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

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.

• Control Lens (stenfilcon A) (Device): One week wear
• Test Lens (senofilcon A) (Device): One week wear

Primary outcomes

• 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)

Sex: All, ages: 18 Years to 35 Years

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.

Participant flow

Outcome results

• Lens Handling on Removal (Primary), Median, Units on a scale: Control Lens 90 +/- 18; Test Lens 95 +/- 8

Adverse events

Time frame: Duration of the study, approximately 2 weeks.

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2023-02-23)

• Gina Wesley, Principal investigator, Complete Eye Care of Medina
• Michael Cymbor, Principal investigator, Nittany Eye Associates
• Shane Kannarr, Principal investigator, Kannarr Eye Care
• Stephen Montaquila, Principal investigator, West Bay Eye Associates