Insertion Clinical Study to Evaluate the Orientation Characteristics of Multiple Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
Phase: NA
Conditions: Astigmatism
Sponsor: Bausch & Lomb Incorporated



ROC2-21-012 Insertion Clinical Study to Evaluate the Orientation Characteristics of Multiple kalifilcon A Daily 
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TABLE OF CONTENTS 
INVESTIGATIONAL SITE AND STUDY PERSONNEL ........................................................... 2 
SYNOPSIS ...................................................................................................................................... 3 
LIST OF ABBREVIATIONS ......................................................................................................... 9 
1.0 INTRODUCTION .................................................................................................................. 10 
2.0 OBJECTIVE ........................................................................................................................... 10 
3.0 STUDY DESIGN.................................................................................................................... 10 
3.1 Description of Study Design ............................................................................................... 10 
3.2 Selection of Study Population ............................................................................................. 10 
3.2.1 Eligibility ..................................................................................................................... 10 
3.2.1.1 Inclusion Criteria ................................................................................................... 10 
3.2.1.2 Exclusion Criteria .................................................................................................. 11 
3.2.2 Point of Enrollment and Randomization ...................................................................... 11 
3.2.3 Subject Completion ...................................................................................................... 11 
3.2.4 Lost to Follow-up ......................................................................................................... 12 
3.3 Investigators ........................................................................................................................ 12 
3.4 Study Duration .................................................................................................................... 12 
3.5 Protocol Changes and Amendments ................................................................................... 12 
4.0 STUDY MATERIALS ........................................................................................................... 12 
4.1 Description of the Test Article(s) ....................................................................................... 12 
4.2 Description of Comparator Product(s) ................................................................................ 13 
4.3 Instructions for Use and Administration ............................................................................. 13 
4.3.1 Storage Requirements .................................................................................................. 13 
4.3.2 Subject Instructions ...................................................................................................... 13 
4.4 Other Study Materials ......................................................................................................... 14 
4.5 Packaging and Labeling ...................................................................................................... 14 
4.6 Accountability ..................................................................................................................... 14 
4.7 Masking............................................................................................................................... 14 
4.8 Product Replacement .......................................................................................................... 14 
4.9 Risk Assessment ................................................................................................................. 14 
4.9.1 Risk Related to Subject ................................................................................................ 15 
4.9.2 Risk Related to Data Management .............................................................................. 15 
4.10 Relevance of Clinical Investigation .................................................................................. 15 

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5.0 STUDY METHODS ............................................................................................................... 16 
5.1 Study Visits ......................................................................................................................... 16 
5.1.1 Methodology: ............................................................................................................... 16 
5.1.2 Unscheduled Visits ...................................................................................................... 17 
5.1.3 Missed Visits ................................................................................................................ 17 
5.1.4 Post-Study Follow-up Visit ......................................................................................... 17 
5.2 Study Completion ........................................................................................................... 17 
5.2.1 Study Termination/Suspension .................................................................................... 17 
5.2.2 Study Termination Procedure ...................................................................................... 17 
5.3 Concomitant Medications/Therapy ..................................................................................... 18 
5.4 Protocol Deviations ............................................................................................................. 18 
6.0 ADVERSE EVENTS .............................................................................................................. 18 
6.1 Adverse Event Definitions .................................................................................................. 18 
6.1.1 Adverse Event (AE) ..................................................................................................... 18 
6.1.2 Serious Adverse Event (SAE) ...................................................................................... 19 
6.1.3 Serious Adverse Ocular Event ..................................................................................... 19 
6.1.4 Significant, Non-Serious Adverse Event ..................................................................... 20 
6.1.5 Non-significant, Non-serious Adverse Event .............................................................. 20 
6.1.6 Adverse Device Effect (ADE) ..................................................................................... 20 
6.1.6.1 Anticipated Serious Adverse Device Effect (ASADE) ......................................... 20 
6.1.6.2 Unanticipated Serious Adverse Device Effect (USADE) ...................................... 21 
6.1.7 Device Deficiency ........................................................................................................ 21 
6.2 Adverse Event Treatment and Culturing ............................................................................ 21 
6.3 Adverse Event Identification and Evaluation ..................................................................... 21 
6.4 Adverse Event Collection and Reporting ........................................................................... 22 
6.5 Reporting Device Deficiencies ........................................................................................... 24 
6.6 Emergency Contact Details for Reporting Serious Adverse Events and Adverse Device 
Effects: ...................................................................................................................................... 24 
7.0 STATISTICAL METHODS ................................................................................................... 25 
7.1 Study Endpoints .................................................................................................................. 25 
7.2 Hypotheses .......................................................................................................................... 25 
7.3 Sample Size ......................................................................................................................... 25 
7.4 Randomization .................................................................................................................... 25 
7.5 Study Populations ............................................................................................................... 25 

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7.6 Statistical Analysis .............................................................................................................. 25 
7.6.1 Pass/Fail Criteria .......................................................................................................... 26 
7.6.2 Interim Analyses .......................................................................................................... 26 
7.6.3 Exploratory/Sensitivity Analysis ................................................................................. 26 
7.6.4 Deviations .................................................................................................................... 26 
8.0 DATA QUALITY ASSURANCE .......................................................................................... 26 
8.1 Study Monitoring ................................................................................................................ 26 
8.1.1 Monitoring Subject Risk .............................................................................................. 26 
8.1.2 Monitoring the Informed Consent Process .................................................................. 26 
8.1.3 Data Verification .......................................................................................................... 27 
8.1.3.1 Direct Entry with Verification ............................................................................... 27 
8.1.3.2 Double Entry of Data ............................................................................................. 27 
8.1.3.3 The Data Management Summary (DMS) .............................................................. 28 
8.1.4 Annual Research Clinic Monitoring Plan .................................................................... 28 
8.1.4.1 Monitoring Procedure ............................................................................................ 28 
8.1.4.2 Site Performance Evaluation & Monitoring Report .............................................. 28 
8.2 Auditing Procedures............................................................................................................ 29 
8.3 Source Documentation ........................................................................................................ 29 
8.4 Maintaining Subject Privacy ............................................................................................... 29 
8.5 Locking the Database .......................................................................................................... 30 
8.6 Retention of Documents ..................................................................................................... 30 
8.7 Clinical Quality Assurance ................................................................................................. 30 
8.8 Institutional Review Board ................................................................................................. 30 
8.9 Statements of Compliance .................................................................................................. 30 
8.10 Informed Consent Process ................................................................................................ 31 
8.10.1 Vulnerable Population ............................................................................................... 31 
8.11 Publication of Results ....................................................................................................... 31 
9.0 BIBLIOGRAPHY ................................................................................................................... 32 
 33 
APPENDIX B: SUBJECT INSTRUCTIONS FOR USE ............................................................. 37 
 
 
 
 

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LIST OF ABBREVIATIONS 
 
Abbreviation/Acronym Term 
AE 
Adverse Event 
B+L 
Bausch + Lomb 
BSCVA 
Best Spectacle-Corrected Visual Acuity 
CFR 
Code of Federal Regulations 
CRT 
Clinical Research Technician  
CRF/e-CRF 
Case Report Form / Electronic Case Report Form 
D 
Diopter 
DOB 
Date of Birth 
EDC 
Electronic Data Capture 
EC 
Ethics Committee 
FDA 
United States Food and Drug Administration 
GCPs 
Good Clinical Practices 
GPRM 
Global Pharmacovigilance and Risk Management 
GPS 
Global Product Surveillance 
GSSP 
Global Safety Surveillance and Pharmacovigilance 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
IOP 
Intraocular Pressure 
ID 
Identification 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
SA 
Spherical Aberration  
US 
United States 
USC 
United States Code 
NOTE:  The first occurrence of some abbreviations is not spelled out in the document (e.g., units of measure). 
 

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1.0 INTRODUCTION 
With Toric contact lenses, the ability of the lens to orient correctly on-eye and to maintain that 
orientation (i.e., rotational stability) are important aspects of acceptable on-eye performance. 
Mechanical design features (
 are components of Toric contact lens designs 
that are added to provide acceptable movement, orientation, and rotational stability and need to 
do so without adversely impacting comfort. This clinical study aims to confirm that the kalifilcon 
A Daily Disposable Toric LD213001 contact lens design is providing acceptable orientation, 
rotational stability, and movement when compared to Ultra (samfilcon A) Toric. 
 
2.0 OBJECTIVE 
The objective is to evaluate the fit characteristics 
 
 of kalifilcon A toric contact lenses as compared to commercially available Ultra 
for Astigmatism contact lenses.  
 
3.0 STUDY DESIGN 
 
3.1 Description of Study Design 
Approximately 30 soft toric contact lens adapted subjects will be enrolled in 
this bilateral, randomized, double masked (subject and investigator masked), repeated measures 
insertion study.  All subjects will be seen for a Screening/Dispensing Visit at which informed 
consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria 
and none of the exclusion criteria, subjects will have study lenses inserted in random, successive 
order according to unique randomization schedules that will be provided to each Investigator.   
 
3.2 Selection of Study Population 
 
Approximately 30 soft toric contact lens adapted subjects 
 
  
 
Written informed consent, enrollment in the study, or dispensing of study products 
cannot begin until the Investigator has received Institutional Review Board (IRB)/Ethics 
Committee (EC) approval to conduct the study. 
 
To reduce the foreseeable factors that could compromise the outcome of the clinical 
investigation, subjects are targeted who are habitual contact lens wearers. To be eligible to 
participate, subjects must have physiologically normal anterior segments not exhibiting clinically 
significant biomicroscopy findings, no active ocular disease or allergic conjunctivitis, not using 
any topical ocular medications and be willing and able to follow instructions.  
 
3.2.1 Eligibility 
3.2.1.1 Inclusion Criteria 
To be eligible for entry into the study, the subject must: 
1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have 
capacity to read, understand and provide written voluntary informed consent.   

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2. Have physiologically normal anterior segments not exhibiting clinically significant 
biomicroscopy findings. 
3. Have no active ocular disease or allergic conjunctivitis. 
4. Not be using any topical ocular medications. 
5. Be willing and able to follow instructions. 
6. Have signed a statement of informed consent. 
3.2.1.2 Exclusion Criteria 
The subject is not eligible to participate in the study if the subject is:  
1. Participating in a conflicting study. 
2. Considered by the Investigator to not be a suitable candidate for participation. 
 
3.2.2 Point of Enrollment and Randomization 
The study subject and investigator will be masked. An unmasked designee will be responsible 
for dispensing study products to the subjects according to the randomization schedule. The 
randomization schedule will be produced prior to study enrollment by Bausch + Lomb’s 
unmasked statistician not otherwise involved in the study. 
 
Randomization will be completed by the unmasked designee. The subjects will be assigned 
randomization numbers sequentially as they are enrolled. The unmasked designee is responsible 
for preparing the clinical trial materials according to the randomization schedule. The unmasked 
designee is also responsible for maintaining study lens inventory, randomization schedule and 
the Product Accountability Log in a masked fashion. 
 
3.2.3 Subject Completion 
The subject will have completed the study when he/she has worn the study lenses. 
 
Subjects who require further follow-up due to an ongoing Adverse Event will be followed 
according to the Adverse Event Section 6.0. 
 
The Investigator may discontinue a subject during the study for any reason if, in his or her opinion, 
it is in the best interest of the subject. Reasons for discontinuation include but are not limited to:  
• 
adverse effects  
• 
other ocular complications  
• 
subject non-compliance  
• 
subject request  
• 
subject found to be ineligible during study participation*  
*Any subject enrolled in the study, who later is found to have not met any of the eligibility 
criteria at entry, will be discontinued at the Sponsor’s request.  
  
Subject discontinuations will be documented clearly on the applicable case report form.   
Subjects that are discontinued from the study following randomization will not be replaced.  
 
Exit visits should be completed for early terminated subjects. 
 
The completion of the clinical investigation shall be deemed to coincide with the last visit of the 

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within the Investigator’s Brochure. Risks are also summarized within the Informed Consent 
document. The assessments required for the study are routinely performed and are standard of 
care for contact lens wearers. The subjects will be informed of any potential study specific risks 
in the ICF or if new risks become apparent during the study. 
 
4.9.1 Risk Related to Subject 
 
With contact lens wear there may be increased risk of corneal edema (swelling of the cornea) 
which may temporarily affect vision or comfort, neovascularization (small blood vessels growing 
into the cornea), giant papillary conjunctivitis (small bumps on the inside of the eyelids), iritis 
(internal inflammation in the eye), corneal infiltrates (corneal inflammation) and corneal 
erosion/abrasion or corneal infection, which if untreated may cause ocular problems. 
 
The risks involved in this study will be minimized because the subjects will be examined 
frequently and at specified intervals.  The risks are further minimized by the study eligibility 
criteria.    
 
The subject may not personally benefit from being in this study other than getting the 
opportunity to wear different types of contact lenses.  However, study results may allow a new or 
improved product to be marketed in the future giving benefit to other contact lens users. 
4.9.2 Risk Related to Data Management 
The risks involved in this study related to data management will be minimized because the CRT 
(Clinical Research Technician) will enter the data directly into the Electronic Data Capture 
(EDC) system. The Primary Investigator or Delegate will visually verify the data as it is entered, 
except masked information when applicable.  If data is not entered directly into the EDC System, 
the data will be double entered.  Then, the two sets of data will be compared to each other and 
then checked for discrepancies.  
  
Risk of data management is further minimized by edit checks built into the EDC system to 
minimize the chance of error.  For example, the EDC system does not allow the same lens to be 
dispensed more than once. Also, the expected ranges of values are specified in the EDC system. 
If data falls outside of the expected range, the CRT will be prompted to answer a query. 
 
4.10 Relevance of Clinical Investigation 
Bausch + Lomb is finalizing the kalifilcon A toric lens design. This this clinical study aims to 
confirm whether the kalifilcon A daily disposable toric contact lenses are providing acceptable 
orientation when worn. 
 
Further information regarding the relevance of this study in the context of state of the art clinical 
practice such as background information, summary of relevant literature, mechanism of action, 
intended clinical performance, and a summary of existing relevant clinical data of the 
investigational device can be found in the Investigator’s Brochure. 
 
 
 

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5.1.2 Unscheduled Visits 
Additional visits may be scheduled, as necessary, to ensure the safety and well-being of 
subjects. All additional visits should be fully documented on Unscheduled Visit forms as 
appropriate.  
 
5.1.3 Missed Visits 
If a subject misses a Study Visit, the visit is considered missed and the subject must be exited 
from the study. The Investigator or designee must check the missed visit box on the first page of 
the applicable e-CRF for that visit. 
 
See Section 3.2.4 Lost to Follow-Up for applicable instructions for subjects who do not 
return for the final visit. 
 
5.1.4 Post-Study Follow-up Visit 
There is no planned follow-up period after the clinical investigation is complete. If a subject 
requires further follow-up upon discontinuation or completion of the study, the Investigator must 
schedule post-study follow-up visits, as necessary. The Investigator is required to follow the 
subject until the condition no longer warrants further follow-up for study purposes. A Post-Study 
Follow-up Visit e-CRF must be completed for each of these visits. 
 
There will not be any routine eye care provided after the clinical investigation is complete. 
Subjects should follow-up with their eye care provider every 1-2 years for comprehensive eye 
care or sooner as recommended by their eye care provider.   
 
5.2 Study Completion 
The subject has completed the study when the last visit is completed. Subjects who require 
further follow-up will be followed according to the Adverse Event or Post- Study Follow-Up 
Section. There is no planned follow-up period after the clinical investigation is complete. 
 
The completion of the clinical investigation shall be deemed to coincide with the last visit of 
the last subject and when follow-up is complete 
 
5.2.1 Study Termination/Suspension  
If during the study it becomes evident that the study should be stopped prematurely or placed on 
hold, appropriate notification will be given to the requestor and IRB/ECs, as applicable. Should 
the Investigator and/or study requester wish to terminate the study, the following Research Clinic 
procedure will be followed. Any subjects with ongoing Adverse Events at the time of premature 
study termination or hold will be followed by the Investigator. 
 
5.2.2 Study Termination Procedure 
The decision to terminate a study will be made by the Director of Clinical Affairs and the 
Principal Investigator (PI). A final slit lamp examination should be performed, and adverse 

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events handled accordingly. All investigational materials (lenses, solutions, and / or devices) will 
be retrieved, all subjects will be exited, and the Trial Master File will be reconciled.  A clinical 
study report will be written and include the reason for study termination.   
 
5.3 Concomitant Medications/Therapy 
Ocular, systemic or topical medications that, in the Investigator’s opinion, could potentially 
affect ocular physiology or lens performance are prohibited. 
 
5.4 Protocol Deviations 
The date of and reason for deviations will be documented in all cases. Significant or 
major protocol deviations impacting the safety of the subject or the integrity of the study 
must be reported by the Investigator to the IRB immediately. Reporting of all other protocol 
deviations must adhere to the requirements of the governing IRB/EC.  
 
Any subject enrolled in the study who later is found to have not met the eligibility criteria 
at entry will be discontinued. Otherwise, unless the protocol deviations put the subject at 
risk or the subject’s condition requires that they be discontinued from the study, subjects 
may continue to participate until the end of the study. 
 
6.0 ADVERSE EVENTS  
Subjects who experience an Adverse Event (AE) during study participation will be discontinued 
from study participation but will be followed by the Investigator until resolution of the AE or 
until the Investigator determines that further improvement is not expected.  
 
6.1 Adverse Event Definitions 
For the purposes of this study, reportable AEs include ocular AEs and non-ocular serious 
adverse events (SAEs). All AEs will be classified first for seriousness and significance and 
then as to whether or not they are device related or non-device related and if device related, 
then, if it is an adverse device effect (ADE), an anticipated serious adverse device effect 
(ASADEs) or an unanticipated serious adverse device effect (USADEs). AEs, ADEs, 
ASADEs, USADEs, SAEs, Significant Non-Serious AEs and Non-Significant Non- 
Serious AEs are defined as follows: 
 
6.1.1 Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects or users, whether or not related to the 
investigational medical device. Adverse events should be categorized as device related or non-
device related.  
Throughout the course of this study all efforts will be made to remain alert to reportable 
AEs. If an AE occurs, the first concern will be the safety of the subject and appropriate 
medical intervention will be made. 
All reportable AEs occurring after signing of informed consent and through the subject’s 
end of participation in the study must be reported. All reportable AEs must be followed 
until the event resolves or stabilizes. 
 

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6.1.2 Serious Adverse Event (SAE) 
An adverse event which:  
• Led to death; 
• Led to serious deterioration in the health of the subject, that resulted in: 
o A life-threatening illness or injury; or 
o A permanent impairment of a body structure or a body function (e.g., blindness); 
or  
o Inpatient or prolonged hospitalization; or 
o Medical or surgical intervention to prevent life-threatening illness or  
o Injury or permanent impairment to a body structure or a body function; 
• Led to fetal distress, fetal death, or a congenital abnormality or birth defect. 
6.1.3 Serious Adverse Ocular Event  
Serious Adverse Ocular Event is a serious adverse event that results in, or has potential to cause, 
either permanent impairment of an ocular function or damage to an ocular structure and may 
necessitate medical or surgical intervention. Serious Adverse Events require expedited reporting. 
Serious adverse events include any hazardous, sight-threatening conditions occurring after 
exposure to a test article, including but not limited to the following: 
 
• A presumed infectious ulcer (defined as a progressive erosion of the corneal tissue). For 
the purposes of reporting, a corneal ulcer which has any of the following characteristics 
should be considered in this category: 
o Central or paracentral location; 
o Penetration of Bowman’s membrane; 
o Infiltrate ≥2 mm diameter; 
o Associated with iritis;  
o Associated with any increase in intraocular pressure; 
o Culture positive for microorganisms; 
o Increasing size or severity at subsequent visits. 
 
Note: Signs of a presumed infectious ulcer may include irregular focal infiltrates; 
active lesions with raised edges; significant diffuse infiltration; anterior corneal to 
mid-stromal involvement; erosion with overlying staining; conjunctival and lid 
edema; anterior chamber reaction (iritis); severe bulbar and limbal redness. Symptoms 
associated with a presumed infectious ulcer (microbial keratitis) may include pain of 
rapid onset; severe redness; purulent or mucopurulent discharge; tearing; photophobia. 
 
• Any central or paracentral (within 6 mm of cornea) corneal event that results in 
permanent opacification (such as corneal scar or vascularization) 
• Any serious adverse ophthalmic events including hypopyon and hyphema. 
• Any neovascularization within the central 6 mm of the cornea. 
• Permanent loss of 2 or more lines (10 letters) of BSCVA. 
• All cases of iritis. 
 

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6.1.4 Significant, Non-Serious Adverse Event  
A Significant, Non-Serious Adverse Event is an Adverse Event that does not meet the serious 
criteria, is considered significant, and requires expedited reporting. These events include (but are 
not limited to): 
• Peripheral non-progressive non-infectious corneal ulcer 
• All symptomatic corneal infiltrative events 
• All cases of corneal staining severity greater than or equal to Grade 3 
• A temporary loss of 2 or more lines (10 or more letters) of BSCVA (for greater than or 
equal to 2 weeks) 
• Increase in neovascularization of 1.5mm or greater. 
• Any ocular event that necessitates temporary lens discontinuation of greater than or equal 
to 2 weeks. 
 
6.1.5 Non-significant, Non-serious Adverse Event 
A Non-Significant Non-Serious Adverse Event may include (but are not limited to) and does not 
require expedited reporting: 
• Asymptomatic, peripheral, corneal infiltrative events. 
• Bacterial Conjunctivitis 
• Viral Conjunctivitis 
• Allergic Conjunctivitis 
• Corneal Edema 
• Contact Lens Related Papillary Conjunctivitis 
 
6.1.6 Adverse Device Effect (ADE) 
An ADE is an Adverse Event that is assessed to be related to the use of an investigational 
medical device. This definition includes Adverse Events resulting from insufficient or inadequate 
instructions for use; deployment, implantation, installation, or operation; or any malfunction of 
the investigational medical device. This definition also includes any event resulting from use 
error or from intentional misuse of the investigational medical device. 
 
6.1.6.1 Anticipated Serious Adverse Device Effect (ASADE)  
An ASADE is an ADE that first meets the serious criteria (see definition above for Serious 
Adverse Event) or significant, non-serious criteria (see above definition for significant, non-
serious AE) and which, by its nature, incidence, severity or outcome, has been previously 
identified in the investigational plan or application (including a supplementary plan or 
application) and/or in the risk analysis report. ASADEs include: 
• Corneal Ulcer (infectious or non-infectious) 
• Keratitis 
• Sensitivity to light (photophobia) 
• Excessive eye secretions including mucopurulent discharge 
• Blurred vision, rainbows or halos around objects 
• Poor visual acuity (reduced sharpness of vision) 
• Moderate to severe eye pain not relieved by removing the lens 
 

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6.1.6.2 Unanticipated Serious Adverse Device Effect (USADE) 
An USADE is an ADE that first meets the serious criteria (see definition above for Serious 
Adverse Event) or significant, non-serious criteria (see above definition for significant, non-
serious AE) and has an effect on health or safety or any life-threatening problem or death caused 
by, or associated with, a device if that effect, problem or death was not previously identified in 
nature, severity or degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of subjects. 
 
6.1.7 Device Deficiency 
Inadequacy of an investigational medical device with respect to its identity, quality, durability, 
reliability, safety, or performance. This includes malfunctions, use errors, inadequate labelling, 
insufficient or inadequate instructions for use. A Device Deficiency can occur with or without 
the occurrence of an Adverse Event. 
 
6.2 Adverse Event Treatment and Culturing 
With any Adverse Event, treat the subject as appropriate to prevent further complications and to 
potentially resolve the event consistent with the standard of care. 
 
A culture should be obtained in cases of corneal ulcer or suspected ocular infection, unless 
medically contraindicated. Cultures should be taken from the cul-de-sac, lower eyelid margin, 
and the corneal lesion (if applicable). When a culture is obtained, the contact lenses and contact 
lens cases which were being utilized by the subject at the time of the AE should be collected 
from the subject (if available at the time of the  
culture) for culturing and processing by the 
clinical laboratory designated by the Research Clinic. Microbial data generated from returned 
subject supplies (e.g., lenses, lens cases and/or lens case solutions) are for information only. 
Because microbes may be introduced into subject supplies during use, recovery of microbes 
from returned subject supplies cannot be presumed to indicate etiology or direction of organism 
transmission. The ocular cultures, along with the associated contact lenses and contact lens 
cases, will be sent to the clinical laboratory designated by the Research Clinic for analysis. The 
clinical laboratory will report the culture results to both the Investigator and to the Research 
Clinic, the Investigator will record the results in the CRF. 
 
6.3 Adverse Event Identification and Evaluation  
Throughout the course of a study all efforts will be made to remain alert to Adverse Events 
(AEs). If an AE occurs, the first concern will be the safety of the subject and appropriate medical 
intervention will be made. The associated product should be retained for further analysis, if 
needed. 
 
All AEs occurring after signing the informed consent and through the end of the subject’s 
participation in the study must be recorded and reported, if applicable. All AEs must be followed 
until the event resolves or stabilizes.  
 
Identify potential adverse events during a clinical study by using the following sources: 
• 
Direct observation by the Investigator 

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• 
Asking the study participant using a non-specific question (i.e. Have you had any 
problems since the last visit?) 
• 
Unsolicited volunteering of information by the study participant (i.e. Doctor, I have had 
numerous headaches since I started using this lens) 
• 
Laboratory or test results that meet protocol requirements for classification as an adverse 
event (i.e. IOP over 30mmHg) 
When evaluating AEs, the Investigator should classify the AE based on the following three 
criteria: 
 
1. Seriousness and/or significance (based on the criteria provided in Section 6.1)  
 
Severity: 
• Mild: Subject awareness of a sign or symptom that is easily tolerated, requires no 
treatment, and does not interfere with subject’s daily activities. 
 
• Moderate: Subject awareness of a sign or symptom which may be a low level of 
concern to the subject and may interfere with daily activities but can be relieved by 
simple therapeutic care. 
 
• Severe: A sign or symptom that interrupts the subject’s daily activity and requires 
systemic therapy or other treatment. 
 
2. The relationship of the event to the study device using the following guidelines   
• Related: There is at least a reasonable possibility that the AE is related to the study 
device (contact lens) and/or solution or rewetting drops. Reasonable possibility means 
that there is evidence to suggest a causal relationship or association between the study 
device and/or solution or rewetting drops and the AE. Also referred to as an ADE.  
• Not Related: There is little or no reasonable possibility that the AE is related to the study 
device (contact lens) and/or solution or rewetting drops. This assessment implies that the 
AE has no evidence to suggest either a causal relationship or association to the study 
device and/or solution or rewetting drops and a more likely or certain alternative etiology 
exists. 
3. Expectedness of the event  
• Unexpected Adverse Event (UAE):  Unexpected Adverse Events must be reported to 
the IRB within 10 calendar days of discovery. 
 
• Expected Adverse Event: An adverse event of which, the nature or severity of which is 
consistent with the current product labeling, investigator brochure, data sheet, etc. 
6.4 Adverse Event Collection and Reporting 
The Research Clinic will delegate each function’s roles and responsibilities related to adverse 
event reporting. The Director of Clinical Affairs is responsible for ensuring that all Research 
Clinic Staff understand their responsibilities for collecting and assessing adverse event 

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information and forwarding applicable adverse event information to the appropriate business 
function. 
 
Research Clinic Staff are responsible for understanding the procedures for adverse event 
collection, evaluation, documentation, and reporting. 
• Collect and record information about any identified adverse event (including the date of 
the adverse event, treatment, resolution, assessment of both the seriousness and the 
relationship to the investigational device and the related procedure) on the Adverse Event 
form. The Adverse Event Form will be completed each time the subject is seen during the 
management of the incident and at resolution of the incident.  
• If an adverse event is determined to be serious or significant and non-serious, notify the 
Principal Investigator immediately. 
• Report all serious or significant and non-serious adverse events within twenty-four (24) 
hours to Regulatory Affairs, Global Product Surveillance and/or Global Safety 
Surveillance and Pharmacovigilance as appropriate for the product being evaluated. 
Continue to send follow-up information or provide support to the appropriate reporting 
business function for any serious adverse event as soon as it becomes available. 
o Ensure that the subject’s identity is protected and the subject’s identifiers in the 
study are properly documented on the form.   
• Report all unexpected adverse device effects to the reviewing Institutional Review Board 
within 10 business days of discovery.  Continue to send follow-up information as soon as 
it becomes available. 
• Report any adverse event resulting from Intentional Misuse of an investigational medical 
device per the same procedures as above.  
• Report any adverse event resulting from a Device Deficiency per the same procedures as 
above. All Device Deficiencies should be recorded and evaluated for the potential to 
cause a serious adverse event.  
 
• All appropriate measures will be taken to ensure the safety of the subject. Follow the 
subject until the adverse event resolves or until an appropriate endpoint is reached. This 
may imply that follow-up will continue after the subject has left the study.  
• A treatment of an AE will depend on the severity of the adverse event. The Principal 
Investigator will refer the subject to a suitably licensed eye  care professional for 
immediate treatment if necessary. 
• Expenses incurred for study-related medical treatment will be paid by Bausch + Lomb. 
Research Clinic Staff will contact Environmental Health and Safety to initiate the 
medical payment claims process. 
• If it is determined, based on evaluation of any serious adverse event or serious adverse 
event trending, that the study presents an unreasonable risk, the Research Clinic may 
choose to terminate the study. Refer to the Study Termination procedures (section 5.2.2) 
for additional information and relevant periods for terminating a study.  
• All adverse events will be documented in the final study report. Adverse Event 
documentation must be saved in the Trial Master File and in the respective study folder in 
the electronic repository. 

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parametric dependent variables. Differences at the p < 0.05 level will be considered statistically 
significant.  
 
It should be noted that the -12.00 test lenses do not have an available parameter matched control. 
Data for the -12.00 lenses will be summarized using descriptive statistics only. 
 
7.6.1 Pass/Fail Criteria 
There are no pass/fail criteria for the results of the clinical investigation. 
 
7.6.2 Interim Analyses 
No interim analyses are planned. 
 
7.6.3 Exploratory/Sensitivity Analysis 
There are no planned exploratory or sensitivity analyses for this study. 
 
7.6.4 Deviations 
Any deviations from the original statistical analysis plan will be summarized in the Clinical Study 
Report.  
 
8.0 DATA QUALITY ASSURANCE 
Prior to the start of the study, member(s) of the Research Clinic and Investigators will review the 
protocol, e-CRFs, regulatory obligations, and other material or equipment relevant to the conduct 
of the study. 
 
During the study, if it is determined that an Investigator is not compliant with the protocol and/or 
applicable regulatory requirements, action will be taken to secure compliance. In addition, the 
Investigator’s participation in the study may be terminated if appropriate, or if the Investigator 
remains non-compliant. 
 
8.1 Study Monitoring 
The monitoring plan for this study includes Informed Consent and Data Verification.   
 
8.1.1 Monitoring Subject Risk  
The risks involved with contact lens wear in this study will be minimized because the subjects 
will be examined frequently and at specified intervals.  The risks are further minimized by the 
study eligibility criteria.  The subject population will be restricted to persons who are 18 years of 
age or older and have full legal capacity to volunteer; no restrictions are made as to gender. 
  
8.1.2 Monitoring the Informed Consent Process   
Informed consent forms are verified for all subjects enrolled in each study.  Subject and witness 
signature and date are visually verified by the CRT and then confirmed in the EDC System at the 
time of enrollment. Informed Consent Form signatures are also verified during study 
reconciliation by CRT. The signed informed consent forms are kept in the study folder.  
 

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8.1.3 Data Verification 
Edit checks are built into the EDC System to minimize the chance of error.  For example, the 
EDC System does not allow the same lens to be dispensed more than once. The expected ranges 
of values are specified in the EDC System. If data falls outside of the expected range, the CRT 
will be prompted to answer a query. 
  
Data is collected by the CRT or Delegate using either Direct Entry with Verification or Double 
Data Entry.   
 
8.1.3.1 Direct Entry with Verification  
Direct Entry with Verification is the preferred method for entering study data. Data is collected 
by the CRT or Delegate and entered directly into the EDC System.  A second person, typically 
the Primary Investigator (or Delegate), will visually verify the data as it is entered, except 
masked information when applicable. 
• In the event that the EDC System is unavailable, a paper CRF will be used to collect 
study data for later entry into the EDC System. After each page of the CRF is entered into 
the EDC System, the CRT or Delegate will initial the CRF to indicate the data has been 
entered into the EDC System and visually verified. 
• Randomization Verification is required at the conclusion of each study prior to data 
distribution. The CRT or Delegate will verify each dispensed article against the study 
randomization and Clinical Trial Material (CTM) label, if applicable. After 
Randomization Verification of dispensed article, the CRT or Delegate will mark the 
Verification checkbox in the EDC System to acknowledge completion of dispensed 
article verification. 
• If discrepancies arise during the verification of a paper source, the CRT or Delegate 
assesses the discrepancy and obtains additional information to determine if the correct 
entry was made or corrects paper source as appropriate. The CRT or Delegate may 
consult the Primary Investigator if necessary. 
• The data is extracted from the EDC System and checked for accuracy by comparing the 
extracted data to the data originally recorded in the EDC System. The data extract is 
checked to confirm the lens reformat codes match the lens key. Calculations performed 
by the EDC System are checked for accuracy. 
• Database Randomization Verification is performed, if applicable, prior to data 
distribution. 
  
8.1.3.2 Double Entry of Data  
If data is not entered directly in the EDC system, the data will be double entered (entered twice) 
and the two sets of data will be compared to each other and then checked for discrepancies.  
 When a paper source (i.e. subject questionnaire) is used to collect study data, this method may 
be used.  For example, a subject questionnaire will be entered into two different spreadsheets.  
The two spreadsheets are then compared to each other. 
• If discrepancies arise during the verification of a paper source, the CRT or Delegate 
assesses the discrepancy and obtains additional information to determine if the correct 
entry was made or corrects the paper source as appropriate. The CRT or Delegate may 
consult the Primary Investigator if necessary. 

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report to the Research Clinic Director (RCD) or Delegate for review. 
 
8.2 Auditing Procedures 
Audits of clinical research activities in accordance with Bausch + Lomb’s internal Standard 
Operating Procedures to evaluate compliance with the principles of GCP may take place. A 
regulatory authority may also wish to conduct an inspection (during the study or after its 
completion).  
 
8.3 Source Documentation 
Source documentation consists of original subject documents, as well as data and records with 
information relevant to the subject and his/her participation in the study.  The data collected in 
the e-CRFs at all the visits will be available to the Investigator after the conclusion of the trial.   
 
Examples of source documents include: hospital records, clinical and office charts, laboratory 
notes, memoranda, signed ICF, evaluation checklists, recorded data from automated instruments, 
copies or transcriptions certified after verification as being accurate copies, and information 
initially recorded in an electronic format. 
 
Subject completed forms are also considered to be source data, if applicable to the study. The 
Investigator or designee should review subject completed forms for completeness and accuracy. 
 
8.4 Maintaining Subject Privacy 
Subjects’ participation in this study and their study records (including photographs and 
video/audiotapes) will be held in a way that will protect their privacy, except when ordered by 
law.  It may be necessary for other people to review their records for study reasons.  These people 
may include:   
  
• 
The Investigator  
• 
The United States Food and Drug Administration (FDA)  
• 
Other state or federal regulatory agencies  
• 
The Institutional Review Board (IRB)  
• 
Contracted monitors or auditors  
• 
Bausch + Lomb personnel associated with the study analysis and reporting  
  
If this occurs, their identity will be protected as legally required.  If results of the study are 
published, subjects will not be identified by name.   
  
The Institutional Review Board (IRB) and accrediting agencies may inspect and copy subjects’ 
records, which may have the subjects’ name on them.  Therefore, total confidentiality cannot be 
guaranteed.  If the study results are presented at meetings or printed in publications, subject 
names will not be used.  
 
Data pertaining to subjects is only available to Bausch + Lomb personnel. Physical data remains 
locked and electronic data is password protected. When subjects receive an electronic 
recruitment invitation, all other potential subjects are blind carbon copied on the invitation to 
ensure privacy.  

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Clinical trial data is input into a secure, electronic data capture system in which only relevant 
study personnel have access. Subject data recorded on e-CRFs during the study will be 
documented in a coded fashion. The subject will only be identified by the subject number. 
Confidentiality of subject records must be maintained to ensure subject privacy.  
 
8.5 Locking the Database 
After the study is complete, the data is approved by the Principal Investigator via electronic 
signature. The database is then locked. Any change to the data after database lock will require 
approval from the EDC Programmer and is documented via electronic audit trail. 
 
8.6 Retention of Documents 
Bausch + Lomb will retain essential documents after the completion of the study. The Research 
Clinic keeps physical study related documents physically on-site for a minimum of 3 years. After 
3 years, the documents may be securely stored in an off- site location. Additionally, data is 
securely stored electronically.  
 
Essential documents include but are not limited to the following: 
• 
IRB approvals for the study protocol, all amendments, ICF(s), and advertisements 
• 
IRB correspondence and reports (e.g., AE reports, protocol deviations, and safety updates) 
• 
regulatory documents  
• 
subject’s signed ICF 
• 
accountability records for the test article(s) 
• 
any other documents relevant to the conduct of the study  
 
8.7 Clinical Quality Assurance 
Prior to being evaluated clinically, investigational devices such as contact lenses or solutions are 
analyzed and approved for release by the project manager and design quality at Bausch and 
Lomb, Rochester, NY.   Documentation of pre-clinical testing can be found on the study’s 
clinical scorecard for the relevant products.  
 
8.8 Institutional Review Board 
The Investigator should ensure their participation in the study, in addition to the protocol, subject 
recruitment materials and the ICF to be used in this study are approved by the reviewing IRB 
prior to entering any subjects in the study. In addition, the Investigator must ensure that the 
reviewing IRB has provided approval for any protocol amendments prior to implementation. If 
the amendment necessitates a revision to the ICF, the Investigator should ensure the revised form 
is also submitted to and approved by the IRB and implemented as directed. 
 
8.9 Statements of Compliance 
This study is being conducted in accordance with 21CFR Parts 11, 50, 54, 56 and 812; 42 USC 
282(j); ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good 
Clinical Practice; International Council for Harmonization (ICH) Good Clinical Practice (GCP) - 
Declaration of Helsinki and applicable local regulations.  
 

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completed. The results of the study may be published or presented by Bausch + Lomb.  
 
9.0 BIBLIOGRAPHY  
There are no references for this study.  
 

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your eyes, contact lenses affect the way in which your eyes function. These effects tend to 
increase with the length of time that the lenses remain on your eyes between removals. Although 
the great majority of people successfully wear contact lenses without problems, before you 
decide whether to begin or to continue wearing contact lenses for daily disposable wear, you 
should discuss with the study investigator the effects of contact lenses on your eyes and the risks 
associated with wearing contact lenses. You also should read the sections in these subject 
instructions entitled "Warnings”, “Adverse Reactions", "Precautions”, and “Wearing Restrictions 
and Indications". Ask the investigator to explain anything that you do not understand, including 
any additional restrictions which may be given to you.  
 
You also need to remember that soft contact lenses, including those covered by these subject 
instructions, are made of a type of plastic that absorbs liquids, vapors, and small particles, and, 
for some people, may collect deposits from your natural eye fluids. Therefore, you should strictly 
follow the instructions contained in these subject instructions entitled “Personal Cleanliness and 
Lens Handling”, and any other instructions given to you by your eye care professional. Any 
failure to follow these instructions and the wearing restrictions will increase the chances of 
contamination, damage to the lenses, or a build-up of deposits on the lenses, which can lead to 
serious, sight-threatening eye infections and injuries. 
 
If problems or symptoms should occur, immediately remove your contact lenses and follow the 
steps described in the sections in these subject instructions entitled "Warnings” and “Adverse 
Reactions". Prompt attention to problems is essential and may require immediate professional 
care. 
 
Remember, when wearing soft contact lenses your eyes should look and feel good, and your 
vision should be clear. 
WEARING RESTRICTIONS AND INDICATIONS: 
Both the Test and Control contact lens designs are intended for the daily disposable wear and 
correction of refractive error (myopia) in persons with non-diseased eyes 
 
WARNINGS: 
You should be aware of and fully discuss with the study investigator the following warnings 
pertaining to contact lens wear: 
• 
Problems with contact lenses could result in serious injury to your eye. It is essential that 
you follow your eye care professional's direction and all labeling instructions for proper use 
of lenses. Eye problems, including corneal ulcers, can develop rapidly and lead to loss of 
vision. 
• 
Strict compliance with your wearing restrictions, wearing schedule, and follow-up visit 
schedule must be followed. 
• 
Daily disposable wear lenses are not indicated for overnight wear, and you should not 
wear lenses while sleeping.  
• 
Clinical studies have shown that the risk of serious adverse reactions is increased when 
daily wear lenses are worn overnight. 
• 
Studies have shown that contact lens wearers who are smokers have a higher incidence of 
adverse reactions than nonsmokers. 

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• 
If you experience eye discomfort, excessive tearing, vision changes, or redness of the eye, 
you should immediately remove lenses and promptly contact your eye care professional. 
 
PRECAUTIONS: 
You should be aware of and fully discuss with your eye care professional the following safety 
precautions: 
 
Lens Handling Precautions 
• 
Always wash and rinse hands before handling lenses. Do not get cosmetics, lotions, soaps, 
creams, deodorants, or sprays in the eyes or on the lenses. It is best to put on lenses before 
putting on makeup. Water-base cosmetics are less likely to damage lenses than oil-base 
products. 
• 
Be certain that the fingers or hands are free of foreign materials before touching your 
lenses, as microscopic scratches of the lenses may occur, causing distorted vision and/or 
injury to the eye. 
• 
Always handle your lenses carefully and avoid dropping them. 
• 
Do not touch the lens with your fingernails. 
• 
Carefully follow the handling, insertion, removal, storing and wearing instructions in these 
subject instructions and those prescribed by the study investigator. 
• 
Never use tweezers or other tools to remove your lenses from the lens container unless 
specifically indicated for that use. Pour the lens into the hand. 
 
Lens Wearing Precautions 
• 
Never wear your lenses beyond the period recommended by your eye care professional. 
• 
If the lens sticks (stops moving) on the eye, follow the recommended directions on Care for 
a Sticking (Nonmoving) Lens. The lens should move freely on the eye for the continued 
health of the eye. If nonmovement of the lens continues, you should immediately consult 
your eye care professional. 
• 
Avoid, if possible, all harmful or irritating vapors and fumes when wearing lenses. 
• 
If aerosol products are used while wearing lenses, exercise caution and keep eyes closed 
until the spray has settled. 
 
Topics to Discuss with the Eye Care Professional: 
• 
You should not wear contact lenses during water related activities. Exposure to water while 
wearing contact lenses in activities such as swimming, water skiing and hot tubs may 
increase the risk of ocular infection including but not limited to Acanthamoeba keratitis. 
• 
Always contact your eye care professional before using any medicine in the eyes. 
 
Who should know that you are wearing contact lenses? 
• 
You may decide to inform your health care professional about being a contact lens wearer. 

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• 
Always inform your employer of being a contact lens wearer. Some jobs may require the 
use of eye protection equipment or may require that you not wear lenses. 
• 
Ask the study investigator whether there are any other wearing restrictions that apply to 
you. Write those restrictions in the spaces provided below and follow them carefully: 
 
 
 
 
 
 
 
 
 
 
 
 
 
ADVERSE REACTIONS (PROBLEMS AND WHAT TO DO): 
You should be aware that the following problems may occur: 
• 
Eyes stinging, burning, itching (irritation), or other eye pain 
• 
Comfort is less than when lens was first placed on eye 
• 
Abnormal feeling of something in the eye (foreign body, scratched area) 
• 
Excessive watering (tearing) of the eyes 
• 
Unusual eye secretions 
• 
Redness of the eyes 
• 
Reduced sharpness of vision (poor visual acuity) 
• 
Blurred vision, rainbows, or halos around objects 
• 
Sensitivity to light (photophobia) 
• 
Dry eyes 
 
If you notice any of the above, you should: 
Immediately remove your lenses 
• 
If the discomfort or problem stops, then look closely at the lens. If the lens is in any way 
damaged, do not put the lens back on your eye. You should remove the lens and place it in 
the provided contact lens case dry. Then insert a new lens on the eye. If the problem 
continues, you should immediately remove the lenses and consult your eye care 
professional. 
 
When any of the above problems occur, a serious condition such as infection, corneal ulcer, 
neovascularization, or iritis may be present. You should keep the lens off your eye and seek 
immediate professional identification of the problem and prompt treatment to avoid serious eye 
damage. 
 
PERSONAL CLEANLINESS AND LENS HANDLING: 
1. 
Preparing the Lens for Wearing: 
It is essential that you learn and use good hygienic methods in the care and handling of 
your new lenses. Cleanliness is the first and most important aspect of proper contact lens 

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care. In particular, your hands should be clean and free of any foreign substances when 
you handle your lenses. The procedures are: 
• 
Always wash your hands thoroughly with a mild soap, rinse completely, and dry 
with a lint-free towel before touching your lenses. 
• 
Avoid the use of soaps containing cold cream, lotion, or oily cosmetics before 
handling your lenses, since these substances may come into contact with the lenses 
and interfere with successful wearing. 
• 
Handle your lenses with your fingertips and be careful to avoid contact with 
fingernails. It is helpful to keep your fingernails short and smooth. 
• 
Start off correctly by getting into the habit of always using proper hygienic 
procedures so that they become automatic. 
 
2. 
Handling the Lenses: 
• 
Develop the habit of always working with the same lens first to avoid mix-ups. 
• 
Position the lens on your index finger and examine it to be sure that it is moist, 
clean, clear, and free of any nicks or tears. 
• 
Should you accidentally place an inside-out lens on your eye, one of the following 
signs should signal you to remove and replace it correctly. 
a) Less than usual comfort, 
b) The lens may fold on the eye, 
c) Excessive lens movement on blink, 
d) Blurred vision. 
• 
If the lens folds and sticks together: Place the lens in the palm of your hand and wet 
thoroughly with the recommended rinsing or storing solution. Then GENTLY rub 
the lens between your index finger and palm in a gentle back and forth motion. 
• 
If the lens flattens or drapes across your finger, the lens or your finger may be too 
wet. To correct this, dry your finger by transferring the lens several times from one 
index finger to the other, drying the opposite finger each time. 
 
3. 
Placing the Lens on the Eye 
There are other methods of lens placement. If the following methods are difficult for you, 
your Study Doctor will provide you with an alternate method.  
 
NOTE: If after placement of the lens, your vision is blurred, check for the following:  
The lens is not centered on the eye (see “Centering the Lens,” next in these instructions).  
If the lens is centered, remove the lens (see “Removing the Lens” section) and check for 
the following:  
• 
Cosmetics or oils on the lens (replace the lens)  
• 
The lens is on the wrong eye  
• 
The lens is inside-out (it would also not be as comfortable as normal)  
 

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If you find that your vision is still blurred after checking the above possibilities, remove 
both lenses and consult your eye care professional.  
 
A. The One-Hand Placement Technique  
• Place the lens on your index finger. Head up, looking straight ahead, pull down your 
lower eyelid with the middle finger of your placement hand. Look up steadily at a point 
above you. Then place the lens on the lower white part of your eye. Remove your index 
finger and slowly release the lower lid. Look down to position the lens properly. Close 
your eyes for a moment; the lens will center itself on your eye.  
 
B. The Two-Hand Placement Technique  
• With the lens on your index finger, use the middle finger of the other hand to pull the 
upper lid against the brow. Use the middle finger of your placement hand to pull down 
the lower lid and then place the lens centrally on your eye. While holding this position, 
look downward to position the lens properly. Slowly release your eyelids.  
• If the lens feels uncomfortable, then look in the mirror and gently place a finger on the 
edge of the contact lens and slowly slide the lens away from your nose while looking in 
the opposite direction. Then by blinking, the lens will re-center itself. If the lens still feels 
uncomfortable, follow the steps described in the section of these instructions entitled 
“Adverse Reactions.”  
 
4. 
Centering the Lens 

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Very rarely, a lens that is on the cornea will be displaced onto the white part of the eye 
during lens wear. This can also occur during placement and removal of the lenses if the 
correct techniques are not performed properly. To center a lens, follow one of the 
procedures below.  
• Hold the upper and lower eyelids open with your fingers. Then while looking in a 
mirror, gently place a finger on the contact lens and gently slide the lens towards the 
center of the eye.  
OR 
• Hold the upper and lower eyelids open with your fingers. Then, while looking in a 
mirror, move your eye towards the lens to place it on the center of the eye.  
 
5. 
Removing the Lens 
• Always remove the same lens first.  
• Wash, rinse, and dry your hands thoroughly.  
• Always be sure that the lens is in the correct position on your eye before you try to 
remove it (a simple check of your vision, closing one eye at a time, will tell you if the 
lens is in the correct position). Look up and slowly pull down your lower eyelid with 
the middle finger of your removal hand and place your index finger on the lower edge 
of lens. Squeeze the lens lightly between the thumb and the index finger and remove 
it. Avoid sticking the edges of the lens together. 
• Remove the other lens by following the same procedure. 
• Follow the required lens care procedures described by your eye care professional. 
• NOTE: If this method of removing your lens is difficult for you, your eye care 
professional will provide you with an alternate method. 
 
6. 
Return of Your Study Lenses 
At each visit, you must return all worn and unworn lenses that were dispensed to you 
during the designated wear periods.  
 
7. 
Emergency: 
If chemicals of any kind (household products, gardening solutions, laboratory chemicals, 
etc.) are splashed into your eyes, you should: FLUSH EYES IMMEDIATELY WITH 
TAP WATER AND THEN REMOVE LENSES PROMPTLY. CONTACT YOUR EYE 
CARE PROFESSIONAL OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT 
DELAY.