Vistakon Investigational Contact Lenses Worn for Daily Wear

Study Overview
=================
Brief Summary
-----------------
This study compares the performance of an investigational contact lens to a currently marketed lens.

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: galyifilcon A control lens
* Device: galyfilcon A with a silver additive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject must be at least 18 years of age. Both males and females may be enrolled. The subject must read, understand, and sign for themselves the STATEMENT OF INFORMED CONSENT and be provided with a copy of the form. The subject is able and willing to wear soft contact lenses on a daily basis for a six month duration. Exclusion Criteria: The subject must be free of Grade 2 or greater slit lamp findings (edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, and other ocular abnormality), which would contraindicate contact lens wear. Any active ocular (i.e. corneal infiltrates, conjunctiva, lids, and intraocular) infection or inflammation of an allergic, bacterial, or viral etiology. Entropion, ectropion, chalazia, recurrent styes, glaucoma or glaucoma suspect, history of recurrent corneal erosions and aphakia. The following medications are prohibited (at lease one week prior to enrollment): oral retinoid isoretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g. antihistamines (e.g. Seldane, Chlor-Trimeton, and Benadryl), and ophthalmic antihistamic Beta-adrenergic blockers (e.g. Propranolol, Timolol, and Practolol), systemic steroids, and and prescribed or OTC ocular medication. Any prescription or PTC medications or preparations containing silver. Moderate or above corneal distortion by keratometry. Known allergy to silver, silver ions, or silver containing compounds. Abnormal discoloration of the cornea and/or conjunctiva. Routine exposure to silver, silver ions, or silver containing compounds. The subject must be free of systemic diseases which may interfere with contact lens wear: diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases (e.g. AIDS) Free of systemic and infectious diseases: hepatitis and tuberculosis. Subjects must be HIV negative. The subject must not be currently be pregnant or lactating (Subject becoming pregnant during the study will be discontinued). The subject's eyes must be best corrected to a visual acuity of 20/30 or better in each eye. The subject must not have more than 1.00D of refractive astigmatism in either eye. The subject's distance spherical contact lens prescription must be between -1.00D and -6.00D. The subject must not be monovision corrected. The subject must have no history of solution reaction to Opti-free RepleniSH MPDS-No Rub Solution. The subject must not have any previous history or signs of a contact lens related corneal inflammatory event (i.e. past peripheral ulcers or round peripheral scars) The subject must not have participated in a device or pharmaceutical clinical trial within 30 days prior to study enrollment. The subject must not have had an eye injury within 8 weeks prior to study enrollment. The subject must not have had previous eye surgery. The subject must be successfully trial fitted with the study contact lenses.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Lens<br>galyfilcon A contact lens with a silver additive | Device: galyfilcon A with a silver additive<br>* Investigational daily wear contact lens<br>|
| Active Comparator: Control Lens<br>galyfilcon A control contact lens | Device: galyifilcon A control lens<br>* Marketed daily wear contact lens<br>* Other names: ACUVUE Advance with Hydraclear;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit Lamp Findings | Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded using a 5- point scale. (Grade 0, 1, 2, 3 and 4). The data was dichotomized by creating 2 groups. Eyes with Grade 3 or Grade 4; eyes with Grade 2 or lower. The number of eyes with Grade 3 or Grade 4 was reported. | 6 months | 
| Subject Reported Symptoms | Subjects were asked Have you experienced any symptoms or problems since your last visit? at each visit and responded 'yes' or 'no' for each eye; at each visit(baseline, 2-, 4-, 12- and 26- week follow-up evaluations). If a subject responded 'yes' then the symptoms was classified into one of the four categories, Dryness, Other, Cloudy/ Blurry / Hazy, Irritation / Discomfort. The percentage of each response across all visits was reported. | 6 months | 
| Visual Acuity | Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts. | 6 months | 
| Average Contact Lens Wear Time | The Contact lens wear time for the study contact lenses was collected for each subject. The average wear time for each contact lens was reported. | 6 Months |