1 Week Crossover Dispensing Study: Buttermere Versus MiSight 1 Day Soft Contact Lenses
Phase: NA
Conditions: Myopia
Sponsor: CooperVision, Inc.

 
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PROTOCOL TITLE: 
1 WEEK CROSSOVER DISPENSING STUDY: 
 VERSUS 
  
 SOFT CONTACT LENSES 
 
Sponsor Study Code: 
 
Site Study Code: (if applicable) 
N/A 
Version Number: 
1.0 
Date: 
 
Sponsor Company: 
COOPERVISION, INC. 
 
 
The information contained in these documents is confidential, privileged and only for the information of the intended 
recipient and may not be used, published or redistributed without the prior written consent of CooperVision. Please 
destroy/delete this document if you have received it in error and are not the intended recipient. 
Clinical Site: 
  
Study Stage:  
 
 
 

 
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Protocol Author: 
  
 
 
Sponsor Management:  
 
 
 
 
Data Management/Statisticia
 
 
CVI Operations Lead: 
 
The information contained in these documents is confidential, privileged and only for the information of the intended 
recipient and may not be used, published or redistributed without the prior written consent of CooperVision. Please 
destroy/delete this document if you have received it in error and are not the intended recipient. 

 
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Document Change History 
Version 
Originator 
Description of Change(s) 
Date 
1.0 
 
Original Protocol 
 
 
 
 
 
 
 
 

 
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Protocol Signature Page – Principal Investigator 
Protocol: 
 
Study Title:  1 Week Crossover Dispensing Study: 
 versus 
 Soft Contact 
Lenses 
Protocol Version: v1.0, Date: 
 
 
I have received and read this protocol and agree to adhere to the requirements. I am aware that my 
adherence to the above protocol is mandatory and that any changes in the protocol or informed 
consent form must first be approved by CVIL, Inc. and the Institutional Review Board, except those 
changes necessary to eliminate apparent immediate hazards to subjects.  I will provide copies of 
this protocol and all pertinent information to the study personnel under my supervision. I will discuss 
this material with them and ensure they are fully informed regarding their role in the study. I will 
ensure that the study is conducted in compliance with the protocol, Good Clinical Practice (GCP), 
and all applicable regulatory requirements, and with the reviewing Institutional Review Board (IRB) 
requirements. I agree to commence this study only after documented IRB approval is obtained. 
 
 
 
 
 
 
 

 
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Study Personnel 
Name: 
Title: 
Address: 
Telephone: 
Email: 
 
 
Principal Investigator: 
Name: 
Title: 
Address: 
 
 
 
 
 
 
 
 
 
Telephone: 
Email: 
 
 
Statistician: 
Name: 
Title: 
Address: 
 
Telephone: 
Email: 
 
 
Medical Monitor: 
Name: 
Title: 
Address: 
 
Telephone: 
Email: 
 
 
CVI Operations Lead:  
 
Name: 
Title: 
Address: 
 
Telephone: 
Email: 
 
 
 
 

 
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TABLE OF CONTENTS 
Document Change History ................................................................................................. 3 
Protocol Signature Page – Principal Investigator ............................................................. 4 
Study Personnel .................................................................................................................. 5 
Overall Synopsis of the Clinical Investigation Plan (Protocol) ........................................ 6 
1 
Study Objective ......................................................................................................... 10 
2 
Study Design ............................................................................................................. 11 
3 
Study Devices and Comparator Products ............................................................... 11 
3.1 
Contact Lenses ..........................................................................................................11 
3.2 
Adjunct Products .......................................................................................................12 
4 
Justification for the Study Design............................................................................ 12 
5 
Benefits/Risks of Study Device(s) and Study Procedures ..................................... 13 
5.1 
Anticipated Clinical Benefits .......................................................................................13 
5.2 
Anticipated Adverse Device Effects ...........................................................................13 
5.3 
Risks Associated with Participation in the Clinical Investigation .................................13 
5.4 
Risks of Clinical Procedures to be Utilized in the Study .............................................13 
5.5 
Possible Interactions with Concomitant Medical Treatments ......................................14 
5.6 
Steps That will be Taken to Control or Mitigate the Risks ..........................................14 
5.7 
Rationale for Benefit-Risk Ratio .................................................................................14 
6 
Ethics Review / Statement of Compliance ............................................................... 14 
6.1 
Relevant Standards / Guidelines ...............................................................................14 
6.2 
Institutional Review Board .........................................................................................15 
6.3 
Informed Consent ......................................................................................................15 
6.4 
Clinical Trial Registration ...........................................................................................15 
7 
Design of the Clinical Investigation ......................................................................... 16 
7.1 
Study Endpoints ........................................................................................................16 
7.2 
Clinical Site ................................................................................................................16 
7.3 
Subjects.....................................................................................................................16 
7.4 
Procedures to Minimize Bias .....................................................................................18 
7.5 
Visit Procedures ........................................................................................................19 
8 
Adverse Events ......................................................................................................... 28 
8.1 
Adverse Event Definitions ..........................................................................................28 
8.2 
Adverse Events Management ....................................................................................29 
8.3 
Reporting Adverse Events .........................................................................................30 

 
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8.4 
Discontinuation from the Study ..................................................................................30 
9 
Device Deficiency Reporting .................................................................................... 30 
9.1 
Product Defect Reporting (Investigator Responsibility) ..............................................30 
9.2 
Device Deficiency Reporting (Sponsor Responsibility) ...............................................31 
10 
Statistical Design and Analysis ................................................................................ 32 
10.1 
Statistical Hypothesis .................................................................................................32 
10.2 
Sample Size Calculations ..........................................................................................32 
10.3 
Statistical Analysis .....................................................................................................32 
10.4 
Interim Data Analysis .................................................................................................33 
10.5 
Data Management .....................................................................................................33 
10.6 
Data Quality Assurance .............................................................................................33 
11 
General Study Management ..................................................................................... 34 
11.1 
Monitoring Plan ..........................................................................................................34 
11.2 
Amendments .............................................................................................................34 
11.3 
Protocol Deviations ....................................................................................................34 
11.4 
Suspension or Premature Termination of the Clinical Investigation ............................35 
11.5 
Record Retention .......................................................................................................36 
11.6 
Confidentiality and Privacy ........................................................................................37 
12 
Device Accountability ............................................................................................... 38 
12.1 
Clinical Supply Inventory ...........................................................................................38 
12.2 
Disposal of Consumables ..........................................................................................38 
12.3 
Ordering and Accountability of Study Materials ..........................................................38 
13 
Study Costs ............................................................................................................... 38 
14 
Publication Policy ..................................................................................................... 38 
15 
References ................................................................................................................. 39 
17 
Appendix 1 – 
 40 
18 
Appendix 2 – 
....................... 50 
19 
Appendix 3 – Randomization .................................................................................... 51 
20 
Appendix 4 – 
 ...................................... 52 
21 
Appendix 5 – 
 
22 
Appendix 6 – 
 
 
 7 – 
 
24 
Appendix 8 – 
 
25 
Appendix 9 – 
 65 

 
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26 
Appendix 10 – Adverse Event Case Report Forms ................................................. 67 
27 
Appendix 11 – Clinical Trial Product Defect Notification Form .............................. 70 
 
 

 
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1 Study Objective  
The objective of this Design Validation clinical investigation is to compare the visual clinical 
performance of the 
 investigational contact lens to 
 contact lenses.  
CooperVision, Inc. (CVI) is aiming to compare visual acuity and subjective vision ratings of vision 
quality between two CooperVision lenses: 
 versus 
 in habitual soft lens 
wearers. The 
 lens is a daily disposable investigational lens in this study (as this lens has 
not been yet approved or commercially available in the US), the 
 is commercially 
available in the US for myopia control. 
 lens is a silicone hydrogel daily disposable (DD) lens with a similar design to 
  
 hydrogel DD lenses.  CooperVision, Inc. is interested in comparing visual acuity and subjective 
vision ratings between these two lenses of different materials to gain insight into the differences 
between these lenses from this aspect.  
The primary outcome variable for this study is: 
• 
High contrast, binocular, distance visual acuity (logMAR) at 1-week visit.  
The secondary outcome variable is: 
• 
Subjective vision quality (0-100 scale) at 1-week visit 
 

 
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3.1.1 Intended Use 
In this clinical investigation, the study lenses are intended to be used as a single use. Single use 
lenses will be used for a maximum of one day of lens wear recommended by the Sponsor. 
3.1.2 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). 
3.2 Adjunct Products 
3.2.1 Contact Lens Care Products  
No contact lens care is required for this study as lenses are to be worn for a single day only. No 
contact lens wetting drops will be used during this study. 
3.2.2 Other 
No other medical devices will be used in this study. 
4 Justification for the Study Design 
Nonclinical testing methods are not adequate to provide the information needed to advance the 
development of the 
 Contact Lens. A biocompatibility assessment has been completed 
and the benefit/risk assessment (see Section 5 below) supports the use of the device in this 
feasibility study. A synopsis of the biocompatibility assessment and prior clinical testing can be found 
in the Investigator Brochure.  
A crossover design has been chosen since it minimizes the impact of potential sympathetic effects 
between the two eyes (e.g. an uncomfortable lens in one eye may impact the subjective rating of 
the fellow eye). The study contact lenses do not alter the physiology and hence there is no carryover 
effect requiring a washout period. The order effect will be tested. 
The choice of comparator product was made in order to assess the clinical performance against a 
currently marketed product representative of generally accepted state of the art. 

 
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5 Benefits/Risks of Study Device(s) and Study Procedures 
5.1 Anticipated Clinical Benefits 
There might not be direct benefits to the subjects in this study, however participation in a new 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 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. 
5.2 Anticipated Adverse Device Effects 
Ocular complications that may occur during the wearing of contact lenses include discomfort, 
dryness, aching or itching eyes, burning, grittiness, 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 daily-wear soft lenses is 0.035%.1  Almost always an infection will occur 
only in one eye.  This risk is assumed by 35-million Americans who currently wear contact lenses. 
Subjects will need to meet the vision requirements for driving if they are old enough and plan to 
drive while participating in this study. 
5.3 Risks Associated with Participation in the Clinical Investigation 
This is considered a non-significant risk study based on United State Food and Drug administration 
(FDA) guidelines due to the daily wear nature of the study. The risks associated with the 
investigational contact lenses have been estimated in accordance with ISO 14971. A synopsis of 
pre-clinical and prior clinical testing results are included in the Investigator’s Brochure. Risk controls 
to reduce the risk as far as possible have been implemented and any residual risks will be further 
mitigated through close evaluation by the investigators under this clinical protocol and 
communicated via informed consent. 
5.4 Risks of Clinical Procedures to be Utilized in the Study 
Routine, non-invasive procedures will be conducted in this study.  Routine clinical procedures 
include auto-refraction, auto-keratometry, visual acuity, anterior ocular health assessment, and 

 
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contact lens fitting will be used. In addition, standard research procedures such as high 
magnification imaging of the lens fit may be made using 35 mm or digital cameras, in vivo confocal 
microscopy, and/or specular microscopy.  
5.5 Possible Interactions with Concomitant Medical Treatments 
The use of contact lenses can interact with concomitant topical, ocular and/or systemic medical 
treatments, therefore only healthy subjects who are not currently taking concomitant medical 
treatments will be included in this study assure in exclusion.  Artificial tears, re-wetting drops, and 
lubricating agents are not considered medical treatments.  Only those products approved for the 
use with contact lenses can be used according to their indication under this protocol. 
5.6 Steps That will be Taken to Control or Mitigate the Risks 
The following Information for Safety for contact lens wear during the clinical study will be reviewed 
with each subject:  
Hands should be washed and dried prior to touching the lenses for insertion or removal. If 
inserting the lenses yourself, they should be checked for tears and/or whether they are inside 
out prior to insertion.  Eye rubbing should be avoided. Contact lenses should never be worn 
while swimming or in any other hazardous environment.  The contact lenses are not to be 
slept in during the study or worn overnight and are to be replaced with a new pair according 
to the study lens wear schedule.   
5.7 Rationale for Benefit-Risk Ratio 
The knowledge gained from this feasibility study may lead to important conclusions regarding the 
ocular response and performance of new contact lens materials and designs. The potential risks for 
participating in this study are minimal, therefore the benefit-risk ratio is acceptable.  
6 Ethics Review / Statement of Compliance 
6.1 Relevant Standards / Guidelines 
This study was developed in accordance with 21 CFR Part 812 Investigational Device Exemptions 
and the good clinical practice (GCP) principles and ethical considerations of ISO 14155 Clinical 
Investigation of Medical Devices for Human Subjects and Declaration of Helsinki. The detailed 

 
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descriptions of ocular Adverse Events details and the biomicroscopy grading scales are adapted 
from ISO 11980 Ophthalmic Optics – Contact lenses and lens care products – Guidelines for clinical 
investigations. 
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. 
This study will adhere to a protocol and informed consent document approved by the I
 
. Each study subpart/implementation will be submitted to Sterling for 
approval prior to commencing the study. 
6.3 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. 
6.4 Clinical Trial Registration 
This study will be registered, and a description of this clinical trial will be available on 
http://www.ClinicalTrials.gov, as required by U.S. Law. 
 
 

 
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7 Design of the Clinical Investigation 
7.1 Study Endpoints 
The primary study endpoint: 
• 
High contrast, binocular, distance visual acuity (logMAR) at 1-week visit.  
The secondary study endpoint is: 
• 
Subjective vision quality (0-100 scale) at 1-week visit 
7.2 Clinical Site 
The clinical site was selected based on the availability of representative population of subjects and 
Investigator’s clinical research experience.  
The Investigators will be required to fulfill the following criteria: 
• 
Trained and experienced in the conduct of clinical research 
• 
Willingness to follow the study protocol 
• 
Trained in Good Clinical Practice (GCP) and the study protocol prior to commencing the 
study.  
7.3 Subjects 
A maximum of up to 40 subjects will be enrolled in this study, in order for a minimum of 10 subjects 
and a maximum of up to 30 subjects, to complete the study. Each subject will be given a unique ID 

 
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number. ID numbers will not be re-used. All subjects must meet the study inclusion and exclusion 
criteria listed below. 
7.3.1 Inclusion criteria 
A person is eligible for inclusion in the study if they have:  
• 
Are 8 to 18 years of age (inclusive) 
• 
Have read, signed and dated: 
• 
Age 18 - The Participant Informed Consent Form (participant only) 
• 
Age 12-17 – The Parental Permission Form (participant and parent)  
• 
Age 8-11 - The Parental Permission Form (parent) and Assent form (participant) 
• 
Are willing and able to follow instructions and maintain the appointment schedule. 
• 
Are habitual daily wearers of spherical single vision soft contact lenses to correct for distance 
vision in each eye, including myopia control soft contact lenses as below  
• 
Currently wears spherical soft contact lenses or myopia control soft contact lenses. 
• 
Have a pair of wearable back-up spectacles. 
• 
Are willing and able to wear contact lenses for at least 10 hours a day, 6 days a week while 
in the study. 
• 
Are myopic with subjective refraction: -0.75D to -7.00D spherical, with an astigmatism  
≤ -0.75D in each eye with maximum spherical equivalent anisometropia of 1.00D 
• 
Are correctable to a visual acuity of +0.10 logMAR or better (in each eye) with sphero-
cylindrical subjective refraction. 
• 
Have clear corneas with no corneal scars or any active ocular disease. 
• 
Can be fit with the study contact lenses with a power between -0.75 and -7.00 DS; this 
translates to best corrected vision sphere refraction that vertexes to a CL power between  
-0.75 and -7.00 (inclusive) at screening visit. 
• 
Demonstrate an acceptable fit with the study contact lenses. 
• 
Demonstrate that they can safely and independently insert and remove contact lenses at the 
screening/fitting visit. 
7.3.2 Exclusion Criteria 
A person will be excluded from the study if they have: 

 
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• 
Have taken part in another clinical research study within the last 14 days. 
• 
Are currently habitual wearers of toric contact lenses. 
• 
Have worn any rigid contact lenses or ortho-keratology contact lenses in the past 30 days. 
• 
Are an extended contact lens wearer (i.e., sleeping with their contact lenses) 
• 
Are on ongoing atropine treatment for myopia control. 
• 
Have a difference of > 1.0 D in best vision sphere subjective refraction between eyes.  
• 
Have amblyopia and/or strabismus/binocular vision problem.  
• 
Have any known active* ocular disease, allergies and/or infection. 
• 
Have a systemic condition that in the opinion of the investigator may affect a study outcome 
variable; 
• 
Are using any systemic or topical medications that in the opinion of the investigator may 
affect a study outcome variable; 
• 
Have a known sensitivity to the diagnostic pharmaceuticals to be used in the study. 
• 
Have undergone refractive error surgery or intraocular surgery. 
• 
Are a member of 
directly involved in the study. 
* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic 
treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, 
papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and 
corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active. 
 Any potential exclusion will be reviewed with the Principal Investigator or Sub-Investigator prior to final decision making. 
7.4 Procedures to Minimize Bias 
7.4.1 Labelling and Masking 
The Test will be labelled with an investigational label, according to local regulations where the clinical 
study is being conducted. The investigational label will also include study contact lens coding in 
order to facilitate investigator masking. 
Although approved for use in the country where the clinical study is taking place, the Control contact 
lenses will be labelled with an investigational label to facilitate masking. 
 

 
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7.5.1 Visit 1A: Baseline Visit 
A documented informed consent process will be conducted with all participants prior to their 
enrollment in the study and prior to any data collection or measurements. 
All participants who signed the informed consent/assent letter will be assigned a study ID number. 
The investigator will determine participant eligibility using the inclusion and exclusion criteria.  
Ineligible participants will be discontinued from the study. The procedures to be performed are 
outlined below. 
Visit procedures: 
1. 
The participant is expected to attend the screening visit with their habitual glasses NOT having 
worn their habitual contact lenses and/or used any rewetting/tear drops from at least one day 
prior to the study day.  
2. 
The parent (for participants ages 8 to 17) and participant will be required to read and sign a 
Parental Permission and Assent Form respectively prior to enrollment. This is not applicable to 
participants aged 18, who will be instead required to read and sign an Informed consent form 
prior to enrollment. When the parent (for those aged 17 and younger) and participant have 
signed the necessary forms as stated below, the participant will be considered enrolled in the 
study. 
• 
Age 18 - The Participant Informed Consent Form (participant only) 
• 
Age 12-17 – The Parental Permission Form (participant and parent)  
• 
Age 8-11 - The Parental Permission Form (parent) and Assent form (participant) 
3. 
Participant demographics and medical history (age, sex, medical conditions, medications, 
allergies). 
4. 
Contact lens history (habitual contact lens information and wearing habits). 
5. 
 
 
 
 
 
 
 
 
 
 
  
  
 
   
  
 
 

 
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14. Slit lamp biomicroscopy will be assessed using Efron grading scale as specified in Appendix 2. 
15. The investigator will confirm that the participant meets the eligibility specifications set out in the 
inclusion criteria and exclusion criteria and is eligible to continue in the study. 
7.5.2 Visit V1-B:  Pair 1 Dispensing  
The Screening Visit (V1-A) will be immediately followed by Pair 1 Dispensing Visit (V1-B) on the 
same day. 
Visit procedures:  
16. Contact lens Pair #1 will be provided to participants in a manner that does not unmask the 
participant or investigator as per the randomization schedule in Appendix 3.  
17. Participant to open blister packs and apply the Contact lens pair 1 OU – powers matched to 
vertexed best sphere refraction OU. Allow to settle for 15 minutes. 
18. Monocular over-refraction (photopic screen luminance with dim room illumination), change in 
power (allow 15 min settling time if CL power is changed) if VA is improved by 3 letters.  
19. LogMAR visual acuity measurements (with Room light illuminance and screen luminance 
conditions as specified in Appendix 4):  
Mesopic vision (mesopic screen luminance with dim room illumination, after 10 
minutes of dark adaptation):  
Distance (6m) Low illumination (LI) HC VA; OU (logMAR) 
Photopic vision (photopic screen luminance with dim room illumination): 
Distance (6m) LIHC VA; OD & OS & OU (logMAR) 
Distance (6m) Low room Illumination Low contrast (LILC) VA; OU (logMAR) 
High contrast near VA (near chart with high room illumination): 
Near (40 cm) HIHC VA; OU (logMAR) 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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22. Review contact lens usage instruction and required wearing time (10 hours per day and 6 days 
per week) with participants and also with parents/guardians where subjects are 17 years and 
younger. 
23. Dispense Pair 1 lenses. Unmasked staff to apply masked over-labels to sufficient R & L Contact 
lenses to last until next visit (include at least 2 spare pairs) 
24. Schedule for 1-week follow up visit (7 + 3 days from Visit 1) 
7.5.3 Visit V2-A:  7 (+3 days) Follow-up Assessment of Pair 1  
Visit procedures: 
25. The participant will attend the visit having worn study Contact lenses at least 2hrs prior to visit. 
26. Review wearing time, problems with CL wear, adverse events, protocol deviations. 
27. Unworn Pair 1 (OU) contact lenses will be collected from the subject by the Investigator.  
30. LogMAR visual acuity measurements (with Room light illuminance and screen luminance 
conditions as specified in Appendix 4): 
Mesopic vision (mesopic screen luminance with dim room illumination, after 10 minutes 
of dark adaptation):  
Distance (6m) Low illumination (LI) HC VA; OU (logMAR) 
Photopic vision (photopic screen luminance dim room illumination): 

 
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Distance (6m) LIHC VA; OD & OS & OU (logMAR) 
Distance (6m) Low room Illumination Low contrast (LILC) VA; OU (logMAR) 
High contrast near VA (near chart with high room illumination): 
Near (40 cm) HIHC VA; OU (logMAR) 
31. Over-refraction (best sphere monocular) distance and monocular photopic screen luminance 
dim room illumination VA (if any over-refraction) 
35. The subject will remove the Pair 1 (OU) study contact lenses worn on the day of Visit 2A, 
which will be retained and stored in saline solution for return to the Sponsor. 
36. Slit lamp biomicroscopy will be assessed using Efron grading scale as specified in Appendix 2. 
37. Subjects will undergo washout with saline solution. 
7.5.4 Visit V2-B:  Pair 2 Dispensing  
The Pair 1 follow-up visit (Visit V2-A) will be immediately followed by Pair 2 Dispensing visit (Visit 
V2-B) on the same day. 
Visit procedures:  
38. Contact Lens Pair #2 will be provided to participants in a manner that does not unmask the 
participant or investigator as per the randomization schedule (Appendix 3). 
39. Participant to open blister packs and apply the Contact Lens pair 2 OU – powers matched to 
vertexed best sphere refraction OU. Allow to settle for 15 minutes. 
40. Monocular over-refraction (photopic screen luminance with dim room illumination), change in 
power if VA is improved by 3 letters.  

 
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41. LogMAR visual acuity measurements (with room light illumination and screen luminance 
conditions as specified in Appendix 4):  
Mesopic vision (mesopic screen luminance with dim room illumination, after 10 
minutes of dark adaptation):  
Distance (6m) Low illumination (LI) HC VA; OU (logMAR) 
Photopic vision (photopic screen luminance with dim room illumination): 
Distance (6m) LIHC VA; OD & OS & OU (logMAR) 
Distance (6m) Low room Illumination Low contrast (LILC) VA; OU (logMAR) 
High contrast near VA (near chart with high room illumination): 
Near (40 cm) HIHC VA; OU (logMAR) 
44. Review contact lens usage instruction and required wearing time (10 hours per day and 6 days 
per week) with participants and also with parents/guardians where subjects are 17 years and 
younger. 
45. Dispense Pair 2 contact lenses. Unmasked staff to apply masked over-labels to sufficient R & 
L Contact lenses to last until next visit (include at least 2 spare pairs). 
46. Schedule for 1-week follow up visit (7 + 3 days from Visit 2A) 
7.5.5 Visit V3-A:  7 (+3 days) Follow-up Assessment of Pair 2 and Study Exit 
47. The participant will attend the visit having worn study Contact lenses for at least 2hrs prior to 
visit. 
48. Review wearing time, problems with CL wear, adverse events, protocol deviations. 
49. Unworn Pair 2 (OU) contact lenses will be collected from the subject by the Investigator.  

 
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52. 
LogMAR visual acuity measurements (with Room light illuminance and screen luminance 
conditions as specified in Appendix 4):   
Mesopic vision (mesopic screen luminance with dim room illumination, after 10 minutes of 
dark adaptation):  
Distance (6m) Low illumination (LI) HC VA; OU (logMAR) 
Photopic vision (photopic screen luminance dim room illumination): 
Distance (6m) LIHC VA; OD & OS & OU (logMAR) 
Distance (6m) Low room Illumination Low contrast (LILC) VA; OU (logMAR) 
High contrast near VA (near chart with high room illumination): 
Near (40 cm) HIHC VA; OU (logMAR) 
53. Over-refraction (best sphere monocular) distance and monocular photopic screen luminance 
dim room illumination VA (if any over-refraction) 

 
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57. The subject will remove the Pair 2 (OU) study contact lenses worn on the day of Visit 3A, 
which will be retained and stored in saline solution for return to the Sponsor. 
 
58. 
 
 
 
 
59. Slit lamp biomicroscopy will be assessed using 
 
60. Subjects will undergo washout with saline solution. 
7.5.6 Study Exit  
Exit visual acuity (LIHC) will be recorded with subjective spherocylindrical refraction result from  
V1-A refraction (OD & OS & OU (logMAR)). An exit biomicroscopy assessment will be conducted 
including Fl staining, if participant was fitted with study contact lenses at the screen visit or if 
biomicroscopy was not completed at a concurrent visit after the screening. 
After the exit assessments have been completed, the participant and investigator will complete the 
study exit and remuneration forms. At this time, the participant will be considered as having exited 
the study. 
When a participant exits the study, the study exit form will be completed. Therefore, this form will be 
completed either at completion of the study, or if the participant is discontinued from the study at 
another time. A study exit form must be completed for all participants who have taken a study ID 
number. If in the opinion of the investigator post-follow-up visits are required, the exit form will be 
completed after the last follow-up visit.  
7.5.7 Summary of Visits and Procedures 
 
 

 
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Table 3 summarizes the visits and procedures for the study.   
 
 

 
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8.3 Reporting Adverse Events 
An Adverse Event Notification Form (Appendix 10) will be completed for each adverse event. 
Whenever possible, the adverse event will be photo documented. 
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 
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 days after the occurrence. 
Sponsor contact details for adverse events are: 
Contact:  
Clinical Operations, CooperVision 
  
 
 
 
  
 
 
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 a discontinuation/exit form will be completed. 
9 Device Deficiency Reporting 
9.1 Product Defect Reporting (Investigator Responsibility) 
Product Defect is the terminology typically used in contact lens products for an unexpected 
observation related to the identity, quality, durability, reliability, or usability of the product under 
investigation.   

 
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NOTE: Observations on study products that are anticipated as a part of the device development 
process are not considered to be Product Defects or Device Deficiencies. 
If the Product Defect is associated with an adverse event, the investigator shall report the Product 
defect via the Adverse Event Notification Form (Appendix 10).  
If the Product Defect is not associated with an adverse event, the investigator shall report the 
Product Defect via the Clinical Product Defect Notification Case Report Form (Appendix 11).  
If the investigator judges that the Product Defect could have led to a Serious Adverse Event if no 
preventative action was taken, the Product Defect should be reported to the Sponsor via the Product 
Defect Notification Case Report Form within 24 hours of becoming aware of the defect. The 
investigator should report to the IRB/EC per their reporting requirements. 
All other Product Defects should be reported to CVI as soon as possible, but no later than 5 working 
days after occurrence.  
Sponsor contact details for Product Defect Notifications are: 
Contact:  
Clinical Operations, CooperVision 
  
 
  
 
 
 
 
 
9.2 Device Deficiency Reporting (Sponsor Responsibility) 
Device Deficiency is defined as the inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, usability, safety or performance.  
The Sponsor will review the Product Defect Notification Case Report Form, gather additional 
information if needed from the Investigator/CRO and determine whether the notification represents 
a Device Deficiency. Device Deficiencies will be reported as per Internal CVI procedures.  
A summary of Device Deficiencies will be documented in the clinical study report. If no Device 
Deficiencies are observed in a study, then a statement stating as such will be included in the clinical 
study report. 

 
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10 Statistical Design and Analysis 
10.1 Statistical Hypothesis 
The primary hypothesis to be tested in this study will be that the binocular high contrast distance 
visual acuity achieved with 
 Test contact lenses is non-inferior to that achieved with 
 Control soft contact lenses. 
10.2 Sample Size Calculations 
The target sample size for this study is 30 participants to be randomized and to wear both contact 
lens types. This target was determined based on the sample size calculation below:   
 
to demonstrate non-inferiority in high contrast binocular distance logMAR visual acuity for the Test 
contact lens compared with the Control contact lens, the sample size estimation is based upon a 
one-sided paired t-test with α =0.025, ß = 0.200 and a non-inferiority margin of 0.050 logMAR when 
postulating a true difference of 0.00 logMAR with a standard deviation of 0.07 logMAR a total of 26 
participants is required. The target for this study will be for 30 participants to complete the study 
without a significant protocol deviation.              
 
Therefore, in this study, a maximum of 40 participants may be randomized to achieve a maximum 
of 30 completed. 
10.3 Statistical Analysis 
Statistical analysis will be undertaken by the study biostatistician. The critical measure for statistical 
significance is set at alpha = 5% level with a P-value ≤ 0.05. All subjects who have completed the 
study will be included in the analysis.  
Lens performance will be compared per study design. Descriptive statistics (e.g., mean, standard 
deviation) and/ or frequency of counts for categorical data may be produced for primary and/or 
second interests. Paired t-test may be used to compare slit lamp biomicroscopy, contact lens fit and 
subjective scores between study contact lens types. Where applicable, Repeated Measures 
Analysis of Variance (ANOVA) or paired analysis may be used to compare the variables between 
study visits. Binomial tests may be used to analyze the results for the frequencies of subjective and 
objective preferences. 

 
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10.4 Interim Data Analysis  
Interim data analysis may be performed to take business decisions. The Sponsor may stop 
enrollment for this study if needed after any interim read.  
10.5 Data Management 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the 
clinical site Principal Investigator. The Principal Investigator is responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported. All source documents should be 
completed in a neat, legible manner to ensure accurate interpretation of data. 
The clinical data for this study may be entered by designated study site personnel onto paper or 
electronic case report forms (CRFs). Case history and symptoms questionnaires may be given to 
subjects to complete in paper or electronic form.  
Unless otherwise documented, the CRFs will be considered the source document.  
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. 
If study information is collected using an automated piece of equipment, the information may be 
recorded directly from the instrument display, captured electronically as output, or printed and 
entered into the CRF. The CRF will become the source document if there is no printout.  
10.6 Data Quality Assurance 
The CRFs will be completed at the time of the visit. All clinical data generated in the study will be 
submitted to the Sponsor for quality assurance review and analysis. All forms will be reviewed for 
completeness and evident recording errors will be rectified by contacting the appropriate clinical 
site. Computerized editing routines will be used to identify missing, invalid, inconsistent, or 
questionable data entries for verification prior to data analysis. These data issues will be resolved 
by contacting the relevant clinical site.  

 
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11 General Study Management 
11.1 Monitoring Plan 
The Sponsor will ensure site qualification of the investigative site has been completed prior to 
conducting the clinical study in order to ensure that the site facility is adequate, personnel are 
qualified and resources are satisfactory.  
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. 
Findings of non-compliance shall be reviewed with the Investigator and disclosed in a written 
monitoring report. The Monitor report will docuemnt any non-compliance with signed agreements, 
conditions imposed by the IRB/EC and the requirements of the study protocol. The Sponsor shall 
then either secure compliance or discontinue shipments of the lenses to the study contact lenses to 
the Investigator and may terminate the Investigator’s participation in the investigation, if required. 
Prior to final data freeze, a close-out visit/discussion may be warranted to check for accuracy and 
completeness of records. The Sponsor will be authorized to gain access to the source 
documentation for the purposes of monitoring and auditing the study. 
11.2 Amendments 
Amendments to this Protocol that may affect the rights, safety, or well-being of subjects will require 
review and approval from IRB before the changes are implemented in the study. Investigators at the 
site will be provided with the revised protocol version, the site trained and the Protocol Signature 
Page of the amended protocol completed prior to enacting the amendments. 
11.3 Protocol Deviations  
A Protocol Deviation is an instance of failure to follow, intentionally or unintentionally, the 
requirements of the protocol. Investigators will not deviate from the protocol except to protect the 

 
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rights, safety and well-being of human subjects. Under emergency circumstances deviations may 
proceed without prior approval of the Sponsor and the IRB. Deviations shall be reported to the 
Sponsor, IRB and the regulatory bodies, as required. 
Significant 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/EC within ten business days of the deviation occurring (or its 
discovery).  All deviations shall be reported to the Sponsor within two working days.  
All deviations occurring during the study will be documented on a protocol deviation form and 
documented in the final Clinical Study Report (CSR). 
Sponsor contact details for Protocol Deviations are: 
Contact:  
Clinical Operations, CooperVision 
  
 
  
 
 
 
 
 
11.4 Suspension or Premature Termination of the Clinical Investigation 
The study may be suspended or prematurely terminated if there is sufficient reasonable cause. 
Written notification, documenting the reason for study suspension or termination, will be provided 
by the suspending or terminating party to the Investigator, the Sponsor and the Institutional Review 
Board (IRB), as appropriate. If the study is prematurely terminated or suspended, the Investigator 
will promptly inform the IRB and will provide the reasons for the termination or suspension. In 
terminating the clinical investigation, CooperVision and the Principal investigator will assure that 
adequate consideration is given to the protection of the subject’s interests. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping 
• 
Insufficient compliance to protocol requirements  
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination of futility 

 
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The blinding/masking code may be broken and communicated to the Principal Investigator only in 
the case of an emergency, such as an Adverse Event that requires knowledge of the identity of the 
investigational product in order to manage the subjects' condition. 
The study may resume once concerns about safety, protocol compliance or data quality are 
addressed and satisfy the Sponsor and IRB/EC. 
Subjects will continue to receive follow-up care until they are able to be exited from the study (in the 
case of study termination) or are able to resume participation in the study (in the case of temporary 
study suspension), whereupon they will also be followed to exit.  
11.5 Record Retention 
Following study completion, data will be available in electronic and/or paper format for audit, 
Sponsor use, or subsequent analysis.  
Documents will be retained in a manner which allows for timely retrieval. Where documents are 
maintained in an electronic system, the system will be required to be maintained for the life of the 
document or the documents migrated to a system allowing for the continued retrieval of the 
document until the retention period has been completed.  
Access to the Network, eQMS or other electronic storage is secured to minimize potential loss or 
unauthorized changes. Documents will be stored in a manner to prevent loss and damage.  
Applicable hard copy documents will be secured as appropriate and maintained in a manner to 
prevent loss or damage.  
If hard copy records are retained in an archive store, a log of the content of each pallet and box in 
the archive should be kept in order to enable swift record retrieval. This log should contain the pallet 
and box owning department, record type and date range covered.  
The content of archives should be reviewed periodically. The storage of the records in the archive 
must be appropriate and in good condition to ensure that records inside are not damaged. 
Certain Quality/Regulatory Documented Information is noted as having permanent retention periods 
due to complex regulatory requirements. Permanent records should be held securely. A fireproof 
room or safe may be used.  

 
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Permanent records may be considered for destruction. Consideration will be based on a 
documented request forwarded to the site Quality Assurance leader, or a member of the Global 
Quality Systems team. The request must be reviewed and approved prior to any destruction.  
The request and approval will include: 
• 
the requestors name and title,  
• 
date of the request,  
• 
approvers name and title,  
• 
date of approval, 
• 
list of the Documented Information to be destroyed.  
 
Since this Protocol document is indicated for Design 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.  
11.6 Confidentiality and Privacy 
This study is confidential in nature. 
 
 
 any information disclosed to the other party under that 
Agreement and identified verbally or in writing as confidential. 
All records will be handled in accordance with HIPAA (1996) standards. The privacy of each subject 
and confidentiality of his/her information shall be preserved in reports and when publishing any data. 
Confidentiality of data shall be observed by all parties involved at all times throughout the clinical 
investigation. All data shall be secured against unauthorized access. Documentation containing 
personal and/or confidential identifying information for clinical trial subjects participating in studies 
will be maintained in a secured locked location. The principal investigator or investigation site shall 
provide direct access to source data during and after the clinical investigation for monitoring, audits, 
IRB review and regulatory authority inspections. 

 
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12 Device Accountability 
12.1 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 study protocol by subjects who are under the direct supervision of an investigator. 
12.2 Disposal of Consumables 
This study dispenses consumables (contact lenses) to participants for use during the study. Study 
contact lenses worn by participants at the Follow-up visits (Visits 2A & 3A) will be collected at the 
visit, and any unworn contact lenses for each lens pair at the Follow-up visit (Visits 2A & 3A).   
12.3 Ordering and Accountability of Study Materials 
The Test and Control contact lenses will be provided by the Sponsor. The investigator must 
complete an accurate accounting of the study product at the completion of the study. All unused and 
used materials will be returned to the Sponsor at the end of the study unless the investigator is 
otherwise directed by the study Sponsor. 
13 Study Costs  
The Sponsor will compensate the clinical site and the subjects for their time and participation in this 
voluntary study. 
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.   
14 Publication Policy 
 may publish the results of this study, subject to the conditions laid out in the 
 

 
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15 References 
1 Cheng K, Leung S, Hoekman H, Beekhuis W, Mulder P, Geerards A, Kijlstra A. Incidence of contact-lens-
associated microbial keratitisand its related morbidity. The Lancet 1999; 354:181-185. 
 
 

 
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17 Appendix 1 – Subjects Habitual CL wear Questionnaire (Visit 1) 

 
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18 Appendix 2 – Slit Lamp Biomicroscopy Grading Scales 

 
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20 Appendix 4 – Room Illumination and Screen Luminance 
 
  
                   
  
 
 
 
 
  
                   
 
 
 
 
 
 
 
 
  
 

 
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21 Appendix 5 – Objective Lens Assessments (Pairs 1&2) 
Lens Surface Assessments 

 
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24  Appendix 8 – 
 

 
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27 Appendix 11 – Clinical Trial Product Defect Notification Form