Clinical Evaluation of Two Silicone Hydrogel Contact Lenses
Phase: NA
Conditions: Myopia
Sponsor: CooperVision, Inc.



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Section 1. Overview 
1.1 
Background 
This  project  seeks  to  compare  the short-term clinical  performance  of  the Biofinity 
(CooperVision Inc.), and Total30 (Alcon Inc.) silicone hydrogel contact lenses. 
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 Total30 contact 
lenses. 
1.4 
Study design 
This will be a randomised, double-masked, crossover, bilateral study, controlled by cross-
comparison. Up  to  38 subjects  will use  each  
lens type for  approximately six  hours  on 
separate study days, in random sequence. 
1.5 
Statistical considerations 
The  principal  hypothesis  
to  be  
tested  
in  
this  work is that there  
is  no  difference  
for lens 
application scores for the two lens types. 
 
Visual acuity  assessment, 
 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. 
  
.  
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. 
1.5.1 Power analysis 
Using  data  from  a  previous  study  
indicates  that  the  standard  deviation  of  
intra-subject 
differences for lens application scores (0-100 scale) is 18 units.   If a meaningful difference 
for lens  application  scores  
is  10  units, 36 completing  subjects  will  provide 90%  power 
assuming  an  alpha  of  0.05  and  a  two-tailed  analysis.  To  allow  
for  discontinuations,  38 
subjects will be recruited. 

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1.6 
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 14155:2020 ‘Clinical 
investigation of medical devices for human subjects - Good 
clinical practice’.  
1.7 
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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Section 2. Resources 
2.1 
Subject selection 
In this work, up to 38 subjects will be consented with the aim of 36 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 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.  
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 between 18 and 40 years.   
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 have successfully worn contact lenses within six months of starting the study. 
5. They can be satisfactorily fitted with the study contact lenses. 
6. They have a contact lens spherical prescription between -0.25 to - 6.00D (inclusive) 
based on the ocular refraction.  
7. They have a spectacle cylindrical correction of -0.75D or less in each eye based on 
the ocular refraction. 
8. They own and habitually wear single vision spectacles.   
9. They can attain at 
least 0.20 
logMAR distance high contrast visual acuity 
in each eye, 
with the study lenses. 
10. They agree not to participate in other clinical research while enrolled on this study. 

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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 contraindicate contact lens  
wear. 
2. They  have  a  systemic  disorder  which  would  normally  contraindicate  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 or pose a risk to study personnel; or they 
have any 
immunosuppressive disease (eg HIV) or a history of anaphylaxis or severe 
allergic reaction. 
9. They have grade 3 or greater of any of the following ocular surface signs: corneal 
oedema,  corneal  vascularisation,  corneal  staining,  
tarsal  conjunctival  changes  or 
any other abnormality, which would normally contraindicate contact lens wear. 
10. They have taken part in any other clinical trial or research, within two weeks prior to 
starting this study, which may impact on this particular work. 
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 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 

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Table 2: Study lenses. 
2.6.1.1 Use of lenses 
Each lens type will be worn on a single day for the six hour study period only and then will 
be discarded.  
2.6.2 Care regimen 
No care system will be used on this study. 
2.6.3 Inventory control 
Biofinity lenses will be supplied by CooperVision Inc.  Total30 lenses will be sourced by 
Eurolens Research. 
 
.  Lenses 
of interest (such as device deficiencies) which have been stored during the study, will be 
discarded  on  completion  of  
the  study  report,  unless  advised  otherwise  by  
the  
Industrial 
Contact Person.  Unworn lenses will be destroyed.  There will be an accurate accounting of 
the study test product at the completion of the study.  All used study test products will be 
documented (Lot number; Expiry date etc.). 
2.6.4 Clinical equipment 
Clinical equipment is regularly maintained and calibrated as required.  Standard operating 
procedures and international standards are used where appropriate. 
2.7 
Study control 
This study is controlled by cross-comparison.  Bias will be minimised by randomising the 
order of assessment. Subjects will be masked to the two lenses - the lens foils will be over-
labelled.  Masking may be ‘broken’ if deemed necessary, by the Principal Investigator or 
Industrial Contact Person. 
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 
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.   

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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 
funding  company  and  any  regulatory  authority  (e.g.  Manchester  UREC).    Eurolens 
Research will take all 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). 
6. Implement the Eurolens Research clinical monitoring standard operating procedure. 
 
 

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current Eurolens  Research  Standard  Operating  Procedure  
‘Assessment  of  visual 
performance using the Bailey-Lovie 
logMAR visual acuity test chart and procedures 
for carrying out an over-refraction’. 
7. 
 
   
 
 
 
 
 
9. The subject will be asked to score the following subjective scores with reference to 
appropriate vertical visual analogue scales (0-100) 
):  
§ Comfort  
§ Vision  
§ 
 
10. The subject will then be discharged and asked to return for the follow-up visit having 
worn the study lenses for approximately six hours. 
3.2.3 Follow-up 1 (6 hours later) 
Subjects  should  attend  wearing  the  study  lenses  which  should  have  been  in  situ  for 
approximately six hours.  Subjects who attend without lenses in situ for approximately six 
hours will usually be rescheduled. The following procedures will be performed (any ocular 
measurement procedures outlined below will be carried out on each eye): 
1. Any medical or ocular issues since the last visit will be recorded. 
2. The  subject  will  be  asked  
to  score  
the  
following  with  reference  
to  appropriate 
vertical visual analogue scales (0-100) 
 
§ Overall comfort 
§ Vision 
§ 
 
  
 
 
 
 
 
3. 
 
 
 
 
 
 
 
 
 
  
 

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§  
 
 
 
 
 
 
 
 
 
 
 
4. 
 
5. 
 
 
 
 
6. 
 
7. Distance high contrast visual acuity will be assessed in the subject’s spectacles. 
8. The subject will be discharged from the study visit and will be asked to return for 
Dispensing 2, wearing their habitual spectacles. 
3.2.4 Dispensing 2 
Subjects should attend wearing their habitual spectacles. 
1. Any changes to medical and ocular histories will be recorded. 
2. Steps  3-10  
from  Dispensing  1 procedures  (3.2.2)  will  be  carried  out,  with  
the 
second study lens being fitted at step 5. 
3.2.5 Follow-up 2 (6 hours later) 
Subjects  should  attend  wearing  the  study  lenses  which  should  have  been  in  situ  for 
approximately six hours.  Subjects who attend without lenses in situ for approximately six 
hours will usually be rescheduled. 
1. The same procedures as at Follow-up 1 (3.2.3) will be carried out. 
2. At the final visit (or when the subject is discontinued at an earlier visit) the subject 
will complete the University PR20 form 
in order for their payment to be processed 
and then 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.   
3.2.6 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 

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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. 

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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 
 
 
 
 
 
  
 
 
 
 
 
Industrial Contact Person