Performance Evaluation of Daily Disposable Contact Lenses in Habitual Lens Wearers Who Use Digital Devices Frequently
- Conditions
- Myopia
- Registration Number
- NCT05805150
- Lead Sponsor
- Coopervision, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
-
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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Lens Handling on Removal 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Kannarr Eye Care
🇺🇸Pittsburg, Kansas, United States
Complete Eye Care of Medina
🇺🇸Medina, Minnesota, United States
Nittany Eye Associates
🇺🇸State College, Pennsylvania, United States
West Bay Eye Associates
🇺🇸Warwick, Rhode Island, United States
Kannarr Eye Care🇺🇸Pittsburg, Kansas, United States