Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - 40 |
Updated: | 4/17/2018 |
Start Date: | October 1, 2016 |
End Date: | March 21, 2017 |
This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month
dispensing study
dispensing study
The aim of this study is to determine if adapted contact lens wearers enfilcon A toric lenses
can be confidently refit into fanfilcon A toric lenses and can be successful after one month
of daily wear.
can be confidently refit into fanfilcon A toric lenses and can be successful after one month
of daily wear.
Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
- Is between 18 and 40 years of age (inclusive)
- Has had a self-reported eye exam in the last two years
- Is a habitual soft toric lens wearer
- Can be successfully fit with study lenses (≥ grade 2 fit acceptance)
- Has a contact lens spherical prescription between -1.00 to -6.00D with a cylinder
between -0.75 and -1.75D (Diopters) (inclusive)
- Has a spectacle cylinder of at least 0.75D in each eye.
- Can achieve best corrected spectacle refraction 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
- Has read, understood and signed the information consent letter
- Has a contact lens refraction that fits within the available parameters of the study
lenses
- Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day
assuming there are no contraindications for doing so)
- Is willing to comply with the visit 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 (5 days per week; >
8 hours/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
- 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.
- Is participating in any other type of eye related clinical or research study.
- Is frequently using rewetting/ lubricating eye drops (more than once per day)
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