At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A clinical study evaluating Test lens and Control lens for Presbyopia Condition. Completed, enrolled 78 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
The test lens is the Deseyne Daily Disposable soft contact lens
The control lens is the 1-Day AcuVue Moist Daily Disposable single vision contact lens