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 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT02299869
Eligibility Criteria:
Inclusion Criteria:
* Is between 18 and 40 years of age (inclusive).
* Has had a self-reported visual exam in the last two years.
* Is an adapted wearer of spherical soft contact lenses.
* Has a contact lens spherical prescription between - 1.00 and - 10.00 (inclusive).
* Has a spectacle cylinder up to 0.75 diopter (D) in each eye
* Can achieve best corrected spectacle distance visual acuity of 20/30 (0.18 logMAR) or better in each eye.
* Has clear corneas and no active ocular disease.
* Has read, understood and signed the information consent letter.
* Is willing to wear his/hers spectacles over the study contact lenses.
* Is willing to comply with the wear schedule.
* 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 contact lens wear (5 days per week; \> 8 hours/day)
* Has a contact lens prescription outside the range of - 1.00 to -10.00D.
* Has a spectacle cylinder ≥1.00D of cylinder in either eye.
* Does not have a pair of corrective spectacles at the time of the visit.
* Cannot achieve best corrected spectacle distance visual acuity of 20/30 (0.18 logMAR) or better in each eye.
* Presence of clinically significant (grade \> 2.0, scale 0-4) 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 such as:
* Pathological dry eye or associated findings
* Pterygium, pinguecula, or corneal scars within the visual axis
* Neovascularization \> 0.75 mm in from of the limbus
* Giant papillary conjunctivitis (GCP) worse than grade 1
* Anterior uveitis or iritis (past or present)
* Seborrheic eczema, Seborrheic conjunctivitis
* History of corneal ulcers or fungal infections
* Poor personal hygiene
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea.
* Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
* 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:
NCT02299869
Study Brief:
Protocol Section:
NCT02299869