no toxicity was reported on slit-lamp examination, and no subjects dropped out 
due to eye drop intolerance[8]. As the PVP-I concentration decreased from 10% to 0.5%, the tolerance 
gradually increased and the antimicrobial efficacy also increased significantly, which is due to the 
balanced distribution of iodine in the aqueous solution [16]. Clinical trials of povidone-iodine (0.4% or 
0.6%/dexamethasone (0.1%) eye drops in the treatment of adenoviral conjunctivitis have shown that PVP-
I/dexamethasone eye drops are safe, well tolerated, and significantly promotes clinical regression and 
adenovirus clearance in patients with acute adenovirus conjunctivitis [17,18]. The inactive ingredients used 
in IVIEW-1201 (1.0% povidone-iodine ophthalmic gel sterile solution) include Gelrite® gellan gum, 
sodium chloride, mannitol, tromethamine, and water for injection, all of which are used in amounts below 
the maximum safe amount established by the FDA for use in ophthalmic preparations. 
Figure 1 Chemical Structure of Povidone Iodine 
1.2.2  Preclinical Study 
1.2.2.1  Antibacterial Activity 
The antimicrobial efficacy of IVIEW-1201 (PVP-I 0.6%) against P. aeruginosa, MRSA, and C. parapsilosis 
was tested at 15s, 30s, and 1min according to the protocol described in Journal of Clinical Microbiology, p635-
639 (1982). The results showed that IVIEW-1201 (PVP-I 0.6%) could kill all tested pathogens at these time 
points.
Molecular Formula: 
C6H9I2NO
Molecular Weight: 
364.951 
CAS No. 
25655-41-8


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1.2.2.2 Anti-viral Activity 
In a cytopathic effect study with human AE549 cells, IVIEW-1201 (PVP-I 0.6%) demonstrated complete 
inactivation of Human Adenovirus Type 5 after 30 ± 5 minutes liquid-liquid contact at 37 ± 2℃. 
To determine whether contact with IVIEW-1201 inactivates (“kills”) virus, IVIEW-1201 was mixed 
directly with virus for 30 ± 5 minutes, then neutralized and the surviving virus was quantified. 
Neutralization controls showed that virus was effectively detected in the titer assay. Toxicity controls 
showed that titer plates were valid and no toxicity was observed in the 1/10 dilution of the test compound. 
The 70% ethanol was fully effective, and untreated virus controls were as expected. The undiluted 
compound IVIEW1201 (PVP-I 0.6%) was an effective virucidal, and the 1/3.2 dilution (28% after virus 
added) had slight virucidal activity. IVIEW1201 (PVP-I 0.6%) exhibited complete inactivation of virus. 
1.2.2.3 Anti-fungal activity 
IVIEW-1201 (PVP-I, 0.6%) demonstrated antimicrobial efficacy on contact with ocular isolates of 
Candida parapsilosis.  
Following the protocol described in Journal of Clinical Microbiology, p635-639, 1982, the eradication of 
Pseudomona aeruginosa, MRSA and Candida Parapsilosis at 15s, 30s and 1min was measured. It showed 
the gel forming povidone iodine formulation IVIEW-1201 (PVP-I 0.6%) eradicated all tested pathogens 
at 15s, 30s and 1 minute. 
1.2.3  Clinical Study 
Phase II clinical study of  IVIEW-1201(1.0% Povidone Iodine Ophthalmic Gel Forming Sterile Solution) is 
currently underway for the treatment of acute adenoviral conjunctivitis. This indication was approved by 
the U.S. FDA on December 30th, 2018 to enter Phase II clinical trials directly, and then  trials were 
conducted in the United States, India and China (approved on November 1st, 2019) in an international 
multi-center format. 
Among them, the results of Indian clinical trial data showed that IVIEW-1201 (1.0% Povidone Iodine 
Ophthalmic Gel Forming Sterile Solution) has good safety for human use. 
1.3 IVIEW-1201 (1.0% Povidone Iodine Ophthalmic Gel Forming Sterile Solution) Phase II Clinical 
Trial for the Treatment of Acute Bacterial Conjunctivitis 
Comprehensive data from public literature and in vitro bacteriological evaluation tests show that 
IVIEW-1201 (1.0% Povidone Iodine Ophthalmic Gel Forming Sterile Solution) is a clinical drug with 
great potential for the treatment of acute bacterial conjunctivitis.Therefore, we plan to conduct a 
multicenter, randomized, parallel-group Phase II clinical trial to evaluate the efficacy and safety of 
IVIEW-1201 (1.0% Povidone Iodine Ophthalmic Gel Forming Sterile Solution) in the treatment of acute 
bacterial conjunctivitis, using ofloxacin eye drops as a positive control, to explore the efficacy and 
safety of IVIEW-1201 (1.0% Povidone Iodine Ophthalmic Gel Forming Sterile Solution) in the treatment 
of acute bacterial conjunctivitis and provide a basis for Phase III clinical trials. 


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2 ．Objectives and Endpoints 
2.1  Objectives 
The objectives of this study are to evaluate the efficacy and safety of IVIEW-1201 in the treatment of 
acute bacterial conjunctivitis. 
2.2 Endpoints 
2.2.1  Primary Endpoints 
Clinical cure rate: The proportion of subjects with a score of 0 (on a 3-point scale) for bulbar conjunctival 
congestion and 0 (on a 3-point scale) for conjunctival secretion/exudation at Visit 4/End of Treatment 
(EOT) (Day 8±1 day) and Visit 5/End of Study (EOS) (Day 14±1 day). 
2.2.2  Secondary Endpoints 
Clearance rate: The clearance rate of each major pathogenic bacteria at Visit 2, 3, 4 and 5: Stratified 
analysis shall be conducted according to the type of pathogenic bacteria and the visit time point, and the 
clearance rate of each kind of bacteria by the investigational drug at different times shall be calculated. 
Bacterial clearance is defined as positive bacterial culture at baseline and negative bacterial culture at the 
last visit. Bacterial clearance rate = (number of subjects cleared + number of subjects assumed to be 
cleared) / total number of subjects enrolled × 100%. 
2.2.3 Exploratory Endpoints 
Mean clinical improvement rate at Visit 2, 3, 4 and 5: 
Clinical improvement rate = (pre-treatment score - post-treatment score) / pre-treatment score x 100%. 
The score of symptoms and signs is the sum of the scores for pain, foreign body sensation, photophobia, 
tearing, conjunctival congestion, conjunctival secretion/exudation and conjunctival edema. 
Total effective rate (%) at Visit 2, 3, 4 and 5: 
Total effective rate (%) = (number of subjects cured+ number of subjects markedly effective) / total 
number of subjects available for evaluation of efficacy × 100%. Comprehensive efficacy evaluation: 
defined as cured, markedly effective, effective and ineffective; Calculate the total effective rate; See 
Appendix 2: Evaluation criteria of comprehensive efficacy for judgment criteria. 
3. Trial Design
3.1 Overall Design 
A multi-center, randomized, parallel, positive drug-controlled study design is used. In this study, the test 
drug IVIEW-1201(1.0% povidone-iodine ophthalmic gel sterile solution) is selected for the test group and 
the positive control drug Ofloxacin Eye Drops is selected for the control group. There are a total of 120 
subjects: 60 in the test group and 60 in the control group.  
The subject population in this study are those aged 15 and above (inclusive) with a confirmed diagnosis of 
acute bacterial conjunctivitis. Subjects should complete the random allocation and initial administration of 
the investigational drug on the day of diagnosis. 


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This study will be divided into 5 visit phases, namely Visit 1 (screening/baseline period, Day 1), Visit 2 
(Day 3), Visit 3 (Day 6), Visit 4/End of Treament(EOT) (Day 8 ±1 day) and Visit 5/End of Study(EOS) 
(Day 14±1 day). 
3.2  Choice of Comparator Drug 
Ofloxacin eye drops are quinolone eye drops that work by inhibiting bacterial DNA gyrase and DNA 
replication. Due to its unique mechanism of action, it has a broad antibacterial spectrum and strong 
antibacterial activity, and has a strong antibacterial effect on both Gram-negative and Gram-positive 
bacteria.It is effective against infections caused by sensitive species of Staphylococcus aureus, 
Streptococcus pyogenes, Streptococcus pyogenes, Enterococcus, Pneumococcus, Escherichia coli, 
Citrobacter, Klebsiella pneumoniae, Enterobacter, Serratia, Proteus, Pseudomonas aeruginosa, 
Haemophilus influenzae, Acinetobacter, Campylobacter, and Chlamydia.Ofloxacin has no cross-
resistance with other antibacterial drugs. It is currently widely used in the clinic to treat external eye 
infections such as bacterial conjunctivitis, keratitis, corneal ulcers, dacryocystitis, and postoperative 
infections. 
After comprehensive consideration, ofloxacin eye drops produced by Santen Pharmaceutical (China) Co., 
Ltd. are selected as the positive control drug. In order to maintain the consistency of the medication 
regimen of the experimental group and the control group, the instructions are referred to determine: 1 
drop/eye/time for the affected eye. The drug is administered once at the research center on the first day, 
and then administered once at least 3 hours apart until bedtime, with a maximum of 4 times; 4 times on the 
second day, with at least 3 hours between each administration; 3 times a day from the third day to the 
seventh day, with at least 3 hours between each administration, and the medication schedule is 7 days. 
3.3  Treatment of Newly Infected Eyes 
If a subject suffers from monocular disease at Visit 1 and the other healthy eye becomes infected and 
develops bacterial conjunctivitis after Visit 1 during the study, the newly infected eye shall be treated with 
the investigational drug of the subject's group, following the prescribed administration regimen for the 
group, i.e. "the drug shall be administered once in the study site on Day 1, and then at least once every 3 
hours until bedtime, up to a maximum of 4 doses; the drug shall be administered 4 doses on Day 2, with 
an interval of at least 3 hours; the drug shall be administered 3 doses a day from Day 3 to Day 7, with an 
interval of at least 3 hours, with duration of administration of 7 days", until Visit 5. At Visit 5, if the 
investigator determines that the newly infected eye still requires continued treatment based on the subject's 
signs and symptoms, the investigator will determine the specific treatment regimen after the subject is 
removed from the study, but the use of IVIEW-1201 (1.0% povidone-iodine ophthalmic gel sterile 
solution) should be discontinued. Newly infected eyes are not included in the group test, but normal 
secretions are taken for bacterial culture. 
3.4  Number of Subjects 
This study preliminarily observed the efficacy and safety of IVIEW-1201 (1.0% povidone-iodine 
ophthalmic gel sterile solution) in the treatment of acute bacterial conjunctivitis, and no statistical analysis 
on the sample size is performed. Based on the safety evaluation requirements, 60 cases were set in the 
experimental group and 60 cases in the control group. 


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3.5  Blinding 
In this study, there are significant differences between the investigational drug and the positive control 
drug in color, taste, properties and the patient's feeling when applying the medicine. The patient can 
easily distinguish them, which make it very easy to break the blind. Therefore, a single-blind or blind 
subject design cannot be used. The excipient components of ofloxacin placebo are unknown and too 
difficult to obtain for a double-blind double-simulation design. Since there are marketed drugs with clear 
efficacy for acute bacterial conjunctivitis, there are ethical issues in using a double-blind design with a 
placebo of 1.0% povidone-iodine eye gel sterile solution as a control. 
The study is a blinded (assessor) study design. This means that the investigators are authorized to be 
blinded and non-blinded. Blinded and non-blinded team members shall be relatively independent in their 
work, limiting non-essential communication and avoiding disclosure of blind information. 
Blindness shall be established when subjects are randomized. Blindness should be maintained until the 
blinded data review is completed, the database is locked and the primary statistical analysis is completed; 
The scope of the maintenance includes the above evaluators and blinded data analysts. The unblinding 
will be performed after the blinded data review is completed and the database is locked, and will be 
performed twice through the operation of the central randomization system. The first unblinding shall be 
performed after the database is locked, and the unblinding area is divided into groups X and Y and sent to 
the blinded data analysts for statistical analysis; The second unblinding shall be performed after the 
completion of the primary statistical analysis, and the specific test group or positive control drug group 
corresponding to groups X and Y shall be determined. 
4. Selection of Subject
4.1 Inclusion Criteria
Inclusion Criteria: 
Potential study subjects must meet all of the following inclusion criteria to be enrolled in this study. 
1. Volunteered to participate in the study and signed the Informed Consent Form after receiving a
verbal and written explanation of this clinical trial. In cases where the subject is unable to sign
the Informed Consent Form, his/her guardian may sign in accordance with relevant regulations.
2. Aged above 15 (inclusive), male or female.
3. A diagnosis of acute bacterial conjunctivitis based on clinical observations: a) a score of ≥1 for
bulbar conjunctival congestion and ≥1 for conjunctival secretion/exudation in at least one eye
(same eye); and b) increased purulent, mucopurulent or mucopurulent secretions are observed in
the conjunctival sac of the affected eye in all patients.
4. Willing to cooperate in the completion of all procedures and visits required for the trial.
4.2 Exclusion Criteria 
Subjects are excluded from the study if any of the following exclusion criteria are met. 
1. Patients with systemic or ocular diseases, or functional disorders with comorbidities, or structural
abnormalities that, in the judgment of the investigator, could adversely affect the course or
results of the trial (e.g. hyperthyroidism, hepatitis, acute and chronic renal insufficiency).
2. Those who have a history of allergy or serious adverse reactions to any component of IVIEW-
1201 (1.0% povidone-iodine ophthalmic gel sterile solution) and Ofloxacin Eye Drops; have a
history of allergy or serious adverse reactions to quinolones; or have a cumulative total of three


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or more allergies to other drugs, food and environment; or who are prone to allergic symptoms 
such as rash and urticaria; 
3. Symptoms or signs of bacterial conjunctivitis for more than 72 hours prior to screening.
4. Suspected fungal, viral or acanthamoeba infections based on clinical observations;
5. Those with severe keratitis or corneal opacity affecting the study results;
6. Active inflammation of the cornea, iris, or anterior chamber;
7. Corrected visual acuity of less than 0.2 in either eye;
8. History of eye surgery within 3 months prior to screening;
9. Those who have a history of acute or chronic dacryocystitis;
10. Those who need to wear corneal contact lenses during the trial;
11. Those who have used antibiotic eye drops or glucocorticoid eye drops within 14 days, and oral or
intravenous antibiotics within 72 hours prior to screening;
12. Systemic use of steroidal drugs within 14 days prior to screening. Local use of eye steroidal drugs
or nonsteroidalanti-inflammatory drugs (NSAIDs) within 7 days before enrollment (nasally or
bronchially inhaled steroidal drugs are not allowed during the study);
13. Those with co-infections requiring treatment with other anti-infective drugs in the study;
14. Those who are using other drugs that may interfere with the efficacy or safety evaluation of the
drug;
15. Participation in other interventional clinical trials within 30 days prior to the study;
16. Pregnant or lactating women, women with positive pregnancy tests and those planning to become
pregnant (including male subjects); subjects who do not take effective contraceptive measures
within 1 month before enrollment, or subjects (including male subjects) who are unwilling to
take effective contraceptive measures within the next 6 months.
17. Other conditions or illnesses judged by the clinical investigator to be unsuitable for enrollment.
4.3 Number of Cases and Allocation of Cases 
There were 120 cases in total, with 60 cases in each group and 60 cases in each positive control group 
(ofloxacin eye drops), and they were allocated to various centers. 
5. Drug Information
5.1 Investigational Drug Information
Drug Name 
IVIEW-1201 (1.0% povidone-iodine ophthalmic gel sterile solution) 
Specification 
5g : 5mg (I2 )/ bottle 
Dosage Form 
Eye Drops 
Characteristics 
It is usually a reddish brown thick liquid or gel, and after shaking it 
becomes a brown uniform transparent solution. 
Manufacturer 
Bio-Concept Laboratorie (USA) 
Storage 
Store in a refrigerator (2~8℃), away from light and moisture 
5.2 Control Drug Information 
Drug Name 
Ofloxacin eye drops (Tarivid®) 
Specification 
5ml:15mg /bottle 
Dosage Form 
Eye Drops 
Characteristics 
Slightly yellowish green clear solution 
Manufacturer 
Santen Pharmaceutical (China) Co., Ltd. 
Storage 
Store in sealed container at 1~30℃ 


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5.3 Package 
Prior to the start of the clinical trial, all investigational drugs will be dispensed and numbered according to 
a randomization table. Each drug is attached with a label on its outer package. The label content includes: 
protocol number, drug number, blinded name of investigational drug (for clinical study use only), 
indication, storage, lot number, expiry date. 
5.4 Study Drug Administration 
IVIEW-1201 
Shake well before use, 1 drop/eye/time in the affected eye. The drug shall be administered once at the 
study site on Day 1, and then at least once every 3 hours until bedtime, up to a maximum of 4 doses; The 
drug shall be administered 4 doses on Day 2, with an interval of at least 3 hours; The drug shall be 
administered 3 doses a day from Day 3 to Day 7, with an interval of at least 3 hours, with duration of 
administration of 7 days. 
Ofloxacin Eye Drops (Tarivid®) 
Shake well before use, 1 drop/eye/time in the affected eye. The drug shall be administered once at the 
study site on Day 1, and then at least once every 3 hours until bedtime, up to a maximum of 4 doses; The 
drug shall be administered 4 doses on Day 2, with an interval of at least 3 hours; The drug shall be 
administered 3 doses a day from Day 3 to Day 7, with an interval of at least 3 hours, with duration of 
administration of 7 days. 
Administration Route 
Sit or lie on back, tilt head back slightly, look up, place the test drug bottle mouth close to the eyelid of the 
affected eye, drop 1 drop, then gently close eyes and press the inner canthus of the eye with fingers for 1 
to 2 minutes, then rest for about 5 minutes. If the test drug is not completely dropped into the eye during 
administration, add one drop. Among them, the test group needs to gently shake the drug solution before 
instilling it before use. 
5.5 Prohibited Drugs or Treatments: 
The Following Drugs or Treatments are Prohibited During the Study: 

Any eye medication other than the investigational drug;

Nasally or bronchially inhaled steroidal drugs;

Systemic use of anti-infective drugs: various antibiotics, antiviral or antifungal drugs, etc., except
non-facial local treatment;

Eye hot or cold compress;

All types of eye surgery and treatment, including physiotherapy

Use of corneal contact lenses.
6. Process and Indicators
This study will be divided into 5 visit phases, namely Visit 1 (screening/baseline period, Day 1), Visit 2 
(Day 3), Visit 3 (Day 6), Visit 4/EOT (Day 8 ±1 day) and Visit 5/EOS (Day 14±1 day). 
6.1 Study Procedures/Visit 1 (screening/baseline Day 1) 
1)
Signing of Informed Consent Form.
2)
Demographic data: including date of birth, gender, ethnicity, height, weight.


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3)
Medical history collection, including past medical history, surgical history, current medical history,
co-morbidity, medication history. Any clinically significant results other than the study disease found
during the screening phase should be recorded as medical history.
4)
Vital signs (temperature, heart rate, blood pressure).
5)
Subjective Symptoms Score
6)
Objective Clinical Score
7)
Best-corrected visual acuity
8)
Corneal fluorescein staining
9)
Slit-lamp examination.
10) Intraocular pressure measurement.
11) Collection of conjunctival sac secretion
12) Fundus examination.
13) Corneal endothelial cell count.
14) 12-Lead ECG.
15) Serum Pregnancy.
16) Recording of adverse events
17) Recording of concomitant medications
18) Review of diary use/instructions
Subjects who meet the inclusion criteria and do not meet the exclusion criteria should be randomized 
immediately. After randomization, the drug and diary card corresponding to the randomization number are 
dispensed to the subjects, and the subjects will be instructed to administer the drug to the affected eye 
while at the site, as soon as possible. 
From the start of screening to the end of screening, adverse events occurring in subjects and the use of 
concomitant medications and treatments must be recorded in the eCRF. Subjects who fail screening are 
required to have basic information and the reason for failure recorded in the subject records in detail. 
6.2  Study Procedures Visit 2 (D3) and Visit 3 (Day 6) (treatment period) 
Subjects will return to the study site for a visit on Day 3 and Day 6 during the treatment period and 
complete the following: 
1)
Vital signs (temperature, heart rate, blood pressure)
2)
Subjective Symptoms Score
3)
Objective Clinical Score
4)
Best-corrected visual acuity
5)
Corneal fluorescein staining
6)
Slit-lamp examination
7)
Intraocular pressure measurement
8)
Collection of conjunctival sac secretion
9)
Check of diary card and evaluation of drug compliance
10) Recording of adverse events
11) Recording of concomitant medications
6.3 Visit 4 (D8 ± 1 day) End of Treatment
Subjects will return to the study site for a visit on Day 8±1 during the treatment period and complete the 
following: 
1)
Vital signs (temperature, heart rate, blood pressure)
2)
Subjective Symptoms Score
3)
Objective Clinical Score


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4)
Best-corrected visual acuity
5)
Corneal fluorescein staining
6)
Slit-lamp examination
7)
Intraocular pressure measurement
8)
Collection of conjunctival sac secretion
9)
Return of investigational drug, recovery and check of diary card, and evaluation of drug compliance.
10) Recording of adverse events
11) Recording of concomitant medications
If a subject forgets to return the investigational drugs, they can be returned at Visit 5. The treatment with 
the investigational drug shall be terminated at the end of this visit. If the investigator determines that 
continued treatment is still required (IVIEW-1201 needs to be discontinued) based on the subject's 
symptoms and signs, the specific treatment regimen will be determined by the investigator end recorded in 
the eCRF.  The subject will need to remain in the study until Visit 5/EOS (Day 14±1 day). 
6.4 End of Study period: Visit 5 (D14 ± 1) End of Study 
Subjects will complete the following: 
1)
Vital signs (temperature, heart rate, blood pressure)
2)
Subjective Symptoms Score
3)
Objective Clinical Score
4)
Best-corrected visual acuity
5)
Corneal fluorescein staining
6)
Slit-lamp examination
7)
Intraocular pressure measurement
8)
Fundus examination
9)
Corneal endothelial cell count
10) Serum Pregnancy
11) Recording of adverse events
12) Recording of concomitant medications
Subjects who have not returned the investigational drugs at Visit 4 should return the investigational drugs.   
Subjects who withdraw early should complete the last visit in accordance with the various tests, if possible. 
See Appendix 1: Symptom Scoring Criteria and Appendix 2: Evaluation criteria of comprehensive 
efficacyfor the specific criteria for scoring the symptoms and signs mentioned above. 
6.5 Indicators 
6.5.1 Indicators of clinical cure rate 
6.5.1.1 Subjective Symptoms Score  

Pain: according to the subjective feelings of subjects, a 3-score scale is used (0=none, 1=mild,
2=moderate, 3=severe)

Sensation of foreign body: according to the subjective feelings of subjects, a 3-score scale is used
(0=none, 1=mild, 2=moderate, 3=severe)

Photophobia: according to the subjective feelings of subjects, a 3-score scale is used (0=none,
1=mild, 2=moderate, 3=severe)


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
Weep: according to the subjective feelings of subjects, a 3-score scale is used (0=none, 1=mild,
2=moderate, 3=severe)
See Appendix 1: Symptom Scoring Criteria for specific scoring criteria. 
6.5.1.2 Objective Clinical Score:  

Scores of conjunctival hyperemia: Score the conjunctival hyperemia of the palpebral conjunctiva
and bulbar conjunctiva respectively, using a 3-point scale (0= none, 1= mild, 2= moderate, 3=
severe) to score the conjunctival hyperemia;

Scores of conjunctival secretions/exudation: A 3-point scale (0= none, 1= mild, 2= moderate, 3=
severe) is used to score conjunctival secretions.

Scores of conjunctival edema: A 3-point scale (0= none, 1= mild, 2= moderate, 3= severe) is used
to score conjunctival edema.
6.5.2 Other Clinical Observation Indicators 
Analysis of best-corrected visual acuity, slit-lamp examination, intraocular pressure measurement, fundus 
examination, corneal endothelial cell count. 
6.5.3 Biological sample test indicators 
Collection of conjunctival sac secretions: Collect a bacterial culture tube and sterile swab from the central 
laboratory before sampling, and fully expose the bulbar conjunctiva and fornical conjunctiva when 
sampling. Use a sterile swab moistened with sterile 0.9% sodium chloride solution to gently swab the 
surface of the conjunctival sac 4 times starting from the inner canthus and rotating from the inside to the 
outside (pay attention not to missing the inner canthus, and collect the dense secretions), avoid contact 
with the eyelashes and eyelid margins, and use eyelid speculum and other appliances if necessary. After 
sampling, put the specimens into a sterile transfer tube, mark them, and send them to the laboratory 
department of the hospital for bacterial culture. All subjects are required to take secretions from both eyes 
separately for bacterial culture, with the subject number and eye type indicated. 
6.5.4 Laboratory test indicators 
Serum Pregnancy (female). 
6.5.5 Adverse Events 
Any abnormal symptoms, signs, laboratory tests or other special tests that occur during the clinical study, 
that are normal before treatment and abnormal clinically significant after treatment or abnormal clinically 
significant before treatment and worsen after treatment, regardless of its severity and whether it is related 
to the drug, should be recorded in detail, including the time of occurrence, clinical manifestation, severity 
(graded according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0), management 
process, results and the degree of correlation with the study drug (definitely related, probably related, 
possibly related, possibly unrelated, definitely unrelated), and followed up until return to normal or 
baseline level or the investigator can give a reasonable explanation for the abnormality and believes that 
follow-up is not necessary. Those that are definitely related, probably related, possibly related are 
classified as adverse reactions. 
In this study, the following abnormal laboratory values that were considered clinically significant were not 
treated as adverse events: 


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Abnormal laboratory test values with clinical significance that existed before enrollment, for example, the 
subject may have other systemic diseases, but no significant clinically significant changes occurred during 
the study will not be considered adverse events.  
7. Assessment of Efficacy
7.1 Clinical Efficacy Assessment
Clinical cure rate: The proportion of subjects with a score of 0 (on a 3-point scale) for bulbar conjunctival 
congestion and 0 (on a 3-point scale) for conjunctival secretion/exudation at Visit 4/End of Treatment 
(EOT) (Day 8±1 day) and Visit 5/End of Study (EOS) (Day 14±1 day). 
Clinical improvement rate = (pre-treatment score - post-treatment score) / pre-treatment score x 100%. 
The score of symptoms and signs is the sum of the scores for pain, foreign body sensation, photophobia, 
tearing, conjunctival congestion, conjunctival secretion/exudation and conjunctival edema. 
Total effective rate (%) = (number of subjects cured+ number of subjects markedly effective) / total 
number of subjects available for evaluation of efficacy × 100%. Comprehensive efficacy evaluation: 
defined as cured, markedly effective, effective and ineffective; Calculate the total effective rate; See 
Appendix 2: Evaluation criteria of comprehensive efficacy for judgment criteria. 
7.2 Biological Sample Test Indicators 
7.2.1 Bacterial clearance rate 
Bacterial clearance is defined as positive bacterial culture at baseline and negative bacterial culture at the 
last visit. 
Bacterial clearance rate = (number of subjects cleared + number of subjects assumed to be cleared) / total 
number of subjects enrolled × 100%. 
For the clearance rate of each major pathogenic bacteria, stratified analysis shall be conducted according 
to the type of pathogenic bacteria and the visit time point, and the clearance rate of each kind of bacteria 
by the investigational drug at different times shall be calculated. 
The specific judgment criteria are as follows: 
Clearance: No pathogenic bacteria of the original infection are cultured in the specimen culture from the 
original infection site after treatment; 
Assumed clearance: Bacteriological results are considered assumed clearance in certain diseases where the 
disappearance of signs and symptoms makes culturable materials unavailable or the method of obtaining 
specimens is too invasive for recovered patients; 
Not cleared: The pathogenic bacteria of the original infection are still cultured in the specimen culture 
from the original infection site after treatment;  
Assumed not cleared: For patients judged to be clinically ineffective, if the culture has not been done or is 
unlikely to be done, the pathogenic bacteria can be assumed not cleared; 


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Partial clearance: At least one of the multiple pathogenic bacteria isolated at the original infection site is 
cleared at the end of treatment; 
 
Replaced: Those whose bacterial culture results 1 week after treatment show negative results for the 
original pathogen bacteria and the appearance of new pathogen bacteria, but with no relevant symptoms 
and signs observed; 
 
Re-infected: Those whose bacterial culture results 1 week after treatment show negative results for the 
original pathogen bacteria, but with new pathogenic bacteria appearing and signs and symptoms related to 
re-infection. 
 
7.2.2 Evaluation of specific etiological efficacy 
(1) Bacterial culture positivity rate = the number of positive bacterial culture as a percentage of the total 
number of cases in the study.  
 
(2) Bacterial species clearance rate = the total number of bacterial species cleared as a percentage of the 
total number of pathogenic species isolated at the end of treatment. 
 
(3) Negative conversion rate of bacterial culture = The percentage of patients whose bacterial culture turns 
negative after treatment among those with positive bacterial culture before treatment.    
 
(4) Stratified evaluation of pathogens 
 
① Analysis of 120 patients at the end of all studies    
Pathogen/Number of patients 
Cleared 
Not cleared 
Replaced 
Re-infected 
Staphylococcus aureus 
 
 
 
 
Streptococcus pneumoniae 
 
 
 
 
Haemophilus influenza 
 
 
 
 
Corynebacterium 
 
 
 
 
Streptococcus hemolyticus 
 
 
 
 
 
② Observation of different pathogens for different duration of administration 
Duration of 
administration / 
Number of patients 
Staphylococcus 
aureus 
Streptococcus 
pneumoniae 
Haemophilus 
influenza 
Corynebacterium 
Streptococcus 
hemolyticus 
Baseline 
 
 
 
 
 
Visit 2 
 
 
 
 
 
Visit 3  
 
 
 
 
 
Visit 4 
 
 
 
 
 
Visit 5 
 
 
 
 
 
8. Compliance 
Compliance will be determined by subject self-report as recorded in subject diaries. Missing diary data 
may be collected by subject questioning. There will also be drug dispensing and return logs to be 
completed by the investigative site.  
 
% = actual number of medication times / theoretical number of medication times  × 100%. 
 
A calculated result less than 80% or greater than 120% was considered to be poor compliance


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9. Assessment of Safety
9.1 Adverse Events (AE)
“Adverse Event” (AE) is any adverse medical event that occurs after administration of investigational 
drug and may manifest itself as a symptom, sign, disease or abnormal laboratory test, but is not 
necessarily causally related to the investigational drug. 
AEs in this trial are collected from the time of the first dose of study drug to the completion of the last 
visit or trial process planned in the protocol. However, for the protection of subjects’ rights, the recording 
of adverse events in this study starts with the signing of Informed Consent Form. The incidence of 
adverse events in this trial is calculated based on adverse events that occur after the first dose. However, 
the following conditions should not be recorded as AEs: 
➢
Pre-existing conditions identified at screening (for example, laboratory tests, vital signs, etc. show
clinically significant abnormalities at screening that, in the judgment of the investigator, exist prior to
the subject’s informed consent); such conditions should be recorded as medical history/concomitant
disease.
➢
Medical and surgical examination process (such as liver biopsy, endoscopy); however, the diseases
that cause these tests may be adverse events.
➢
Existing concomitant diseases or pre-existing signs and symptoms at screening have progressed as
expected, but have not worsened.
The sources of adverse events include: 
➢
Subject’s responses to questions about his/her health status (non-leading questions at each visit such
as “How are you feeling since your last visit”) .
➢
Symptoms spontaneously reported by the subject.
➢
Changes or abnormal findings or examinations that are assessed by the investigator to be clinically
significant.
➢
Other information related to the health of the subject that is made known to the investigator (e.g.
hospitalization).
9.2 Serious Adverse Events (SAE) 
Each AE is to be classified by the Investigator as SERIOUS or NON-SERIOUS. 
An SAE is generally an adverse event that results in any one or more of the following outcomes, 
including: 
➢
Leading to death.
➢
Life-threatening (It refers to the immediate risk of death, not the death that may occur in the future
when the disease progresses).
➢
Leading to hospitalization or prolonged hospitalization; this does not include elective surgery or
prolonged hospitalization or prolonged hospitalization due to non-adverse events.


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➢
Leading to permanent or significant loss of function.
➢
Congenital anomaly/birth defects
➢
Other medically important events: They may not be immediately life-threatening, lead to death or
hospitalization, but are also usually considered serious if medical measures are required to prevent
one of the above. Examples include important treatment in the emergency room or allergic
bronchospasm at home, cachexia or convulsions requiring no hospitalization, development of drug
dependence or addiction.
9.3 Suspected Unexpected Serious Adverse Reaction 
A Suspected Unexpected Serious Adverse Reaction (SUSAR) refers to a serious adverse reaction whose 
nature or severity is beyond the information available in the investigator's brochure of the test drug, the 
package insert of the marketed drug or the summary of product characteristics. 
The sponsor will promptly report SUSARs to all investigators and clinical study sites participating in the 
clinical trial; the sponsor will report any known SUSARs to the drug regulatory agency and the health 
administrative department as required. 
9.4 Assessment of Adverse Event Correlation 
The correlation between the adverse event and the study drug is assessed by the investigator according to 
the following: 
☆Definitely related to the study drug
There is evidence of taking the study drug; the occurrence of adverse events and the time sequence of 
taking the study drug are reliable; the occurrence of adverse events is explained more reasonably by the 
study drug than by other reasons; the withdrawal reaction is positive; the repeated drug use test is positive; 
the pattern of adverse events is consistent with previous understanding of this drug or this type of drug. 
☆Probably related to the study drug
There is evidence of taking the study drug; the occurrence of adverse events and the time sequence of 
taking the study drug are reliable; the occurrence of adverse events is explained more reasonably by the 
study drug than by other reasons; the withdrawal reaction is positive. 
☆Possibly related to the study drug
There is evidence of taking the study drug; the occurrence of adverse events and the time sequence of 
taking the study drug are reliable; adverse events may be caused by the study drug or by other reasons; 
the withdrawal reaction is positive. 
☆Possibly unrelated to the study drug
There is evidence of taking the study drug; adverse events are more likely to be caused by other reasons; 
the withdrawal reaction is negative or ambiguous; the repeated drug use test is negative or ambiguous. 
☆Definitely unrelated to the study drug


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The subject does not take the study drug; or the occurrence of adverse events and the time sequence of 
taking the study drug are not reliable; or there are other significant reasons that lead to adverse events. 
9.5 Severity of Adverse Events 
The investigators will categorize the severity of each adverse event by describing the clinical symptoms 
with reference to the five-grade judgment criteria developed by NCI CTCAE V5.0. The severity 
classification is as follows. 
•
Grade 1: mild, asymptomatic or slight; only seen in clinical practice or diagnosis; no treatment is
required;
•
Grade 2: minor, local, or non-invasive treatment is required; age-appropriate instrumental
activities of daily living are limited*;
•
Grade 3: Serious or medically significant but not immediately life-threatening; leading to
hospitalization or prolonged hospitalization; disabling; self care activities of daily living are
limited**;
•
Grade 4: life-threatening, requiring emergency treatment;
•
Grade 5: AE-related deaths.
*Instrumental activities of daily living refer to cooking, shopping for clothes, telephone use, money
management, etc.
**Self care activities of daily living refer to bathing, dressing and undressing, eating, washing hands and 
face, taking medication, etc., in a non-bedridden state. 
9.6 Recording of Adverse Event 
Any adverse event, whether serious or not, and whether or not related to the study drug, must be recorded 
on the case report form. Patients who withdraw due to any adverse event should be followed up by the 
investigator until recovery or stabilization, or until baseline levels are reached, or until clinical 
manifestions is judged by the investigator to be basically stable that require no further follow-up, and 
should be recorded in the original document. Follow up can be divided into hospitalization, outpatient, 
home visit, telephone, communication and other forms according to the severity of adverse events.   
9.7 Name of Adverse Event 
The name of an adverse event should be a medical term and a medical diagnosis should be used in 
preference. That is, if multiple symptoms, signs and abnormal laboratory values can be described or 
attributed to the manifestation of a disease or impairment, this is treated as an adverse event. If a 
definitive diagnosis cannot be made, symptoms/signs should be used. When the later diagnosis is clear, 
the record is updated to replace the previous signs/symptoms with the diagnosis. 
9.8 Start and End Time of the Adverse Event 
The onset time of the AE is the time when the subject first experiences the AE or related symptoms and 
signs, not the time reported by the subject or the time when the investigator is informed. If the AE is a 
clinically significant abnormal laboratory test or auxiliary examination, the onset time is recorded as the 
sampling or examination time. 
The end time of the AE is the date when the AE or AE-related symptoms and signs cease. If the AE is a 
clinically significant abnormal laboratory test or auxiliary examination, the end time is the sampling or 
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If the same AE occurred two or more times in the same subject and the subject recovered between the two 
events, it is counted as two AEs. 
The severity of the AE increased without adding an additional AE record. 
The SAE report needs to provide: 
1) Time of event occurrence (first symptom or laboratory test abnormality);
2) Time when the event reaches the SAE severity standard;
3) Time when the event ends.
9.9 Outcome of adverse events
The researchers followed up the subjects' adverse events and filled in the adverse event outcomes/results, 
including recovery, recovery with sequelae, improved, not improved, died, and unknown. 
9.10 Reporting Process of Serious Adverse Events 
Serious adverse events occurring during the clinical trial, whether or not related to the study drug, must be 
reported immediately to the sponsor by the investigator, who must complete an adverse event attached 
table and notify the sponsor and the contract research organization within 24 hours. The investigator 
should then provide a detailed, written follow-up report in a timely manner, which should adhere to the 
24-hour time limit and the reporting process described above. The investigator should also report to the
research institution, ethics committee, etc. of this site as required by the study site.
In the event that the sponsor and the investigator cannot agree on the causal relationship between the 
adverse event and the drug, expedited reporting should also be conducted if either party determines that a 
correlation with the trial drug cannot be excluded. Therefore, the sponsor requires to provide supporting 
documents of serious adverse events (such as attached table of adverse events, checklist), and the study 
site should assist in submitting information to the sponsor as soon as possible. 
For the reporting of death events, the investigator should provide the sponsor and the Ethics Committee 
with required data, such as autopsy report and final medical report. For fatal or life-threatening SAE 
events, the investigator should report the follow-up report and complete the follow-up information within 
7 days of the initial report whenever possible. 
The investigator is the first responsible person for the collection and follow-up of adverse events/serious 
adverse events and should follow up until the event is over, the condition is stable, a reasonable 
explanation has been given, loss to follow-up or death; the investigator should timely provide follow-up 
information as requested by the sponsor, and ensure the accuracy and consistency of the report content. 
The investigator should sign for and read the safety information of the clinical trial provided by the 
sponsor in a timely manner, and consider whether the subject’s treatment should be adjusted accordingly. 
If necessary, the investigator should communicate with the subject as early as possible and report 
SUSARs provided by the sponsor to the Ethics Committee. 
9.11 Pregnancy 
The investigator should inform the subjects that any pregnancy that occurs during the study and within 6 
months after the completion of the study must be reported to the investigator.Pregnancy is not an adverse 
event, but if the investigator learns that the subject or her spouse is pregnant, it must be reported to the 
principal investigator, ethics committee, contract research organization and sponsor of the center within 
24 hours. 


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Researchers should advise subjects and discuss the risks of continuing pregnancy and possible effects on 
the fetus. Female subjects should be advised to stop taking the drug. Subjects should continue to be 
followed up until 1 month after termination of pregnancy or delivery. 
Pregnancy in the partner of a male subject during the study should also be reported to the investigator and 
sponsor. Partners of patients should also be advised and followed as described above. 
10. Data Management and Statistical Analysis
An independent third party will be responsible for data management and biostatistics, participate in trial 
design and program implementation, be responsible for clinical data management and statistical analysis, 
and complete data management reports and statistical analysis reports. 
10.1 Randomization 
Approximately 120 patients will be randomized in a 1:1 ratio to either IVIEW-1201 or positive control 
drug. This trial adopts a randomized block method to randomly assign subjects, using a central 
randomization system. The Interactive Web Response System (IWRS) will be used for the allocation of 
randomization numbers and the drugs will be dispensed according to the drug numbers assigned by the 
IWRS. The drug number will be recorded in the subject's eCRF. There is competition for enrollment 
among the study sites participating in this study. The investigators at each study site should log into the 
system after screening all eligible subjects and fill in the screening information, so that the subjects can be 
randomized and obtain a randomization number. 
The authorized investigator will obtain a randomization number of each randomly assigned patient 
through the randomization system, prompting the results of the random treatment allocation. And obtain 
the corresponding drug number. 
10.2 Data Management 
10.2.1 Original Data and Original Documents 
Original data 
Original data is all the information in the original records generated by clinical findings, observations or 
other activities in the trial and their qualified copies, which are necessary for the restoration and 
evaluation of the trial. Original data is included in the original record. 
Original record 
Original records are the earliest documents, data and records (e.g. hospital records, clinical and office 
charts, laboratory records, memoranda, subject diaries or evaluation forms, drug dispensing records, data 
recorded by automated instruments, qualified copies or duplicates that have been verified as accurate 
copies, microfilm, photographic negatives, microfilm or magnetic media, x-rays, subject files and records 
kept by pharmacies, laboratories and pharmaceutical technical departments participating in clinical trials). 
Clinical trial specific original data 
The investigator must keep the records of the subjects. 
The subject’s medical history results and other clinically relevant outcomes, demographic data and AEs 
should be recorded in specific original records and then transcribed into the Case Report Form (CRF) for 
each subject. Laboratory results will be transcribed into the CRF by the investigator and labeled as normal, 


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abnormal not clinically significant or abnormal clinically significant. If necessary, specific exceptions will 
be described in detail in the CRF. 
CRF 
This trial uses an electronic case report form, the content of which is collected by the researcher or his/her 
authorized personnel through the clinical electronic data collection and management system. 
1) All subjects who have signed the informed consent form must fill in the case report form in accordance
with the instructions, and record any items in the case report form carefully and in detail;
2) All data in the case report form must be checked with the subject’s original document data to ensure
accuracy;
3) Data that are significantly higher or outside the clinically accepted range must be verified and, if
necessary, judged by the researcher;
4) For other details, please refer to the electronic case report form filling guide.
After the completed electronic case report form is reviewed by the clinical monitor, the data manager will 
conduct data verification and management. After data collection and cleaning are completed, the 
researcher will sign and confirm online. 
The original subject file is the original record of the subject kept by the trial unit. The trial data must be 
entered into the CRF in a timely manner. 
The completed CRF is the exclusive property of the sponsor and cannot be provided to a third party in any 
form without the sponsor's written permission, except for the authorized representative of the relevant 
regulatory agency or ethics committee (EC). 
10.2.2 Data management process 
1) This study adopts an electronic data management system. Construction of electronic CRF:
The data administrator constructs the electronic CRF (eCRF) according to the study protocol. 
2) Permission allocation: The data administrator creates separate accounts and grants different
permissions according to the different identities (e.g. data entry staff, investigator, CRO). The data 
entry person has the permission to enter, modify, question and feedback data; the principal 
investigator has the permission to modify, browse, question feedback and sign electronically; the 
CRO has the permission to browse and send queries; the data administrator has the permission to 
browse, send queries and lock data. 
3) Data entry: The clinical investigator or a data entry person (clinical coordinator) appointed
by the investigator enters data from the study medical record into the eCRF in a timely and accurate 
manner. For external data, the appropriate protocols for external data transfer need to be developed 
during the operation of the project. At least 2 transfers should be made before the database is locked 
in order to confirm the accuracy of external data. After the database is locked, the data is needed to be 
transferred to the statistical analysis unit according to the external data transfer protocol. 
4) Sending and resolution of queries: The CRO, the data administrator, the CRO send all
queries through the EDC system, and the data entry person or the investigator answers the questions 
and correct incorrect data. Queries can be sent repeatedly if necessary and all records are kept in the 
eCRF. 


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5) Modification and review of data: Data can be modified by the data entry person or the
investigator after verifying the data, and the reasons for the modifications need to be filled in on the 
eCRF. The investigator has the permission to sign all final data electronically. 
6) Data locking and export: After all data has been verified for accuracy, the data administrator
locks the data. Any modifications required after the data has been locked need to be signed off by the 
sponsor, investigator, data entry person, CRO and data administrator before implementation. All data 
is eventually exported by the data administrator and handed over to the statistician for analysis. 
10.3 Statistical Analysis 
10.3.1 Selection of statistical analysis data set 
1)
Full Analysis Set (FAS): All subjects randomized and for whom the data of at least one post-dose
efficacy indicator is collected. Only the following randomized subjects are excluded: Subjects who
violates key eligibility criteria, who are not treated with the investigational drug, and who have no
observed data after randomization.
2)
Per Protocol Set (PPS): A subset of the FAS, excluding subjects with significant protocol violations
that may affect the primary efficacy evaluation based on the FAS.
3)
Safety Set (SS): All subjects who have used the study drug at least once.
The efficacy analysis is mainly based on the FAS, but also on the PPS; the SS is used for safety analysis. 
10.3.2 Statistical analysis method 
This study will use SAS software version 9.4 or above for statistical analysis. 
The statistical description of quantitative indicators will calculate the number of subjects, mean, standard 
deviation, median, minimum and maximum (25% quantile Q1, 75% quantile Q3 where necessary), the 
statistical description of categorical indicators will calculate the number of subjects and percentage. 
The T-test or non-parametric comparison is used for inter-group comparison of quantitative indicators, 
and the chi-square test or Fisher's exact probability method is used for inter-group comparison of 
categorical indicators. 
10.3.3 Missing value imputation 
For primary efficacy indicators, missing data are imputed using appropriate methods. If applicable, data 
from the last observation before dropout may be used to impute (LOCF method), and other missing value 
imputation methods should be explored for sensitivity analysis. 
10.3.4 Statistical analysis and methods 
o
Subject disposition
All enrolled, dropped, eliminated and completed subjects at each study site are listed to compare the
compliance of each group.
o
Demographic data
A baseline analysis is performed on the demographic and related characteristics of enrolled subjects in
each group to investigate the comparability among groups.


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o
Efficacy analysis
Statistical analysis of the primary efficacy indicators and secondary indicators for comparison between
groups is performed based on the FAS and PPS respectively.
Primary efficacy indicators: The clinical cure rate of each group is counted and compared using the χ2 test 
or Fisher's exact probability method. 
Secondary efficacy indicators: fungal clearance and change in best-corrected visual acuity will be 
calculated based on the target eye. In addition, pain improvement and clinical effective rate will be 
described and compared between groups. 
o
Safety analysis
Adverse event: Treatment-Emergent Adverse Event (TEAEs) should be focused on, i.e. treatment-
emergent adverse events. The χ2 test or Fisher's exact probability method is used to compare the incidence
of adverse events in each group and the incidence of adverse events related to the study drug. All adverse
events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) and the number
of cases, incidence and frequency of each type of adverse event occurring during the trial will be
summarized by SOC/PT. The adverse events occurring in this trial will be tabulated and described.
Ocular and systemic signs and symptoms, ECG and other indicators: Descriptive statistics of ocular and 
systemic signs and symptoms, ECG and other indicators is performed by visit. Clinically significant 
changes in relevant examinations in subjects before and after treatment are described, with special 
attention given to the occurrence of abnormal clinically significant conditions following drug 
administration in subjects who are normal or abnormal not clinically significant before treatment. 
See the Statistical Analysis Plan for the statistical analysis methods of other indicators. 
11. Trial Management
11.1 Subject Withdrawal Criteria
Subjects will be removed from the study for the following reasons:
1)
Death;
2)
Allergy or intolerance to the study drug;
3)
Pregnancy events during the course of the study;
4)
Self-withdrawal by the subject/guardian;
5)
Subject is lost to follow-up;
6)
Adverse events occurring in subjects that, in the judgment of the investigator, will adversely affect
the subject during the continued treatment period;
7)
Serious violation of the protocol by the subject which, in the judgment of the investigator, affects the
evaluation of the trial results;
8)
Other reasons for subject withdrawal in the judgment of the investigator.
11.2 Trial Termination
1)
The National Medical Products Administration requires the trial to be terminated;
2)
The Ethics Committee requires the trial to be terminated;
3)
The sponsor requires the trial to be terminated.


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11.3 Ethics 
This study will follow the Declaration of Helsinki and comply with ICH guidelines, GCP and other 
relevant regulations. This study will be carried out in strict accordance with the trial protocol. The 
protocol and Informed Consent Form and any modifications must be approved by the Ethics Committee 
prior to implementation. The rights, safety and health of the subjects are given priority over scientific and 
social interests. Prior to the start of the trial, the investigator should provide the subject with an Informed 
Consent Form and explain detailed information about the study to the subject in easy-to-understand 
language. The investigator should give the subject necessary time to understand the details about the study 
before the Informed Consent Form is signed and dated by the subject himself/herself or his/her guardian 
and the investigator. 
 
11.4 Quality Control and Quality Assurance of Trials 
This clinical trial is a multi-center clinical trial, and the trial task is jointly undertaken by several national 
drug clinical trial institutions. All researchers should have the professional expertise, qualifications and 
capabilities to undertake this clinical trial, and undergo GCP-related training. Each center conducts 
clinical trials at the same time, manages the trial drugs with the same procedures, trains researchers 
participating in the trial according to the same trial protocol, establishes standardized methods for efficacy 
and safety evaluation, and has unified quality control for clinical evaluation methods in each center. The 
research leader of each trial unit should hold a meeting of researchers to learn the trial protocol, unify 
standards, and unify understanding before implementing clinical research work in a division of labor. 
During the clinical trial, the principal investigator audits the trials of each center according to the 
requirements of NMPA, and the monitor regularly monitors the progress and quality of the trial, verifies 
the data, and performs necessary coordination work. At the end of the trial, the clinical research leader 
unit and the sponsor organize a summary meeting to complete the clinical research summary report in a 
timely manner. 
11.5 Study Drug Handling 
The sponsor is responsible for printing the forms in the research plan, providing qualified trial drugs free 
of charge, and working with the clinical research unit to complete: 
 
1) Records of the use of trial drugs, including quantity, transportation, acceptance, distribution, 
application and recovery; 
2) The use of trial drugs is the responsibility of the researcher, and the drugs are distributed according to 
random sequence numbers. All trial drugs are only used for the subjects of the trial; 
3) All remaining trial drugs are returned to the sponsor and recorded; 
4) The dosage and usage of drugs comply with the provisions of the trial plan; 
5) The sponsor must have appropriate packaging and labels for all drugs used in clinical trials, and 
indicate that they are for clinical trials only; 
6) The monitor monitors the supply, use, storage and handling of remaining trial drugs. 
11.6 Data Retention 
According to GCP guidelines, researchers/clinical trial institutions must keep all CRFs, original 
documents supporting data collected from each subject, and all research documents required by GCP and 
current regulations. Researchers/clinical trial institutions must take measures to prevent these documents 
from being accidentally or prematurely destroyed. The above documents must be kept for at least 5 years 
after the end of this trial. 
 


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If the sponsor or drug regulatory agency needs to review information related to this study, the researcher 
must provide this information. 
 
11.7 Duties 
The sponsor, investigator, research responsible unit and participating research unit must strictly abide by 
the "Good Clinical Practice for Drugs" and the provisions of this plan and assume corresponding 
responsibilities. 
 
11.8 Protocol Amendment 
The principal investigator leads the study, and the participating institutions and the sponsor jointly 
develop the plan through a plan discussion meeting. After the ethics committee of the lead institution 
reviews and approves the plan, in principle, the plan will not be changed. If it is found during the trial that 
the plan needs to be modified, it must be submitted to the ethics committee of the lead institution for 
approval before implementation. Under this item, the revision content should be recorded in detail, the 
plan version should be updated, and the plan should be submitted to each center for ethical filing/review. 
 
12. Publication 
After the trial is completed, and after obtaining the written consent of the sponsor, the research unit can 
publish the research results of this clinical trial in the form of a paper, but the source of the drug must be 
stated, and the researchers of each research unit have the right to sign the paper. The sponsor can also 
publish the paper or use the trial content, or participate in the signing as needed. 
 
13. Reference 
1. Segal, K. L. ,    Lai, E. C. , &     Starr, C. E. . (2014). Management of acute conjunctivitis. 
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14. Appendix
Appendix 1: Symptom Scoring Criteria
(1) Eye pain
Visual analogue scale (VAS), using a vernier scale with values from 0 to 10 on which the subject 
indicates the location of their pain degree. The score is determined by location. The higher the score, the 
more intense the pain degree.  
It will be scored for ocular comfort (Scale 0 for no pain; 10 for the most severe pain) Calculate the 
improvement rate based on the scale difference. 
0  No pain  
1  1 - 3  
2  4 - 6  
3  7 - 10 
(2) Sensation of foreign body
0  No sensation of foreign body
1  Mild sand-like sensation
2  Moderate sand-like sensation
3  Intolerable
(3) Photophobia
0  No photophobia
1  Discomfort in the presence of light
2  Reluctant to open eyes in the presence of light
3  Unable to open eyes in the presence of light
(4) Tears
0  No tears
1  A few tears
2  Significant tears
3  Constant tears
Appendix 2: Evaluation criteria of comprehensive efficacy 
Cured: ≥ 90% reduction in Scores of subjective symptoms and Objective Clinical Score 
Markedly effective: ≥70% but <90% reduction in Scores of subjective symptoms and Objective Clinical 
Score 
Effective: ≥30% but <70% reduction in Scores of subjective symptoms and Objective Clinical Score 
Ineffective: <30% reduction in Scores of subjective symptoms and Objective Clinical Score