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 |
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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