Evaluation of Comfilcon A and Senofilcon A Lenses

Study Overview
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Brief Summary
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Evaluation of Comfilcon A and Senofilcon A Lenses

Detailed Description
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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.

Official Title
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Clinical Comfort Evaluation of Biofinity and Acuvue Oasys Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: Senofilcon A; Comfilcon A
* Device: Comfilcon A; Senofilcon A


Participation Criteria
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Eligibility Criteria
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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

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Senofilcon A<br>Senofilcon A; Comfilcon A | Device: Senofilcon A; Comfilcon A<br>* Senofilcon A; Comfilcon A<br>Device: Comfilcon A; Senofilcon A<br>* Comfilcon A; Senofilcon A<br>|
| Experimental: Comfilcon A<br>Comfilcon A; Senofilcon A | Device: Senofilcon A; Comfilcon A<br>* Senofilcon A; Comfilcon A<br>Device: Comfilcon A; Senofilcon A<br>* Comfilcon A; Senofilcon A<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Responses for Comfort Rated on a 0-100 Visual Scale. | 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) | Baseline Insertion, 10 Minutes, 5 hours and 10 hours |