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| Name | Class |
|---|---|
| iuvo BioScience Operations, LLC | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test lens | Experimental | Participants wear the test lens first (before crossing over to the control lens) |
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| Control lens | Active Comparator | Participants wear the control lens first (before crossing over to the test lens) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test lens | Device | The test lens is the Deseyne Daily Disposable soft contact lens |
| |
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Mean Monocular (Study Eye Only) Photopic Distance-corrected Near Visual Acuity (DCNVA) at 40 cm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charlles Medical Director, MD | Oculos, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Omega VisionCenter PA | Longwood | Florida | 32779 | United States | ||
| Kannarr Eye Care, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28606456 | Background | 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. | |
| 27743644 | Background | MacRae 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. |
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No internal company decision has been reached regarding he publishing of completed studies.
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The same 78 participants wore both test and control lenses in the same (study) eye. Randomization was done to determine sequence (test group is test lens first, and control group is control lens first).
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Lens First | The Deseyne Daily Disposable contact lens (test lens) was used first, followed by crossover to the control lens. |
| FG001 | Control Lens First | The 1-Day Acuvue Moist Daily Disposable single vision contact lens (control lens) was used first, followed by crossover to the test lens. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 24, 2026 | Jan 27, 2026 |
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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).
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| Control lens |
| Device |
The control lens is the 1-Day AcuVue Moist Daily Disposable single vision contact lens |
|
Method is to test visual acuity through the distance contact lens correction at 40cm from the patient. |
| Day 1 |
| Pittsburg |
| Kansas |
| 66762 |
| United States |
| West Bay Eye Associates | Warwick | Rhode Island | 02888 | United States |
| 33775378 | Background | Richdale 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. |
| 37418305 | Background | Molina-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. |
| 27879499 | Background | Fedtke 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. |
| 21039845 | Background | Morgan 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. |
| 26704141 | Background | Sivardeen 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Lens First | The Deseyne Daily Disposable contact lens (test lens) was used first, followed by crossover to the control lens. |
| BG001 | Control Lens First | The 1-Day Acuvue Moist Daily Disposable single vision contact lens (control lens) was used first, followed by crossover to the test lens. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Pupil diameter OD | Pupil diameter in the right (study) eye | Mean | Standard Deviation | mm |
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| BCDVA without lenses OD | Best-corrected distance visual acuity without lenses in the right (study) eye | Mean | Standard Deviation | letters read |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All 77 eyes were analyzed for both Test and Control lenses | Posted | Mean | Standard Deviation | D | Day 1 | Eyes | Eyes |
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| Secondary | 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. | All 77 eyes were analyzed for both Test and Control lenses | Posted | Mean | Standard Deviation | logMAR | Day 1 | Eyes | Eyes |
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| Secondary | 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. | All 77 eyes were analyzed for both Test and Control lenses | Posted | Mean | Standard Error | logMAR | Day 1 | Eyes | Eyes |
|
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1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Lens | The Deseyne Daily Disposable contact lens was the test lens. | 0 | 78 | 0 | 78 | 0 | 78 |
| EG001 | Control Lens | The 1-Day Acuvue Moist Daily Disposable single vision contact lens was the control lens. | 0 | 78 | 0 | 78 | 0 | 78 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | iuvo Bioscience Operations, LLC | 813.690.0255 | chuck.slonim@oculoscr.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2026 | Jan 27, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Eyes |
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| Eyes |
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