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.
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Administration (FDA) Premarket Notification 510(k) Guidance for Daily Wear Contact Lenses adopted in May 1994, and any unpublished subsequent policy declarations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
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.
Omega Vision Center PA
Longwood, Florida, United States
Kennaar Eye Care
Pittsburg, Kansas, United States
West Bay Eye Associates
Warwick, Rhode Island, United States
Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye
To assess each eye for the change from baseline to each post-baseline visit in distance logMAR VA (letters read)
Time frame: Baseline, Day 1, Week 1, Month 1, Month 2, Month 3
Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline
To assess the number and percentage of subjects with no more than 5 letters read loss from baseline
Time frame: Day 1, Week 1, Month 1, Month 2, Month 3
Slit Lamp Findings Grade >2 at Any Follow-Up Visit
To assess the following slit lamp findings: epithelial edema, epithelial microcysts, limbal injection, bulbar injection, upper lid tarsal conjunctival, corneal neovascularization, and corneal infiltrates
Time frame: 3 months
Symptoms/Complaints
This unnamed questionnaire measures change from baseline in discomfort, excessive tearing, photophobia, halos, itching/burning/spectacle blur, variable vision, blurred vision, lens needs cleaning, handling using a 0 (no symptoms) to 4 (severe symptoms) scale for each symptom
Time frame: Month 3
Lens Wettability, Centration, and Movement
Wettability Analog Scale 0-4 (0=100% wettable, 4=more than one dry spot greater than 0.5 mm) Lower score is better Centration Analog Scale 0-4 (0=superior cornea, 4=inferior cornea) Lower score is better Movement Analog Scale 0-4 (0=adequate, 4=adherence to cornea) Lower score is better
Time frame: 3 months
Lens Deposits
To assess type of deposit
Time frame: 3 months
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Masking
NONE
Enrollment
81