The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses
Phase: NA
Conditions: Astigmatism
Sponsor: CooperVision, Inc.



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Section 1. Overview 
1.1 
Background 
This project seeks to compare the clinical performance of the MyDay Toric (CooperVision 
Inc.) and DAILIES Total1 Toric (Alcon Inc.) daily disposable soft toric contact lenses. 
1.2 
Personnel 
This  work  will  be managed  by 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. Approximately 19 subjects  will  be enrolled  by 
Eurolens Research. Subjects will also be seen at a minimum of three external optometric 
practices, who will enrol approximately 36 subjects between them. 
 
In addition to the university, the investigators are all UK-based optometrists registered to 
practice optometry with the General Optical Council: 
 

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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 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, up to 55 subjects will be enrolled at multiple sites, with the aim of 50 subjects 
completing the study.   
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 initial 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.  
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. 
4. Advertisement at external sites. 
5. Contacting existing patients at external sites. 
2.1.3 Inclusion criteria 
Subjects will only be eligible for the study if: 
1. They are aged between 18 and 40 years 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 currently wear soft contact lenses or have done so in the past two years. 
5. They have a spherical component of their contact lens prescription between Plano 
to - 6.00DS (inclusive). 
6. They  have  a  cylindrical  component  of  their  contact  lens  prescription  between  
-0.75DC and -2.50DC (inclusive). 
7. They can be satisfactorily fitted with the study lens types. 
8. At  dispensing,  
they  can  attain  at  
least  6/12  distance high  contrast  visual  acuity  
in 
each eye with the study lenses within the available power range. 

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9. They are willing to comply with the wear schedule (at least five days per week and 
for at least eight hours per day). 
10. They own a wearable pair of spectacles. 
11. They agree not to participate in other clinical research while enrolled on this study. 
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 ocular abnormality which would, in the opinion of the investigator, 
normally contraindicate contact lens wear. 
9. They  have  eye  or  health  conditions including  immunosuppressive or  infectious 
diseases, 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. 
10. They are currently wearing one of the study contact lenses. 
11. 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. 

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2.3 
Safety parameters, adverse events and concurrent illnesses 
The key safety parameters are the serious and significant ocular adverse events listed in 
  (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  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 
In the case of a ‘serious’ or ‘significant’ adverse event, the investigator will notify Eurolens 
Research as soon as possible. The Principal Investigator will notify the Sponsor Contact 
Person  as  soon as  possible following  notification  of  
the  event.  
  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 Sponsor Contact 
Person will notify the Principal Investigator who will end the study with the cooperation of 
all sites. Manchester UREC will be informed.  If the Principal Investigator becomes aware 
of  any  reason  
to  
terminate  
the  study  earlier  
than  planned  (e.g.  reported  unusual  ocular 
findings  or  subject  symptoms),  
the  Principal  
Investigator  will  notify  
the  Sponsor  Contact 
Person to discuss the matter,   
2.5 
Protocol deviations 
Any  deviations  
from  
this  protocol  will  be recorded  and reported  
to  
the Sponsor Contact 
Person as appropriate.  Manchester UREC will be informed as necessary. 
2.5.1 Protocol amendments 
Any amendments will be agreed between the Sponsor Contact Person and the Principal 
Investigator with the cooperation of all sites.  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. 

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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 20 years  after  completion  of  the  final  report.    The  Sponsor company’s 
permission will be sought before the documents are destroyed.   
2.9 
Data collection and analysis 
a) At  Eurolens  Research,  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 are considered 
to be source data.   
b) External  sites  will  
record  study  data  on  paper  CRFs,  which  will  be  sent  
to  Eurolens 
Research for data input and analysis. Paper CRFs are considered source data for the 
external sites.  Personal identifiable information will not leave individual sites.   
2.10 
Study completion 
The clinical  phase  of  
the  study will  be  considered  as complete  when  all  subjects  have 
attended their last visit.  
2.11 
Confidentiality 
All  matters  related  to  this  work  will  remain  confidential  within  Eurolens  Research, the 
external sites, the funding company and any regulatory authority (e.g. Manchester UREC).  
All  sites will  
take  
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). 

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6. Implement  the  Eurolens  Research  clinical  monitoring  standard  operating 
procedure. 
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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7. 
8. Retrieval of any unused lenses. 
9. 
10
11. Lens fit, toric lens fit, rotational recovery 
, as described 
in section 3.2.2 above. 
12. The lenses will then be removed and discarded. 
13. 
 
 
14. The  second  randomised  lens  pair  will  be  fitted  and  allowed  to  settle  for  five 
minutes. 
15. The subject will apply the second randomised pair of lenses.  Orientation of toric 
markings do no need to be taken into consideration.   
16. Lenses are allowed to settle for five minutes.  
17. Toric lens fit will be assessed as described in Section 3.2.2. 
18. Rotational recovery will be assessed one minute after manually displacing the lens 
30 degrees temporally: 
a. 
 
   
 
 
 

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1. The  same  procedures  as  at  Follow-up  1 (Section 3.2.4  above) will  be  carried 
out. 
2. 
 
 
 
3. At  the  final  visit  (or  when  the  subject  is  discontinued  at  an  earlier  visit) 
arrangements  to  
issue  the subject with  their  payment  will  be  made,  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.   
3.2.6 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  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(s) 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. 

Eurolens Research (C20-691, EX-MKTG-121)        Protocol Amendment 2 
February 3, 2023 
Confidential (T1) 
Protocol amendment 
Study title: The comparative clinical performance of two daily disposable toric contact lenses 
The table below lists the changes to be implemented in this work: 
New 
revision 
no. 
Section/s to be 
Amended and details 
1 
Inclusion criterion 1 originally read ‘They are aged between 18 and 40 years old and have capacity to 
volunteer’.  
Now amended to ‘They are at least 18 years old and have capacity to volunteer’ 
2 
Number of subjects 
The original protocol stated that up to 55 subjects should be enrolled, as the power calculation is based 
on 50 subjects completing the study. Protocol amendment 1 increased the maximum number to 65. In 
order  
to  avoid  
to  
falling  short  of  
the  required  number  of  completed  subjects, owing  
to  a  high  rate  of 
subjects being  found  
ineligible  at  the  
initial  visit, the  maximum  number  of  subjects  to  be  enrolled  
is 
increased to 70.  
 Table 1:  Changes to protocol C20-691 (version 1.0) 
Document approved by: