Clinical Validation Study of Phoebe Lens
Phase: NA
Conditions: Myopia
Sponsor: CooperVision, Inc.



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Study Implementation document: 
 
CLINICAL VALIDATION STUDY OF PHOEBE LENSES  
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sponsor Study Code: 
CV-17-60 
Version Number: 
1.0 
Implementation document Date: 
28 September 2017 
Sponsor Company:  
CooperVision, Inc. 
Study Category: 
 
Design Validation 
Clinical Sites: 
CORL, Indiana University  

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TABLE OF CONTENTS 
1 
Introduction ................................................................................................................. 4 
2 
Study Objective ........................................................................................................... 4 
2.1 
Study Hypotheses ...................................................................................................... 4 
3 
Study Design ............................................................................................................... 5 
4 
Ethics Review / Statement of Compliance ................................................................. 5 
4.1 
Relevant Standards / Guidelines ................................................................................ 5 
4.2 
Institutional Review Board .......................................................................................... 5 
4.3 
Informed Consent ....................................................................................................... 5 
5 
Clinical Trial Registration ........................................................................................... 6 
6 
Potential Risks and Benefits to Human Subjects ..................................................... 6 
7 
Materials and Methods ................................................................................................ 7 
7.1 
Clinical sites ............................................................................................................... 7 
7.2 
Participants ................................................................................................................. 7 
7.3 
Study Materials ........................................................................................................... 8 
7.4 
Visit Schedule and Procedures ..................................................................................10 
8 
Adverse Event Reporting .......................................................................................... 16 
8.1 
Adverse Event Definitions ..........................................................................................16 
8.2 
Procedures for Adverse Events .................................................................................18 
8.3 
Reporting Adverse Events .........................................................................................18 
8.4 
Discontinuation from the Study ..................................................................................19 
9 
Device Malfunctions .................................................................................................. 19 
10 
Statistical Analysis .................................................................................................... 20 
10.1 
Statistical analysis .....................................................................................................20 
11 
Data Quality Assurance ............................................................................................ 20 
11.1 
Study monitoring ........................................................................................................20 
11.2 
Record keeping .........................................................................................................21 
11.3 
Record retention ........................................................................................................21 
11.4 
Data Entry / Data Management .................................................................................21 
11.5 
Protocol Deviations ....................................................................................................21 
11.6 
Confidentiality ............................................................................................................22 
11.7 
Publication .................................................................................................................22 
12 
Study Costs ............................................................................................................... 22 
13 
Appendices ................................................................................................................ 23 
 

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DOCUMENT CHANGE HISTORY 
 
Version 
Originator 
Description of 
Change(s) 
Date 
1.0 
 
Original Protocol 
28 September 2017 
 
 
 
 
 
 
 

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1 Introduction 
CooperVision is evaluating the clinical performance of its Phoebe contact lenses (Test) 
compared to the commercially available MyDay contact lenses (Control) over 3-day of lens wear 
on a daily wear, daily disposable modality in a randomized, double masked, bilateral, cross-over 
dispensing study.  
2 Study Objective 
 
The purpose of this study is to validate the clinical performance of the Phoebe contact lenses. 
 
The primary variable of interest is: 
• 
Anterior ocular health examination 
The secondary variable of interest is: 
• 
Visual acuity and Vision quality 
 
 
 
 
 
 
 
 
 
2.1 Study Hypotheses  
The primary study hypothesis is that the Phoebe contact lens performs substantially equivalent to 
the MyDay contact lens for ocular health. 
The secondary study hypotheis is that The Phoebe contact lens is not inferior to the MyDay 
contact lens for vision and visual acuity. 
 
 
 
 
 
 

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3 Study Design  
This will be a double-masked, randomized, bilateral, cross-over, 3-day dispensing study comparing 
the Phoebe Test lens against the MyDay Control lens. Each subject will be randomized to wear 
either the Test or Control lenses first as a matched pair. Each lens pair will be worn for 3 days. All 
lenses will be replaced daily.  
It is anticipated that this study will involve up to 4 scheduled visits:  
• 
Visit 0:  Enrolment / Screening / Baseline Visit  
• 
Visit 1:  Dispensing of Pair 1  
• 
Visit 2:  Follow-up of Pair 1 (+2 days) and Dispensing of Pair 2  
• 
Visit 3:  Follow-up of Pair 2 (+2 days) and Exit  
 
4 Ethics Review / Statement of Compliance 
4.1 Relevant Standards / Guidelines 
This implementation document has been developed in accordance with the following:   
• 
ISO 14155 Clinical Investigation of Medical Devices for Human Subjects, 21CFR 812.2 (b) 
IDE-abbreviated requirement 
• 
Declaration of Helsinki 
 
4.2 Institutional Review Board 
This study will be conducted in accordance with Institutional Review Board (IRB) regulations (U.S. 
21CFR Part 56.103). Copies of all IRB/IEC correspondence with the investigator/sponsor will be 
kept on file.   
The conduct of this study will be approved by an Institutional Review Board prior to commencement. 
4.3 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. 

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5 Clinical Trial Registration 
This Study will be registered with ClinicalTrials.gov in accordance with Section 801 of the Food 
and Drug Administration Act (FDAA) which mandates the registration of certain clinical trials of 
drugs and medical devices. 
6 Potential Risks and Benefits to Human Subjects 
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 due to the daily 
wear nature of the study and existing approvals from FDA for the MyDay control contact lens. The 
contact lenses used in this study are intended for daily wear (NOT extended wear) with usage 
consistent with typical daily wear. 
The Phoebe test lens is manufactured with the same material as the MyDay control lens with a 
modified optical design, and should therefore not present increased risk to the patient.   
There might not be direct benefits to the subjects in this study. However, 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.  
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. 
 
Non-Invasive clinical procedures including auto-refraction, auto-keratometry, visual acuity, anterior 
ocular health assessment, and 
will be used. 
 
 
There might not be direct benefits to the subjects in this study. However, participation in a study may 
contribute to scientific research information that may be used in the development of new contact 

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lens products. In addition, participants will receive an examination of the front part of their eyes and 
may have the opportunity to try a different type of soft contact lens and/or different lens care products 
at no cost to them.  
7 Materials and Methods 
7.1 Clinical sites 
The study will take place at Indiana University School of Optometry, Clinical Optics Research Lab. 
This site was selected based on the experience of the site investigators and staff in conducting 
clinical trials, the availability of potential study participants, and the interest of the site in 
performing the trial.  A site investigator agreement and financial disclosure document will be in 
place prior to commencement of the trial. 
7.2 Participants 
Up to 80 subjects will be recruited for this study with the goal to have approximately 50 subjects to 
complete in total. 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:  
• 
Between and 18 and 35 years of age and has full legal capacity to volunteer 
• 
Has had a self-reported oculo-visual examination in the last two years    
• 
Has read and understood the information consent letter  
• 
Is willing and able to follow instructions and maintain the appointment schedule  
• 
Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual 
correction or 20/20 best corrected  
• 
Has a Contact Lens Refraction between -1.00D and -6.00D 
• 
Cylinder power ≤ -0.75DC in Spherical Cylindrical Refraction 
• 
Currently wears soft contact lenses  
• 
Is willing to wear lenses for a minimal of 8 hours a day and everyday during the 
course of the study 
• 
Has clear corneas and no active ocular disease 
• 
Has not worn lenses for at least 12 hours before the first visit 

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Exclusion Criteria 
A person will be excluded from the study if he/she: 
• 
Has never worn contact lenses before  
• 
Is wearing Monovision modality 
• 
Has any systemic disease affecting ocular health  
• 
Is using any systemic or topical medications that will affect ocular health 
• 
Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe 
dry eyes) that would affect the wearing of contact lenses  
• 
Has persistent, clinically significant corneal or conjunctival staining using sodium 
fluorescein dye 
• 
Has any clinically significant lid or conjunctival abnormalities, active neovascularization or 
any central corneal scars  
• 
Is aphakic  
• 
Has undergone corneal refractive surgery  
• 
Is participating in any other type of eye related clinical or research study 
 
7.3 Study Materials 
7.3.1 Contact lens 
Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit 
per a predetermined randomization schedule.  The lenses used in this study will be provided by the 
Sponsor.   
The Test lens material is approved by the FDA and the Control lens is commercially available. 
However, both the Test and Control lenses will be labelled with “Investigational” wording on the 
labels for study masking purpose.  
Details of the contact lenses are shown in Table 1. 
 
Phoebe (Test) 
MyDay (Control) 
Material 
stenfilcon A 
stenfilcon A 
Manufacture 
CooperVision 
CooperVision 
Base curve (mm) 
8.4 
8.4 
Diameter (mm) 
14.2 
14.2 
Power (D) 
-1.00 to -6.00 (0.25D steps) 
-1.00 to -6.00 (0.25D steps) 
Table 1: Study lenses 

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7.3.2 Contact Lens care 
No contact lens care is required for this study as lenses are to be worn for a single day only. 
Subjects are allowed to use saline solution for rinsing purpose as needed. The saline solution will 
be provided to subject by the clinical site. Subject’s habitual rewetting drdops may be used if 
needed. 
7.3.3 Storage of Lenses and Lens Care Solutions 
The study materials must be stored in a secured area. All lenses and lens care solutions should be 
stored at controlled room temperature (59-86°F). 
7.3.4 Clinical Supply Inventory 
The investigator must keep an accurate accounting of the study product during the study. A 
detailed inventory must be completed for study supplies. The study supplies are to be used in 
accordance with the implementation document by subjects who are under the direct supervision of 
an investigator. 
7.3.5 Disposal of Consumables 
This study dispenses consumables (lenses) to participants for use during the study. Participants 
will be instructed to dispose of worn lenses (both test and control lenses) daily. However, 
participants will be instructed to retain and return “problem” lenses. Study lenses worn by 
participants on the follow-up visits will be collected and returned to the sponsor at the completion 
of the study. Worn lenses will be stored in saline solutions. All unworn lenses will also be returned 
to the sponsor. 
7.3.6 Masking and Control of Study Materials 
The contact lenses coding will be masked to both the investigator and subject.   
7.3.7 Ordering and Accountability of Study Materials 
The test and control lenses will be provided by the sponsor.  
The investigator must complete an accurate accounting of the study product at the completion of 
the study. A detailed inventory must be completed for study supplies.  
All unused will be returned to the Sponsor at the end of the study unless the investigator is otherwise 
directed by the study Sponsor. Worn lenses on the last day of each lens type will be returned to the 
Sponsor. 

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7.4 Visit Schedule and Procedures 
7.4.1 Visit 0:  Baseline /Screening Visit  
Procedures to be Performed 
The following evaluations will be performed to assess eligibility according to the Inclusion and 
Exclusion Criteria at the baseline visit only:  
1. The patient is expected to attend the baseline visit not wearing their habitual contact lens 
products. 
2. 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. 
3. Participant demographics (age, sex, medications, allergies) will be recorded. 
4. Habitual lens wearing time (average, maximum, average comfortable) will be recorded.  
5.  
 
6. Auto Refraction/Auto Keratometry: steepest and flattest K readings (mm). 
7. Pupil Sizes in High and Low Illumination will be measured using the Neuroptics 
pupilometer while looking in the distance. 
8. Sphero-cylindrical refraction will be conducted  
9. Visual Acuity will be assessed with be assessed with Sphero-cylindrical refraction (D) 
a. Distance visual acuity 
i. High Illumination High Contrast (OU) 
ii. High Illumination Low Contrast (OD, OS, OU) 
iii. Low Illumination High Contrast (OD, OS, OU) 
b. Near visual acuity 
 
i. High Illumination High Contrast (OU) 
ii. Low Illumination High Contrast (OU) 
High Illumination: Overhead lights on, Ideal: 60cd/m2, Range: 120-200cd/m2  
Low Illumination: Overhead lights off, Ideal: Ideal: 3cd/m2, Range: 1-5cd/m2 
10. Slit lamp biomicroscopy will be assessed according to the guidelines set out in the CVI 
Grading scales.  

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11. The investigator will confirm that the patient meets the criteria set out in the inclusion criteria.   
7.4.2 
Visit 1: Dispensing visit 
Dispensing visit may occur on same day as Visit 0.  In which case, steps 1,2 &3 are redundant. 
1. Entrance distance HIHC VA (OD, OS) with best sphero cylindrical correction. 
 
2. Slit lamp biomicroscopy will be assessed according to the criteria set out in the Appendix 2. 
a. Not required if done in combination with Visit 0.  
3. The investigator will confirm that the patient meets the criteria set out in the inclusion criteria. 
4. The first pair of lenses will be inserted by the subject according to randomization schedule.   
5. Initial contact lens power chosen based on vertexed, spherical equivalent obtained from 
refraction. 
6. The initial lens fit will be assessed for fit acceptance (acceptable or not acceptable).  If the 
fit is acceptable, the subject will be allowed to sit in the waiting area for a minimal of 10 
minutes to allow for the lenses to settle. 
 
7. Visual acuity with initial contact lens power will be assessed. 
a. Distance visual acuity 
i. High Illumination High Contrast (OU) 
ii. Low Illumination High Contrast (OU) 
b. Near visual acuity  
iii. High Illumination High Contrast (OU) 
iv. Low Illumination High Contrast (OU) 
   
8. After lens settling a standard distant monocular over-refraction will be performed.  The 
endpoint of this over refraction will be the best objective acuity and subjective acuity 
improvement. 
a. Up to -0.50D will be given if objective visual acuity is improved. 
b. -0.25D will be given if subjective visual acuity is significantly improved.  
 
9. A lens change will be implemented if over-refraction dictates.  The replacement lens will be 
allowed to settle for 10 minutes.  
 
10. Change lens prescription to that noted by over-refraction, if needed. 
 
11. Visual Acuity will be assessed with the final lens powers. 
c. Distance visual acuity 
v. High Illumination High Contrast (OU) 
vi. High Illumination Low Contrast (OD, OS, OU) 

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b. Near visual acuity  
i. High Illumination High Contrast (OU) 
ii. Low Illumination High Contrast (OU) 
High Illumination: Overhead lights on, Ideal: 60cd/m2, Range: 120-200cd/m2  
Low Illumination: Overhead lights off, Ideal: Ideal: 3cd/m2, Range: 1-5cd/m2 
6. Monocular over-refraction and High Illumination High Contrast logMAR VA @ 4m (OU) will 
be performed and recorded. 
7. 
 
8. Lens removal and lens storage.  
9. Slit lamp biomicroscopy will be assessed set out in the CVI grading scales. 
10. Eyes will be rinsed. 
11. The Randomised Pair 2 lenses will be fitted.   
12. Initial contact lens power chosen based on vertexed, spherical equivalent obtained from 
refraction (i.e. match the initial power of the first pair). 
13. The intial lens fit will be assessed for fit acceptance (acceptable or not acceptable).  If the 
fit is acceptable, the subject will be allowed to sit in the waiting area for a mimimal of 10 
minutes to allow for the lenses to settle.   
 
14. Visual acuity with initial contact lens power will be assessed. 
a. Distance visual acuity 
i. 
High Illumination High Contrast (OU) 
ii. 
Low Illumination High Contrast (OU) 
b. Near visual acuity  
i. 
High Illumination High Contrast (OU) 
ii. 
Low Illumination High Contrast (OU) 
 
15. After lens settling a standard monocular over-refraction will be performed.  The endpoint of 
this over refraction will be the best objective acuity and subjective acuity improvement. 
 
c. Up to -0.50D will be given if objective visual acuity is improved. 
d. -0.25D will be given if subjective visual acuity is significantly improved.  
 
16. A lens change will be implemented if over-refraction dictates.  The replacement lens will be 
allowed to settle for 10 minutes. 
 
17. Change lens prescription to that noted by over-refraction, if needed. 

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AE classification, coding (for reporting to the sponsor) and examples are provided in the following 
table of Contact Lens Adverse Event Classification and Reporting table:  
 
Code 
Condition 
Reporting 
Serious Adverse Events 
01 
Presumed infectious keratitis or infectious corneal ulcer 
Notify sponsor as 
soon as possible, 
within 24 hours; 
IRB reporting as 
per requirements 
02 
Permanent loss of ≥ 2 lines of best spectacle corrected visual acuity (BSCVA) 
03 
Corneal injury that results in permanent opacification within central cornea 
(6mm) 
04 
Uveitis or Iritis (e.g. presence of anterior segment inflammation as described 
in ISO 11980, Annex B) 
05 
Endophthalmitis 
06 
Hyphema 
07 
Hypopyon 
08 
Neovascularization within the central 6mm of cornea 
00 
Other serious event 
Significant Adverse Events 
11 
Peripheral (outside central 6mm), non-progressive, non-infectious ulcer 
Notify sponsor as 
soon as possible, 
within 5 working 
days; IRB 
reporting as per 
requirements 
12 
Symptomatic corneal infiltrative event 
13 
Superior epithelial arcuate lesions (SEALs) involving epithelial split 
14 
Corneal staining ≥ dense coalescent staining up to 2mm in diameter (e.g. 
moderate, ISO 11980 grade 3) 
15 
Corneal neovascularization ≥ 1.0mm vessel penetration  
(e.g. ≥ ISO 111980 Grade 2), if 2 grade change from baseline 
16 
Any temporary loss of ≥ 2 lines BSCVA for ≥ 2wks 
17 
Any sign and/or symptom for which subject is administered therapeutic 
treatment or which necessitates discontinuation of lens wear for ≥ 2 weeks 
10 
Other significant event 
Non-significant Adverse Events 
21 
Conjunctivitis (bacterial, viral or allergic) 
Classification 
Definition 
Serious Adverse 
Event 
Those events that are life-threatening, or result in permanent impairment of a body 
function, or permanent damage to a body structure or necessitate medical 
(therapeutic) or surgical intervention to preclude permanent impairment of a body 
function or permanent damage to a body structure. 
Significant 
Adverse Event 
Those non-serious adverse events that occur with contact lens usage that are not 
sight-threatening but are usually symptomatic and may warrant therapeutic 
management and /or temporary or permanent discontinuation of contact lens wear. 
Non-Significant 
Adverse Events 
Those less severe non-serious adverse events that occur with contact lens usage 
that are not sight-threatening, may or may not be symptomatic and may warrant 
palliative management, such as ocular lubricants or  temporary interruption of contact 
lens wear. 
Unanticipated 
Adverse Device 
Effect 
Adverse events in a clinical trial that were not previously identified in the protocol in 
terms of nature, severity, or degree of incidence. An Unanticipated Serious Adverse 
Device Effect is an unanticipated adverse event that is serious in nature and caused 
by or associated with the device and is considered reportable. 

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Papillary conjunctivitis if ≥ mild scattered papillae/follicles approximately 1mm 
in diameter (e.g. ISO 11890 Grade 2), if 2 grade change from baseline 
Notify sponsor as 
soon as possible, 
within 5 working 
days; IRB 
reporting as per 
requirements 
23 
Asymptomatic corneal infiltrative events 
24 
Any sign and/or symptom for which temporary lens discontinuation for > 1 day 
is recommended (if not already classified) 
20 
Other sign and/or symptom warranting classification as a non-significant 
adverse event 
 
Normal or adaptive symptoms 
Transient symptoms such as end-of-day dryness, lens awareness, itching or burning or other 
discomfort may occur with contact lens wear and may occasionally reduce wearing time. These are 
not reported as adverse events unless in the investigator’s opinion they are unexpected in 
nature, severe or have a high rate of occurrence. 
 
 
 
 
 
8.2 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. 
 
8.3 Reporting Adverse Events 
All potential Serious and Unanticipated Adverse Device Effects that are related or possibly related 
to subject participation 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 

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the IRB as soon as possible (by fax, mail/delivery, phone, or email).  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. 
Sponsor contact details are: 
  
 
  
 
 
 
  
  
 
 
 
 
 
8.4 Discontinuation from the Study  
A subject’s study participation may be discontinued at any time if, in the opinion of the sponsor or 
the investigator it is in the best interest of the subject. All discontinuations will be fully documented 
on the appropriate study forms and the Discontinuation Form will be completed. 
9 Device Malfunctions 
A device malfunction means the failure of the device to meet its performance specification or 
otherwise perform as intended. Any defective lens that is likely to cause or contribute to a Serious 
Adverse Event should be reported to the Principal Investigator and the sponsor within 24 hours of 
the investigator becoming aware of the malfunction. 
Other defective lenses should be reported to the Sponsor as soon as possible. 
 
 
 

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10 Statistical Analysis  
10.1 Statistical analysis 
Summary statistics will be produced (e.g. mean, standard deviation). Paired t test will be used to 
compare slit lamp biomicroscopy, 
.  Repeated 
Measures Analysis of Variance (ANOVA) or paired analysis will be used to compare the variables 
between study visits. The critical alpha level for statistical significance will be set at p ≤ 0.05, with 
adjustment for multiple comparisons. Non-inferiory or equivalence testing will be conducted as 
appropriate.  
All participants who were evaluated will be used in the analysis. In the event of missing data, 
individual data points will be excluded in the analysis and not extrapolated from the collected data. 
11 Data Quality Assurance 
11.1  Study monitoring 
Site qualification of the investigative site has been completed to ensure that the site facility is 
adequate, personnel are qualified and resources are satisfactory to conduct clinical studies for the 
Sponsor. The protocol will be reviewed by the investigators prior to enrollment of the first subject. 
This will involve an overview of the protocol, which includes information on study objectives, 
inclusion and exclusion criteria, study visits and adverse event reporting. Data collection forms will 
also be reviewed and this will provide an opportunity to discuss any questions.  
During the course of the study, a site visit may be conducted to verify that written informed consent 
was obtained using the IRB approved ICF prior to each subject’s participation in the study. 
 
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. 
 

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11.2 Record keeping 
Detailed records of all study visits will be made using the Case Report Forms (CRFs). All data 
recorded on forms will be in ink. Any corrections to the forms will be initialed and dated at the time 
they are modified. 
 
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. The investigator will send the data collected to the study sponsor within 
approximately 5 business days after the last subject completes the final visit. 
11.5 Protocol Deviations 
Protocol deviations are unanticipated or unintentional changes to a study after it has received prior 
sponsor approval and ethics clearance.  Protocol deviations can be major or minor.  
Major protocol deviations may impact the research protocol, Informed Consent form or other study 
materials, usually cannot be anticipated ahead of time and are often necessary to ensure the 
safety and welfare of the subjects. 
The following are examples of protocol deviations that must be reported to the IRB: 
1. Changes in procedures initiated to eliminate immediate risks/hazards to subjects; 
2. Enrolment of subjects outside the protocol inclusion/exclusion criteria; 
3. Inadvertent deviation in specific research intervention procedures or timing of the research 
intervention which could impact upon the safety or efficacy of the study-related intervention 
or upon the experimental design; 

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4. Informed Consent documentation violations: no documentation of informed consent; 
incorrect version of, or incomplete, informed consent documentation used. 
Minor protocol deviations are caused by or which originate with research subjects and normally 
are not reported to the IRB unless these result in increased risk to the subjects(s). The following 
are examples of protocol deviations that are considered minor and do not require reporting to the 
IRB: 
• 
Logistical or administrative aspects of the study (e.g., study subject missed appointment, 
change in appointment date or time); 
• 
Inadvertent deviation in specific research intervention procedures or timing of the research 
intervention which would not impact upon the safety or efficacy of the study-related 
intervention or upon the experimental design (i.e., missing a measurement during a session 
that is not considered critical for the study).  
11.5.1 Reporting and documenting protocol deviations  
Major protocol deviations which require changes to the research protocol or informed consent 
process/document or other corrective actions to protect the safety, welfare, or rights of patients or 
others must be reported to the IRB according to the site’s guidelines.  All protocol deviations (major 
and minor) occurring during the study will be documented and included in the final report and data 
safety monitoring report to the IRB 
11.6 Confidentiality 
This study is confidential in nature.  Both Indiana University and Sponsor agree to hold in confidence, 
in accordance with the conditions laid out in the CooperVision Master Services Research Agreement 
(dated 20 June 2007), any information disclosed to the other party under that Agreement and 
identified verbally or in writing as confidential..  
 
All records will also be handled in accordance with HIPAA (1996) standards. 
 
11.7 Publication 
Indiana University may publish the results of this study, subject to the conditions laid out in the 
CooperVision Master Services Research Agreement, dated 20 June 2007. 
12 Study Costs  
The sponsor will compensate the clinical site and the subjects for their time and participation in this 
voluntary study. 

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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 participant must be followed until resolution and a written 
report completed indicating the subsequent treatment and resolution of the condition.   
13 Appendices 
Appendix 1 
Randomization Table 
Appendix 2 
CVI Grading Scales 
Appendix 3 
Questionnaires 
 
 

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APPENDIX 2 
 
 
 

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, 
 

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: 
 
 
Based on the STUDY lens performance only, how likely are you to continue wearing the STUDY lenses 
that you are wearing? 
Very Likely 
Likely 
Unlikely 
Very unlikely 
☐ 
☐ 
☐ 
☐ 
Comment/Reason: 
 
 

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