Dispensing Evaluation of Investigational Contact Lenses

This is an interventional treatment trial for Myopia; Astigmatism Read More

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.