A Clinical Comparison of Two Soft Multifocal Contact Lenses
Phase: NA
Conditions: Presbyopia
Sponsor: CooperVision, Inc.



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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 
10 
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 
13 
Section 4. 
Study co-ordination 
14 
4.1 Document processing 
14 
4.2 Disclosure 
14 
4.3 Personnel 
14 
 
 
 

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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 Philip Morgan. 
1.3 
Study objectives 
CooperVision Inc. wishes to gather short-term clinical performance data for two of the soft 
multifocal contact lenses which they currently manufacture. This non-dispensing iteration 
will compare the performance of Proclear Multifocal and Biofinity Multifocal 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. All subjective scores will be assessed using 
0-100 visual analogue scales 
 
1.5 
Study design 
Forty-seven participants  will  take  part  
in  a subject-masked,  non-randomised,  controlled 
non-dispensing study, which will be controlled by cross comparison.  Subjects will attend 
for  one  visit  only  which  will  
last  
for  approximately 2.5 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. 
 subjective responses will 
generate data that are likely to be continuous and normally distributed.  As 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 
 
 
  Assuming an 
equivalence margin of seven units, an alpha of 0.5, data from 47 subjects are required to 
provide power of 0.80 or greater for equivalence testing for these four parameters.  This 
number of subjects will be recruited. In the eventuality that a subject attends the clinic visit 
and  
is  
ineligible  
for  
the  study,  a  
replacement  subject  will  be  
identified  and  
the  
ineligible 
subject will not count towards the 47. 
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, 47 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 at least 42 years of age 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 have had a full eye examination within the past two years (by self-report). 
4. They are willing and able to follow the protocol. 
5. They habitually use vision correction for near vision (multifocal soft contact lenses, 
sphere  lenses  for  monovision,  sphere  lenses  for  distance  vision  correction  and 
spectacles for near vision correction, or have a different spectacle prescription for 
distance and near vision correction) and have done so for at least the past three 
months.  
6. They have refractive astigmatism of no greater than -0.75DC. 
7. They  are  expected  
to  be  able  
to  be  
fitted  with  
the  study  
lenses  within  
the  power 
range available, and to achieve binocular distance HCVA of +0.20 or better in the 
study lenses. 

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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. 
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. 
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.  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  
 
  
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. 

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statistical  package  for  analysis.  Most  clinical  data  will  be  entered  directly  onto  the 
electronic case report form and are considered to be source data.   
2.7 
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 
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  (including  habitual  lenses,  modality,  wear  time  and  comfortable  wear 
time). 
2. 
 
3. 
 
 
 
 
 

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13. The contact lenses will be removed and discarded. 
14. The  second  lens  pair,  Biofinity  Multifocal, will  be  fitted  selecting  the  closest 
available lenses for the subject based on the manufacturer’s fitting guide. 
15. The  same  procedures  will  be  carried  out  for  the  second  lens  pair  (Biofinity 
Multifocal) as the first lens pair, points 9 to 13 (above). 
16. 
 
 
17. 
 
18. 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. 
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