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 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT02625220
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult males or females that are ≥18 years of age and ≤39 years of age.
* The subject must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* The subject must be a habitual toric contact lens wearer. Habitual wearer is defined as someone who wears toric lenses for at least 6 hours a day, 5 days a week for the past 30 days.
* Subject's vertex corrected spherical component of their distance refraction must be between -1.50 Diopters Sphere (DS) to -4.00 DS (inclusive) in each eye.
* Subject's vertex corrected refractive cylinder must be between -0.75 and -1.50 Diopters Cylinder (DC) (inclusive) in each eye.
* Subject's refractive cylinder axis must be within 180±15° and 90±15° in each eye.
* If needed, the subject must have a wearable pair of spectacles with 20/30 or better vision Ocular Uterque (OU). If spectacles are not needed, the subject must have 20/40 or better vision OU without correction.
* Subject's best corrected distance acuity must be 20/25-2 or better in each eye.
Exclusion Criteria:
* Females who are currently pregnant or lactating.
* Any ocular or systemic allergies or diseases that may contraindicate contact lens wear.
* Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, and/or Stevens-Johnson syndromes, by self-report.
* Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report.
* Habitual wearer of extended wear contact lenses.
* Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
* History of seizures.
* Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by report.
* History of binocular vision abnormality or strabismus, by self-report.
* Habitual wearer of rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
* Employee and family members of employee of investigational clinic (e.g., Investigator, Coordinator, Technician).
* Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
* Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA classification scale.
* Any history of a contact lens-related corneal inflammatory event within the past year that may contraindicate contact lens wear.
* Any active ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Any fluctuations in vision due to clinically significant dry eye or other ocular conditions.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT02625220
Study Brief:
Protocol Section:
NCT02625220