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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT02637804
Eligibility Criteria:
Inclusion Criteria:
\- A person is eligible for inclusion in the study if he/she:
* Is over 18 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted daily disposable non-silicone hydrogel spherical contact lens wearer
* Can achieve best corrected spectacle distance visual acuity of 20/25 or better in each eye.
* Can achieve a distance visual acuity of 20/30 or better in each eye with the study contact lenses.
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter.
* Has a CL (Contact Lens) spherical prescription between - 0.75 and - 8.00 (inclusive)
* Is willing to comply with the wear schedule.
* Is willing to comply with the visit schedule
Exclusion Criteria:
\- A person will be excluded from the study if he/she:
* Is not a habitual wearer of daily disposable non-silicone hydrogel spherical contact lenses
* Has a CL prescription outside the range of the inclusion power range
* Has a spectacle cylinder ≥1.00D of cylinder in either eye.
* Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
* Has contact lens best corrected distance vision worse than 20/25 in either eye
* Presence of clinically significant (grade 2-4) anterior segment abnormalities
* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear
* Slit lamp findings that would contraindicate contact lens wear
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea.
* 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
Maximum Age:
40 Years
Study:
NCT02637804
Study Brief:
Protocol Section:
NCT02637804