NCT05927753

Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens

A Randomized, Active-Controlled, Open-Label Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Bruno Vision Care · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This clinical study is to provide clinical performance data comparing the test lens (Deseyne \[vifilcon C\] daily disposable soft contact lens) to a control lens (1-Day Acuvue Moist \[etafilcon A\] daily disposable soft contact lens) in the same indication for use (single use prior to removal followed by a fresh lens upon the next lens wear exposure). The study is designed to test the hypothesis that the test lens is substantially equivalent to the control lens in like indications for use.

Detailed description

A multicenter, randomized, active-controlled, open-label study design will be used to compare the clinical performance of the Deseyne (vifilcon C) test soft contact lens to the similarly indicated 1-Day Acuvue® Moist® (etafilcon A) control soft contact lens. Study participation is approximately 90 days in duration and will consist of approximately 80 subjects assigned in a 2:1 ratio to test or control lens bilaterally, respectively. Subjects must be otherwise healthy, with myopia between -1.00 D and -6.00 D and astigmatism no greater than 1.00 D that does not interfere with VA. At the Screening Visit, approximately two-thirds of the eligible subjects will be randomized to receive the test lens (Deseyne \[vifilcon C\] lenses) and the other one-third eligible subjects will be randomized to receive the control lens (1-Day Acuvue Moist \[etafilcon A\] lenses). At the Dispensing Visit (Visit 2), subjects will be provided with test or control lenses as part of the dispensing package, along with instructions for the use and care of the lenses. They will be recommended unpreserved lubricating/rewetting solution for use as needed during the study. Subjects will wear their assigned lenses bilaterally on a daily wear basis, for a minimum of 6 hours/day throughout the study (no maximum time is mandated, as long as subjects do not sleep in their lenses), with additional visits planned for 1 Week (Visit 3), 1 Month (Visit 4), 2 Months (Visit 5), and 3 Months/Exit Visit (Visit 6). This study follows United States Food and Drug Administration (FDA) Premarket Notification 510(k) Guidance for Daily Wear Contact Lenses adopted in May 1994, and any unpublished subsequent policy declarations.

Conditions

• Refractive Error - Myopia Bilateral

Interventions

Type	Name	Description
DEVICE	Deseyne Daily Disposable Contact Lens (Test Device)	Comparison of contact lens performance between the test lens under study (Deseyne Daily Disposable Contact Lens) and the control lens f(1-Day Acuvue Moist Contact Lens) for safety and effectiveness.

Timeline

• Start date: 2023-06-08
• Primary completion: 2024-01-08
• Completion: 2024-01-08
• First posted: 2023-07-03
• Last updated: 2025-10-02
• Results posted: 2025-03-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study