Evaluation of Comfilcon A and Senofilcon A Lenses

Not Applicable

Completed

Interventions: Device: Senofilcon A; Comfilcon A
Device: Comfilcon A; Senofilcon A

Detailed Description: Non-dispensing, single-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.

Recruitment & Eligibility

Inclusion Criteria

Subjects must satisfy the following conditions prior to inclusion in the study:

Has had an oculo-visual examination in the last two years
Is at least 18 years of age and has full legal capacity to volunteer
Has read and understood the information consent letter
Is willing and able to follow instructions and maintain the appointment schedule
Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
Currently wears soft contact lenses at least 3 days a week, 8 hours a day
Has clear corneas and no active ocular disease
Has not worn lenses for at least 12 hours before the examination
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 amblyopia
- No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes)
- No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).
- No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)
- No aphakia
- Has prescription to match the available power range.

Exclusion Criteria

Any of the following will render a subject ineligible for inclusion:

Greater than 0.75 of refractive astigmatism in either eye
Has never worn contact lenses before
Wears contact lenses on an extended wear basis
Has any systemic disease affecting ocular health
Is a known sufferer of ocular allergies
Is taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities
Is aphakic
Has undergone corneal refractive surgery.
Is wearing monovision
Is participating in any other type of clinical or research study
Female who is currently pregnant or is breast-feeding
Has > grade 1 ocular corneal staining in both type and extent by > grade 2 in either type or extent

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Subjective Responses for Comfort Rated on a 0-100 Visual Scale.	Baseline Insertion, 10 Minutes, 5 hours and 10 hours	Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)

Secondary Outcome Measures