Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear
Phase: NA
Conditions: Astigmatism
Sponsor: CooperVision, Inc.

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EX-MKTG-102 Refitting somofilcon A Toric Contact Lens Wearers into fanfilcon A Toric Lenses for 4-weeks of Wear 
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Refitting somofilcon A Toric Contact Lens Wearers into fanfilcon A 
Toric Lenses for 4-weeks of Wear 
 
Sponsor Study Code: 
EX-MKTG-102 
 
 
 
 
Sponsor Company: 
 
CooperVision, Inc. 
Document Type: 
Protocol 
Study Category: 
 
Post Market  
 
 
 
 
Clinical Site: 
 
 
 
 
Dr. Ruben Velazquez Guerrero  
National Autonomous University of Mexico. Av. 
de los Barrios no. 1, Los Reyes Iztacala, 
Tlalnepantla Edo. de México. Código Postal 
54090 (México) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Revision History 
Document number 
Date 
Comments 
 
 
 
 
 
  
  
EX-MKTG-102 
March 4, 2019 
FINAL 
 

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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 ............................................................................................................. 11 
8.2.1 
Contact lens .............................................................................................................. 11 
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 .................................................................. 12 
8.2.7 
Ordering and Accountability of Study Materials ...................................................... 12 
8.3 
Visit Schedule and Procedures...................................................................................... 12 
8.3.1 
Visit 1: Baseline visit (Baseline / Fit Clariti Toriclenses) ............................................ 12 
8.3.2 
Visit 2: Dispense Clariti ToricLenses .......................................................................... 13 
8.3.3 
Visit 3: 1-month follow-up Clariti Toric/ dispense Avaira Vitality Toric ................... 14 
8.3.4 
Visit 4: Follow-up Avaira Vitality Toric (After 2 weeks of wear) ............................... 15 
8.3.5 
Visit 5: Follow-up Avaira Vitality Toric (After 1- month of wear / exit) .................... 16 
9 
Adverse Response Definitions ........................................................................... 17 

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9.1 
Procedures for Adverse Events ..................................................................................... 19 
9.2 
Discontinuation from the Study .................................................................................... 19 
9.3 
Reporting Adverse Events ............................................................................................. 19 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
11 Data Quality Assurance ....................................................................................... 20 
11.1 
Study monitoring .......................................................................................................... 20 
11.2 
Record keeping ............................................................................................................. 20 
11.3 
Record retention ........................................................................................................... 20 
11.4 
Data Entry / Data Management .................................................................................... 21 
11.5 
Confidentiality ............................................................................................................... 21 
11.6 
Publication .................................................................................................................... 21 
12 Study Costs and Subject Compensation ........................................................... 21 
13 Appendices ........................................................................................................... 22 
 

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1 Introduction 
The utilization of soft toric contact lenses has increased significantly over the past few years. 
Contact lens spectrum data for 2018 international prescribing habits with soft toric lenses ranged 
from 13% to 59%. Toric contact lens wearers demand two things from their contact lenses, great 
comfort and excellent vision. CooperVision’s Avaira Vitality™ toric uses a third-generation silicone 
hydrogel material which makes the lens inherently wettable with no surface treatments and uses 
naturally wettable building blocks to improve compatibility between silicone and hydrophilic 
domains. This combined with the higher water content of Avaira Vitality™ toric ensures a high 
performing, comfortable lens. 
Clariti Toric contact lenses are part of a generation of silicone hydrogel portfolio from 
CooperVision which will be discontinued from the market in the near future. Therefore, 
CooperVision is interested in evaluating the clinical performance of existing wearers of Clariti Toric 
contact lenses after a refit with Avaira Vitality™ silicone hydrogel toric lenses over 1-month of 
daily wear. 
2 Study Objective 
 
The aim  of  this  prospective  study  is  to  evaluate  the  clinical performance of habitual wearers 
of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear. 
 
The primary variables of interest are: 
• Lens fitting characteristics  
The secondary variables of interest are: 
• Wearing times (average and comfortable) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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3 Study Hypothesis  
3.1 Study Hypothesis  
• Null hypothesis (Ho): There is no difference in lens fitting characteristics between the 
two toric lenses for the key variables tested. 
• Alternative hypothesis (H1): There is a difference in lens fitting characteristics between 
the two toric lenses for the key variables tested. 
4 Study Design  
This is a prospective, subject masked; bilateral, 1-month refit study comparing the fitting 
characteristics of Clariti Toric silicone hydrogel lenses, (somofilcon A); against Avaira Vitality 
silicone hydrogel Toric lenses (fanfilcon A). A total of 40 subjects will be enrolled with the aim of 
completing 34. 
Subject’s will be evaluated at the first visit and then fitted with both study lenses to confirm lens 
fit 
 
 
 
  
. At the second visit, the first pair of study lenses, (e.g. 
somofilcon A), will be dispensed and worn for 1-month. After 1-month of daily wear with the first 
pair, subjects will return for a third evaluation and then fitted with the second pair, (e.g. fanfilcon 
A), of study lenses for 1-month. A fourth visit will be scheduled after 2-weeks of lens wear. A fifth 
and final visit will be scheduled after 1-month of lens wear. The study timeline is shown in 
Appendix 2. 
5 Investigational Sites 
5.1 Number of Sites 
This will be a single-center investigational site in Mexico City. (Target 40 subjects, complete 34).   
5.2 Investigator Recruitment  
This study will be conducted at the 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. 

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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 for Human Subjects, Parts 1 & 2, 2011. 
• 
ICH Harmonized Tripartite Guideline for Good Clinical Practice E6, 1996. 
• 
Declaration of Helsinki 
• 
COFEPRIS Applicable Guidelines 
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 jrjf@unam.mx. 
 
6.3 Clinical Trial Registration 
This study will be registered with clinicaltrials.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 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 

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cost to them. The contact lens materials used in this study are commercially available as daily or 
extended wear. This study will investigate participants’ wearing schedule 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 (Appendix 2).   
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. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 Patients will be monitored every two weeks until the end of the study 
to reduce if not eliminate the occurrence of adverse or potential adverse events. Patients will be 
given instructions from their ECP regarding early symptoms and signs of adverse events and their 
contact information.  
8 Materials and Methods 
8.1 Participants 
Approximately 40 habitual soft toric contact lens wearers will be enrolled. Each subject will be 
required to attend up to five scheduled study visits over a period of approximately two months.  
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:  
• 
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 toric contact lens wearer    
• 
Has a contact lens spherical prescription between +6.00 to - 8.00 (inclusive)  

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• 
Have 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: 
• 
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.  
• 
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 
• 
Has a known history of corneal hypoesthesia (reduced corneal sensitivity) 
• 
Has aphakia, keratoconus or a highly irregular cornea.  
• 
Has Presbyopia or has dependence on spectacles for near work over the contact lenses.  
• 
Has undergone corneal refractive surgery.  
• 
Is participating in any other type of eye related clinical or research study. 

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8.2.6 Masking and Control of Study Materials 
The study contact lenses will be masked to the subject only. Study lenses will be transferred, by 
an assistant, out of their packaging to unmarked new contact lens cases filled with unpreserved 
sterile saline just prior to dispensing to maintain subject masking of the study lenses.    
8.2.7 Ordering and Accountability of Study Materials 
The study lenses and solutions will be provided by the sponsor. If additional lenses are required, 
the study sponsor will re-supply the investigator as requested. 
8.3 Visit Schedule and Procedures 
8.3.1 Visit 1: Baseline visit (Fit Clariti Toric lenses/ Avaira Vitality Toric lenses) 
The following evaluations will be performed to assess eligibility according to the Inclusion and 
Exclusion Criteria at the baseline visit only:  
o The subjects should attend the first visit wearing their spectacle lenses.  If they are not 
wearing their spectacle lenses, please reschedule the visit. 
o The subject will be required to read and sign an Informed Consent Form prior to 
enrolment. When the subject has signed the consent form, the subject will be considered 
to be enrolled on to the study. 
o The person explaining the consent and Investigator should also sign the consent form.  
Provide the subject with a copy and keep the original in the subject’s paper chart or scan 
into the subject’s electronic medical record (EMR) file. 
o The subject is assigned with a Subject ID number. Subjects must be enrolled sequentially.   
o Full anterior segment ocular health will be established 
Visit 1a: Baseline Spectacle Lenses 
The following baseline measurements and assessments will be recorded: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
  
 
 
 
    
 

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• 
 
 
 
 
• 
If at this point the subject is found to be ineligible, then complete an Exit form and exit the 
subject from the study. 
Visit 1 b: Fitting Clariti Toric lenses / Avaira Vitality Toric lenses  
If subject is eligible, complete the Enrollment from.  The subjects will undergo a trial fit in both 
eyes with the Clariti Toric and Avaira Vitality Toric lenses, (according to manufacturer’s fitting 
guides), to ensure optimization of the lens parameters needed to provide the best distance visual 
acuity.  Reorder final lens if appropriate. If the fit and vision are satisfactory schedule subjects for 
visit 2. If the lenses are not suitable to be dispensed then the subject will be discontinued and an 
Exit form will be completed. 
8.3.2 Visit 2: Dispense Clariti Toric Lenses 
• Data is only collected on the final pair of study lenses dispensed after the power has been 
assessed and if needed corrected.  
• Record the parameters of the lenses, lens type and power, on the Dispensing CRF 
(Appendix 6). 
• The performance of the lenses should be assessed after 10-15 minutes settling time and 
the following variables will be assessed (Appendix 3, grading scales):   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
o 
 
, binocular logMAR distance visual acuities 
o Lens Fit 
− Lens centration (centered/slightly decentered/substantially decentered) 
− Corneal coverage [Y/N] 
− Post-blink movement (0-5 Likert scale) 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
   
 
   
 
   
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
− Overall fit acceptance (0 - 4) and reason if Grade 2 or less. 

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• Lost or damaged study lenses may be replaced. Note which lens was replaced, date of 
replacement and reason for replacement on the Lens Replacement Log, (Appendix 6).   
• The subject will be instructed to wear the lenses on a daily wear basis, (at least 40 hours 
per week), until the 1-month follow-up appointment, unless they experience a problem 
which warrants lens removal. 
• The Investigator or a clinical assistant will review instructions and warnings for lens wear, 
when to remove lenses, and other important issues with the participant. 
• Participants, who appear unable or unwilling to follow instructions to a degree that, in the 
Investigator's opinion, jeopardises the participant's wellbeing or the validity of the study, 
will be discontinued. The reason for discontinuation will be documented.  
• The subject will be discharged and asked to return for a follow-up visit (V2) after 1-month. 
8.3.3 Visit 3: 1-month follow-up Clariti Toric / dispense Avaira Vitality Toric 
The 1-month follow-up visit will be scheduled four weeks (28 + 2 days) from the initial lens 
dispensing date.  The subject should wear the lenses for a minimum of 2 hours prior to the 
appointment.  If the subject attends without lenses or with less than 2 hours of lens wear on that 
day and they are not having any problems with their lenses, the visit should be rescheduled, if 
possible within the visit window. 
Visit 3a: Lens Evaluation Clariti Toric Lenses 
• The following clinical test variables will be recorded on the Follow-Up Visit CRF: 
o Wearing times: 
− Wearing time today (hours). 
− Average daily wearing time (hours/day) 
− Average comfortable wearing time (hours/day) 
− Number of days/week (lenses are worn). 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 

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o Lens Fit 
˗ 
Lens centration (centered/slightly decentered/substantially decentered) 
˗ 
Corneal coverage [Y/N] 
˗ 
Post-blink movement (0-5 Likert scale) 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
   
 
   
 
   
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
˗ 
Overall fit acceptance (0 - 4) and reason if Grade 2 or less. 
˗ 
 
 
 
 
 
 
 
 
 
Visit 3b: Dispense Avaira Vitality Toric  
The study subjects will undergo a trial fit in each eye with the second pair of study lenses.   
• The performance of the second pair of study lenses should be assessed after 10 - 15 
minutes settling time. The same variables as those collected on visit 2, section 8.3.2 will be 
assessed. 
8.3.4 Visit 4: Follow-up Avaira Vitality Toric (After 2 weeks of wear) 
The 2-week follow-up visit for pair 2 will be scheduled two weeks (14 + 2 days) from the initial 
lens dispensing date for pair 2.  The subject should wear the lenses for a minimum of 2 hours prior 
to the appointment.  If the subject attends without lenses or with less than 2 hours of lens wear 
on that day and they are not having any problems with their lenses, the visit should be 

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rescheduled, if possible within the visit window. The same variables as those collected on section 
8.3.3 (visit 3a) will be assessed at this visit. 
8.3.5 Visit 5: Follow-up Avaira Vitality Toric (After 1- month of wear / exit) 
The 1-month follow-up visit for pair 2 will be scheduled four weeks (28 + 2 days) from the initial 
lens dispensing date for pair 2.  The subject should wear the lenses for a minimum of 2 hours prior 
to the appointment.  If the subject attends without lenses or with less than 2 hours of lens wear 
on that day and they are not having any problems with their lenses, the visit should be 
rescheduled, if possible within the visit window. The same variables as those collected on section 
8.3.3 (visit 3a) will be assessed at this visit. In addition, a lens preference question between 
habitual, (Vertex Toric), and test lenses, (Avaira Vitality Toric), will be asked at the end of this visit. 
• The Study Exit Form must be completed when a subject exits the study.  This will occur 
either at study completion, i.e. at Visit 5, or if the subject is discontinued from the study at 
another time.  If there are records entered into the clinics own patient chart system the 
exit date should be recorded on these source documents. A Study Exit Form must be 
completed for all subjects who have taken a study ID number. Post-study follow-up visits 
will be scheduled if the Investigator judges this is necessary. 
• At the study Exit Visit the following measurements are taken: 
 Remove study lenses 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
o Post-study follow-up requirement (Y/N).  If yes, the reason and date of the follow-
visit must also be recorded. 
• 
If the subject is being exited due to discontinuation, further details need to be recorded 
on the exit form.   
 
 
 

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9.1 Procedures for Adverse Events 
Treatment of an adverse event will depend on its nature and severity. Based on the clinical 
judgment of the investigator the subject may be referred to an ophthalmologist for treatment. 
The investigator will attempt to determine whether the reaction is related to the test device or a 
result of other factors.  
An Adverse Event Form will be completed for each adverse event. If both eyes are involved, a 
separate Adverse Event Form will be completed for each eye. Whenever possible, the adverse 
event will be photo-documented. 
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. 
9.2 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. 
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 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
  
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 

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Data Quality Assurance 
10.3  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. 
 
10.4 Record keeping 
Detailed records of all study visits will be made using the electronic Case Report Forms (CRFs).  
10.5 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 

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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. 
 
10.6 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. 
 
10.7 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). 
10.8 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.  
11 Study Costs and Subject Compensation 
CVI will compensate the Investigator, (principal investigator), and the Subjects, (each a “Subject” 
and together the “Subjects”), for their time and participation in this voluntary study.    Payments 
to the Clinical Investigator are per subject visit with a total of 5 visits for 40 subjects. The study 
lenses will be provided by the sponsor to the Clinic Site. Clinical Site will receive the payment for 
the Subjects and are responsible in distributing the Subject’s compensation (contact lenses).  
Complete outline/details of the payment compensation are detailed in the Clinical Study 
Agreement. The statistical analysis, and study final report are “one-time costs” There will be no 
payments to the Clinical Site for interim visits, unless Subjects are visiting regarding an adverse 
event.  Data from interim office visits, if mandated by your clinic, can be collected and entered 
using the unscheduled visit form.  
Expenses incurred for medical treatment as part of Study participation will be paid by CVI (bills 
and prescription receipts kept). The Subject must be followed until resolution and a written report 
is completed indicating the subsequent treatment and resolution of the condition. 
 

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