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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT02341859
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 soft spherical contact lens wearer
* Has a contact lens spherical prescription between -4.00 to - 6.00 and higher than -7.00D (Diopters) (inclusive)
* Has a BFS (Best Fit Sphere) that is higher than 8.2 measured and calculated by corneal topography
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) 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
* Patient contact lens refraction should fit within the available parameters of the study lenses
* Is willing to comply with the wear schedule
* Is willing to comply with the visit schedule
Exclusion Criteria:
* Is not a habitual wearer of soft spherical contact lenses
* Has a contact lens prescription outside the range of the available parameters of the study lenses
* Has a contact lens 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 contact lens wear (5 days per week; \> 8 hours/day)
* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye
* Presence of clinically significant (grade \> 2) 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:
* Moderate to severe dry eye
* 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:
NCT02341859
Study Brief:
Protocol Section:
NCT02341859