A Clinical Performance of Two Soft Toric Contact Lenses
Phase: NA
Conditions: Astigmatism
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 
10 
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 
14 
3.4 
Missing, unused and spurious data 
14 
Section 4. 
Study co-ordination 
15 
4.1 
Document processing 
15 
4.2 
Disclosure 
15 
4.3 
Personnel 
15 
 
 
 

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  As such, these will 
be compared using linear regression models or other parametric methods. Subjective 
 
  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 toric contact lenses, typical inter-subject standard deviation 
values on a 0-10 scale for comfort, vision, 
 (at lens 
dispensing) were 1.76, 1.51, 1.83 and 1.69, respectively.  Power of 0.90 or more is 
achieved for each of these parameters with 37 subjects.  To allow for any inadequate lens 
fits, 40 subjects will be recruited for this work.   
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, 40 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 have ocular astigmatism in both eyes of between 0.75DC and 3.00DC. 
6. 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. 

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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. 
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 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 
 (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. 

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2.6 
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.   
2.7 
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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11. 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 
12. 
  
13.
 
 
   
 
 
 
 
18. 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 
19. 
  
20. The contact lenses will be removed and discarded. 
21. The second lens pair, Avaira Vitality Toric will be fitted selecting the closest 
available lenses for the subject based on refraction from the lens bank. 
22. The same procedures will be carried out for the second lens pair (Avaira Vitality 
Toric) as the first lens pair, points 8 to 20 (above). 
23. 
 
 
24. 
 
25. 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.   
 

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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.