Performance Evaluation of Daily Disposable Contact Lenses in Habitual Lens Wearers Who Use Digital Devices Frequently

Not Applicable

Completed

Interventions: Device: Control Lens (stenfilcon A)
Device: Test Lens (senofilcon A)

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

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;
1. No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys
2. 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.

Arm && Interventions

Group	Intervention	Description
Control Lens, Then Test Lens	Test Lens (senofilcon A)	Participants will wear control lenses for one week and then crossover to test lenses for one week.
Control Lens, Then Test Lens	Control Lens (stenfilcon A)	Participants will wear control lenses for one week and then crossover to test lenses for one week.
Test Lens, Then Control Lens	Control Lens (stenfilcon A)	Participants will wear test lenses for one week and then crossover to control lenses for one week.
Test Lens, Then Control Lens	Test Lens (senofilcon A)	Participants will wear test lenses for one week and then crossover to control lenses for one week.

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

Locations (4): Complete Eye Care of Medina
🇺🇸
Medina, Minnesota, United States
Kannarr Eye Care
🇺🇸
Pittsburg, Kansas, United States
Nittany Eye Associates
🇺🇸
State College, Pennsylvania, United States
West Bay Eye Associates
🇺🇸
Warwick, Rhode Island, United States