Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses

• Corneal Swelling [ Time Frame: after 8 hours of lens wear ] [ Designated as safety issue: Yes ]
  measured in microns with pachymetry equipment, reported as percentage of swelling from approximately -10% to +10%
• Limbal Redness [ Time Frame: after 8 hours of lens wear ] [ Designated as safety issue: No ]
  grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade.
• Endothelia Blebs [ Time Frame: after 20 minutes of lens wear ] [ Designated as safety issue: No ]
  0 to 100% of area; measured as a percentage of corneal area with blebs.

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

• Device: galyfilcon A
  contact lenses worn bilaterally for 8-12 hours
• Device: galyfilcon A plus
  contact lenses worn bilaterally for 8-12 hours
• Device: lotrafilcon A
  contact lenses worn bilaterally for 8-12 hours
• Device: polymacon
  contact lenses worn bilaterally for 8-12 hours
• Other: spectacles
  habitual spectacles owned by subject, non-specific manufacturer

• Sequence 1

  Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

  1. Lotrafilcon A
  2. Spectacles
  3. Galyfilcon A Plus
  4. Polymacon
  5. Galyfilcon A
  Interventions:

  • Device: galyfilcon A
  • Device: galyfilcon A plus
  • Device: lotrafilcon A
  • Device: polymacon
  • Other: spectacles
• Sequence 2

  Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

  1. Galyfilcon A Plus
  2. Galyfilcon A
  3. Lotrafilcon A
  4. Polymacon
  5. Spectacles
  Interventions:

  • Device: galyfilcon A
  • Device: galyfilcon A plus
  • Device: lotrafilcon A
  • Device: polymacon
  • Other: spectacles
• Sequence 3

  Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

  1. Galyfilcon A
  2. Polymacon
  3. Galyfilcon A Plus
  4. Spectacles
  5. Lotrafilcon A
  Interventions:

  • Device: galyfilcon A
  • Device: galyfilcon A plus
  • Device: lotrafilcon A
  • Device: polymacon
  • Other: spectacles
• Sequence 4

  Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

  1. Spectacles
  2. Lotrafilcon A
  3. Polymacon
  4. Galyfilcon A Plus
  5. Galyfilcon A
  Interventions:

  • Device: galyfilcon A
  • Device: galyfilcon A plus
  • Device: lotrafilcon A
  • Device: polymacon
  • Other: spectacles
• Sequence 5

  Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

  1. Polymacon
  2. Galyfilcon A
  3. Spectacles
  4. Galyfilcon A Plus
  5. Lotrafilcon A
  Interventions:

  • Device: galyfilcon A
  • Device: galyfilcon A plus
  • Device: lotrafilcon A
  • Device: polymacon
  • Other: spectacles
• Sequence 6

  Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

  1. Galyfilcon A
  2. Galyfilcon A Plus
  3. Polymacon
  4. Lotrafilcon A
  5. Spectacles
  Interventions:

  • Device: galyfilcon A
  • Device: galyfilcon A plus
  • Device: lotrafilcon A
  • Device: polymacon
  • Other: spectacles
• Sequence 7

  Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

  1. Polymacon
  2. Spectacles
  3. Galyfilcon A
  4. Lotrafilcon A
  5. Galyfilcon A Plus
  Interventions:

  • Device: galyfilcon A
  • Device: galyfilcon A plus
  • Device: lotrafilcon A
  • Device: polymacon
  • Other: spectacles
• Sequence 8

  Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

  1. Galyfilcon A Plus
  2. Lotrafilcon A
  3. Galyfilcon A
  4. Spectacles
  5. Polymacon
  Interventions:

  • Device: galyfilcon A
  • Device: galyfilcon A plus
  • Device: lotrafilcon A
  • Device: polymacon
  • Other: spectacles
• Sequence 9

  Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

  1. Lotrafilcon A
  2. Galyfilcon A Plus
  3. Spectacles
  4. Galyfilcon A
  5. Polymacon
  Interventions:

  • Device: galyfilcon A
  • Device: galyfilcon A plus
  • Device: lotrafilcon A
  • Device: polymacon
  • Other: spectacles
• Sequence 10

  Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:

  1. Spectacles
  2. Polymacon
  3. Lotrafilcon A
  4. Galyfilcon A
  5. Galyfilcon A Plus
  Interventions:

  • Device: galyfilcon A
  • Device: galyfilcon A plus
  • Device: lotrafilcon A
  • Device: polymacon
  • Other: spectacles

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.