A Non-dispensing Fit Evaluation of Investigational Limbal Ring Soft Contact Lenses With Polyvinylpyrrolidone (PVP) in Asian Eyes

Inclusion criteria

• 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 the clinical protocol.
• The subject must be an Asian female (self-reported).
• The subject must be at least 18 years old and less than 41 years old.
• The subject must meet two of the four East Asian anatomical categories (Appendix D) and have a prominent epicanthic fold to be classified East Asian ethnicity. For the purpose of this protocol, East Asian ethnicities may include: China, Japan, Korea, Taiwan, Vietnam, Hong Kong, Malaysia, and Singapore but are not inclusive of these regions.
• The subject must be a habitual soft contact lens wearer. Habitual is defined as: at least one month of daily wear where the lenses are worn a minimum of six (6) hours per day and a minimum of three (3) days per week prior to enrollment in the study.
• The subject's optimal non-vertexed spherical equivalent distance correction (based on their optimal sphero-cylinder refraction) must be between +2.00 D and -12.00 D.
• Any cylinder power must be less than or equal to -1.00 D confirmed by refraction.
• The subject must possess a functional/usable pair of spectacles and wear them to the visit (only if applicable-to the investigator's discretion).
• The subject's best correctable visual acuity is 20/40 or better (OD and OS) at the baseline visit.

Exclusion criteria

• Ocular or systemic allergies which might interfere with contact lens wear.
• Ocular or systemic disease which might interfere with contact lens wear.
• Any known hypersensitivity or allergic reaction to contact lenses or contact lens solutions.
• Use of any ocular or topical medication.
• Use of any systemic (oral) medication that is taken for an ocular condition which might interfere with contact lens wear.
• Use of any systemic (oral) medication that is taken for a systemic condition which might interfere with the contact lens wear (this determination will be at the discretion of the investigator).
• Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection or any other abnormalities of the cornea and/or conjunctiva which would contraindicate contact lens wear.
• Rigid gas permeable or hybrid design (rigid gas permeable center and a soft lens skirt) contact lens wear within the past 30 days.
• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
• Any previous or planned (during duration of the study), ocular or intraocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), peripheral iridotomy, etc.)
• Pregnancy or lactation.
• Diabetes.
• Infectious disease.
• Habitual contact lens type is multifocal, monovision or worn as extended wear.
• Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
• Suspicion of or recent history od alcohol or substance abuse.
• History of serious mental illness.
• History of seizures.
• Employee or family member of the investigational clinic (e.g. Investigator, Coordinator, Technician).