Dispensing Evaluation of a New Galyfilcon A Prototype and Biofinity® Lenses

• Visual acuity assessment [ Time Frame: 10-15 minutes after lens insertion ] [ Designated as safety issue: No ]
  Visual acuity assessed by the eye doctor using an eye chart.
• Subject reported comfort [ Time Frame: after 6-8 days lof ens wear ] [ Designated as safety issue: No ]
  Subject reported comfort using a survey.
• Subject reported vision [ Time Frame: after 6-8 days of lens wear ] [ Designated as safety issue: No ]
  Subject reported vision using a survey.

• Limbal redness assessment [ Time Frame: after 6-8 days of lens wear ] [ Designated as safety issue: No ]
  Eye doctor assessment of limbal redness using a slit lamp.
• Bulbar redness assessment [ Time Frame: after 6-8 days of lens wear ] [ Designated as safety issue: No ]
  Eye doctor assessment of bulbar redness using a slit lamp.
• Post lens fitting comfort assessment [ Time Frame: 10-15 minutes after lens insertion ] [ Designated as safety issue: No ]
  Subject reported comfort, using a survey, after the eye doctor fit the subject with lenses.

The purpose of this study is to compare the visual acuity and the limbal and bulbar redness of the new galyfilcon A prototype lenses against Biofinity® lenses when worn as daily wear for seven (7) days.

• Device: galyfilcon A prototype
  silicone hydrogel contact lens
• Device: comfilcon A
  silicone hydrogel contact lens
  Other Name: Biofinity® contact lens

• Active Comparator: galyfilcon A/comfilcon A
  galyfilcon A prototype contact lenses worn first and comfilcon A contact lenses worn second.
  Interventions:

  • Device: galyfilcon A prototype
  • Device: comfilcon A
• Active Comparator: comfilcon A/galyfilcon A
  comfilcon A contact lenses worn first and galyfilcon A prototype contact lenses worn second.
  Interventions:

  • Device: galyfilcon A prototype
  • Device: comfilcon A

Inclusion Criteria:

• The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study.
• The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
• Any cylinder power must be ≤ -0.75D.
• The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
• The subject must read and sign the Statement of Informed Consent.
• The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.

Exclusion Criteria:

• Ocular or systemic allergies or disease which might interfere with contact lens wear.
• Systemic disease or use of medication which might interfere with contact lens wear.
• Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
• Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
• Any ocular infection.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Pregnancy or lactation.
• Diabetes.
• Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
• Habitual contact lens type is toric, multifocal, or is worn as extended wear.