Dispensing Evaluation of Investigational Contact Lenses

Non-randomized, single-masked, 2-visit, bilateral wear, single-arm dispensing study to evaluate the visual acuity, rotational performance, lens fit, stability and subjective characteristics of a senofilcon-based JJVCI investigational toric contact lens design.


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.