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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT03372551
Eligibility Criteria:
Inclusion Criteria:
* Is at least 17 years of age and has full legal capacity to volunteer;
* Has had a self-reported oculo-visual examination in the last two years;
* Has read, understood, and signed the information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity);
* Must be able to achieve 20/30 or better (in each eye) with the study lenses;
* Currently wears soft contact lenses for at least 3 days per week, 8 hours each day;
* Requires spectacle lens powers between -0.75 and -06.50 diopters sphere (0.25D steps);
* Has no more than 0.75 diopters of refractive astigmatism;
* Has clear corneas and no active\* ocular disease;
* Has not worn lenses for at least 12 hours before the examination.
Exclusion Criteria:
* Is presently participating in any other clinical or research study including eye related clinical or research study;
* Has never worn contact lenses before.
* Has any systemic disease affecting ocular health.
* Has any active\* ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
* Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
* Has any known sensitivity to fluorescein dye or products to be used in the study.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Is aphakic.
* Has undergone corneal refractive surgery.
* Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
17 Years
Study:
NCT03372551
Study Brief:
Protocol Section:
NCT03372551