Performance Comparison Between Comfilcon A and Senofilcon C Lenses
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - 34 |
Updated: | 1/11/2018 |
Start Date: | September 2016 |
End Date: | November 23, 2016 |
The aim of this study is to determine the clinical performance of comfilcon A in comparison
to senofilcon C.
to senofilcon C.
This is a prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily
wear, two month dispensing study comparing the clinical performance of comfilcon A and
senofilcon C lenses after one month of wear.
wear, two month dispensing study comparing the clinical performance of comfilcon A and
senofilcon C lenses after one month of wear.
Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
- Is between 18 and 34 years of age (inclusive)
- Has had a self-reported eye exam in the last two years
- Is a spherical soft contact lens wearer
- Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)
- 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
- Has read, understood and signed the information consent letter.
- Has a contact lens prescription that fits within the available parameters of the study
lenses.
- Is willing and anticipated to be able to comply with the wear schedule (at least 6
days per week, 12 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 (defined as 6 days
per week; > 10 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
- 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.
- Is participating in any other type of eye related clinical or research study.
- Is habitually using rewetting/ lubricating eye drops more than once per day
- Is currently wearing daily disposable lenses
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