A Clinical Comparison of Two Soft Contact Lenses (Iteration Under Umbrella Protocol C19-678)
Phase: NA
Conditions: Myopia, Hyperopia
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 
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 
13 
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 Philip Morgan. 
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 Clariti Elite 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 
Forty five 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  1.5  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. 
 
 
 

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   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 study with soft contact lenses, typical inter-subject standard deviation values 
on a 0-100 scale for comfort, vision 
 
  Assuming  an  equivalence  margin  of  seven  units  and  an 
alpha  of  0.5,  data  
from  41  subjects  are  
required  
to  provide  power  of  0.80  or  greater  
for 
equivalence testing for these three parameters. 
 
 
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, 45 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 o
f 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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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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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. 
 
 
19. The same procedures will be carried out for the second lens pair (Clariti 1day) as 
the first lens pair, points 8 to 17 (above). 
20. 
 
 
21. 
 
22. 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.  

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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