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:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT03209505
Eligibility Criteria:
Inclusion Criteria:
1. Must be able to read and understand the study informed consent
2. Must be a minimum of 18 years of age and less than 46 years of age at study enrollment
3. Must be healthy non-soft contact lens wearers (neophytes), or experienced contact lens wearers that have not worn their contact lenses for a minimum of 7 days
4. Have a spherical equivalent refractive error between -0.75 to -6.50DS at the spectacle plane
5. The subject must be able to attend study visits at the prescribed visit times and adhere to the study instructions
Exclusion Criteria:
1. Pregnant and/or lactating females by self-report
2. Presence of current LWE on the upper eyelid (\>0.5 in height or width)
3. Has greater than -1.00DC of refractive cylinder
4. Has greater than 1.00D of anisometropia
5. Is aphakic
6. Has clinically significant corneal or conjunctival staining that would prevent contact lens fitting, as assessed with sodium fluorescein dye
7. Has significant ocular surface disease (e.g. Sjögrens Disease, Stevens-Johnson Syndrome, etc.) or significant Dry Eye Syndrome
8. Has clinically significant corneal vascularization or central corneal scaring
9. Has active ocular surface infection (e.g. conjunctivitis)
10. Has a positive history of eyelid surgery or trauma
11. Has a positive history of refractive surgery
12. Takes medications that significantly impact contact lens comfort and/or ocular surface health
13. Has taken part in another contact lens or contact lens solution clinical trial within the last 7 days
14. Is unwilling to have eyes photographed or video recorded
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
46 Years
Study:
NCT03209505
Study Brief:
Protocol Section:
NCT03209505