Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens
Phase: NA
Conditions: Refractive Errors
Sponsor: Alcon Research



Document ID: 
V-CLN-0004327 
Status: Approved, Version: 1.0 
Approved Date: 11 Dec 2020 
Page 2 of 42 
 
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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: 
 

Document ID: 
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Status: Approved, Version: 1.0 
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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) 
LID021201 
Name of Control 
Product(s) 
N/A 
Title of Trial 
Clinical Characterization of an Investigational Frequent 
Replacement Daily Wear Silicone Hydrogel Sphere Contact 
Lens 
Protocol Number 
CLL949-E003 
Number of Sites 
Country 
~3 
US 
Planned Duration of 
Exposure  
Test Product: ~ 7 days 
Number of Subjects  
Target to complete: 30 
Planned to enroll: ~ 48 
Study Population 
Volunteer subjects aged 18 or over who are habitual 
spherical daily wear soft frequent replacement contact lens 
wearers, have at least 3 months of contact lens wearing 
experience, and who wear their habitual lenses at least 5 
days per week for at least 8 hours per day. 
Objective(s) 
The primary objective of this study is to evaluate the clinical 
performance of an investigational frequent replacement daily 
wear silicone hydrogel (SiHy) sphere contact lens  
 
 over 7 days of daily wear. 
 
 
 
 
 
 
 
 
Endpoints 
Primary Effectiveness 
• Front surface wettability 
 
 
 
 
 

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Safety 
• AEs 
• Biomicroscopy findings 
• Device deficiencies 
Assessments 
Effectiveness 
 
 
 
 
 
 
 
 
 
 
 
 
 

Document ID: 
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Status: Approved, Version: 1.0 
Approved Date: 11 Dec 2020 
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• Lens surface evaluation (front surface wettability, 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 
LID021201 
Manufacturer 
Alcon Laboratories, Inc. 
6201 South Freeway 

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Approved Date: 11 Dec 2020 
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Fort Worth, Texas 76134-2099 
USA  
 
 
  
  
 
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 daily wear frequent 
replacement soft contact lenses in both eyes for a 
minimum of 5 days per week and 8 hours per day during 
the past 3 months. 
 
 
 
 
 
 
 
 
 
 
 
 
 
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. 

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Approved Date: 11 Dec 2020 
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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. 
 
 
 
 
 
 
  
 
 
 
Associated Materials 
• OPTI-FREE® RepleniSH® multipurpose solution (OFR) 
for contact lens cleaning and disinfecting will be used 
with the study lenses 
• 
 
.  
 

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Status: Approved, Version: 1.0 
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Table 1-1 
Schedule of Study Procedures and Assessments 
Procedure/ Assessment 
Visit 1 
Screening/ 
Baseline/ 
Order 
Spectacles 
Visit 2† 
Dispense 
Visit 3 
Week 1 
Follow-up/ 
Exit 
Early Exit 
USV 
 
 
 
 
 
 
 
 
 
 
 
Informed Consent 
 
- 
- 
- 
- 
Demographics 
 
- 
- 
- 
- 
Medical History* 
 
** 
 
 
 
Concomitant Medications* 
 
** 
 
 
 
Inclusion/Exclusion 
 
- 
- 
- 
- 
Habitual lens 
(brand, power* and 
lenscare) 
 
- 
- 
- 
- 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Biomicroscopy 
 
** 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dispense study lenses*∞ 
- 
 
- 
- 
- 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Procedure/ Assessment 
Visit 1 
Screening/ 
Baseline/ 
Order 
Spectacles 
Visit 2† 
Dispense 
Visit 3 
Week 1 
Follow-up/ 
Exit 
Early Exit 
USV 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Lens surface assessments 
(OD, OS): 
• Front surface wettability 
 
 
 
 
- 
 
 
 
() 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Procedure/ Assessment 
Visit 1 
Screening/ 
Baseline/ 
Order 
Spectacles 
Visit 2† 
Dispense 
Visit 3 
Week 1 
Follow-up/ 
Exit 
Early Exit 
USV 
 
 
Day 1 
(+ 0 to 4 
Days after 
V1) 
7-1 days 
from 
dispense$ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
AEsΩ 
 
 
 
 
 
Device deficiencies  
 
 
 
 
 
Exit Form 
(✓) 
(✓) 
 
() 
(✓) 
 
 

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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 
 
 
 
 
 
 
 
 
N/A 
Not applicable 
OD 
Right eye 
OFR 
OPTI-FREE RepleniSH multipurpose solution 
OS 
Left eye 
OU 
Both eyes 
SAE 
Serious adverse event 
SADE 
Serious adverse device effect 
SiHy 
Silicone hydrogel 
US 
United States 
USV 
Unscheduled visit 
VA 
Visual acuity 
 
 

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2 TABLE OF CONTENTS 
Vision Care SEE Protocol for CLL949-E003 ............................................................................ 1 
1 
PROTOCOL SYNOPSIS .................................................................................................... 3 
1.1 
Abbreviations .................................................................................................... 11 
2 
TABLE OF CONTENTS ................................................................................................... 12 
List of Tables............................................................................................................................ 14 
List of Figures .......................................................................................................................... 14 
3 
INTRODUCTION ............................................................................................................. 15 
3.1 
Study 
 Purpose ............................................................................. 15 
3.2 
Trial Objective ................................................................................................... 15 
3.3 
Risks and Benefits ............................................................................................. 15 
3.4 
Subject Population ............................................................................................. 16 
3.5 
Outline of Study ................................................................................................ 16 
4 
TREATMENTS ADMINISTERED .................................................................................. 16 
4.1 
Identity of Study Treatments ............................................................................. 17 
 
 
 
 
5 
STUDY PROCEDURES AND ASSESSMENTS ............................................................. 19 
5.1 
Visits and Examinations .................................................................................... 19 
5.1.1 
Visit 1 – Screening/Baseline/
s ................................. 19 
5.1.2 
Visit 2 
 – Dispense Study Lens ........... 20 
5.1.3 
Visit 3 
 – Week 1 Follow-up/Exit........... 23 
5.2 
Unscheduled Visits ............................................................................................ 24 
5.3 
Discontinued Subjects ....................................................................................... 25 
5.4 
Clinical Study Termination ................................................................................ 25 
6 
ANALYSIS PLAN ............................................................................................................ 26 
6.1 
Subject Evaluability........................................................................................... 26 
6.2 
Analysis Data Sets ............................................................................................. 26 
6.2.1 
Safety Analysis Set ............................................................................ 26 
6.3 
Demographic and Baseline Characteristics ....................................................... 27 
6.4 
Effectiveness Analyses ...................................................................................... 27 

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6.4.1 
Primary Effectiveness ........................................................................ 27 
6.4.1.1 
Statistical Hypotheses ........................................................ 27 
6.4.1.2 
Analysis Methods .............................................................. 27 
 
 
 
 
 
 
 
 
 
 
6.6 
Handling of Missing Data ................................................................................. 29 
 
 
6.8 
Safety Analysis .................................................................................................. 29 
 
 
 
 
7 
ADVERSE EVENTS AND DEVICE DEFICIENCIES ................................................... 30 
7.1 
General Information .......................................................................................... 32 
7.2 
Monitoring for Adverse Events ......................................................................... 35 
7.3 
Procedures for Recording and Reporting .......................................................... 35 
 
 
7.5 
Follow-Up of Subjects with Adverse Events ..................................................... 38 
7.6 
Pregnancy in the Clinical Study ........................................................................ 38 
8 
CONFIDENTIALITY, BIAS, AND MASKING .............................................................. 38 
8.1 
Subject Confidentiality and Methods Used to Minimize Bias .......................... 38 
8.2 
Unmasking of the Study Treatment ................................................................... 38 
9 
DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ............................... 39 
9.1 
Completion of Source Documents and Case Report Forms .............................. 39 
 
 
9.3 
Regulatory Documentation and Records Retention .......................................... 40 
10 ETHICS AND COMPLIANCE ......................................................................................... 40 
10.1 Compliance ........................................................................................................ 40 
10.2 Institutional Review Board (IRB) ..................................................................... 40 
 
 
 
 

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List of Tables 
Table 1-1 
Schedule of Study Procedures and Assessments ............................................... 8 
 
List of Figures 
Figure 7–1 
Categorization of All AEs ................................................................................ 32 
Figure 7-2 
Categorization of All Serious Adverse Events ................................................. 33 
 
 
 

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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 48 volunteer subjects to be enrolled at 
approximately 3 sites, with approximately 16 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 frequent replacement daily 
wear contact lenses in both eyes,
 
 
  
 
  
 
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 
7 days, with up to 3 scheduled visits. The study is expected to be completed in approximately 
6 weeks.  
4 TREATMENTS ADMINISTERED 
All subjects will receive the test lens to wear bilaterally throughout the study duration.  

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4.1 Identity of Study Treatments 
 
Test Lens 
LID Number 
LID021201 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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. 
Usage 
• Wear: 
o Daily Wear 
o Bilateral 
o Single arm open-
label 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 

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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. 
 
 
 
 
 
 
2 
Obtain demographic information and medical history, including information on all 
medications used within the past 30 days. 
 
 
3 
 
 
 
Record habitual lens information (brand, power) and lens care information (brand). 
If subject is wearing contact lenses, ask them to remove them after taking VA.  
 
 
 
 
 
 
 
 

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6 
Perform slit-lamp biomicroscopy (without contact lenses) to evaluate the following: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
11 
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. 
 
  
13 
Schedule Visit 2 
 
 
 
  
 
5.1.2 
Visit 2 
 – Dispense Study Lens 
 
 
 
. 
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: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
s 
• Other findings 
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. 
 
 
  
14 
Schedule Visit 3 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
15 
 
 
 
 
 

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5.1.3 
Visit 3 
 – Week 1 Follow-up/Exit 
 
 
 
2 
Record any device deficiencies or AEs, including those associated with changes in 
concomitant medication dosing, which are observed or reported since the previous 
visit. 
 
  
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9 
Evaluate the study lenses by performing the following assessments*: 
• 
 
  
• Lens surface evaluation (front surface wettability,
 
 
 
  

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11 
Perform slit-lamp biomicroscopy (without contact lenses) to evaluate the following: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
s 
 
 
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 
 
 
 
 
  
• Collect AE and Device Deficiency information 
 
  
 
 

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• Perform biomicroscopy (assessments with or without lenses, 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. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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. 
  
 
 

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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. 
 
 
For treatment-emergent safety analyses, subjects/eyes will be categorized under the actual 
study lenses exposed.  

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6.3 Demographic and Baseline Characteristics 
Demographic information (age, sex, ethnicity, race) will be summarized on the Safety 
Analysis Set. 
 
  
 
 
 
 
 
6.4.1 
Primary Effectiveness 
The primary objective of this study is to evaluate the clinical performance of an 
investigational frequent replacement daily wear SiHy sphere contact lens,
 
, over 7 days 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 
 
 
 
 
 
 
 
 
 
 
 
 
 

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l 
 
 
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. 
 
 
 
 
6.8 Safety Analysis 
The safety endpoints for this study are AEs, biomicroscopy findings, and device deficiencies.  
All AEs occurring from the time a subject signs informed consent to study exit will be 
accounted for in the reporting. 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
No inferential testing will be done for safety analysis.  

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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 (ASADE) 
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 

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performance of the device refers to the intended use for which the 
device is labeled or marketed. 
Nonserious 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 
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. 

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Serious Adverse 
Device Effect 
(SADE) 
ADE that has resulted in any of the consequences characteristic of 
an SAE. 
Significant 
Nonserious Adverse 
Event 
A significant nonserious AE is a symptomatic, device-related, 
nonsight 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 Nonserious AEs. 
Unanticipated 
Serious Adverse 
Device Effect 
(USADE) 
Serious adverse device effect which by its nature, incidence, 
severity or outcome has not been identified in the risk management 
file. 
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?” 
 
 
 
 
  
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 in the Medical 
History section of the eCRF. 
 
 
 
 
 
 
 
 
 

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Status: Approved, Version: 1.0 
Approved Date: 11 Dec 2020 
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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.  
 
 
 
 
 
 
 
 
  
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.
 
 
 
 
. 
This is an open label study with all subjects assigned to wear LID021201 bilaterally for the 
duration of the 1-week treatment period. 
8.2 Unmasking of the Study Treatment 
Not applicable; this study is open-label. 

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Status: Approved, Version: 1.0 
Approved Date: 11 Dec 2020 
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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.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Approved Date: 11 Dec 2020 
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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. 
 
  
 
 
 
 
 
 
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. 
 
 
 
 
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. 

Document ID: 
V-CLN-0004327 
Status: Approved, Version: 1.0 
Approved Date: 11 Dec 2020 
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Document ID: 
V-CLN-0004327 
Status: Approved, Version: 1.0 
Approved Date: 11 Dec 2020 
Page 42 of 42 
 
Alcon – Business Use Only