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

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Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1
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.

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
We found this trial at
4
sites
5075 Ruffin Road
San Diego, California 92123
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San Diego, CA
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Pittsburg, Kansas 66762
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Pittsburg, KS
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Sarasota, Florida 34242
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Sarasota, FL
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428 Windmere Drive
State College, Pennsylvania 16801
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State College, PA
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