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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT02956460
Eligibility Criteria:
Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
* Is between 18 and 40 years of age (inclusive)
* Has read, understood and signed the information consent letter
* Has had a self-reported eye exam in the last two years
* Is a spherical soft contact lens wearer
* Has a contact lens prescription that fits within the available parameters of the study lenses
* Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye
* 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
* Is willing and anticipated to be able to comply with the wear schedule (8 hours per day; 5 days a week of lens wear)
* Is willing and able to follow instructions and maintain the appointment schedule
Exclusion Criteria:
A person will be excluded from the study if he/she:
* Has a history of not achieving comfortable CL (Contact Lens) wear (defined as 5 days per week; \>8 hours/day)
* Is currently wearing senofilcon C (2 weeks lens), senofilcon A 1-Day, senofilcon C (monthly lens) or enfilcon A contact lenses
* Is habitually using rewetting/ lubricating eye drops more than once per day
* Presents with clinically significant anterior segment abnormalities
* Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear
* Presents with slit lamp findings that would contraindicate contact lens wear such as:
* Pathological dry eye or associated findings
* Significant 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 (or history in past year)
* Seborrheic eczema of eyelid region, 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02956460
Study Brief:
Protocol Section:
NCT02956460