A Clinical Comparison of Two Daily Disposable Soft Contact Lenses
Phase: NA
Conditions: Myopia
Sponsor: CooperVision, Inc.



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Section 1. Overview 
1.1 
Background 
This project seeks to compare the clinical performance of the clariti® 1 day and MyDay® 
daily disposable contact lenses (CooperVision Inc.) in existing wearers of the Biofinity® 
monthly lens (CooperVision Inc.).  
1.2 
Personnel 
This work will be conducted at Eurolens Research, The University of Manchester under 
the general direction of Philip Morgan PhD MCOptom FAAO FBCLA.  The Principal 
Investigator for the work is Carole Maldonado-Codina PhD MCOptom FAAO FBCLA.  
1.3 
Study objectives 
The aim of this clinical work is to compare the clinical performance and subjective 
acceptance of two daily disposable soft contact lenses (clariti 1 day and MyDay daily 
disposable) when a subject is switched into these from Biofinity monthly lenses.  
1.4 
Study design 
This will be a randomised, double-masked, crossover study, in which 55 subjects who 
have been ‘pre-conditioned’ (i.e. fitted) with Biofinity spherical lenses for one month are 
switched into daily disposable lenses.  Subjects will wear each daily disposable lens type 
for one week, in random order. 
1.5 
Statistical considerations 
 lens surface data and subjective responses will generate 
data that are likely to be continuous and normally distributed.  As such, these will be 
compared using linear regression models or other parametric methods. Subjective 
preferences will be compared using chi-squared tests.  Lens fit data are expected to be 
ordinal data and assessed with non-parametric approaches. Deviations from this 
statistical plan will be discussed in the final report.  Deviations may be necessary due to 
differences between the actual data distribution compared with the anticipated data 
distribution. 
1.5.1 
Power analysis 
A power analysis for end-of-day comfort has shown that 51 subjects completing the study 
will provide a sufficient number of subjects for this purpose (non-inferiority testing).  This 
will also provide enough subjects to show non-inferiority between lenses for insertion 
comfort and overall comfort. To allow for discontinuations, 55 subjects will be dispensed 
with contact lenses. 

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1.6 
Risk analysis 
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.  With the potential benefit of this study, the work 
is considered to be ethically justifiable.  Ethical approval will be sought from the University 
of Manchester Senate Committee on the Ethics of Research on Human Beings (hereafter 
referred to as Manchester UREC).  The work where practical will be conducted in 
accordance with the ICH Good Clinical Practice Guidelines and the international standard 
BS EN ISO 14155:2011 ‘Clinical investigation of medical devices for human subjects’.  
 

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Section 2. Resources 
2.1 
Subject selection 
In this work 55 subjects will be dispensed contact lenses.   
2.1.1 
Subject withdrawal and replacement 
This study includes four clinical visits. Once the study consent form is signed, the subject 
is considered to be enrolled on the study.  Subjects who have signed the consent form, 
but who have not completed the dispensing visit will usually be replaced.  All subject data 
will be included in the final analyses unless there are strong grounds for exclusion; such 
grounds will be detailed in the final report. At the end the study, all subjects will sign a 
study exit form. 
2.1.2 
Subject recruitment 
Subjects will be recruited by one or more of following means: 
1. Posting study details on The University of Manchester’s ‘Research Volunteers’ 
website. 
2. Correspondence to existing wearers on the Eurolens Research database of 
subjects. 
3. Advertising through a variety of media via a format separately approved by 
Manchester UREC. 
2.1.3 
Inclusion criteria 
Subjects will only be eligible for the study if: 
1. They are between 18 and 40 years of age (inclusive).   
2. They understand their rights as a research subject and are willing and able to sign a 
Statement of Informed Consent. 
3. They are willing and able to follow the protocol. 
4. They are an existing soft reusable spherical contact lens wearer in both eyes. 
5. They have a contact lens spherical prescription between -0.50 to -6.00D (inclusive) 
based on the ocular refraction. 
6. They have a cylindrical correction of -0.875DC or less in each eye based on the 
ocular refraction 
7. They own a wearable pair of spectacles and wear them on the day of the initial visit. 
8. They have distance high contrast logMAR visual acuity of 0.2 or better in each eye 
with their  habitual spectacles.   
9. They agree not to participate in other clinical research for the duration of the study. 

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2.1.4 
Exclusion criteria 
Subjects will not be eligible to take part in the study if: 
1. They have an ocular disorder which would normally contra-indicate contact lens  
wear. 
2. They have a systemic disorder which would normally contra-indicate contact lens 
wear. 
3. They are using any topical medication such as eye drops or ointment. 
4. They are aphakic. 
5. They have had corneal refractive surgery. 
6. They have any corneal distortion resulting from previous hard or rigid lens wear or 
have keratoconus. 
7. They are pregnant or breastfeeding. 
8. They have any infectious disease which would, in the opinion of the investigator, 
contraindicate contact lens wear or pose a risk to study personnel; or they have 
any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe 
allergic reaction. 
9. They have taken part in any other contact lens or care solution clinical trial or 
research, within two weeks prior to starting this study. 
2.2 
Subject discontinuation 
In general, subjects should be discontinued at any time, if it is in their best interests, as 
judged by the investigator.  Reasons for this may include clinical signs of grade 3 or more, 
lack of motivation, discomfort, repeated refusal to follow instructions or the use of non-
study products such as solutions or lenses. Subjects will be discontinued if a serious 
adverse event occurs or if they miss two or more planned consecutive visits. Subjects who 
fail to satisfy all the inclusion and exclusion criteria will be discontinued and replaced.  
Subjects may choose to leave the study at their own request.  All discontinuations will be 
carefully recorded. 
2.3 
Safety parameters, adverse events and concurrent illnesses 
The key safety parameters are the serious and significant adverse events listed in 
Appendix A (adverse events are classified as ‘serious’, ‘significant’ or ‘non-significant’).  
Clinical assessment is made at the study visit(s) for these parameters.  The presence of 
any ocular adverse event will be recorded on the eCRF and reported to the Sponsor using 
CVI report forms, and those ocular adverse events described as ‘serious’ or ‘significant’ 
will be detailed in the final report.  Similarly, any concurrent illness that is likely to impact 
on the relevance and quality of the captured data will be noted on the case report form. 

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2.3.1 
Investigator obligations 
At all times the investigator will act in the best interest of the subject. Referral or treatment 
of an adverse event or other clinical finding should be initiated in the best clinical 
judgement of the investigator, irrespective of the participation in the clinical study. 
2.3.2 
Reporting obligations 
In the case of a ‘serious’ or ‘significant’ adverse ocular event, the Principal Investigator will 
notify the Industrial Contact Person as soon as possible.  Manchester UREC and any 
regulatory authorities will be informed as required. 
2.4 
Study termination 
If it becomes necessary to terminate the study earlier than planned, the Industrial Contact 
Person will notify the Principal Investigator who will end the study with the cooperation of 
other staff members. Manchester UREC will be informed. 
2.5 
Protocol deviations and device deficiencies 
Any deviations from this protocol will be recorded, and reported to the Industrial Contact 
Person as appropriate.  Manchester UREC will be informed as necessary. Device 
deficiencies will be recorded and reported to the Industrial Contact Person. 
2.5.1 
Protocol amendments 
Any amendments will be agreed between the Industrial Contact Person and the Principal 
Investigator with the cooperation of other staff members.  Amendments will be recorded, 
identified and distributed.  Approval from Manchester UREC will be obtained as 
necessary. 
2.6 
Study resources 
Study products will be stored according to the manufacturer’s product instructions. 
2.6.1 
Lenses 
Details of the study lenses are provided in Table 2.  All lens types are CE marked.  Initial 
lens selection will be as indicated by the manufacturer fitting guidelines. 
 
 

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2.8 
Documentation 
Documents related to this work that require archiving will be kept by Eurolens Research 
for a period of 10 years after completion of the final report.  The Sponsor’s permission will 
be sought before the documents are destroyed.   
2.9 
Data collection and analysis 
Data collected in this work will be recorded on a custom developed database and an 
established data trail.  Data handling will include export of the study information from the 
clinical database into spreadsheet format for manipulation, followed by export into a 
statistical package for analysis. Most clinical data will be entered directly onto the 
electronic case report form and is considered to be source data.  
 
 
2.10 
Study completion 
The clinical phase of the study will be considered as complete when all subjects have 
signed the exit statement.  
2.11 
Confidentiality 
All matters related to this work will remain confidential within Eurolens Research, the 
funding company and any regulatory authority (e.g. Manchester UREC).  Eurolens 
Research will take all reasonable steps to ensure that specific lens-related information is 
not passed on to study participants unless this is required for clinical management of an 
adverse event.  Personal subject information will not be made available.  To cater for this, 
subjects will only be referred by their unique identity number in the study report.  The data 
activities of Eurolens Research are registered with the data protection officer at The 
University of Manchester. 
2.12 
Study monitoring 
In order to provide quality control and quality assurance as part of this work, the study 
monitor will: 
1. Liaise closely with the Principal Investigator. 
2. Monitor and ensure the safety of the subjects. 
3. Ensure that the investigation is being conducted according to the protocol. 
4. Monitor and review (or oversee review of) the study records to ensure accuracy. 
5. Document their observations and make them available to relevant authorised 
parties (e.g. Manchester UREC). 
6. Implement the Eurolens Research clinical monitoring standard operating 
procedure. 

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2.13 
Clinical trial registration 
This study will be registered with clinicaltrials.gov in accordance with section 801 of the 
Food and Drug Administration (FDA) Act which mandates the registration of certain 
clinical trials of drugs and medical devices. 
 
 

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3.2.2 
Visit 1 Dispensing with Biofinity  
Subjects should attend this visit wearing their spectacles (the visit can still go ahead if 
they attend wearing their contact lenses). They will then be required to sign an informed 
consent form prior to enrolment (Appendix C).  A copy of the signed form will be issued to 
the subject.  When the subject has signed the consent form, they are considered to be 
enrolled on the study. 
 
Subjects will be instructed on the following: 
! 
Lens handling, application and removal, where necessary. 
! 
Use of multipurpose care regimen 
! 
Specific study instructions, such as the importance of not using any other contact 
lens products. 
! 
General contact lens information such as the management of red eyes. 
 
The following procedures will be performed (any ocular measurement procedures outlined 
below will be carried out on each eye): 
1. Details of the ocular and contact lens wearing history of the subject will be noted 
(including habitual lenses, modality, wear time and comfortable wear time). 
2. Details of general health and medications will be recorded. 
3. 
 
4. 
 
 
 
 
 
5. 
 
 
 
 
 
 
 
 

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14. 
 
 
15. The investigator will answer the following question: “The fit of the lens is 
acceptable?” using the following grading scale. If the grade is 3 or more, the 
reasons why should be stated: 
1. Strongly agree 
2. Agree 
3. Neither agree not disagree 
4. Disagree 
5. Strongly disagree 
16. Subjects will be given an additional spare pair of lenses (and care solution at Visit 
1 only). 
17. Subjects will be discharged and asked to return for a one-month follow-up visit 
wearing the Biofinity lenses, which need to have been worn for at least two hours. 
Subjects should be asked to wear their lenses for a minimum of eight hours per 
day, five days per week.  
3.2.3 
Visit 2: Follow-up with Biofinity/dispensing of first daily disposable lens 
Subjects should attend wearing their Biofinity lenses which should have been in situ for at 
least two hours.  Subjects who attend without lenses in situ for at least two hours will 
usually be rescheduled. The following procedures will be performed (any ocular 
measurement procedures outlined below will be carried out on each eye): 
1. Any medical or ocular issues since the last visit will be recorded. 
2. Lens wearing times since the previous visit will be recorded (hours per day, 
days per week and comfortable hours per day). 
3. Lens wearing time on study visit day.  
4. Retrieval of any unused lenses (and care solution at Visit 2 only). 
5. 
 
 
 
6. The subject will be asked to score the following with reference to appropriate 
visual analogue scales (0-100) 
: 
! 
Comfort after insertion 
! 
Comfort before removal 
! 
Overall comfort 
! 
 
 
 

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! 
 
 
 
 
 
! 
 
! 
 
 
 
 
 
7. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8. 
 
 
 
 
 
 
9. Lens fit 
assessment, as described in section 3.2.2 (including push-
up). 
10. The investigator will answer the following question:  “The fit of the lens is 
acceptable?” using the following grading scale. If the grade is 3 or more, the 
reasons why should be stated: 
! 
Strongly agree 
! 
Agree 
! 
Neither agree not disagree 
! 
Disagree 
! 
Strongly disagree 

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11. The study lenses will be removed and discarded. 
12. 
 
 
13. The first daily disposable study lens will be fitted and allowed to settle for five 
minutes, according to the randomisation table 
 
14. The same procedures as for Visit 1 (section 3.2.2) steps 8-15 will be carried out.  
15. 
 
 
16. The subject will be discharged and asked to return for a one week follow-up visit 
wearing the study lenses which need to been worn for at least two hours. 
Subjects should be asked to wear their lenses for a minimum of eight hours per 
day, five days per week. 
3.2.4 
Visit 3: Follow-up first daily disposable lens/dispensing second lens 
This visit will be identical to Visit 2 (Section 3.2.3), with the first daily disposable study lens 
first being assessed, before the second daily disposable lens is fitted, assessed and 
dispensed. 
 
 
 
 
3.2.5 
Visit 4: Follow-up second daily disposable lens  
This study visit will be identical to Visit 2 (Section 3.2.3) steps 1-12, with the second daily 
disposable lens being assessed, 
 (per 3.2.4) between Biofinity 
and the second daily disposable lens. 
 
 
 
 
 the following will be carried out: 
1. At the final visit (or when the subject is discontinued at an earlier visit) the 
subject will sign a study exit statement acknowledging that the work is complete, 
although they may have been asked by the investigator to attend a post-study 
follow-up visit, and that they should continue to use their lenses (and solutions) 
as advised, and seek aftercare for their contact lenses.  A copy of this signed 
form will be issued to the subject. 
2. The subject will be issued with their payment and discharged. 

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3.2.6 
Post-study follow-up visit 
In the case of a subject who exits the study with significant clinical signs or symptoms, the 
investigator must undertake to examine the subject at intervals they determine to be 
clinically appropriate until the sign or symptom has resolved or returned to a level that is 
considered to be clinically acceptable.  Details from these visits will be recorded on a post-
study follow-up visit eCRF. 
3.3 
Monitoring subject compliance 
Subjects are required to adhere to the instructions provided during this clinical 
investigation.  This will be confirmed at the study visits by verbal questioning of the subject 
by the investigator. 
3.4 
Missing, unused and spurious data 
The absence of any data will be carefully and critically considered.  If appropriate, partial 
datasets will be included in the final analysis.  Any data missing from a subject visit will be 
outlined in the report by indicating the number of subjects included for each analysis.  
Data that are unused or considered to be spurious will be detailed and discussed in the 
report. 

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Section 4. Study co-ordination 
4.1 
Document processing 
All case report forms will be processed and evaluated by Eurolens Research, who will 
produce the final report with full statistical analysis.  A draft report will be sent to the 
Industrial Contact Person in order to make comments and ask for re-drafts.  If no 
comments are received from the Industrial Contact Person within eight weeks, a final 
report will be released with a separate document control page (in duplicate), requesting 
the Industrial Contact Person to sign both copies, one to keep and the other to be 
returned to Eurolens Research. 
4.2 
Disclosure 
All matters relating to this clinical study are confidential and should only be disclosed to 
relevant authorised parties.  More precise details relating to disclosure are outlined in the 
Research Agreement.  None of the investigators involved in this work owns equity in the 
funding company. 
4.3 
Personnel 
 
 
 
 
 
 
 
 
 
 
Industrial Contact Person