Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens
Phase: NA
Conditions: Refractive Errors
Sponsor: Alcon Research



Document ID: 
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Approved Date: 28 Oct 2020 
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Investigator Agreement: 
• I have read the clinical study described herein, recognize its confidentiality, and 
agree to conduct the described trial in compliance with Good Clinical Practice 
(GCP), the ethical principles contained within the Declaration of Helsinki, this 
protocol, all applicable regulatory authority regulations, and conditions of approval 
imposed by the reviewing IRB or regulatory authority. 
• I will supervise all testing of the device involving human subjects and ensure that 
the requirements relating to obtaining informed consent and IRB review and 
approval are met in accordance with applicable local and governmental regulations. 
• I have read and understand the appropriate use of the investigational product(s) as 
described in the protocol, current Investigator’s Brochure, product information, or 
other sources provided by the Sponsor. 
• I understand the potential risks and side effects of the investigational product(s).  
• I agree to maintain adequate and accurate records in accordance with government 
regulations and to make those records available for inspection. 
• I agree to comply with all other requirements regarding the obligations of clinical 
Investigators and all other pertinent requirements of the Sponsor and government 
agencies. 
• I agree to ensure that all associates, colleagues, and employees assisting in the 
conduct of the study are informed of their obligations in meeting the above 
commitments. 
 
Have you ever been disqualified as an Investigator by any Regulatory Authority? 
 No        Yes 
Have you ever been involved in a study or other research that was terminated? 
 No        Yes 
If yes, please explain here: 
 
 
Principal Investigator: 
 
Signature 
 
 
 
 
 
Date 
Name and professional 
position: 
Address: 
 

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1 PROTOCOL SYNOPSIS 
Trial Sponsor 
Alcon Research, LLC 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
Name of Test Product(s) 
LID020098 
Name of Control 
Product(s) 
None 
Title of Trial 
Clinical Characterization of an Investigational Soft Silicone 
Hydrogel Contact Lens 
Protocol Number 
CLY935-E006 
Number of Sites 
Country 
~3 
US 
Planned Duration of 
Exposure  
Test Product: ~ 14 ± 2 days 
Number of Subjects  
Target to complete: 30 
Planned to enroll: ~36 
Study Population 
Volunteer subjects aged 18 or over who are habitual spherical 
weekly/monthly soft contact lens wearers, have at least 3 months of 
contact lens wearing experience, and who wear their habitual 
contact lenses at least 5 days per week and at least 8 hours per day.  
 
 
 
 
 
 
 
  
Objective(s) 
The primary objective of this study is to evaluate the overall clinical 
performance of an investigational silicone hydrogel contact lens  
 over 2 weeks of daily wear.  
Endpoints 
Primary Effectiveness 
• Front surface wettability  
 
 

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Safety 
• AEs 
• Biomicroscopy findings 
• Device deficiencies 
Assessments 
 
Effectiveness 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
• Lens surface evaluation front surface wettability, 
 
 

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Safety 
• AEs 
• Biomicroscopy  
• Device deficiencies 
Study Design 
 Prospective 
 Single-masked  
(trial subject) 
 Single-masked (Investigator) 
 Double-masked 
 Open-label 
 Other 
 Single group 
 Parallel group 
 Crossover 
 Other 
 Contralateral 
 Bilateral 
 Monocular lens wear 
 Randomized 
Test Product Details 
 
 
 
LID Number 
LID020098 
Manufacturer 
Alcon Laboratories, Inc. 
 
 
  
 
  
Inclusion Criteria 
1. Subject must be at least 18 years of age.  
2. Subject must be able to understand and must sign an ICF that 
has been approved by an IRB. 
3. Successful wear of spherical weekly/monthly soft contact lenses 
in both eyes for a minimum of 5 days per week and 8 hours per 
day during the past 3 months. 
 
 
 
 
 

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8. Subject must be willing to stop wearing their habitual contact 
lenses for the duration of study participation.   
 
 
  
Exclusion Criteria 
1. Any anterior segment infection, inflammation, or abnormality or 
disease (including systemic) that contraindicates contact lens 
wear, as determined by the Investigator. 
2. Any use of systemic or ocular medications for which contact 
lens wear could be contraindicated, as determined by the 
Investigator. 
3. History of refractive surgery or plan to have refractive surgery 
during the study or irregular cornea in either eye. 
 
 
 
 
 
 
 
 
6. Current or history of pathologically dry eye in either eye that, in 
the opinion of the Investigator, would preclude contact lens 
wear. 
 
 
 
 
 
 
 
 
10. Wearing habitual contact lenses in an extended wear modality 
(routinely sleeping in lenses for at least 1 night per week) over 
the last 3 months prior to enrollment. 
11. Any use of topical ocular medications and artificial tear or 
rewetting drops that would require instillation during contact 
lens wear. 
 
 
 
  

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1.1 Abbreviations 
Abbreviation 
Definition 
ADE 
Adverse device effect 
AE 
Adverse event 
 
 
CFR 
Code of Federal Regulations 
 
 
D/C 
Discontinue 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
FDA 
US Food and Drug Administration 
GCP 
Good Clinical Practice 
ICF 
Informed consent form 
IP 
Investigational product 
IRB 
Institutional review board 
ISO 
International Organization for Standardization 
LID 
Lens identification 
 
 
 
 
MOP 
Manual of procedures 
N/A 
Not applicable 
OD 
Right eye 
OFR 
OPTI-FREE RepleniSH multipurpose disinfection solution 
OS 
Left eye 
OU 
Both eyes 
SAE 
Serious adverse event 
SADE 
Serious adverse device effect 
US 
United States 
USV 
Unscheduled visit 
VA 
Visual acuity 
 
 

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2 TABLE OF CONTENTS 
Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens ............. 1 
1 
PROTOCOL SYNOPSIS .................................................................................................... 3 
1.1 
Abbreviations..................................................................................................... 10 
2 
TABLE OF CONTENTS ................................................................................................... 11 
List of Tables ............................................................................................................................ 13 
List of Figures .......................................................................................................................... 13 
3 
INTRODUCTION ............................................................................................................. 14 
3.1 
Study 
 Purpose ............................................................................. 14 
3.2 
Trial Objective ................................................................................................... 14 
3.3 
Risks and Benefits ............................................................................................. 14 
3.4 
Subject Population ............................................................................................. 15 
3.5 
Outline of Study................................................................................................. 15 
4 
TREATMENTS ADMINISTERED................................................................................... 15 
4.1 
Identity of Study Treatments ............................................................................. 15 
 
 
 
 
5 
STUDY PROCEDURES AND ASSESSMENTS ............................................................. 18 
5.1 
Visits and Examinations .................................................................................... 18 
5.1.1 
Visit 1 – Screening/Baseline/
 ................................. 18 
5.1.2 
Visit 2 
 – Dispense Study Lens ............ 19 
5.1.3 
Visit 3 (
 – Week 2 Follow-up/Exit .... 21 
5.2 
Unscheduled Visits ............................................................................................ 23 
5.3 
Discontinued Subjects ....................................................................................... 24 
5.4 
Clinical Study Termination ................................................................................ 24 
6 
ANALYSIS PLAN ............................................................................................................ 25 
6.1 
Subject Evaluability ........................................................................................... 25 
6.2 
Analysis Data Sets ............................................................................................. 25 
6.2.1 
Safety Analysis Set ............................................................................ 25 
6.3 
Demographic and Baseline Characteristics ....................................................... 25 
6.4 
Effectiveness Analyses ...................................................................................... 26 

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6.4.1 
Primary Effectiveness ........................................................................ 26 
6.4.1.1 
Statistical Hypotheses ........................................................ 26 
6.4.1.2 
Analysis Methods............................................................... 26 
 
 
 
 
 
 
 
 
6.6 
Handling of Missing Data .................................................................................. 27 
 
 
6.8 
Safety Analysis .................................................................................................. 28 
 
 
 
 
7 
ADVERSE EVENTS AND DEVICE DEFICIENCIES ................................................... 29 
7.1 
General Information .......................................................................................... 31 
7.2 
Monitoring for Adverse Events ......................................................................... 34 
7.3 
Procedures for Recording and Reporting .......................................................... 34 
 
 
7.5 
Follow-Up of Subjects with Adverse Events ..................................................... 36 
7.6 
Pregnancy in the Clinical Study ........................................................................ 37 
8 
CONFIDENTIALITY, BIAS, AND MASKING ............................................................... 37 
8.1 
Subject Confidentiality and Methods Used to Minimize Bias .......................... 37 
8.2 
Unmasking of the Study Treatment ................................................................... 37 
9 
DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ............................... 38 
9.1 
Completion of Source Documents and Case Report Forms .............................. 38 
9.2 
Data Review and Clarifications ......................................................................... 39 
9.3 
Regulatory Documentation and Records Retention .......................................... 39 
10 ETHICS AND COMPLIANCE ......................................................................................... 39 
10.1 Compliance ........................................................................................................ 39 
10.2 Institutional Review Board (IRB)...................................................................... 39 
11 PROTOCOL AMENDMENT HISTORY .......................................................................... 40 
12 REFERENCES .................................................................................................................. 41 
12.1 References applicable for all clinical trials ........................................................ 41 
12.1.1 
US references applicable for clinical trials ........................................ 41 

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12.2 References for this clinical trial ......................................................................... 41 
 
List of Tables 
Table 1-1 
Schedule of Study Procedures and Assessments ............................................... 7 
 
List of Figures 
Figure 7–1 
Categorization of All AEs ................................................................................ 31 
Figure 7-2 
Categorization of All Serious Adverse Events ................................................. 32 
 
 

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The site personnel will educate subjects on proper hygiene and lens handling, and compliance 
with the use of contact lenses according to the protocol. Subjects should be instructed not to 
wear contact lenses while sleeping or swimming. The site personnel will also advise the 
subjects to remove contact lenses and return for prompt follow-up of symptoms, such as 
ocular discomfort, foreign body sensation, excessive tearing, vision changes, or hyperemia. 
3.4 Subject Population 
The study population includes approximately 36 volunteer subjects to be enrolled at 
approximately 3 sites, with approximately 12 subjects enrolled per site. The study population 
will consist of subjects with normal eyes (other than the need for optical correction for 
refractive ametropia), who are adapted, existing wearers of soft weekly/monthly contact 
lenses in both eyes, 
 
  
 
  
Rescreening of subjects after screen failure is not allowed in this study. 
3.5 Outline of Study 
This will be a multi-site, prospective, single arm, open-label study examining 1 type of 
contact lens. The expected duration of subject participation in the study is approximately 
2 weeks, with up to 3 scheduled visits. The study is expected to be completed in 
approximately 5 weeks. 
4 TREATMENTS ADMINISTERED 
All subjects will be receive the test lens to wear bilaterally throughout the study duration.  
4.1 Identity of Study Treatments 
DESCRIPTION OF TEST PRODUCTS 
LID Number 
LID020098 
Lens identified in 
randomization system as:  
N/A 
 
  

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DESCRIPTION OF TEST PRODUCTS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Usage 
• Wear:  
o Daily Wear  
o Bilateral 
o Single arm open-label 
 
 
 
 

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DESCRIPTION OF TEST PRODUCTS 
 
 
 
  
 
 
 
 
• Lens Care: OFR  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 

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5 STUDY PROCEDURES AND ASSESSMENTS 
5.1 Visits and Examinations 
5.1.1 
Visit 1 – Screening/Baseline/Order Spectacles 
1 
Explain the purpose and nature of the study, and have the subject read, sign, and date 
the IRB-approved informed consent document. Additionally, have the individual 
obtaining consent from the subject and a witness, if applicable, sign and date the 
informed consent document. Provide a photocopy of the signed document to the 
subject and place the original signed document in the subject’s chart. After signing 
the ICF, a subject will be assigned a subject number by the EDC system. A signed 
informed consent document defines the point of enrollment. 
2 
Obtain demographic information and medical history, including information on all 
medications used within the past 30 days. Include herbal therapies, vitamins, and all 
over-the-counter as well as prescription medications. 
 
 
 
 
 
  
 
 
 
 
 
 
 
 

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8 
Review inclusion/exclusion criteria to determine if the subject qualifies to be in the 
study. If subject does not qualify, exit the subject from the study as a screen failure. 
9 
Determine and record study lens powers based upon the manifest refraction and 
habitual lens powers. 
10 
Assess and record any device deficiencies and AEs reported or observed during the 
study visit.  
• Note: AEs must be recorded for all enrolled subjects from the time of 
signature of informed consent including those subjects who screen fail. 
11 
Optimize study contact lens power 
 
   
12 
Schedule Visit 2
.  
 
 
 
5.1.2 
Visit 2 
 – Dispense Study Lens 
1 
If Visit 2 immediately follows Visit 1, go to step 5 of this visit. 
Obtain information on any changes in medical health and/or the use of concomitant 
medications. 
2 
Assess and record any device deficiencies and AEs, including those associated with 
changes in concomitant medication dosing, which are observed or reported since the 
previous visit(s). 

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4 
Perform slit-lamp biomicroscopy (without contact lenses) to evaluate the following: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5 
Have the subject insert the appropriate study lenses, being careful to maintain the 
correct OD and OS lens assignments. 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 

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10 
Evaluate the study lenses by performing the following assessments*: 
 
  
• Lens surface evaluation (front surface wettability, 
 
 
 
   
 
 
 
12 
Assess and record any AEs and device deficiencies reported or observed during the 
study visit. 
Note: AEs and device deficiencies must be recorded for all enrolled subjects from the time of 
signature of informed consent including those that screen fail, as applicable. 
13 
Dispense new lens case(s), and lens care solution (OFR). Provide the subject with 
written and verbal instructions on lens wear and care.  
14 
Schedule Visit 3 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
5.1.3 
Visit 3 
 – Week 2 Follow-up/Exit 
1 
Obtain information on any changes in medical health and/or the use of concomitant 
medications. 

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11 
Perform slit-lamp biomicroscopy (without contact lenses) to evaluate the following: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
14 
Assess and record any AEs and device deficiencies reported or observed during the 
study visit.  
Note: AEs and device deficiencies must be recorded for all enrolled subjects from the 
time of signature of informed consent including those subjects who screen fail, as 
applicable. 
15 
Exit the subject from the study. 
 
5.2 Unscheduled Visits 
Any visit that occurs between regularly scheduled visits is an Unscheduled Visit. If a subject 
requires an Unscheduled Visit, he/she must be advised to return to the office wearing the 
study lenses, if at all possible (unless he/she is experiencing a sign or symptom [as indicated 
in Section 3.3 Risks and Benefits]). During all unscheduled visits, the Investigator must 
conduct the following procedures:  
• Collect AE and Device Deficiency information 
• Assess and record changes in medical health or concomitant medication  
• Assess and record VAs 
• Perform biomicroscopy (assessments with or without lenses, as possible) 

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In addition, refer to Table 1-1 Unscheduled Visit for required procedures. The Investigator 
may perform additional procedures for proper diagnosis and treatment of the subject. The 
Investigator must document this information in the subject’s case history source documents. 
If during an Unscheduled Visit the subject is discontinuing the study lenses or discontinuing 
from the study, the Investigator must conduct Exit procedures according to Table 1-1: 
Schedule of Study Procedures and Assessments, as possible. 
5.3 Discontinued Subjects 
Discontinued subjects are those who withdraw or are withdrawn from the study after signing 
the informed consent, including screen failures. Subjects may discontinue from the study at 
any time for any reason. Subjects may also be discontinued from the study at any time if, in 
the opinion of the Investigator, their continued participation poses a risk to their health. 
Discontinued subjects will not be replaced (ie, their subject numbers will not be 
re-assigned/re-used). 
Should a subject exhibit any clinically relevant signs, symptoms, or other clinical 
observations that possibly could be associated with suspected sensitivity or intolerance to one 
of the study treatments, the Investigator must document those observations on an AE Form. 
Any subject who exits early from the study (excluding screen failures) must undergo all 
procedures outlined at Visit 3, as applicable. 
The Investigator must document the reason for study or treatment discontinuation in the 
subject’s case history source documents. 
To ensure the safety of all subjects who discontinue early, Investigators must assess each 
subject and, if necessary, advise them of any therapies and/or medical procedures that may be 
needed to maintain their health. 
5.4 Clinical Study Termination 
The Study Sponsor reserves the right to close the investigational site or terminate the study in 
its entirety at any time, for reasonable cause. 
If the clinical study is prematurely terminated or suspended by the Study Sponsor:  
• The Study Sponsor must: 
o Immediately notify the Investigator(s) and subsequently provide 
instructions for study termination. 

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o Inform the Investigator and the regulatory authorities of the 
termination/suspension and the reason(s) for the termination/suspension, 
as applicable.  
• The Investigator must: 
o Promptly notify the IRB of the termination or suspension and of the 
reasons.  
o Provide subjects with recommendations for post-study treatment options 
as needed. 
The Investigator may terminate a site’s participation in the study for reasonable cause. 
6 ANALYSIS PLAN 
Continuous variables will be summarized using the number of observations, mean, standard 
deviation, median, minimum, and maximum. Categorical variables will be summarized with 
frequencies and percentages from each category.  
 
 
6.1 Subject Evaluability 
The final subject evaluability will be determined prior to locking the database, based on the 
Deviations and Evaluability Plan. 
6.2 Analysis Data Sets 
6.2.1 
Safety Analysis Set 
Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. 
As such, the safety analysis set will include all subjects/eyes exposed to any study lenses 
evaluated in this study, except for the lenses used with the purpose of power optimization. 
For treatment-emergent safety analyses, subjects/eyes will be categorized under the actual 
study lenses exposed.  
6.3 Demographic and Baseline Characteristics 
Demographic information (age, sex, ethnicity, race) will be summarized on the Safety 
Analysis Set. Baseline data pertaining to habitual lens (lens brand, lens care brand) and 
keratometry will be summarized on the Safety Analysis Set as well. 

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6.4 Effectiveness Analyses 
This study defines one primary endpoint
 The Safety 
Analysis Set will be used for all effectiveness analyses.  
6.4.1 
Primary Effectiveness 
The primary objective of this study is to evaluate the overall performance of an 
investigational silicone hydrogel contact lens over 2 weeks of daily wear. The primary 
endpoint is front surface wettability, collected on a 5-point scale, for each eye.  
6.4.1.1 
Statistical Hypotheses 
No inferences are to be made on the primary effectiveness endpoint; therefore, no hypotheses 
are formulated. 
6.4.1.2 
Analysis Methods 
Descriptive statistics will be presented, to include frequencies and percentages in each grade 
as well for the combined category of Grade 0 and Grade 1. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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. 
 
 
 
 
6.6 Handling of Missing Data 
All data obtained in evaluable subjects/eyes will be included in the analysis. No imputation 
for missing values will be carried out. 
 
 
 
 

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7 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
Terms and Definitions 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the 
investigational medical device (test product). Note: For subjects, 
this definition includes events related to the test product, the 
control product, or the procedures involved. For users or other 
persons, this definition is restricted to events related to the test 
product. 
Adverse Device 
Effect (ADE) 
AE related to the use of an investigational medical device (test 
product) or control product. Note: This definition includes AEs 
resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation; any 
malfunction; and use error or intentional misuse of the test product 
or control product.  
Anticipated Serious 
Adverse Device 
Effect 
Serious ADE which by its nature, incidence, severity or outcome 
has been identified in the risk management file. 
Device Deficiency 
Inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. Note: This definition 
includes malfunctions, use errors, and inadequate labeling. 
Malfunction 
Failure of a medical device to meet its performance specifications 
or otherwise perform as intended. Performance specifications 
include all claims made in the labeling of the device. The intended 
performance of the device refers to the intended use for which the 
device is labeled or marketed. 
Non-serious Adverse 
Event 
AE that does not meet the criteria for an SAE. 
Serious Adverse 
Event (SAE) 
AE that led to any of the following: 
• Death. 
• A serious deterioration in the health of the subject that either 
resulted in: 
a) a life-threatening illness or injury. 
Note: Life-threatening means that the individual was at 
immediate risk of death from the event as it occurred, ie, it 

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does not include an event which hypothetically might have 
caused death had it occurred in a more severe form. 
b) any potentially sight-threatening event or permanent 
impairment to a body structure or a body function. 
c) in-patient hospitalization or prolonged hospitalization. 
Note: Planned hospitalization for a pre-existing condition, 
without serious deterioration in health, is not considered 
an SAE. In general, hospitalization signifies that the 
individual remained at the hospital or emergency ward for 
observation and/or treatment (usually involving an 
overnight stay) that would not have been appropriate in the 
physician's office or an out-patient setting. Complications 
that occur during hospitalization are adverse events. If a 
complication prolongs hospitalization or fulfills any other 
serious criteria, the event is serious. When in doubt as to 
whether “hospitalization” occurred, the event should be 
considered serious. 
d) a medical or surgical intervention to prevent a) or b).  
e) any indirect harm as a consequence of incorrect diagnostic 
test results when used within manufacturer’s instructions 
for use. 
• Fetal distress, fetal death, or a congenital abnormality or birth 
defect. 
Refer to Section 7.1 for additional SAEs. 
Serious Adverse 
Device Effect 
(SADE) 
ADE that has resulted in any of the consequences characteristic of 
an SAE. 
Significant Non-
Serious Adverse 
Event 
A significant non-serious AE is a symptomatic, device-related, 
non-sight threatening AE that warrants discontinuation of any 
contact lens wear for greater than or equal to 2 weeks. 
Refer to Section 7.1 for additional Significant Non-Serious AEs. 
Unanticipated 
Serious Adverse 
Device Effect 
Serious adverse device effect which by its nature, incidence, 
severity or outcome has not been identified in the risk management 
file. 

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Use Error 
Act or omission of an act that results in a different medical device 
response than intended by manufacturer or expected by user.  
Note: This definition includes slips, lapses, and mistakes. An 
unexpected physiological response of the subject does not in itself 
constitute a use error. 
 
7.1 General Information 
An AE is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, 
whether or not related to the investigational medical device (test product). 
Figure 7–1 
Categorization of All AEs 
ADE
Device /
procedure-
related?
Symptomatic, 
Device-related, 
Non sight-
threatening, D/C 
Lens Wear?
Meets 
seriousness 
criteria?
SAE
All AEs
AE
Significant     
Non-Serious AE
No
No
Yes
Yes
Yes
 
 

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Figure 7-2 
Categorization of All Serious Adverse Events 
All SAEs
Device /
procedure 
related?
SAE
SADE
Anticipated?
Unanticipated 
SADE
No
Yes
No
Anticipated 
SADE
Yes
 
 
  
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Device Deficiencies 
A device deficiency is inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. A device deficiency may or may not be 
associated with patient harm (ie, ADE or SADE); however, not all ADEs or SADEs are due 
to a device deficiency. The Investigator should determine the applicable category listed in the 
Device Deficiency eCRF for the identified or suspect device deficiency and report any patient 
harm separately.
  
 
 
 

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7.2 Monitoring for Adverse Events 
At each visit, after the subject has had the opportunity to spontaneously mention any 
problems, the Investigator should inquire about AEs by asking the standard questions: 
• “Have you had any health problems since your last study visit?” 
• “Have there been any changes in the medicines you take since your last study visit?” 
Additionally, changes in any protocol-specific parameters and/or questionnaires evaluated 
during the study are to be reviewed by the Investigator. Any untoward (unfavorable and 
unintended) change in a protocol-specific parameter or questionnaire response that is 
clinically relevant, in the opinion of the Investigator, is to be reported as an AE. These 
clinically relevant changes will be reported regardless of causality.  
7.3 Procedures for Recording and Reporting 
AEs are collected from the time of informed consent. Any pre-existing medical conditions or 
signs/symptoms present in a subject prior to the start of the study (ie, before informed 
consent is signed) are not considered AEs in the study and should be recorded as medical 
history. 
 
 
  
 
 
  
 
 
  

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Any AEs and device deficiencies for non-study marketed devices/products (ie, OFR) will be 
considered and processed as spontaneous (following the postmarket vigilance procedures) 
and should be communicated to the device’s/product’s manufacturer as per local 
requirements. 
Study Sponsor representatives may be contacted for any protocol related question. 
 
 
 
 
 
 
 
 
 
 
 

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The Study Sponsor will assess the AEs and may upgrade the Investigator’s assessment of 
seriousness and/or causality. The Study Sponsor will notify the Investigator of any AEs that 
are upgraded from non-serious to serious or from unrelated to related. 
 
 
 
 
 
 
  
7.5 Follow-Up of Subjects with Adverse Events  
The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study.  
 
 
 

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7.6 Pregnancy in the Clinical Study 
Women of childbearing potential or women who are pregnant at the time of study entry are 
not excluded from participation. 
 
 
 
 
8 CONFIDENTIALITY, BIAS, AND MASKING 
8.1 Subject Confidentiality and Methods Used to Minimize Bias 
The Investigator must ensure that the subject’s anonymity is maintained throughout the 
course of the study. In particular, the Investigator must keep an enrollment log with 
confidential identifying information that corresponds to the subject numbers and initials of 
each study participant. All documents submitted to the Sponsor will identify the subjects 
exclusively by number and demographic information. No other personally identifying 
information should be transmitted to the Sponsor. 
This an open label study with all subjects assigned to wear LID020098 bilaterally for the 
duration of the 2-week treatment period.  
8.2 Unmasking of the Study Treatment 
Not applicable; this study is open-label. 

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9 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS 
9.1 Completion of Source Documents and Case Report Forms 
The nature and location of all source documents will be identified to ensure that original data 
required to complete the eCRFs exist and are accessible for verification by the site monitor, 
and all discrepancies shall be appropriately documented via the query resolution process. 
Study monitors are appointed by the Study Sponsor and are independent of study site staff. If 
electronic records are maintained, the method of verification must be determined in advance 
of starting the study.  
At a minimum, source documents should include the following information for each subject: 
• Subject identification (name, sex, race/ethnicity) 
• Documentation of subject eligibility 
• Date of informed consent 
• Dates of visits 
• Documentation that protocol specific procedures were performed 
• Results of study parameters, as required by the protocol 
• IP accountability records 
• Documentation of AEs and other safety parameters (if applicable) 
• Records regarding medical histories and the use of concomitant therapies prior to and 
during the study 
• Date of study completion and reason for early discontinuation, if applicable 
It is required that the author of an entry in the source documents be identifiable. Direct access 
to source documentation (medical records) must be allowed for the purpose of verifying that 
the data recorded on the eCRF are consistent with the original source data. 
Only designated individuals may complete the eCRFs. The eCRFs will be submitted at 
regular intervals following the clinical study visit schedule. It is expected that all data 
reported will have corresponding entries in the source documents. The Principal Investigator 
is responsible for reviewing and certifying that the eCRFs are accurate and complete. The 
only subject identifiers recorded on the eCRFs will be subject number and subject 
demographic information. 

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9.2 Data Review and Clarifications 
Upon completion of the eCRFs, a targeted review of the eCRF data to the subject’s source 
data will be completed by the site monitor to ensure completeness and accuracy. Additional 
data clarifications and/or additions may be needed as a result of the data cleaning process. 
Data clarifications are documented and are part of each subject’s eCRFs. 
9.3 Regulatory Documentation and Records Retention 
The Investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the Sponsor and the Investigator’s files will be reviewed as part of the ongoing 
study monitoring. Financial disclosure is not subject to regulatory inspection and should be 
kept separately.  
Additionally, the Investigator must keep study records and source documents until the 
Sponsor provides written approval for their destruction. If the Investigator retires, relocates, 
or for any other reason withdraws from responsibility of keeping the study records, the 
Sponsor must be notified and suitable arrangements made for retention of study records and 
source documents needed to comply with national and international regulations (generally 
2 years after discontinuing clinical development or after the last marketing approval). 
10 ETHICS AND COMPLIANCE 
This trial will be conducted in accordance with the ethical principles that have their origin in 
the Declaration of Helsinki and the referenced directives, regulations, guidelines, and/or 
standards. 
10.1 Compliance 
The Investigator must ensure that all personnel involved in the conduct of the study are 
qualified to perform their assigned responsibilities through relevant education, training, and 
experience. The Investigator and all clinical study staff must conduct the clinical study in 
compliance with the protocol. Deviations from this protocol, regulatory requirements and/or 
GCP must be recorded and reported to the Sponsor prior to database lock. If needed, 
corrective and preventive action should be identified, implemented, and documented within 
the study records. 
10.2 Institutional Review Board (IRB) 
This trial requires IRB approval prior to initiation. This protocol, subject informed consent, 
and subsequent amendments will be reviewed and approved by an IRB. 

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Before clinical study initiation, this protocol, the ICF (and assent form, if applicable), any 
other written information given to subjects, and any advertisements planned for subject 
recruitment must be approved by an IRB. The Investigator must provide documentation of 
the IRB approval to the Study Sponsor. The approval must be dated and must identify the 
applicable protocol, amendments (if any), ICF, assent form (if any), all applicable recruiting 
materials, written information for subject, and subject compensation programs. The IRB must 
be provided with a copy of the Investigator’s Brochure, any periodic safety updates, and all 
other information as required by local regulation and/or the IRB. At the end of the study, the 
Investigator must notify the IRB about the study’s completion. The IRB also must be notified 
if the study is terminated prematurely. Finally, the Investigator must report to the IRB on the 
progress of the study at intervals stipulated by the IRB. 
Voluntary informed consent must be obtained from every subject (and/or legal representative, 
as applicable) prior to the initiation of any screening or other study-related procedures. The 
Investigator must have a defined process for obtaining consent. Specifically, the Investigator, 
or delegate, must explain the clinical study to each potential subject and the subject must 
indicate voluntary consent by signing and dating the approved informed consent form. The 
subject must be provided an opportunity to ask questions of the Investigator, and if required 
by local regulation, other qualified personnel. The Investigator must provide the subject with 
a copy of the consent form written in a language the subject understands. The consent 
document must meet all applicable local laws and provide subjects with information 
regarding the purpose, procedures, requirements, and restrictions of the study, along with any 
known risks and potential benefits associated with the IP, the available compensation, and the 
established provisions for maintaining confidentiality of personal, protected health 
information. Subjects will be told about the voluntary nature of participation in the study and 
must be provided with contact information for the appropriate individuals should questions or 
concerns arise during the study. The subject also must be told that their records may be 
accessed by appropriate authorities and Sponsor-designated personnel. The Investigator must 
keep the original, signed copy of the consent and must provide a duplicate copy to each 
subject according to local regulations. Following this study, the subject will return to their 
eye care professional for their routine eye care and contact lenses. 
11 PROTOCOL AMENDMENT HISTORY 
Version 
Brief Description and Rationale 
1 
Initial Version of this document 
 

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12 REFERENCES 
12.1 References applicable for all clinical trials 
• ISO 11980:2012 Ophthalmic optics - Contact lenses and contact lens care products - 
Guidance for clinical investigations 
• ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good 
clinical practice 
12.1.1 US references applicable for clinical trials 
• 21 CFR Part 11 - Electronic Records; Electronic Signatures 
• 21 CFR Part 50 - Protection of Human Subjects 
• 21 CFR Part 56 - Institutional Review Boards 
• 21 CFR Part 812 - Investigational Device Exemptions 
• 21 CFR Part 54 - Financial Disclosure by Clinical Investigators 
• The California Bill of Rights 
12.2 References for this clinical trial 
Not applicable. 

Signature Page for V-CLN-0000847 v1.0
Signature Page for V-CLN-0000847 v1.0