Presbyopia ConditionEDOFNCT06698731
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)
A study testing Test lens in people with Presbyopia Condition, run by Bruno Vision Care at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia Condition
- What is being tested?
- Test lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Oct 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 45 to 70 years
- Presence of clear corneas
- Correction between -6.00 and +4.00 D in the spectacle plane
- Phakic and/or pseudophakic subjects
- Monocular best-corrected distance visual acuity (BCDVA) of 0.1 logMAR or better in the right eye
- Be an adapted soft contact lens wearer in each eye
- Able and willing to attend all scheduled sessions
- Able to read, understand, and provide written informed consent -
Who cannot join
- Anisometropia (spherical equivalent >2.00 D) in either eye
- Ocular astigmatism >1.00 D in either eye
- Monocular BCDVA worse than 0.3 logMAR in either eye
- Any corneal infiltrates in either eye
- Grade ≥2 slit lamp findings during Screening in either eye
- Any scar or neovascularization within the central 4 mm of the cornea during Screening in either eye
Show all 14Show fewer
- 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
- 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
- History of any corneal surgery, including refractive or laser surgery, in either eye
- 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
- 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
- Participation in any drug or device clinical investigation within 2 weeks prior to Screening or during the period of study participation
- Women of childbearing potential (those who are not surgically sterilized or postmenopausal) who are currently pregnant or breastfeeding
- Systemic disease or use of any systemic medications that may, in the opinion of the Investigator, interfere with normal lens wear
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Omega VisionCenter PA
Longwood, Florida, 32779
Kannarr Eye Care, LLC
Pittsburg, Kansas, 66762
West Bay Eye Associates
Warwick, Rhode Island, 02888
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Presbyopia Condition
- Being tested
- Test lens, Control lens
- Keywords
- presbyopia, extended focus
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test lensDevice
The test lens is the Deseyne Daily Disposable soft contact lens
Control lensDevice
The control lens is the 1-Day AcuVue Moist Daily Disposable single vision contact lens
| Study group | Role | What they receive |
|---|---|---|
| Test lens | Experimental | Participants wear the test lens first (before crossing over to the control lens) Receives: Device: Test lens |
| Control lens | Active comparator | Participants wear the control lens first (before crossing over to the test lens) Receives: Device: Control lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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).
Measured: Day 1
Secondary outcomes (2)
Mean Monocular (Study Eye Only) Photopic Distance-corrected Intermediate Visual Acuity (DCIVA) at 66 cm
Method defines measurement of visual acuity through the distance correction contact lens measured at a distance of 66 cm from the patient.
Measured: Day 1
Mean Monocular (Study Eye Only) Photopic Distance-corrected Near Visual Acuity (DCNVA) at 40 cm
Method is to test visual acuity through the distance contact lens correction at 40cm from the patient.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start28 Oct 2024
- Primary completion13 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Presbyopia ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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 Extended depth of focus (EDOF (test) to the 1-Day Acuvue Moist (etafilcon A) soft contact lens for Single Vision (control).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruno Vision Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- iuvo BioScience Operations, LLC
- Responsible party
- Sponsor
- Investigators
- Charlles Medical Director, MD, Study director, Oculos, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698731
- Sponsor's protocol ID
- 23001-2
- Acronym
- EDOF
- Status last verified
- Feb 2026
- First submitted
- 18 Nov 2024
- Last updated
- 17 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: No internal company decision has been reached regarding he publishing of completed studies.
Publications
Bakaraju RC, Ehrmann K, Ho A. Extended depth of focus contact lenses vs. two commercial multifocals: Part 1. Optical performance evaluation via computed through-focus retinal image quality metrics. J Optom. 2018 Jan-Mar;11(1):10-20. doi: 10.1016/j.optom.2017.04.003. Epub 2017 Jun 9.
PubMed 28606456MacRae S, Holladay JT, Glasser A, Calogero D, Hilmantel G, Masket S, Stark W, Tarver ME, Nguyen T, Eydelman M. Special Report: American Academy of Ophthalmology Task Force Consensus Statement for Extended Depth of Focus Intraocular Lenses. Ophthalmology. 2017 Jan;124(1):139-141. doi: 10.1016/j.ophtha.2016.09.039. Epub 2016 Oct 13. No abstract available.
PubMed 27743644Richdale K, Cox I, Kollbaum P, Bullimore MA, Bakaraju RC, Gifford P, Plainis S, McKenney C, Newman S, Tomiyama ES, Morgan PB. CLEAR - Contact lens optics. Cont Lens Anterior Eye. 2021 Apr;44(2):220-239. doi: 10.1016/j.clae.2021.02.005. Epub 2021 Mar 25.
PubMed 33775378Molina-Martin A, Pinero DP, Martinez-Plaza E, Rodriguez-Vallejo M, Fernandez J. Efficacy of Presbyopia-Correcting Contact Lenses: A Systematic Review. Eye Contact Lens. 2023 Aug 1;49(8):319-328. doi: 10.1097/ICL.0000000000001013.
PubMed 37418305Fedtke C, Sha J, Thomas V, Ehrmann K, Bakaraju RC. Impact of Spherical Aberration Terms on Multifocal Contact Lens Performance. Optom Vis Sci. 2017 Feb;94(2):197-207. doi: 10.1097/OPX.0000000000001017.
PubMed 27879499Morgan PB, Efron N, Woods CA; International Contact Lens Prescribing Survey Consortium. An international survey of contact lens prescribing for presbyopia. Clin Exp Optom. 2011 Jan;94(1):87-92. doi: 10.1111/j.1444-0938.2010.00524.x. Epub 2010 Oct 6.
PubMed 21039845Sivardeen A, Laughton D, Wolffsohn JS. Randomized Crossover Trial of Silicone Hydrogel Presbyopic Contact Lenses. Optom Vis Sci. 2016 Feb;93(2):141-9. doi: 10.1097/OPX.0000000000000780.
PubMed 26704141
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06698731
- Acronym / sponsor ID
- EDOF / 23001-2
- Conditions
- Presbyopia Condition
- Keywords
- presbyopia, extended focus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Bruno Vision CareIndustry (pharma, biotech, devices)
- Collaborators
- iuvo BioScience Operations, LLC
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 21 Nov 2024 (actual)
- Results
- Posted 17 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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 Extended depth of focus (EDOF (test) to the 1-Day Acuvue Moist (etafilcon A) soft contact lens for Single Vision (control).
| Arm | Type | Receives |
|---|---|---|
| Test lens | Experimental | Device: Test lensParticipants wear the test lens first (before crossing over to the control lens) |
| Control lens | Active comparator | Device: Control lensParticipants wear the control lens first (before crossing over to the test lens) |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 45 to 70 years
- Presence of clear corneas
- Correction between -6.00 and +4.00 D in the spectacle plane
- Phakic and/or pseudophakic subjects
- Monocular best-corrected distance visual acuity (BCDVA) of 0.1 logMAR or better in the right eye
Key exclusion criteria (14 listed)
- Anisometropia (spherical equivalent >2.00 D) in either eye
- Ocular astigmatism >1.00 D in either eye
- Monocular BCDVA worse than 0.3 logMAR in either eye
- Any corneal infiltrates in either eye
- Grade ≥2 slit lamp findings during Screening in either eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test lensThe test lens is the Deseyne Daily Disposable soft contact lens | Device | Test lens |
| Control lensThe control lens is the 1-Day AcuVue Moist Daily Disposable single vision contact lens | Device | Control lens |
Primary outcome
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).
2 secondary outcomes
Mean Monocular (Study Eye Only) Photopic Distance-corrected Intermediate Visual Acuity (DCIVA) at 66 cm
Time frame: Day 1
Mean Monocular (Study Eye Only) Photopic Distance-corrected Near Visual Acuity (DCNVA) at 40 cm
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28606456Bakaraju RC, Ehrmann K, Ho A. Extended depth of focus contact lenses vs. two commercial multifocals: Part 1. Optical performance evaluation via computed through-focus retinal image quality metrics. J Optom. 2018 Jan-Mar;11(1):10-20. doi: 10.1016/j.optom.2017.04.003. Epub 2017 Jun 9.
- Background: PubMed 27743644MacRae S, Holladay JT, Glasser A, Calogero D, Hilmantel G, Masket S, Stark W, Tarver ME, Nguyen T, Eydelman M. Special Report: American Academy of Ophthalmology Task Force Consensus Statement for Extended Depth of Focus Intraocular Lenses. Ophthalmology. 2017 Jan;124(1):139-141. doi: 10.1016/j.ophtha.2016.09.039. Epub 2016 Oct 13. No abstract available.
- Background: PubMed 33775378Richdale K, Cox I, Kollbaum P, Bullimore MA, Bakaraju RC, Gifford P, Plainis S, McKenney C, Newman S, Tomiyama ES, Morgan PB. CLEAR - Contact lens optics. Cont Lens Anterior Eye. 2021 Apr;44(2):220-239. doi: 10.1016/j.clae.2021.02.005. Epub 2021 Mar 25.
- Background: PubMed 37418305Molina-Martin A, Pinero DP, Martinez-Plaza E, Rodriguez-Vallejo M, Fernandez J. Efficacy of Presbyopia-Correcting Contact Lenses: A Systematic Review. Eye Contact Lens. 2023 Aug 1;49(8):319-328. doi: 10.1097/ICL.0000000000001013.
- Background: PubMed 27879499Fedtke C, Sha J, Thomas V, Ehrmann K, Bakaraju RC. Impact of Spherical Aberration Terms on Multifocal Contact Lens Performance. Optom Vis Sci. 2017 Feb;94(2):197-207. doi: 10.1097/OPX.0000000000001017.
- Background: PubMed 21039845Morgan PB, Efron N, Woods CA; International Contact Lens Prescribing Survey Consortium. An international survey of contact lens prescribing for presbyopia. Clin Exp Optom. 2011 Jan;94(1):87-92. doi: 10.1111/j.1444-0938.2010.00524.x. Epub 2010 Oct 6.
- Background: PubMed 26704141Sivardeen A, Laughton D, Wolffsohn JS. Randomized Crossover Trial of Silicone Hydrogel Presbyopic Contact Lenses. Optom Vis Sci. 2016 Feb;93(2):141-9. doi: 10.1097/OPX.0000000000000780.
- Individual participant dataSharing planned: Undecided. No internal company decision has been reached regarding he publishing of completed studies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlles Medical Director, MD study director
Oculos, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test lens in people with Presbyopia Condition, run by Bruno Vision Care at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06698731, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.