A Randomized, Active-Controlled, Double-Masked, Crossover Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens for Presbyopia Extended Depth of Focus (EDOF)
Phase: NA
Conditions: Presbyopia Condition
Sponsor: Bruno Vision Care

Bruno Vision Care, LLC 
Protocol 23001-2 
Clinical Study Protocol 
Version 3.0, 30 Sep 2024 
 
Page 1 of 9 
 
A Randomized, Active-Controlled, Double-Masked, Crossover Study to Evaluate the Clinical 
Performance of Deseyne (vifilcon C) Daily Disposable Soft Contact Lens for Presbyopia 
Extended Depth of Focus (EDOF) 
 
Protocol 23001-2 
 
 
 
24JAN2026  
 
 

Bruno Vision Care, LLC 
Protocol 23001-2 
Clinical Study Protocol 
Version 3.0, 30 Sep 2024 
 
Page 2 of 9 
TITLE PAGE 
 
A Randomized, Active-Controlled, Double-Masked, Crossover Study to Evaluate the Clinical 
Performance of Deseyne (vifilcon C) Daily Disposable Soft Contact Lens for Presbyopia 
Extended Depth of Focus (EDOF)  
 
PROTOCOL 23001-2 
 
Sponsor: Bruno Vision Care, LLC 
 
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 Good 
Clinical Practice, and applicable local regulations. The Sponsor intends to register this clinical 
trial with the public database https://ClinicalTrials.gov. 
 
 
 
 
 
 
 
 
Revision Chronology:  
Original 
1.0 
11 Jun 2024 
Amendment 1 
2.0 
17 Jul 2024 
Amendment 2  
3.0 
30 Sep 2024 
 
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, LLC 
Protocol 23001-2 
Clinical Study Protocol 
Version 3.0, 30 Sep 2024 
 
Page 3 of 9 
SPONSOR APPROVAL PAGE 
 
A Randomized, Active-Controlled, Double-Masked, Crossover Study to Evaluate the Clinical 
Performance of Deseyne (vifilcon C) Daily Disposable Soft Contact Lens for Presbyopia 
Extended Depth of Focus (EDOF) 
 
PROTOCOL 23001-2 
 
Author: Jennifer Klem, PhD 
Approved by:  
 
 
 
_____________________________________ 
 
_____________________ 
Richard E. Lippman, OD, FAAO 
 
 
 
Date 
RE Lippman Regulatory Pathways 
301-580-3931 
Richard.lippman@gmail.com 
 
 
 
_____________________________________ 
 
_____________________ 
Eddie Catalfamo  
 
 
 
 
 
Date 
Sponsor Executive 
Bruno Vision Care, LLC  
646-239-2024 
e.catalfamo@brunopharma.com 
 
 
 
_____________________________________ 
 
_____________________ 
Charles Slonim, MD  
 
 
 
 
Date 
Medical Monitor 
iuvo BioScience Operations, LLC 
813-690-0255 
Chuck.slonim@oculoscr.com 

Bruno Vision Care, LLC 
Protocol 23001-2 
Clinical Study Protocol 
Version 3.0, 30 Sep 2024 
 
Page 4 of 9 
INVESTIGATOR STATEMENT OF APPROVAL 
 
A Randomized, Active-Controlled, Double-Masked, Crossover Study to Evaluate the Clinical 
Performance of Deseyne (vifilcon C) Daily Disposable Soft Contact Lens for Presbyopia 
Extended Depth of Focus (EDOF) 
 
PROTOCOL 23001-2 
 
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 Good Clinical 
Practice, 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 (EC) 
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, LLC 
Protocol 23001-2 
Clinical Study Protocol 
Version 3.0, 30 Sep 2024 
 
Page 5 of 9 
1. 
SYNOPSIS 
Title: 
A Randomized, Active-Controlled, Double-Masked, Crossover 
Study to Evaluate the Clinical Performance of Deseyne (vifilcon 
C) Daily Disposable Soft Contact Lens for Presbyopia Extended 
Depth of Focus (EDOF) 
 
Sponsor:  
Bruno Vision Care, LLC 
 
Phase of study: 
Effectiveness 
 
Study number: 
23001-2  
 
Number of study 
centers and 
subjects: 
Approximately 75 subjects will be treated at approximately 
3 investigational (non-institutional) sites in the United States. 
 
Objective: 
To evaluate improvements in near vision and EDOF with the 
Deseyne (vifilcon C) Daily Disposable Soft Contact Lens for 
Presbyopia EDOF 
 
Study design: 
A multicenter, randomized, active-controlled, double-masked, 
crossover study design will be used to compare the clinical 
performance of the Deseyne (vifilcon C) for Presbyopia EDOF 
soft contact lens (test) to the 1-Day Acuvue Moist (etafilcon A) 
soft contact lens for Single Vision (control).  
This is a 1-day crossover study and will consist of approximately 
75 subjects (75 study eyes [all study eyes will be right eyes]) 
randomly assigned in-office to wear the test or the control lens 
first. A 30-minute washout period will be scheduled between the 
crossover. Subjects must be otherwise healthy, with spectacle 
refraction between -6.00 and +4.00 D and astigmatism ≤1.00 D 
that does not interfere with visual acuity (VA). 
The Screening and Lens Fitting Visit (Visit 1) will determine 
eligibility for inclusion in the study, and subjects will be fitted 
with the test and control devices in both eyes. To maintain subject 
masking, each time study lenses are to be inserted (at Visit 1 and 
Visit 2), an unmasked technician will remove the foil labels from 
the assigned contact lens blister packs before giving the opened 
blister packs to the subject, who will insert both lenses. The 
Testing Visit (Visit 2) will be conducted in the manner described 
to assess vision with either the test or control lens followed by a 
30-minute washout period (after the first set of lenses is removed) 
followed by crossover to the second set of lenses. To maintain 
Investigator masking, the subject (not the Investigator) will 

Bruno Vision Care, LLC 
Protocol 23001-2 
Clinical Study Protocol 
Version 3.0, 30 Sep 2024 
 
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remove study lenses and immediately dispose of them. With this 
approach, the Investigator will not see the lenses either through 
the slit lamp or out of the subject’s eye. 
Subjects will wear their assigned lenses bilaterally only for the 
period required for testing. Lenses will not be dispensed to 
subjects for wear beyond the visit. This is a non-dispensing study. 
Subject selection: 
Inclusion Criteria: 
1. Age 45 to 70 years 
2. Presence of clear corneas 
3. Correction between -6.00 and +4.00 D in the spectacle 
plane  
4. Phakic and/or pseudophakic subjects 
5. Monocular best-corrected distance visual acuity (BCDVA) 
of 0.1 logMAR or better in the right eye 
6. Be an adapted soft contact lens wearer in each eye 
7. Able and willing to attend all scheduled sessions  
8. Able to read, understand, and provide written informed 
consent  
Exclusion Criteria: 
1. Anisometropia (spherical equivalent >2.00 D) in either eye 
2. Ocular astigmatism >1.00 D in either eye 
3. Monocular BCDVA worse than 0.3 logMAR in either eye 
4. Any corneal infiltrates in either eye 
5. Grade ≥2 slit lamp findings during Screening in either eye 
6. Any scar or neovascularization within the central 4 mm of 
the cornea during Screening in either eye 
7. History of ocular disease (eg, dry eye disease, blepharitis, 
conjunctivitis, ocular herpes simplex or herpes zoster, etc.) 
within 30 days prior to Screening in either eye 
8. History of gas-permeable lens wear within 30 days prior to 
Screening in either eye or history of "hard" contact lens 
wear within 3 months of Screening in either eye 
9. History of any corneal surgery, including refractive or laser 
surgery, in either eye  
10. Implantation or removal of absorbable punctal plug within 
6 months of Screening in either eye or permanent punctal 
occlusion in 1 or more puncta or nasolacrimal duct 
obstruction in either eye  

Bruno Vision Care, LLC 
Protocol 23001-2 
Clinical Study Protocol 
Version 3.0, 30 Sep 2024 
 
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11. Use of any prescription ocular medication or any over-the-
counter eyedrops within 1 week of Screening in either eye 
or during the period of study participation 
12. Participation in any drug or device clinical investigation 
within 2 weeks prior to Screening or during the period of 
study participation 
13. Women of childbearing potential (those who are not 
surgically sterilized or postmenopausal) who are currently 
pregnant or breastfeeding 
14. Systemic disease or use of any systemic medications that 
may, in the opinion of the Investigator, interfere with 
normal lens wear 
Planned study 
period and 
duration of 
treatment: 
Total duration of study participation is 2 visits (separated by no 
more than 1 month):  
1. Screening and Lens Fitting 
2. Testing  
The duration of lens wear is limited to the Testing Visit, during 
which vision testing will be performed in clinic.  
Test lens: 
The Deseyne (vifilcon C) Daily Disposable Soft Contact Lens for 
Presbyopia EDOF is proposed to be indicated for the optical 
correction of refractive ametropia (myopia and hyperopia) in 
non-diseased presbyopic eyes with ≤1.00 D of astigmatism that 
does not interfere with VA. 
• 
Sphere power: -6.00 to +4.00 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 for Single Vision (Vistakon): 
• 
Sphere power: -6.00 to +4.00 D 
• 
Diameter: 14.2 mm 
• 
Base curve: 9.0 mm 
• 
Material: etafilcon A  
Schedule of study 
visits:  
Visits and visit windows: 
1. Screening and Lens Fitting Visit: 14 to 2 days prior to the 
Testing Visit 
2. Testing Visit 

Bruno Vision Care, LLC 
Protocol 23001-2 
Clinical Study Protocol 
Version 3.0, 30 Sep 2024 
 
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Primary 
effectiveness 
endpoints: 
The primary effectiveness endpoint for the study is monocular 
(study [right] eye only) photopic negative lens-induced distance-
corrected depth of focus (DOF) at the 0.2 logMAR VA threshold. 
The statistical hypothesis is stated in terms of 1-sided hypotheses 
to reflect the superiority claims. 
H0: The monocular photopic negative lens-induced 
distance-corrected DOF with the test lens is smaller than 
0.5 D compared with the control lens. 
H1: The monocular photopic negative lens-induced 
distance-corrected DOF with the test lens is greater than or 
equal to 0.5 D compared with the control lens.  
The study eye will be used to evaluate this hypothesis. 
Secondary 
effectiveness 
endpoints: 
• Mean monocular (study eye only) photopic distance-
corrected intermediate visual acuity (DCIVA) at 66 cm  
The statistical hypothesis is stated in terms of 1-sided hypotheses 
to reflect the superiority claims. 
H0: The monocular photopic DCIVA with the test lens is 
less than or equal to the monocular photopic DCIVA with 
the control lens. 
H1: The monocular photopic DCIVA with the test lens is 
greater than the monocular photopic DCIVA with the 
control lens.  
• Mean monocular (study eye only) photopic distance-
corrected near visual acuity (DCNVA) at 40 cm 
The secondary effectiveness endpoints will be summarized 
descriptively over all visits by treatment group and eye for the ITT 
and PP populations. Comparisons between treatment groups will 
use the same analysis of covariance as for the primary 
effectiveness endpoint, but inferential results for the secondary 
effectiveness endpoints will be considered exploratory. 
No formal hypothesis will be tested for these endpoints. 
Additional 
analyses: 
• Defocus curves (study eye only) 
• Binocular contrast sensitivity (mesopic conditions with 
and without glare)  
• Age stratification into 2 age groups (<60 and ≥60 years) 
to identify the effect of EDOF as age increases 
• Pupil diameter (study eye) stratification into 3 tertiles 
• DCNVA stratification into 3 tertiles based on monocular 
(study eye) near VA with the control lens 

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Protocol 23001-2 
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Version 3.0, 30 Sep 2024 
 
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Statistical plan: 
All analyses will compare values between the test and control 
lenses. A full declaration of planned statistical analyses will be 
documented in a formal Statistical Analysis Plan. 
Sample size: 
The primary effectiveness endpoint is the monocular photopic 
negative lens-induced distance-corrected DOF. To test the 
hypothesis that the difference between test and control means is 
less than 0.5 D at alpha=0.025 using a 2×2 crossover design, 
75 subjects (75 study eyes) are required to achieve 90% power, 
assuming a standard deviation of the paired differences = 1.06 D 
and an observed difference of at least 0.90 D.