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)

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.

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.

Conditions

• Presbyopia Condition

Interventions

DEVICE

Test lens

The test lens is the Deseyne Daily Disposable soft contact lens

DEVICE

Control lens

The control lens is the 1-Day AcuVue Moist Daily Disposable single vision contact lens

Sponsors & Collaborators

• iuvo BioScience Operations, LLC

  collaborator UNKNOWN

• Bruno Vision Care

  lead INDUSTRY

Principal Investigators

• Charlles Medical Director, MD · Oculos, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

45 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-10-28

Primary Completion

2025-01-13

Completion

2025-01-15

FDA Device

Yes

Countries

• United States

Study Locations