Clinical Performance of Qualis Silicone Hydrogel Soft Contact Lens Over 3 Months of Daily Wear
Phase: NA
Conditions: Refractive Errors
Sponsor: Unicon Optical Co. Ltd.

Protocol: Clinical Performance of Qualis Silicone Hydrogel Soft Contact Lens over 3 Months of Daily Wear 
(AVDR 2019-05 v 1.1) 
Andre Vision and Device Research
CLINICAL STUDY PROTOCOL
Protocol No: 
AVDR 2019-05 (v 1.1) 
Version Date: 
May 28th, 2020 
Prepared by: 
Andre Vision and Device Research 
Title: 
Clinical Performance of Qualis Silicone Hydrogel Soft Contact Lens 
over 3 Months of Daily Wear 
Sponsor: 
UNICON OPTICAL CO., LTD. 
No.16, Gongye E. 9th Rd.  
Hsinchu Science Park,  
Baoshan Township Hsinchu County Hsinchu - District,  
TAIWAN 30075 
CRO: 
Andre Vision and Device Research 
6119 Canter Ln. 
West Linn, OR 97068 
United States 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
2 
 
Table of Contents 
 
 
1. 
GENERAL INFORMATION __________________________________________________________________ 7 
1.1. 
INTRODUCTION ______________________________________________________________________ 7 
1.2. 
IDENTIFICATION OF THE CLINICAL INVESTIGATIONAL PLAN __________________________________ 8 
1.3. 
SPONSOR ___________________________________________________________________________ 8 
1.4. 
PRINCIPAL INVESTIGATOR(S) AND INVESTIGATIONAL SITE(S) ________________________________ 9 
1.5. 
OVERALL SYNOPSIS OF THE CLINICAL INVESTIGATION ______________________________________ 9 
2. 
IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE _______ 12 
2.1. 
INVESTIGATIONAL DEVICE ____________________________________________________________ 12 
3. 
JUSTIFICATION FOR THE DESIGN OF THE CLINICAL INVESTIGATION _____________ 13 
4. 
RISKS AND BENEFITS ______________________________________________________________________ 14 
4.1. 
BENEFITS __________________________________________________________________________ 14 
4.2. 
RISKS _____________________________________________________________________________ 14 
5. 
OBJECTIVES AND HYPOTHESIS OF THE CLINICAL INVESTIGATION ________________ 15 
6. 
DESIGN OF THE CLINICAL INVESTIGATION ____________________________________________ 15 
6.1. 
GENERAL __________________________________________________________________________ 15 
6.1.1. 
Study Design _______________________________________________________________________ 15 
6.1.2. 
Measures Taken to Avoid Bias _________________________________________________________ 15 
6.1.3. 
Study Endpoints ____________________________________________________________________ 15 
6.1.4. 
Schedule of Visits and Clinical Parameters _______________________________________________ 16 
6.1.5. 
Equipment for Assessing Clinical Investigation Variables ___________________________________ 18 
6.1.6. 
Replacement of Subjects _____________________________________________________________ 18 
6.1.7. 
Investigational Site Selection and Investigator Qualification Criteria__________________________ 18 
6.1.8. 
Clinical Trial Registration _____________________________________________________________ 18 
6.2. 
INVESTIGATIONAL DEVICE AND COMPARATORS __________________________________________ 18 
6.2.1. 
Investigational Device ________________________________________________________________ 18 
6.2.2. 
Comparator (Control Device) __________________________________________________________ 19 
6.2.3. 
Additional Care Products _____________________________________________________________ 19 
6.3. 
SUBJECTS __________________________________________________________________________ 20 
6.3.1. 
Inclusion Criteria ____________________________________________________________________ 20 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
3 
 
6.3.2. 
Exclusion Criteria ____________________________________________________________________ 20 
6.3.3. 
Subject Withdrawal or Discontinuation _________________________________________________ 21 
6.3.4. 
Point of Enrollment __________________________________________________________________ 21 
6.3.5. 
Duration of the Clinical Investigation ___________________________________________________ 22 
6.3.6. 
Number of Subjects Required _________________________________________________________ 22 
6.3.7. 
Enrolment Period ___________________________________________________________________ 22 
6.3.8. 
Subject Payment ____________________________________________________________________ 22 
6.4. 
PROCEDURES _______________________________________________________________________ 22 
6.4.1. 
Enrolment Procedures _______________________________________________________________ 22 
6.4.2. 
Remote Enrolment Procedures ________________________________________________________ 23 
6.4.3. 
Study Procedures ___________________________________________________________________ 23 
6.4.4. 
Remote Study Procedures ____________________________________________________________ 24 
6.4.5. 
Subject Instructions _________________________________________________________________ 24 
6.4.6. 
Examination Schedule _______________________________________________________________ 24 
6.4.7. 
Clinical Parameters __________________________________________________________________ 25 
6.4.8. 
Study Completion Procedures _________________________________________________________ 28 
6.5. 
MONITORING PLAN _________________________________________________________________ 30 
7. 
STATISTICAL CONSIDERATIONS ________________________________________________________ 31 
8. 
DATA MANAGEMENT ______________________________________________________________________ 32 
9. 
AMENDMENTS TO THE CLINICAL INVESTIGATIONAL PLAN ________________________ 33 
10. DEVIATIONS FROM THE CLINICAL INVESTIGATIONAL PLAN _______________________ 33 
11. DEVICE ACCOUNTABILITY ________________________________________________________________ 34 
12. STATEMENTS OF COMPLIANCE __________________________________________________________ 35 
13. INFORMED CONSENT PROCESS __________________________________________________________ 36 
14. ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES ______ 36 
15. VULNERABLE POPULATION ______________________________________________________________ 39 
16. SUSPENSION OR PREMATURE TERMINATION ________________________________________ 40 
17. PUBLICATION POLICY _____________________________________________________________________ 40 
18. BIBLIOGRAPHY _____________________________________________________________________________ 40 
 
 
 
 
 
 
 
 

Unicon Optical Co., Ltd. 
Protocol#: AVDR 2019-05 v1.1 
May 28th, 2020 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
4 
Table of Contents – Appendices 
Pg. 
Appendix 1 
Clinical Sites and Investigators List 
41 
Appendix 2 
Methods of Measurements  
42 
Appendix 3 
Sample Case Report Forms  
52 
Appendix 4 
Culture Procedures  
94 

Unicon Optical Co., Ltd. 
Protocol#: AVDR 2019-05 v1.1 
May 28th, 2020 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
5 
Protocol Revision History 
Revision 
Description of Revision(s) 
Date 
1.1 
Added Section 6.4.2 and Section 6.4.4 - The study 
procedures are revised to optionally allow remote reporting 
for subject questionnaires (vision/comfort/wear 
time/symptoms), reporting of adverse events, and changes 
in medication and health history.  Additionally, the 
informed consent process is revised to allow for electronic 
distribution of the informed consent form to potential 
participants and remote review of the consent form with 
designated study personnel. 
Updated content on the baseline, follow up and adverse 
event eCRFs (Appendix 3) – updated “recent lens wearing 
experience” questions on baseline eCRF. Added “wetting 
drop usage” question to follow up eCRF. Added 
documentation of additional information for the Adverse 
Event eCRF. 
May 28th, 
2020 
1.2 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
6 
 
 
Abbreviations Referenced in Protocol 
 
 
AE 
Adverse Event 
BCVA 
Best Corrected Visual Acuity 
BSCVA 
Best Spectacle Corrected Visual Acuity 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
D 
Diopter 
SLF 
Slit Lamp Finding 
FDA 
U.S. Food & Drug Administration 
GCP 
Good Clinical Practices 
ICF 
Informed Consent Form 
ID 
Identification 
IDE 
Investigation Device Exception  
IRB 
Institutional Review Board 
ISO 
International Standards Organization 
INC 
Incorporated 
LogMAR 
Logarithmic Minimal Angle of Resolution 
n 
Number of observations 
N/A 
Not Applicable 
OTC 
Over the Counter 
QA 
Quality Assurance 
Rx 
Medical Prescription 
SD 
Standard Deviation 
UADE 
Unanticipated Adverse Device Effect 
UCVA 
Uncorrected Visual Acuity 
VA 
Visual Acuity 
 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
7 
 
 
1. GENERAL INFORMATION 
 
1.1. INTRODUCTION 
 
The objective of this clinical investigation is to collect scientifically valid safety and 
effectiveness data on the Qualis Silicone Hydrogel Soft Contact Lens over 3 months of 
daily wear.  The clinical performance data reported from this study are intended to be 
submitted to the U.S. Food and Drug Administration Center for Devices and Radiological 
Health (CDRH) to establish substantial equivalence to a currently marketed contact lens 
in support of a new 510(k) premarket notification application. 
 
Silicone hydrogel contact lenses are a unique category of soft (hydrophilic) contact lenses 
that contain a gel-like plastic materials called Silicone. Similar to standard hydrogel soft 
lenses, these are made of a plastic material which hardens when dried out but actively 
absorbs water to become soft and pliable again. The primary benefit of silicone hydrogel 
materials is increased oxygen transmissibility versus standard hydrogel contact lenses.  
The clinical effects of wearing contact lenses that limit oxygen supply have been 
extensively reported—with potential complications related to hypoxia including corneal 
swelling, epithelial microcysts, limbal hyperemia, corneal vascularization, refractive error 
changes and corneal distortion. 1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 Fonn, Desmond; Sweeney, Deborah. The Benefits of Silicone Hydrogel Daily Disposable Lenses. Contact Lens 
Spectrum, Volume: 30, Issue: December 2015, page(s): 42-45 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
8 
 
1.2. IDENTIFICATION OF THE CLINICAL INVESTIGATIONAL PLAN 
 
Title: 
Clinical Performance of Qualis Silicone Hydrogel Soft 
Contact Lens over 3 Months of Daily Wear 
 
Protocol No: 
 
 
AVDR 2019-05 
 
Protocol Version: 
 
1.0 
 
Protocol Version Date: 
February 20th, 2020 
 
 
1.3. SPONSOR 
 
Sponsor: 
 
 
UNICON OPTICAL CO., LTD. 
 
 
 
No.16, Gongye E. 9th Rd.  
 
 
 
Hsinchu Science Park,  
 
 
 
Baoshan Township Hsinchu County Hsinchu - District,   
 
 
 
TAIWAN 30075 
 
 
  
 
Email:  
celine.hsu@uniconvision.com.tw 
 
 
  
 
Contact: 
Celine Hsu 
 
CRO:  
  
 
Andre Vision and Device Research 
 
 
  
 
6119 Canter Lane 
 
 
  
 
West Linn, OR 97068 
 
 
  
 
United States 
 
 
  
 
Telephone: 
1-(503)-372-5226 
 
 
  
Email:  
bandre@fdapproval.com 
 
 
  
Contact:  
Bret Andre, MS 
 
Lead Clinical Monitor: 
Mijeong Andre, MS 
 
 
  
 
6119 Canter Lane 
 
 
  
 
West Linn, OR 97068 
 
 
  
 
United States 
 
 
  
 
Telephone: 
1-(503)-372-5226 
 
 
Medical Monitor: 
 
Dr. Larry Rich M.D. 
 
 
 
14170 N.W. Bordeaux Lane 
 
 
 
Portland, Oregon   97229 
 
 
 
503-614-8604 
 
 
 
imaricci1@gmail.com 
 
 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
9 
 
1.4. PRINCIPAL INVESTIGATOR(S) AND INVESTIGATIONAL SITE(S) 
 
 
Refer to Appendix 1 
 
1.5. OVERALL SYNOPSIS OF THE CLINICAL INVESTIGATION 
 
Protocol Title: 
Clinical Performance of Qualis Silicone Hydrogel Soft Contact Lens over 3 
Months of Daily Wear 
Objective(s): 
The objective of this clinical investigation is to collect scientifically valid 
safety and effectiveness data on the Qualis Silicone Hydrogel Soft Contact 
Lens for Daily Wear.  The clinical performance data reported from this study 
is intended to be submitted to the U.S. Food and Drug Administration Center 
for Devices and Radiological Health (CDRH) to establish substantial 
equivalence to a currently marketed contact lens in support of a new 510(k) 
premarket notification application.   
Overall Study 
Design: 
Three-month, open-label, bilateral, parallel group, randomized, daily wear 
contact lens dispensing study comparing the Qualis Silicone Hydrogel Soft 
Contact Lens for Daily Wear with the currently marketed Acuvue Vita 
(senofilcon C) Monthly Contact Lens (FDA cleared under K160212).  
Eligible subjects will be examined for baseline evaluation and lens fitting.  
Up to fifty (50) subjects will wear the test contact lenses and up to twenty-
five (25) subjects will wear the control contact lenses. The subjects will 
undergo standard ophthalmic evaluation for contact lens wear and will be 
followed for a period of at least ninety (91) days. 
Duration: 
For each subject, the study will involve a minimum of six (6) scheduled 
visits.  The total duration of the treatment period will be at least ninety-one 
(91) days from lens dispensing. 
Test Device: 
- Test Device Name: Qualis Silicone Hydrogel Soft Contact Lens  
- Water Content: 38% 
- Dk: 100 x 10-11 (cm2/sec)(mlO2/ml-mmHg) 
- Additives: C.I. Reactive Blue No. 19 (listed in 21 CFR Part 73.3127); 
benzotriazole UV absorbing monomer  
- Packaging: Lenses are supplied sterile in sealed blister packs containing 
sterile isotonic phosphate buffered saline. 
Control Device: 
- Control Device Name: Acuvue Vita (senofilcon C) Monthly Contact 
Lens 
- Water Content: 41% 
- Dk: 103 x 10-11 (cm2/sec)(mlO2/ml-mmHg) 
- Additives: Reactive Blue Dye #4; benzotriazole UV absorbing monomer  
- Packaging: The lens is supplied sterile (steam) in a foil sealed plastic 
package stored in buffered saline solution with methyl ether cellulose. 
Care Solutions: 
The Subjects will be using FDA cleared contact lens care products that are 
commercially available for silicone hydrogel daily lens maintenance, care 
and storage. To disinfect the contact lenses daily, Biotrue MPS and Alcon 
ClearCare Peroxide will be used. A randomization scheme will be provided 
to the investigational site to randomly assign subjects to one of the two lens 
care system (Biotrue or ClearCare) in a 1:1 manner. PuriLens Plus 
Preservative Free Saline will be supplied to subjects for use as needed in 
conjunction with the daily disinfection system. 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
10 
 
Summary of Visit 
Schedule: 
There will be a total of six (6) scheduled study visits*:  
Visit 1: Screening/Enrolment/Baseline/Lens Dispensing 
Visit 2: Day 7 (5 to 9 days after dispensing) 
Visit 3: Day 14 (12 to 16 days after dispensing) 
Visit 4: Day 30 (25 to 35 days after dispensing) 
Visit 5: Day 60 (55 to 65 days after dispensing) 
Visit 6: Day 91 (91 to 101 days after dispensing) 
* Interim visits to be undertaken as required 
Number of Subjects: 
To ensure a minimum of 50 completed subjects (with 30 completed subjects 
in the test arm), 75 subjects will be enrolled to participate.  Up to fifty (50) 
subjects will wear the test contact lenses and up to twenty-five (25) subjects 
will wear the control contact lenses. 
The number of subjects was determined based on the recommendations in 
Premarket Notification [510(k)] Guidance Document for Class II Daily 
Wear Contact Lenses. 
Number of Sites: 
A minimum of three (3) sites and five (5) independent investigators will 
participate in this clinical study.  The target subject enrollment at each study 
site will be equivalent. 
Inclusion Criteria: 
Prior to being considered eligible to participate in this study, each subject 
MUST meet the following criteria: 
• 
The subject must read, understand, and sign the informed consent 
form and receive a fully executed copy of the form. 
• 
The subject must appear able and willing to adhere to the 
instructions set forth in this clinical protocol. 
• 
The subject must be at least 18 years of age. 
• 
The subject's vertex corrected spherical equivalent distance 
refraction must be in the range of -1.00 to -6.00 in each eye. 
• 
The subject's refractive cylinder must be ≤ 0.75 Diopters in each eye. 
• 
The subject must have best corrected visual acuity of 20/25 
(LogMAR) or better in each eye. 
• 
Subjects should own a wearable pair of spectacles. 
• 
The subject must have normal eyes (i.e., no ocular medications or 
infections of any type). 
• 
Subjects must be able and willing to wear the study lenses at least 6 
hours a day, a minimum of 5 days per week 
Exclusion Criteria: 
Subjects may not be enrolled into the study if ANY of the following apply: 
• 
Currently pregnant or lactating (subjects who become pregnant 
during the study will be discontinued). 
• 
Any systemic disease, autoimmune disease, or use of medication, 
which may interfere with contact lens wear. This may include, but 
not be limited to, diabetes, hyperthyroidism, recurrent herpes 
simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, 
Stevens-Johnson syndrome, and immunosuppressive diseases or any 
infectious diseases (e.g. hepatitis, tuberculosis). 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
11 
 
• 
The use of systemic or ocular medications that would contraindicate 
contact lens wear. 
• 
Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, 
history of recurrent corneal erosions, aphakia, or moderate or above 
corneal distortion by keratometry. 
• 
Any previous, or planned, ocular or interocular surgery (e.g., radial 
keratotomy, photorefractive keratectomy (PRK), laser in situ 
keratomileusis (LASIK), etc.). 
• 
Any grade 2 or greater slit lamp findings for corneal staining, and 
any grade 3 or greater slit lamp findings for other abnormalities (e.g., 
edema, corneal neovascularization, tarsal abnormalities, conjunctival 
injection) on the ISO 11980 classification scale, any current 
inflammatory events or events within the last 6 months, or any other 
ocular abnormality that may contraindicate contact lens wear. 
• 
Any known hypersensitivity or allergic reaction to Biotrue or 
ClearCare contact lens care solutions 
• 
Any ocular infection, allergy or clinically significant ocular disease 
(e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular 
hypertension), or ocular conditions (e.g. strabismus), which might 
interfere with the study. 
• 
Any corneal distortion resulting from previous hard or rigid gas 
permeable contact lens wear. 
• 
Extended wear, monovision or multi-focal contact lens correction. 
• 
Participation in any contact lens or lens care product clinical trial 
within 30 days prior to study enrollment. 
• 
Any subject where the randomized lens demonstrates a fit that is 
deemed inappropriate by the investigator, including, but not limited 
to, the lens being too flat, too steep, have excessive or inadequate 
movement, and/or insufficient limbal coverage. 
• 
Employee or relative of employees of sponsor or investigational 
clinic (e.g., Investigator, Coordinator, Technician) 
Evaluation Criteria 
Primary Outcome 
Measures: 
1. Ocular adverse events/adverse reactions, and adverse device effects; 
2. Visual Acuity 
Secondary 
Outcome 
Measures: 
1. Keratometry changes/Refractive Changes; 
2. Discontinuations (and their reasons); 
3. Lens Replacements (and their reasons);  
4. Device Deficiencies; 
5. Ocular symptoms, problems and complaints; 
6. Average lens wear time 
Protection of Human 
Rights: 
This non-significant risk contact lens trial requires approval by an 
institutional review board (IRB) prior to commencement. 
 
 
 
 
 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
12 
 
2. IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE 
 
2.1. INVESTIGATIONAL DEVICE  
 
The Qualis Silicone Hydrogel Soft Contact Lens is a class II (FDA Group V – Silicone 
Hydrogel) daily wear soft contact lens in a spherical design that is characterized by a 
high oxygen permeability (Dk).  The water content is 38%.  The hydrogel lens' material 
is a random copolymer composed of Silicone Hydrogel.  A benzotriazole UV absorbing 
monomer is used to block UV radiation.  UV absorbers on the lens block UV radiation 
Qualis Silicone Hydrogel Soft Contact Lens is tinted with color additive C.I. Reactive 
Blue No. 19 listed in 21 CFR Part 73.3127 for handling visibility purpose.  The 
transmittance characteristics are less than 5% in the UVB range of 280-315nm and less 
than 30% in the UVA range of 316-380nm. 
 
Lenses are supplied sterile in sealed blister packs containing sterile isotonic phosphate 
buffered saline.  The compatibility and package integrity of the blister pack packaging 
system has been demonstrated and successfully used for other marketed lens products, 
and packaged lenses are effectively steam sterilized in a validated autoclave.  Blister 
pack container is labeled with the lens parameters, lot number and product expiration 
date. 
 
The Qualis Silicone Hydrogel Soft Contact Lens is available in the following 
parameters: 
 
 
Table #1 - Qualis Silicone Hydrogel Soft Contact Lens Parameters 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Items  
Parameters  
Material  
Silicone Hydrogel  
Diameter Range  
13.5 mm to 15.0 mm   
Base curve Range  
8.0 mm to 9.5 mm  
Center Thickness  
0.080 mm at -3.00D  
Power  
+20.00D to -20.00D in 0.25D per step  

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
13 
 
The properties of the Qualis Silicone Hydrogel Soft Contact Lens are as follows: 
 
Table #2 - Qualis Silicone Hydrogel Soft Contact Lens Properties 
 
Lens Property 
Test Value 
Light transmittance  
95%  
UV transmittance  
@280~315 nm: Avg＜5%  
@316~380 nm: Avg＜30%  
Refractive index  
1.415 
Water content  
38%   
Oxygen permeability  
(DK, 35℃)  
100x 10-11 (cm2/sec)(mlO2/mlmmHg)  
  
 
 
The Qualis Silicone Hydrogel Soft Contact Lens is manufactured at the following 
facility: 
 
UNICON Optical Co., LTD. 
No 16, Gongye E. 9th Rd., Hsinchu Science Park,  
Baoshan Township, Hsinchu County 30075,  
Taiwan (R.O.C.) 
 
 
3. JUSTIFICATION FOR THE DESIGN OF THE CLINICAL INVESTIGATION 
 
The risk-benefit profile for soft (hydrophilic) daily wear contact lenses is well established 
through currently marketed devices.  This clinical investigation plan was designed based on 
the FDA guidance titled Premarket Notification [510(k)] Guidance Document for Class II 
Daily Wear Contact Lenses, and ISO 11980:2009(E) – Ophthalmic optics - contact lenses 
and contact lens care products - guidance for clinical investigations. 
 
 
 
 
 
 
 
 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
14 
 
4. RISKS AND BENEFITS 
 
4.1. BENEFITS 
 
There might not be direct benefits to the participants in this study. However, 
participation in a study may contribute to scientific research information that may be 
used in the development of new contact lens products. In addition, subjects will receive 
an examination of the front part of their eyes and may have the opportunity to try 
different types of soft contact lenses at no cost to them.  
 
4.2. RISKS 
 
Daily wear contact lenses studies are considered to be a non-significant risk studies based 
on United States Food and Drug administration (FDA) 2 and International Standards 
Organization (ISO) guidelines. The investigational contact lenses used in this study are 
intended for daily wear with usage consistent with typical daily wear.  
 
All the assessments are routine clinical procedures, and none present any increased risk to 
subjects compared with normal clinical routine for eye examination and contact lens care.  
 
The risks associated with wearing the study contact lenses are similar to wearing any type 
of commercially available soft (hydrophilic) silicone hydrogel contact lens.  These 
include discomfort during adaptation period, eye irritation, pain, redness and swelling; a 
painful scrape or scratch on the surface of the clear part of the eye; blurred vision and 
sensation of dry eyes.  More serious risks may include photophobia, iritis, corneal edema 
or eye infection. Although contact lens-related infections are very infrequent, they may 
occur.  The incidence of infection due to daily wear lenses is relatively very low 3.  
Almost always an infection will occur only in one eye.  This risk is assumed by more 
than 130 million current contact lens wearers worldwide.  Since some subjects will be 
current contact lens wearers, the risks of taking part in the study are no greater than those 
associated with wearing their own contact lenses.  
 
Complications may occur due to non-compliant behavior. This will be mitigated by the 
investigator providing the subject with indications for use for both the lens and lens care 
product prior to dispensing and by the greater follow-up visit frequency associated with 
the study than routine practice that will allow the investigator to re-enforce the 
importance of following a compliant behavior. 
 
 
 
 
 
 
2 FDA Guidance Significant Risk and Nonsignificant Risk Medical Device Studies UCM126418 
3 Schein, O. D., et al. (1989). "The relative risk of ulcerative keratitis among users of daily-wear and extended-wear 
soft contact lenses. A case-control study. Microbial Keratitis Study Group." New England Journal of Medicine 
321(12): 773-778. 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
15 
 
5. OBJECTIVES AND HYPOTHESIS OF THE CLINICAL INVESTIGATION 
 
The objective of this clinical investigation is to collect scientifically valid safety and 
effectiveness data on the Qualis Silicone Hydrogel Soft Contact Lens for Daily Wear.  The 
clinical performance data reported from this study is intended to be submitted to the U.S. 
Food and Drug Administration Center for Devices and Radiological Health (CDRH) to 
establish substantial equivalence to a currently marketed contact lens in support of a new 
510(k) premarket notification application.   
 
 
6. DESIGN OF THE CLINICAL INVESTIGATION 
 
6.1. GENERAL 
 
6.1.1. Study Design 
 
This is a three-month, open-label, bilateral, parallel group, randomized, daily wear 
contact lens dispensing study comparing the Qualis Silicone Hydrogel Soft Contact 
Lens for Daily Wear with the currently marketed Acuvue Vita (senofilcon C) 
Monthly Contact Lens (FDA cleared under K160212).  Eligible subjects will be 
examined for baseline evaluation and lens fitting.  Up to fifty (50) subjects will wear 
the test contact lenses and up to twenty-five (25) subjects will wear the control 
contact lenses. The subjects will undergo standard ophthalmic evaluation for contact 
lens wear and will be followed for a period of ninety days. 
 
6.1.2. Measures Taken to Avoid Bias 
 
The assignment to the test or control contact lens and to the lens care system will be 
randomized to minimize bias.  The target subject enrollment will be equivalent for 
each study site to account for assignment bias.  
 
6.1.3. Study Endpoints 
 
Primary Outcome Measures: 
 
- 
Ocular adverse events/adverse reactions, and adverse device effects;  
- 
Visual acuity 
 
Secondary Outcome Measures: 
 
- 
Keratometry changes/Refractive Changes; 
- 
Discontinuations (and their reasons); 
- 
Lens Replacements (and their reasons);  
- 
Device Deficiencies; 
- 
Ocular symptoms, problems and complaints; 
- 
Average lens wear time 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
16 
 
 
 
6.1.4. Schedule of Visits and Clinical Parameters 
 
This study will involve a total of six (6) scheduled study visits*:  
 
- 
Visit 1: Screening/Enrolment/Lens Dispensing 
- 
Visit 2: Day 7 (5 to 9 days after dispensing) 
- 
Visit 3: Day 14 (12 to 16 days after dispensing) 
- 
Visit 4: Day 30 (25 to 35 days after dispensing) 
- 
Visit 5: Day 60 (55 to 65 days after dispensing) 
- 
Visit 6: Day 91 (91 to 101 days after dispensing) 
 
*Interim visits to be undertaken as required 
 
Refer to the following page for a table depicting the clinical parameters at each 
scheduled visit. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
17 
 
Table #3 - Schedule of Visits and Clinical Parameters 
Procedure / Data 
Visit 1 
Screening/ 
Enrolment/B
aseline/ 
Dispense 
Visit 2, 3 
Day 7, 14 
Follow Up 
Visit 4, 5 
Day 30, 60 
Follow Up 
Visit 6 
Day 91 
Final Visit 
Interim 
(as required) 
Visit window 
N/A 
+/- 2days 
+/- 5 days 
+10 days 
N/A 
Informed consent2 
 
- 
- 
- 
- 
Randomization (assign subject ID) 
 
- 
- 
- 
- 
Demographics 
 
- 
- 
- 
- 
Brief Medical History (including 
medication)3 
 
1 
1 
1 
1 
Habitual correction information 
 
- 
- 
- 
- 
Average wear and comfort time3 
 
 
 
 
() 
Sphero-cylindrical and Best sphere 
refraction 
 
 
 
 
() 
Visual acuity with spectacle refraction 
(Sphero-cylindrical & best sphere) 
(monocular and binocular) 
 
 
 
 
() 
Keratometry 
 
 
 
 
() 
Biomicroscopy 
 
 
 
 
() 
Verify Inclusion/exclusion criteria 
 
- 
- 
- 
- 
Dispense Test or Control Device 
 
() 
 
() 
() 
Contact lens use and care instruction 
 
- 
- 
- 
- 
Visual acuity with dispensed contact 
lenses 
 
 
 
 
() 
Spherical over-refraction (with visual 
acuity) 
 
 
 
 
() 
Evaluate lens fit & surface 
 
 
 
 
() 
Comfort, vision, and handling 
questionnaires3 
 
 
 
 
() 
Symptom questionnaires3 
 
 
 
 
() 
Device deficiency reporting 
() 
() 
() 
() 
() 
Adverse event reporting4 
() 
() 
() 
() 
() 
Protocol deviation reporting 
() 
() 
() 
() 
() 
Scheduling3 
 
 
 
 
() 
Trial exit form 
() 
() 
() 
 
() 
 = mandatory, () = as applicable for visit 
1 Monitor changes only 
2 Informed Consent form may be electronically distributed (i.e. email or fax) to potential participants and reviewed remotely. 
Remote Informed Consent signatures (e.g. DocuSign) may be available at some sites. Refer to Section 6.4.2. 
3 Study procedure may be conducted remotely. Refer to Section 6.4.4. 
4Any adverse reactions or complications observed by the investigator or reported by the subjects throughout the study will be 
recorded in the subject’s Adverse Event Case Report Form. 
 
 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
18 
 
6.1.5. Equipment for Assessing Clinical Investigation Variables 
 
This investigation will require equipment used for a typical soft contact lens 
fitting examination, including: 
 
• Phoropter 
• Slit Lamp 
• Keratometer 
• Visual acuity chart (LogMAR) 
 
6.1.6. Replacement of Subjects 
 
To ensure a minimum of 50 completed subjects (with 30 completed subjects in 
the test arm), 75 subjects will be enrolled to participate.  Subjects that have 
dropped out of the study will not be replaced. 
 
6.1.7. Investigational Site Selection and Investigator Qualification Criteria 
The study site will be selected based on the experience of the site investigator and 
staff in conducting clinical research trials, the availability of potential study 
subjects, and the interest of the site in performing the trial. 
The trial will be conducted at a minimum of three (3) sites with at least five (5) 
independent investigators.  Principal Investigators for this trial will be licensed 
optometrists or ophthalmologists with experience in clinical research, and the 
remaining Sub-Investigators may be optometrists or ophthalmologists trained in 
contact lens fitting. For Principal Investigators that are optometrists, an 
ophthalmology clinic or hospital in near proximity to the clinical site location will 
be predesignated for treatment of serious adverse events.   Principal Investigators 
and Sub-Investigators must provide a curriculum vitae reflecting experience in 
contact lens fitting. Any decisions or actions related to potential adverse events 
must be addressed by the Principal Investigators. 
 
6.1.8. Clinical Trial Registration 
 
The study will be registered in the clinical trials registry (www.ClinicalTrials.gov) 
 
6.2. INVESTIGATIONAL DEVICE AND COMPARATORS 
 
6.2.1. Investigational Device 
 
The investigational device is the Qualis Silicone Hydrogel Soft Contact Lens 
manufactured from a novel silicone hydrogel material.  Refer to section 2.1 of this 
clinical investigation plan for more detailed information regarding the 
investigational device. 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
19 
 
6.2.2. Comparator (Control Device) 
 
This study will report the primary outcome measures in summary tables compared 
against the Acuvue Vita (senofilcon C) Monthly Contact Lens, which is FDA 
510(k) cleared under K160212.  The control device has the following attributes: 
 
- 
Water Content: 41% 
- 
Dk: 103 x 10-11 (cm2/sec)(mlO2/ml-mmHg) 
- 
Additives: Reactive Blue Dye #4; benzotriazole UV absorbing monomer  
- 
Packaging: The lens is supplied sterile (steam) in a foil sealed plastic  
package stored in buffered saline solution with methyl ether cellulose. 
 
6.2.3. Additional Care Products 
 
The Subjects will be using FDA cleared contact lens care products that are commercially 
available for silicone hydrogel daily lens maintenance, care and storage.  To disinfect the 
contact lenses daily, Biotrue MPS and Alcon Clear Care Peroxide will be used.  A 
randomization scheme will be provided to the investigational site to randomly assign subjects 
to one of the two lens care system (Biotrue or Clear Care) in a 1:1 manner.  The lens care 
system will be supplied with a contact lens storage case. PuriLens Plus Preservative Free 
Saline will be supplied to subjects for use as needed in conjunction with the daily disinfection 
system.  
 
Table #4 – Care Products 
Care system 
Manufacturers 
Composition 
Description of 
use 
FDA 510(k) 
Clearance 
Biotrue MPS 
Bausch + Lomb polyaminopropyl 
biguanide 0.00013% 
and polyquaternium 
0.0001%. 
To condition, 
clean, remove 
daily protein, 
disinfect, and 
store lenses 
K161819 
Clear Care  
Alcon 
Preservative free 
hydrogen peroxide 3%, 
PLURONIC† 17R4 (a 
cleaning agent), and 
HydraGlyde* Moisture 
Matrix (EOBO-21* – 
polyoxyethylene- 
polyoxybutylene, for 
silicone hydrogel soft 
lenses 
To condition, 
clean, remove 
daily protein, 
disinfect, and 
store lenses 
K173538 
PuriLens Plus 
Preservative Free 
Saline 
PuriLens, Inc. 
preservative-free, pH 
balanced, isotonic, 
sterile saline solution 
for use in rinsing, 
cleaning and 
disinfection, and 
storage of SOFT 
(hydrophilic) 
contact lenses. 
K002319 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
20 
 
6.3. SUBJECTS 
 
To be eligible for the study subjects must be at least 18 years old.  There are no 
requirements as to race, gender or occupation. Participants who have the ability to freely 
consent to participate in the study, are capable of comprehending the nature of the study, 
and are likely to comply with the visit schedule are to be entered into the study provided 
they conform to the following criteria.  To be eligible to participate in the study a 
subject must have ALL of the Inclusion Criteria and have NONE of the exclusion 
criteria present. 
 
6.3.1. Inclusion Criteria 
 
Prior to being considered eligible to participate in this study, each subject MUST 
meet the following criteria: 
• 
The subject must read, understand, and sign the informed consent form and 
receive a fully executed copy of the form. 
• 
The subject must appear able and willing to adhere to the instructions set 
forth in this clinical protocol. 
• 
The subject must be at least 18 years of age. 
• 
The subject’s vertex corrected spherical equivalent distance refraction must 
be in the range of -1.00 to -6.00 in each eye. 
• 
The subject’s refractive cylinder must be ≤ 0.75 Diopters in each eye. 
• 
The subject must have best corrected visual acuity of 20/25 (LogMAR) or 
better in each eye. 
• 
Subjects should own a wearable pair of spectacles. 
• 
The subject must have normal eyes (i.e., no ocular medications or infections 
of any type). 
• 
Subjects must be able and willing to wear the study lenses at least 6 hours 
a day, a minimum of 5 days per week 
 
6.3.2. Exclusion Criteria 
 
Subjects may not be enrolled into the study if ANY of the following apply: 
• 
Currently pregnant or lactating (subjects who become pregnant during the 
study will be discontinued). 
• 
Any systemic disease, autoimmune disease, or use of medication, which 
may interfere with contact lens wear. This may include, but not be limited 
to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren’s 
syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and 
immunosuppressive diseases or any infectious diseases (e.g. hepatitis, 
tuberculosis). 
• 
The use of systemic or ocular medications that would contraindicate contact 
lens wear. 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
21 
 
• 
Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, 
history of recurrent corneal erosions, aphakia, or moderate or above corneal 
distortion by keratometry. 
• 
Any previous, or planned, ocular or interocular surgery (e.g., radial 
keratotomy, photorefractive keratectomy (PRK), laser in situ keratomileusis 
(LASIK), etc.). 
• 
Any grade 2 or greater slit lamp findings for corneal staining, and any grade 
3 or greater slit lamp findings for other abnormalities (e.g., edema, corneal 
neovascularization, tarsal abnormalities, conjunctival injection) on the ISO 
11980 classification scale, any current inflammatory events or events within 
the last 6 months, or any other ocular abnormality that may contraindicate 
contact lens wear. 
• 
Any known hypersensitivity or allergic reaction to Biotrue or ClearCare 
contact lens care solutions 
• 
Any ocular infection, allergy or clinically significant ocular disease (e.g. 
corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular 
hypertension), or ocular conditions (e.g. strabismus), which might interfere 
with the study. 
• 
Any corneal distortion resulting from previous hard or rigid gas permeable 
contact lens wear. 
• 
Extended wear, monovision or multi-focal contact lens correction. 
• 
Participation in any contact lens or lens care product clinical trial within 30 
days prior to study enrollment. 
• 
Any subject where the randomized lens demonstrates a fit that is deemed 
inappropriate by the investigator, including, but not limited to, the lens 
being too flat, too steep, have excessive or inadequate movement, and/or 
insufficient limbal coverage. 
• 
Employee or relative of employees of sponsor or investigational clinic (e.g., 
Investigator, Coordinator, Technician) 
 
6.3.3. Subject Withdrawal or Discontinuation 
 
Refer to section 6.4.6 for information regarding subject withdrawal or 
discontinuation. 
 
6.3.4. Point of Enrollment 
 
The investigational site will screen subjects to determine if each subject is eligible 
to participate in the investigation.  Pre-screening of basic eligibility may occur 
prior to the initial visit; however, Subjects are required to complete the informed 
consent process prior to the baseline/screening visit (Visit 1).  All subjects who 
sign an Informed Consent form and meet the eligibility criteria during the 
screening visit are defined as “enrolled” into the clinical investigation regardless 
of any further participation.   

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
22 
 
 
6.3.5. Duration of the Clinical Investigation 
 
The total duration of treatment will be at least 91 days from lens dispensing for 
each individual subject.  
 
6.3.6. Number of Subjects Required 
 
To ensure a minimum of 50 completed subjects (with 30 completed subjects in 
the test arm), 75 subjects will be enrolled to participate.  Up to fifty (50) subjects 
will wear the test contact lenses and up to twenty-five (25) subjects will wear the 
control contact lenses. 
 
The number of subjects was determined based on the recommendations in 
Premarket Notification [510(k)] Guidance Document for Class II Daily Wear 
Contact Lenses. 
 
6.3.7. Enrolment Period 
 
The estimated enrolment period for this investigation is forty-five (45) days. 
 
6.3.8. Subject Payment 
 
Subjects in will be paid a specified amount in return for their time and travel to 
the clinic to attend the six (6) scheduled study visits.  If participation ends prior to 
completing all study visits, this payment will be prorated accordingly.  If interim 
or additional visits are required, the subject will receive an additional $50 USD 
per visit. 
 
6.4. PROCEDURES 
 
6.4.1. Enrolment Procedures 
 
Each subject who is considered for the investigation must be presented with the 
Informed Consent document and must read the document or have the document 
read to them.  The investigator or an authorized, delegated member of the 
investigational staff will explain the study purpose, procedures, and subject 
responsibilities to the potential participant.  Subjects will be informed that their 
participation is voluntary and that they may withdraw consent to participate at any 
time.  They will be informed that choosing not to participate will not affect the 
care the subject will receive.  Finally, they will be told that if needed their records 
may be accessed by the health (regulatory) authorities, the IRB, and authorized 
sponsor and CRO staff without violating the confidentiality of the subject, to the 
extent permitted by the applicable law(s) or regulations.  The subjects’ 
willingness and ability to meet the follow-up requirements will be determined.  
The subject will be given sufficient time to read the informed consent form and 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
23 
 
the opportunity to ask questions.  The subject will sign and date the informed 
consent form.  The investigator will also sign and date the consent form.  The 
original informed consent form will be retained with the subject records and a 
copy will be provided to the subject.  An Affidavit of Informed Consent will be 
completed for the clinical monitor to confirm that consent was obtained. 
 
6.4.2. Remote Enrolment Procedures 
 
The Informed Consent form may be electronically distributed (i.e. email or fax) to 
potential participants, and the investigator or delegated study personnel may 
remotely review the Informed Consent form content and address initial questions 
via phone or video conferencing (e.g. Zoom).  Remote Informed Consent review 
is optional to investigators and subjects and is supplemental to the in-person 
informed consent process.  In all cases an in-person review of the Informed 
Consent form, as described in the above enrolment procedures, must occur at the 
scheduled in-person screening visit.  Each investigational site will determine if the 
Informed Consent signing may be conducted remotely using electronic signature 
(e.g. Docusign), or if all Informed Consent forms shall be signed during the in-
person screening visit. 
 
6.4.3. Study Procedures 
 
At the first visit after informed consent has been given, the investigator will 
review the subject’s medical history, ocular history (including concomitant 
treatments), demographics and contact lens wear history.  The subject will 
complete a baseline symptoms questionnaire. A series of routine optometric 
assessments and tests will be conducted to evaluate the subject’s ocular health and 
refractive status. This will include measurement of manifest sphero-cylindrical 
refraction, best sphere refraction and resultant visual acuity, keratometry, and 
biomicroscopy (slit-lamp examination).  Once it has been verified that the subject 
meets the inclusion / exclusion criteria the test lens parameters will be determined 
based on Rx.  The lens parameters will be recorded, and the subject will be 
randomized to receive the test or control lenses, which will be dispensed from a 
stock at the site.  After insertion of the study lenses the fit and visual acuity will 
be evaluated and an over-refraction with visual acuity will be performed.  The 
subject will be educated on safe contact lens use, and will be instructed to wear 
the study lenses on a one-month replacement schedule for at least 6 hours a day 
for a minimum of 5 days per week.  The subject will be provided with Biotrue or 
ClearCare for routine cleaning, disinfection and storage; and will be educated on 
the daily care regimen for the study lenses.  At the conclusion of the visit, follow-
up visits will be scheduled. 
 
There will be five scheduled follow-up visits during the treatment period at the 
following intervals: 7 days, 14 days, 30 days, 60 days, and 91 days. During these 
follow-up visits any changes to medical history will be reviewed, the subject will 
complete a symptom questionnaire, and a series of routine optometric assessments 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
24 
 
and tests will be conducted to evaluate the subject’s ocular health and refractive 
status.  This will include measurement of manifest sphero-cylindrical refraction, 
best sphere refraction and resultant visual acuity, visual acuity with contact lens, 
over-refraction with visual acuity, and biomicroscopy (slit-lamp examination) 
including evaluation of the fit and surface of the study lens. Additionally, on the 
91 day visit keratometry will be recorded.  At the conclusion of each visit, the 
subject will be instructed to continue to wear and care for the study lenses, and the 
next follow-up visit will be scheduled.  Additional supply of study lenses and care 
solution will be dispensed on Day 30 and Day 60 visits (or as needed).   At the 
completion of the 91 day visit the subject will be discharged from the study and a 
Trial Exit Form will be completed. 
 
6.4.4. Remote Study Procedures 
 
With consideration for the current global pandemic (COVID-19), the follow-up 
study visit procedures listed below may be conducted remotely (via telephone or 
video conference) and recorded on the eCRF to reduce physical exposure time 
between the subjects and study personnel:  
 
• Questionnaires (vision/comfort/handling/wear time/symptoms) 
• Changes in medication (concomitant treatments) and health history 
• Scheduling 
 
All remote reporting of questionnaires must occur on the same calendar day of the 
scheduled in-person visit and must be prior to the visit.  Scheduling may occur 
remotely at any time between visits. Any eligible procedures not conducted 
remotely prior to the visit shall be conducted during the in-person visit.  If remote 
reporting was conducted and the subject is not present for the in-person visit on 
the same calendar day, then the completed procedures shall be reported again on 
the date of the actual in-person visit.  The utilization of remote reporting 
procedures in this study is optional to investigators and subjects. 
 
All other study visit procedures not identified in this section (6.4.4) or section 
6.4.2 shall be conducted with the subject physically present during the in-person 
clinic visit. 
 
6.4.5. Subject Instructions 
 
The subjects will be provided with a patient instruction guide for the Qualis 
Silicone Hydrogel Soft Contact Lens.  All study contact lens care solutions and 
control contact lenses will be dispensed with a package insert/patient instructions. 
 
6.4.6. Examination Schedule 
 
There will be a total of six (6) scheduled study visits:  
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
25 
 
Visit 1: Screening/Enrolment/Baseline/Lens Dispensing 
Visit 2: Day 7 (5 to 9 days after dispensing) 
Visit 3: Day 14 (12 to 16 days after dispensing) 
Visit 4: Day 30 (25 to 35 days after dispensing) 
Visit 5: Day 60 (55 to 65 days after dispensing) 
Visit 6: Day 91/Study Exit (91 to 101 days after dispensing) 
 
6.4.7. Clinical Parameters 
 
All procedures for the study are routine procedures that are performed as part of 
standard clinical care. 
 
 
 
 
Visit 1: Screening/Enrollment/Baseline/Lens Dispense 
Investigators will adhere to the following routine: 
 
• Explanation of the study* 
• Signing of the consent form* 
• Assignment of the subject identification number 
• Demographics and ocular history questionnaire 
• Concomitant treatments 
• Habitual contact lens wearing history  
• Comfort, vision, and handling questionnaire 
• Symptoms questionnaire 
• Manifest sphero-cylindrical and best sphere refraction  
• Visual acuity (LogMAR) with spectacle refraction 
• Keratometry 
• Slit lamp biomicroscopy examination to evaluate ocular integrity 
(limbal redness, bulbar redness, corneal staining, corneal infiltrates, 
other findings; GPC, vascularization, edema/striae, microcysts, 
pinguecula, etc.) 
• Review of inclusion and exclusion criteria / eligibility determination  
• For subjects that fail to meet enrolment criteria, document the screening 
failure 
• For subjects that meet the study criteria document their enrolment, 
assign a subject ID, and apply the subject ID to the Subject 
Randomization List. Determine the applicable contact lens power based 
on Rx and dispense lenses. 
 
 
 
 
~ INSERT study lenses and wait 5 minutes~ 
 
 
• Visual acuity (LogMAR) and over-refraction with dispensed contact 
lenses 
• Slit lamp evaluation for contact lens fit and contact lens surface quality 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
26 
 
• Instruction on contact lens care and use 
• Adverse event identification and reporting 
• Device deficiency reporting 
• Protocol deviation reporting 
• Schedule follow up visit(s)* 
 
* May be completed remotely. 
 
 
 
 
Visit 2, 3, 4, and 5: Follow Up Visit – Day 7, Day 14, Day 30, and Day 60.  
 
Investigators will adhere to the following routine: 
 
~ subject is instructed to wear study lenses at the visit ~ 
 
• Update medical history/concomitant treatments questionnaire* 
• Comfort, vision, and handling questionnaire* 
• Symptoms questionnaire* 
• Visual acuity (LogMAR) and over-refraction with dispensed contact 
lenses 
• Slit lamp evaluation for contact lens fit and contact lens surface quality 
 
~ REMOVE study lenses~ 
 
• Slit lamp biomicroscopy examination to evaluate ocular integrity 
(limbal redness, bulbar redness, corneal staining, corneal infiltrates, 
other findings; GPC, vascularization, edema/striae, microcysts, 
pinguecula, etc.) 
• Manifest sphero-cylindrical and best sphere refraction  
• Visual acuity (LogMAR) with spectacle refraction 
• Keratometry 
• Adverse event identification and reporting 
• Device deficiency reporting 
• Protocol deviation reporting 
• Additional supply of one-month study lenses dispensed (Day 30 and 
Day 60 visits) 
• Additional care product dispensed as needed 
• Schedule follow up visit(s)* 
• For discontinued subjects, complete Exit Form and collect all study 
lenses from the subjects then discharge subjects from the study 
 
* May be completed remotely. 
 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
27 
 
 
 
 
Visit 6: Follow Up Visit – Day 91 – Final Treatment/Exit Visit 
Investigators will adhere to the following routine: 
 
~ subject is instructed to wear study lenses at the visit ~ 
 
• Update medical history/concomitant treatments questionnaire* 
• Comfort, vision, and handling questionnaire* 
• Symptoms questionnaire* 
• Visual acuity (LogMAR) and over-refraction with dispensed contact 
lenses 
• Slit lamp evaluation for contact lens fit and contact lens surface quality 
 
~ REMOVE study lenses~ 
 
• Slit lamp biomicroscopy examination to evaluate ocular integrity 
(limbal redness, bulbar redness, corneal staining, corneal infiltrates, 
other findings; GPC, vascularization, edema/striae, microcysts, 
pinguecula, etc.) 
• Manifest sphero-cylindrical and best sphere refraction  
• Visual acuity (LogMAR) with spectacle refraction 
• Keratometry 
• Adverse event identification and reporting 
• Device deficiency reporting 
• Protocol deviation reporting 
• Collect all study lenses from the subjects 
• Complete Exit Form and discharge subjects from the study 
 
* May be completed remotely. 
 
 
Refer to the table in section 6.1.4 for the clinical parameters and testing frequency. 
 
Some procedures (e.g. keratometry, questionnaires) may be performed 
independently by office technicians / clinical research associates or optometrists 
under the investigator’s supervision, after training into the protocol and 
qualification, using methods described in Appendix 2.  When possible, each 
subject’s measurements will be performed by the same operator or technician, using 
the same piece of equipment at the site. 
 
Additional examinations (such as photography etc.) may be conducted if deemed 
appropriate. 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
28 
 
 
 
 
Interim Visits 
Subjects may return for interim visits between scheduled visits as necessary.  The 
Follow Up Visit Form should be completed for all interim visits (specify 
“unscheduled visit” on the eCRF). 
 
- 
Adverse Event Related Interim Visits:  when a potentially significant 
adverse event occurs the Investigator should schedule frequent follow up 
to monitor and thoroughly document the duration of the event.  The 
Clinical Monitor or Medical Monitor should be consulted when 
determining a follow up schedule to the adverse event.   
- 
Loss of BCVA: in the case of a specific event where the subject’s visual 
acuity is reduced by ≥ 10 letters (LogMAR), a follow up visit should be 
scheduled within 3 days of the event.  If the visual acuity loss persists at 
follow up, ongoing follow up visits should be scheduled within 3 days 
until the visual acuity loss has resolved or the Investigator determines the 
condition is stable. 
- 
Lost or broken lenses: in the case where the subject requires replacement 
of a lost or broken lens an interim visit will be scheduled and the 
following procedures will be conducted at the visit (and recorded on the 
follow up visit eCRF): 
o Visual acuity (LogMAR) and over-refraction with dispensed 
contact lenses 
o Slit lamp evaluation for contact lens fit and contact lens surface 
quality 
o Adverse event identification and reporting 
o Device deficiency reporting 
o Protocol deviation reporting 
 
6.4.8. Study Completion Procedures 
 
A study exit form must be completed for all subjects. 
 
Subject Completion: 
 
Subjects are considered to have completed the study if they have completed follow-
up examinations through the 91-day study period and when all of the study 
procedures have been completed.  All completed subjects’ data will be considered 
evaluable unless a significant protocol deviation was reported.  Written justification 
will be required for the use of data in the evaluation of the safety and/or efficacy of 
study product from any subject found to have a protocol deviation. 
 
Subject Discontinuation: 
 
Possible reasons for discontinuation include: 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
29 
 
1. 
Screen Failure – the subject does not meet the protocol specified inclusion 
criteria or has one or more of the exclusion criteria present. 
2. 
Adverse Event – the subject has been reported to have an adverse event and 
was discontinued due to the adverse event. 
3. 
Subject Decision – the subject decides for whatever reason to exit from the 
study.  The reason must be recorded in the comments section of the Exit Form. 
4. 
Investigator, Sponsor or IRB Decision – the subject is exited from the study 
based on a decision by the investigator the Sponsor or the reviewing IRB.  The 
reason for discontinuation must be recorded in the comments section of the 
Exit Form. 
5. 
Protocol Violation – the subject or the investigator is repeatedly found to be in 
violation of the study protocol. 
Subjects may be discontinued from the study at the discretion of the investigator 
only for reasons related to the study treatment regimen that would jeopardize the 
subjects' health and/or welfare if they were to continue in the study. 
Discontinued subjects will be considered to have completed the study and should 
not be replaced.  However, every effort will be made to follow discontinued 
subjects to obtain as much follow-up data as possible regarding the subject's current 
visual status until the planned end of the study period. 
NOTE: The Investigator will immediately (within 2 working days) notify 
Monitor/CRO if a subject discontinues from the study. 
 
Subjects Lost to Follow-up: 
 
Subjects may be lost to follow-up from the study for non-treatment related reasons.  
Reasons for loss to follow-up include, but are not necessarily limited to:  
 
1) voluntary withdrawal from the study by the subject;  
2) subject has moved from the area; or  
3) subject is unwilling or unable to return for follow-up. 
 
The reason for loss to follow-up will be recorded on the appropriate case report 
form.  Every effort should be made to contact the subject in an effort either to get 
the subject back into compliance with the protocol or to obtain as much follow-up 
data as possible regarding the subject's current refractive status and ocular health. 
 
 
 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
30 
 
Data to be collected: 
 
Visual acuity and slit lamp examination should be completed for each subject at the 
time of discontinuation. 
 
Any follow-up required: 
 
Subjects who are to be exited from the study for an adverse event must be followed 
until the condition has resolved, returned to pre-study status or warrants no further 
follow-up before being discontinued from the study.   
 
Unscheduled visits must be conducted until the condition has resolved, returned to 
pre-study status or warrants no further follow-up. 
 
If the resolution has not occurred within 6 weeks after the study end-date, the 
subject will be exited from the study but must continue to be followed by the 
investigator until the condition has resolved, returned to pre-study status or 
warrants no further follow-up. 
 
Medical Care Post Study Completion: 
 
No continuing medical care will be provided for subjects after completion except 
for the care required to follow-up and resolve a device related adverse event that 
started during the study. 
 
6.5. MONITORING PLAN 
 
Andre Vision and Device Research will monitor the investigation pursuant to ISO 
14155:2011, any applicable health authority regulations and the clinical research 
procedures adopted by the CRO.  The clinical monitor will maintain close contact with the 
Investigators and the Study Coordinators.  The Investigator will permit CRO 
representatives direct access to source data/documents for study-related monitoring, audits, 
review, and inspection(s). The monitor’s responsibilities will include: 
 
• Ensuring that the investigation is being conducted according to the protocol; 
• Ensuring the rights and wellbeing of subjects are protected; 
• Ensuring that protocol deviations are documented with corrective action plans, as 
applicable; 
• Clarifying questions regarding the study; 
• Resolving study issues or problems that may arise; 
• Reviewing the study records to ensure completeness and accuracy. Study and 
patient source document records reviewed will include: 
o 
The Information and Consent Form  
o 
Source documentation including consenting, medical history, concomitant 
medications, and adverse event information as applicable.   
o 
Study related regulatory documents 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
31 
 
 
Study monitoring will involve the following elements: 
 
• CRO representatives will meet with the investigator(s) and conduct a site visit 
prior to the enrollment of subjects at the site in order to review the adequacy of the 
subject population, facilities, and equipment with respect to the needs of the study 
and to train the investigator to the clinical investigation plan. 
• On an ongoing basis CRO representatives will remotely monitor study records and 
data. 
• CRO representatives may visit the clinical site during the study (interim visit) to 
review study progress and verify source documents if needed.   
• Telephone/email consultation will occur as necessary during the course of the 
investigation to ensure the proper progress and documentation of the study 
findings. 
• CRO representatives will meet with the investigator(s) at the completion of the 
investigation in order to verify accuracy of data to source documents (when 
applicable), complete disposition of study materials, and study close out activities. 
 
7. STATISTICAL CONSIDERATIONS 
 
The CRO will manage data analysis and reporting. Subject characteristics and study conduct 
summaries will be reported—including tables such as a subject disposition table, demographics 
and baseline characteristics tables (including age, gender, baseline refraction, lens wear 
experience), summary table of screen failures by reason, accountability of eyes enrolled, and 
subjects excluded from key analysis sets. 
 
All descriptive summary statistics will be displayed with n and % for categorical data, and with 
mean, standard deviation, median, minimum, and maximum for continuous data. The unit will 
be eye.  Tables will be presented by treatment and overall.  Slit lamp findings will be presented 
by all study visits, tabulated by eyes and incidence rate for completed test lens group, 
completed control lens group, discontinued test lens group and discontinued control eyes 
group.  Primary and secondary outcomes will be analyzed by descriptive statistics only.  As 
such, there are no statistical hypotheses to be tested. 
 
Trend analysis profile will be provided following directions provided in the FDA guidance 
Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses.  
All participants who meet the eligibility criteria, adhere to the protocol, and successfully 
complete the full study assessment will be available for the per-protocol analysis. Subjects 
with missing data will be included in the analysis unless there is some non-response-related 
reason to exclude them, such as a protocol violation/invalid data.  Data from all enrolled 
subjects will be used for reporting of adverse events or other safety related outcomes. 
 
 
 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
32 
 
8. DATA MANAGEMENT 
 
The clinical data will be recorded directly on electronic case report forms (eCRFs) generated 
using Andre Vision and Device Research eClinical Software.  All data captured with this 
software will be stored using the secure Amazon Web Services Cloud.  
 
The eCRFs constitute the subjects’ original source documents, which will be reviewed for 
accuracy and comprehensiveness by the study monitor once completed and signed by the 
investigator.  The content and structure of the eCRFs are compliant with 21 CFR Part 11. 
 
Electronic Case Report Forms (eCRF): 
 
Electronic Case Report Forms (eCRF) access will be made available to the sites.  A sample of 
the case report forms are found in Appendix 3.  Only designated individuals will receive a user 
account to access and complete the eCRFs.  Upon completion, the independent investigator 
will electronically sign the eCRF.  Upon completion, the subject identifiers will be recorded 
on the eCRFs beyond subject number and demographic information. 
 
If any study information is collected using an automated piece of equipment, and if the 
automated instrument has a printed output, the printed output will be kept in the subject’s 
clinical file as a source document with the subject number and the date of recording noted on 
the printout. 
 
The eCRFs are time stamped with full audit trail for any changes made.  In the event of a query 
being raised by the Clinical Monitor, a data flag will be raised for the investigator to review. 
Complete tracking information containing the change, the person making the change, the date 
and time of the change and the reason for the change are to be documented on the eCRF 
Correction Log. 
 
Additional Source Documents: 
 
Adequate original records will be maintained for the study, including subject medical records 
(if used), data collection forms, worksheets, exam printouts, investigator/tech notes, signed 
informed consent forms, device use records, adverse event documentation, and information 
regarding subjects who discontinue. 
 
Records Retention: 
 
The investigator will maintain the following accurate, complete, and current records relating 
to the investigator’s participation in this study: 
 
• All correspondence with another investigator, the IRB, CRO, the study monitor, and 
regulatory bodies 
• Records of receipt, use or disposition of the investigational device 
• Records of each subject’s case history and exposure to the investigational device 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
33 
 
The investigator will maintain these records during the investigation and for a period of seven 
(7) years after the date on which the investigation is terminated or completed.  
 
9. AMENDMENTS TO THE CLINICAL INVESTIGATIONAL PLAN 
 
The Sponsor, CRO, or Investigators may determine that an amendment to the clinical 
investigational plan is necessary following IRB and IDE approval.  When the Sponsor and 
Investigators have agreed to the amended investigational plan, it will be submitted to the IRB 
and FDA (via IDE supplement) for approval.  Investigators may not follow the amended 
protocol until receiving approval letters for the IRB and FDA unless the changes affect the 
subjects’ rights, safety and wellbeing, or the scientific integrity of the clinical investigation.  
If the changes are minor (such as a technical change related to subject scheduling), 
amendment may be applied with a “note-to-file” in lieu of submitting a supplement to the 
IDE.  All amendments, including minor amendments, will be submitted to the IRB for 
approval prior to implementation. 
 
In the event that the clinical investigational plan has been amended, all Investigators and 
coordinators involved in the study will be trained to the new procedures prior to 
implementation. 
 
10. DEVIATIONS FROM THE CLINICAL INVESTIGATIONAL PLAN 
 
Protocol deviations are unanticipated or unintentional changes to a study after it has received 
prior sponsor and IRB approval. Protocol deviations can be major or minor. All protocol 
deviations must be reported on the Protocol Deviation Form eCRF.  If the deviation affects 
subject’s rights, safety and wellbeing, or the scientific integrity of the clinical investigation, 
the IRB must be contacted with requests for deviations, and reports of deviations. Under 
emergency circumstances, deviations from the clinical investigational plan to protect the rights, 
safety and well-being of subjects may proceed without prior approval of the sponsor and the 
IRB.  Such deviations shall be documented and reported to the sponsor and the IRB as soon as 
possible. 
 
Throughout the course of the study the Clinical Monitor will review study data for subject and 
investigator compliance to the protocol.  Non-compliances will be documented as protocol 
deviation(s).  If a deviation is determined to be major, the deviation will be reported to the IRB 
as per reporting requirements. 
 
Major Protocol Deviations: 
 
Major protocol deviations may impact the research protocol, information consent document or 
other study materials, usually cannot be anticipated ahead of time and are often necessary to 
ensure the safety and welfare of the subjects. 
 
The following are examples of protocol deviations that must be reported to the IRB: 
• Changes in procedures initiated to eliminate immediate risks/hazards to subjects; 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
34 
 
• Enrolment of subjects outside the protocol inclusion/exclusion criteria whether agreed 
to or not by the sponsor; 
• Inadvertent deviation in specific research intervention procedures or timing of the 
research intervention which could impact upon the safety or efficacy of the study-
related intervention or upon the experimental design; 
• Information consent documentation violations: no documentation of informed consent; 
incorrect version of, or incomplete, informed consent documentation used. 
Minor Protocol Deviations: 
 
Protocol deviations caused by or which originate with research subjects are generally 
considered minor, and normally are not reported to the IRB unless these results in increased 
risk to the subjects).  
 
The following are examples of protocol deviations that are considered minor and do not require 
reporting to the IRB: 
• Logistical or administrative aspects of the study (e.g., study subject missed 
appointment, change in appointment date); 
• Inadvertent deviation in specific research intervention procedures or timing of the 
research intervention which would not impact upon the safety or efficacy of the study-
related intervention or upon the experimental design (e.g., missing a measurement 
during a session that is not considered critical for the study).  
 
11. DEVICE ACCOUNTABILITY 
 
Access to investigational devices will be controlled and the investigational devices are to be 
used only in the clinical investigation.  All study products will be stored in a secure 
environment at room temperature.  Access is to be limited to key study personnel.  No 
investigational device will be released until the investigator has received IRB approval to 
conduct the study.  Once released to the investigator, all investigational device inventories will 
be monitored and accounted for throughout the course of the study.   
 
The Sponsor will maintain records that documents the physical location of all investigational 
devices from shipment of investigational devices to the investigation sites until return or 
disposal. The Investigator will maintain the Study Product Shipment Receipt Log and 
Dispensing and Accountability Logs.  These records include: 
 
• the date of receipt, 
• identification of each investigational device (batch number/serial number or unique 
code), 
• the expiry date (if applicable), 
• the date or dates of use, 
• subject identification, 
• date on which the investigational device was returned/explanted from subject and 
• the date of return of unused, expired or malfunctioning investigational devices.   
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
35 
 
The clinical monitor will ensure product is reconciled and any discrepancies are investigated 
and either corrected or documented. At the conclusion of the study all investigational devices 
will be reconciled. Once the reconciliation of all devices has been documented by the clinical 
monitor, the remaining collected devices will be disposed using municipal services. 
 
 
Investigational Device Packaging and Labeling: 
 
The investigational test contact lenses will be supplied sterile in sealed blister packs containing 
isotonic phosphate buffered saline. The package labeling is printed with lot numbering, 
expiration date and lens parameter identification.   
 
The lenses will be shipped to all study sites with an open label.  An invoice with ‘Caution – 
Investigational Device Limited by Federal (or US) Law to Investigational Use, and ‘to be used 
by Qualified Investigators only’ will be included with the lenses.   
 
Neither CRO nor the investigator may represent the investigational test device as safe or 
effective for the purpose for which it is under clinical study or otherwise promote the product. 
 
12. STATEMENTS OF COMPLIANCE 
 
This clinical investigation will be conducted in substantial conformance with the ethical 
principles of the Declaration of Helsinki and the following regulations and standards: 
 21 CFR Part 812 Investigational Device Exemptions 
 21 CFR Part 11 Electronic records; Electronic Signatures 
 ISO 14155 Clinical investigation of medical devices for human subjects: Clinical 
investigation plans (2011). 
 21 CFR Part 50 Protection of Human Subjects 
 21 CFR Part 54 Financial Disclosure by Clinical Investigators 
 21 CFR Part 56 Institutional Review Boards 
The following documents were referenced for the development of this study protocol:  
 US FDA/CDRH. Premarket Notification [510(k)] Guidance Document for Class II Daily 
Wear Contact Lenses 
 ISO 11980:2009(E) – Ophthalmic optics - contact lenses and contact lens care products - 
guidance for clinical investigations. 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
36 
 
Pursuant to the abbreviated Investigational Device Exemption (IDE) requirements under 21 
CFR 812.2, this is a non-significant risk daily wear contact lens investigation that requires 
approval by an institutional review board (IRB) prior to commencement. 
13. INFORMED CONSENT PROCESS 
 
Written informed consent will be obtained from all potential subjects prior to any study 
specific procedures. The study will be explained to the prospective subject by the 
investigator, sub-investigator, or designated study staff.  The nature if the investigational 
device will be explained together with the potential hazards, including any possible adverse 
events. If s/he agrees to participate, the subject will sign and date the informed consent form.  
The investigator will also sign and date the consent form.  The original informed consent 
form will be retained with the subject records and a copy will be provided to the subject.  An 
Affidavit of Informed Consent will be completed as part of the baseline electronic case report 
form to document that consent was obtained.  Refer to Section 6.4.2 for a description of the 
aspects of the informed consent process that may be conducted remotely at the discretion of 
the investigator and potential subject. 
 
In no circumstance will the subject be exposed to the investigational device or study products 
prior to signing the Informed Consent Form and passing the screening inclusion/exclusion 
criteria. 
 
This clinical investigation does not involve emergency treatments and informed consent will 
not be accepted through a legally authorized representative. 
 
14. ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES 
 
Throughout the course of the proposed study, all efforts will be made to remain alert to possible 
adverse reactions or untoward findings.  If adverse reactions occur, the first concern will be 
the safety and welfare of the subject and appropriate medical intervention will be made.  Any 
adverse reactions or complications observed by the investigator or reported by the subjects will 
be recorded in the appropriate section of the subject’s Case Report Form. 
 
Any serious adverse event and/or severe, sight-threatening adverse event will be promptly 
communicated by telephone to CRO, the Medical Monitor, and to the IRB. These reports must 
be confirmed in writing within five (5) working days of the occurrence.   
 
Any subjects who are terminated from the study due to adverse events will be followed until 
their medical outcome is determined and the Investigator will provide written reports to CRO 
as appropriate. 
 
Definition and Classification of Adverse Events: 
 
Definition and classification of adverse reactions in this study will follow the requirements 
outlined in US FDA/CDRH Guidance Document for Class II Daily Wear Contact Lenses. 
(1994) Parts 3 and 4 Clinical Section -Appendix B and C page 45-96, and  ISO 11980:2009 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
37 
 
Ophthalmic optics -- Contact lenses and contact lens care products -- Guidance for clinical 
investigations. 
 
Adverse Reaction: Considered to include but not limited to a hazardous, sight threatening 
condition such as corneal ulcers, severe corneal abrasion > 2mm in diameter, iritis, other ocular 
infections or inflammations, corneal scarring or permanent loss of vision 
 
Slit Lam Finding (SLF) Requiring Treatment: Any slit lamp finding in any examination, 
scheduled or unscheduled that requires treatment including temporary discontinuation of lens 
wear, to maintain normal ocular health.  This does not include SLFs that are corrected by 
refitting of lenses without discontinuation of wear or by retraining patients in proper lens care. 
 
Symptom, Problem or Complaint (SPC) Requiring Treatment: Any symptom, problem or 
complaint that requires treatment including temporary discontinuation of lens wear, to 
maintain normal ocular health.  This does not include SPCs that are corrected by refitting of 
lenses without discontinuation of wear or by retraining patients in proper lens care. 
 
In general, an ‘adverse event’ refers to any undesirable clinical occurrence in a subject, whether 
it is considered to be device-related or not. Adverse events (AE) may be classified as ‘serious 
adverse events’ or ‘significant adverse events’ as defined below. 
Classification 
Definition and condition 
Reporting 
Serious Adverse 
Events 
Serious AEs are those events that result in, or have potential to cause, either permanent 
impairment of an ocular function or damage to an ocular structure, and may 
necessitate medical or surgical intervention.  
Serious AEs may include any hazardous, sight-threatening conditions occurring after 
exposure to test article, including but not limited to the following.  
a) A presumed infectious ulcer (defined as a progressive erosion of the corneal tissue). 
Signs may include irregular focal infiltrates (> 1 mm); active lesions with raised 
edges; significant diffuse infiltration; anterior corneal to mid-stromal involvement; 
erosion with overlying staining; conjunctival and lid edema; anterior chamber reaction 
(iritis); severe bulbar and limbal redness. Symptoms associated with a presumed 
infectious ulcer (microbial keratitis) may include pain of rapid onset; severe redness; 
purulent or mucopurulent discharge; tearing; photophobia. For the purposes of 
reporting, a corneal ulcer which has any of the following characteristics should be 
considered in this category:  
1) central or paracentral location;  
2) penetration of Bowman’s membrane;  
3) infiltrate > 2 mm diameter;  
4) associated with iritis ≥ grade 2;  
5) associated with any increase in intraocular pressure;  
6) culture positive for microorganisms;  
7) increasing size or severity at subsequent visits.  
b) Any central or paracentral corneal event (such as vascularization) that results in 
permanent opacification.  
c) Any serious adverse ophthalmic events including hypopyon and hyphema.  
d) Any neovascularization within the central 6 mm of the cornea.  
e) The loss of two or more lines of visual acuity that fail to resolve.  
f) All cases of iritis. 
Notify sponsor 
as soon as 
possible, within 
24 hrs; IRB and 
FDA reporting 
as per 
requirements 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
38 
 
Significant but 
non-serious 
adverse events 
Significant but non-serious AEs should include, but not be limited to: 
— peripheral non-progressive non-infectious ulcers;  
— all symptomatic corneal infiltrative events;  
— all cases of corneal staining greater than or equal to grade 3;  
— a temporary loss of two or more lines of best corrected visual acuity (for greater 
than or equal to 2 weeks);  
— cases greater than or equal to grade 2 neovascularization;  
— any ocular event that necessitates temporary lens discontinuation of greater than or 
equal to 2 weeks; 
— lens adhesion or lens binding to the cornea; 
— significantly distorted corneal topography (significant distortion of keratometry 
mires or aberrant findings in corneal topography); 
— any ocular AE that requires the practitioner’s intervention, including medication 
(not including minimal lubrication).   
Notify sponsor 
as soon as 
possible, within 
5 working days; 
IRB and FDA 
reporting as per 
requirements 
Unanticipated 
Adverse Device 
Effect 
Unanticipated adverse device effect means any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, a device, 
if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects. 
Notify sponsor 
immediately; 
IRB and FDA 
reporting as per 
requirements 
 
 
Procedures for Handling Adverse Events: 
 
Treatment of an adverse event will depend on its nature and severity. Based on the clinical 
judgment of the investigator, the subject may be referred to a pre-designated ophthalmologist 
for treatment. The investigator will attempt to determine whether the reaction is related to the 
contact lenses or a result of other factors. An Adverse Event Form will be completed for each 
adverse event. If both eyes are involved, each eye will be counted as one adverse event and 
Adverse Event information will be completed for each eye. Whenever possible, the adverse 
event will be photo-documented. 
 
In any case of a corneal infiltrate with overlying full thickness epithelial loss, or in any case of 
presumed corneal keratitis a culture will be taken in accordance with the procedures identified 
in Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact 
Lenses, which may be referenced in Appendix 4 of this protocol. The investigator will 
immediately (same business day) report cases that require culturing to the Medical Monitor 
and CRO.   
 
Expenses incurred for medical treatment as part of study participation will be paid by the 
sponsor (bills and prescription receipts kept). The subject must be followed until resolution 
and a written report completed indicating the subsequent treatment and resolution of the 
condition. 
 
Procedures for Reporting Adverse Events: 
 
All serious and Unanticipated Adverse Device Effects that are related or possibly related to 
participation will be reported to the Principal Investigator and the sponsor within 24 hours of 
the investigator becoming aware of the event. The Principal Investigator will report the event 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
39 
 
to the Institutional Review Board (IRB) as soon as possible, but in no event later than 10 
working days after the investigator first learns of the event (21 CFR 812.150(a)(1)). All fatal 
or life-threatening events will be reported immediately to the IRB. 
 
The CRO/Sponsor will immediately conduct an evaluation of an UADE and will report the 
results of the evaluation to FDA, all reviewing IRBs, and participating investigators within 10 
working days after the sponsor first receives notice of the effect (21 CFR 812.46(b), 
812.150(b)(1)). 
 
All adverse events—including non-serious adverse events that are not related to the device—
will be documented and submitted by the investigator on the Adverse Event Form.  In the final 
clinical report for this study all adverse events, regardless of classification (i.e. non-device 
related, serious, significant, and non-significant), will be reported. 
 
Medical Monitor Responsibilities: 
 
The Medical Monitor will be a physician specializing in optometry or ophthalmology. To 
reduce study bias concerns, the Medical Monitor will not have any real or potential conflict of 
interest with the Sponsor, Study Investigator or participating Investigative site.  
 
The primary purpose of the Medical Monitor is to ensure an independent review all Serious 
Adverse Events (SAE), device-related Adverse Events and AE related to the safety endpoints. 
When reviewing SAE and device-related adverse events, the Medical Monitor will report the 
relationship between the AE and the study device and the study procedure. The results of all 
events reviewed by the Medical Monitor will be documented. 
 
The Medical Monitor will be Dr. Larry Rich, who is contracted by Andre Vision and Device 
Research for this activity. 
 
Device Deficiencies: 
 
A device deficiency is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance.  All device deficiencies related to the identity, 
quality, durability, reliability, safety or performance of an investigational medical device is 
documented throughout the clinical investigation on the Device Deficiency Form (eCRF).  All 
device deficiencies will be reviewed by the Clinical Monitor.  If it is determined by the Clinical 
Monitor and Medical Monitor that the deficiency could have led to a serious adverse device 
effect, the event will be reported to the IRB as soon as possible, but in no event later than 10 
working days after the investigator first learns of the event. 
 
15. VULNERABLE POPULATION 
 
No vulnerable populations will be included in this investigation. 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
40 
 
16. SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL 
INVESTIGATION 
 
The Sponsor, the IRB or the governing regulatory agency can suspend or terminate the study 
prior to completion for reasons of safety or failure of the product to demonstrate efficacy. 
 
If the decision is made to discontinue the study, the site will be notified to perform a final study 
examination and complete study exit forms and documentation. 
 
17. PUBLICATION POLICY 
 
The investigational site participating in the study may not report on the study results until the 
study has been completed and all data verified.  The Sponsor reserves the right to review and 
comment on any presentation, publication or other written or oral communication prior to 
publication or presentation. 
 
Confidentiality Statement: 
 
This study is confidential in nature.  All information gathered during this study is proprietary 
and should be made available only to those directly involved in the study, when necessary.   
 
Authorized recipients of these data include: 
 Investigator and sub-investigator(s) 
 Other allied health care personnel necessary for the conduct of the study 
 Institutional Review Board personnel 
 CRO (Sponsor) 
 Designated Study Monitor 
 FDA or other government regulatory agencies 
 
All above personnel who are provided with data concerning this study will be informed of its 
confidential and proprietary nature.   
 
Release of this data (through presentation, publication or other written or oral communication) 
to other than the above listed personnel requires the prior written permission from the study 
Sponsor.  Study investigators and all office personnel are prohibited from acknowledging 
participation in the study to individuals and organizations except those listed above.  This 
includes sales representatives and other departments and/or subsidiaries of the parent company 
of the Sponsor without direct written permission of the Sponsor. 
 
 
18. BIBLIOGRAPHY 
 
[none] 
 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
41 
 
 
 
 
 
Appendix 1 
Clinical Sites and Investigators List 
 
Site 
Address 
Principal Investigators 
#1 – State University of 
New York (SUNY) 
35 State Street, Albany, New 
York 12207 
Dr. Azinda Morrow 
#2 – The Ohio State 
University (tOSU) 
338 West 10th Avenue, 
Columbus, OH 43210 
Dr. Jennifer Fogt 
#3 – Ala Moana Advanced 
Eye Clinic 
1441 Kapiolani Blvd Ste 2005, 
Honolulu, HI 96814 
Dr. Randall Sakamoto 
 
 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
42 
 
Appendix 2 – Methods of Measurements 
Subjective Distance Refractions 
 
The manifest subjective refraction will be performed at all study visits using phoropter. 
Wavefront/retinoscopy/autorefraction result can be used as a starting point for subjective 
refraction.  It is essential that a standard procedure be used to obtain manifest refraction. 
 
Visual Acuity Measurement 
 
It is essential that a standard procedure be used to obtain visual acuity measurements at all study 
visits. Visual Acuity will be measured using distance high contrast ETDRS charts under high 
illumination and recorded in LogMAR.  For the final report, data will be presented in both in 
LogMAR and 20/XX grouping as per guidance document. 
 
Visual Acuity with Spectacle Refraction –  
- Best Corrected Visual Acuity (BCVA)will be performed with manifest spherical-cylinder 
refraction by the Investigator. High contrast ETDRS VA chart with phoropter will be used for 
this procedure.   
- Visual Acuity with Best Sphere Refraction – Testing will be done with High contrast ETDRS 
VA chart and phoropter.   
 
 
Visual Acuity with Study Lenses – Testing should be done one eye at a time, starting with the 
right eye first, then the left eye with and without over-refraction.  
 
Slit Lamp Examination – Ocular 
 
Slit lamp examination will be performed at all study visits.  Use diffuse illumination to start with 
followed by direct illumination using either optic section or parallel piped as required. 
For corneal evaluation, the assessment will be done without contact lenses. 
Edema 
Edema will be recorded on a 5-point scale as follows: 
i. 
Epithelial Edema 
0 = none 
No epithelial or sub-epithelial haziness. Normal transparency 
1 = trace 
Barely discernible localized epithelial or subepithelial 
haziness 
2 = mild 
Faint but definite localized or generalized haziness 
3 = moderate 
Significant localized or generalized haziness 
4 = severe 
Definite widespread, epithelial cloudiness giving dull glass 
appearance to cornea, or numerous coalescent bullae (note 
the number and location of bullae)  

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
43 
 
   
ii. 
Epithelial Microcysts 
0 = none 
No microcysts 
1 = trace 
1 to 20 microcysts 
2 = mild 
21 to 50 microcysts 
3 = moderate 
51 to 100 microcysts 
4 = severe 
> 100 microcysts or bullae 
                 
Note for the presence/absence of fluid-filled or debris-filled cysts 
______________________________________________________________
______________________________________________________________ 
 numbers:____________   location:______________ 
 
iii. 
Stromal Edema 
0 = none 
No stromal cloudiness. Normal transparency 
1 = trace 
Barely discernible localized stromal cloudiness 
2 = mild 
Faint but definite localized or generalized stromal cloudiness, 
2 or fewer corneal striae 
3 = moderate 
Significant localized or generalized stromal cloudiness,  
3 pronounced corneal striae  
4 = severe 
Definite widespread, stromal cloudiness, folds in 
Descement’s membrane and ≥ 4 pronounced striae 
Corneal Infiltrates 
The severity of corneal infiltrates will be recorded on a 5-point scale as follows: 
 
Corneal Infiltrates Severity Grading Scale 
0 = none 
no infiltrates 
1 = trace 
single or multiple epithelial infiltrates < 1 mm in diameter 
2 = mild 
Single or multiple epithelial infiltrates ≥ 1 mm and < 2 mm in 
diameter 
3 = moderate 
Multiple infiltrates ≥ 2 mm and < 3 mm in diameter 
4 = severe 
Multiple dense infiltrates ≥ 3 mm in diameter 
 
Outcomes Classification for Corneal Infiltrates will be recorded on a 5-point level as follows: 
Corneal Infiltrates Classification Level 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
44 
 
Level 1 
High probability of microbial keratitis attributed to contact 
lens wear with loss of vision and/or surgical intervention 
attributed to event 
Level 2 
High probability of microbial keratitis attributed to contact 
lens wear without loss of vision or surgical intervention 
attributed to event 
Level 3 
High probability of infiltrative keratitis of indeterminate 
etiology attributed to contact lens wear without loss of vision 
or surgical intervention attributed to event 
Level 4 
High probability of sterile infiltrative keratitis attributed to 
contact lens wear without loss of vision or surgical 
intervention attributed to event 
Level 5 
High probability of infiltrative keratitis not attributed to 
contact lens wear 
Definitions for classification 
Loss of vision 
Defined as loss of 2 lines of corrected acuity in affected eye. 
Change in best spectacle-corrected visual acuity will be used 
for affected eyes having this data available at baseline and 
follow-up. Change from baseline to final soft contact lens-
corrected acuity will be used if spectacle-corrected data 
unavailable. 
Surgical 
intervention 
Defined as any laser or incisional technique used to restore 
vision or prevent additional complications or any application 
of tissue adhesive to treat impending/actual perforation of the 
cornea. 
High 
probability of 
microbial 
keratitis 
One or more corneal stromal infiltrates greater than 1mm in 
size with pain more than mild and one or more of following: 
anterior chamber reaction more than minimal; mucopurulent 
discharge; positive corneal culture. The presence of a 
subsequent corneal scar is a requirement in cases in which 
adequate follow-up data and medical records are available.  
High 
probability of 
infiltrative 
keratitis of 
indeterminate 
etiology 
One or more corneal stromal infiltrates accompanied by 
signs/symptoms not clearly meeting criteria for the sterile or 
microbial groups.  

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
45 
 
High 
probability of 
sterile 
infiltrative 
keratitis 
One or more corneal stromal infiltrates the largest of which is 
1mm or less in size, and all of the following: outside central 
6mm; minimal or no anterior chamber reaction, no 
mucopurulent discharge; mild or no pain.   
 
The location of infiltrates observed should be recorded in source documents as indicated in 
Figure 5-1, using numbers for corneal quadrants. Depth of corneal infiltrates should be 
abbreviated as follows: 
E = epithelial, AS = anterior stromal, P = mid/posterior stromal 
In addition, the “Infiltrates” form in electronic data capture (EDC) system should be completed 
including: 
• Eye  
(OD, OS) 
• Location  
(Central, Peripheral) 
• If peripheral, location of infiltrates (superior, inferior, nasal, temporal) 
• Type  
(focal, diffuse) 
• Depth of largest infiltrate  (epithelial, anterior stromal, mid/posterior stromal) 
• Number of infiltrates 
• Size of the largest infiltrate  (in mm) 
 
 
 
 
 
 
 
 
Corneal Zones to be used for Recording Location 
                 
 
Corneal Vascularization 
Maximal corneal vascularization will be recorded on a 5-point scale as follows: 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
46 
 
 
Corneal Vascularization Grading Scale 
0 = none 
no vessel penetration 
1 = trace 
<1.00 mm vessel penetration 
2 = mild 
W 1.00 mm to u 1.5 mm vessel penetration 
3 = moderate 
 > 1.5 mm to u 2.00 mm vessel penetration 
4 = severe 
Vessel penetration> 2.00 mm  
 
Indicate location: 
 
Nasal (N), Inferior (I), C (Circumferential), T (Temporal), S (superior) X Other (describe) 
 
Corneal staining 
 
Set the slit-lamp’s cobalt blue light to full intensity and magnification at 16X. 
 
Epithelial integrity will be monitored using a single instillation of fluorescein: one drop of 1% 
sodium fluorescein or fluorescein sterile strip hydrated with unpreserved normal saline. 
 
Staining will be recorded topographically, the cornea being divided into one central (diameter 
6mm) and four peripheral zones (nasal, temporal, inferior and superior). The nature of the 
staining will be recorded for its severity and depth for each zone as follows 
 
Corneal Extent Staining Severity 
 
0 = none 
no staining 
1 = trace 
Minimal superficial staining or stippling 
a. dimpling, discrete dot staining, or 
b. trace superficial lens insertion marks or foreign body 
tracks 
2 = mild 
Regional or diffuse punctate staining  
a. Central or generalized or 
b. Peripheral including 3-9 o’clock staining or 
c. Mild abrasion or foreign body tracks 
3 = moderate 
Dense coalesced staining up to 2 mm in diameter 
      a. corneal abrasion, or  
      b. foreign body track  
4 = severe 
Severe abrasion greater than 2mm, ulcerations, epithelial 
loss, or full thickness abrasion.   
 
Depth 
0 
= 
None 
1 
= 
Superficial 
2  
= 
Full epithelial 
3 
= 
Stromal 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
47 
 
 
Bulbar Redness 
Bulbar redness (hyperemia) will be recorded on a 5-point scale as follows: 
Bulbar Redness Grading Scale 
0 = none 
no hyperemia 
1 = trace 
slight regional hyperemia 
2 = mild 
diffuse hyperemia 
3 = moderate 
marked regional or diffuse hyperemia 
4 = severe 
diffuse episcleral or scleral hyperemia 
 
Limbal Redness  
Limbal redness (hyperemia) will be recorded on a 5-point scale as follows: 
Limbal Redness Grading Scale 
0 = none 
no hyperemia 
1 = trace 
slight limbal hyperemia (mild segmented)  
2 = mild 
mild limbal hyperemia (mild circumcorneal) 
3 = moderate 
significant limbal hyperemia (marked segmented) 
4 = severe 
severe limbal hyperemia (marked circumcorneal) 
Palpebral Conjunctival Observations (Upper and Lower) 
The severity and maximal palpebral conjunctival response will be recorded on a 5-point scale as 
follows: 
Palpebral Conjunctival Observations Grading Scale 
0 = none 
uniform satin appearance of the conjunctiva 
1 = trace 
slight conjunctival injection without texture 
2 = mild 
mild or scattered papillae/follicles less than 1 mm in diameter 
3 = moderate 
a) significant papillae/follicles less than 1mm in diameter, 
and/or marked conjunctival injection 
b) staining of the top of 1 papilla 
4 = severe 
a) localized or generalized papillae/follicles 1 mm or more 
in diameter 
b) staining of the top of more than 1 papilla 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
48 
 
 
 
 
 
 
 
 
 
Other Complications/Findings 
Other findings (ie, giant papillary conjunctivitis, vascularization, pinguecula) will be recorded on 
a 5-point scale as follows: 
Other Findings Grading Scale 
0 = none 
no other significant biomicroscopic findings 
1 = trace 
minimal findings such as a tear film abnormality (debris of 
low tear break up time) 
2 = mild 
mild findings such as:  
lens adhesion 
3 = moderate 
significant findings 
a. iritis with minimal cells or flare  
b.conjunctivitis or EKC 
4 = severe 
severe findings such as:  
a. iritis with marked cells and/or flare  
b. corneal or conjunctival infection  
c. corneal ulcer  
d. recurrent erosion 
 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
49 
 
Slit Lamp Examination – Contact Lens 
Lens wettability 
Front lens surface evaluation of wettability will be assessed at all visits.  A slit-lamp must be 
used with maximum illumination, a diffuser, and magnification of X16. 
The front lens surface wettability will be graded as follows: 
Front Lens Wettability Grading Scale 
0  
A smooth uniformly reflecting wettable surface. 
1 
A coarse hazy wettable surface which seems resolved momentarily 
with each blink and becomes exacerbated with staring. 
2 
One stable dry (non-wetting) area of some magnitude. 
3 
More than 1 stable dry (non-wetting) area of some magnitude. 
4 
Non-wettable lens surface of severe magnitude. 
 
Lens front surface deposits 
Lens surface deposits will be assessed at all visits.  A slit-lamp must be used with maximum 
illumination, a diffuser, and low magnification. 
The front lens surface deposits will be graded as follows: 
Front Lens Deposits Grading Scale 
0  
None 
1 
Trace 
2 
Mild 
3 
Moderate 
4 
Severe 
 
Lens back surface deposits 
Lens surface deposits will be assessed at all visits.  A slit-lamp must be used with maximum 
illumination, a diffuser, and low magnification. 
The lens back surface deposits will be graded as follows: 
Back Lens Deposits Grading Scale 
0  
Absent, clean surface 
1 
Very slight, 3 spots or less of moving particles 
2 
Slight, up to 10 spots of moving particles 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
50 
 
3 
Moderate, 3 or less non-moving deposits adherent to lens 
4 
Severe, 4 or more deposits adherent to the lens and/or corneal 
indentation 
 
Lens fit assessment 
Lens fitting characteristics will be assessed with the lens on-eye and utilizing the biomicroscope 
with low magnification (X10 to X16) and white light with a diffuser. Lens centration and overall 
lens fit/movement will be assessed at all visits. 
Lens centration 
Using a slit lamp with white light, a diffuse and/or broad beam and low-medium magnification, 
the lens centration of the right and left contact lenses should be evaluated with the eye in the 
primary position (relaxed, looking straight ahead) and assessed as follows: 
Lens Centration Grading Scale 
0  
Optimal lens centration 
1 
Acceptable decentration 
2 
Unacceptable decentration 
3 
Corneal exposure 
 
Overall lens fit / movement 
Using a slit lamp with white light, a diffuse and/or broad beam and low-medium magnification, 
the movement of the right and left contact lenses should be evaluated a) immediately after the 
blink with the eye in the primary position and if necessary b) recovery following digitally 
applied lower lid margin push-up with the lower lid and then fit assessed as follows: 
 
Overall Lens Fit / Movement Grading Scale 
-2 
Unacceptably tight (reduced movement, unacceptable) 
-1 
Acceptably tight (reduced movement, acceptable) 
0 
Optimal fit / movement 
+1 
Acceptable loose (excessive movement, acceptable) 
+2 
Unacceptable loose (excessive movement, unacceptable) 
Note: +2 and -2 are NOT acceptable for study eligibility. 
 
Keratometry Reading 
Corneal curvature measurement using a standard keratometer will be performed at all visits.  It is 
essential that best alignment is achieved prior to taking the measurement and the subject opens the 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
51 
 
eye as wide as possible.  The methodology recommended by the manufacturer will be used.  When 
possible the same operator/technician should use the same equipment at all visits to obtain 
consistent readings. This measurement will provide corneal curvature measurements.  Steep and 
Flat K readings and axis will be recorded.  Readings for this study are required in Diopter (D) for 
all visits and additionally in mm at baseline visit for contact lens base curve parameter. 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
52 
 
 
 
 
Appendix 3 
Case Report Forms 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
53 
 
 
 
 
 
 
 
 
Screening/Enrolment/Baseline/Lens Dispense 
 Visit Case Report Form 
 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
54 
 
Screening/Enrolment/Baseline/Lens Dispense Visit Form 
 
Subject ID: ________________________ 
       Date: _____/______/__________ (MM/DD/ YYYY) 
Collection Start Time: ______:______ (HH:MM, 24h) 
 
Principal Investigator:____________________  
Clinical Investigator: _____________________ 
 
 
 
Subject Sex:  □ Male   □ Female   
 
 
Subject Age: ___________ 
 
Subject Ethnicity:  
Do you consider yourself Hispanic/Latino or not Hispanic/Latino (select single best answer)? 
□ Hispanic/Latino    
 □ not Hispanic/Latino 
Subject Race: 
Which of the following five racial designations best describes you (select all that applies)?  
 
□ American Indian or Alaska Native  
 
□ Asian (add specific location of asia) 
 
□ Black or African American 
 
 
□ White 
 
□ Native Hawaiian or Other Pacific Islander  
 
 
Signed Inform Consent Collected:  □ Yes   □ No 
 
 
 
 
 
 
 
 
 
 
Medical/Ocular Tab 
Medical and Ocular history 
 
a. Medical history (include pregnancy and lactation) 
Record clinically significant medical history if occurred within the last 2 years and any ongoing 
disease/conditions 
 □ None  
Condition 
Date Started 
(MM/DD/YYYY) 
Date Stopped 
(MM/DD/YYYY) 
Ongoing 
 
 
 
Yes / No 
 
 
 
Yes / No 
 
 
 
Yes / No 
 
b. Ocular history  
Record clinically significant ocular history if occurred within the last 2 years and any ongoing ocular 
disease/conditions 
□ None  
Condition 
Eye 
Date Started 
(MM/DD/YYYY) 
Date Stopped 
(MM/DD/YYYY) 
Ongoing 
 
OD  / OS  / OU 
 
 
Yes / No 
 
OD  / OS  / OU 
 
 
Yes / No 
 
OD  / OS  / OU 
 
 
Yes / No 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
55 
 
c. Concomitant Medication 
List all systemic and ocular medication used within the past 30 days (include all over the counter and 
prescription medications) 
□ None  
Medicatio
n name 
Dos
e 
Route 
Freq 
Condition 
Eye 
Date Started 
MM/DD/YYYY 
Date Stopped 
MM/DD/YYYY 
Continui
ng 
 
 
☐po 
☐SC 
☐IM 
☐IV 
☐topical 
☐other 
_______ 
☐ qd 
☐ bid 
☐ tid 
☐ qid 
☐ prn 
☐other 
______ 
 
NA 
OD  
OS  
OU 
 
 
Yes / No 
 
 
☐po 
☐SC 
☐IM 
☐IV 
☐topical 
☐other 
_______ 
☐ qd 
☐ bid 
☐ tid 
☐ qid 
☐ prn 
☐other 
______ 
 
NA 
OD  
OS  
OU 
 
 
Yes / No 
 
 
☐po 
☐SC 
☐IM 
☐IV 
☐topical 
☐other 
_______ 
☐ qd 
☐ bid 
☐ tid 
☐ qid 
☐ prn 
☐other 
______ 
 
NA 
OD  
OS  
OU 
 
 
Yes / No 
 
 
 
 
 
 
 
 
Most Recent Contact Lens Wearing Experience 
□ Previous experience unknown 
 
 
□ No prior lens experience  
 
□ New wearer (less than 2 months wear)  
 
□ Lens wearer of 2 months or greater 
 
Was the most recent contact lens wearing experience successful? 
 
□ Yes, Successful        
 
 
□ No, Unsuccessful (describe why uncussessful________________________) 
 
 
Most Recent Primary Contact Lens Type:  
□ Rigid lens  
 
□ Hydrogel lens 
□ Silicone hydrogel lens  
 
 
 
 
□ Other (if other, describe_________________) 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
56 
 
Most Recent Contact Lens Modality,  
□ daily wear 
 □ extended wear  
 
 
Recent Lens Care Solution System: ______________________________________  
 
 
 
 
 
□ no use  
□ unknown 
Recent Rewetting Drops: _______________________________________ 
 
 
 
 
 
□ no use  
□ unknown 
 
Average and Comfortable Wear Time 
1) At what time of day do you usually insert your habitual contact lenses?  
□  NO DATA 
 
___________ 
(HH:MM, 24h) 
2) At what time of day do you usually remove your habitual contact lenses? 
□  NO DATA 
 
___________ 
(HH:MM, 24h) 
3) Are contact lenses comfortable all day long?   
□ Yes  □ No 
 
□  NO DATA 
    If No, at what time of day do your habitual contact lenses usually begin to feel uncomfortable? 
     
 
□  NO DATA     ___________ 
(HH:MM, 24h)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Questionnaires Tab 
Comfort, Vision and Handling Questionnaires    
 
1) Comfort 
a. Rate the overall comfort at insertion when you wear your habitual correction last 7 days: 
                
 
Right eye: 0 / 1 / 2 / 3 / 4 / 5 
 
Left eye: 0 / 1 / 2 / 3 / 4 / 5 
5 
Excellent, cannot be felt 
4 
Very comfortable, just felt occasionally 
3 
Comfortable, noticeable but not irritating 
2 
Slightly uncomfortable, just irritating or annoying 
1 
Very uncomfortable, very irritating or annoying 
0 
Cause pain, lens cannot be tolerated 
             
b. Rate the overall comfort during the day while you wear your habitual correction last 7 days: 
                
 
Right eye: 0 / 1 / 2 / 3 / 4 / 5 
 
Left eye: 0 / 1 / 2 / 3 / 4 / 5 
5 
Excellent, cannot be felt 
4 
Very comfortable, just felt occasionally 
3 
Comfortable, noticeable but not irritating 
2 
Slightly uncomfortable, just irritating or annoying 
1 
Very uncomfortable, very irritating or annoying 
0 
Cause pain, lens cannot be tolerated 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
57 
 
 
c. Rate the overall comfort at the end of wearing when you wear your habitual correction last 
7 days:   
Right eye: 0 / 1 / 2 / 3 / 4 / 5 
 
Left eye: 0 / 1 / 2 / 3 / 4 / 5 
5 
Excellent, cannot be felt 
4 
Very comfortable, just felt occasionally 
3 
Comfortable, noticeable but not irritating 
2 
Slightly uncomfortable, just irritating or annoying 
1 
Very uncomfortable, very irritating or annoying 
0 
Cause pain, lens cannot be tolerated 
    
 
2) Vision 
a. Rate your overall vision during the day when you wear your habitual correction last 7 days: 
 
 
 
Right eye: 0 / 1 / 2 / 3 / 4 / 5 
 
Left eye: 0 / 1 / 2 / 3 / 4 / 5 
5 
Excellent, cannot notice any visual loss 
4 
Very good, just noticeable and very occasional reduction 
3 
Good, occasional noticeable but acceptable reduction  
2 
Poor, noticeable but acceptable reduction 
1 
Very poor, marked and unacceptable reduction 
0 
Unacceptable, lens cannot be worn 
 
b. Rate your satisfaction with vision during the day when you wear your habitual correction 
last 7 days: 
Right eye: 0 / 1 / 2 / 3 / 4 / 5 
 
Left eye: 0 / 1 / 2 / 3 / 4 / 5 
5 
Excellent 
4 
Very good 
3 
Good  
2 
Poor 
1 
Very poor  
0 
Unacceptable 
 
3) Handling 
a. Rate your overall handling of your habitual contact lenses: 
 
 
 
Right eye: 0 / 1 / 2 / 3 / 4 / 5 
 
Left eye: 0 / 1 / 2 / 3 / 4 / 5 
5 
Excellent 
4 
Very good 
3 
Good  
2 
Poor 
1 
Very poor  
0 
Unacceptable 
 
 
 
 
 
 
 
 
Symptoms Questionnaire   
How often do your eyes experience the following symptoms during the day when your wear 
your habitual correction last 7 days?  
 
 
 
 
 
 
 
  

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
58 
 
 
Presence 
Eye 
If yes, please select the 
frequency 
If yes, please select 
the severity level 
Discomfort 
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Excess Tearing  
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Sensitivity to 
light  
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Glare  
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Halos  
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Itching  
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Burning  
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Blurred Vision  
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Variability of 
Vision  
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Lens Needs 
cleaning 
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Other (describe) 
 
 
 
 
 
 
 
 
 
VA / Refraction / Keratometry Tab 
Sphero-cylindrical Manifest Refraction and Best Corrected Visual Acuity  
 
 
Sphero-cylindrical Manifest Refraction 
Sphero-cylindrical VA 
(BCVA) 
Sph (D) 
Cyl (D) 
Axis (°) 
LogMar 
OD 
 
(-)  
 
 
OS 
 
(-)  
 
 
OU 
n/a 
n/a 
n/a 
 
 
Best Sphere Refraction and Visual Acuity 
 
Best Sphere Refraction 
Best Sphere VA 
Sph (D) 
LogMar 
OD 
 
 
OS 
 
  
OU 
n/a 
 
 
Keratometry  
 
K readings 
Corneal Cylinder 
 
Flat (D) 
Steep (D) 
Meridian of 
Steep Power 
Cyl (D) 
Axis (°) 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
59 
 
OD 
 
 
 
(-)  
 
OS 
 
 
 
(-)  
 
 
 
Slit Lamp Tab 
Slit Lamp Findings- Ocular (Biomicroscopy)              
                                                            
a. Bulbar Conjunctival hyperaemia : Record severity of bulbar hyperemia(redness) on a 5-point scale. 
 
OD: 0 / 1 / 2 / 3 / 4  
 
 
OS: 0 / 1 / 2 / 3 / 4                       
0 = none 
no hyperemia 
1 = trace 
slight regional hyperemia 
2 = mild 
diffuse hyperemia 
3 = moderate 
marked regional or diffuse hyperemia 
4 = severe 
diffuse episcleral or scleral hyperemia 
 
b. Limbal Hyperaemia: Record the severity of limbal redness (hyperemia) on a 5-point scale. 
OD: 0 / 1 / 2 / 3 / 4  
 
 
OS: 0 / 1 / 2 / 3 / 4                       
0 = none 
no hyperemia 
1 = trace 
slight limbal hyperemia (mild segmented)  
2 = mild 
mild limbal hyperemia (mild circumcorneal) 
3 = moderate 
significant limbal hyperemia (marked segmented) 
4 = severe 
severe limbal hyperemia (marked circumcorneal) 
 
c. Palpebral Conjunctival Observations (upper and lower) 
Record the severity of the palpebral conjunctival on a 5-point scale on each locations.  
  
  
 
Severity 
Eye 
Location 
Severity* 
Eye 
Location 
Severity* 
 OD 
  
  
  
  
Upper lid-S (1) 
0 / 1 / 2 / 3 / 4 
 OS 
Upper lid-S (1) 
0 / 1 / 2 / 3 / 4 
Upper lid-C (2) 
0 / 1 / 2 / 3 / 4 
Upper lid-C (2) 
0 / 1 / 2 / 3 / 4 
Upper lid-I (3) 
0 / 1 / 2 / 3 / 4 
Upper lid-I (3) 
0 / 1 / 2 / 3 / 4 
Upper lid-N (4) 
0 / 1 / 2 / 3 / 4 
Upper lid-N (4) 
0 / 1 / 2 / 3 / 4 
Upper lid-T (5) 
0 / 1 / 2 / 3 / 4 
Upper lid-T (5) 
0 / 1 / 2 / 3 / 4 
Lower lid-L (6) 
0 / 1 / 2 / 3 / 4 
Lower lid-L (6) 
0 / 1 / 2 / 3 / 4 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
60 
 
0 = none 
uniform satin appearance of the conjunctiva 
1 = trace 
slight conjunctival injection without texture 
2 = mild 
mild or scattered papillae/follicles less than 1 mm in diameter 
3 = moderate 
a) significant papillae/follicles less than 1mm in diameter, and/or marked conjunctival 
injection 
b) staining of the top of 1 papilla 
4 = severe 
a) localized or generalized papillae/follicles 1 mm or more in diameter 
b) staining of the top of more than 1 papilla 
 
d. Corneal Edema : Record the severity of the edema on a 5-pint scale. 
 
i. 
Epithelial Edema 
OD: 0 / 1 / 2 / 3 / 4  
 
 
OS: 0 / 1 / 2 / 3 / 4                       
0 = none 
No epithelial or sub-epithelial haziness. Normal transparency 
1 = trace 
Barely discernible localized epithelial or subepithelial haziness 
2 = mild 
Faint but definite localized or generalized haziness 
3 = moderate 
Significant localized or generalized haziness 
4 = severe 
Definite widespread, epithelial cloudiness giving dull glass appearance to cornea, or 
numerous coalescent bullae (note the number and location of bullae)  
 
ii. 
Epithelial Microcysts 
OD: 0 / 1 / 2 / 3 / 4  
 
 
OS: 0 / 1 / 2 / 3 / 4                       
0 = none 
No microcysts 
1 = trace 
1 to 20 microcysts 
2 = mild 
21 to 50 microcysts 
3 = moderate 
51 to 100 microcysts 
4 = severe 
> 100 microcysts or bullae 
      
Note for the presence/absence of fluid-filled or debris-filled cysts                  □  NO DATA  
____________________________________________________________________________ 
OD- numbers:____________   location:______________ 
OS- numbers:____________   location:______________ 
 
iii. 
Stromal Edema 
OD: 0 / 1 / 2 / 3 / 4  
 
 
OS: 0 / 1 / 2 / 3 / 4                       
0 = none 
No stromal cloudiness. Normal transparency 
1 = trace 
Barely discernible localized stromal cloudiness 
2 = mild 
Faint but definite localized or generalized stromal cloudiness,  
2 or fewer corneal striae 
3 = moderate 
Significant localized or generalized stromal cloudiness,  
3 pronounced corneal striae  
4 = severe 
Definite widespread, stromal cloudiness,  
folds in Descement’s membrane and ≥ 4 pronounced striae 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
61 
 
 
e. Corneal Vascularization 
Record the severity of Maximal corneal vascularization on a 5-point scale along with its depth and 
location.  
Eye 
Severity 
Depth 
Location 
Describe if other  
OD 
0 
None 
Nasal 
  
1 
Superficial 
Temporal 
  
  
2 
Stromal 
Inferior 
  
  
3 
Superior 
  
  
4 
Circumlimbal 
  
  
  
  
Other 
  
OS 
0 
None 
Nasal 
  
 
1 
Superficial 
Temporal 
  
  
2 
Stromal 
Inferior 
  
  
3 
 
Superior 
  
  
4 
 
Circumlimbal 
  
  
  
  
Other 
  
Severity 
0 = none 
no vessel penetration 
1 = trace 
 <1.00 mm vessel penetration 
2 = mild 
W 1.00 mm to u 1.5 mm vessel penetration 
3 = moderate 
> 1.5 mm to u 2.00 mm vessel penetration 
4 = severe 
vessel penetration > 2.00 mm  
 
f. Corneal staining  
Record the staining topographically, the cornea being divided into one central (diameter 6mm) and four 
peripheral zones (nasal, temporal, inferior and superior).  
Record the nature of the staining for its severity and depth for each zone. 
Eye 
Location 
Severity 
Depth 
Staining is associated with an 
underlying infiltrate? 
OD 
Central 
0 / 1 / 2 / 3 / 4 
0=None 
Yes 
 
1=Superficial 
No 
 
 
2 =Full epithelial 
 
 
 
3=Stromal 
 
 
Peripheral-Nasal 
0 / 1 / 2 / 3 / 4 
0 / 1 / 2 / 3 
Yes / No 
 
Peripheral-Temporal 
0 / 1 / 2 / 3 / 4 
0 / 1 / 2 / 3 
Yes / No 
 
Peripheral-Inferior 
0 / 1 / 2 / 3 / 4 
0 / 1 / 2 / 3 
Yes / No 
 
Peripheral-Superior 
0 / 1 / 2 / 3 / 4 
0 / 1 / 2 / 3 
Yes / No 
OS 
Central 
0 / 1 / 2 / 3 / 4 
0 / 1 / 2 / 3 
Yes / No 
 
Peripheral-Nasal 
0 / 1 / 2 / 3 / 4 
0 / 1 / 2 / 3 
Yes / No 
 
Peripheral-Temporal 
0 / 1 / 2 / 3 / 4 
0 / 1 / 2 / 3 
Yes / No 
 
Peripheral-Inferior 
0 / 1 / 2 / 3 / 4 
0 / 1 / 2 / 3 
Yes / No 
 
Peripheral-Superior 
0 / 1 / 2 / 3 / 4 
0 / 1 / 2 / 3 
Yes / No 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
62 
 
Severity 
0 = none 
no staining 
1 = trace 
Minimal superficial staining or punctate staining 
       a. dimpling, discrete dot staining, or 
      b. trace superficial lens insertion marks or foreign body tracks 
2 = mild 
Regional or diffuse punctate staining  
      a. central or generalized, or 
      b. peripheral including 3-9 o’clock staining, or 
    c. mild abrasion or foreign body tracks 
3 = moderate 
Dense coalesced staining up to 2 mm in diameter 
 a. corneal abrasion, or  
b. foreign body track 
4 = severe 
Dense coalescent staining greater 2mm in diameter, ulcerations, epithelial loss, or full 
thickness abrasion.  Diagram and explain on source document.  
 
g. Corneal Infiltrates 
Record the nature of the corneal infiltrates followed by locations, classification, severity, type, depth of 
infiltrate, number of infiltrates and size of the largest infiltrates.  
 
□ None 
E
y
e 
Location 
Classific
ation 
Severity 
Type 
Depth of 
infiltrate* 
Number 
of 
infiltrates 
Size of 
largest 
infiltrate(
mm)  
Vision 
affected? 
O
D 
n/a 
Central 
P-Superior 
P-Nasal 
P-Inferior 
P-Temporal
 
 
Level 1 
Level 2 
Level 3 
Level 4 
Level 5
 
 
0 
1 
2 
3 
4 
focus 
diffuse 
E 
AS  
P  
               
  
  
  
  
Yes 
No 
  
O
S 
  
n/a 
Central 
P-Superior 
P-Nasal 
P-Inferior 
P-Temporal
 
 
Level 1 
Level 2 
Level 3 
Level 4 
Level 5
 
 
0 
1 
2 
3 
4 
focus 
diffuse 
E 
AS  
P  
               
  
  
  
  
Yes 
No 
  
*E = epithelial, AS = anterior stromal, P = mid/posterior stromal 
Corneal Zones to be used for Recording Location 
    
                 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
63 
 
Outcomes Classification for Corneal Infiltrates  
Level 1 
High probability of microbial keratitis attributed to contact lens wear with loss of 
vision and/or surgical intervention attributed to event 
Level 2 
High probability of microbial keratitis attributed to contact lens wear without loss of 
vision or surgical intervention attributed to event 
Level 3 
High probability of infiltrative keratitis of indeterminate etiology attributed to contact 
lens wear without loss of vision or surgical intervention attributed to event 
Level 4 
High probability of sterile infiltrative keratitis attributed to contact lens wear without 
loss of vision or surgical intervention attributed to event 
Level 5 
High probability of infiltrative keratitis not attributed to contact lens wear 
Definitions for classification 
Loss of vision 
Defined as loss of 2 lines of corrected acuity in affected eye. Change in best spectacle-
corrected visual acuity will be used for affected eyes having this data available at 
baseline and follow-up. Change from baseline to final soft contact lens-corrected 
acuity will be used if spectacle-corrected data unavailable. 
Surgical intervention 
Defined as any laser or incisional technique used to restore vision or prevent 
additional complications or any application of tissue adhesive to treat 
impending/actual perforation of the cornea. 
High probability of 
microbial keratitis 
One or more corneal stromal infiltrates greater than 1mm in size with pain more than 
mild and one or more of following: anterior chamber reaction more than minimal; 
mucopurulent discharge; positive corneal culture. The presence of a subsequent 
corneal scar is a requirement in cases in which adequate follow-up data and medical 
records are available.  
High probability of 
infiltrative keratitis of 
indeterminate etiology 
One or more corneal stromal infiltrates accompanied by signs/symptoms not clearly 
meeting criteria for the sterile or microbial groups.  
High probability of 
sterile infiltrative 
keratitis 
One or more corneal stromal infiltrates the largest of which is 1mm or less in size, and 
all of the following: outside central 6mm; minimal or no anterior chamber reaction, no 
mucopurulent discharge; mild or no pain.   
 
Severity of corneal infiltrates on 5-point scale  
0 = none 
no infiltrates 
1 = trace 
single or multiple epithelial infiltrates < 1 mm in diameter 
2 = mild 
Single or multiple epithelial infiltrates ≥ 1 mm and < 2 mm in diameter 
3 = moderate 
Multiple infiltrates ≥ 2 mm and < 3 mm in diameter 
4 = severe 
Multiple dense infiltrates ≥ 3 mm in diameter 
 
a. Other complications/Findings 
Record other findings (ie, pinguecula) on a 5-point scale and its description. List all report. 
OD: 0 / 1 / 2 / 3 / 4  
 
 
OS: 0 / 1 / 2 / 3 / 4                       
NOTE 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
64 
 
0 = none 
no other significant biomicroscopic findings 
1 = trace 
minimal findings such as a tear film abnormality (debris of low tear break up time) 
2 = mild 
mild findings such as:  
lens adhesion 
3 = moderate 
significant findings 
c. iritis with minimal cells or flare  
d. conjunctivitis or EKC 
4 = severe 
severe findings such as:  
a. iritis with marked cells and/or flare  
b. corneal or conjunctival infection  
c. corneal ulcer  
d. recurrent erosion 
    
 
 
 
 
 
 
 
 
 
 
 
 
 
Is this subject eligible for the study participation?   
 
□ Yes  □ No 
(Fill out Paper “Inclusion & Exclusion Criterial Checklist”)  
 
 
If no, submit the form by signing on the last tab and fill out Exit Form.  
If yes, perform the rest of procedures. 
Dispense Tab  
Randomization Group:   
A / B /C / D 
Study Lens Type:  
 
Q / V 
Care Solution:   
 
B / C 
Dispense Contact Lens Rx 
 
 
 
Lens Lot #  
Rx-Sph (D) 
BC (mm) 
Diameter (mm) 
OD 
 
 
 
 
OS 
 
  
 
 
Note 
 
Insert the study Lens and wait for 5 minutes!    
Visual Acuity and Over-refraction with Dispensing Contact Lens 
 
 
VA with Dispensing Lens 
(logMar) 
Spherical Over-Refraction 
(D) 
VA with Over-Refraction 
(logMar) 
OD 
 
 
 
OS 
 
 
 
OU 
 
n/a 
n/a 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
65 
 
Lens Surface / Fitting Tab 
Slit Lamp Lens Surface/Fit Assessment 
a. Lens Front Surface Wettability 
OD: 0 / 1 / 2 / 3 / 4  
 
 
OS: 0 / 1 / 2 / 3 / 4                       
0  
A smooth uniformly reflecting wettable surface. 
1 
A coarse hazy wettable surface which seems resolved momentarily with each blink and becomes 
exacerbated with staring. 
2 
One stable dry (non-wetting) area of some magnitude. 
3 
More than 1 stable dry (non-wetting) area of some magnitude. 
4 
Non-wettable lens surface of severe magnitude. 
 
b. Lens Front Surface Deposits: Observe under low slit lamp magnification 
OD: 0 / 1 / 2 / 3 / 4  
 
 
OS: 0 / 1 / 2 / 3 / 4                       
0  
Absent, clean surface 
1 
Very slight, only visible after tear film drying 
2 
Slight, visible deposits easily removable 
3 
Moderate, deposits adherent and not removable 
4 
Severe, non-removable deposits and comfort affected 
 
c. Lens Back Surface Deposits: Observe under low slit lamp magnification 
 
OD: 0 / 1 / 2 / 3 / 4  
 
 
OS: 0 / 1 / 2 / 3 / 4                       
0  
Absent, clean surface 
1 
Very slight, 3 spots or less of moving particles 
2 
Slight, up to 10 spots of moving particles 
3 
Moderate, 3 or less non-moving deposits adherent to lens 
4 
Severe, 4 or more deposits adherent to the lens and/or corneal indentation 
 
d. Lens Centration 
OD: 0 / 1 / 2 
 
 
 
OS: 0 / 1 / 2  
Lens centration of the right and left contact lenses should be evaluated with the eye in the primary 
position (relaxed, looking straight ahead) and assessed as follows: 
0  
Optimal lens centration 
1 
Acceptable decentration 
2 
Unacceptable decentration 
 
e. Lens Overall Movement (after blink) 
 
 
OD: -2 / -1 / 0 / +1 / +2   
 
OS: -2 / -1 / 0 / +1 / +2      
 
    
 
Evaluate immediately after the blink with the eye in the primary position; 
-2 
Unacceptably tight (reduced movement, unacceptable) 
-1 
Acceptably tight (reduced movement, acceptable) 
0 
Optimal fit / movement 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
66 
 
+1 
Acceptable loose (excessive movement, acceptable) 
+2 
Unacceptable loose (excessive movement, unacceptable) 
 
End Tab 
Instruction for Use for Contact Lens and Care System? □ Yes  □ No 
 
Study Products Supplied? 
 
 
 
□ Yes  □ No 
 
 
(If Yes, complete Study Product Dispensing and Accountability Log on Trial Master File) 
 
Any Adverse Events to be Reported? 
 
 
□ Yes  □ No 
 
  
(If Yes, fill out Adverse Event Form and contact to CRO accordingly) 
 
Any Protocol Deviation?  
 
 
 
 □ Yes  □ No 
 
 
(If Yes, fill out Protocol Deviation Report and contact to CRO accordingly) 
 
Any Device Deficiencies to be Reported?           
□ Yes  □ No 
 
  
(If Yes, fill out Device Deficiency Report and contact to CRO accordingly) 
 
Is This Subject Eligible For Study Participation?   
□ Yes  □ No  
(If No, fill out Exit Form) 
Comments 
 
 
 
 
 
A signed and dated copy of the Informed Consent (by the subject and investigator) was provided to 
the subject. By electronically signing below I am confirming that Informed Consent was obtained for 
this subject as per the study protocol, and I am accepting the data pertaining to this subject to be 
complete and accurate.  
 
Date: _____/______/__________ (MM/DD/ YYYY) 
 
Time: ______:______ (HH:MM, 24h) 
 
Investigator Printed name of the signer_____________________________________   
 
Signature_______________________________________ 
 
 
 
 
 
 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
67 
 
 
 
 
 
 
 
 
 
Follow Up Visit Case Report Form 
 
 

Unicon Optical Co., Ltd. 
Protocol#: AVDR 2019-05 v1.1 
May 28th, 2020 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
68 
Follow-up/Unscheduled Visit Form 
Subject ID: ________________________ 
       Date: _____/______/__________ (MM/DD/ YYYY) 
Collection Start Time: ______:______ (HH:MM, 24h) 
Principal Investigator:_____________________  
Clinical Investigator: _____________________ 
Visit: Day 7 /  Day14 / Day 30  /  Day 60  /  Day 91   
/ Unscheduled (When from the initial Visit?, Reason for Visit) __________________________ 
/ AE Follow-up (When from the initial AE visit?) ________________________________________ 
Is this study completion final visit? □ Yes  □ No 
Medical / Ocular Tab 
Medical and Ocular history 
a.
Medical history (include pregnancy and lactation)
Record clinically significant medical history if occurred within the last 2 years and any ongoing
disease/conditions
□None
□No Change Since Last Visit
Condition 
Date Started 
(MM/DD/YYYY) 
Date Stopped 
(MM/DD/YYYY) 
Ongoing 
Yes / No 
Yes / No 
Yes / No 
b.
Ocular history
Record clinically significant ocular history if occurred within the last 2 years and any ongoing ocular
disease/conditions
□None
□No Change Since Last Visit
Condition 
Eye 
Date Started 
(MM/DD/YYYY) 
Date Stopped 
(MM/DD/YYYY) 
Ongoing 
OD  / OS  / OU 
Yes / No 
OD  / OS  / OU 
Yes / No 
OD  / OS  / OU 
Yes / No 
c.
Concomitant Medication
List all systemic and ocular medication used within the past 30 days (include all over the counter and
prescription medications)
□None
□No Change Since Last Visit

Unicon Optical Co., Ltd. 
Protocol#: AVDR 2019-05 v1.1 
May 28th, 2020 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
69 
Medicatio
n name 
Dos
e 
Route 
Freq 
Condition 
Eye 
Date Started 
MM/DD/YYYY 
Date Stopped 
MM/DD/YYYY 
Continui
ng 
☐po
☐SC
☐IM
☐IV
☐topical
☐other
_______
☐qd
☐bid
☐tid
☐qid
☐prn
☐other
______
NA 
OD 
OS 
OU 
Yes / No 
☐po
☐SC
☐IM
☐IV
☐topical
☐other
_______
☐qd
☐bid
☐tid
☐qid
☐prn
☐other
______
NA 
OD 
OS 
OU 
Yes / No 
☐po
☐SC
☐IM
☐IV
☐topical
☐other
_______
☐qd
☐bid
☐tid
☐qid
☐prn
☐other
______
NA 
OD 
OS 
OU 
Yes / No 
Average and Comfortable Wear Time 
1) At what time of day have you usually inserted your contact lenses since last visit?
□NO DATA
___________ 
(HH:MM, 24h) 
2)At what time of day have you usually removed your contact lenses since last visit?
□NO DATA
___________ 
(HH:MM, 24h) 
3) Are contact lenses comfortable while wearing?  
□ Yes   
□ No  
□  NO DATA
If No, at what time of day do your contact lenses usually begin to feel uncomfortable?      □  NO DATA
___________ 
(HH:MM, 24h) 
4) How many days per week have you wear the study lenses since last visit?
_______ days/week 
Rewetting Drop Usage 
1) If a rewetting drop dispensed last visit, how often have you used since last visit? _____times/day

Unicon Optical Co., Ltd. 
Protocol#: AVDR 2019-05 v1.1 
May 28th, 2020 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
70 
Questionnaires Tab 
Comfort, Vision and Handling Questionnaires   
□NO DATA
1)
Comfort
a. Rate the overall comfort at insertion when you wear your study lenses last 7 days:
Right eye: 0 / 1 / 2 / 3 / 4 / 5 
Left eye: 0 / 1 / 2 / 3 / 4 / 5 
5 
Excellent, cannot be felt 
4 
Very comfortable, just felt occasionally 
3 
Comfortable, noticeable but not irritating 
2 
Slightly uncomfortable, just irritating or annoying 
1 
Very uncomfortable, very irritating or annoying 
0 
Cause pain, lens cannot be tolerated 
b. Rate the overall comfort during the day while you wear your study lenses last 7 days:
Right eye: 0 / 1 / 2 / 3 / 4 / 5 
Left eye: 0 / 1 / 2 / 3 / 4 / 5 
5 
Excellent, cannot be felt 
4 
Very comfortable, just felt occasionally 
3 
Comfortable, noticeable but not irritating 
2 
Slightly uncomfortable, just irritating or annoying 
1 
Very uncomfortable, very irritating or annoying 
0 
Cause pain, lens cannot be tolerated 
c. Rate the overall comfort at the end of wearing when you wear your study lenses last 7 days:
Right eye: 0 / 1 / 2 / 3 / 4 / 5 
Left eye: 0 / 1 / 2 / 3 / 4 / 5 
5 
Excellent, cannot be felt 
4 
Very comfortable, just felt occasionally 
3 
Comfortable, noticeable but not irritating 
2 
Slightly uncomfortable, just irritating or annoying 
1 
Very uncomfortable, very irritating or annoying 
0 
Cause pain, lens cannot be tolerated 
2)
Vision
a. Rate your overall vision during the day when you wear your study lenses last 7 days:
Right eye: 0 / 1 / 2 / 3 / 4 / 5 
Left eye: 0 / 1 / 2 / 3 / 4 / 5 
5 
Excellent, cannot notice any visual loss 
4 
Very good, just noticeable and very occasional reduction 
3 
Good, occasional noticeable but acceptable reduction 
2 
Poor, noticeable but acceptable reduction 
1 
Very poor, marked and unacceptable reduction 
0 
Unacceptable, lens cannot be worn 

Unicon Optical Co., Ltd. 
Protocol#: AVDR 2019-05 v1.1 
May 28th, 2020 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
71 
b. Rate your satisfaction with vision during the day when you wear your study lenses last 7
days: 
 
Right eye: 0 / 1 / 2 / 3 / 4 / 5 
 
Left eye: 0 / 1 / 2 / 3 / 4 / 5
5 
Excellent 
4 
Very good 
3 
Good 
2 
Poor 
1 
Very poor 
0 
Unacceptable 
3)
Handling
a. Rate your overall handling of your study lenses:
Right eye: 0 / 1 / 2 / 3 / 4 / 5 
Left eye: 0 / 1 / 2 / 3 / 4 / 5 
5 
Excellent 
4 
Very good 
3 
Good 
2 
Poor 
1 
Very poor 
0 
Unacceptable 
Symptoms Questionnaire  
How often do your eyes experience the following symptoms during the day when your wear 
your study lenses last 7 days?   
Presence* 
Eye* 
If yes, please select the 
frequency* 
If yes, please select 
the severity level* 
Discomfort 
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Excess Tearing 
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Sensitivity to 
light 
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Glare 
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Halos 
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Itching 
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Burning 
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Blurred Vision 
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Variability of 
Vision 
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Lens Needs 
cleaning 
Yes / No 
Right/Left/Both 
Rarely / Sometimes / Often / 
Always 
Slight / Moderate / 
Severe 
Other (describe) 

Unicon Optical Co., Ltd. 
Protocol#: AVDR 2019-05 v1.1 
May 28th, 2020 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
72 
VA/OR with Dispense CL Tab 
Visual Acuity and Over-refraction with Dispensed Contact Lens 
VA with Dispensed Lens 
(logMar) 
Spherical Over-Refraction 
(D) 
VA with Over-Refraction 
(logMar) 
OD 
OS 
OU 
n/a 
n/a 
Is VA with Dispensed Lens on this visit 0.2 logMar worse than initial visit BCVA?  
□ Yes   □ No 
If “Yes”, which eye? 
 □ OD   □  OS    □ OU 
If “Yes”, describe the causes of visual acuity change: ________________________________________ 
In the case of visual acuity is reduced by ≥ 0.2 LogMAR, a follow up visit should be scheduled within 3 days of the 
event.  If the visual acuity loss persists at follow up, ongoing follow up visits should be scheduled within 3 days 
until the visual acuity loss has resolved or the Investigator determines the condition is stable. 
If “Yes”, is this VA change greater or equal to 14 days?  □ Yes   □ No (If yes, file Adverse Event Form) 
Replacement Lenses 
Any new study lens dispensed since last visit without parameter change?  
□ Yes   □ No 
If yes,  □ OD   □  OS    □ OU 
Primary Reason for the Lens Re-dispense: ______________________________ 
Secondary Reason for the Lens Re-dispense: ____________________________ 
•
Lost
•
Torn
•
Lens Deposits
•
Other (Specify)______________________________________________________________
Randomization Group: 
A / B /C / D 
Study Lens Type:  
Q / V 
Care Solution:   
B / C 

Unicon Optical Co., Ltd. 
Protocol#: AVDR 2019-05 v1.1 
May 28th, 2020 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
73 
Replacement - Contact Lens Rx 
□NO DATA
Eye 
Lens Lot # 
Rx-Sph (D) 
BC (mm) 
Diameter (mm) 
OD 
OS 
Note 
Lens Surface / Fitting Tab 
Slit Lamp Lens Surface/Fit Assessment 
a.
Lens Front Surface Wettability
OD: 0 / 1 / 2 / 3 / 4 
OS: 0 / 1 / 2 / 3 / 4 
0 
A smooth uniformly reflecting wettable surface. 
1 
A coarse hazy wettable surface which seems resolved momentarily with each blink and becomes 
exacerbated with staring. 
2 
One stable dry (non-wetting) area of some magnitude. 
3 
More than 1 stable dry (non-wetting) area of some magnitude. 
4 
Non-wettable lens surface of severe magnitude. 
b.
Lens Front Surface Deposits: Observe under low slit lamp magnification
OD: 0 / 1 / 2 / 3 / 4 
OS: 0 / 1 / 2 / 3 / 4 
0 
Absent, clean surface 
1 
Very slight, only visible after tear film drying 
2 
Slight, visible deposits easily removable 
3 
Moderate, deposits adherent and not removable 
4 
Severe, non-removable deposits and comfort affected 
c.
Lens Back Surface Deposits: Observe under low slit lamp magnification
OD: 0 / 1 / 2 / 3 / 4 
OS: 0 / 1 / 2 / 3 / 4 
0 
Absent, clean surface 
1 
Very slight, 3 spots or less of moving particles 
2 
Slight, up to 10 spots of moving particles 
3 
Moderate, 3 or less non-moving deposits adherent to lens 
4 
Severe, 4 or more deposits adherent to the lens and/or corneal indentation 
d.
Lens Centration
OD: 0 / 1 / 2 
 
 
 
OS: 0 / 1 / 2
Lens centration of the right and left contact lenses should be evaluated with the eye in the primary
position (relaxed, looking straight ahead) and assessed as follows:

Unicon Optical Co., Ltd. 
Protocol#: AVDR 2019-05 v1.1 
May 28th, 2020 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
74 
0 
Optimal lens centration 
1 
Acceptable decentration 
2 
Unacceptable decentration 
e.
Lens Overall Movement (after blink)
OD: -2 / -1 / 0 / +1 / +2 
OS: -2 / -1 / 0 / +1 / +2  
Evaluate immediately after the blink with the eye in the primary position; 
-2
Unacceptably tight (reduced movement, unacceptable) 
-1
Acceptably tight (reduced movement, acceptable) 
0 
Optimal fit / movement 
+1
Acceptable loose (excessive movement, acceptable) 
+2
Unacceptable loose (excessive movement, unacceptable) 
Remove contact lenses!        
 Slit Lamp Tab 
Slit Lamp Findings- Ocular (Biomicroscopy)   
f. Bulbar Conjunctival hyperaemia : Record severity of bulbar hyperemia(redness) on a 5-point scale.
OD: 0 / 1 / 2 / 3 / 4 
OS: 0 / 1 / 2 / 3 / 4 
0 = none 
no hyperemia 
1 = trace 
slight regional hyperemia 
2 = mild 
diffuse hyperemia 
3 = moderate 
marked regional or diffuse hyperemia 
4 = severe 
diffuse episcleral or scleral hyperemia 
g. 
Limbal Hyperaemia: Record the severity of limbal redness (hyperemia) on a 5-point scale.
OD: 0 / 1 / 2 / 3 / 4 
OS: 0 / 1 / 2 / 3 / 4 
0 = none 
no hyperemia 
1 = trace 
slight limbal hyperemia (mild segmented) 
2 = mild 
mild limbal hyperemia (mild circumcorneal) 
3 = moderate 
significant limbal hyperemia (marked segmented) 
4 = severe 
severe limbal hyperemia (marked circumcorneal) 
h. 
Palpebral Conjunctival Observations (upper and lower)
Record the severity of the palpebral conjunctival on a 5-point scale on each locations.
Eye 
Location 
Severity* 
Eye 
Location 
Severity* 
 OD 
Upper lid-S (1) 
0 / 1 / 2 / 3 / 4 
 OS 
Upper lid-S (1) 
0 / 1 / 2 / 3 / 4 
Upper lid-C (2) 
0 / 1 / 2 / 3 / 4 
Upper lid-C (2) 
0 / 1 / 2 / 3 / 4 
Upper lid-I (3) 
0 / 1 / 2 / 3 / 4 
Upper lid-I (3) 
0 / 1 / 2 / 3 / 4 
Upper lid-N (4) 
0 / 1 / 2 / 3 / 4 
Upper lid-N (4) 
0 / 1 / 2 / 3 / 4 
Upper lid-T (5) 
0 / 1 / 2 / 3 / 4 
Upper lid-T (5) 
0 / 1 / 2 / 3 / 4 
Lower lid-L (6) 
0 / 1 / 2 / 3 / 4 
Lower lid-L (6) 
0 / 1 / 2 / 3 / 4 

Unicon Optical Co., Ltd. 
Protocol#: AVDR 2019-05 v1.1 
May 28th, 2020 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
75 
Severity 
0 = none 
uniform satin appearance of the conjunctiva 
1 = trace 
slight conjunctival injection without texture 
2 = mild 
mild or scattered papillae/follicles less than 1 mm in diameter 
3 = moderate 
a) significant papillae/follicles less than 1mm in diameter, and/or marked conjunctival
injection
b) staining of the top of 1 papilla
4 = severe 
a) localized or generalized papillae/follicles 1 mm or more in diameter
b) staining of the top of more than 1 papilla
i. Corneal Edema : Record the severity of the edema on a 5-pint scale.
i. 
Epithelial Edema
OD: 0 / 1 / 2 / 3 / 4
OS: 0 / 1 / 2 / 3 / 4 
0 = none 
No epithelial or sub-epithelial haziness. Normal transparency 
1 = trace 
Barely discernible localized epithelial or subepithelial haziness 
2 = mild 
Faint but definite localized or generalized haziness 
3 = moderate 
Significant localized or generalized haziness 
4 = severe 
Definite widespread, epithelial cloudiness giving dull glass appearance to cornea, or 
numerous coalescent bullae (note the number and location of bullae)  
ii. 
Epithelial Microcysts
OD: 0 / 1 / 2 / 3 / 4
OS: 0 / 1 / 2 / 3 / 4 
0 = none 
No microcysts 
1 = trace 
1 to 20 microcysts 
2 = mild 
21 to 50 microcysts 
3 = moderate 
51 to 100 microcysts 
4 = severe 
> 100 microcysts or bullae
Note for the presence/absence of fluid-filled or debris-filled cysts                  □  NO DATA  
___________________________________________________________________________________________
___________________________________________________________________________ 
OD- numbers:____________   location:______________ 
OS- numbers:____________   location:______________ 

Unicon Optical Co., Ltd. 
Protocol#: AVDR 2019-05 v1.1 
May 28th, 2020 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
76 
iii. 
Stromal Edema
OD: 0 / 1 / 2 / 3 / 4
OS: 0 / 1 / 2 / 3 / 4 
0 = none 
No stromal cloudiness. Normal transparency 
1 = trace 
Barely discernible localized stromal cloudiness 
2 = mild 
Faint but definite localized or generalized stromal cloudiness, 
2 or fewer corneal striae 
3 = moderate 
Significant localized or generalized stromal cloudiness, 
3 pronounced corneal striae  
4 = severe 
Definite widespread, stromal cloudiness,  
folds in Descement’s membrane and ≥ 4 pronounced striae 
j. 
Corneal Vascularization: Record the severity of Maximal corneal vascularization on a 5-point scale
along with its depth and location.
Eye 
Severity 
Depth 
Location 
Describe if other 
OD 
0 
None 
Nasal 
1 
Superficial 
Temporal 
2 
Stromal 
Inferior 
3 
Superior 
4 
Circumlimbal 
Other 
OS 
0 
None 
Nasal 
1 
Superficial 
Temporal 
2 
Stromal 
Inferior 
3 
Superior 
4 
Circumlimbal 
Other 
Severity 
0 = none 
no vessel penetration 
1 = trace 
 <1.00 mm vessel penetration 
2 = mild 
W 1.00 mm to u 1.5 mm vessel penetration 
3 = moderate 
> 1.5 mm to u 2.00 mm vessel penetration
4 = severe 
vessel penetration > 2.00 mm 
k. Corneal staining
Record the staining topographically, the cornea being divided into one central (diameter 6mm) and four
peripheral zones (nasal, temporal, inferior and superior). Record the nature of the staining for its severity
and depth for each zone.
Eye 
Location 
Severity 
Depth 
Staining is associated with an 
underlying infiltrate? 
OD 
Central 
0 / 1 / 2 / 3 / 4 
0=None 
Yes 
1=Superficial 
No 
2 =Full epithelial 
3=Stromal 
Peripheral-Nasal 
0 / 1 / 2 / 3 / 4 
0 / 1 / 2 / 3 
Yes / No 

Unicon Optical Co., Ltd. 
Protocol#: AVDR 2019-05 v1.1 
May 28th, 2020 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
77 
Peripheral-Temporal 
0 / 1 / 2 / 3 / 4 
0 / 1 / 2 / 3 
Yes / No 
Peripheral-Inferior 
0 / 1 / 2 / 3 / 4 
0 / 1 / 2 / 3 
Yes / No 
Peripheral-Superior 
0 / 1 / 2 / 3 / 4 
0 / 1 / 2 / 3 
Yes / No 
OS 
Central 
0 / 1 / 2 / 3 / 4 
0 / 1 / 2 / 3 
Yes / No 
Peripheral-Nasal 
0 / 1 / 2 / 3 / 4 
0 / 1 / 2 / 3 
Yes / No 
Peripheral-Temporal 
0 / 1 / 2 / 3 / 4 
0 / 1 / 2 / 3 
Yes / No 
Peripheral-Inferior 
0 / 1 / 2 / 3 / 4 
0 / 1 / 2 / 3 
Yes / No 
Peripheral-Superior 
0 / 1 / 2 / 3 / 4 
0 / 1 / 2 / 3 
Yes / No 
Severity 
0 = none 
no staining 
1 = trace 
Minimal superficial staining or punctate staining 
a. dimpling, discrete dot staining, or
b. trace superficial lens insertion marks or foreign body tracks
2 = mild 
Regional or diffuse punctate staining 
a. central or generalized, or
b. peripheral including 3-9 o’clock staining, or
c. mild abrasion or foreign body tracks
3 = moderate 
Dense coalesced staining up to 2 mm in diameter 
a. corneal abrasion, or
b. foreign body track
4 = severe 
Dense coalescent staining greater 2mm in diameter, ulcerations, epithelial loss, or full 
thickness abrasion.  Diagram and explain on source document.  
l. Corneal Infiltrates
Record the nature of the corneal infiltrates followed by locations, classification, severity, type, depth of
infiltrate, number of infiltrates and size of the largest infiltrates. 
 
□ None
E
y
e 
Location 
Classific
ation 
Severity 
Type 
Depth of 
infiltrate* 
Number 
of 
infiltrates 
Size of 
largest 
infiltrate(
mm) 
Vision 
affected? 
O
D 
n/a 
Central 
P-Superior
P-Nasal
P-Inferior
P-Temporal
Level 1 
Level 2 
Level 3 
Level 4 
Level 5 
0 
1 
2 
3 
4 
focus 
diffuse 
E 
AS 
P 
Yes 
No 
O
S 
n/a 
Central 
P-Superior
P-Nasal
P-Inferior
P-Temporal
Level 1 
Level 2 
Level 3 
Level 4 
Level 5 
0 
1 
2 
3 
4 
focus 
diffuse 
E 
AS 
P 
Yes 
No 
*E = epithelial, AS = anterior stromal, P = mid/posterior stromal

Unicon Optical Co., Ltd. 
Protocol#: AVDR 2019-05 v1.1 
May 28th, 2020 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
78 
Corneal Zones to be used for Recording Location
Outcomes Classification for Corneal Infiltrates 
Level 1 
High probability of microbial keratitis attributed to contact lens wear with loss of 
vision and/or surgical intervention attributed to event 
Level 2 
High probability of microbial keratitis attributed to contact lens wear without loss of 
vision or surgical intervention attributed to event 
Level 3 
High probability of infiltrative keratitis of indeterminate etiology attributed to contact 
lens wear without loss of vision or surgical intervention attributed to event 
Level 4 
High probability of sterile infiltrative keratitis attributed to contact lens wear without 
loss of vision or surgical intervention attributed to event 
Level 5 
High probability of infiltrative keratitis not attributed to contact lens wear 
Definitions for classification 
Loss of vision 
Defined as loss of 2 lines of corrected acuity in affected eye. Change in best spectacle-
corrected visual acuity will be used for affected eyes having this data available at 
baseline and follow-up. Change from baseline to final soft contact lens-corrected 
acuity will be used if spectacle-corrected data unavailable. 
Surgical intervention 
Defined as any laser or incisional technique used to restore vision or prevent 
additional complications or any application of tissue adhesive to treat 
impending/actual perforation of the cornea. 
High probability of 
microbial keratitis 
One or more corneal stromal infiltrates greater than 1mm in size with pain more than 
mild and one or more of following: anterior chamber reaction more than minimal; 
mucopurulent discharge; positive corneal culture. The presence of a subsequent 
corneal scar is a requirement in cases in which adequate follow-up data and medical 
records are available.  
High probability of 
infiltrative keratitis of 
indeterminate etiology 
One or more corneal stromal infiltrates accompanied by signs/symptoms not clearly 
meeting criteria for the sterile or microbial groups.  
High probability of 
sterile infiltrative 
keratitis 
One or more corneal stromal infiltrates the largest of which is 1mm or less in size, and 
all of the following: outside central 6mm; minimal or no anterior chamber reaction, no 
mucopurulent discharge; mild or no pain.   
Severity of corneal infiltrates on 5-point scale 
0 = none 
no infiltrates 
1 = trace 
single or multiple epithelial infiltrates < 1 mm in diameter 
2 = mild 
Single or multiple epithelial infiltrates ≥ 1 mm and < 2 mm in diameter 
3 = moderate 
Multiple infiltrates ≥ 2 mm and < 3 mm in diameter 
4 = severe 
Multiple dense infiltrates ≥ 3 mm in diameter 

Unicon Optical Co., Ltd. 
Protocol#: AVDR 2019-05 v1.1 
May 28th, 2020 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
79 
m. Other complications/Findings
Record other findings (ie, pinguecula) on a 5-point scale and its description. List all report.
OD: 0 / 1 / 2 / 3 / 4 
OS: 0 / 1 / 2 / 3 / 4 
NOTE 
0 = none 
no other significant biomicroscopic findings 
1 = trace 
minimal findings such as a tear film abnormality (debris of low tear break up time) 
2 = mild 
mild findings such as: 
lens adhesion 
3 = moderate 
significant findings 
e. iritis with minimal cells or flare
f. conjunctivitis or EKC
4 = severe 
severe findings such as: 
a. iritis with marked cells and/or flare
b. corneal or conjunctival infection
c. corneal ulcer
d. recurrent erosion
VA / Refraction / Keratometry Tab 
Sphero-cylindrical Manifest Refraction and Best Corrected Visual Acuity  
Sphero-cylindrical Manifest Refraction 
Sphero-cylindrical VA 
(BCVA) 
Sph (D) 
Cyl (D) 
Axis (°) 
LogMar 
OD 
(-) 
OS 
(-) 
OU 
n/a 
n/a 
n/a 
Best Sphere Refraction and Visual Acuity 
Best Sphere Refraction 
Best Sphere VA 
Sph (D) 
LogMar 
OD 
OS 
OU 
n/a 
Is BCVA on this visit 0.2 logMar worse than initial visit BCVA?  □ Yes   □ No 
If “Yes”, which eye? 
 □ OD   □  OS    □ OU 
If “Yes”, describe the causes of visual acuity change: ________________________________________ 

Unicon Optical Co., Ltd. 
Protocol#: AVDR 2019-05 v1.1 
May 28th, 2020 
Andre Vision and Device Research 
Follow-up Visits Case Report Form 
80 
In the case of visual acuity is reduced by ≥ 0.2 LogMAR, a follow up visit should be scheduled within 3 days of the 
event.  If the visual acuity loss persists at follow up, ongoing follow up visits should be scheduled within 3 days 
until the visual acuity loss has resolved or the Investigator determines the condition is stable. 
If “Yes”, is this VA change greater or equal to 14 days?  □ Yes   □ No (If yes, file Adverse Event Form) 
Keratometry 
K readings 
Corneal Cylinder 
Flat (D) 
Steep (D) 
Meridian of 
Steep Power 
Cyl (D) 
Axis (°) 
OD 
(-) 
OS 
(-) 
Redispense Tab 
Randomization Group: 
A / B /C / D 
Study Lens Type:  
Q / V 
Care Solution:   
B / C 
Any Lens Parameter Change or Additional Lens Dispense? 
□Yes    □ No
If yes,  □  OD   □  OS    □ OU 
Primary Reason for the Parameter Change or Additional Lens Dispense: _______________________ 
Secondary Reason for the Parameter Change or Additional Lens Dispense: _____________________ 
•
Regular lens replacement schedule
•
Visual acuity
•
Comfort
•
Pathology
•
Contact lens fit
•
Lost
•
Torn
•
Lens Deposits
•
Bad Edge
•
Bad Surface / non-wetting
•
Other (Specify)
New Dispense - Contact Lens Rx 
□NO DATA
Eye 
Lens Lot # 
Rx-Sph (D) 
BC (mm) 
Diameter (mm) 
OD 
OS 
Note 

Unicon Optical Co., Ltd. 
Protocol#: AVDR 2019-05 v1.1 
May 28th, 2020 
CONFIDENTIAL 
81
Insert the study Lens and wait for 5 minutes! 
Visual Acuity and Over-refraction with New Dispense Contact Lens 
VA with Dispensed Lens 
(logMar) 
Spherical Over-Refraction 
(D) 
VA with Over-Refraction 
(logMar) 
OD 
OS 
OU 
n/a 
n/a 
Study Lenses Collected/Returned?  
 
 
 
□ Yes    □ No
 (Complete Study Product Dispensing and Accountability Log on Trial Master File) 
Study Product Supplied (Day 30, Day 60, and Unscheduled)? 
□ Yes    □ No   
 (Complete Study Product Dispensing and Accountability Log on Trial Master File) 
Any Adverse Events to be Reported? 
 
□Yes    □ No
(If Yes, fill out the Adverse Event Form and contact to CRO accordingly) 
Any Protocol Deviation?  
 
 
 
 
□ Yes    □ No
(If Yes, fill out the Protocol Deviation Report and contact to CRO accordingly) 
Any Device Deficiencies to be Reported?           
 
□ Yes    □ No
(If Yes, fill out the Device Deficiency Report and contact to CRO accordingly) 
Is subject Exit the study?  
□Yes    □ No
(If Yes, fill out Exit form and collect all study lenses) 
I am accepting the data pertaining to this subject to be complete and accurate. 
Date: _____/______/__________ (MM/DD/ YYYY) 
Time: ______:______ (HH:MM, 24h) 
Investigator Printed name of the signer_____________________________________  
Signature _______________________________________ 

Unicon Optical Co., Ltd. 
Protocol#: AVDR 2019-05 v1.1 
May 28th, 2020 
CONFIDENTIAL 
82
Exit Form 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
 
 
 
CONFIDENTIAL 
 
83 
 
 
 
 
Exit Form 
 
 
 
 
 
 
 
 
 
 
 
 
     
Subject ID: ________________________ 
       Date: _____/______/__________ (MM/DD/ YYYY) 
 
 
 
 
 
 
Principal Investigator:_____________________ 
Clinical Investigator: _____________________ 
 
 
 
Did the subject complete the study?  
○ Yes    ○ No 
At which visit was the patient exited from the study treatment? 
Dispense / Day 7 /  Day 14 / Day 30  /  Day 60 / Day 91 / Other 
(details_____________________________) 
 
Reason for Exit from Study (multiple choice) 
• 
Completed Visit Schedule 
• 
Patient Decision (Disinterest) 
• 
Investigator Decision 
• 
Lost to Follow up 
• 
Poor Visual Acuity 
• 
Positive Slit Lamp Finding 
• 
Adverse Reaction 
• 
Lens Positioning 
• 
Discomfort 
• 
Handling Problem 
• 
Other (specify)__________________________________________________________ 
 
 
I am accepting the data pertaining to this subject to be complete and accurate.  
 
Date:_____/_____/_______  
 
                                                           Time: _____:_______(24hr) 
 
Investigator Printed name of the signer_____________________________________   
 
Signature_______________________________________ 
 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
 
 
 
CONFIDENTIAL 
 
84 
 
 
 
 
 
 
 
 
 
 
 
 
Adverse Event Form 
 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
 
 
 
CONFIDENTIAL 
 
85 
 
 
 
 
Adverse Event Form 
 
Subject ID: __________  
                                       
Date:_______________ (MM/DD/ YYYY) 
 
 
 
                  
 
 
Time: _______________(HH:MM, 24h) 
 
Principal Investigator:____________________  
Clinical Investigator: ______________________ 
 
Indicate Visit:  Baseline / Day 7 / Day 14 / Day 30  / Day 60  /  Day 91  /    
 
Other (please explain the time in investigation from dispensing________________________)  
 
Date of Dispensing: _______________________ 
  
 
Type of Report: □ Initial AE 
□ AE Follow-up ( Number of Days following the initial AE Visit: _____ ) 
 
Adverse events should be differentiated into device related and non-device related. Any corneal infiltrate, ulcer, 
neovascularization, etc. shall be presumed to be device related unless the case history clearly indicates some other 
origin. All corneal ulcers shall be recorded in the study report. 
Type of Adverse Event:______________________  
Classification 
Definition and condition 
Reporting 
Serious 
Adverse 
Events (SAE) 
Serious Adverse Device Events are those events that result in, or have 
potential to cause, either permanent impairment of an ocular function or 
damage to an ocular structure, and may necessitate medical or surgical 
intervention.  
Serious AEs may include any hazardous, sight-threatening conditions 
occurring after exposure to test article, including but not limited to the 
following.  
a) A presumed infectious ulcer (defined as a progressive erosion of 
the corneal tissue). Signs may include irregular focal infiltrates (> 1 
mm); active lesions with raised edges; significant diffuse 
infiltration; anterior corneal to mid-stromal involvement; erosion 
with overlying staining; conjunctival and lid edema; anterior 
chamber reaction (iritis); severe bulbar and limbal redness. 
Symptoms associated with a presumed infectious ulcer (microbial 
keratitis) may include pain of rapid onset; severe redness; purulent 
or mucopurulent discharge; tearing; photophobia. For the 
purposes of reporting, a corneal ulcer which has any of the 
following characteristics should be considered in this category:  
Notify sponsor 
as soon as 
possible, 
within 24 hrs; 
IRB and FDA 
reporting as 
per 
requirements 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
 
 
 
CONFIDENTIAL 
 
86 
 
 
 
 
1) central or paracentral location;  
2) penetration of Bowman’s membrane;  
3) infiltrate > 2 mm diameter;  
4) associated with iritis ≥ grade 2;  
5) associated with any increase in intraocular pressure;  
6) culture positive for microorganisms;  
7) increasing size or severity at subsequent visits.  
b) Any central or paracentral corneal event (such as 
vascularization) that results in permanent opacification.  
c) Any serious adverse ophthalmic events including hypopyon and 
hyphema.  
d) Any neovascularization within the central 6 mm of the cornea.  
e) The loss of two or more lines of visual acuity that fail to resolve.  
f) All cases of iritis. 
Significant 
but non-
serious 
adverse 
events 
Significant but non-serious AEs should include, but not be limited to: 
— peripheral non-progressive non-infectious ulcers;  
— all symptomatic corneal infiltrative events;  
— all cases of corneal staining greater than or equal to grade 3;  
— a temporary loss of ten or more letters of best spectacle 
corrected visual acuity (for greater than or equal to 2 weeks);  
— cases greater than or equal to grade 2 neovascularization;  
— any ocular event that necessitates temporary lens 
discontinuation of greater than or equal to 2 weeks; 
— lens adhesion or lens binding to the cornea; 
— significantly distorted corneal topography (significant distortion 
of keratometry mires or aberrant findings in corneal topography); 
— any ocular AE that requires the practitioner’s intervention, 
including medication (not including minimal lubrication).   
Notify sponsor 
as soon as 
possible, no 
later than 10 
business days; 
IRB and FDA 
reporting as 
per 
requirements 
Unanticipated 
Adverse 
Device Effects 
(UADE) 
Unanticipated adverse device effect means any serious adverse effect on 
health or safety or any life-threatening problem or sight-threatening, or 
death caused by, or associated with, a device, if that effect, problem, or 
death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or 
welfare of subjects. 
Notify sponsor 
and IRB as 
soon as 
possible, but 
no later than 
10 business 
days, if events 
that are fatal 
or life 
threatening, 
report 
immediately; 
IRB and FDA 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
 
 
 
CONFIDENTIAL 
 
87 
 
 
 
 
reporting as 
per 
requirements 
Date of Occurrence:  _____/______/__________ (MM/DD/ YYYY) 
Date First AE is Observed by Investigator: _____/______/__________ (MM/DD/ YYYY) 
Date of Resolution: _____/______/__________ (MM/DD/ YYYY)      
Duration of Event: __________ days 
  
Eye Involved: OD / OS /OU 
 
Clinical Observations 
Describe event including slit lamp observation 
 
 
 
 
 
 
Diagnosis:____________________________________________________________________________ 
 
_____________________________________________________________________________________ 
 
List of Acuities at Visits (logMar VA) 
 
Uncorrected VA 
Contact Lens 
Corrected VA 
Best Corrected VA 
Pinhole VA if 
needed 
OD 
OS 
OD 
OS 
OD 
OS 
OD 
OS 
Baseline 
 
 
 
 
 
 
 
 
 
Beginning of 
Event 
 
 
 
 
 
 
 
 
Poorest Acuity 
during Event 
 
 
 
 
 
 
 
 
At Resolution or  
Final Visit Seen 
 
 
 
 
 
 
 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
 
 
 
CONFIDENTIAL 
 
88 
 
 
 
 
Severity: _______ 
1 = Mild   
2 = Moderate    
3 = Severe  
4 = Life-Threatening  
 
If applicable, were images captured for documentation of the AE?  
□ Yes    □ No 
AE Treatment:  select all that applies 
 
 
0 = None 
 
 
1 = Study device replacement/modification 
 
 
2 = Medical intervention 
 
   
3 = Culturing 
 
   
4 = Study device discontinued for ____ time period 
 
 
5 = Hospitalization 
 
 
6 = Other 
Describe details including relevant tests/laboratory data with dates 
 
 
 
 
 
Outcome of AE / Resolution Status:  
 
 
 
 
0 = Resolved without sequelae 
 
 
 
 
1 = Recovered with minor impairment / sequelae 
 
 
 
 
2 = Recovered with major impairment / sequelae 
 
   
 
 
3 = Ongoing/Continuing treatment without sequelae 
 
 
 
 
4 = Ongoing/Continuing treatment with sequelae 
 
   
 
 
5 = Condition worsening 
 
 
 
 
6 = Death 
 
 
 
 
7 = Unknown 
 
 
 
 
8 = Other 
Describe details including relevant tests/laboratory data with dates 
 
 
 
 
 
Other Relevant History, including Preexisting Medical Conditions 
Describe 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
 
 
 
CONFIDENTIAL 
 
89 
 
 
 
 
 
 
Study Device Relationship: 0 = Unrelated (clearly not related to the study device) 
 
 
 
      1 = Unlikely related (doubtfully related to the study device) 
 
 
 
      2 = Possibly related (may be related to the study device) 
 
 
 
      3 = Probably related (likely related to the study device) 
 
 
 
      4 = Definitely related (clearly related to the study device) 
Describe details 
 
 
 
 
Is this Ocular event?  
 
 
 
 
□ Yes    □ No 
Is this an Unanticipated Adverse Effect?  
 
□ Yes    □ No 
Is this a Serious Adverse Event? 
 
 
□ Yes    □ No 
 
 
 
(If yes, complete paper SAE form and report to IRB and CRO as soon as possible) 
Is this Significant but non-serious Adverse Event? 
□ Yes    □ No 
Did Subject Continue in Study?  
 
 
□ Yes    □ No   
 
 
 
(If Yes, fill out the Protocol Deviation Report and contact to CRO accordingly) 
 
Reportable to CRO/Sponsor?  □ Yes    □ No          When? _____/______/__________ (MM/DD/ YYYY) 
 
Reportable to IRB/FDA?  
□ Yes    □ No          When? _____/______/__________ (MM/DD/ YYYY) 
 
 
I am accepting the data pertaining to this subject to be complete and accurate.  
 
Date:______________   
Time: ______________ 
 
Investigator Printed name of the signer_____________________________________   
 
Signature_______________________________________ 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
 
 
 
CONFIDENTIAL 
 
90 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol Deviation Report 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
 
 
 
CONFIDENTIAL 
 
91 
 
 
 
 
Protocol Deviation Report  
Subject ID: ____________ 
 
                     
           Date:_______________ (MM/DD/ YYYY) 
 
 
 
                  
 
 
              Time: _______________(HH:MM, 24h) 
 
Principal Investigator:____________________  
Clinical Investigator: ______________________ 
 
Indicate Visit:  Dispense V / Day 7  /   Day 14 / Day 30  /  Day 60   /  Day 91  /   
 
 
Other (please explain the time in investigation from dispensing___________________)  
 
Date of Deviation: _____/______/__________ (MM/DD/ YYYY) 
 
Description 
 
 
Reason 
 
 
Result in AE?   
 
 
○ Yes     
○ No 
 
Did Subject Continue in Study?  
○ Yes     
○ No 
 
Corrective Action 
Please describe what action(s) you have taken to prevent recurrence of this deviation in the future:        
 
 
Reportable to IRB/FDA?  
 
○ Yes     
○ No 
When? _____/______/__________ (MM/DD/ YYYY) 
 
I am accepting the description to this subject to be complete and accurate.  
Clinical investigator Name (Printed) ______________________________ 
 
Investigator Signature____________________________ 
 
Date: _____________________ 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
 
 
 
CONFIDENTIAL 
 
92 
 
 
 
 
 
 
 
 
 
 
 
 
Device Deficiency Form 
 
 
 
 
 
 
 
 
 
 
 
 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
 
 
 
CONFIDENTIAL 
 
93 
 
 
 
 
Device Deficiency Form  
Subject ID: ____________ 
 
                     
           Date:_______________ (MM/DD/ YYYY) 
 
 
 
                  
 
 
              Time: _______________(HH:MM, 24h) 
 
Principal Investigator:____________________  
Clinical Investigator: ______________________ 
 
Indicate Visit:  Dispense V / Day 7  /  Day 14 / Day 30  /  Day 60   /  Day 91  /   
 
 
Other (please explain the time in investigation from dispensing___________________)  
Device Detail (type of device) 
 
 
Date of Occurrence: _____/______/__________ (MM/DD/ YYYY) 
 
Description of Deficiency 
 
 a) Is this a deficiency with respect to identity, quality, durability, reliability, safety or performance of the 
device?  
 
 
○ Yes     
○ No 
 
b) Is the deficiency due to a malfunction, use error or inadequate labeling?  
 
 
○ Yes     
○ No 
 
c) Did the deficiency lead to an Adverse Event?  
 
 
○ Yes    
 ○ No 
 
d) Did the deficiency lead to unmasking of the device?  
 
 
○ Yes     
○ No 
 
Action Taken 
 
 
I am accepting the description to this subject to be complete and accurate.  
Clinical investigator Name (Printed) ______________________________ 
 
Investigator Signature____________________________ 
 
Date: _____________________ 

Unicon Optical Co., Ltd. 
 
Protocol#: AVDR 2019-05 v1.1 
 
 
May 28th, 2020 
 
 
 
 
CONFIDENTIAL 
 
94 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix 4 
 
Culture Procedures