A Clinical Evaluation of Two Contact Lenses Used With Three Care Systems
Phase: NA
Conditions: Myopia
Sponsor: CooperVision, Inc.



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Section 1. Overview 
1.1 
Background 
The performance of different contact lens brands may vary when used with certain types 
of contact lens care systems.  This includes the level of corneal staining seen at follow-up 
visits and may also include other measures of lens performance including subjective 
comfort and surface deposition.  This project will evaluate two key CooperVision monthly 
replacement lens brands (Biofinity and Avaira Vitality) when used with three CooperVision 
care systems (Hy-Care, All in One Light, Refine One Step). 
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 Philip Morgan. 
1.3 
Study objectives 
This study aims to compare the clinical performance of the Biofinity and Avaira Vitality 
lenses when used in combination with three care systems (Hy-Care, All in One Light and 
Refine One Step). 
1.4 
Study design 
This will be a randomised, open-label, crossover study, controlled by cross-comparison. 
Thirty subjects will use each lens and solution combination for a month in random 
sequence; that is for a total of six months.  Follow-up visits for each lens will be performed 
after one month of wear. Lenses will be worn on a daily wear, reusable wear schedule. 
1.5 
Statistical considerations 
The principal hypothesis to be tested in this work is 
 subjective 
scores for the lenses will be substantially equivalent. 
 
 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. 

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1.5.1 
Power analysis 
Using subjective comfort data from a previous, similar study, 22 subjects are required to 
complete the study for 80% power, assuming a difference of 10 points and a deviation of 
16 points on a 0-100 scale. To allow for discontinuations, 30 subjects will be dispensed. 
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 30 subjects will be recruited and enrolled.   
2.1.1 
Subject withdrawal and replacement 
This study includes seven 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 first 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 aged 18-50 and have capacity to volunteer.   
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 wearer of reusable, single vision, spherical soft contact lenses. 
5. They have a contact lens spherical prescription between  -1.00 to - 6.50D (inclusive)  
6. They have a spectacle cylindrical correction of -1.00D or less in each eye.   
7. At dispensing, they can attain at least 0.20 logMAR distance high contrast visual 
acuity in each eye with the study lenses within the available power range. 
8. They are willing to comply with the wear schedule (at least five days per week and 
for at least eight hours per day). 
9. They agree not to participate in other clinical research for the duration of the study. 
2.1.4 
Exclusion criteria 
Subjects will not be eligible to take part in the study if: 

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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 have had cataract surgery. 
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 ocular abnormality which would, in the opinion of the investigator, 
normally contraindicate contact lens wear. 
9. 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. 
10. 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 ocular adverse events listed in 
  
Clinical assessment is made at the study visit(s) for these parameters.  The presence of 
any ocular adverse event will be reported on the case report forms and those 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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2.11 
Confidentiality 
All matters related to this work will remain confidential within Eurolens Research, the 
funding company and any regulatory authority (e.g. Manchester UREC). 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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Section 3. Subject management 
3.1 
Visit scheduling 
Subjects will be required to attend seven visits – an initial dispensing visit and six follow-
up visits, after one month of use of each lens/solution combination.  
 
 
 
3.1.1 
Unscheduled visits 
Subjects who attend at their own volition, (or as instructed to do so by the investigator) 
rather than for a scheduled study visit, will be examined and the visit will be classified as 
‘unscheduled’. Data collected at these visits will be recorded on the clinical study 
database. 
Should a subject attend for their initial visit and be ineligible for the study owing to a 
reason which the investigator believes to be transient (for instance slit lamp signs higher 
than those acceptable according to inclusion/exclusion criteria), a repeat first visit can be 
conducted a short time later. This visit may involve some or all of the scheduled initial visit 
procedures, with the exception of the consent process, which would not be repeated. 
3.1.2 
Missed visits 
Subjects not attending for a visit will be contacted and encouraged to return for 
assessment.  If two consecutive study visits are missed, the subject will be discontinued.  
It is expected that Eurolens Research personnel will attempt all reasonable means of 
communication in this event, including corresponding with the subject by letter. 
3.2 
Visit conduct 
3.2.1 
Initial visit 
Prior to the dispensing visit, each subject will receive a study-specific information form 
outlining the study at least 24 hours before the consent visit and will be asked to watch a 
short on-line information presentation detailing study visits and procedures. They will be 
asked to complete several multiple-choice questions to gauge their understanding of the 
study. Upon successful completion of these questions, the subject will be booked to 
attend the Dispensing 1 visit.  Subjects should attend this visit wearing their spectacles. 

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3.2.3 
Two to five month visits 
 
 
 
 
1. The same procedures as at the one month visit (3.2.2) will be carried out, with 
the next study lens and solution being fitted and dispensed in each case. 
3.2.4 
Six month visit 
 
 
 
1. The same procedures as at the one month visit (3.2.2) will be carried out. 
2. 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. 
3. The subject will be issued with their payment and discharged. 
3.2.5 
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 he/she determines 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 form. 
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 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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