Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses

The purpose of this study is to evaluate corneal swelling, limbal redness, and endothelial bleb response to wearing galyfilcon A lenses in asian eyes.

Inclusion Criteria:

• Be of legal age (i.e. 18 years)

• Be of Asian descent and have -Asian eye‖ identifying features (see Appendix A)

• Be mentally competent, willing and able to sign a written informed consent form.

• Have contact lens distance sphere requirement in the range 1.00D to 6.00D.

• Have spectacle astigmatism <1.25D in each eye

• Currently wear soft contact lenses (for at least 3 months prior to the trial ) without experiencing difficulties or contact lens related complications

• Have had an oculo-visual examination within the previous 12 months.

• 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 evidence of lid abnormality or infection
  • No conjunctival abnormality or infection
  • No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
  • No other active ocular disease

Exclusion Criteria:

• Requires concurrent ocular medication.
• Clinically significant (Grade 3 or 4) corneal staining (FDA scale), corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
• Has had refractive surgery.
• Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrolment for this study.
• History of abnormal lachrymal secretions.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Keratoconus or other corneal irregularity.
• Extended lens wear in last 3 months.
• PMMA, hybrid or RGP lens wear in the previous 8 weeks
• Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
• Has diabetes
• Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
• History of chronic eye disease (e.g. glaucoma or ARMD).
• Pregnancy, lactating, or planning a pregnancy at the time of enrolment.
• Participation in any concurrent clinical trial or in last 30 days.
• Family member or employee of the clinical site, investigator or other study staff.
• Currently wears habitual contact lenses on an EW basis.