A One-Week Crossover Dispensing Evaluation of Gemini Daily Wear Soft Contact Lenses
Phase: NA
Conditions: Myopia
Sponsor: CooperVision, Inc.



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TABLE OF CONTENTS 
1 
Introduction ................................................................................................................. 4 
2 
Study Objective ........................................................................................................... 4 
2.1 
Study Hypothesis ........................................................................................................ 4 
3 
Study Design ............................................................................................................... 4 
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 ........................................................................................... 5 
6 
Potential Risks and Benefits to Human Subjects ..................................................... 6 
7 
Materials and Methods ................................................................................................ 6 
7.1 
Participants ................................................................................................................. 6 
7.2 
Sites ........................................................................................................................... 7 
7.3 
Study Materials ........................................................................................................... 8 
7.4 
Visit Schedule and Procedures ................................................................................... 9 
8 
Adverse Event Reporting .......................................................................................... 17 
8.1 
Adverse Event Definitions ..........................................................................................17 
8.2 
Procedures for Adverse Events .................................................................................19 
8.3 
Reporting Adverse Events .........................................................................................20 
8.4 
Discontinuation from the Study ..................................................................................20 
9 
Device Malfunctions .................................................................................................. 20 
10 
Statistical Analysis .................................................................................................... 21 
10.1 
Statistical analysis .....................................................................................................21 
11 
Data Quality Assurance ............................................................................................ 21 
11.1 
Study monitoring ........................................................................................................21 
11.2 
Record keeping .........................................................................................................22 
11.3 
Record retention ........................................................................................................22 
11.4 
Data Entry / Data Management .................................................................................22 
11.5 
Confidentiality ............................................................................................................23 
11.6 
Publication .................................................................................................................23 
12 
Study Costs ............................................................................................................... 23 

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DOCUMENT CHANGE HISTORY 
Version 
Originator 
Description of Change(s) 
Date 
1.0 
Original Protocol 
30 May 2017 
1.1 
 
 
- Additional variable added (lens fit parameters)
- Reference to ISO 14155 updated
- Clinical trial registration amended
- Addition, ID number will not be reused in event of
screen failure or discontinuation
 
 
 
 
 
 
 
 
- Minor modifications to, and errors corrected in, procedures
- Early read of data with subsequent report added to Statistical
Analysis section
- Modification of publication & confidentiality sections
14 July 2017 

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1 Introduction 
CooperVision is evaluating the clinical performance of 
 riofilcon A lens (test) compared to 
Alcon Focus Dailies All Day Comfort lens (control) when worn on a daily wear, daily disposable 
modality in a randomized, bilateral crossover dispensing study. 
2 Study Objective 
This  pilot study seeks to compare  the performance of 
 design lenses against Alcon Focus 
Dailies All Day Comfort lenses and will be used to provide additional performance information to 
add business confidence prior to a larger post market study. 
The primary variables of interest are: 
•
Lens fit acceptability
Additional variables are: 
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2.1 Study Hypothesis 
The study hypothesis is that there will be no difference in clinical performance between the 
 
test lens and the Alcon Focus Dailies control. 
3 Study Design 
This will be a double-masked, randomized, bilateral, 1-week crossover, dispensing study, 
comparing the 
 test  lens against  Focus Dailies All Day Comfort control lens, such that 
each lens type will be worn for a week each.  Each subject will be randomized to wear either the 
test lenses or the control lenses as a matched pair, according to a predetermined randomization 

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schedule.  All lenses will be replaced daily.  E
 
 
 
 
 
 
 
 
 
 
 
 
It is anticipated that this study will involve up to 4 scheduled visits:  
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Visit 0:  Enrolment / Screening / Baseline Visit (Day 0)
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Visit 1:  Dispensing of Pair 1 (Day 0)
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Visit 2:  One-week follow-up of Pair 1 (-1/+4 days) and Dispensing of Pair 2
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Visit 3:  One-week follow-up of Pair 2 (-1/+4 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
•
ICH Harmonized Tripartite Guideline for Good Clinical Practice
•
Declaration of Helsinki
4.2 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 conduct of this study will be approved by Sterling Institutional Review Board. Approval will be 
received prior to undertaking the study. 
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. 
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 

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6 Potential Risks and Benefits to Human Subjects 
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.  
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.  The risks to the subjects are also reduced based on the results of 
previous cytoxicity testing. 
Complications that may occur during the wearing of contact lenses include discomfort, dryness, 
aching or itching eyes, excessive tearing, discharge, hyperemia and variable or blurred vision. 
More serious risks may include photophobia, iritis, corneal edema or eye infection. Although 
contact lens-related infections are very infrequent, the possibility does exist.  The incidence of 
infection due to day-wear soft lenses is 0.035%. Almost always an infection will occur only in one 
eye.  This risk is assumed by 35-million Americans who currently wear contact lenses. 
Routine clinical procedures including auto-refraction, auto-keratometry, visual acuity, anterior 
ocular health assessment, and contact lens fitting will be used. In addition, high magnification 
imaging of the lens fit may be made using 35 mm or digital cameras, in vivo confocal microscopy, 
and/or specular microscopy. 
7 Materials and Methods 
7.1 Participants 
Up to 45 subjects will be enrolled and dispensed in order for approximately 40 subjects to 
complete the study.  Each subject will be given a unique ID number. ID numbers will not be reused 
in event of screen failure or discontinuation.  All subjects must meet the study inclusion and 
exclusion criteria listed below. 

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Inclusion criteria  
A person is eligible for inclusion in the study if he/she: 
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Is at least 18 years of age and has full legal capacity to volunteer.
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Is no greater than 55 years of age.
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Has read and understood the information consent letter.
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Is willing and able to follow instructions and maintain the appointment schedule.
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Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior
to the study.
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Has spectacle cylinder ≤1.00D in both eyes.
•
Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
•
Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent  of
20/25 in each eye.
•
Wears CLs in both eyes (monvision acceptable, but not monofit)
•
Has clear corneas and no active ocular disease.
•
Has not worn lenses for at least 12 hours before the examination.
•
Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week
Exclusion Criteria 
A person will be excluded from the study if he/she: 
•
Has never worn contact lenses before.
•
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 strabismus/amblyopia.
•
Has undergone corneal refractive surgery.
•
Is pregnant, lactating or planning a pregnancy.
•
Is participating in any concurrent clinical or research study.
7.2 Sites 
The study will be take place at a single site: CORL, Indiana University. 
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 

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7.3.5 Disposal of Consumables 
This study dispenses consumables (lenses) to participants for use during the study. All study 
lenses worn between study visits will be discarded by the participant, although subjects will be 
asked to retain the study lens foils.  Lenses worn to the follow-up visits will be collected and stored 
in unpreserved saline for return to the Sponsor. Unworn test 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.  If standard 
labelling does not sufficiently mask the study material then over-labelling will be performed.  
7.3.7 Ordering and Accountability of Study Materials 
The test will be provided by the sponsor and the control lenses sourced by the site. 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 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. 
7.3.8 Rewetting Drops 
Subjects will be allowed use of habitual rewetting drops if required during the study, except for on 
the days of the study visits. Type of drop and frequency of use will be recorded, if any. 
7.4 Visit Schedule and Procedures 
The investigator should confirm with the subject that they are able to attend the follow-up visits 
within the visit window before enrolling them in the study. Visits that fall outside of the specified 
visit windows will be counted as unscheduled visits for analysis purposes. 
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:  
• The patient is expected to attend the baseline visit not wearing their habitual contact lens
products.

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• 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.
• Habitual lens wearing time (average, maximum, average comfortable). Also habitual type of
comfort/re-wetting drop and frequency of use, if any, will be recorded.
• Sphero-cylindrical refraction will be conducted and baseline monocular and binocular High
Illumination High Contrast  (HIHC) and High Illumination Low Contrast (HILC) logMAR
distance visual acuities recorded.
• Slit lamp biomicroscopy will be assessed according to the guidelines set out in the CVI
Grading scales (Appendix 1).
• The investigator will confirm that the patient meets the criteria set out in the inclusion
criteria.
7.4.2 Visit 1:  Dispensing Pair 1 (Day 0) 
Dispensing visit may occur on same day as Visit 0.  If Visit 1 is conducted on a different day to 
Visit 0, slit lamp biomicroscopy should be conducted again to confrm eligibility. 
• Baseline auto-keratometry if not done within the previous 6 months.
• HVID (mm) and palpebral aperture size (mm) measurements using slit lamp oculars.
• The first study pair of contact lenses will be selected according to the randomization table
(Appendix 2).
• The contact lenses will be provided by a study coordinator/technician to maintain masking
of the investigator. The lenses will be inserted by the subject from the blister pack after the
label is removed by the study coordinator/technician.
•
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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• An initial fit assessment will be made to ensure lens fit is acceptable.  The subject should be
discontinued and exited if the lens fit is found unacceptable and the primary reason for poor
fit recorded.
• Monocular spherical over-refraction (SOR) will be conducted to determine if a different lens
power is required.
• Final lenses will be inserted and allowed  to settle for 15 minutes, if applicable.
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Lens fit (OD/OS) will be assessed and graded according to the CVI grading scales
(Appendix 1):
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Overall lens fit acceptance (0-4 scale) and investigator reason, if unacceptable.
•
The subject will be instructed to wear the study lenses for a minimum of 8 hours per day / 6
days per week.
•
The subject will be dispensed adequate lenses (including spares) to last them until the next
study visit.
•
The subject will be discharged and scheduled to return for Visit 2 within the required study
visit window.
7.4.3 Visit 2:  One-Week Follow-up Pair 1 (-1/+4 days) & Dispensing Pair 2 
Subjects will be asked to wear lenses for at least 3 hours prior to the visit appointment. 
 
 
 
 
 
 
 
 
 
 
 
 
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•
  
 
 
 
 
 
 
 
 
 
 
 
 
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Overall lens fit acceptance  (0-4 scale) and investigator reason, if unacceptable
•
The subject will be instructed to wear the study lenses for a minimum of 8 hours per day / 5
days per week.
•
The subject will be dispensed adequate lenses (including spares) to last them until the next
study visit.
•
The subject will be discharged and scheduled to return for Visit 3 within the required study
visit window.
7.4.4 Visit 3:  One-Week Follow-up Pair 2 (Day 7 +4/-1 days) and Exit 
Subjects will be asked to wear lenses for at least 3 hours prior to the visit appointment. 
•
 
 
 
 
 
 
 
 
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7.4.5 Comfort Throughout the Day Questionnaire 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
     
 
 
    
 
 
  
 
 
 
 
    
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  

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

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Other defective lenses should be reported to the Sponsor as soon as possible. 
This clinical study will also ascertain satisfaction or preference with subjective attributes such as 
comfort, vision, or lens handling. Responses to these subjective questionnaires will not be 
considered as complaints or Device Malfunctions. 
10 Statistical Analysis 
10.1 Statistical analysis 
Summary statistics will be produced (e.g. mean, standard deviation). Paired t-test or two sample t-
test will be used to compare slit lamp biomicroscopy, lens fit and subjective scores between study 
lens types.  Repeated Measures Analysis of Variance (ANOVA) or paired analysis will be used to 
compare the variables between study timepoints. The critical alpha level for statistical significance 
will be set at p ≤ 0.05, with adjustment for multiple comparisons. 
An early read  of performance variables (interim data) will be taken prior and a report produced 
prior to completion of the study.    
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.  

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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. 
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.  Copies of all original raw data forms and completed CRF’s will be forwarded to the 
sponsor at completion of the final report at the Sponsor’s request.  
11.4 Data Entry / Data Management 
Data will be entered into an electronic spreadsheet. Study staff will only be able to modify the data 
file via password entry. The investigators will be responsible for the data integrity, and complete 
data entry for each visit as well as the web-delivered comfort questionnaires. The investigator will 
send the data collected  to the study sponsor within approximately 5 business days after the last 
subject completes the final visit. 

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11.5 Confidentiality 
This study is confidential in nature.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
All records will also be handled in accordance with HIPAA (1996) standards. 
11.6 Publication 
Indiana University may publish the results of this study, subject to the conditions laid out in the 
 
 
 
 
 
 
 
 
 
12 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.