Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - 40 |
Updated: | 4/17/2018 |
Start Date: | October 27, 2016 |
End Date: | December 14, 2016 |
Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1
month dispensing study (2 weeks each lens pair)
month dispensing study (2 weeks each lens pair)
The aim of this study is to determine the clinical performance of fanfilcon A in comparison
to senofilcon A sphere contact lenses.
to senofilcon A sphere contact lenses.
Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
- Is between 18 and 40 years of age (inclusive)
- Has read, understood and signed the information consent letter
- Has had a self-reported eye exam in the last two years
- Is a spherical soft contact lens wearer
- Has a contact lens prescription that fits within the available parameters of the study
lenses
- Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye
- Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or
better in each eye
- Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with
the study contact lenses
- Has clear corneas and no active ocular disease
- Is willing and anticipated to be able to comply with the wear schedule (8 hours per
day; 5 days a week of lens wear)
- Is willing and able to follow instructions and maintain the appointment schedule
Exclusion Criteria:
A person will be excluded from the study if he/she:
- Has a history of not achieving comfortable CL (Contact Lens) wear (defined as 5 days
per week; >8 hours/day)
- Is currently wearing senofilcon C (2 weeks lens), senofilcon A 1-Day, senofilcon C
(monthly lens) or enfilcon A contact lenses
- Is habitually using rewetting/ lubricating eye drops more than once per day
- Presents with clinically significant anterior segment abnormalities
- Presents with ocular or systemic disease or need of medications which might interfere
with contact lens wear
- Presents with slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Significant pterygium, pinguecula, or corneal scars within the visual axis
- Neovascularization > 0.75 mm in from of the limbus
- Giant papillary conjunctivitis (GCP) worse than grade 1
- Anterior uveitis or iritis (or history in past year)
- Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
- Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- Has aphakia, keratoconus or a highly irregular cornea
- Has presbyopia or has dependence on spectacles for near work over the contact lenses
- Has undergone corneal refractive surgery
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