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 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT02196766
Eligibility Criteria:
Inclusion Criteria:
* Is over 18 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is currently an adapted spherical soft CL wearer
* Has a CL spherical prescription between - 0.25 and - 12.00 (inclusive)
* Has less than 1.00D spectacle cylinder in each eye.
* Is correctable to a visual acuity of 20/20 or better in both eyes
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter.
* Is willing to comply with the wear schedule (at least 40 hrs per week)
* Is willing to comply with the visit schedule
Exclusion Criteria:
* Has never worn contact lenses before.
* Currently wears rigid gas permeable contact lenses.
* Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
* Has a CL prescription outside the range of - 0.25 to -12.00D
* Has a spectacle cylinder greater than -0.75D of cylinder in either eye.
* Has best corrected spectacle distance vision worse than 20/20 in either eye.
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that will affect ocular health.
* Has any ocular pathology or severe insufficiency of lacrimal secretion
* Has persistent, clinically significant corneal or conjunctival staining
* Has active neovascularization or any central corneal scars.
* Is aphakic.
* Is pregnant or lactating.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02196766
Study Brief:
Protocol Section:
NCT02196766