Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design
Phase: NA
Conditions: Ametropia
Sponsor: CooperVision, Inc.

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EX-MKTG-141 Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design 
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FINAL 
Clinical Evaluation of Two Daily Disposable 
Lenses in Sphere Design  
 
 
Sponsor Study Code: 
EX-MKTG-141 
Protocol Date: 
July 08, 2022 
Sponsor Company:   
CooperVision, Inc. 
Document Type: 
Protocol 
Study Category: 
 
Post Market  
Start Date: 
Finish Date: 
Clinical Site: 
August  2022 
October 2022 
School of Optometry Clinic, National 
Autonomous University (UNAM), Mexico City 
 
Revision History 
Document number 
Date 
Comments 
EX-MKTG-141 
7/08/2022 
First draft (v 1.0)  
EX-MKTG-141 
7/12/2022 
Second Draft (v 2.0) 
EX-MKTG-141 
7/18/2022 
FINAL 
 
 

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EX-MKTG-141 Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design 
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PERSONNEL & FACILITTIES 
 
 
 
   
 
 
 
 
 

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Table of Contents 
1 Introduction 
.............................................................................................................................. 6 
2 Study Objective 
........................................................................................................................ 6 
3 Study Hypothesis 
..................................................................................................................... 6 
3.1 
Study Hypothesis 
................................................................................................................ 6 
4 Study Design 
............................................................................................................................ 7 
5 Investigational Sites 
................................................................................................................. 7 
5.1 
Number of Sites 
.................................................................................................................. 7 
5.2 
Investigator Recruitment 
..................................................................................................... 7 
6 Ethics Review / Statement of Compliance 
.............................................................................. 7 
6.1 
Relevant Standards / Guidelines ........................................................................................ 7 
6.2 
Institutional Review Board .................................................................................................. 7 
6.3 
Clinical Trial Registration 
.................................................................................................... 8 
6.4 
Informed Consent 
............................................................................................................... 8 
7 Potential Risks and Benefits to Human Subjects .................................................................. 8 
8 Materials and Methods 
............................................................................................................. 9 
8.1 
Participants 
......................................................................................................................... 9 
Inclusion criteria ......................................................................................................................... 9 
8.2 
Study Materials 
................................................................................................................. 
10 
8.2.1 Contact lens 
................................................................................................................ 
10 
8.2.2 Contact Lens care 
....................................................................................................... 
10 
8.2.3 Storage of Study Medications/Treatments .................................................................. 
10 
8.2.4 Clinical Supply Inventory 
............................................................................................. 
10 
8.2.5 Disposal of Consumables ........................................................................................... 
11 
8.2.6 Masking and Control of Study Materials 
...................................................................... 
11 
8.2.7 Ordering and Accountability of Study Materials 
........................................................... 
11 
8.3 
Visit Schedule and Procedures 
......................................................................................... 
11 
8.3.1 Visit 1: Baseline / Trial Fit / Lens order 
........................................................................ 
11 
8.3.2 Visit 2: Lens dispensing (Fit LENS A / Evaluate) 
......................................................... 
12 
8.3.3 Visit 3a: 15 minutes (Evaluate LENS A) 
...................................................................... 
12 
8.3.4 Visit 3b: Lens dispensing (Fit LENS B / Evaluate) 
....................................................... 
12 
8.3.5 Visit 4: 15 minutes (Evaluate LENS B / Study Exit) 
..................................................... 
13 
9 Adverse Event Reporting 
....................................................................................................... 
13 

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9.1 
Adverse Response Definitions 
.......................................................................................... 
13 
9.2 
Procedures for Adverse Events ........................................................................................ 
15 
9.3 
Reporting Adverse Events 
................................................................................................ 
16 
9.4 
Discontinuation from the Study 
......................................................................................... 
16 
10 Statistical Analysis 
................................................................................................................. 
16 
10.1 Statistical analysis ............................................................................................................ 
16 
10.2 Sample size 
...................................................................................................................... 
17 
11 Data Quality Assurance 
......................................................................................................... 
18 
11.1 Study monitoring 
............................................................................................................... 
18 
11.2 Record keeping ................................................................................................................ 
18 
11.3 Record retention 
............................................................................................................... 
18 
11.4 Data Entry / Data Management ........................................................................................ 
18 
11.5 Confidentiality 
................................................................................................................... 
18 
11.6 Publication 
........................................................................................................................ 
18 
11.7 References 
....................................................................................................................... 
19 
 
 
 

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1 Introduction 
According to a recent International survey in 2021 daily disposable soft contact lenses 
were prescribed 
to 49% of patients (Contact Lens Spectrum market data).1 There is considerable variation between 
countries with respect to prescribing by lens material but on average daily disposable hydrogel lenses 
were prescribed 13% while daily disposable silicone hydrogel lenses 28%. In the United States silicone 
hydrogels were reported in usage at 69%, while hydrogels were reportedly used in 20% of fits in 2021. 
When comparing soft contact lens fits & refits in 2021 by replacement schedules, the daily disposable 
modality continues to lead in terms of prescribing by soft lens replacement schedule (range of 43% to 
51%).1 Daily disposable contact lenses are able to provide many benefits to contact lens wearers when 
compared with frequent replacement lens modality.2 These include the convenience of not having to 
clean and disinfect lenses after each use and the ability to have spare, replacement contact lenses 
readily available in the event of loss or damage. When a new lens is worn each day, there is 
significantly less spoliation from lens surface deposits. 3,4,5. Therefore, CooperVision is interested in 
comparing the short-term clinical performance and subjective acceptance of Proclear® 1 day, (LENS 
A), to the Select 1 Day, (LENS B), contact lenses. A non-dispensing fitting study is proposed to 
evaluate the short-term clinical performance of these lenses. 
2 Study Objective   
The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision performance 
and patient subjective experiences of the Proclear® 1 day when compared to the Select 1 Day lenses 
after 15 minutes of daily wear each. 
The primary outcome variable is: 
• Lens Fit Acceptance ratings (assessed by the investigator) 
 
 
 
 
  
 
 
 
 
 
 
 
 
3 Study Hypothesis   
3.1  Study Hypothesis  
 
• Null hypothesis (Ho): There is no difference in clinical performance and subjective 
assessments between lens types. 
• Alternative hypothesis (H1): There is a difference in clinical performance and subjective 
assessments between lens types. 

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4 Study Design  
This is a 40-subject, single-blind, (participant masked), interventional, prospective, direct refit, bilateral 
wear study. It is anticipated that this study will involve 4 visits as follows: V1: (BL/trial fit/lens order), 
V2: Dispense / evaluate P1. V3: 15 minutes. Evaluate P1/Dispense P2. V4: 15 minutes. Evaluate P2 
/ study exit. 
5 Investigational Sites 
5.1 Number of Sites 
This will be a single center investigational site in Mexico City. (Target 40 subjects).   
5.2  Investigator Recruitment  
This study will be conducted at School of Optometry Clinic; National Autonomous University (UNAM) 
Mexico City. The Investigators will be required to fulfil the following criteria: 
• 
Licensed optometrist with at least two years of contact lens fitting experience. 
• 
Experienced Investigators who will be trained in Good Clinical Practice (GCP) by the principal 
investigator. 
• 
In-office email or fax. 
• 
Willingness to follow the study protocol and to co-operate with the study monitors. 
This clinical study is designed to be in conformance with the ethical principles in the Declaration of 
Helsinki, with the ICH guidelines for Good Clinical Practice (GCP) and all the applicable local 
guidelines.  
6 Ethics Review / Statement of Compliance 
6.1  Relevant Standards / Guidelines 
This implementation document has been developed in accordance with the following:   
• ISO 14155. Clinical Investigation of Medical Devices 
• ICH Harmonized Tripartite Guideline for Good Clinical Practice 
• Declaration of Helsinki 
6.2  Institutional Review Board 
This study will be conducted in accordance with Institutional Review Board regulations (U.S. 21CFR 
Part 56.103) or applicable IEC regulations. Copies of all IRB/IEC correspondence with the 
investigator/sponsor will be kept on file. The study will commence upon approval from the following 
Ethics Committee: Comisión de Ética de la FESI. Avenida de los Barrios no. 1, Los Reyes Iztacala, 
Tlalnepantla Edo. de México. CP 54090. Telephone number 56-23-12-20 and email address 
ceticafesi@gmail.com. 

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6.3  Clinical Trial Registration 
This study will be registered with clinical trials.gov in accordance with section 801 of the Food and 
Drug Administration (FDA) Act which mandates the registration of certain clinical trials of drugs and 
medical devices. 
6.4  Informed Consent 
Informed consent, (Appendix 1), shall be obtained in writing from the subject and the process shall be 
documented before any procedure specific to the clinical investigation is carried out. 
7 Potential Risks and Benefits to Human Subjects 
There may be direct benefits to the subjects in this study such as improved vision, comfort, 
convenience, and cosmetic advantage.   Participation in a study may contribute to scientific research 
information that may be used in the development of new contact lens products. In addition, subjects 
will receive an examination of the front part of their eyes and may have the opportunity to try a different 
type of soft contact lenses and/or different lens care products at no cost to them. The contact lens 
materials used in this study are commercially available intended for daily wear (NOT extended wear) 
similar to the average wearing time of 10-16 hours for daily wear lenses.  
This study is considered to be a non-significant risk study based on United State Food and Drug 
administration (FDA) and International Standards Organization (ISO) guidelines because the study 
devices used as intended in this study (daily wear) don’t represent a potential for serious risk to the 
health, safety or welfare of the subject, and (2) it is not an implant, (3) it is not used to support or 
sustain human life, (4) it is not of substantial importance in diagnosing, curing, mitigating or treating 
disease or otherwise prevents impairment of human health, (5) does not present a potential for serious 
risk to the health, safety or welfare of the subject.   
Complications that may occur during the wearing of contact lenses include discomfort, dryness, aching 
or itching eyes, excessive tearing, discharge, hyperemia and variable or blurred vision.  More serious 
risks may include photophobia, iritis, corneal edema or eye infection. Although contact lens-related 
infections are very infrequent, the possibility does exist.  The incidence of infection due to day-wear 
soft lenses is 0.035%. Almost always an infection will occur only in one eye.  This risk is assumed by 
35-million Americans who currently wear contact lenses.  
Routine clinical procedures including auto-refraction, auto-keratometry, visual acuity, anterior ocular 
health assessment, and contact lens fitting will be used. In addition, high magnification imaging of the 
lens fit may be made using 35 mm or digital cameras, in vivo confocal microscopy, and/or specular 
microscopy. Patients will be monitored in the clinic during the study to reduce if not eliminate the 
occurrence of adverse or potential adverse events. Patients will be given instructions from the study 
investigator regarding early symptoms and signs of adverse events and their contact information.  

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8 Materials and Methods 
8.1  Participants 
Habitual soft contact lens wearers who currently wear sphere lenses for distance vision correction and 
provide written informed consent and meet the protocol entrance criteria. Subjects will be recruited 
from the National Autonomous University School of Optometry databases who agree to voluntarily 
participate in the study (Appendix 2, timeline). All subjects will be screened to determine study 
eligibility. Each subject will be given a unique ID number. Additionally, all subjects must meet the study 
inclusion and exclusion criteria listed below.  
Inclusion criteria 
A person is eligible for inclusion in the study if he/she: 
1. Is at least 18 years of age and has full legal capacity to volunteer. 
2. Has read and signed an information consent letter. 
3. Self-reports having a full eye examination in the previous two years. 
4. Anticipates being able to wear the study lenses for the required time of the study. 
5. Is willing and able to follow instructions and maintain the appointment schedule. 
6. Has refractive astigmatism no higher than -0.75 DC. 
7. Can be fit with the available lens parameters (sphere +8.00 to -10.00D). See Table 1. 
8. Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study 
contact lenses. 
Exclusion Criteria 
A person will be excluded from the study if he/she: 
1. Is participating in any concurrent clinical or research study. 
2. Has any known active* ocular disease and/or infection that contraindicates contact lens wear. 
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable. 
4. Is using any systemic or topical medications that in the opinion of the investigator may affect 
contact lens wear or a study outcome variable. 
5. Has known sensitivity to the diagnostic sodium fluorescein used in the study. 
6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment. 
7. Has undergone refractive error surgery or intraocular surgery. 
 
* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires 
therapeutic treatment. Mild (i.e., not considered clinically relevant) lid abnormalities (blepharitis, meibomian 
gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular 
disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and 
are therefore not active. 

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8.2.5 Disposal of Consumables 
This study dispenses consumables (lenses) to participants for use during the study. Study lenses worn 
by participants will be discarded by the principal investigator at the end of the study.  
8.2.6 Masking and Control of Study Materials 
The contact lenses, (LENS A, and LENS B), will be masked to the subject only. The lenses will be 
removed from their blister pack by an assistant and transferred to an unmarked lens case to maintain 
the participants masked of the study lenses. Participants will then be instructed to remove the lenses 
from the lens case and insert them onto their eyes. It is not possible for the study investigators to be 
masked because of the need to follow the specific lens fitting guide during the lens prescription 
optimization visit.     
8.2.7 Ordering and Accountability of Study Materials 
The study sponsor will supply the investigators with the study lenses to use during the study.  
8.3 Visit Schedule and Procedures 
This will be an interventional, subject masked, bilateral, non-dispensing fitting study.  Participants will 
be examined at two different points over the course of one day, V1 (lens dispensing), V2 (15 minutes 
post lens settling).  Participants will wear two different pairs of lenses with LENS A fitted first to all 
participants, followed by LENS B. Anterior ocular health examination will be performed at baseline 
without the use of fluorescein*.  
* Fluorescein will not be used before lens dispensing to prevent potential eye discomfort that could influence 
subjective comfort ratings after lens fitting and settling. However, fluorescein will be instilled at the last visit upon 
lens removal. 
The following outline identifies the two study visits and the general procedures, (Appendix 5), to be 
conducted at each visit for each day of the study and recorded in the case report forms (Appendix 6): 
8.3.1 Visit 1: Baseline / Trial Fit / Lens order 
• Explanation of the study. 
• Sign informed consent form.  
• Anterior ocular health examination (Slit lamp without fluorescein). 
• Insert trial LENS A   
• 
 
•  Evaluate lens fit 
 lens fit acceptance) 
• Order final LENS A. 
• Remove LENS A and insert trial LENS B.  
• 
 
•  Evaluate lens fit (
 lens fit acceptance) 
• Order final LENS B. 
 

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8.3.2 Visit 2: Lens dispensing (Fit LENS A / Evaluate) 
• 
  
 
 
 
 
 
 
• Lens fit assessment  
 
  
 
 
 Overall fit acceptance (0 – 4)‡ and reason if Grade 2 or less. 
 
8.3.3 Visit 3a: 15 minutes (Evaluate LENS A) 
•
  
 
 
 
 
 
 
• Lens Fit Assessment  
 
  
 
 
 Overall fit acceptance (0 – 4)‡ and reason if Grade 2 or less. 
 Remove LENS A 
8.3.4 Visit 3b: Lens dispensing (Fit LENS B / Evaluate) 
• 
  
 
 
 
 
 
 
• Lens Fit Assessment  
 
  
 
 
 Overall fit acceptance (0 – 4)‡ and reason if Grade 2 or less. 
 
 
 

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9.3  Reporting Adverse Events 
All potential Serious and Unanticipated Adverse Device Effects that are related or possibly related 
to subject participation in the investigation will be reported to the Principal Investigator and the sponsor 
within 24 hours of the investigator becoming aware of the event. The Principal Investigator will report 
the event to the EC/IRB as soon as possible (by fax, mail/delivery, phone, or email), but within 10 
business days of becoming aware of the problem.  All fatal or life threatening events will be reported 
immediately to the IRB. 
 
Significant and Non-Significant Adverse Events will be reported to the sponsor as soon as 
possible, but no later than 5 working days after the occurrence. 
 
 
   
 
 
    
 
 
  
 
 
   
 
 
 
 
9.4    Discontinuation from the Study  
All discontinuations will be fully documented on the appropriate CRF Exit and Adverse Event forms as 
needed.  Participants will be followed until resolution (in most instances) and are free of the ophthalmic 
insert related complications or other ocular pathology. When possible study lenses involved in an 
Adverse Event will be returned to the sponsor in a new tightly sealed contact lens case, and labeled 
with the subject identification and stored in Unisol non-preserved saline. 
10 Statistical Analysis  
10.1 Statistical analysis 
Summary statistics will be produced,  
(e.g., mean, standard deviation), by the principal investigator 
(GIO). Differences between lenses will be compared using Paired t-tests. Paired t-tests /analysis of 
variance for normal (interval/continuous) data, Wilcoxon’s signed ranks test for non-normal (ordinal) 
data, chi-squares test for nominal data. A Binomial test will be used to evaluate lens preference 
questions. All participants who are evaluated in the study will be used in the analysis. In the event of 
missing data individual number of points will be excluded in the analysis and not extrapolated from the 
collected data. The critical alpha level for statistical significance will be set at p ≤ 0.05, with adjustment 
for multiple comparisons. 
 

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11 Data Quality Assurance 
11.1  Study monitoring 
A site visit or discussion may be conducted during the course of the study as appropriate. Prior to final 
data freeze, a close-out visit/discussion may be warranted to check for accuracy and completeness of 
records. The sponsor or sponsor’s representatives will be authorized to gain access to the source 
documentation for the purposes of monitoring and auditing the study. 
 
11.2 Record keeping 
Detailed records of all study visits will be made using the electronic Case Report Forms (CRFs).  
 
11.3 Record retention 
Following study completion, data will be available in electronic and/or paper format for audit, sponsor 
use, or subsequent analysis. The original clinical raw data (including completed CRFs and Informed 
Consent forms) will be retained according to guidelines set forth in the general work agreement with 
the site. The Sponsor will be notified and consulted if ever the files are to be destroyed.  In the event 
that this implementation document is indicated for design verification and validation purposes, as 
indicated on the title page, all original raw data forms and completed CRF’s will be forwarded to the 
sponsor at completion of the final report. 
11.4 Data Entry / Data Management 
Data will be entered into an electronic spreadsheet. Study staff will only be able to modify the data file 
via password entry. The investigators will be responsible for the data integrity, and complete data entry 
for each visit as well as the take home questionnaires. The investigator will send the data collected to 
the study sponsor within 5 business days after the last subject completes the final visit. A full report 
will be provided by the investigator at the mutually agreed timeline after the study completion date. 
11.5 Confidentiality 
This study is confidential in nature. All information gathered during this study is proprietary and should 
be made available only to those directly involved in the study. Information and reports arising from this 
project are the property of the sponsor.  
All records will also be handled in accordance with HIPAA (1996). 
 
 
 
 

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