Evaluation of The Clinical Acceptance of Soft Contact Lenses for Myopia Control
Conditions: Myopia
Sponsor: CooperVision, Inc.



STRICTLY CONFIDENTIAL                                                  
 
 
 
ID20-28 V1.0 Protocol Myopia Control Dispensing 
 
Clinical Investigational Plan
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Clinical Investigational Plan 
 
Evaluation of The Clinical Acceptance of Soft Contact Lenses for Myopia Control  
 
OTG-i Study Number and Version: ID20-28 Version 1.0 
Study Sponsor Number: CV-20-51 
Issue Date: 03 September 2020  
 
 
Protocol Signature Page 
As Chief Investigator, I agree to conduct this study in accordance with all applicable laws and regulations and 
in compliance with the provisions of this Clinical Investigational Plan. 
I am responsible for ensuring that the investigation is conducted according to this plan and for protecting the 
rights, safety, and welfare of the research participants. 
 
 
 
 
 
 
Chief Investigator Name (printed) 
 
Signature 
 
 
   Date 
 
 
 
 
 
Confidentiality Statement
The information in the following document is provided to you as an investigator, potential investigator, or 
consultant, for review by you, your staff, and applicable Ethics Committee or Institutional Review Board, and 
is considered confidential.  It is understood that the information will not be disclosed to others without written 
authorization from OCULAR TECHNOLOGY GROUP - International, except to the extent necessary to obtain 
informed consent from the study participants. 
 
 
OTG-i Study 
OCULAR TECHNOLOGY GROUP - International,
 TECHNOLOGY 

STRICTLY CONFIDENTIAL                                                  
 
 
 
ID20-28 V1.0 Protocol Myopia Control Dispensing 
 
Clinical Investigational Plan 
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DOCUMENT CHANGE HISTORY 
Revision 
Originator 
Description of Change(s) 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Clinical Investigational Plan 
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Clinical Investigational Plan 
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Table of Contents 
1 
Overall Synopsis .......................................................................................................................... 8 
2 
Introduction and Rationale ........................................................................................................... 11 
2.1 
Background ..................................................................................................................... 11 
2.2 
Objectives ....................................................................................................................... 11 
2.3 
Hypothesis ...................................................................................................................... 12 
2.4 
Endpoints ........................................................................................................................ 12 
3 
Study Sponsor and Investigators ................................................................................................. 12 
3.1 
Study Sponsor ................................................................................................................. 12 
3.2 
Clinical Research Organization ....................................................................................... 12 
3.3 
Study Site & Investigators ............................................................................................... 12 
3.4 
Medical Monitor ............................................................................................................... 13 
3.5 
Data Controller and Statistical Analysis .......................................................................... 13 
3.6 
Independent Ethics Committee ....................................................................................... 13 
4 
Study Material .............................................................................................................................. 13 
4.1 
Study Products ................................................................................................................ 13 
4.2 
Control Contact Lenses .................................................................................................. 14 
4.3 
Test Contact Lenses ....................................................................................................... 14 
4.4 
Adaptation Contact Lenses ............................................................................................. 15 
4.5 
Labelling .......................................................................................................................... 16 
4.5.1 
Test & Control Contact Lenses .......................................................................... 16 
4.5.2 
Adaptation Contact Lenses ................................................................................ 16 
5 
Study Population .......................................................................................................................... 16 
5.1 
Recruitment Procedure ................................................................................................... 16 
5.2 
Number of Participants ................................................................................................... 17 
5.3 
Inclusion and Exclusion Criteria ...................................................................................... 17 
5.3.1 
Inclusion Criteria ................................................................................................ 17 
5.3.2 
Exclusion Criteria ............................................................................................... 17 
5.4 
Premature Withdrawal..................................................................................................... 18 
5.5 
Informed Consent ............................................................................................................ 18 
6 
Study Design & Procedures ......................................................................................................... 18 
6.1 
General Description ........................................................................................................ 18 
6.2 
Experimental Routine ...................................................................................................... 20 
6.3 
Measures to Avoid Bias .................................................................................................. 22 
6.3.1 
Randomization ................................................................................................... 22 
6.3.2 
Masking .............................................................................................................. 22 
6.3.3 
Participant Instructions ....................................................................................... 22 

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Clinical Investigational Plan 
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6.4 
Study Procedures ............................................................................................................ 23 
6.4.1 
Efficacy Procedures ........................................................................................... 23 
6.4.2 
Safety Procedures ............................................................................................. 23 
6.4.3 
Population Profiling Procedures ......................................................................... 23 
6.4.4 
Study Management Procedures ........................................................................ 23 
6.5 
Contact Lens Wearers (CLW) Study Visit Routine ......................................................... 23 
CLW Visit 1 – Screening/ Enrolment/ Baseline ............................................................... 24 
CLW Visit 2 – Lens Order 1 Dispensing ......................................................................... 24 
CLW Visit 3 – Lens Order 1 Follow-up & Order 2 Dispensing (Visit 2 + 10±3 days) ...... 24 
CLW Visit 4 – Lens Order 2 Follow-up & Order 3 Dispensing (Visit 2 + 10±3 days) ...... 25 
CLW Visit 5 – Lens Order 3 Follow-up and Exit (Visit 3 + 10±3 days) ........................... 26 
6.6 
Non-Contact Lens Wearers (NW) Study Visit Routine ................................................... 26 
NW Visit 1 – Screening/ Enrolment /Baseline Visit/ Adaptation Contact Lens 
Dispensing ......................................................................................................... 26 
NW Visit 2 – Adaptation Contact Lens Follow-up & Order 1 Dispensing (Visit 1+ 14±7 
days) .................................................................................................................. 27 
NW Visit 3 – Order 1 Follow-up & Order 2 Dispensing (Visit 2+ 10±3 days) .................. 27 
NW Visit 4 – Order 2 Follow-up & Order 3 Dispensing (Visit 2+ 10±3 days) .................. 28 
NW Visit 5 – Order 3 Follow-up Visit and Exit (Visit 3+ 10±3 days) ............................... 28 
7 
Statistical Analysis and Sample Size Determination ................................................................... 28 
7.1 
Determination 
of 
Sample 
Size .................................................................................................................................
 
7.2 
Statistical Analysis Plan .................................................................................................. 29 
8 
Risk Analysis ................................................................................................................................ 30 
8.1 
Site Specific Risk Analysis .............................................................................................. 30 
8.2 
Benefits ........................................................................................................................... 30 
8.3 
Risks ............................................................................................................................... 30 
8.4 
Conclusion ...................................................................................................................... 31 
9 
Adverse Events and Reporting .................................................................................................... 32 
9.1 
Adverse Events ............................................................................................................... 32 
9.1.1 
Adverse Event Definitions .................................................................................. 32 
9.1.2 
Normal or Adaptive Symptoms .......................................................................... 33 
9.1.3 
Procedures for Adverse Events ......................................................................... 34 
9.2 
Reporting Adverse Events .............................................................................................. 34 
10 
Device Deficiencies ...................................................................................................................... 34 
11 
Investigator, Sponsor and Medical Monitor Responsibilities ....................................................... 34 
11.1 
Investigator Responsibilities ........................................................................................... 34 
11.2 
Sponsor Responsibilities ................................................................................................. 35 

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Clinical Investigational Plan 
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11.3 
Medical Monitor Responsibilities ..................................................................................... 35 
12 
General Clinical Management ...................................................................................................... 36 
12.1 
Data Recording ............................................................................................................... 36 
12.2 
Clinical Monitoring ........................................................................................................... 36 
12.3 
Study Product Accounting ............................................................................................... 36 
12.4 
Participant Compliance Monitoring ................................................................................. 36 
12.5 
Unmasking of Study Information ..................................................................................... 37 
12.6 
Participant Payments ...................................................................................................... 37 
13 
Administration Management ........................................................................................................ 38 
13.1 
Relevant Standards......................................................................................................... 38 
13.2 
Deviations from the Protocol ........................................................................................... 38 
13.2.1 Major Protocol Deviations .................................................................................. 38 
13.2.2 Minor Protocol Deviations .................................................................................. 39 
13.3 
Modifications to the Clinical Investigational Plan ............................................................ 39 
13.4 
Termination of the Study ................................................................................................. 39 
13.5 
Data Protection ............................................................................................................... 39 
13.6 
Data Handling and Record Keeping ............................................................................... 40 
13.7 
Reporting ......................................................................................................................... 40 
13.8 
Publication Policy ............................................................................................................ 40 
13.9 
Compensation ................................................................................................................. 40 
13.10 
Indemnity/Insurance ........................................................................................................ 40 
 
 
 
 
 

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Clinical Investigational Plan 
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The time required by participants who are current contact lens wearers at the time of enrolment into the 
study will be a total of 9.25 hours for the five visits (Table 2A) and for those who are non-contact lens 
wearers 10.00 hours (Table 2B). 
 
 

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Clinical Investigational Plan 
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 
Once it has been verified that the participants meet the inclusion/exclusion criteria they will be 
familiarised with the various vision measurements and tasks outlined in the protocol. 
 
They will then be fitted with Proclear Single Vision contact lenses.  Modification to the lens power (up to 
three attempts) to determine the optimal lens powers for the specific lens type for the participant will be 
done according to the fitting guide.  The participants will wear these contact lenses for a period of 
approximately 10-15 minutes to get used to the contact lenses.  If after three attempts, no suitable contact 
lenses can be prescribed, the participants will be discharged from the study.   
At the conclusion of the visit: 
 
For contact lens wearers, the second study visit will be scheduled. 
 
For non-contact lens wearers, the participants and their parents/guardians will be shown how to use the 
contact lenses and instructed to wear the study contact lenses for at least 8 hours a day, at least 6 days 
a week and the second study visit will be scheduled within14 ± 7 days. 
Visit 2 (for contact lens wearers) – Contact Lens Order 1 Dispensing Visit  
The participants will return for the second visit wearing their spectacles.  Their concomitant medications will 
once again be reviewed.  The study contact lenses will be randomized to the order in which the two tests and 
the control contact lenses will be worn (Lens Order 1). The study contact lenses will be selected and fitted 
according to the manual of procedures, fitting guide and the visual acuity and lens fitting characteristics 
assessed.  Modification to the lens power (up to three attempts) to determine the optimal lens powers for the 
specific lens type for the participants will be carried out according to the fitting guide.  The participants will 
wear these contact lenses for a period of approximately 15 minutes in order to adapt to the correction and 
then visual acuity will be measured according to the requirements, lens fitting characteristics will be evaluated.  
If after two contact lenses modifications (three pairs of contact lenses being tested), no suitable contact lens 
can be prescribed, the participants will be discharged from the study. 
At the conclusion of the visit, the final contact lenses will be dispensed, the participants will be instructed to 
wear the study lenses for at least 8 hours a day, at least 6 days a week and scheduled for the third  study 
visit to take place  10±3days later. 
Visit 2 (for non-contact lens wearers) - Adaption Contact Lens Follow-up / Contact Lens Order 1 
Dispensing Visit 
The participants will return for the second study visit wearing their adaptation contact lenses.  Their contact 
lens wearing history and satisfaction will be reviewed along with their concomitant treatments.  Routine 
measurements of visual acuity will be carried out and lens fitting characteristics will be evaluated. The 
adaptation contact lenses will then be removed, and the participant’s ocular health be evaluated prior to the 
insertion of the study contact lens. 
The study contact lenses (Lens Order 1) will be dispensed following the same protocol as for the current 
contact lenses wearers described in the previous section. 
At the conclusion of the visit, the final contact lenses will be dispensed, the participants will be instructed to 
wear the study lenses for at least 8 hours a day, at least 6 days a week and scheduled for the third  study 
visit to take place   10±3days later. 
Visit 3 – Contact Lens Order 1 Follow-up / Contact Lens Order 2 Dispensing Visit 
Participants will return for their third study visit after having worn the first study contact lenses for 10±3days. 
They will attend the visit wearing their contact lenses and the following routine will take place: 
 Their medical, ocular and contact lens wearing history will once again be reviewed. Participants will then 
complete a satisfaction questionnaire.  A series of measurements of visual acuity with the study contact 

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Clinical Investigational Plan
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CLW Visit 1 – Screening/ Enrolment/ Baseline1 
The routine below will be followed: 
 
Explanation of the study2 
 
Signing of the consent form 
 
Participant demographics and ocular history questionnaire (Questionnaire A) 
 
Concomitant treatments questionnaire (Questionnaire B) 
 
Habitual vision satisfaction and wearing history questionnaire (Questionnaire C) 
 
Manifest Refraction (sphero-cylindrical & best sphere monocular and binocular) distance and near 
 
Standard Snellen visual acuity at distance (monocular & binocular) and near (with +2.00D add) with 
sphero-cylindrical and best sphere refractions 
 
Review of inclusion and exclusion criteria 
 
Ocular dominance measurement 
 
Pupil size measurements 
 
Dynamic VA familiarization 
 
Glare VA familiarization 
 
iPad tasks familiarisation 
 
Safety ocular integrity examination 
 
Proclear Spherical CONTACT LENS INSERTION & WEAR 15 MINUTES  
 
Over refraction (best sphere monocular & binocular) distance and near 
 
Standard Snellen visual acuity at distance (monocular & binocular) distance and near 
 
Decision to accept contact lenses or try an alternative prescription  
 
Contact lens fit clinical evaluation 
 
Proclear Spherical CONTACT LENS REMOVAL  
 
Decision to continue with determination of eligibility 
 
Scheduling 
CLW Visit 2 – Lens Order 1 Dispensing 
The routine below will be followed: 
 
Concomitant treatments questionnaire (Questionnaire B) 
 
STUDY CONTACT LENS INSERTION & WEAR 15 MINUTES (ORDER 1)3 
 
Over refraction (best sphere monocular & binocular) distance and near 
 
Standard Snellen visual acuity at distance (monocular & binocular) distance and near 
 
Decision to dispense contact lenses or try an alternative prescription4 
 
Contact lens fit clinical evaluation 
 
Decision to dispense contact lenses5 
 
Dispensing of Study product 
 
Contact lens usage instruction with participants and parents/guardians 
 
Scheduling 
CLW Visit 3 – Lens Order 1 Follow-up & Order 2 Dispensing (Visit 2 + 10±3 days) 
 
1 All participants will attend the visit wearing spectacles 
2 The participants and parents/guardians will be given full details of the investigation at the time of making the appointment for the 
enrolment visit.  The explanation at the time of the visit will be to reinforce the information given during the initial telephone contact 
and answer any questions the participants and their parents/ guardians may have. 
3 Randomly as per the randomization scheme in place one of the two test contact lenses or the control contact lens 
4 If an alternative prescription is tried the routine above will be repeated. Up to three attempts will be allowed. 
5 If the contact lens fit is not suitable for dispensing the participant will be discharged from the study 
Dynamic VA familiarization
Glare VA familiarization

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Clinical Investigational Plan
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The routine below will be followed: 
 
Concomitant treatments questionnaire (Questionnaire B) 
 
Visual satisfaction and contact lens wearing characteristics questionnaire (Questionnaire D) 
 
Over refraction (best sphere monocular & binocular) distance and near 
 
Standard Snellen visual acuity at distance (monocular & binocular) distance and near 
 
Dynamic VA measurement 
 
Glare VA measurement 
 
Visual satisfaction questionnaire following iPad use vision activities (Questionnaire D) 
 
Contact lens fit clinical evaluation 
 
STUDY CONTACT LENS REMOVAL (ORDER 1) 
 
Safety ocular integrity examination 
 
STUDY CONTACT LENS INSERTION & WEAR 15 MINUTES (ORDER 2)6 
 
Over refraction (best sphere monocular & binocular) distance and near 
 
Standard Snellen visual acuity at distance (monocular & binocular) distance and near 
 
Decision to dispense contact lenses or try an alternative prescription7 
 
Contact lens fit clinical evaluation 
 
Decision to dispense contact lenses8 
 
Dispensing of Study product 
 
Contact lens usage instruction  
 
Scheduling 
CLW Visit 4 – Lens Order 2 Follow-up & Order 3 Dispensing (Visit 2 + 10±3 days) 
The routine below will be followed: 
 
Concomitant treatments questionnaire (Questionnaire B) 
 
Visual satisfaction and contact lens wearing characteristics questionnaire (Questionnaire D) 
 
Over refraction (best sphere monocular & binocular) distance and near 
 
Standard Snellen visual acuity at distance (monocular & binocular) distance and near 
 
Dynamic VA measurement 
 
Glare VA measurement 
 
Visual satisfaction questionnaire following iPad use vision activities (Questionnaire D) 
 
Contact lens fit clinical evaluation 
 
STUDY CONTACT LENS REMOVAL (ORDER 2) 
 
Safety ocular integrity examination 
 
STUDY CONTACT LENS INSERTION & WEAR 15 MINUTES (ORDER 3)9 
 
Over refraction (best sphere monocular & binocular) distance and near 
 
Standard Snellen visual acuity at distance (monocular & binocular) distance and near 
 
Decision to dispense contact lenses or try an alternative prescription10 
 
Contact lens fit clinical evaluation 
 
Decision to dispense contact lenses11 
 
Dispensing of Study product 
 
Contact lens usage instruction  
 
6 Randomly as per the randomization scheme in place; one of the two test contact lenses or the control contact lens. 
7 If an alternative prescription is tried the routine above will be repeated. Up to three attempts will be allowed.  
8 If the contact lens fit is not suitable for dispensing the participant will be discharged from the study. 
9 Randomly as per the randomization scheme in place; one of the two test contact lenses or the control contact lens. 
10 If an alternative prescription is tried the routine above will be repeated. Up to three attempts will be allowed.  
11 If the contact lens fit is not suitable for dispensing the participant will be discharged from the study. 
Glare VA measurement
Dynamic VA measurement
Dynamic VA measurement
Glare VA measurement

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Clinical Investigational Plan
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 
Contact lens usage instruction with participants and parents/guardians 
 
Scheduling 
NW Visit 2 – Adaptation Contact Lens Follow-up & Order 1 Dispensing (Visit 1+ 14±7 days) 
The routine below will be followed: 
 
Concomitant treatments questionnaire 
 
Visual satisfaction and contact lens wearing history questionnaire (Questionnaire C) 
 
Over refraction (best sphere monocular & binocular) distance and near 
 
Standard Snellen visual acuity at distance (monocular & binocular) distance and near 
 
Contact lens fit clinical evaluation 
 
PROCLEAR SPHERICAL CONTACT LENS REMOVAL 
 
Safety ocular integrity examination 
 
BREAK 15 MINUTES 
 
STUDY CONTACT LENS INSERTION (ORDER 1) & WEAR 15 MINUTES16 
 
Over refraction (best sphere monocular & binocular) distance and near 
 
Standard Snellen/LogMAR visual acuity at distance (monocular & binocular) distance and near 
 
Decision to dispense contact lenses or try an alternative prescription17 
 
Contact lens fit clinical evaluation 
 
Decision to dispense contact lens18 
 
Dispensing of Study product 
 
Contact lens usage instruction with participants and parents/guardians 
 
Scheduling 
NW Visit 3 – Order 1 Follow-up & Order 2 Dispensing (Visit 2+ 10±3 days) 
The routine below will be followed: 
 
Concomitant treatments questionnaire (Questionnaire B) 
 
Visual satisfaction and contact lens wearing characteristics questionnaire (Questionnaire D) 
 
Over refraction (best sphere monocular & binocular) distance and near 
 
Standard Snellen visual acuity at distance (monocular & binocular) distance and near 
 
Dynamic VA measurement 
 
Glare VA measurement 
 
Visual satisfaction questionnaire following iPad use vision activities (questionnaire D) 
 
Contact lens fit clinical evaluation 
 
STUDY CONTACT LENS REMOVAL (ORDER 1) 
 
Safety ocular integrity examination 
 
STUDY CONTACT LENS INSERTION & WEAR 15 MINUTES (ORDER 2)19 
 
Over refraction (best sphere monocular & binocular) distance and near 
 
Standard Snellen visual acuity at distance (monocular & binocular) distance and near 
 
Decision to dispense contact lenses or try an alternative prescription20 
 
Contact lens fit clinical evaluation 
 
Decision to dispense contact lens21 
 
16 Randomly as per the randomization scheme in place; one of the two test contact lenses or the control contact lens 
17 If an alternative prescription is tried the routine above will be repeated. Up to three attempts will be allowed 
18 If the contact lens fit is not suitable for dispensing the participant will be discharged from the study 
19 Randomly as per the randomization scheme in place one of the two test contact lenses or the control contact lens 
20 If an alternative prescription is tried the routine above will be repeated. Up to three attempts will be allowed 
21 If the contact lens fit is not suitable for dispensing the participant will be discharged from the study 
Dynamic VA measurement
Glare VA measurement