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)

Completed · Not applicable

Conditions studied: Presbyopia Condition

In brief

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.

Key facts

Study ID

NCT06698731

Run by

Bruno Vision Care

People needed

78

Starts

2024-10-28

Expected to finish

2025-01-15

Last updated by the study team

2026-03-17

Who can join

Age: 45 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 -

You may not qualify if…

• 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
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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