A Randomized, Active-Controlled, Open-Label Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens
Phase: NA
Conditions: Refractive Error - Myopia Bilateral
Sponsor: Bruno Vision Care

 
 
 
Protocol 22001 for A Randomized, Active-Controlled, Open-Label Study to 
Evaluate the Clinical Performance of Deseyne (vifilcon C) Daily Disposable 
Soft Contact Lens 
      
26APR2023 

Bruno Vision Care 
Protocol 22001 
Clinical Study Protocol 
Version 3.0, 26 April 2023 
 
Page 1 of 9 
TITLE PAGE 
 
A Randomized, Active-Controlled, Open-Label Study to Evaluate the Clinical Performance of 
Deseyne (vifilcon C) Daily Disposable Soft Contact Lens  
 
PROTOCOL 22001 
 
Sponsor: Bruno Vision Care 
 
This clinical investigation is being conducted in accordance with 21 Code of Federal Regulations 
(CFR) Parts 11, 50, 54, 56, and 812. The protocol was developed with consideration of the 
provisions in: International Organization for Standardization (ISO) 14155-1:2011 Clinical 
investigation of medical devices for human subjects – Part 1:  General requirements; 14155-
2:2011 Part 2:  Clinical investigation of medical devices for human subjects – Part 2:  Clinical 
investigational plan; ISO 11980:2012 Ophthalmic Optics – Contact lenses and contact lens care 
products – Guidance for clinical investigations; International Council for Harmonisation (ICH) 
Good Clinical Practice (GCP) and applicable local regulations. The Sponsor intends to register 
this clinical trial with the public database https://ClinicalTrials.gov. 
 
 
 
 
 
 
 
 
 
Revision Chronology:  
Original 
2.0 
13 February 2023 
Amendment  
3.0 
26 April 2023 
 
The confidential information in the following document is provided to you, as an Investigator or 
consultant, for review by you, your study personnel, and the applicable Institutional Review Board/Ethics 
Committee. By accepting this document, you agree that the information contained herein will not be 
disclosed to others without written authorization from Sponsor, except to the extent necessary to obtain 
consent from those persons who participate in this study.  
1-Day Acuvue® Moist® is a registered trademark of Vistakon, a subsidiary of Johnson & Johnson.  

Bruno Vision Care 
Protocol 22001 
Clinical Study Protocol 
Version 3.0, 26 April 2023 
 
Page 2 of 9 
SPONSOR APPROVAL PAGE 
 
A Randomized, Active-Controlled, Open-Label Study to Evaluate the Clinical Performance of 
Deseyne (vifilcon C) Daily Disposable Soft Contact Lens 
 
PROTOCOL 22001 
 
Author: Jennifer Klem, PhD 
Approved by:  
 
 
_____________________________________ 
 
_____________________ 
Richard E. Lippman, OD, FAAO 
RE Lippman Regulatory Pathways 
301-580-3931 
Richard.lippman@gmail.com 
 
 
_____________________________________ 
 
_____________________ 
Eddie Catalfamo  
Sponsor Executive 
Bruno Vision Care  
2255 Glades Road, Suite 324A 
Boca Raton, FL 33431 
646-239-2024 
e.catalfamo@brunopharma.com 
 
 
 
_____________________________________ 
 
_____________________ 
Charles Slonim, MD 
Medical Monitor 
iuvo BioScience Operations, LLC 
813-690-0255 
Chuck.slonim@oculoscr.com 
 

Bruno Vision Care 
Protocol 22001 
Clinical Study Protocol 
Version 3.0, 26 April 2023 
 
Page 3 of 9 
INVESTIGATOR STATEMENT OF APPROVAL 
 
A Randomized, Active-Controlled, Open-Label Study to Evaluate the Clinical Performance of 
Deseyne (vifilcon C) Daily Disposable Soft Contact Lens 
 
PROTOCOL 22001 
 
I have read the attached document, concur that it contains all information necessary to conduct 
the study, and agree to abide by all provisions set forth therein.  
I agree to conduct this study in accordance with 21 Code of Federal Regulations (CFR) Parts 11, 
50, 54, 56, and 812. The protocol was developed with consideration of the provisions in: 
International Organization for Standardization (ISO) 14155-1:2011 Clinical investigation of 
medical devices for human subjects – Part 1:  General requirements; 14155-2:2011 Part 2:  
Clinical investigation of medical devices for human subjects – Part 2:  Clinical investigational 
plan; ISO 11980:2012 Ophthalmic Optics – Contact lenses and contact lens care products – 
Guidance for clinical investigations, International Council for Harmonisation (ICH) Good 
Clinical Practice (GCP) and applicable local regulations.. I will not initiate the study until I have 
obtained written approval by the appropriate Institutional Review Board (IRB)/Ethics Committee 
and have complied with all financial and administrative requirements of the governing body of 
the clinical institution and the Sponsor. I will obtain written informed consent from each study 
subject prior to performing any study specific procedures.  
I understand that my signature on a case report form indicates that the data therein has been 
reviewed and accepted by me. 
I understand that this document and related information is subject to confidentiality terms found 
in my signed Confidentiality or Clinical Services Agreement. I agree to protect the 
confidentiality of my patients when allowing the Sponsor of this clinical investigation, and/or 
relevant regulatory authorities and IRB/ECs, direct access to my medical records for study 
subjects. 
 
 
_____________________________________ 
 
Principal Investigator, Printed Name 
 
 
_____________________________________ 
 
_____________________ 
Principal Investigator, Signature 
 
 
 
Date 
 

Bruno Vision Care 
Protocol 22001 
Clinical Study Protocol 
Version 3.0, 26 April 2023 
 
Page 4 of 9 
1. 
SYNOPSIS 
Title: 
A Randomized, Active-Controlled, Open-Label Study to Evaluate 
the Clinical Performance of Deseyne (vifilcon C) Daily Disposable 
Soft Contact Lens 
Sponsor:  
Bruno Vision Care 
Phase of study: 
Safety and effectiveness 
Study number: 
22001 
Number of study 
centers and subjects: 
Approximately 80 subjects (160 eyes) will be treated at 
approximately 4 to 5 investigational (non-institutional) sites in the 
United States. 
Objective: 
The objective of this clinical study is to provide clinical performance 
data comparing the test lens (Deseyne [vifilcon C] daily disposable 
soft contact lens) to a control lens (1-Day Acuvue® Moist® [etafilcon 
A] daily disposable soft contact lens) in the same indication for use 
(single use prior to removal followed by a fresh lens upon the next 
lens wear exposure). 
Study design: 
A multicenter, randomized, active-controlled, open-label study design 
will be used to compare the clinical performance of the Deseyne 
(vifilcon C) test soft contact lens to the similarly indicated 1-Day 
Acuvue Moist (etafilcon A) control soft contact lens.  
Study participation is approximately 90 days in duration and will 
consist of approximately 80 subjects assigned in a 2:1 ratio to test or 
control lens bilaterally, respectively. Subjects must be otherwise 
healthy, with myopia between -1.00 diopter (D) and -6.00 D and 
astigmatism no greater than 1.00 D that does not interfere with visual 
acuity (VA). 
At the Screening Visit, approximately two-thirds of the eligible 
subjects will be randomized to receive the test lens (Deseyne [vifilcon 
C] lens) and the other one-third eligible subjects will be randomized 
to receive the control lens (1-Day Acuvue Moist [etafilcon A] lens). 
At the Dispensing Visit (Visit 2), subjects will be provided with test 
or control lenses as part of the dispensing package, along with 
instructions for the use and care of the lenses. They will be 
recommended unpreserved lubricating/rewetting solution for use as 
needed during the study.  
Subjects will wear their assigned lenses bilaterally on a daily wear 
basis, for a minimum of 6 hours/day throughout the study (no 
maximum time is mandated, as long as subjects do not sleep in their 
lenses), with additional visits planned for 1 Week (Visit 3), 1 Month 

Bruno Vision Care 
Protocol 22001 
Clinical Study Protocol 
Version 3.0, 26 April 2023 
 
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(Visit 4), 2 Months (Visit 5), and 3 Months/Exit Visit (Visit 6).  
Subject selection: 
Inclusion criteria:  
1. 
18 to 40 years of age on the date the informed consent form 
(ICF) is signed  
2. 
Presence of clear central corneas and absence of any anterior 
segment disorders in each eye 
3. 
Presence of myopia and requirement for lens correction 
from -1.00 D to -6.00 D in each eye 
4. 
Best-corrected distance visual acuity (BCDVA) of 50 Early 
Treatment Diabetic Retinopathy Study letters (0.1 logMAR) 
or better in each eye  
5. 
Be an adapted soft contact lens wearer in each eye and 
agreement to wear study lenses in each eye on a daily wear 
basis and not wear a non-study lens for approximately 3 
months 
6. 
Able and willing to comply with all treatment and follow-
up/study procedures 
7. 
Able to read, understand, and provide written informed 
consent on the Institutional Review Board−approved ICF 
and provide authorization as appropriate for local privacy 
regulations 
Exclusion criteria: 
1. 
Participation in any drug or device clinical investigation 
within 2 weeks prior to Screening and/or during the period 
of study participation 
2. 
Women of childbearing potential (those who are not 
surgically sterilized or postmenopausal) who meet any of the 
following conditions: 
a. 
Currently pregnant 
b. 
Plans to become pregnant during the study 
c. 
Currently breastfeeding 
3. 
History of gas permeable lens wear in either eye within 
30 days prior to Screening or history of 
polymethylmethacrylate lens wear in either eye within 
3 months prior to Screening 
4. 
Current monovision, multifocal, or toric contact lens wear in 

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Protocol 22001 
Clinical Study Protocol 
Version 3.0, 26 April 2023 
 
Page 6 of 9 
either eye  
5. 
In either eye, current nonabsorbable punctal plug or 
implantation of absorbable punctal plug within 2 to 6 months 
(depending on type of absorbable plug) prior to Screening, or 
punctal plug removal within 2 months prior to Screening. 
Permanent punctal occlusion in 1 or more puncta or 
nasolacrimal duct obstruction in either eye is excluded 
6. 
Use of any prescription ocular medication throughout the 
duration of the study. Prescription eyedrops for dry eye 
disease (eg, Restasis, Xiidra, Cequa, Eysuvis), as well as 
nasally administered Tyrvaya, must be discontinued 2 weeks 
prior to Screening and are prohibited throughout the duration 
of the study 
7. Use of over-the-counter eyedrops (eg, oxymetazoline, 
naphazoline, ketotifen, etc.), except for unpreserved lubricant 
eyedrops or artificial tears (eg, Systane, Refresh), within 1 
week prior to Screening and throughout the duration of the 
study 
8. Use of any systemic or topical medications that may, in the 
Investigator’s opinion, affect ocular physiology or lens 
performance 
9. Anisometropia (spherical equivalent) >2.00 D 
10. Ocular astigmatism >1.00 D in either eye 
11. Amblyopia in either eye 
12. Aphakia in either eye 
13. Active ocular disease (eg, dry eye disease, blepharitis, 
conjunctivitis, keratitis, etc.) in either eye. Subjects must be 
symptom free for at least 7 days 
14. History or evidence of ocular infection within 30 days prior 
to Screening 
15. History or evidence of ocular herpes simplex or ocular 
herpes zoster 
16. Any grade corneal infiltrates in either eye 
17. Grade ≥2 finding in either eye during slit lamp examination 
18. Any “Present” finding in either eye during slit lamp 
examination that, in the Investigator’s opinion, may interfere 
with contact lens wear 
19. Any scar or neovascularization within the central 4 mm of 
the cornea in either eye. Subjects with minor peripheral 
corneal scarring (not extending into the central area) that, in 
the Investigator’s opinion, does not interfere with contact 
lens wear are eligible to participate in this study 

Bruno Vision Care 
Protocol 22001 
Clinical Study Protocol 
Version 3.0, 26 April 2023 
 
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20. History of any corneal surgery (eg, refractive surgery or 
therapeutic) in either eye 
21. Any systemic disease currently affecting ocular health or 
which, in the Investigator’s opinion, may have an effect on 
ocular health in either eye during the course of the study 
22. Allergy to any component in the study care products 
23. Meet any of the following criteria: 
a. 
Subject is an employee of the investigative site 
b. 
Subject or a member of the subject’s household is an 
ophthalmologist, an optometrist, an optician, or an 
ophthalmic assistant/technician 
c. 
Subject or a member of the subject’s household is an 
employee of a manufacturer of contact lenses or 
contact lens care products  
d. 
Subject or a member of the subject’s household is an 
employee of a market research firm 
Planned study period 
and duration of 
treatment: 
The duration of lens wear (and duration of study participation) will be 
approximately 90 days. 
Test lens: 
The Deseyne (vifilcon C) investigational spherical soft hydrophilic 
lens is proposed to be indicated for the optical correction of refractive 
ametropia (myopia and hyperopia) in phakic and/or aphakic persons 
with non-diseased eyes with up to and including 1.00 D of 
astigmatism that does not interfere with VA. 
• Sphere power: -12.00 to +7.00 D 
• Diameter: 14.1 mm 
• Base curve: 8.6 mm 
• Material: vifilcon C 
Control lens:  
1-Day Acuvue Moist (etafilcon A) daily disposable soft contact lens 
(Vistakon): 
• Sphere power: -9.00 to +6.00 D 
• Diameter: 14.2 mm 
• Base curve: 8.5, 9.0 mm 
• Material: etafilcon A  

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Protocol 22001 
Clinical Study Protocol 
Version 3.0, 26 April 2023 
 
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Schedule of study 
visits:  
Visit Number 
Visit Name 
Target 
Acceptable Visit Range  
1 
Screening Visit 
None 
Day -30 to -7 
2 
Dispensing Visit 
Day 1 
Not applicable 
3 
1-Week Visit 
Day 8 
Day 5−9 
4 
1-Month Visit 
Day 31  
Day 27−35 
5 
2-Month Visit 
Day 61 
Day 54−68 
6 
3-Month/Exit Visit Day 92  
Day 91−101 
 
Primary effectiveness 
endpoints: 
There will be 2 primary effectiveness endpoints for the study:  
1. Change from baseline to each post-baseline visit in distance 
logMAR VA by eye 
2. Number and percentage of subjects, where there is no more 
than a 5−logMAR letters read loss from baseline (change 
from baseline in number of letters read ≥ -5). This is 
calculated by eye at each post-baseline visit. 
Secondary 
effectiveness 
endpoints: 
Secondary effectiveness endpoints will include distance VA; 
symptoms/complaints and subjective assessments; lens wettability, 
centration, and movement; and lens deposits at each post-baseline 
visit and the satisfaction survey (modified Visual Functioning 
Questionnaire) at the Screening and Exit Visits. 
Safety endpoints: 
The primary safety endpoint will be the proportion of eyes with any 
slit lamp findings (including corneal edema [epithelial, stromal], 
corneal infiltrates, corneal vascularization, corneal staining, palpebral 
conjunctival injection, and limbal injection) Grade >2 at any 
follow-up visit between the test and control lenses. 
Secondary safety endpoints will include adverse reactions (serious 
and incidental), adverse device effects, pinhole VA (for eyes with a 
2-line decrease in BCDVA or worse from baseline), conjunctival 
hyperemia as measured by the Cornea and Contact Lens Research 
Unit grading scale, keratometry, slit lamp biomicroscopy, 
spherocylindrical refraction, BCDVA, corneal fluorescein staining, 
lens discontinuation rates at any follow-up visit, and use of 
unpreserved lubricant eyedrops or artificial tears during the study. 
Statistics: 
All analyses will be descriptive in nature. A full declaration of 
planned statistical analyses will be documented in a formal Statistical 
Analysis Plan. 
Sample size: 
The sample size of approximately 80 subjects (160 eyes) is considered 
sufficient for evaluation of the clinical performance of the test and 
control lenses. The sample size was not based on statistical power 
considerations. A dropout rate of approximately 20% is expected; 

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Clinical Study Protocol 
Version 3.0, 26 April 2023 
 
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thus, approximately 60 subjects (120 eyes) are targeted to be 
described in this study.