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NCT06698731: EDOF

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 NA Results posted Last updated 17 March 2026
What this trial tests

NA trial testing Test lens in Presbyopia Condition in 78 participants. Completed in 15 January 2025.

Timeline
28 October 2024
Primary endpoint
13 January 2025
15 January 2025

Quick facts

Lead sponsorBruno Vision Care
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment78
Start date28 October 2024
Primary completion13 January 2025
Estimated completion15 January 2025
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Bruno Vision Care — full company profile →

Who can join

Adults 45 to 70, any sex, with Presbyopia Condition. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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. Primary · 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).

GroupValue95% CI
Test-2.22± 0.774
Control-1.44± 0.672
Mean Monocular (Study Eye Only) Photopic Distance-corrected Intermediate Visual Acuity (DCIVA) at 66 cm Secondary · Day 1

Method defines measurement of visual acuity through the distance correction contact lens measured at a distance of 66 cm from the patient.

GroupValue95% CI
Test0.015± 0.1135
Control0.158± 0.1360
Mean Monocular (Study Eye Only) Photopic Distance-corrected Near Visual Acuity (DCNVA) at 40 cm Secondary · Day 1

Method is to test visual acuity through the distance contact lens correction at 40cm from the patient.

GroupValue95% CI
Test0.196± 0.1145
Control0.353± 0.1707

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Test lens

Trials testing the same drug.

Other Bruno Vision Care trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06698731.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing