Clinical Comparison of Two Silicone-Hydrogel Contact Lenses

Study Overview
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Brief Summary
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The objective of this study is to evaluate the clinical performance of two silicone-hydrogel contact lenses.

Conditions
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Refractive Error

Intervention / Treatment
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* Device: galyfilcon A
* Device: comfilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must be at least 18 and less than or equal to 39 years of age and have a need for vision correction in both eyes. The subject must require a lens power between -1.00 to -6.00D and have no more than 1.00D of corneal cylinder. The subject, based on his/her knowledge, must be in good general health. The subject must be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluations. Subject must be a current adapted daily wearer of soft contact lenses with at least 6 months of CL wear. Subject must agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study. Subject must be willing and able to use only the care systems and lubricating drops provided for the study during the 4 week period. The subject must read, indicate understanding of and sign the Informed Consent Form. Exclusion Criteria: The subject is a rigid gas permeable (RGP) or daily disposable lens wearer. The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids or associated structures. The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjogren's syndrome, type II diabetes, etc.) Slit lamp findings that would contraindicate contact lens wear such as: pathological dry eye or associated findings pterygium or corneal scars within the visual axis neovascularization equal to or greater than 1mm in from the limbus history of giant papillary conjunctivitis (GPC) worse than grade 2 anterior uveitis or iritis (past or present) seborrhoeic eczema seborrhoeic conjunctivitis A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections. A known history of corneal hypoesthesia (reduced corneal sensitivity). Contact lens snellen visual acuities (VA) worse than 20/30. Aphakia, keratoconus or a highly irregular cornea. Current pregnancy or lactation (to the best of the subject's knowledge) Any active participation in another clinical study at any time during this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: galyfilcon A/comfilcon A<br>galyfilcon A first, comfilcon A second | Device: galyfilcon A<br>* galyfilcon A<br>Device: comfilcon A<br>* comfilcon A<br>|
| Active Comparator: comfilcon A/galyfilcon A<br>comfilcon A first, galyfilcon A second | Device: galyfilcon A<br>* galyfilcon A<br>Device: comfilcon A<br>* comfilcon A<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Comfort | >0 = comfortable, <0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. | 1-week, 2- weeks | 
| Comfort Symptoms | A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. >0 = comfortable, <0 = uncomfortable | 1-week, 2-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Corneal Staining | Measured for 5 zones of the cornea (superior, nasal, central, inferior, temporal)on a 0 to 3 grade scale (NEI 0-3 scale). Grade 0 = Normal/ grade 1 = mild, superficial stippling/ grade 2 = moderate, punctate staining including superficial abrasion of the cornea/ grade 3 = severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion. | 2 weeks |