Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT05805150
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT05805150
Study Brief:
Protocol Section:
NCT05805150