A Clinical Comparison of Two Daily Disposable Soft Contact Lenses
Phase: NA
Conditions: Astigmatism Bilateral
Sponsor: CooperVision, Inc.



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Power analysis was conducted for the following variables using data from a previous 
study: 
 
• 
 
 
 
 
 
 
 
• 
Vision 
• 
 
 
 
 
 
 
 
 
 
 
 
  A one-sided power analysis for this 
variable, assuming an alpha of 0.05, a standard deviation of 28.4 units and a meaningful 
difference of 10 units (on a 100 unit scale) determined that 51 completing subjects would 
provide 0.80 power.  As such, this number of subjects will provide at least 0.80 power for 
all the variables listed above.  To allow for discontinuations, 55 subjects will be recruited. 
1.7 
Risk analysis 
This study is considered to be a non-significant risk study based on United State 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 55 subjects will be recruited and enrolled.   
2.1.1 
Subject withdrawal and replacement 
This study includes three 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 study 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. At the end the study, all subjects will sign 
a study exit form. 
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 between 18 and 40 years of age (inclusive). 
2. They understand their rights as a research subject and are willing to sign a 
Statement of Informed Consent. 
3. They are willing and able to follow the protocol. 
4. They are an existing silicone hydrogel reusable spherical contact lens wearer in 
both eyes. 
5. They have a contact lens spherical prescription between -0.25D and -6.00D 
(inclusive) based on ocular refraction. 
6. They own a wearable pair of spectacles and wear them on the day of the initial visit. 
7. At dispensing, they can attain at least 0.20 logMAR distance high contrast visual 
acuity in each eye with the study lenses within the available power range.  
8. They are willing to comply with the wear schedule (at least five days per week and 
for at least eight hours per day). 
9. They agree not to participate in other clinical research for the duration of the study.   

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2.1.4 
Exclusion criteria 
Subjects will not be eligible for 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, or use any 
rewetting/lubricating drops whilst on this study. 
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 any infectious disease 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), or a history of anaphylaxis or severe allergic 
reaction. 
10.  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 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 
any ocular adverse event will be reported on CVI report forms and those ocular adverse 
events described as ‘serious’ or ‘significant’ will be detailed in the final report.  Similarly, 

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Table 2: Study lenses. 
2.6.1.1 Use of lenses 
The study lenses will be worn on a daily wear, daily disposable basis (i.e. removed at end 
of day and discarded). Lenses should be worn for a minimum of eight hours per day, five 
days per week.  The lenses are also to be worn for a minimum of two hours before 
attending the follow-up visits.  
2.6.2 
Care regimen 
No care system will be used on this study. 
2.6.3 
Inventory control 
All study lenses will be provided by CooperVision Inc. All worn lenses will be discarded.  
 
 
 
 
 
 
 
 
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 and investigators will be masked to the two lenses  - 
lenses 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 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 

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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 as complete when all subjects have 
signed the exit statement.  
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. This study will be performed in accordance with the General 
Data Protection Regulation (GDPR) and Data Protection Act 2018. 
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. 
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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3.2.3 
Visit 2 – follow-up 1 
Subjects should attend wearing their 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.  
 
1. Any medical or ocular issues since the last visit will be recorded. 
2. 
 
 
3. 
  
4. Retrieval of any unused lenses. 
5. 
 
6. The subject will be asked to score the following with reference to appropriate 
vertical visual analogue scales (0-100) 
 
 
 
 
 
 
 
! 
Vision 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7. 
 
 
 
 
 
 
 
 
 
 
 
 
 

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! 
 
 
 
 
 
 
 
 
 
 
 
 
 
8. 
 
 
 
9. 
 
  
 
 
 
 
 
 
 
 
 
 
10
 
 
 
 
 
 
11. Lens fit 
 assessment, as described in section 3.2.2. 
12. The lenses will be removed and discarded. 
13. 
 
 
14. The second lens will be fitted and allowed to settle for five minutes. 
15. The same procedures as for Visit 1 (section 3.2.2) points 8-14 will be carried 
out.  
16. Subjects will be given a supply of over-labelled contact lenses 
. 
 
The subject will then be discharged and asked to return for a one-week follow-up visit 
wearing the study lenses which need to have been worn for at least two hours. 
Subjects should be asked to wear their lenses for a minimum of eight hours per day 
and to wear their lenses every day until the next visit unless he/she experiences 
symptoms such as redness, discomfort etc. on any given day.  

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3.2.4 
Visit 3 – follow-up 2 
Subjects should attend wearing their 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.  
 
Any medical or ocular issues since the last visit will be recorded. 
1. 
 
 
2. 
  
3. Retrieval of any unused lenses. 
4. 
 
5. The subject will be asked to score the following with reference to appropriate 
vertical visual analogue scales (0-100) 
 
 
 
 
 
 
 
! 
Vision 
! 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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! 
 
 
 
 
 
 
7. 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
11. Lens fit 
 assessment, as described in section 3.2.2. 
12. The lenses will be removed and discarded. 
13. 
 
 
 
At the final visit (or when the subject is discontinued at an earlier visit) the subject will sign 
a study exit statement acknowledging that the work is complete, although they may have 
been asked by the investigator to attend a post-study follow-up visit, and that they should 
continue to use their lenses and solutions as advised, and seek aftercare for their contact 
lenses.  A copy of this signed form will be issued to the subject. 
 
 

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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 visits 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