Clinical trial NCT05501860
Conditions: Anesthesia, Local
Keywords: AG-920 Articaine Septocaine
Sponsor: American Genomics, LLC
Start date: 2022-07-30; Completion date: 2022-12-07
Enrollment: 249 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase 3, randomized, placebo-controlled, double-masked, parallel study in healthy subjects. It is designed to evaluate the ocular safety of a single topical ocular administration of AG-920 sterile topical ophthalmic solution compared to placebo..

Detailed description:
A Phase 3, randomized, placebo-controlled, double-masked, parallel study in healthy subjects performed in the US. It is designed to evaluate the ocular safety of one dose of AG-920 compared to placebo. I). In this study, subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 2:1 ratio to receive one dose of AG-920 or identical looking placebo into one (study) eye. A subset of subjects will undergo endothelial cell count (ECC) evaluations.

Each dose of AG-920 or placebo will consist of two drops in the study eye. After the completion of dosing, subjects will undergo a series of eye exams that will be documented. Investigational medicinal product (IMP) dosing will be performed by the study staff.

Arms: arm 1: Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%. arm 2: Placebo Sterile Topical Ophthalmic Solution
Interventions: intervention 1: AG-920 intervention 2: Placebo
Intervention descriptions: intervention 1: AG-920 Sterile Topical Ophthalmic Solution intervention 2: Placebo Sterile Topical Ophthalmic Solution

Protocol documents:
Prot_000.pdf: 
American Genomics, LLC 
Clinical Study Protocol 
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CONFIDENTIAL 
 
American Genomics, LLC 
 
Clinical Study Protocol 
AG-920-CS303 
 
A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group 
Evaluation of the Ocular Safety of Articaine Sterile Topical Ophthalmic 
Solution 
 
Protocol Number: 
AG-920-CS303 
IND Number: 
IND # 145052 
Investigational Product: 
Articaine Sterile Topical Ophthalmic Solution 
(AG-920) 
Indication: 
Topical anesthesia for intravitreal injection 
Phase: 
Phase 3 
Sponsor: 
American Genomics, LLC 
39 Sycamore Avenue  
Little Silver, NJ 07739 
Phone (848) 444-0665 
Medical Monitor 
Lawrence Singerman, MD, FACS 
InFocus Clinical Research 
205 Powell Place 
Brentwood, TN 37027 
Phone (615) 944-0508 
Protocol Date: 
21 April 2022  
Protocol Version: 
1.0 
Replaces: 
N/A 
 
 
 
CONFIDENTIAL 
This document contains American Genomics, LLC (American Genomics, LLC) 
information that is confidential, a trade secret and/or proprietary in nature.  It is loaned to 
you for your confidential use on behalf of American Genomics, LLC and is not to be 
photocopied, disclosed or transmitted to any other person or party who is not covered by a 
Confidential Disclosure Agreement with American Genomics, LLC.  As the Principal 
Investigator you are responsible for the safekeeping and return of this document to 
American Genomics, LLC upon request.  You will be sent updated information and/or 
amendments as they become available. 
 
 
 


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Contact Information and Protocol Authorization 
 
Clinical Study Protocol 
AG-920-CS303  
Phase 3 
 
 
Protocol Title: 
A Randomized, Double-Masked, Placebo-Controlled, Parallel-
Group Evaluation of the Ocular Safety of Articaine Sterile 
Topical Ophthalmic Solution 
Protocol Number: 
AG-920-CS303 
This study will be conducted in compliance with the clinical study protocol (and 
amendments), International Conference on Harmonisation (ICH) guidelines for current 
Good Clinical Practice (GCP) and applicable regulatory requirements. 
Sponsor Signatory: 
Martin Uram, M.D. 
Chairman 
American Genomics LLC 
Signature: 
Date: 
 
 
 
 
04/22/22


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Abbreviations and Terms 
 
Abbreviation 
Full text 
AE 
Adverse event 
AG-920 
Articaine sterile topical ophthalmic solution 
BCVA 
Best corrected visual acuity 
CFR 
Code of Federal Regulations 
COVID-19 
Coronavirus Disease 2019 
CRO 
Contract Research Organization 
EDC 
Electronic Data Capture 
ETDRS 
Early Treatment of Diabetic Retinopathy Study 
FDA 
Food and Drug Administration  
GCP 
Good Clinical Practices 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
HCl 
Hydrochloride 
ICH 
International Conference on Harmonisation 
ICF 
Informed Consent Form 
IEC 
Independent Ethics Committee  
IMP 
Investigational Medical Product 
IOP 
Intraocular pressure 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
logMAR 
Logarithmic Minimum Angle of Resolution 
MedDRA 
Medical Dictionary for Regulatory Activities 
NSAID 
Non-steroidal anti-inflammatory drug 
OD 
Oculus dexter (Right eye) 
OTC 
Over the Counter 
OS 
Oculus sinister (Left eye) 
PP 
Per protocol 
PPE 
Personal protective equipment 
PT 
Preferred Term 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
SOC 
System/Order/Class 
SOP 
Standard Operating Procedures 
TEAE 
Treatment emergent adverse event 
UPT 
Urine Pregnancy Test 
US 
United States 
VA 
Visual acuity 
 
 
 


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Summary 
Study Number 
AG-920-CS303 
Clinical Phase: 
Phase 3 
Type of study 
Safety 
Name of Investigational product: 
Articaine Sterile Topical Ophthalmic Solution (AG-920) 
Duration of treatment per subject 1 day 
Objectives and Endpoints: 
Primary Objective 
Primary Endpoints 
 
To evaluate the ocular 
safety of a single topical 
ocular administration of 
Articaine Sterile Topical 
Ophthalmic Solution (2 
drops 30 seconds apart)   
Visual acuity, intraocular 
pressure, biomicroscopy, 
AEs, TEAEs, SAEs, 
withdrawals due to TEAEs 
 
Secondary Objectives 
Secondary Endpoints 
 
A subset of up to 20 
subjects (with expectations 
that 12 receiving AG-920 
and 6 receiving vehicle) 
will undergo specular 
microscopy prior to and 3 
months after receiving 
masked study medication 
to evaluate the effect of 
AG-920 on corneal 
endothelial cell count 
(ECC). 
Mean change from 
baseline in corneal 
endothelial cell density 
after treatment with AG-
920 
Subject Population:  
Healthy volunteers 
Exclusion criteria may be found in Section 4.2.  
Design: 
Randomized, placebo (vehicle) controlled, double-
masked, parallel-group.  Unequal randomization (2:1 
Active:Placebo) 
Visit Schedule: 
Study visits will consist of: 
• a 1-3 day Screening Period 
• a dosing visit (multiple timepoints over 90 
minutes)  
• a follow-up phone call 1-4 days following dosing  
And 
• a follow-up visit at 90-95 days following dosing 
(ONLY for the subset of subjects participating in 
the ECC evaluation) 
Number of Investigational Sites: 
Up to 5 US sites  
Estimated Total Sample Size: 
240 total evaluable subjects; 160 AG-920; 80 Placebo. 
 
  


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A subset of up to 20 of subjects will have specular 
microscopy performed. 
Plan for Data Analysis:  
The size of this study is driven by the minimal safety 
exposure required for an eventual regulatory marketing 
application. 
Investigational/Comparator 
Product(s), Dose and Mode of 
Administration 
Subjects will receive a single dose of IMP (2 drops 30 
seconds apart) in one (study) eye.  The IMP will be 
randomized as either AG-920 or Placebo.  The study eye 
will be randomized as either right eye (OD) or left eye 
(OS).  The dose will be administered by the clinic staff.  
 
 
 


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TABLE OF CONTENTS 
CONTACT INFORMATION AND PROTOCOL AUTHORIZATION.......................................................... 2 
ABBREVIATIONS AND TERMS ....................................................................................................................... 3 
SUMMARY ............................................................................................................................................................ 4 
1 
INTRODUCTION........................................................................................................................................ 8 
1.1 
Findings from nonclinical and clinical studies ...................................................................................... 8 
1.2 
Potential Risks and benefits to human subjects .................................................................................... 9 
1.3 
Design justification .................................................................................................................................. 9 
2 
OBJECTIVES AND ENDPOINTS .......................................................................................................... 10 
3 
STUDY DESIGN ........................................................................................................................................ 10 
3.1 
Description and schedule of visits and procedures ............................................................................. 10 
3.2 
Measures taken to minimize/avoid bias ............................................................................................... 12 
3.3 
Study medications ................................................................................................................................. 12 
 
IMP Packaging and labeling .......................................................................................................... 12 
 
Storage of study medication .......................................................................................................... 13 
 
Study medication accountability .................................................................................................... 13 
3.4 
Expected duration of subject participation ......................................................................................... 13 
3.5 
Randomization and procedure for breaking the code ....................................................................... 13 
3.6 
Participant and Study completion ....................................................................................................... 14 
 
Completed subject ......................................................................................................................... 14 
 
Non-completing subject/Subject Withdrawal ................................................................................ 14 
 
Discontinuation of the Study ......................................................................................................... 15 
 
Discontinuation of a Clinical Site .................................................................................................. 15 
 
Actions after discontinuation ......................................................................................................... 15 
 
Completed study ............................................................................................................................ 15 
 
Procedure after the completion of the study .................................................................................. 15 
4 
SUBJECT INCLUSION AND EXCLUSION CRITERIA ..................................................................... 16 
4.1 
Subject inclusion criteria ...................................................................................................................... 16 
4.2 
Subject exclusion criteria ...................................................................................................................... 16 
4.3 
Subject replacement .............................................................................................................................. 17 
5 
TREATMENT OF SUBJECTS ................................................................................................................ 17 
5.1 
Concomitant medications ..................................................................................................................... 17 
 
Prohibited medications .................................................................................................................. 17 
 
Allowed medications ..................................................................................................................... 17 
5.2 
Female Subjects ..................................................................................................................................... 18 
6 
STUDY PROCEDURES............................................................................................................................ 18 
6.1 
General Procedures: ............................................................................................................................. 18 
6.2 
Re-screening Procedures: ..................................................................................................................... 18 
6.3 
Visit 1 (Screening) – Day -2 to 0/1 ........................................................................................................ 18 
6.4 
Visit 2 (Randomization/Treatment) – Day 1 ....................................................................................... 19 
 
Pre-dose ......................................................................................................................................... 19 
 
IMP Treatment – Dose #1 .............................................................................................................. 19 
 
Post-dose (60-90 minute Follow-up) ............................................................................................. 20 
6.5 
Follow-Up Phone Call (Day 2-5) .......................................................................................................... 20 
6.6 
Visit 3 - Specular microscopy (90 days) – subset of subjects ONLY ................................................. 20 
6.7 
Unscheduled visits ................................................................................................................................. 21 
6.8 
COVID-19 Pandemic Accommodations .............................................................................................. 21 
7 
ASSESSMENT OF EFFICACY ............................................................................................................... 21 
8 
ASSESSMENT OF SAFETY .................................................................................................................... 21 
8.1 
Specification of safety parameters ....................................................................................................... 21 


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8.2 
The methods and timing for assessing, recording, and analyzing safety parameters ..................... 22 
8.3 
Adverse events ....................................................................................................................................... 22 
 
Adverse Event (AE) definitions ..................................................................................................... 22 
 
Serious Adverse Event (SAE) definitions...................................................................................... 23 
 
Expedited reporting of Serious and Unexpected Adverse Events.................................................. 25 
 
Follow-up of subjects after adverse events .................................................................................... 26 
9 
STATISTICS .............................................................................................................................................. 26 
9.1 
Primary Hypotheses .............................................................................................................................. 26 
9.2 
Sample Size Considerations .................................................................................................................. 26 
9.3 
Analysis populations ............................................................................................................................. 27 
9.4 
Statistical methods to be employed ...................................................................................................... 27 
 
General Considerations .................................................................................................................. 27 
 
Interim analyses ............................................................................................................................. 27 
 
Analysis of Baseline Data .............................................................................................................. 27 
 
Subject Disposition ........................................................................................................................ 27 
 
Protocol Deviations ....................................................................................................................... 28 
 
Analysis of Efficacy ...................................................................................................................... 28 
 
Analysis of Safety .......................................................................................................................... 28 
 
Adverse Events .............................................................................................................................. 28 
9.5 
Procedure for accounting for missing, unused, or spurious data ...................................................... 28 
9.6 
Procedure for reporting deviations from the statistical plan ............................................................ 28 
9.7 
Data listings ........................................................................................................................................... 28 
10 
QUALITY CONTROL AND QUALITY ASSURANCE ....................................................................... 29 
10.1 
Audit and Inspection ........................................................................................................................ 29 
10.2 
Direct Access to Source Data Documents ....................................................................................... 29 
10.3 
Clinical Monitoring .......................................................................................................................... 29 
10.4 
Data Management and Coding ........................................................................................................ 29 
11 
ETHICAL CONSIDERATIONS AND COMPLIANCE WITH GOOD CLINICAL PRACTICE .... 30 
11.1 
Independent Ethics Committee or Institutional Review Board ................................................... 30 
11.2 
Regulatory Authorities ..................................................................................................................... 30 
11.3 
Ethical Conduct of the Study ........................................................................................................... 30 
11.4 
Written Informed Consent .............................................................................................................. 30 
11.5 
Subject Confidentiality .................................................................................................................... 31 
12 
DATA HANDLING AND RECORD KEEPING .................................................................................... 31 
12.1 
Data quality control and reporting ................................................................................................. 31 
12.2 
Inspection of Records ....................................................................................................................... 31 
12.3 
Records retention ............................................................................................................................. 31 
12.4 
Amendments to the protocol ............................................................................................................ 32 
13 
PUBLICATION ......................................................................................................................................... 32 
14 
REFERENCES ........................................................................................................................................... 32 
14.1 
Published references ......................................................................................................................... 32 
14.2 
Internal references ........................................................................................................................... 33 
 
APPENDIX 1: PROCEDURES............................................................................................................. 34 
APPENDIX 2: INVESTIGATOR SIGNATURE PAGE ............................................................................. 38 
 
List of tables 
TABLE 1: SCHEDULE OF VISITS AND PROCEDURES ......................................................................... 11 
TABLE 2: AE ASSESSMENT OF CAUSALITY .................................................................................... 24 
TABLE 3: ASSESSMENT OF SEVERITY (INTENSITY) ......................................................................... 25 
TABLE 4: COMPARISON OF SNELLEN RATIO AND LOGMAR UNITS ................................................. 35 
 
















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 Discontinuation of the Study 
If the clinical study is prematurely terminated or suspended, the Sponsor or designee will inform 
the Investigators and the regulatory authorities of the termination/suspension and the reason(s) for 
the termination/suspension.  The Investigators should promptly notify their Independent Ethics 
Committee (IEC) or Institutional Review Board (IRB) of the termination or suspension and of the 
reasons. 
 Discontinuation of a Clinical Site 
The Sponsor reserves the right to close an investigational site or terminate the study in its entirety 
at any time, for reasonable cause.  Reasons for the closure of any investigational site or termination 
of the study may include: 
• Failure to accrue subjects into the study at an acceptable rate. 
• Failure of the Investigator to comply with applicable regulations and Good Clinical 
Practice (GCP) guidelines. 
• Submission of knowingly false information from the research facility to the Sponsor, Food 
and Drug Administration (FDA), or other regulatory authorities. 
• Insufficient adherence to protocol requirements and procedures. 
If the study is prematurely discontinued, all study data must be returned to the Sponsor or designee.  
Additionally, the site must conduct final disposition of all unused IMP in accordance with CRO 
procedures.  Study termination and follow-up will be performed in compliance with the conditions 
set forth in regulatory guidelines. 
 
Financial compensation to the Investigator and/or institution will be in accordance with the 
agreement established between the Investigator and the Sponsor or Sponsor designee. 
 Actions after discontinuation 
All subjects who discontinue IMP due to a report of an AE must be followed-up and provided 
appropriate medical care until their signs and symptoms have remitted, stabilized, determined to 
be chronic, or until abnormal laboratory findings have returned to acceptable or pre-study limits.  
 
For the subject who chooses to withdraw consent or who is non-compliant, every possible effort 
should be made by the Investigator to assure there is a final visit that includes all examinations 
listed for Visit 2.  
 
For the subset of subjects participating in the specular microscopy who choose to withdraw consent 
or who is non-compliant, every possible effort should be made by the Investigator to assure there 
is a final visit that includes all examinations listed for Visit 3. 
 Completed study 
The end of the study is defined as the date the last subject completes the specular microscopy visit 
(Visit 3).   
 Procedure after the completion of the study 
When the study is completed and the site has been closed out, the Investigator will be asked to 
notify the governing IRB.  












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6.7 
Unscheduled visits 
To ensure subject safety during the trial, any subject who requires additional follow-up during the 
study for any reason (that does not fall on a scheduled study visit) should have that visit recorded 
as an Unscheduled Visit.   
6.8 
COVID-19 Pandemic Accommodations 
This study may be conducted during the COVID-19 pandemic.  As a result, American Genomics 
is providing guidance to Investigators on how to modify the current protocol based on guidance 
documents from the FDA and other regulatory authorities.  The objective of these potential 
modifications is to ensure the safety of trial participants and clinic staff, maintain compliance with 
good clinical practice (GCP), and minimize the risks to trial integrity during the COVID-19 
pandemic. 
 
To ensure the safety of trial participants and to minimize or eliminate hazards as a result of the 
COVID-19 pandemic, the following alternative processes and procedures may be implemented 
when necessary:  
1. Depending on local COVID-19 prevalence and prevailing local ordinances and guidances, 
some screening visit procedures may be conducted by telephone, by video conferencing, 
or by remote staff in the subject’s home.   
2. The Randomization/Treatment Visits cannot be done by telephone or video conferencing 
and must be completed at the investigative site, if it is safe and feasible, per Investigator’s 
judgment.   
3. Site specific accommodations should be implemented per state and local guidances 
possibly including social distancing or personal protective equipment (PPE) requirements. 
4. Remote monitoring visits of clinical trial data may be implemented. 
7 ASSESSMENT OF EFFICACY 
The is no measure of efficacy in this study. 
8 ASSESSMENT OF SAFETY 
8.1 
Specification of safety parameters 
The assessment of safety and tolerability will be evaluated changes in by: 
• BCVA (ETDRS) 
• Intraocular pressure  
• Biomicroscopy and external eye exam of anterior segment including evaluation of cornea, 
conjunctiva and anterior chamber.  
• Heart rate and Blood pressure 
• AEs (post treatment) 
• AEs will be collected at every visit.  See Section 8.3 for details on collection and reporting of 
AEs. 
• (Subset only) Specular microscopy for assessment of corneal health. 
 
 


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Screening only: 
• Urine pregnancy test for females of childbearing potential 
8.2 
The methods and timing for assessing, recording, and analyzing safety parameters 
Methods may be found in Table 1 and Appendix 1.   
8.3 
Adverse events1 
All AEs occurring after the first dose of IMP and throughout the remainder of the study period 
(Follow-up Phone Call; Visit 3 for subjects participating in specular microscopy)ill be considered 
TEAEs and must be documented on the relevant Electronic Data Capture (EDC) pages and in the 
source documents.  Whenever possible, the diagnosis, if available, and not the symptoms should 
be reported as the AE.  AEs and Serious Adverse Events (SAEs) will be coded according to the 
Medical Dictionary for Regulatory Activities (MedDRA).  
 
Documentation of adverse events/adverse reactions includes start date and stop date, severity, 
action(s) taken, seriousness and outcome.   
 Adverse Event (AE) definitions 
An AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally 
associated with the use of a medicinal product, whether or not considered related to the medicinal 
product. 
 
Note: An AE can therefore be any untoward or unfavorable medical occurrence in a human subject, 
including any abnormal sign (for example, abnormal physical exam or laboratory finding), 
symptom, or disease, temporally associated with the subject’s participation in the research, 
whether or not considered related to the subject’s participation in the research. 
 
Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign 
(for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally 
associated with the subject’s participation in the research, whether or not considered related to the 
subject’s participation in the research will be documented.  
 
Events meeting the definition of an AE include: 
• Exacerbation of a chronic or intermittent pre-existing condition including either an increase 
in frequency and/or intensity of the condition 
• New conditions detected or diagnosed after study drug administration even though it may 
have been present prior to the start of the study 
• Signs, symptoms, or clinical sequelae of a suspected interaction 
• Signs, symptoms, or clinical sequelae of a suspected overdose of either study drug or a 
concomitant medication (overdose per se will not be reported as an AE/SAE). 
 
                                                 
1 Note: This section is referenced to 21 CFR 312.32 (IND safety reports), updated as per “Investigational New Drug 
Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for 
Bioavailability and Bioequivalence Studies in Humans (Fed Reg 2010: 75 (188): 59935-59963). 


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Events that do not meet the definition of an AE include: 
• Medical or surgical procedure (e.g., endoscopy, appendectomy); the condition that leads to 
the procedure is an AE 
• Situations where an untoward medical occurrence did not occur (social and/or convenience 
admission to a hospital) 
• Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or 
detected at the start of the study that do not significantly worsen 
• The disease/disorder being studied, or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless rescue medication or other medical treatment is 
required. 
 
8.3.1.1 Life-threatening adverse event or life-threatening suspected adverse reaction.   
An adverse event or suspected adverse reaction is considered “life-threatening” if, in the view of 
either the Investigator or Sponsor, its occurrence places the subject at immediate risk of death.  It 
does not include an adverse event or suspected adverse reaction that, had it occurred in a more 
severe form, might have caused death.   
8.3.1.2 Suspected adverse reaction 
Suspected adverse reaction means any adverse event for which there is a reasonable possibility 
that the drug caused the adverse event.  For the purposes of IND safety reporting, ‘‘reasonable 
possibility’’ means there is evidence to suggest a causal relationship between the drug and the 
adverse event.  Suspected adverse reaction implies a lesser degree of certainty about causality than 
adverse reaction, which means any adverse event caused by a drug.   
8.3.1.3 Unexpected adverse event or unexpected suspected adverse reaction.   
An adverse event or suspected adverse reaction is considered ‘‘unexpected’’ if it is not listed in 
the Investigator brochure or is not listed at the specificity or severity that has been observed; or, if 
an investigator brochure is not required or available, is not consistent with the risk information 
described in the general investigational plan or elsewhere in the current application, as amended.  
For example, under this definition, hepatic necrosis would be unexpected (by virtue of greater 
severity) if the investigator brochure referred only to elevated hepatic enzymes or hepatitis.  
Similarly, cerebral thromboembolism and cerebral vasculitis would be unexpected (by virtue of 
greater specificity) if the Investigator brochure listed only cerebral vascular accidents.  
“Unexpected,” as used in this definition, also refers to adverse events or suspected adverse 
reactions that are mentioned in the Investigator brochure as occurring with a class of drugs or as 
anticipated from the pharmacological properties of the drug, but are not specifically mentioned as 
occurring with the particular drug under investigation. 
 
Note: Any medical condition present prior to administration of the masked study medication which 
remains unchanged or improved should not be recorded as an adverse event at subsequent visits. 
 Serious Adverse Event (SAE) definitions 
An SAE is an AE that:  
• Results in death. 


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• Is life-threatening (an AE is life-threatening if the subject was at immediate risk of death 
from the event as it occurred, i.e., it does not include a reaction that might have caused 
death if it had occurred in a more serious form). 
• Requires or prolongs inpatient hospitalization.  Complications occurring during 
hospitalization are AEs or SAEs if they cause prolongation of the current hospitalization.  
Hospitalization or prolonged hospitalization for elective treatment of a pre-existing non 
worsening condition is not, however, considered an AE.   
• Results in persistent or significant disability/incapacity.  (An AE is incapacitating or 
disabling if it results in a substantial and/or permanent disruption of the subject’s ability to 
carry out normal life functions). 
• Is a congenital anomaly/birth defect. 
• Is an important medical event that may jeopardize the subject or may require medical 
intervention to prevent one of the outcomes listed above. 
 
Medical and scientific judgment is required to decide if prompt notification is required in situations 
other than those defined for SAEs above.  This can include an AE that suggests any significant 
hazard, contraindication, adverse event, or precaution that may be associated with the use of the 
IMP. 
8.3.2.1 Recording an AE and/or SAE including Onset Date, End Date  
When an AE/SAE occurs, it is the responsibility of the investigator to review all documentation 
(eg, hospital progress notes, laboratory reports, and diagnostics reports) related to the event. The 
investigator will then record all relevant AE/SAE information in the CRF. 
If an AE starts but does not end before the final visit, the Investigator must make a reasonable 
effort to establish the outcome and the end date of the AE.  If this is not possible (e.g., because the 
AE is still ongoing) or the subject is lost to follow-up, there will be no end date for the AE and the 
status will be recorded as “ongoing.”  For all AEs that resolve, resolve with sequelae, or have a 
fatal outcome, an end date must be provided. 
The investigator will attempt to establish a diagnosis of the event based on signs, symptoms, and/or 
other clinical information. Whenever possible, the diagnosis (not the individual signs/symptoms) 
will be documented as the AE/SAE. 
8.3.2.2 Assessment of Causality 
Every effort will be made by the Investigator to assess the relationship of the AE, if any, to the 
IMP.  Causality should be assessed as unrelated or related using the categories defined in Table 2.   
 
Table 2: AE Assessment of Causality 


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Unrelated: 
• Clinical event with an incompatible time relationship to IMP 
administration, and that could be explained by underlying disease or other 
drugs or chemicals or is incontrovertibly not related to the IMP, or 
• Clinical event whose time relationship to IMP makes a causal connection 
improbable, but that could plausibly be explained by underlying disease 
or other drugs or chemicals. 
Related: 
• Clinical event with a reasonable time relationship to IMP, but that could 
also be explained by concurrent disease or other drugs or chemicals, or 
• Clinical event with a reasonable time relationship to IMP and is unlikely 
to be attributed to concurrent disease or other drugs or chemicals, or 
• Clinical event with plausible time relationship to IMP, and that cannot be 
explained by concurrent disease or other drugs or chemicals. 
Abbreviations:  AE=Adverse Event; IMP=investigational medicinal product 
8.3.2.3 Assessment of Severity (Intensity) 
The severity of an adverse event is defined as a qualitative assessment of the level of discomfort 
of an adverse event as is determined by the Investigator or reported to him/her by the subject.  The 
assessment of intensity is made irrespective of study medication relationship or seriousness of the 
event.  The investigator will make an assessment of intensity for each AE and SAE reported during 
the study and assign it to 1 of the following categories: and should be evaluated according to the 
scale in Table 3. 
 
 
Table 3: Assessment of Severity (Intensity) 
Mild 
An event that is easily tolerated by the participant, causing minimal discomfort 
and not interfering with everyday activities. 
Moderate 
An event that causes sufficiently discomfort and interferes with normal 
everyday activities. 
Severe 
An event that prevents normal everyday activities. An AE that is assessed as 
severe should not be confused with a SAE. Severe is a category utilized for 
rating the intensity of an event; and both AEs and SAEs can be assessed as 
severe. 
 
Please note: the term “severe” is used to describe the intensity (severity, see above) of an 
event/reaction; the event/reaction itself may be of relatively minor medical significance (such as 
severe headache).  This is not the same as a “Serious” Adverse Event, which is based on 
subject/event outcome or action criteria usually associated with events that pose a threat to the 
subject’s life or vital functions.  “Serious” (NOT severity) serves as a guide for defining regulatory 
reporting obligations.  An event is defined as ‘serious’ when it meets at least 1 of the predefined 
outcomes as described in the definition of an SAE, NOT when it is rated as severe. 
 Expedited reporting of Serious and Unexpected Adverse Events 
Safety reports   
An investigator must immediately report to the Sponsor or Sponsor representative any serious 
adverse event, whether or not considered drug-related, including those listed in the protocol or 
investigator brochure and must include an assessment of whether there is a reasonable possibility 






American Genomics, LLC 
Clinical Study Protocol 
Confidential 
 
Protocol AG-920-CS303 
Page - 28 - 
21 April 2022 
 
 Protocol Deviations 
Important protocol deviations are deviations from the protocol that potentially could have a 
meaningful impact on study conduct, or on the primary efficacy or key safety outcomes for an 
individual subject.  The criteria for identifying important protocol deviations will be defined within 
the appropriate protocol-specific document.  Important protocol deviations will be reviewed as 
part of the ongoing data cleaning process and all important deviations will be identified and 
documented prior to unmasking to confirm exclusion from analysis sets.  Further details will be 
provided in the SAP. 
 Analysis of Efficacy 
Not applicable. 
 Analysis of Safety 
Intraocular pressure, slit lamp biomicroscopy, external eye exam, intraocular pressure and 
cardiovascular measures will be summarized at each measured time point using discrete summary 
statistics. 
 
Visual Acuity data will be summarized at each time point using both continuous summaries 
(Logarithmic Minimum Angle of Resolution, logMAR), including change from baseline, and 
discrete summaries, including change from baseline in the number of lines and the proportion of 
subjects with a worsening of ≥ 3 lines from baseline.   
 
 
 
 Adverse Events 
Verbatim descriptions of AEs will be mapped to MedDRA thesaurus terms and be presented in a 
data listing.  Treatment emergent AEs, those that occur after the first dose of study medication, 
will be summarized by treatment group using frequency counts and percentages for each system 
organ class (SOC) and preferred term (PT) within each SOC.  Summaries will be presented 
separately for ocular and non-ocular AEs.  These summaries will also be presented by the 
relationship to the Investigational Medical Product (related, unrelated) and by severity of the AE 
(mild, moderate, severe).  Fisher’s exact test will be used to test the difference in proportions of 
subjects with each AE between treatment groups (SOC and PT).   
9.5 
Procedure for accounting for missing, unused, or spurious data 
For this safety study, only observed data will be used.  This is no planned method for imputation 
of missing data. 
9.6 
Procedure for reporting deviations from the statistical plan 
Any deviations from the statistical plan will be described and a justification given in the final 
statistical report. 
9.7 
Data listings 
Data listings will be prepared for all data on the database. 


American Genomics, LLC 
Clinical Study Protocol 
Confidential 
 
Protocol AG-920-CS303 
Page - 29 - 
21 April 2022 
 
10 QUALITY CONTROL AND QUALITY ASSURANCE 
10.1 Audit and Inspection 
Study centers and study documentation may be subject to Quality Assurance audits during the 
study by the Sponsor or its designee.  In addition, inspections may be conducted by regulatory 
authorities at their discretion. 
10.2 Direct Access to Source Data Documents 
Authorized representatives of the Sponsor, a regulatory authority, an IEC or IRB may visit the site 
to perform audits or inspections, including source data verification.  The purpose of a Sponsor 
audit or inspection is to systematically and independently examine all study-related activities and 
documents to determine whether these activities were conducted, and data were recorded, 
analyzed, and accurately reported according to the protocol, GCP guidelines, and any applicable 
regulatory requirements.  The Investigator should contact the Sponsor immediately if contacted by 
a regulatory agency about an inspection. 
10.3 Clinical Monitoring 
Data for each subject will be recorded in a source document and in EDC for each subject who 
signs an informed consent form (ICF) and is administered IMP. 
 
In accordance with current GCP and International Conference of Harmonisation (ICH) guidelines, 
the study monitor will carry out source document verification at regular intervals to ensure that the 
data collected in EDC are accurate and reliable.  
 
The Investigator must permit the monitor, the IEC/IRB, the Sponsor’s internal auditors, and 
representatives from regulatory authorities’ direct access to all study-related documents and 
pertinent hospital or medical records for confirmation of data contained within EDC.   
 
Due to the COVID-19 Pandemic, remote monitoring visits may replace some of the onsite 
monitoring visits.  It will still be the responsibility of the monitor to discuss the study and any 
issues with the Principal Investigator via telephone or videoconference.  
10.4 Data Management and Coding 
The CRO will be responsible for data management per their SOPs.  This will include setting up a 
relevant database and data transfer mechanisms, along with appropriate validation of data and 
resolution of queries.  Data generated within this clinical study will be handled according to the 
relevant standard operating procedures of the data management and biostatistics departments of 
the CRO. 
 
All data for subjects who sign an ICF and receive a dose of IMP will be recorded via EDC.  
Subjects who are screened but found ineligible for the study and who do not receive IMP will be 
considered screen failures.  The reason for exclusion from the study will be recorded.   
 
Study centers will enter data directly into the EDC via a secure internet connection.  Data entered 
into EDC must be verifiable against source documents at the study center.  Data recorded directly 
into EDC, if any, will be identified and the EDC will be considered the source document.  Any 


American Genomics, LLC 
Clinical Study Protocol 
Confidential 
 
Protocol AG-920-CS303 
Page - 30 - 
21 April 2022 
 
changes to the data entered into the EDC system will be recorded in the audit trail and will be FDA 
Code of Federal Regulations (CFR) 21 Part 11 compliant. 
 
MedDRA will be used to code AEs.  Medications will be coded by WHODrug.  Missing or 
inconsistent data will be noted within the EDC system and queried with the Investigator for 
clarification.  Subsequent modifications to the database will be documented. 
11 ETHICAL CONSIDERATIONS AND COMPLIANCE WITH GOOD 
CLINICAL PRACTICE 
11.1 Independent Ethics Committee or Institutional Review Board 
Before initiation of the study at each study center, the protocol, the ICF, other written material 
given to the subject, and any other relevant study documentation will be submitted to the 
appropriate IEC/IRB.  Written approval of the study and all relevant study information must be 
obtained before the study center can be initiated or the IMP released to the Investigator.  Any 
necessary extensions or renewals of IEC/IRB approval must be obtained for changes to the study 
such as amendments to the protocol, the ICF or other study documentation. The written approval 
of the IEC/IRB together with the approved ICF must be filed in the study files. 
The Investigator will report promptly to the IEC/IRB any new information that may adversely 
affect the safety of the subjects or the conduct of the study.  The Investigator will submit written 
summaries of the study status to the IEC/IRB as required.  On completion of the study, the IEC/IRB 
will be notified that the study has ended. 
11.2 Regulatory Authorities 
Relevant study documentation will be submitted to the regulatory authorities of the participating 
countries, according to local/national requirements, for review and approval before the beginning 
of the study.  On completion of the study, the regulatory authorities will be notified that the study 
has ended. 
11.3 Ethical Conduct of the Study 
The Investigator(s) and all parties involved in this study should conduct the study in adherence to 
the ethical principles based on the Declaration of Helsinki, GCP, ICH guidelines, and the 
applicable national and local laws and regulatory requirements. 
11.4 Written Informed Consent 
The process of obtaining informed consent must be in accordance with applicable regulatory 
requirement(s) and must adhere to GCP. 
 
The Principal Investigator(s) at each center will ensure that the subject is given full and adequate 
oral and written information about the nature, purpose, possible risk, inconveniences, and potential 
benefit of the study.  Subjects must also be notified that they are free to discontinue from the study 
at any time.  The subject should be given the opportunity to ask questions and allowed time to 
consider the information provided.  The subject should be given every opportunity to ask for 
clarification of any points s/he does not understand and, if necessary, ask for more information.  
The subject will be required to sign and date the ICF.  After signatures are obtained, the ICF will 
be kept and archived by the Investigator in the Investigator’s study file.  A signed and dated copy 


American Genomics, LLC 
Clinical Study Protocol 
Confidential 
 
Protocol AG-920-CS303 
Page - 31 - 
21 April 2022 
 
of the subject ICF will be provided to the subject.  The Principal Investigator(s) must maintain the 
original, signed ICF. 
 
The Investigator is responsible for ensuring that no subject undergoes any study-related 
examination or activity before the subject has given written informed consent to participate in the 
study. 
 
It should be emphasized that the subject may decline to participate in the study and may withdraw 
from the study at any time without consequences for their further care or penalty or loss of benefits 
to which the subject is otherwise entitled.  
 
If new information becomes available that may be relevant to the willingness of the subject to 
continue in the study, a new ICF will be approved by the IEC(s)/IRB(s) (and regulatory authorities, 
if required). The subject will be informed about this new information and reconsent will be 
obtained. 
11.5 Subject Confidentiality 
Monitors, auditors, and other authorized agents of the Sponsor and/or its designee, the 
IEC(s)/IRB(s) approving this research, as well as that of any other applicable agency, will be 
granted direct access to the study subjects’ original medical records for verification of clinical 
study procedures and/or data, without violating the confidentiality of the subjects to the extent 
permitted by the law and regulations.  In any presentations of the results of this study or in 
publications, the subjects’ identity will remain confidential. 
12 DATA HANDLING AND RECORD KEEPING 
All procedures for the handling and analysis of data will be conducted using good computing 
practices meeting ICH and U.S. Food and Drug Administration (FDA) guidelines for the handling 
and analysis of data for clinical trials. 
12.1 Data quality control and reporting 
After data have been entered into the study database, a system of computerized data validation 
checks will be implemented and applied to the database.  Query reports pertaining to data 
omissions and discrepancies will be forwarded to the clinical Investigator and the Sponsor for 
resolution.  The study database will be updated by the clinical investigator or their staff, in 
accordance with the resolved query reports.  All changes to the study database will be documented.   
12.2 Inspection of Records 
American Genomics or designee will be allowed to conduct site visits to the investigation facilities 
for the purpose of monitoring any aspect of the study.  The Investigator agrees to allow the monitor 
to inspect the drug storage area, IMP stocks, drug accountability records, subject charts and study 
source documents, and other records pertaining to study conduct. 
12.3 Records retention 
Essential documents are those documents that individually and collectively permit evaluation of 
the study and quality of the data produced.  After completion of the study, all documents and data 
relating to the study will be kept in an orderly manner by the Investigator in a secure study file.  
This file will be available for inspection by the Sponsor or its representatives.  Essential documents 




American Genomics, LLC 
Clinical Study Protocol 
Confidential 
 
Protocol AG-920-CS303 
Page - 33 - 
21 April 2022 
 
14.2 Internal references 
• American Genomics, LLC, Articaine Sterile Topical Ophthalmic Solution Investigator’s 
Brochure, 2021.  
 











SAP_001.pdf: 


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