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

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Eurolens Research  (C24-750) (EX-MKTG-159) Clinical protocol version 1 
March 11, 2024  
 
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Confidential (T9) 
 
 
 

Eurolens Research  (C24-750) (EX-MKTG-159) Clinical protocol version 1 
March 11, 2024  
 
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Confidential (T9) 
Section 1. Overview 
1.1 
Background 
This project seeks to compare the clinical performance of the Proclear Multifocal Toric and 
Biofinity Toric Multifocal soft 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 Carole Maldonado-Codina PhD MCOptom FAAO FBCLA. 
1.3 
Study objectives 
This study aims to compare the short-term clinical performance of the two study contact 
lenses. 
1.4 
Study design 
This will be a subject-masked, bilateral study, controlled by cross-comparison. Up to 40 
subjects will wear the Proclear Multifocal Toric and the Biofinity Toric Multifocal lens in the 
clinic only, following an initial visit to determine ideal lens specifications.  
1.5 
Statistical considerations 
The principal hypothesis to be tested in this work is that subjective scores for the lenses will 
be substantially equivalent. The primary outcome variable is subjective distance vision. 
 
 
  As such, these will be compared using 
linear regression models or other parametric methods. 
 
  
 
  Deviations from this 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 
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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1.5.2 
Power analysis 
Using data from a previous study with multifocal contact lenses, minimum intra-subject 
standard deviation values on a 0-100 scale for comfort, distance vision, near vision and 
overall score were 18, 16, 19 and 17 units, respectively. Assuming a meaningful difference 
of 10 units and an alpha of 0.05, data from 30 subjects are required to provide power of 
0.80 or greater for equivalence testing for these four parameters. To allow for ineligible 
subjects and discontinuations, up to 40 subjects will be recruited.  
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 Organisation (ISO) guidelines due 
to the daily wear nature of the study.  The work where practical will be conducted in 
accordance with: 
• ICH Good Clinical Practice Guidelines  
• BS EN ISO 14155 ‘Clinical investigation of medical devices for human subjects - Good 
clinical practice’ 
• Declaration of Helsinki  
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).   
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 40 subjects will be consented with the aim of 30 subjects completing the 
study.   
2.1.1 
Subject withdrawal and replacement 
This study includes two 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. 
2.1.3 
Inclusion criteria 
Subjects will only be eligible for the study if: 
1. They are aged 35 years or over and have capacity to volunteer. 
2. They understand their rights as a subject and are willing to sign a Statement of 
Informed Consent. 
3. They are willing and able to follow the protocol. 
4. They agree not to participate in other clinical research for the duration of this study. 
5. They are currently wearing soft contact lenses or have done so within the past 12 
months. 
6. They have a spherical prescription between +10.00 and -10.00DS inclusive, (based 
on the ocular refraction). 
7. They have astigmatism of between -0.75 and -5.75DC (based on the ocular 
refraction) in each eye. 
8. They have a reading addition component to their spectacle refraction of between 
+0.75 and +2.50DS. 
9. They can be satisfactorily fitted with the study lenses. 
10. They own a wearable pair of spectacles. 

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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.   
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 
Subject confidentiality 
All matters related to this work will remain confidential within Eurolens Research, the 
Sponsor 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 subjects 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. Review study product accountability. 
6. Document their observations and make them available to relevant authorised parties 
(e.g. Manchester UREC). 
7. Implement the Eurolens Research clinical monitoring standard operating procedure. 
 
 

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2. 
 
 
 
4. The Proclear MFT lenses will be applied and allowed to settle for one minute. 
5. 
 
6. The subject will be allowed to adapt to the lenses away from the consulting room 
for 15 minutes.  
7. After 15 minutes adaptation, the subject will return to the clinic.  
8. 
 
9. 
 
 
 
 
10. 
 
 
11. The subject will be asked to score the following with reference to appropriate 
vertical visual analogue scales (0-100)
: 
§ 
 
§ 
Distance vision 
§ 
 
§ 
 
8. The Proclear MFT lenses will be removed. 
9. The Biofinity TMF lenses will be applied and allowed to settle for one minute. 
10. 
 
11. The subject will be allowed to adapt to the lenses away from the consulting room 
for 15 minutes. 
12. 
 
 
 
 
 
15. The subject will be asked to score the following with reference to appropriate 
vertical visual analogue scales (0-100)
: 
§ 
 
§ 
Distance vision 
§ 
 
§ 
 

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16. The Biofinity TMF lenses will be removed. 
17. 
 
 
 
18.
 
 
20. At the final visit (or when the subject is discontinued at an earlier visit) the subject 
will either be provided with a cash payment 
 
  They will then be 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 if applicable) as 
advised, and seek aftercare for their contact lenses.   
3.2.5 
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. 

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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 
in order to make comments and ask for re-drafts.  If no comments are received from the 
Sponsor within eight weeks, a final report will be released with a separate document control 
page, requesting the Sponsor to sign and return 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 
Personnel