Clinical Evaluation of Two Toric Contact Lenses in Current Non-toric Lens Users

Inclusion criteria

Subjects must satisfy the following conditions prior to inclusion in the study:

• One of the following:

• Spherical contact lens user (minimum of 2 months wear, four days a week, 8 hours a day)
• Contact Lens drop-out (no contact lens wear in the last 6 months but wearing glasses at least four days a week,8 hours a day)
• Neophyte (no habitual contact lens wear except for trial fits up to 1 week, but wearing glasses at least four days a week,8 hours a day For patients not currently wearing lenses, patient should have expressed a desire to try lenses.
• Between 16 and 60 years of age.
• Have signed an informed consent form (documented by the investigator in the Case Report Form [CRF]).
• Distance requirement in the range of +4.00D to -9.00D (i.e. -10.00D refractive)
• Refractive astigmatism between -0.75D and -3.00D in both eyes.
• Have best corrected VA of 6/9 (20/30) or better in each eye.
• Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having:

• No amblyopia.
• No evidence of lid abnormality or infection.
• No conjunctival abnormality or infection.
• No clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, vascularisation, infiltrates or abnormal opacities).
• No other active ocular disease.
• Presbyopes may be included (no monovision, no spectacles over contact lenses or bifocal glasses only)

Exclusion criteria

Any of the following will render a subject ineligible for inclusion:

• Requires concurrent ocular medication.
• Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularisation, tarsal abnormalities, bulbar hyperaemia, limbal hyperaemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
• Corneal staining Grade 3 in more than two regions.
• Extended wear in the last 3 months.
• Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study.
• Abnormal lachrymal secretions.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Keratoconus or other corneal irregularity.
• Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
• Has diabetes.
• Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
• Pregnancy, lactating, or planning a pregnancy at the time of enrollment.
• Participation in any concurrent clinical trial or in last 60 days.