Clinical Evaluation of Investigational Multifocal Toric Contact Lenses

Clinical Evaluation of Biofinity Multifocal Toric Contact Lenses

This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).

This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).

Inclusion Criteria:

• Has had a self-reported oculo-visual examination in the last two years.
• Is aged 40-75 years, inclusive and has full legal capacity to volunteer.
• Has read and understood the participant information sheet.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Is able to participate in Parts A and B related to this work.
• Has a contact lens spherical prescription between +10.00 to -10.00D (inclusive).
• Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).
• Has astigmatism between -0.75 and -5.75DC (based on the vertexed ocular refraction in each eye.
• Can be satisfactorily fitted with the study lenses.
• Is correctable to a visual acuity of 20/40 (0.30 logMAR) or better (in each eye) with their habitual vision correction or 20/25 (0.10 logMAR) best-corrected.
• They have successfully worn soft contact lenses in the last six months
• Has clear corneas and no active ocular disease.
• Has not worn lenses for at least 12 hours before the examination.
• Has an up-to-date pair of spectacles.

Exclusion Criteria:

• Has never worn contact lenses before.
• Has any systemic disease affecting ocular health.
• Is using any systemic or topical medications that will affect ocular health.
• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would, in the opinion of the investigator, affect the wearing of contact lenses.
• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye that would, in the opinion of the investigator, be problematic for their participation in the study.
• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
• Is aphakic.
• Has undergone corneal refractive surgery.
• Has a history of anaphylaxis or severe allergic reaction.
• Has diabetes or an infectious or immunosuppressive disease which could contraindicate contact lens wear or pose a risk to the investigator.
• They are pregnant or breast-feeding.
• Is participating in any other type of eye-related clinical or research study.