Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens

Study Overview
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Brief Summary
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The purpose of this investigation is to compare the fit characteristics and vision attributes of an investigational Galyfilcon A contact lens and an approved Galyfilcon A contact lens.

Conditions
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Myopia

Intervention / Treatment
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* Device: Galyfilcon A Habitual Lens
* Device: Galyfilcon A 8.7 BC (Investigational)
* Device: Galyfilcon A 8.3 BC (Investigational)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be of legal age (i.e., at least 18 years old) Sign a written informed consent Have contact lens distance sphere requirement in the range -1.00D to -6.00D Have spectacle astigmatism <1.25D in each eye Currently wear ACUVUE® ADVANCE™ (for at least 6 months) with documentation of current prescription. Have normal eyes with no evidence of abnormality or disease. Exclusion Criteria: Required concurrent ocular medication Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear. Eye injury or surgery within eight weeks immediately prior to enrollment for this study. Abnormal lacrimal secretions Pre-existing ocular irritation that would preclude contact lens fitting. Keratoconus or other corneal irregularity. Pregnancy, lactating or planning a pregnancy at the time of enrolment. Participation in any concurrent clinical trial Known allergy to silver, silver ions, or silver containing compounds.

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3<br>Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental) | Device: Galyfilcon A Habitual Lens<br>* Comparison of three soft contact lens designs.<br>Device: Galyfilcon A 8.7 BC (Investigational)<br>* Comparison of three soft contact lens designs.<br>Device: Galyfilcon A 8.3 BC (Investigational)<br>* Comparison of three soft contact lens designs<br>|
| Other: Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL<br>Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) | Device: Galyfilcon A Habitual Lens<br>* Comparison of three soft contact lens designs.<br>Device: Galyfilcon A 8.7 BC (Investigational)<br>* Comparison of three soft contact lens designs.<br>Device: Galyfilcon A 8.3 BC (Investigational)<br>* Comparison of three soft contact lens designs<br>|
| Other: GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7<br>Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental) | Device: Galyfilcon A Habitual Lens<br>* Comparison of three soft contact lens designs.<br>Device: Galyfilcon A 8.7 BC (Investigational)<br>* Comparison of three soft contact lens designs.<br>Device: Galyfilcon A 8.3 BC (Investigational)<br>* Comparison of three soft contact lens designs<br>|
| Other: Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3<br>Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental) | Device: Galyfilcon A Habitual Lens<br>* Comparison of three soft contact lens designs.<br>Device: Galyfilcon A 8.7 BC (Investigational)<br>* Comparison of three soft contact lens designs.<br>Device: Galyfilcon A 8.3 BC (Investigational)<br>* Comparison of three soft contact lens designs<br>|
| Other: Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7<br>Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental) | Device: Galyfilcon A Habitual Lens<br>* Comparison of three soft contact lens designs.<br>Device: Galyfilcon A 8.7 BC (Investigational)<br>* Comparison of three soft contact lens designs.<br>Device: Galyfilcon A 8.3 BC (Investigational)<br>* Comparison of three soft contact lens designs<br>|
| Other: Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL<br>Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) | Device: Galyfilcon A Habitual Lens<br>* Comparison of three soft contact lens designs.<br>Device: Galyfilcon A 8.7 BC (Investigational)<br>* Comparison of three soft contact lens designs.<br>Device: Galyfilcon A 8.3 BC (Investigational)<br>* Comparison of three soft contact lens designs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Lens Fit Characteristics | At the screening visit, the following baseline measurements will be taken of the subject's habitual contact lenses (Control): Visual Acuity (logMar) Over-refraction with Visual Acuity Fit acceptability (acceptable/non-acceptable) | Approximately 40 minutes of wear time | 
| Evaluation of Inter-Changeability | In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed: Ease of handling of the lenses- by Investigator Comfort on insertion After 30-40 minutes of settling time the following variables will be collected: Subjective comfort after settling Visual Acuity (logMar) Corneal coverage (Y/N) Post-blink movement (mm) Version Lag (mm) Tightness on push-up (0-100 scale) Overall fit acceptance (0-5 scale) | Approximately 40 minutes of wear time | 
| Determination of fit or Vision Differences | In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed: Ease of handling of the lenses- by Investigator Comfort on insertion After 30-40 minutes of settling time the following variables will be collected: Subjective comfort after settling Visual Acuity (logMar) Corneal coverage (Y/N) Post-blink movement (mm) Version Lag (mm) Tightness on push-up (0-100 scale) Overall fit acceptance (0-5 scale) | Approximately 40 minutes of wear time |