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) (EDOF)

February 24, 2026 updated by: Bruno Vision Care

The goal of this clinical trial is to learn if the contact lens we are testing will work to extend the range of clear focus at distance to provide an increase in clear vision at closer ranges without the additional need for bifocal lenses or reading correction.

The clinical study will compare the use of the test lens for extended range of focus (far to near) to a standardized contact lens designed for distance vision (far) (ie. Walking, driving, etc., where closer-in vision is not anticipated to be helpful, particularly in a population of users in the age range of 45-70.

We will also learn about the effectiveness of the lens to maintain good contrast in low illumination such as during evening and night-time periods.

The main questions we aim to address in the study are:

*. Does the contact lens provide adequate vision at distances closer to the patient such as during reading or computer usage?

* Whether the contact lens in use introduces any visual disturbance or safety concern as compared to a currently designed lens for distance use?

The study is designed to be conducted in the doctor's office:

  • Using electronic vision measuring equipment familiar to the user.
  • A total of two visits are necessary to complete he study
  • All patients will experience using the test lens as well as the control lens during the study
  • No contâct lenses will be given to the study patients to take home.
  • It is anticipated that the total amount of time of participation in the study will be approximately 3 hours of your time over two separate visits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Deseyne daily disposable soft contact lens is intended for the correction of presbyopia and considered to be one of the growing class of extended depth of focus (EDOF) devices that uses a variety of strategies to provide useful intermediate and near vision. The lens is manufactured with vifilcon C material containing hyaluronic acid and tamarind seed polysaccharide, with a water content of 60% in a single diameter of 14.1 mm and base curve of 8.6 mm. The profile of the anterior surface is spherical across the 11-mm optic. Centrally, there is a 1.0 mm diameter zone that is optically inactive, contiguous with the optical zone. Light passes through the zone but is not intended to form a usable image. The central steep zone is at least 8.00 D steeper than the optical zone. The non-focusing central zone is intended to provide for an increased depth of focus, thus improving near and intermediate vision for the presbyopic patient.

Deseyne (vifilcon C) daily disposable soft contact lenses are proposed to be indicated for the optical correction of refractive ametropia (myopia and hyperopia) in non-diseased eyes with up to 1.00 D of astigmatism that does not interfere with visual acuity (VA).

A multicenter, randomized, active-controlled, double-masked, crossover study design will be used to compare the clinical performance of the Deseyne (vifilcon C) soft contact lens for Presbyopia EDOF (test) to the 1-Day Acuvue Moist (etafilcon A) soft contact lens for Single Vision (control). This is a 1-day crossover study (conducted over 2 visits) 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 -6.00D and +4.00 D and astigmatism ≤1.00 D that does not interfere with VA.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Longwood, Florida, United States, 32779
        • Omega VisionCenter PA
    • Kansas
      • Pittsburg, Kansas, United States, 66762
        • Kannarr Eye Care, LLC
    • Rhode Island
      • Warwick, Rhode Island, United States, 02888
        • West Bay Eye Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test lens
Participants wear the test lens first (before crossing over to the control lens)
Device: Test lens
The test lens is the Deseyne Daily Disposable soft contact lens
Active Comparator: Control lens
Participants wear the control lens first (before crossing over to the test lens)
Device: Control lens
The control lens is the 1-Day AcuVue Moist Daily Disposable single vision contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Day 1
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.. This is accomplished by adding small incremental negative lens power over the distance best corrected vision correction until blurred vision is determined (study eye only).
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Monocular (Study Eye Only) Photopic Distance-corrected Intermediate Visual Acuity (DCIVA) at 66 cm
Time Frame: Day 1
Method defines measurement of visual acuity through the distance correction contact lens measured at a distance of 66 cm from the patient.
Day 1
Mean Monocular (Study Eye Only) Photopic Distance-corrected Near Visual Acuity (DCNVA) at 40 cm
Time Frame: Day 1
Method is to test visual acuity through the distance contact lens correction at 40cm from the patient.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bruno Vision Care

Collaborators

iuvo BioScience Operations, LLC

Investigators

  • Study Director: Charlles Medical Director, MD, Oculos, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2024

Primary Completion (Actual)

January 13, 2025

Study Completion (Actual)

January 15, 2025

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Actual)

November 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23001-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

No internal company decision has been reached regarding he publishing of completed studies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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