A Clinical Comparison of the Comfilcon A (Extended Range) XR Toric Multifocal and Omafilcon B Toric XR Multifocal 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 and subjective acceptance of the 
Biofinity XR Toric Multifocal and the Proclear Toric XR Multifocal soft contact lenses (both 
CooperVision Inc.). CooperVision (CVI) is extending the power range of the commercially 
available Biofinity Toric silicone hydrogel contact lenses to include multifocals. The 
extended power range for Biofinity Toric for subjects requiring a multifocal product will be 
called Biofinity XR Toric Multifocal. The Proclear Toric XR Multifocal is an existing lens 
which will be used as the control lens. 
1.2 
Personnel 
 
  
 
 
 
 
 
 
 
 
 
 
  
1.3 
Study objectives 
This study aims to compare the clinical performance and subjective acceptance of the 
Biofinity XR Toric Multifocal and the Proclear Toric XR Multifocal soft contact lenses. 
1.4 
Study design 
This will be a randomised, subject-masked, crossover, bilateral study, controlled by cross-
comparison. Thirty subjects will use each lens type for two weeks in random sequence.  
Follow-up visits for each lens will be performed after two weeks of wear. Lenses will be 
worn on a daily wear basis. 
1.5 
Statistical considerations 
The principal hypothesis to be tested in this work is that subjective scores and visual 
acuity for the lenses will be substantially equivalent. 
 

 
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9. They can attain at least 0.30 logMAR binocular distance high contrast visual acuity 
with the study lenses within the available power range. 
10. They have successfully worn soft contact lenses in the last two years. 
11. They are willing to comply with the wear schedule (at least five days per week and 
for at least six hours per day). 
12. They agree not to participate in other clinical research for the duration of this study. 
13. They own a wearable pair of spectacles. 
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 have had cataract surgery. 
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 breast-feeding. 
8. They have any clinically meaningful slit lamp findings contraindicating contact lens 
wear (e.g. ≥ Grade 3 finding of oedema, corneal neovascularisation, corneal 
staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland 
dysfunction) on the Efron classification scale or any other ocular abnormality that 
in the opinion of the investigator would contraindicate contact lens wear. 
9. They have any infectious disease (e.g. hepatitis) which would, in the opinion of the 
investigator, contraindicate contact lens wear or pose a risk to study personnel; or 
they have any immunosuppressive disease (e.g. HIV).  
10. They have a history of anaphylaxis or severe allergic reaction. 
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 

 
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2.8 
Documentation 
Documents related to this work that require archiving will be kept 
 
for a period of 10 years after completion of the final report.  The Sponsor’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 is considered to be source data.   
2.10 
Study completion 
The clinical phase of the study will be considered complete when all subjects have signed 
the exit statement.  
2.11 
Confidentiality 
All matters related to this work will remain confidential within 
, the 
funding company and any regulatory authority 
).  
 
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.  
 
 
 
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 
 
6. Implement 
clinical monitoring standard operating 
procedure. 
 

 
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18. 
 
19. An overall grade for lens fit acceptance will be provided for both general lens fit 
and toric lens fit measures using the grading scales 
. 
20. High illumination, high contrast distance monocular and binocular visual acuity will 
be recorded using distance logMAR charts before and after spherical over-
refraction.  
21. High illumination, high contrast near monocular and binocular visual acuity will be 
recorded at 40 cm using near logMAR charts.  
22. High illumination, high contrast near binocular visual acuity will be recorded at the 
optimal reading distance using near logMAR charts (without over-refraction). The 
range of clear near vision will also be recorded. 
23. 
 
 
 
 
 
 
 
 
 
26. The lens care system will be explained and dispensed. 
27. The subject will be asked to return two weeks later having worn lenses for a 
minimum of six hours and five days a week. 
3.2.3 
Two-week follow-up/dispensing 2 visit 
Subjects should attend wearing the study lenses which should have been in situ for at 
least two hours.  Subjects who attend without lenses in situ for at least two hours will 
usually be rescheduled.  The following procedures will be performed: 
1. Lens wearing time on study visit day will be recorded.  
2. Any study products relating to the previous two weeks of the study will be 
collected. 
3. Details of the contact lens wear since the previous visit will be recorded (including 
wear time and comfortable wear time). 
4. The subject will be asked to score the following with reference to appropriate 
visual analogue scales (0-100) as outlined in the ‘Subjective ratings’ document in 
 
 

 
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• Overall comfort 
• Dryness during the day 
 
• Visual fluctuation/stability  
 
 
• Overall handling 
• Overall satisfaction 
• Distance vision 
• Intermediate vision 
• Near vision 
• Near vision in dim illumination 
• Ghosting at distance 
• Ghosting at near 
• 
 
• Vision whilst driving during the day 
• Vision whilst driving at night 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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6. High illumination, high and low contrast distance and near (40 cm) monocular and 
binocular visual acuity will be recorded using distance and near logMAR charts 
before over-refraction.  The range of clear vision at near (binocularly) will also be 
recorded for high contrast measures. 
7. High illumination, binocular high contrast near visual acuity will be recorded at the 
subject’s habitual working distance (which was recorded at the initial visit) using a 
near logMAR chart. 
8. Spherical over-refraction will be performed on each eye if binocular distance high 
contrast visual acuity is less than 0.2. High illumination, high and low contrast 
distance and near (40 cm) monocular and binocular visual acuity will be recorded 
using distance and near logMAR charts.  The range of clear vision at near 
(binocularly) will also be recorded for high contrast measures. 
 
 
 
11. Lens rotation and stability will be recorded. 
12. Lens fit and surface will be recorded as described in Section 3.2.1. 
 
 
 
15. An overall grade for lens fit acceptance will be provided for both general lens fit 
and toric lens fit measures using the grading scales 
. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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18. The lenses will then be removed and discarded. 
19. Slit lamp biomicroscopy will be carried out, as detailed in section 3.2.1. The 
presence of any adverse events will be recorded 
 
20. The second lens pair will be applied (according to the randomisation table). The 
subject will be masked from the lens type, but will apply the lenses themselves 
without taking note of the position of any visible markings.  
21. The steps outlined in Section 3.2.1, 13-25 will be repeated. 
22. A new bottle of solution and a new case will be issued. 
23. The subject will be discharged and asked to return for the four-week follow-up visit. 
Subjects should be asked to wear their lenses for a minimum of six hours per day, 
five days per week and to have worn lenses for at least two hours prior to 
attending the next scheduled visit. 
3.2.4 
Four week follow-up/exit visit 
Subjects should attend wearing the study lenses which should have been in situ for at 
least two hours.  Subjects who attend without lenses in situ for at least two hours will 
usually be rescheduled. 
The same procedures as at the two week follow-up (Section 3.2.3) will be carried out 
except that no more lenses will be dispensed. The following additional procedures will be 
carried out:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Section 4. Study co-ordination 
4.1 
Document processing 
All case report forms will be processed and evaluated by 
, 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 sign both copies, one to keep and the other to be returned 
to
. 
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 
Study Leader 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Principal Investigator 
 
 
 
 
 
 
 
 
 

 
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Director 
 
 
 
 
 
 
 
 
 
Operations Manager 
 
 
 
 
 
 
 
  
 
Investigators 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Project Officer 
 
 
 
 
 
 
 
  
 
Study Monitor 
 
 
 
 
 
 
 
 
 
Research Administrators 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Industrial Contact Person