dispensing evaluation of investigational contact lenses

Conditions: Myopia; Astigmatism

Summary: 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.