A Clinical Comparison of Two Soft Contact Lenses (Iteration Under Umbrella Protocol C19-678)
Phase: NA
Conditions: Myopia
Sponsor: CooperVision, Inc.



Eurolens Research  (C23-747, EX-MKTG-154)  Clinical protocol version 1 
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Contents 
Document control 
3 
Study summary 
 
Section 1. 
Overview 
5 
1.1 Background 
5 
1.2 Personnel 
5 
1.3 Study objectives 
5 
1.4 Study outcome measures 
5 
1.5 Study design 
5 
1.6 Statistical considerations 
5 
1.7 Risk analysis 
6 
Section 2. 
Resources 
7 
2.1 Subject selection 
7 
2.2 Subject discontinuation 
8 
2.3 Safety parameters, adverse events and concurrent illnesses 
8 
2.4 Protocol deviations 
9 
2.5 Study resources 
9 
2.6 Data collection and analysis 
9 
2.7 Study monitoring 
9 
Section 3. 
Subject management 
11 
3.1 Visit scheduling 
11 
3.2 Visit conduct 
11 
3.3 Monitoring subject compliance 
13 
3.4 Missing, unused and spurious data 
14 
Section 4. 
Study co-ordination 
15 
4.1 Document processing 
15 
4.2 Disclosure 
15 
4.3 Personnel 
15 
 
 
 

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Section 1. Overview 
1.1 
Background 
This clinical investigation plan describes a clinical contact lens study (iteration) which will 
run under the umbrella protocol entitled, ‘Multiple non-dispensing soft contact lens fitting 
studies’ (C19-678) which received full ethical approval from The University of Manchester 
Research Ethics Committee 1 on May 20, 2021. The umbrella protocol describes a series 
of iterations which would recruit up to 50 subjects and compare CE marked contact lenses 
using routine clinical investigations at a single, non-dispensing visit and at a single study 
site (Carys Bannister Building, The University of Manchester). This iteration conforms to all 
of these requirements. 
 
This document provides an outline of the specific details for this particular iteration. 
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 
CooperVision Inc. wishes to gather short-term clinical performance data for two of the soft 
contact 
lenses which they currently manufacture. This non-dispensing 
iteration will compare 
the performance of the Live Daily Disposable and Clariti 1day lenses.  
1.4 
Study outcome measures 
The  primary  outcome  measure  
for  
this  study  
is  
the  subjective  overall  score.  Secondary 
measures are subjective comfort and vision. 
 
1.5 
Study design 
Up to  fifty participants  will  take  part  in  a subject-masked, non-randomised crossover, 
controlled non-dispensing study, which will be controlled by cross comparison.  Subjects 
will  attend  
for  one  visit  only  which  will  
last  
for  approximately 2.0 hours.  They  will  not  be 
given any contact lenses to take away with them. 
1.6 
Statistical considerations 
The principal hypothesis to be tested in this work is that subjective scores will be similar for 
the two lenses. 
 
 such, these will 

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be  compared  using linear  regression  models or  other  parametric  methods. 
 
 
  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. 
1.6.1 Power analysis 
In a previous iteration of this study with soft spherical contact lenses, typical inter-subject 
standard deviation values on a 0-100 scale for comfort, vision 
 (at 
lens  dispensing)  were  13.4,  14.1 and  13.7 units,  
respectively.  Assuming  an  equivalence 
margin of seven units and an alpha of 0.5, data from 44 subjects are required to provide 
power of 0.90 or greater for equivalence testing for these three parameters. To allow for 
any inadequate lens fits, up to 50 subjects will be recruited for this work. 
1.7 
Risk analysis 
This study 
is considered to be a non-significant risk study based on United States 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 Research Ethics Committee (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: ‘Clinical  investigation  of 
medical devices for human subjects’.  
1.7.1 Clinical trial registration 
This study will be registered on www.clinicaltrials.gov. 
 

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Section 2. Resources 
2.1 
Subject selection 
In this work, up to 50 subjects will be enrolled.   
2.1.1 Subject withdrawal and replacement 
This study is a single clinical visit study. 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 had the first lens applied to the eye 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.  
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 of legal age (18) and 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 currently wear soft contact lenses, or have done so within the past two years.  
5. They  are  expected  
to  be  able  
to  be  
fitted  with  
the  study  
lenses  within  
the  power 
range available. 
2.1.4 Exclusion criteria 
Subjects will not be eligible 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. 

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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 lactating. 
8. They have an eye or health condition including an immunosuppressive or infectious 
disease which would, in the opinion of the investigator, contraindicate contact lens 
wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic 
reaction. 
9. They have taken part in any contact lens or care system clinical 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 
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 an 
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. 
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 
Adverse  events  will  be  reported  to  the  sponsor  in  accordance  with  their  reporting 
requirements.  Manchester  UREC  and  any  regulatory  authorities  will  be  informed  as 
required. 

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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 
Each subject will attend for a single study visit. Lenses will be worn for a defined period of 
time, with assessments occurring at various intervals, in accordance with the visit schedule 
detailed 
in this protocol. The subject will wear both of the study ‘lens pairs’ during the single 
study visit.    
3.2 
Visit conduct 
Visit procedures are carried out 
in accordance with the relevant, current Eurolens Research 
Standard Operating Procedures. 
3.2.1 Pre-enrolment  
The  subject  will  
receive  a  study-specific  
information  
form  outlining  
the  study  at  
least  24 
hours before the initial visit.  
3.2.2 Study visit 
Subjects should attend wearing their spectacles. 
They will then be required to sign an informed consent form prior to enrolment. 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: 
1. Lens handling, application and removal, where necessary. 
2. Specific study instructions, such as the importance of not using any other contact 
lens products. 
3. 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, medical and contact lens-wearing histories of the subject will 
be noted
 
2. 
. 
3. 
 
 
 
 

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4. 
 
 
 
 
5. The investigator will confirm that the subject satisfies all the inclusion and exclusion 
criteria.    Subjects  who  fail  to  meet  all  the  criteria  at  this  time  will usually be 
discontinued and replaced unless the reason is considered to be transient in which 
case a further visit can be scheduled.   
6.  The first lens pair, 
Live Daily Disposable, will be fitted selecting the closest available 
lenses for the subject based on refraction from the lens bank. 
7. The subject will apply the lenses. 
As soon as possible (~1 minute after 
lens application), lens fit will be assessed 
using 
the following evaluations: horizontal and vertical centration, corneal coverage and 
movement. Normally, for an acceptable fit, centration and movement will fall within 
currently accepted clinical criteria 
 
8. Distance high contrast monocular logMAR visual acuity will be recorded. 
9. The subject will be asked to score the following subjective scores with reference to 
appropriate vertical visual analogue scales (0-100) 
  
§ Comfort  
§ Vision  
 
 
§ Overall score 
10. 
  
11.  Fifteen minutes after lens application, lens fit will be assessed (as above). 
12. 
 
13. 
 
 

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15. The subject will be asked to score the following subjective scores with reference to 
appropriate vertical visual analogue scales (0-100) 
  
§ Comfort  
§ Vision  
§ Overall score 
16. 
  
17. The contact lenses will be removed and discarded. 
18. 
 
  
 
  
19. The second lens pair, 
Clariti 1day, will be fitted selecting the closest available 
lenses 
for the subject based on refraction from the lens bank. 
20. The same procedures will be carried out for the second lens pair (Clariti 1day) as 
the first lens pair, points 8 to 18 (above). 
21.
 
. 
22. 
 
23. At the end of the visit (or 
if the subject 
is discontinued earlier 
in the visit) the subject’s 
payment  will  be  processed  and  
the  subject  discharged,  although  
they  may  have 
been asked by the investigator to attend a post-study follow-up visit.  They should 
continue to use their lenses and solutions as advised, and seek aftercare for their 
contact lenses.   
 
3.2.3 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  visit by  verbal  questioning  of  the  subject  by  the 
investigator. 

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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 Sponsor 
Contact  Person  
in  order  
to  make  comments  and  ask  
for  
re-drafts.  
  
If  no  comments  are 
received from the Sponsor Contact Person within eight weeks, a final report will be released 
with  a  separate  document  control  page  (in  duplicate),  requesting  the  Sponsor 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 
sponsor company. 
4.3