Clinical Evaluation of Clariti Monthly Multifocal and Clariti 1 Day Multifocal
Phase: NA
Conditions: Presbyopia
Sponsor: CooperVision, Inc.

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EX-MKTG-136 Clinical Evaluation of clariti Monthly Multifocal and clariti® 1 day Multifocal  
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Final 
Clinical Evaluation of clariti Monthly Multifocal and  
clariti® 1 day Multifocal  
 
Sponsor Study Code: 
EX-MKTG-136 
Protocol Date: 
April 23, 2022 
Sponsor Company:  
CooperVision, Inc. 
Document Type: 
Protocol 
Study Category: 
 
Post Market  
Start Date: 
Finish Date: 
Clinical Site: 
May  2022 
July 2022 
School of Optometry Clinic, National 
Autonomous University (UNAM), Mexico City 
Revision History 
Document number 
Date 
Comments 
EX-MKTG-136 
4/15/2022 
First draft (v 1.0)  
EX-MKTG-136 
4/22/2022 
FINAL 
EX-MKTG-136 
4/23/2022 
FINAL UPDATED 
 

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PERSONNEL & FACILITTIES 
 
 
 
   
 
 
 
 

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Table of Contents 
1 
Introduction .............................................................................................................................. 6 
2 
Study Objective ........................................................................................................................ 6 
3 
Study Hypothesis ..................................................................................................................... 7 
3.1 
Study Hypothesis ................................................................................................................ 7 
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 .............................................................................. 8 
6.1 
Relevant Standards / Guidelines ........................................................................................ 8 
6.2 
Institutional Review Board .................................................................................................. 8 
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 ....................................................................................................... 11 
8.2.3 
Storage of Study Medications/Treatments .................................................................. 11 
8.2.4 
Clinical Supply Inventory ............................................................................................. 11 
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 ........................................................... 12 
8.3 
Visit Schedule and Procedures ......................................................................................... 12 
 

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8.3.1 
Visit 1: Baseline / Trial Fit / Lens order ........................................................................ 12 
8.3.2 
Visit 2: Lens dispensing (Fit LENS A / Evaluate) ......................................................... 12 
8.3.3 
Visit 3: 15 minutes (Evaluate LENS A / Fit LENS B).................................................... 13 
8.3.4 
Visit 3: Lens dispensing (Fit LENS B / Evaluate) ......................................................... 13 
8.3.5 
Visit 4: 15 minutes (Evaluate LENS B / Study Exit) ..................................................... 13 
9 
Adverse Event Reporting ....................................................................................................... 14 
9.1 
Adverse Response Definitions .......................................................................................... 14 
9.2 
Procedures for Adverse Events ........................................................................................ 16 
9.3 
Reporting Adverse Events ................................................................................................ 16 
9.4 
Discontinuation from the Study ......................................................................................... 17 
10 
Statistical Analysis ................................................................................................................. 17 
10.1 
Statistical analysis ............................................................................................................ 17 
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 ........................................................................................ 19 
11.5 
Confidentiality ................................................................................................................... 19 
11.6 
Publication ........................................................................................................................ 19 
 
 
 
 
 

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1 Introduction 
Silicone hydrogel materials make up the majority of contact lens fits, and refits as recently reported 
(Contact Lens Spectrum market data). 1 For 2021, silicone hydrogels were reported in usage at 69%, 
with soft multifocal lenses at 14% versus 12% in 2020. 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.  
Soft multifocal contact lenses, (MFCLs), are a great option for new and established presbyopes, 
offering good vision performance with the added benefit of improved cosmesis and convenience 
compared to spectacles, and provide them the flexibility to change-up their vision correction.6 CL 
manufacturers are continually innovating in this area, with the increased availability of soft MFCLs with 
novel designs in a range of replacement frequencies from daily disposable to monthly replacement, 
and different materials including silicone hydrogels. 
Therefore, CooperVision is interested in comparing the short-term clinical performance and subjective 
acceptance of Clariti Monthly Multifocal, (LENS A), to the Clariti 1-Day Multifocal, (LENS B), silicone 
hydrogel 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 Clariti Monthly Multifocal when compared to the Clariti 1-
Day Multifocal after 15 minutes of daily wear.  
The primary outcome variable is: 
• 
Subjective comfort ratings on insertion (assessed by subjects) 
 
 
  
 
 
 
  
 
 
 

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3 Study Hypothesis  
3.1 Study Hypothesis  
• 
Null hypothesis (Ho): There is no difference in clinical performance and subjective 
assessments between multifocal lens types. 
• 
Alternative hypothesis (H1): There is a difference in clinical performance and subjective 
assessments between multifocal lens types. 
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.  
 
 

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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. 
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.   

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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.  
8 Materials and Methods 
8.1 Participants 
Habitual soft contact lens wearers who currently wear multifocal contact lenses, sphere lenses for 
monovision, or sphere lenses for distance vision correction and use spectacles for near vision 
correction, that 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 42 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 at least 8 hours a day, 5 days a week. 
5. Is willing and able to follow instructions and maintain the appointment schedule. 
6. Habitually wears multifocal soft contact lenses, or sphere lenses for monovision, or sphere lenses 
for monovision, or sphere lenses for distance vision correction and use spectacles for near vision 
correction, for the past 3 months minimum. 
7. Has refractive astigmatism no higher than -0.75DC. 
8. Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D. 
9. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 
logMAR) which participants also deem to be ‘acceptable’, with the available study lens 
parameters (powers +4.00 to -6.00DS) (see Table 1). 
 

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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. 
Age ≥ 42 years is an inclusion criterion because presbyopia is unlikely in persons aged < 42 years 
and, if present, may not be due solely to presbyopic changes representative of the wider population.  
Pregnant and lactating women are not being excluded from the study due to safety concerns but due 
to fluctuations in refractive error, accommodation and/ or visual acuity that occur secondary to 
systemic hormonal changes. It has further been shown that pregnancy could impact tear production, 
which could impact dry eye symptoms. Such fluctuations could affect data, thereby negatively affecting 
study data integrity. 
 
 
8.2 Study Materials 
8.2.1 Contact lens 
CooperVision will provide the site with an inventory of both study lenses (LENS A) and (LENS B) to 
allow participants to be fit with the lens powers available for this study i.e., sphere +4.00D to - 6.00D, 
in 0.25D steps, in both add powers.  
All subjects will be trial fitted and, if suitable, dispensed the first pair of the assigned lens brand 
assigned per a determined table (Appendix 3). The lenses used in this study are all FDA approved 
and marketed products.  Details of the study contact lenses are shown in Table1. 
 
 
 
 

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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.  
• 
 
• 
Insert trial LENS A, evaluate the fit and optimize the prescription if needed. 
• 
 
• 
Order final LENS A. 
• 
Remove LENS A and insert trial LENS B. Evaluate fit and optimize the prescription if needed. 
• 
 
• 
Order final LENS B. 
 
8.3.2 Visit 2: Lens dispensing (Fit LENS A / Evaluate) 
• 
Subjective assessments  
 
  
 Comfort on insertion (0 -10 scale) 
 
 
• 
  
 
  
 
 
 
 
 
 

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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 Chi-Square 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. 
10.2 Sample size 
The sample size was calculated using data of lens comfort at insertion on day 1 collected in a previous 
study that evaluated the clariti 1day multifocal lens (CooperVision, data on file). Figure 1 shows the 
sample size determination for a paired t-test, (alpha=0.05), in order to detect a difference 
 
Assuming a standard deviation of 2.2, a sample size of 40 
completed subjects provides 80% power to detect a difference of 1.0 points on a 0 - 10 scale in 
subjective comfort ratings at insertion. 
Figure 1. Sample size calculation (Minitab 20.2. Statistics software) 
 

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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. 

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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). 
11.6 Publication 
The investigators will not be permitted to publish or present at scientific meetings results obtained from 
the clinical study without prior written consent from the sponsor.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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13 Appendixes 
APPENDIX 1 – STATEMENT OF INFORMED CONSENT 
APPENDIX 2 – STUDY TIMELINE 
APPENDIX 3 – LENS RANDOMIZATION 
APPENDIX 4 – LENS REPLACEMENT LOG 
APPENDIX 5 – GRADING & MEASUREMENT SYSTEM  
APPENDIX 6 – CRF’s / UNSCHEDULED VISIT & ADVERSE EVENT FORM 
 
 
 
 

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APPENDIX 1 – STATEMENT OF INFORMED CONSENT 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX 3 – RANDOMIZATION TABLE  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX 4– STUDY LENS REPLACEMENT LOG 
 
Date 
Investigator 
Initials 
Subject 
Initials 
Visit Just 
Prior to Lens 
Replacement 
Number of 
Days Lens 
was Worn 
prior to 
Replacement 
Lens 
Replaced 
(check one) 
Reason 
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to enter a 
date. 
 
 
 
 
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APPENDIX 6 – CRF’s / UNSCHEDULED VISIT & ADVERSE EVENT FORM