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

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EX-MKTG-137 Clinical Evaluation of clariti Monthly Toric and clariti® 1 day Toric  
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Final 
Clinical Evaluation of clariti Monthly Toric and  
clariti® 1 day Toric  
 
Sponsor Study Code: 
EX-MKTG-137 
Protocol Date: 
June 16, 2022 
Sponsor Company:  
CooperVision, Inc. 
Document Type: 
Protocol 
Study Category: 
 
Post Market  
Start Date: 
Finish Date: 
Clinical Site: 
July  2022 
September 2022 
School of Optometry Clinic, National 
Autonomous University (UNAM), Mexico City 
Revision History 
Document number 
Date 
Comments 
EX-MKTG-137 
6/16/2022 
First draft (v 1.0)  
EX-MKTG-137 
6/16/2022 
FINAL 
 
 
   

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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 ....................................................................................................... 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) ......................................................... 13 
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) ..................................................... 14 
9 
Adverse Event Reporting ....................................................................................................... 14 
9.1 
Adverse Response Definitions .......................................................................................... 14 
9.2 
Procedures for Adverse Events ........................................................................................ 16 
9.3 
Reporting Adverse Events ................................................................................................ 17 
9.4 
Discontinuation from the Study ......................................................................................... 17 
10 
Statistical Analysis ................................................................................................................. 17 
10.1 
Statistical analysis ............................................................................................................ 17 
10.2 
Sample size ...................................................................................................................... 18 
11 
Data Quality Assurance ......................................................................................................... 19 
11.1 
Study monitoring ............................................................................................................... 19 
11.2 
Record keeping ................................................................................................................ 19 
11.3 
Record retention ............................................................................................................... 19 
11.4 
Data Entry / Data Management ........................................................................................ 19 
11.5 
Confidentiality ................................................................................................................... 19 
 
 
 
 
 
 
 

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1 Introduction 
Toric soft contact lenses, (TSCL), work best for people with astigmatism and other refractive errors 
(e.g., nearsightedness, farsightedness). The use of toric soft contact lenses (TSCL) has increased 
significantly in recent years. Recently released data on prescription habits with soft toric lenses ranged 
from 13% to 59%. Soft toric contact lens wearers demand two things from their contact lenses, great 
comfort and excellent vision. 
Contact lens manufacturers are continuously innovating in this area, with increased availability of soft 
toric contact lenses with novel designs in a range of replacement frequencies, from daily disposables 
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 Toric Monthly contact lenses (LENS A) with Clariti 1-Day Toric (LENS B) silicone 
hydrogel 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 Toric when compared to the Clariti 1-Day 
Toric after 15 minutes of daily wear.  
The primary outcome variable is: 
•
Subjective handling ratings on insertion (assessed by subjects)
 
3 Study Hypothesis 
3.1 Study Hypothesis 
•
Null hypothesis (Ho): There is no difference in clinical performance and subjective
assessments between toric lens types.
•
Alternative hypothesis (H1): There is a difference in clinical performance and subjective
assessments between toric lens types.

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4 Study Design  
This is a subject 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 37- 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 toric contact lens wearers 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:  
• 
A person is eligible for inclusion in the study if he/she: 
• 
Is between 18 and 40 years of age (inclusive) 
• 
Has had a self‐reported visual exam in the last two years 
• 
Is an adapted soft contact lens wearer 
• 
Is not a habitual wearer of either study lens 
• 
Has a contact lens spherical prescription between +4.00 to ‐ 9.00 (inclusive) best corrected 
visual acuity of 20/30 or better in either eye 
• 
Have contact lens prescription of no less than ‐0.75D of astigmatism and no more than ‐2.25 
D in both eyes. 
• 
Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better 
in each eye. 
• 
Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the 
study contact lenses. 
• 
Has clear corneas and no active ocular disease 
• 
Has read, understood and signed the information consent letter. 
• 
Patient contact lens refraction should fit within the available parameters of the study lenses. 
• 
Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day 
assuming there are no contraindications for doing so). 
• 
Is willing to comply with the visit schedule 
 
Exclusion Criteria 
A person will be excluded from the study if he/she: 
• 
A person was excluded from the study if he/she: 
• 
Has a CL prescription outside the range of the available parameters of the study lenses. 
• 
Has a spectacle cylinder less than ‐0.75D or more than ‐2.50 D of cylinder in either eye. 

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• 
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day) 
• 
Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye. 
• 
Presence of clinically significant (grade 2‐4) anterior segment abnormalities 
• 
Presence of ocular or systemic disease or need of medications which might interfere with 
contact lens wear. 
• 
Slit lamp findings that would contraindicate contact lens wear such as: 
o Pathological dry eye or associated findings 
o Pterygium, pinguecula, or corneal scars within the visual axis 
o Neovascularization > 0.75 mm in from of the limbus 
o Giant papillary conjunctivitis (GCP) worse than grade 1 
o Anterior uveitis or iritis (past or present) 
o Seborrheic eczema, Seborrheic conjunctivitis 
o History of corneal ulcers or fungal infections 
o Poor personal hygiene 
o Has a known history of corneal hypoesthesia (reduced corneal sensitivity) 
o Has aphakia, keratoconus or a highly irregular cornea. 
o Has Presbyopia or has dependence on spectacles for near work over the contact 
lenses. 
o Has undergone corneal refractive surgery. 
o Is participating in any other type of eye related clinical or research study. 
 
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.  
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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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 
• 
Subjects should attend this visit wearing their spectacle lenses 
• 
Explanation of the study. 
• 
Sign informed consent form.  
• 
Collect habitual toric lens brand information 
o Brand  
o Power(s) 
o Replacement schedule (daily, 2-week, monthly) 
• 
Anterior ocular health examination (Slit lamp without fluorescein). 
• 
Insert trial toric LENS A, evaluate the fit and optimize the prescription if needed. 
• 
 
• 
 
• 
Order final LENS A. 
• 
Remove LENS A and insert trial toric LENS B. Evaluate fit and optimize the prescription if needed. 
• 
 
• 
 
• 
Order final LENS B. 
 

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8.3.2 Visit 2: Lens dispensing (Fit LENS A / Evaluate) 
• 
Subjective assessments  
 Handling on insertion (0 -10 scale).  
 
 
 
 
 
) 
• 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
8.3.3 Visit 3: 
 (Evaluate LENS A) 
• 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
8.3.4 Visit 3: Lens dispensing (Fit LENS B / Evaluate) 
• 
Subjective assessments  
 Handling on insertion (0 -10 scale).  
 
 
 
 
 
 

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• 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
8.3.5 Visit 4: 
 (Evaluate LENS B / Study Exit) 
• 
  
 
 
 
 
 
 
• 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
9 Adverse Event Reporting 
9.1 Adverse Response Definitions 
Adverse Event (AE): An AE refers to any untoward medical occurrence (sign, symptom or disease) 
in a trial subject that does not necessarily have a causal relationship with the study device.  AEs may 
be classified as ‘unanticipated adverse device effects,’ ‘serious AEs,’ ‘significant AEs,’ or ‘non-
significant AEs,’ as defined below.   
 

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Expenses incurred for medical treatment as part of study participation will be paid by the sponsor (bills 
and prescription receipts kept). The subject must be followed until resolution and a written report 
completed indicating the subsequent treatment and resolution of the condition. 
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 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. 

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10.2 Sample size 
Figure 1 shows the sample size determination for a paired t-test, (alpha=0.05), in order to detect a 
difference in mean subjective handling scores between lenses. Assuming a standard deviation of 1.2, 
a sample size of about 37 completed subjects provides 84% power to detect a difference in subjective 
handling ratings of 0.6 points on a 0 - 10 scale. In order to account for potential subject dropouts or 
AEs, 10%-15% should be added to the sample size. Therefore, 40 subjects should be enrolled with 
the aim to complete 37. 
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. 
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.  
 

Study Code: EX-MKTG-137 
Amendment 2 
October 12-2022 
Protocol Amendment 
The table below lists the changes to be implemented on this study protocol. 
New revision No. 
Section (s) to be amended and details. 
 
1. 
 
 
 
 
 
The study protocol currently indicates that assessment of subjective 
comfort will be collected using a 0 -10 visual analog scale with two 
anchors on each end of the scale.  
 
It is recommended to change to a 0 -100 visual analog scale with 
descriptors at different intervals. 
 
The change to be implemented will apply to sections 2.0, 8.3.2, 8.3.3, 
8.3.4, and 8.3.5 of the study protocol.  
 
 
Table 1. Changes to protocol EX-MKTG-137