Performance Evaluation of Different Daily Disposable Contact Lenses in Habitual Lens Wearers Who Report Frequent Use of Digital Devices
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- CooperVision, Inc.
- Enrollment
- 69
- Locations
- 4
- Primary Endpoint
- Lens Handling on Removal
Study Overview
Brief Summary
The goal of this study is to compare the performance of two daily disposable silicone hydrogel lenses.
Detailed Description
This study is prospective, bilateral eye, double masked, randomized, 1 week cross-over, daily wear design involving in two different daily disposable lens types. Each lens type will be worn for approximately one week.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Self-reports having a full eye examination in the previous two years;
- •Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;
- •Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Habitually wears soft contact lenses, for the past 3 months minimum;
- •No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys
- •No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day.
- •Has refractive astigmatism no higher than -0.75DC in each eye;
- •Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere -1.00 to -6.00D, 0.25D steps).
Exclusion Criteria
- •Is participating in any concurrent clinical or research study;
- •Has any known active ocular disease and/or infection that contraindicates contact lens wear;
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- •Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
- •Has known sensitivity to the diagnostic sodium fluorescein used in the study;
- •Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
- •Has undergone refractive error surgery or intraocular surgery.
Arms & Interventions
Control Lens, Then Test Lens
Participants will wear control lenses for one week and then crossover to test lenses for one week.
Intervention: Test Lens (senofilcon A) (Device)
Test Lens, Then Control Lens
Participants will wear test lenses for one week and then crossover to control lenses for one week.
Intervention: Control Lens (stenfilcon A) (Device)
Test Lens, Then Control Lens
Participants will wear test lenses for one week and then crossover to control lenses for one week.
Intervention: Test Lens (senofilcon A) (Device)
Control Lens, Then Test Lens
Participants will wear control lenses for one week and then crossover to test lenses for one week.
Intervention: Control Lens (stenfilcon A) (Device)
Outcomes
Primary Outcomes
Lens Handling on Removal
Time Frame: Collected once on day 6 at the end of wear
Ease of lens removal on a 0-100 scale (0= very difficult, 100= very easy)
Secondary Outcomes
No secondary outcomes reported