A Double-Masked, Placebo-Controlled, Randomized, Phase II Clinical Trial To Assess The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis
Phase: PHASE2
Conditions: Acute Infectious Conjunctivitis (Disorder)
Sponsor: Sacsh

Version 8-29-2020 
 
Document: Study Protocol and Statistical Analysis Plan 
 
Study: A Double-Masked, Placebo-Controlled, Randomized Phase 
II Clinical Trial to Assess The Efficacy of SCH1 in the Treatment 
of Acute Infectious Conjunctivitis 
 
NCT05356793 
 
Date of Revision: 4/1/2026 
 
 
 

Version 8-29-2020 
 
Protocol Sasch-1 
 
A Double-Masked, Placebo-Controlled, Randomized, 
Phase II Clinical Trial to Assess The Efficacy Of SCH1 
in The Treatment Of Acute Infectious Conjunctivitis 
 
 
 
 
Primary Investigator: Jacqueline Dauhajre (JD) MD 
 
Sponsor:  David Ritterband (DR) MD  
 
Investigational Product:  
SCH1 
 
Protocol Number: WIRB 20202223 
 
 
 
Phase: 
 
 
 
 
II 
 
 
 
 
 
 
 
 
 
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.  
 

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Table of Contents 
 
 
Abbreviations 
Synopsis 
1.0 Introduction  
2.0 Background 
   2.1  Acute Infectious Conjunctivitis 
   2.2  Medical Need in Acute Infectious Conjunctivitis 
   2.3  SCH1 
   2.4  Study Rationale 
   2.5  Dose Rationale 
3.0  Objective 
4.0  Endpoints 
4.1 Primary Endpoints 
4.2 Secondary Endpoints 
4.3 Analysis Unit 
5.0 Trial Design 
   5.1  Randomization and Masking 
   5.2  Treatments 
   5.3  Duration 
6.0 Selection and Withdrawal of Subjects 
   6.1  Inclusion Criteria 
   6.2  Exclusion Criteria 
   6.3  Subject Withdrawal Criteria 
   6.4 Subject Rescue Criteria and Procedures 
7.0  Treatment of Subjects 
   7.1  Screening Prior To Randomization 
   7.2  Study Procedures / Assessments 
8.0  Study Treatment 
   8.1  Storage and Handling 
   8.2  Study Drug Administration 
   8.3  Compliance   
9.0 Assessment of Efficacy 
   9.1  Graded Measure of Conjunctival Discharge / Exudates  
   9.2  Graded Measure of Conjunctival Injection 
   9.3  Confirmatory Bacterial Cultures  
   9.4  Confirmatory Viral Testing by PCR 
   9.5 Other Assessments of Efficacy 
10.0  Assessment of Safety 

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  10.1  Best Corrected Visual Acuity 
  10.2  Examination of Corneal Epithelium With Slit Lamp Biomicroscopy 
  10.3  Intraocular Pressure 
  10.4  Cataract Assessment 
  10.5  Vital Signs 
  10.6 Adverse Events 
  10.6.1 Definition of Adverse Events 
  10.6.2 Relationship to Study Drug 
  10.6.3 Adverse Event Intensity Grading 
  10.6.4 Likely Adverse Events 
  10.6.5 Serious Adverse Events 
  10.6.6 Serious Adverse Events Reporting 
11.0  Statistical Considerations 
12.0  Direct Access to Source Documents 
13.0  Quality Control and Assurance 
14.0  Ethics 
15.0  Subject Informed Consent 
16.0  Institutional Review 
17.0  General Information 
18.0  Data Handling and Record Keeping 
  18.1  Confidentiality 
  18.2  Case Report Forms 
  18.3  Record Keeping 
  18.4  Financial 
  18.5  Publication 
 
References 
 
 
 
 
 
 
 
 
  
 
 
 
 

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Abbreviations 
 
AV 
 
Adenovirus 
AE 
 
Adverse event 
API  
Active Pharmaceutical Ingredient 
BCVA 
Best corrected visual acuity 
BP 
 
Blood Pressure 
CBC  
Complete Blood cell Count 
CRF  
Case Report Form 
CRO  
Contract Research Organization 
DR 
 
David Ritterband MD (Co-investigator) 
ECG  
Electrocardiogram 
ECC  
Corneal Endothelial Cell Count 
ETDRS 
Early Treatment Diabetic Retinopathy Study 
EW  
Emily Waisbren (Principal investigator) 
FDA  
Food and Drug Administration 
GCP  
Good Clinical Practices 
HIPAA 
Health Insurance Portability and Accountability Act 
ICH  
International Conference on Harmonization 
IND  
Investigational New Drug 
ITT  
Intent-to-treat 
PCR  
Polymerase Chain Reaction 
IRB  
Institutional Review Board 
QID  
Four times daily 
SAE  
Serious Adverse Event 
SCH-1 
The investigation drug 
SD 
 
Standard Deviation 
SPK  
Superficial Punctate Keratitis 
TOC  
Test of Cure 
 
 
 
 
 
 

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Synopsis 
 
Title
SCH1 In The treatment of Acute Infectious Conjunctivitis
Investigator 
Jacqueline Dauhajre MD 
82-11 37th Ave Suite 604 
Jackson Heights, NY  11372
Sponsor 
David Ritterband MD 
MEETH Ophthalmology 
210 E. 64th Street  
New York, NY 10065
Indication
Treatment of acute infectious conjunctivitis, bacterial and/or viral.
Objective 
The objective of this study is to evaluate the efficacy of Sasch1 in the 
treatment of acute infectious conjunctivitis.
Eligibility 
Criteria 
Inclusion Criteria 
 Conjunctivitis (as defined below) within 72 hours of initial ocular 
symptoms. 
 At least 18 years of age. 
 Subjects capable of understanding the purpose and risks of the 
study, and able to give informed consent. 
 Conjunctivitis diagnosis defined as presence of the two cardinal 
signs of acute conjunctivitis- 1) bulbar conjunctival injection and 
2) conjunctival discharge/exudates. 
 A three-point rating scale (0=absent, 1=mild, 2=moderate, 
3=severe) will be employed to grade conjunctival 
discharge/exudates. 
 All patients will require a rating of 1(mild) or greater for 
conjunctival discharge/exudates. 
 Patients will require a rating of 1 (mild) for bulbar conjunctival 
injection.
 
Exclusion Criteria 
 Conjunctivitis greater than 72 hours after initial ocular symptoms 
 Corneal ulcer, endophthalmitis, or any other confounding infection 
of the eye 
 Patients taking topical anti-inflammatory medications on a chronic 
basis 
 Known steroid glaucoma responders 
 Active herpes ocular infection 
 Pregnant women 
 Known allergy to chlorhexidine
Trial Design
This is a phase II single-center, prospective, placebo-controlled, 
randomized study of SCH1 in the treatment of acute infectious 
conjunctivitis.  Study drug will be evaluated against vehicle. 
Primary 
Endpoint 
Clinical cure defined as rating of 0/3 for bulbar conjunctival injection and 
0/3 for conjunctival exudates/discharge or clinical success defined as an 
overall decrease by 3 in the sum of both grades.

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Secondary 
 Patients will keep a self log of symptom score each of the 5 days of 
the study
Number of 
Subjects
 30 (15 per treatment arm) 
Target 
Population 
 Patients with infectious conjunctivitis defined by bulbar 
conjunctival injection (rated at least 1 on 3 point grading scale) and 
conjunctival exudates / discharge (rated at least 1 on 3 point 
grading scale).  
 Patients greater than one year of age. 
 Patients of any race or ethnic group. 
Length of 
Study 
Enrollment period: 12 months 
Treatment period: 5 days 
Overall duration: 6 months 5 days 
Study Drug 
Subjects will be randomized to one of the following treatment arms: 
Treatment Arm A: SCH1 
Treatment Arm B: Placebo (Vehicle only)
Assessment 
of Safety 
 Incidence of SPK at day 1 
 Incidence of SPK at Day 5 
 Intraocular pressure at Day 5 
VA loss of 4 or greater lines on Snellen VA Chart
Interim 
Analysis 
and Safety 
Monitoring 
 Safety data will be reviewed by Dr. David Ritterband, Medical 
Monitor and Sponsor. A summary report of the safety points will 
be created every 3 months, as well as the end of the study, and 
reported to the IRB.
Statistical 
Analysis 
The statistical analysis will evaluate: 1) The overall clinical success rate 
defined as the percentage of study participants achieving a clinical cure by 
Day 5 or an overall decrease in the sum of both grades by 3; 2) 
Microbiological cure rate defined as the percentage of study participants 
who demonstrate elimination of pre-treatment pathogen(s) by the Day 5 
TOC exam. 
 
A statistical difference in clinical cure rate will be defined where the 95% 
confidence limit for the difference in the two study groups (SCH1 vs. 
Placebo) is greater than (+/- )15%. 
 
All data will be examined employing an “Intent to Treat” analysis for all 
patients. Mean outcome variables in the two study groups will be 
compared. Statistical means between both study groups will be analyzed 
by both parametric and non-parametric tests to allow for deviations of data 
from normal distributions.

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Schedule of Visits and Assessments 
 
 
Screen / Visit 1 
Visit 2 
Visit 3 
 
Day 1 
Day 3 
Day 5 
General Exams 
 
 
 
Informed consent 
x 
 
 
Inclusion/exclusion criteria 
x 
 
 
Medical history 
x 
 
 
Vital signs 
x 
 
x 
Physical Exam 
x 
 
 
Patient comfort exam 
x 
x 
x 
AE assessment 
x 
x 
x 
Current meds 
x 
x 
x 
Ophthalmic exams 
 
 
 
BCVA 
x 
 
x  
Visual acuity 
x 
x 
x 
Anterior segment slit lamp exam and 
tonometry 
x 
x 
x 
Dilated fundus exam 
x 
  
x  
 
1.0 INTRODUCTION  
This document is a protocol for a human clinical investigation.  The study is to be 
conducted according to US and international standards of Good Clinical Practice (GCP), 
Food and Drug Administration (FDA) Title 21 part 312 and International Conference on 
Harmonization (ICH) Guidelines, applicable government regulations and institutional 
research policies and procedures.   
 
2.0 BACKGROUND 
2.1 Acute Infectious Conjunctivitis 
Acute infectious conjunctivitis (“pink eye”) is one of the most common and most 
contagious ocular infections in the US and the rest of the world. It is usually caused by 
either bacteria (both Gram-positive and Gram-negative) or more commonly, multiple 
serotypes of human adenovirus. In addition to the direct damage caused by the infection 
itself, the body’s stereotyped immune response often overwhelms the delicate structures 
of the eye and leads to secondary, often permanent, inflammatory damage.  While some 
combination antibiotic/anti-inflammatory drugs have been useful for routine bacterial 
conjunctivitis, all are suffering from increasing antibiotic resistance, and are 
contraindicated in the case of suspected viral infection due to their propensity to worsen 
the duration and severity of viral infections.  

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2.2 MEDICAL NEED IN ACUTE INFECTIOUS CONJUNCTIVITIS 
 
Clinical differentiation of bacterial and viral conjunctivitis has depended on clinical 
signs, symptoms and history1,2.  These factors are often accepted among practicing 
ophthalmologists as reliable indicators of etiology with little or no peer-reviewed 
literature substantiation.  An evidence-based review by Rietveld et al3 reviewed several 
databases, including the Cochrane Controlled Trials Register, along with standard 
ophthalmology texts and concluded that there is no evidence that signs and symptoms 
definitively differentiate viral from bacterial conjunctivitis.  This lack of ability to 
clinically determine viral versus bacterial, combined with the known high prevalence of 
viral infections requires that physicians suspect virus in every case of acute 
conjunctivitis. 
 
Although exact numbers are difficult to determine, estimates from a national survey of 
outpatient health encounters4,9, comparison with epidemiological surveys completed in 
other countries5,6,7 and studies of incidence in military recruits8 suggest that the number of 
cases of viral conjunctivitis may be as high as 15-20 million per year in the United States. 
Experts estimate the socioeconomic impact (in terms of lost work hours) from this 
disease is in the billions of US dollars. There is no FDA approved drug available to treat 
these cases: there are no antibiotics, anti-inflammatories or combination products FDA-
approved for the treatment of viral conjunctivitis.  This represents a massive unmet need 
in ophthalmology. 
 
2.3 SCH1 
SCH1 is a novel combination anti-infective / steroid eye drop with in vitro efficacy 
against many bacteria, yeasts, fungi and human adenovirus. The product contains two 
FDA-approved active pharmaceutical ingredients (Pred Forte, or prednisolone acetate 
1%, application #017011, approved May 30, 1973; chlorhexidine gluconate, approved 
Decmeber 28, 1995).  The combination is formulated as a 0.2% chlorhexidine 1% 
prednisolone acetate ophthalmic suspension.  In preclinical evaluation, it demonstrated 
antimicrobial efficacy on contact with ocular isolates of S.aureus, P. aeruginosa, E. coli, 
C. albicans, and A. brasiliensis  A review of preclinical studies is provided in the 
investigators brochure.  
 
2.4 Study Rationale 
Acute infectious conjunctivitis is a leading cause of ocular morbidity, epidemic eye 
infection, lost productivity, patient discomfort and in some cases permanent visual 
compromise. The infectious agent is frequently viral in origin and frequently bacterial in 
origin with very little to reliably distinguish one from the other.  Concomitant 
inflammatory damage often occurs and can lead to long term ocular morbidity.  No 
current treatments are capable of treating both viruses and bacteria.  Additionally no 
current combination antibiotic/steroid combinations can safely be administered in 
suspected viral infections.  The objective of this study is to assess the efficacy of SCH1 

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as a first-line treatment for ocular inflammation and infection in the setting of an acute 
viral or bacterial conjunctivitis infection. 
 
 
2.5 Dose Rationale 
Each drop of SCH1 (approx. 80-110 microliters) contains 0.2% chlorhexidine gluconate 
and 1% prednisolone acetate.  To adequately treat both the inflammatory and infectious 
components of acute conjunctivitis, frequent dosing is employed early in the course of 
infection which can be tapered rapidly as symptoms resolve.  We will employ a regimen 
of 1 drop every two hours while awake in affected eyes on Day 1 followed by 1 drop four 
times a day for the remaining four days of treatment. 
 
3.0 Objective 
The objectives of this study are to evaluate the effectiveness of SCH1 in the treatment of 
infectious conjunctivitis. 
 
4.0 Endpoints 
 
4.1 Primary Endpoints 
The primary endpoint will be the achievement of a clinical cure defined as a rating of 0/3 
for bulbar conjunctival injection and 0/3 for conjunctival exudates/discharge or clinical 
success defined as an overall decrease by 3 in the sum of both scores. 
 
4.2 Secondary Endpoint 
Patients will keep a log and rate their symptoms on a pre-determined scale each of the 5 
days of the study. 
 
4.3 Analysis Unit 
The primary analysis will be performed on one eye of each subject. If both eyes qualify, 
the eye with the worse grade will be designated as the study eye. If both eyes have equal 
grade, the eye with more recent onset of symptoms will be designated as the study eye. If 
both eyes experienced onset of symptoms at the same time, the right eye will be 
designated as the study eye. 
 
5.0 Trial Design 
This is a Phase II single-center, double-masked, placebo controlled, randomized study of 
SCH1 for the treatment of infectious conjunctivitis. Approximately 30 subjects will be 
enrolled, who will be randomized in a 1:1 ratio between SCH1and placebo. Subjects will 
be assessed at day 1, day 3, and day 5 for efficacy and safety. 
 
5.1 Randomization and Masking 
Approximately 30 patients will be randomized in a 1:1 ratio to either SCH1 or placebo. 
Randomization will be administered through “block randomization” (blocks of 4). The 
code will be kept by DR, who will not be involved in examining or grading patients.  

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Each investigator will receive a sealed envelope containing the description of the study 
medication assigned to each patient number.  Investigators will be instructed not to open 
the envelope unless a medical emergency requires identification of the study medication.  
 
5.2 Treatments 
The test article consists of one 3mL bottle of SCH1 ophthalmic suspension.  Doses will 
be administered directly from the bottle.  See section 8.0 for storage, handling and 
administration.  The placebo, which consists of the vehicle for SCH1, will be supplied in 
an identical 3mL bottle the placebo will. 
 
5.3 Duration 
Enrollment for the study is expected to require twelve months. Patients will be followed 
for five days. 
 
6.0 Selection and Withdrawal of Subjects 
6.1 Inclusion Criteria 
Subjects must meet all of the following criteria to be included in the study: 
 A documented history of symptoms consistent with infectious conjunctivitis 
 Onset of symptoms in most recently affected eye less than 72 hours prior to visit 
 At least 18 years of age 
 Women of childbearing age must have a negative urine pregnancy test prior to 
starting the study drug and must not be lactating. 
 
 Female subjects of non-childbearing potential must meet at least one of the 
following criteria: 
 
 
1. Premenarche females, defines as: 
 
 
 
a. Females who have not had onset of menstrual cycle 
 
 
2. Postmenopausal females, defined as: 
 
 
 
a. Females over 60 
 
 
 
b. Females between 45 and 60 of age who are amenorrheic for at  
 
 
 
least 2 years 
 
 
3. Females who have had a hysterectomy and/or bilateral oophrectomy. 
 
All other female subjects will be considered to be of childbearing potential. 
 Subjects or their guardians must be capable of understanding the purpose and 
risks of the study; able to give informed consent (and assent by pediatric subjects, 
if required) and to comply with the study requirements 
 
6.2 Exclusion Criteria 
Subjects with any of the following will be excluded from the study: 
 Conjunctivitis in which the most recently affected eyes had onset of symptoms 
greater than 72 hours prior to visit 
 History of chronic allergic conjunctivitis, including vernal or atopic 
keratoconjunctivitis 
 Presence of corneal ulcer, endophthalmitis, or other confounding ocular infectious 
process 
 Active herpes virus ocular infection 

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 Patient with ocular conditions potentially interfering with conjunctival or corneal 
grading (e.g. chronic conjunctival injection after multiple surgeries, 
pseudophakia, or bullous keratopathy, etc.) 
 Known steroid-responder (steroid-response glaucoma) 
 Patient taking topical anti-inflammatory drops on a chronic basis 
 Pregnant women 
 Any current or history of substance abuse, psychiatric disorder or a condition that, 
in the opinion of the investigator, may invalidate communication or compliance 
with the protocol or return to study visits 
 Known allergy to chlorhexidine gluconate or prednisolone acetate 
 
6.3 Subject Withdrawal Criteria 
Subjects will be removed from the study for the following reasons: 
 Subjects meet criteria for rescue (see section 6.4) 
 Subjects withdrawal of consent 
 Investigator decides it is in best interest of subject to withdraw from the study due 
to safety or efficacy issues 
 Subject lost to follow up 
 Study discontinuation by JD  
  
An excessive rate of withdrawals can render the study uninterpretable: therefore 
unnecessary withdrawal of subjects should be avoided. A subject who withdraws for any 
reason should be encouraged to return to have the End of Treatment assessments 
performed. If a subject is lost to follow-up at any point during the study, attempts to 
contact the subject should be documented, and Subjective Symptoms Score should also 
be obtained. The reason for withdrawal from the study must be documented in the CRF 
by the Investigator. 
 
If the subject withdraws from the trial and also withdraws consent for disclosure of future 
information, no further evaluation should be performed and no additional data should be 
collected. JD or DR may retain and continue to use any data collected before such 
withdrawal of consent. 
 
6.4 Subject Rescue Criteria and Procedures 
Subjects who experience onset of a corneal infiltrate, intraocular inflammation, or 
glaucoma are to receive rescue therapy. Dosing with SCH1/placebo is to be stopped at 
the time of administration of rescue therapy. All evaluations scheduled for visit 3/End of 
Treatment should be performed at this time. 
 
7.0 Treatment of Subjects 
Subjects meeting all the inclusion criteria and none of the exclusion criteria will be 
accepted into the study. Each subject must read and sign an informed consent form (or 
assent provided for pediatric subjects) prior to any screening procedures being performed. 
Subjects will be randomized either to placebo or SCH1, and will be followed in an 
outpatient setting. After their initial visit, subjects will come to the study center on day 3 
and Day 5. Safety and efficacy measurements will be taken on these visits.  

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Potential risks and benefits to subjects participating in this study are detailed in the 
Subject Informed Consent Form. 
 
7.1 Screening Prior To Randomization 
A screening examination is performed on the initial visit. Screening procedures will 
include: 
Informed consent 
Inclusion/exclusion criteria 
Complete medical history and demographic information 
Best corrected visual acuity 
Slit lamp examination and tonometry 
Graded assessment of conjunctival inflammation and cornea 
Dilated fundus examination or Optos Fundus photography 
Conjunctival culture swab (A pre-packaged swab (Visufarma Adenoplus) to obtain a viral 
culture from the eye) 
Documentation of the subject’s fulfillment of the entry criteria for all subjects considered 
for the study and subsequently included or excluded is to be completed by the 
Investigator or designee. Documentation of screening failure details will be recorded in 
the source documentation. 
 
7.2 Study Procedures/Assessments 
The second visit has a +/- 1 day window. The third visit has a +/-1 day window. 
 
Visit 1 
Perform the following activities on Visit 1 (baseline) 
 
Review 
 
BCVA 
 
SLE and tonometry 
 
DFE 
 
Grading of injection / discharge 
 
Dispense study medication 
             
 
Visit 2 
Perform the following activities on Visit 2 
 
Record AEs 
 
Review of current medications 
 
Visual acuity 
 
SLE 
 
Grading of injection / discharge 
 
Visit 3 
Perform the following activities on Visit 3 
 
Record AEs 
 
Review of current medications 
 
Visual acuity 

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SLE 
 
Grading of injection / discharge 
 
DFE 
 
 
8.0 Study Treatment 
DR will provide SCH1 (the study drug) and identically packaged placebo (vehicle only). 
The SCH1 test article is an eyedrop suspension. 
 
8.1 Storage and Handling 
Study drug and placebo can both be safely stored at room temperature and ambient 
conditions for the duration of the trial.  Study drug and placebo storage will be in locked 
cabinet with 24 hour alarmed temperature monitoring. Central storage and study package 
delivery will be coordinated by DR in concert with contract research and manufacturing 
organizations. 
 
8.2 Study Drug Administration 
The study drug is administered as one drop to the affected eye every two hours while 
awake on Day 1, four times per day while awake for Day 2 through Day 5.  The drugs are 
administered by the patient. 
 
8.3 Compliance   
Compliance will be assessed by maintaining adequate drug dispensing and return logs.  
Patients will also keep written record of when treatments were given. 
 
9.0 Assessment of Efficacy 
Efficacy will be assessed by objective clinical score and microbiological culture. 
 
9.1 Graded Measure of Conjunctival Discharge / Exudates 
A three-point rating scale (0=absent, 1=mild, 2=moderate, 3=severe) will be employed to 
grade conjunctival discharge/exudates. Clinical efficacy will be defined as reduction in 
score by 2 grades (i.e. 3->1, 2->0) or a score of 0. 
 
9.2  Graded Measure of Conjunctival Injection 
A three-point rating scale (0=absent, 1=mild, 2=moderate, 3=severe) will be employed to 
grade conjunctival injection. Clinical efficacy will be defined as reduction in of each 
score to 0 or an overall reduction by 3 in the sum of both scores. 
 
9.3 Other Assessments of Efficacy 
Patients will keep a record of their own subjective symptom score from 1-5. 
 
10.0 Assessment of Safety 
The safety population is defined as all subjects who received one or more doses of SCH1. 
Standard summary and/or analysis techniques will be used for the evaluation of AEs, 
vital sign measurements, clinical laboratory results and physical examinations, and these 
are to be detailed within the body of the report. The safety data will be presented in 
individual listings and summary tables where appropriate. 

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10.1 Best Corrected Visual Acuity 
BCVA will be measured using ETRDRS method at each visit. 
 
10.2 Corneal Epithelium Grading 
Corneal epithelium grading, including the presence of SPK, will be recorded at each visit. 
 
10.3 Intraocular Pressure 
Intraocular pressure will be measured by tonometry at screening and at each visit. 
 
10.4 Cataract Assessment 
Cataract grading will be recorded at each visit. 
 
10.5 Vital Signs 
Vital signs will be recorded at each visit. 
 
10.6 Adverse Events 
10.6.1 Definition of Adverse Events 
An adverse event is defined as any untoward medical occurrence in a patient or clinical 
investigation subject administered a pharmaceutical product and which does not 
necessarily have a causal relationship with this treatment.  
 
10.6.2 Relationship to Study Drug 
Relationship to study drug will be determined by the Investigator and so reported to the 
medical monitor. 
 
10.6.3 Adverse Event Intensity Grading 
The intensity of all AEs will be graded according to the following table: 
 
Mild: AE requiring no special treatment and not requiring deviation from the usual 
activities
Moderate: AE that impairs usual activities but are ameliorated by simple therapeutic 
interventions
Severe: AE which impairs usual activities and requiring intervention
 
10.6.4 Eliciting Adverse Events 
At each study visit the subject will be questions about AEs. All AEs, whether observed 
by the Investigator, elicited by the Investigator or designee, or spontaneously reported by 
the subject will be documented in the subject’s chart and the Adverse Event Reporting 
Form. The investigator must assess whether or not the AE is related to the study drug, 
and to determine whether to continue or discontinue the study drug. 
 
10.6.5 Serious Adverse Events 
Each AE is to be classified by the Investigator as SERIOUS or NON-SERIOUS. 
 
10.6.6 Serious Adverse Event Reporting 

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If an SAE or a clinically significant AE occurs, the Investigator must verbally and/or in 
writing (via fax) notify EW or its designee within 24 hours of the occurrence of the SAE. 
Report the SAE to: 
 
Contact Information for SAE Reporting:        
 
Isha Mehta (IM) DO 
MEETH Ophthalmology 
210 E. 64th Street 7th Floor 
New York, NY 10065  
Mobile 1-302-983-0280 
 
David Ritterband MD 
MEETH Ophthalmology 
210 E. 64th Street 7th Floor 
New York, NY 10065  
W 212-702-7313 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical Monitor:  David Ritterband, MD 
 
The initial SAE report must be followed by a written report, signed by the Investigator, 
and received by DR or his designee via fax within two working days. The Investigator 
must provide written follow-up reports until the SAE or clinically significant AE has 
resolved or until a stable clinical endpoint is reached. Notification of an SAE or clinically 
significant AE must also be submitted to the IRB in accordance with its requirements. 
 
11.0 Statistical Considerations 
The clinical success rate is expected 50%-75% higher in the treatment group than in the 
placebo group.  The microbiological cure rate is expected to be 60%-80% higher in the 
treatment drug arm compared to the placebo arm.  Based on these estimates of efficacy, 
statistical and clinical significance will be demonstrable with 30 patients in each group to 
assure an outcome analysis with a power of >80% to detect the difference between the 
two groups at the 95% confidence interval. 
 
12.0 Direct Access to Source Documents 
Source data includes all information, original records of clinical findings, observations, or 
other activities in the clinical trial necessary for the reconstruction and evaluation of the 
trial. Source data are contained in source documents. Examples of these include but are 
not limited to: hospital records, clinical and office charts, laboratory notes, subjects’ 
diaries or evaluation checklists, pharmacy dispensing records, recorded data from 
automated instruments, photographs,  
 
13.0 Quality Control and Quality Assurance 
A site visit will be held prior to initiation of subject enrollment. The protocol, CRFs, 
study drug supplies, and relevant procedures will be explained in detail at the site visit. 

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Subsequent to subject enrollment, a study site monitor from JD or its designees will 
review the CRFs and source documents to ensure that the study is conducted according to 
the protocol and GCP/ICH guidelines. 
 
To ensure compliance with GCP/ICH guidelines and all applicable regulatory 
requirements, DR or its designee may conduct a quality assurance audit. Regulatory 
agencies may also conduct a regulatory inspection of this study. Such audits or 
inspections can occur at any time during or after completion of the study. If audits or 
inspections occur, the Investigator and the Institution agree to allow the auditor/inspector 
direct access to all relevant documents and to allocate his/her time and the time of his/her 
staff to the auditor/inspector to discuss findings and any relevant issues. 
 
14.0 Ethics 
This study will be conducted in accordance with local regulations, GCP, ICH guidelines 
and, where applicable, the Declaration of Helsinki. The Investigator at each site will be 
responsible for the overall conduct of the clinical trial for the site and will be responsible 
for ensuring the trial is conducted according to the protocol and all regulatory 
requirements and IRB/EC regulations. 
 
15.0 Subject Informed Consent 
Subjects (or their legal guardian) will sign written informed consent document.  A copy 
of the document is attached. 
 
16.0 Institutional Review 
The protocol and informed consent form for the study must be approved by an 
appropriately constituted IRB as defined by local requirements. The list of the IRB voting 
members, their titles and/or occupations, and their institutional affiliations and/or the IRB 
general assurance number, if applicable, must be submitted to the Sponsor or its designee 
prior to shipment of study drug to the investigator. 
 
A copy of the Letter of the Approval from the IRB which also contains the study’s 
protocol title, number, and protocol version date, must be received by JD or (DR) or its 
designee prior to shipment of drug supplies to the Investigator. 
 
Significant changes to the protocol by JD must also be approved by the IRB and 
documentation of this approval must be submitted to JD or its designee prior to 
implementation of any changes. Records of IRB annual review, if applicable, and 
approval of all documents pertaining to this study must be sent to DR or his designee and 
kept on file by the Investigator. These documents are subject to regulatory authority or 
the Sponsor or its designee inspection at any time during the study. 
 
Periodic status reports and adverse drug events must be submitted to the IRB according to 
the IRB’s reporting requirements. The IRB must also be notified of completion of the 
study and a final report must be submitted to the IRB in accordance with the IRB’s 
reporting requirements. A copy of these reports should be sent to DR or his designee. The 

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Investigator must maintain an accurate and complete record of all communication, reports 
and submissions to the IRB. 
 
17.0 General Information 
All study records including CRFs, signed Form FDA 1572, originals of test results, 
informed consent forms, IRB approval letters, correspondence, and all other documents 
pertaining to the conduct of the study must be kept on file by the Investigator. 
 
Changes to the protocol can be made only by written amendment agreed upon by EW and 
the Investigator. The IRB must be informed of all changes and must approve all changes 
that may increase risk to the subjects. 
 
A new FDA 1752 form must be prepared and signed for any of the following 
circumstances: if there is any addition or name/address changes of the Investigator, a sub-
Investigator, laboratory, facilities or IRB. This form and a copy of any additional CVs, 
laboratory license and certificates, and/or IRB membership list/assurance number, if 
applicable, must be sent to JD or its designee. A copy must also be retained in the 
Investigator’s file. JD or its designee must be notified, in writing, when an Investigator 
leaves the institution where the study has been conducted. The Investigator must assign a 
designee to assume his/her study-related responsibilities. 
 
18.0 Data Handling and Record Keeping 
18.1 Confidentiality 
The sponsor (DR) will preserve the confidentiality of all subjects taking part in this trial.  
The data in this trial may be used in company publications and regulatory submissions.  
Information about study subjects will be kept confidential in accordance with guidelines 
established by the HIPPA. 
 
18.2 Case Report Forms 
The sponsor (DR) will provide CRF’s for each subject.  Each subject will be identified by 
study identification number and subject’s initials.  All data reported on CRFs will be 
supported by source documents.  The source documents must be made available to the 
Sponsor clinical monitors during scheduled monitoring visits, auditors during any audits 
requested by the Sponsor and to regulatory agencies during inspections. When a subject 
discontinues the study, the CRF must be completed in a timely manner and signed by the 
Investigator.  
 
18.3 Record Keeping 
All study records are subject to inspection by regulatory agencies or the Sponsor or the 
Sponsors designees at any time.  Records must be kept for two years following written 
notification by the Sponsor of either regulatory approval or discontinuation of the 
development program. 
 
18.4 Financial 
As required by US Federal Regulation 21 CFR 54, each listed investigator who is 
involved in the treatment or evaluation of research subjects must disclose certain 

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financial arrangements with the Sponsor.  To ensure compliance, each investigator listed 
on Form FDA 1572 must complete a financial disclosure form prior to the shipment of 
study drug and one year after the completion of the study.  If any relevant changes in this 
information occur during this interval, a new or updated financial disclosure must be 
provided.  
 
18.5 Publication 
The first publication or disclosure of study results shall be a publication or disclosure 
coordinated by the Sponsor.  Thereafter, all subsequent publications will reference the 
original publication(s).  
 
 
 
 

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References 
 
1.  Mahajan VM. Acute bacterial infections of the eye: their 
aetiology and treatment. Br J Ophthalmol 1983;67:191– 4. 
 
2. Dawson CR, Sheppard J. Follicular conjunctivitis. In: Tasman 
W, Jaeger EA, eds. Duane’s Clinical Ophthalmology. Philadelphia: 
Lippincott-Raven, 1995; vol. 4, chap. 7;2–8. 
 
3. Rietveld RP, van Weert HC, ter Riet G, Bindels PJ. Diagnostic 
impact of signs and symptoms in acute infectious conjunctivitis: 
systematic literature search. BMJ 2003;327:789. 
 
4. Nash, EA, et. al. Patterns of emergency department visits for disorders of the eye and 
ocular adnexa Arch Ophthalmol, 1998; 116: 1222-1226. 
 
5. Saitoh-Inagawa W. et. al. Ten years' surveillance of viral conjunctivitis in Sapporo, 
Japan.  Graefes Archive for Clinical & Experimental Ophthalmolog,. 1999; 237:35-8. 
 
6. Ishii K. et al. Comparative studies on aetiology and epidemiology of viral 
conjunctivitis in three countries of East Asia--Japan, Taiwan and South Korea.  Int 
Journal of Epidemiology 1987; 16: 98-103. 
 
7. Aoki, K. et. al. A twenty-one year surveillance of Adenoviral Conjunctivitis in 
Sapporo, Japan.Int Ophthalmol Clinics. 2002; 42:49-54. 
 
8.  Heggie, AD.  Incidence and etiology of conjunctivitis in Navy recruits. Mil Med. 
1990; 155: 1-3. 
 
9.  Shields, T, et. al. A comparison of eye problems in primary care and ophthalmology 
practices, Family Medicine. 1991; 23: 544-6. 
 
10. Kilchington, PR et. al. Use of polymerase chain amplification reaction for the 
detection of adenoviruses in ocular swab specimens. Invest Ophthalmol Vis Sci 1994 
35(12):4126-34. 
 
 
 
 
 
 
 
 
 
 

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Statistical Analysis Plan  
 
 
 
Statistical and Analytic Plans 
 
Chi-Square tests of homogeneity or Fisher exact tests (depending on 
validity of normality assumptions) were performed to assess if the 
distribution of the categorical outcome of clinical cure (i.e. score of zero on 
both conjunctival injection and conjunctival discharge) varied by treatment 
with either SCH-1 or placebo. 
 
Descriptive statistics (i.e. mean and standard deviations [SD] for normally 
distributed data, median with interquartile ranges [IQR] for non-normally 
distributed data) were calculated for all relevant measures.  Percentage 
breakdowns will be used for categorical variables (ie: gender, age). All P-
Values will be two-sided with statistical significance evaluated at the 0.05 
alpha level. 
 
All analyses were performed in SAS Version 9.4 (SAS Institute, Inc. Cary, 
NC). 
 
 
Determination of Sample Size 
 
The determination of sample size was derived from clinical experience, in 
which we expected the clinical cure rates at day 5 to be approximately 
20% and 80 % in the placebo and SCH-1 groups respectively. A sample of 
15 patients per group will yield 87% power to detect a difference between 
20% and 80%, based on a Fisher’s exact test with a 0.05 significance 
level.  
 
 
Changes in the Conduct of the Study or Planned Analyses 
 
 
There were no changes in the conduct of the study or planned analysis.