Performance of Two Silicone Hydrogel Toric Contact Lenses

• Lens Orientation [ Time Frame: 1 minute after insertion ] [ Designated as safety issue: No ]
  Proportion of eyes with lens orientation within 5 degrees of optimal
• Lens Stability [ Time Frame: 10-15 minutes after insertion ] [ Designated as safety issue: No ]
  Lens stability is measured as the amount of rotation induced from blink after the lens has settled.
• Subjective Comfort [ Time Frame: 2 weeks of lens wear ] [ Designated as safety issue: No ]
  Subjective comfort was derived from a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. >0 = comfortable, < 0 = uncomfortable. Combined measures from Week 1 and Week 5.

• Time to Fit Lens [ Time Frame: after lens insertion ] [ Designated as safety issue: No ]
  Time required for the optometrist to fit the lens.
• Subjective Lens Vision [ Time Frame: measured at 1 and 2 weeks ] [ Designated as safety issue: No ]
  A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response was used to derive vision outcomes. >0 = satisfactory vision, < 0 = unsatisfactory vision. Analysis is performed on combined 1 week and 2 week data.
• Overall Corneal Staining [ Time Frame: After 2 weeks use ] [ Designated as safety issue: No ]
  National Eye Institute 0-3 Scale: Grade 0 = Normal, Grade 1 = Mild, superficial stippling, Grade 2 = Moderate, punctuate staining including superficial abrasion of the cornea, Grade 3 = Severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.

• Visual acuity (Snellen VA to nearest letter) [ Time Frame: 30 minutes and 2 weeks ] [ Designated as safety issue: Yes ]
• General contact lens fit [ Time Frame: 30 mintues and 2 weeks ] [ Designated as safety issue: No ]
• Slit lamp findings [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: Yes ]
• Subjective comfort [ Time Frame: measured at 1 and 2 weeks ] [ Designated as safety issue: No ]
• Subjective vision [ Time Frame: measured at 1 and 2 weeks ] [ Designated as safety issue: No ]
• Corneal staining by corneal sector (NEI scale) [ Time Frame: After 2 weeks use ] [ Designated as safety issue: Yes ]

Evaluation of the clinical performance of two toric contact lenses in a 2-week, single masked (subject), daily wear, randomized, bilateral, parallel group study.

• Device: senofilcon A toric
  silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
  Other Name: ACUVUE OASYS
• Device: balafilcon A toric
  silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
  Other Name: PureVision Toric

• Experimental: senofilcon A toric
  senofilcon A, daily wear, toric contact lens worn for two weeks
  Intervention: Device: senofilcon A toric
• Active Comparator: balafilcon A toric
  balafilcon A, daily wear, toric contact lens worn for two weeks
  Intervention: Device: balafilcon A toric

Inclusion Criteria:

• Be between 18 and 45 years of age.
• Sign Written Informed Consent (See separate document).
• Be an existing successful daily wear toric soft contact lens.
• Require a visual correction in both eyes (monovision or uniocular fitting is NOT allowed).
• Does not require presbyopic correction (can read J1 @ normal reading distance).
• Have a sphere requirement in the range -1.00 and -5.00D (-5.25D refractive)
• Have refractive astigmatism between 0.75D and 2.50D in both eyes.
• Achieve visual acuity of 20/30 or better in each eye with spherical distance correction.

• Have normal eyes with no evidence of abnormality or disease. For the purposes 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 edema, vascularisation, infiltrates or abnormal opacities).
  • No other active ocular disease.

Exclusion Criteria:

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