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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT00349856
Eligibility Criteria:
Inclusion Criteria:
1. Has had an oculo-visual examination in the last 2 years.
2. Is between 18-45 years old and has full legal capacity to volunteer.
3. Has read and understood the Information Consent Letter
4. Is willing and able to follow participant instructions for product usage and meet the protocol-specified schedule of follow-up visits.
5. Is correctable with the prescription of the available lenses (-1.00 to -4.00 DS in 0.50D step).
6. Is correctable to at least 20/40 distance visual acuity with contact lenses in each eye.
7. Is a current soft contact lens wearer (both daily wear and extended wear experience allowed).
8. Has refractive astigmatism of \<= 1.00 diopters
9. Has clear corneas and ocular clinical findings considered to be "normal".
Exclusion Criteria:
1. Has any systemic disease affecting ocular health.
2. Is using any systemic or topical medications that will affect ocular health.
3. Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
4. Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities.
5. Has limbal injection, bulbar injection or corneal staining that, in the Investigator's opinion, is clinically significant.
6. Has never worn contact lenses before.
7. Has corneal distortion resulting from rigid lens wear.
8. Is aphakic.
9. Has undergone corneal refractive surgery.
10. Is participating in any other type of clinical or research study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00349856
Study Brief:
Protocol Section:
NCT00349856