Comfort Evaluation of Comfilcon A and Senofilcon A Lenses



Status:Recruiting
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:September 2012
Contact:Jan Bergmanson, OD, PhD
Email:jbergmanson@uh.edu
Phone:713-743-1950

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The purpose of this study is to investigate the overall comfort performance of the Comfilcon
A and Senofilcon A lenses during a single day of daily wear.


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
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