The aim of this prospective study is to evaluate the clinical performance of filcon IV1 toric and ocufilcon D toric contact lenses after 1 week of wear in each pair.

This is a 30-subject, prospective, randomized, double masked, bilateral, 1 week cross-over study comparing the fitting characteristics of filcon IV1 toric lenses against ocufilcon D hydrogel toric lenses.

Inclusion Criteria:

• A person is eligible for inclusion in the study if he/she:

  • Is between 18 and 40 years of age (inclusive)
  • Has had a self-reported visual exam in the last two years
  • Is an adapted soft toric contact lens wearer
  • Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)
  • Have no less than -0.75D of astigmatism and no more than -2.00 D in both eyes.
  • Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
  • Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
  • Has clear corneas and no active ocular disease
  • Has read, understood and signed the information consent letter.
  • Patient contact lens refraction should fit within the available parameters of the study lenses.
  • Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
  • Is willing to comply with the visit schedule

Exclusion Criteria:

• A person will be excluded from the study if he/she:

  • Has a CL prescription outside the range of the available parameters of the study lenses.

  • Has a spectacle cylinder less than -0.75D or more than -2.00 D of cylinder in either eye.

  • Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)

  • Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.

  • Presence of clinically significant (grade 2-4) anterior segment abnormalities

  • Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. Confidential EX-MKTG-66 Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear 10

  • Slit lamp findings that would contraindicate contact lens wear such as:

    • Pathological dry eye or associated findings
    • Pterygium, pinguecula, or corneal scars within the visual axis
    • Neovascularization > 0.75 mm in from of the limbus
    • Giant papillary conjunctivitis (GCP) worse than grade 1
    • Anterior uveitis or iritis (past or present)
    • Seborrheic eczema, Seborrheic conjunctivitis
    • History of corneal ulcers or fungal infections
    • Poor personal hygiene

  • Has a known history of corneal hypoesthesia (reduced corneal sensitivity)

  • Has aphakia, keratoconus or a highly irregular cornea.

  • Has Presbyopia or has dependence on spectacles for near work over the contact lenses.

  • Has undergone corneal refractive surgery.

  • Is participating in any other type of eye related clinical or research study.

There was 1 protocol deviation. Therefore, of the 30 subjects who completed the study, data from one subject is not included in the analysis.