Comparison of Clinical Performance and Subjective Preference Out of Three Cosmetic Contact Lenses (Limbal Ring-enhancing Lenses, LRE Lenses)
Phase: NA
Conditions: Myopia
Sponsor: CooperVision, Inc.

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Clinical Investigation Plan 
Study Title: Comparison of clinical performance and subjective preference 
out of three cosmetic contact lenses (limbal ring-enhancing lenses, LRE 
lenses) 
SPONSOR: CooperVision Korea, Inc. 
CLINICAL SITE: School of Optometry & Vision Science, Catholic University of 
Daegu, Korea (Rep) 
PROTOCOL DATE: October 21, 2016 
PROPOSED START DATE: Dec, 2016 

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Study summary 
This bilateral subject-masked, randomized, crossover dispensing study will investigate the 
clinical performance 
 
 
 of the Hydron 1-day cosmetic contact lens 
(Hydron Inc.), when compared to the 1-day Acuve Define (Johnson & Johnson Vision Care 
Inc.) and Claren 1-day Iris (Interrozzo Inc). Sixty subjects will be enrolled into this three- 
week study, where they will wear each lens type for one week. The order of lens wear will be 
randomized so that the effects related to order are minimized. The outcome measures will 
divided into subjective and objective measure. Primary subjective measure 
 
 
 
 
 
 
 
 
 
 comfort, 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 f 
 
 
 
 
Table 1: Study summary 

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Section 1. Overview 
1.1 Background 
Contact lenses markets has been steadily increased. One of driving factors for growing 
market is a cosmetic contact lenses which is designed to change the appearance of their eye in 
addition to correction of refractive error. With its popularity, there are many cosmetic contact 
lenses available in market and personnel preference are all different. Therefore, this study 
aims to evaluate the performance of a new daily disposable limbal ring lens, Hydron-1day 
(Hydron Inc), compared to the existing daily disposable limbal ring lens, 1.Day ACUVUE®
Define™ (Johnson & Johnson Vision Care Inc) and Claren 1-day Iris (Interrozzo  Inc). 
Limbal ring lenses are cosmetic lenses which enlarge and define the wearer’s iris and are 
particularly popular in East Asian countries. 
1.2 Personnel 
This work will be conducted at 
1.3 Study Objectives 
The purpose of this study is to evaluate the clinical performance 
 
 
 out 
of three LRE lens types; 1-day Acuve Define, Claren 1-day Iris and Hydron 1-day cosmetic 
contact lenses. Clinical performance measures will include comfort, 
f 
f 

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1.4 Study Design 
This will be a subject-masked if possible, bilateral, randomized, crossover dispensing study 
to compare clinical performance and subjective preference out of three lens types. Sixty 
subjects will be assigned into three groups and each group will wear the test and control 
lenses as matched pairs for one week each in random order. Lenses will be worn on a daily 
wear, daily disposable schedule. 
Figure 1. Grouping and lens randomization order 
1.5 Statistical considerations 
The prinicpal null hypothesis is that the 
comfort for the three lens types are equal. Prior to statistical analysis, normality of data will 
be assessed. Ordinal measure such as lens fit, biomicroscopy 
Deviations from this 
statistical plan will be discussed in the final report. 
1.5.1 Power analysis 

 
 
 
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Study sample size was estimated a priori for the principal outcome measure, the subject's 
preference with respect to attractiveness. We are testing the null hypothesis that there is no 
difference in the subject's preference with respect to attractiveness between the three lens 
types. The sample size was estimated using G* Power, to detect a small effect size of 0.20, 
α=0.05 for one group, three repetitions and an assumed correlation of 0.5 amongst the 
repeated measures with a power of 0.90. The total sample size was estimated at 55. To allow 
for discontinuations, 60 participants will be recruited. 
 
1.6 Risk analysis 
 
There are no expected risks in this study other than wearing contact lenses. Also all subjects 
enrolled in this study will be existing contact lens wearers, therefore all subjects are very 
familiar with handling contact lenses. 
 
1.7 Ethics Review and statement of compliance 
 
Ethical approval will be sought from the Institutional Review Board Catholic University of 
Daegu (hereafter referred to as CU IRB, Phone Number: +82-53-850-2653, e-mail address: 
swji@cu.ac.kr). 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’. 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 
 
Sixty subjects who are currently existing contact lenses wearers will be enrolled. Out of 60 
subjects, twenty subjects will be recruited from the current wearers of 1.Day ACUVUE® 
Define™ (Johnson & Johnson Vision Care Inc) and another twenty subjects will be current 
wearers of Claren 1-day Iris (Interrozzo Inc). Rest twenty subjects will be no previous wearer 
of any study lenses. All subjects will go through the screening procedure to ensure they 
satisfy the inclusion criteria. At the screening visit, a detailed Participant Information Sheet 
explaining  the  nature  of  the  study  will  be  provided  to  potential  subjects  along  with  a 
Participant Instruction Sheet, which includes study-specific instructions as well as general 
lens wear precautions. Once subject agrees to participate, then will be asked to sign a written 
consent form to confirm their agreement to participate the study. 
 
 
2.1.1 Subject withdrawal and replacement 
 
Subject’s participation in this study is voluntary. Subjects have the right to withdraw from 
participation at any time during the study without comment or penalty. Withdrawal from the 
study will not impact upon current or future relationship with the School of Optometry & 
Vision Science, Catholic University of Daegu. Subjects who have agreed to enroll the study, 
but have not completed the dispensing visit will be replaced. 
 
2.1.2 Subject recruitment 
 
Subjects will be recruited by one or more of following means: 
1. Posting study details on the notice board of the optometry clinic in the Catholic 
University of Daegu. 
2. Advertising through the optometry clinic around the Catholic University of Daegu 

 
 
 
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2.1.3 Inclusion criteria 
 
Subjects will be only eligible for the study if they meeting the following inclusion criteria: 
1. Age of 18 years and above and has full legal capacity as a volunteer 
2. Understand the rights as a research subject and willing and able sign a statement of 
informed consent. 
2. Existing soft contact lens wearers or previous experience of contact lens wear 
3. Being able to wear the study lenses for at least eight hours a day 
4. At least 6/9 visual acuity in each eye with the study lenses 
5. Astigmatism less than 1.50 D in both eyes 
5. Agreed to follow the protocol and not to participate in other clinical research for the 
duration of this study. 
 
 
2.1.4 Exclusion criteria 
 
Subjects will not be eligible to take part in the study if they: 
1. Have an ocular disorder which would normally contraindicate contact lens wear. 
2. Have  a  systemic  disorder  or  any  infectious  diseases  which  would  normally 
contraindicate contact lens wear. 
3. Have previously had any ocular surgery such as corneal refractive surgery 
4. Have less than 6/9 visual acuity in each eye with the study lenses 
5. Are currently using any topical medication such as eye drops or ointment. 
6. Have  any  corneal  distortion  resulting  from  previous  rigid  lens  wear  or  have 
keratoconus. 
7. Are currently pregnant or lactating. 
8. No previous contact lens wear 
 
 
2.2 Subject discontinuation 
 
All  subjects have the right  to  discontinue the  study at  any time. Also subjects  will  be 
discontinued if a serious adverse event occurs or non-compliance of study protocol. 

 
 
 
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2.3 Safety parameters, adverse events and concurrent illnesses 
Any adverse events either the study lens related or non-study lens related will be described as 
anticipated condition. These adverse event are classified as ‘serious’, ‘significant’, or ‘non- 
significant’ by clinical assessment. Any adverse events occurring during the study period 
must be recorded. The clinical course of each event should be followed until resolution. 
 
2.3.1 Investigator obligations 
 
All potential Serious and Unanticipated Adverse Device Effects that are related or possibly 
related to subject participation in the investigation will be reported to the Principal 
Investigator and to the designated medical monitor of the sponsor within 24 hours of the 
investigator becoming aware of the event. The Principal Investigator will report the event to 
the EC/IRB as soon as possible (by fax, mail/delivery, phone, or email), but within 10 
business days of becoming aware of the problem. All fatal or life threatening events will be 
reported immediately to the IRB. Significant and Non-Significant Adverse Events will be 
reported to the sponsor and the study coordinator as soon as possible, but no later than 5 
working days after the occurrence. Sponsor medical monitor contact details are: 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.4 Study termination 
 
If study needs to terminate earlier than planned due to any reason, the Industrial Contact 
Person will notify the Principal Investigator who will end the study with the cooperation of 
other staff members. CU IRB will be informed. 
 
2.5 Protocol deviations 

 
 
 
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If there is any protocol deviation, these will be recorded and reported to the Industrial Contact 
Person. CU IRB will be informed as necessary. 
 
 
2.5.1 Protocol amendments 
 
Any amendments will be agreed between the Industrial Contact Person and the Principal 
Investigator with the cooperation of other staff members. Amendments will be recorded, 
identified and distributed. Approval from CU IRB will be obtained as necessary. 
 
 
2.6 Study resources 
 
Study products will be stored according to the manufacturer’s product instructions. 
 
 
2.6.1 Lenses 
 
Details of the study lenses are provided in Table 2. 
 
1-day Acuve Define 
Claren 1-day Iris 
Hydron 1-day 
Manufacturer 
Johnson&Johnson 
Interozzo 
Coopervision 
Replacement 
1-day 
1-day 
1-day 
Material 
Etafilcon A 
Methafilcon A 
Methafilcon A 
Water Content (%) 
59% 
55% 
55% 
Base curve (mm) 
8.5mm 
8.6mm 
? 
Lens 
diameter 
(mm) 
14.2 
14.2 
? 
Power (D) 
0.00, 
-0.50 
~ 
- 
6.00(0.25steps) 
-6.50 ~ -9.00(0.50steps) 
0.00, 
-0.50 
~ 
- 
6.00(0.25steps) 
-6.50 ~ -10.00(0.50steps) 
? 
Wearing schedule 
Daily disposable 
Daily disposable 
Daily disposable 
Table 2: Study contact lens parameters 
 
 
 
 
2.6.1.1 Use of lenses 

 
 
 
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The lenses in this study will be all daily disposable lenses, therefore it will be only worn on a 
daily wear with a minimum of eight hours per day, five days a week. 
 
2.6.2 Care regimens 
 
No care regimen will be required, as the lenses are to be worn on a daily disposable basis 
 
 
 
2.6.3 Inventory control 
 
All lenses will be supplied by CooperVision Inc. All worn lenses will be discarded. 
 
 
 
2.6.4 Clinical equipment 
 
Clinical equipment such as 
 
 
 is regularly maintained and 
calibrated as required. Standard operating procedures and international standards are used 
where appropriate. 
 
 
2.7 Study control 
 
The study design is controlled crossover comparison design. The order to wear the lenses will 
be pseudo-randomized to minimize the impact of order. The lenses will be masked if possible 
by covering name of contact lens brand. 
 
 
2.8 Documentation 
 
Documents related to this work that require archiving will be kept by the School of 
Optometry & Vision Science for a period of 5 years after completion of the final report, 
before being destroyed. 
 
 
2.9 Data collection and analysis 
 
Data collected in this work will be recorded on a spreadsheet format. This spreadsheet will be 
exported into a statistical package for analysis. 

 
 
 
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2.10 Study completion 
 
The study is complete when all subjects have signed the exit statement. 
 
 
2.11 fidentiality 
 
All matters and responses are anonymous and will be treated confidentially. The name of 
individual persons are not required in any of the responses and subjects will only be referred 
by their unique identity number in the study report. No individual will be identified in any 
presentation or publication. 
 
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 in the monitoring report for the study and make them 
available to relevant authorised parties (e.g. CU IRB). 

 
 
 
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Section 3. Subject management 
 
 
3.1 Visit scheduling 
 
Subjects will be required to attend for up to four visits –an initial dispensing visit, and three 
follow-up visits. Acceptable date ranges are shown in Table 3. 
 
 
 
Visit 
Target day to visit 
Allowable range 
Initial dispensing 
NA 
NA 
One week 
7 days from dispensing visit. 
5-10 days from dispensing visit 
Two week 
7 days from dispensing visit. 
5-10 days from dispensing visit 
Three week 
7 days from dispensing visit. 
5-10 days from dispensing visit 
 
 
3.1.1 Unscheduled visits 
 
If any subjects experience any discomfort or problem with the study lenses, they will be 
asked to return to the clinic to be examined. This visit will be classified as ‘unscheduled’. All 
necessary documentation such as the reason for the visit, clinical findings and action taken 
will be recorded on the clinical study database. 
 
 
3.1.2 Missed visits 
 
If any subjects are not attending, investigator will attempt all reasonable means to encourage 
to attend the study. However, any subjects not attending for two consecutive study visits are 
missed. 
 
 
3.2 Visit conduct 
 
3.2.1 Initial dispensing visit 
 
The subject will receive a study summary form prior to enrolment and will then be required 

 
 
 
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to sign an informed consent form. 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: 
1. Details of the ocular history and contact lens wearing history of the subject. 
2. Refraction and distance monocular logMAR visual acuity 
3. Auto-keratometry measures using the Keratoraph 5M (Oculus, Germany) 
4. Slit lamp biomicroscopy will be carried out for the signs of any abnormality using 
Efron Grading Scales. 
5. The investigator will confirm that the subject satisfies all the inclusion and exclusion 
criteria. Subjects who fail to meet all the criteria at this time will be discontinued and 
replaced. 
6. The study lenses will be fitted according to the randomisation order and allowed to 
settle for five minutes. The subject will be masked from the lens type. 
7. Monocular logMAR visual acuity will be recorded before performing an over- 
refraction, and then monocular logMAR visual acuity will be carried out with the over- 
refraction in place. 
8. Lens fit will then be assessed using the following evaluations: horizontal and 
vertical centration, corneal coverage and movement. Normally, for an acceptable 
fit, centration and movement will fall within currently accepted clinical criteria 
9. The subject will then be discharged and asked to return for the one-week follow-up 
visit wearing the study lenses for a minimum of two hours. Subjects should be asked to 
wear their lenses for a minimum of eight hours per day, five days per week. 
 
3.2.2 One-week follow-up visit 
 
Subjects should attend wearing the study lenses which should have been in situ for at least 

 
 
 
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7. The lenses will then be removed and discarded. 
8. The investigator will then conduct a complete biomicroscopic examination of the 
clinical signs 
9. The second pair of lenses will be applied 
10. . Visual acuity & lens fit will be assessed with second pair of lenses worn 
 
 
3.2.3 Two and Three-week 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 (any ocular measurement 
procedures outlined below will be carried out on each eye): 
1. The same procedures as the 1-week visit (3.2.2) sections 1-10 will be carried out. 
2. Additionally, subjects will be asked to rank the lens in order of preference. 
3. 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. 
 
 
3.2.4 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 

 
 
 
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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 the School of Optometry & Vision 
Science, Catholic University of Daegu, 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 the School of Optometry & Vision Science, Catholic 
University of Daegu. 
 
4.2 Disclosure 
 
All matters relating to this clinical study are confidential and should only be disclosed to 
relevant authorized 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. 
 Personnel 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 

 
 
 
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