Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses

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

Conditions
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Myopia

Intervention / Treatment
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* Device: galyfilcon A
* Device: galyfilcon A plus
* Device: lotrafilcon A
* Device: polymacon
* Other: spectacles


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sequence 1<br>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: Lotrafilcon A Spectacles Galyfilcon A Plus Polymacon Galyfilcon A | Device: galyfilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: galyfilcon A plus<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: lotrafilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: polymacon<br>* contact lenses worn bilaterally for 8-12 hours<br>Other: spectacles<br>* habitual spectacles owned by subject, non-specific manufacturer<br>|
| Other: Sequence 2<br>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: Galyfilcon A Plus Galyfilcon A Lotrafilcon A Polymacon Spectacles | Device: galyfilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: galyfilcon A plus<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: lotrafilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: polymacon<br>* contact lenses worn bilaterally for 8-12 hours<br>Other: spectacles<br>* habitual spectacles owned by subject, non-specific manufacturer<br>|
| Other: Sequence 3<br>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: Galyfilcon A Polymacon Galyfilcon A Plus Spectacles Lotrafilcon A | Device: galyfilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: galyfilcon A plus<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: lotrafilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: polymacon<br>* contact lenses worn bilaterally for 8-12 hours<br>Other: spectacles<br>* habitual spectacles owned by subject, non-specific manufacturer<br>|
| Other: Sequence 4<br>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: Spectacles Lotrafilcon A Polymacon Galyfilcon A Plus Galyfilcon A | Device: galyfilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: galyfilcon A plus<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: lotrafilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: polymacon<br>* contact lenses worn bilaterally for 8-12 hours<br>Other: spectacles<br>* habitual spectacles owned by subject, non-specific manufacturer<br>|
| Other: Sequence 5<br>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: Polymacon Galyfilcon A Spectacles Galyfilcon A Plus Lotrafilcon A | Device: galyfilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: galyfilcon A plus<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: lotrafilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: polymacon<br>* contact lenses worn bilaterally for 8-12 hours<br>Other: spectacles<br>* habitual spectacles owned by subject, non-specific manufacturer<br>|
| Other: Sequence 6<br>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: Galyfilcon A Galyfilcon A Plus Polymacon Lotrafilcon A Spectacles | Device: galyfilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: galyfilcon A plus<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: lotrafilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: polymacon<br>* contact lenses worn bilaterally for 8-12 hours<br>Other: spectacles<br>* habitual spectacles owned by subject, non-specific manufacturer<br>|
| Other: Sequence 7<br>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: Polymacon Spectacles Galyfilcon A Lotrafilcon A Galyfilcon A Plus | Device: galyfilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: galyfilcon A plus<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: lotrafilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: polymacon<br>* contact lenses worn bilaterally for 8-12 hours<br>Other: spectacles<br>* habitual spectacles owned by subject, non-specific manufacturer<br>|
| Other: Sequence 8<br>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: Galyfilcon A Plus Lotrafilcon A Galyfilcon A Spectacles Polymacon | Device: galyfilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: galyfilcon A plus<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: lotrafilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: polymacon<br>* contact lenses worn bilaterally for 8-12 hours<br>Other: spectacles<br>* habitual spectacles owned by subject, non-specific manufacturer<br>|
| Other: Sequence 9<br>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: Lotrafilcon A Galyfilcon A Plus Spectacles Galyfilcon A Polymacon | Device: galyfilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: galyfilcon A plus<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: lotrafilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: polymacon<br>* contact lenses worn bilaterally for 8-12 hours<br>Other: spectacles<br>* habitual spectacles owned by subject, non-specific manufacturer<br>|
| Other: Sequence 10<br>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: Spectacles Polymacon Lotrafilcon A Galyfilcon A Galyfilcon A Plus | Device: galyfilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: galyfilcon A plus<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: lotrafilcon A<br>* contact lenses worn bilaterally for 8-12 hours<br>Device: polymacon<br>* contact lenses worn bilaterally for 8-12 hours<br>Other: spectacles<br>* habitual spectacles owned by subject, non-specific manufacturer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Swelling | measured in microns using the Optical Low Coherence Reflectometry (OLCR) Pachymeter. This pachymeter gives corneal thickness measurements to the accuracy of 1 micron (µm) | after 8 hours of lens wear | 
| Limbal Redness | grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade. | after 8 hours of lens wear | 
| Endothelia Blebs | 0 to 100% of area; measured as a percentage of corneal area with blebs. | after 20 minutes of lens wear |